عن الملكية الفكرية التدريب في مجال الملكية الفكرية إذكاء الاحترام للملكية الفكرية التوعية بالملكية الفكرية الملكية الفكرية لفائدة… الملكية الفكرية و… الملكية الفكرية في… معلومات البراءات والتكنولوجيا معلومات العلامات التجارية معلومات التصاميم الصناعية معلومات المؤشرات الجغرافية معلومات الأصناف النباتية (الأوبوف) القوانين والمعاهدات والأحكام القضائية المتعلقة بالملكية الفكرية مراجع الملكية الفكرية تقارير الملكية الفكرية حماية البراءات حماية العلامات التجارية حماية التصاميم الصناعية حماية المؤشرات الجغرافية حماية الأصناف النباتية (الأوبوف) تسوية المنازعات المتعلقة بالملكية الفكرية حلول الأعمال التجارية لمكاتب الملكية الفكرية دفع ثمن خدمات الملكية الفكرية هيئات صنع القرار والتفاوض التعاون التنموي دعم الابتكار الشراكات بين القطاعين العام والخاص أدوات وخدمات الذكاء الاصطناعي المنظمة العمل مع الويبو المساءلة البراءات العلامات التجارية التصاميم الصناعية المؤشرات الجغرافية حق المؤلف الأسرار التجارية أكاديمية الويبو الندوات وحلقات العمل إنفاذ الملكية الفكرية WIPO ALERT إذكاء الوعي اليوم العالمي للملكية الفكرية مجلة الويبو دراسات حالة وقصص ناجحة في مجال الملكية الفكرية أخبار الملكية الفكرية جوائز الويبو الأعمال الجامعات الشعوب الأصلية الأجهزة القضائية الموارد الوراثية والمعارف التقليدية وأشكال التعبير الثقافي التقليدي الاقتصاد التمويل الأصول غير الملموسة المساواة بين الجنسين الصحة العالمية تغير المناخ سياسة المنافسة أهداف التنمية المستدامة التكنولوجيات الحدودية التطبيقات المحمولة الرياضة السياحة ركن البراءات تحليلات البراءات التصنيف الدولي للبراءات أَردي – البحث لأغراض الابتكار أَردي – البحث لأغراض الابتكار قاعدة البيانات العالمية للعلامات مرصد مدريد قاعدة بيانات المادة 6(ثالثاً) تصنيف نيس تصنيف فيينا قاعدة البيانات العالمية للتصاميم نشرة التصاميم الدولية قاعدة بيانات Hague Express تصنيف لوكارنو قاعدة بيانات Lisbon Express قاعدة البيانات العالمية للعلامات الخاصة بالمؤشرات الجغرافية قاعدة بيانات الأصناف النباتية (PLUTO) قاعدة بيانات الأجناس والأنواع (GENIE) المعاهدات التي تديرها الويبو ويبو لكس - القوانين والمعاهدات والأحكام القضائية المتعلقة بالملكية الفكرية معايير الويبو إحصاءات الملكية الفكرية ويبو بورل (المصطلحات) منشورات الويبو البيانات القطرية الخاصة بالملكية الفكرية مركز الويبو للمعارف الاتجاهات التكنولوجية للويبو مؤشر الابتكار العالمي التقرير العالمي للملكية الفكرية معاهدة التعاون بشأن البراءات – نظام البراءات الدولي ePCT بودابست – نظام الإيداع الدولي للكائنات الدقيقة مدريد – النظام الدولي للعلامات التجارية eMadrid الحماية بموجب المادة 6(ثالثاً) (الشعارات الشرفية، الأعلام، شعارات الدول) لاهاي – النظام الدولي للتصاميم eHague لشبونة – النظام الدولي لتسميات المنشأ والمؤشرات الجغرافية eLisbon UPOV PRISMA UPOV e-PVP Administration UPOV e-PVP DUS Exchange الوساطة التحكيم قرارات الخبراء المنازعات المتعلقة بأسماء الحقول نظام النفاذ المركزي إلى نتائج البحث والفحص (CASE) خدمة النفاذ الرقمي (DAS) WIPO Pay الحساب الجاري لدى الويبو جمعيات الويبو اللجان الدائمة الجدول الزمني للاجتماعات WIPO Webcast وثائق الويبو الرسمية أجندة التنمية المساعدة التقنية مؤسسات التدريب في مجال الملكية الفكرية الدعم المتعلق بكوفيد-19 الاستراتيجيات الوطنية للملكية الفكرية المساعدة في مجالي السياسة والتشريع محور التعاون مراكز دعم التكنولوجيا والابتكار نقل التكنولوجيا برنامج مساعدة المخترعين WIPO GREEN WIPO's PAT-INFORMED اتحاد الكتب الميسّرة اتحاد الويبو للمبدعين WIPO Translate أداة تحويل الكلام إلى نص مساعد التصنيف الدول الأعضاء المراقبون المدير العام الأنشطة بحسب كل وحدة المكاتب الخارجية المناصب الشاغرة المشتريات النتائج والميزانية التقارير المالية الرقابة
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القوانين المعاهدات الأحكام التصفح بحسب الاختصاص القضائي

Regulation (EC) No. 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed، الاتحاد الأوروبي

عودة للخلف
النص مستبدل  الذهاب إلى أحدث إصدار في ويبو لِكس
التفاصيل التفاصيل سنة الإصدار 2003 تواريخ الاعتماد : 22 سبتمبر 2003 نوع النص نصوص أخرى الموضوع الملكية الصناعية، مواضيع أخرى

المواد المتاحة

النصوص الرئيسية النصوص ذات الصلة
النصوص الرئيسية النصوص الرئيسية بالفرنسية Règlement (CE) n° 1829/2003 du Parlement européen et du Conseil du 22 septembre 2003 concernant les denrées alimentaires et les aliments pour animaux génétiquement modifiés         بالإنكليزية Regulation (EC) No. 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed         بالإسبانية Reglamento (CE) N° 1829/2003 del Parlamento Europeo y del Consejo, de 22 de septiembre de 2003, sobre alimentos y piensos modificados genéticamente        
 Regulation (EC) No. 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed

18.10.2003 EN Official Journal of the European Union L 268/1

I

(Acts whose publication is obligatory)

REGULATION (EC) No 1829/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2003

on genetically modified food and feed

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Com- munity, and in particular Articles 37, 95 and Article 152(4)(b) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Economic and Social Committee (2),

Having regard to the opinion of the Committee of the Regions (3),

Acting in accordance with the procedure referred to in Article 251 of the Treaty (4),

Whereas:

(1) The free movement of safe and wholesome food and feed is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.

(2) A high level of protection of human life and health should be ensured in the pursuit of Community policies.

(3) In order to protect human and animal health, food and feed consisting of, containing or produced from geneti- cally modified organisms (hereinafter referred to as genetically modified food and feed) should undergo a safety assessment through a Community procedure before being placed on the market within the Commu- nity.

(1) OJ C 304 E, 30.10.2001, p. 221. (2) OJ C 221, 17.9.2002, p. 114. (3) OJ C 278, 14.11.2002, p. 31. (4) Opinion of the European Parliament of 3 July 2002 (not yet

published in the Official Journal), Council Common Position of 17 March 2003 (OJ C 113 E, 13.5.2003, p. 31), Decision of the European Parliament of 2 July 2003 (not yet published in the Offi- cial Journal) and Council Decision of 22 July 2003.

(4) Differences between national laws, regulations and administrative provisions concerning the assessment and authorisation of genetically modified food and feed may hinder their free movement, creating conditions of unequal and unfair competition.

(5) An authorisation procedure involving Member States and the Commission has been established for genetically modified foods in Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredi- ents (5). This procedure should be streamlined and made more transparent.

(6) Regulation (EC) No 258/97 also provides for a notifica- tion procedure for novel foods which are substantially equivalent to existing foods. Whilst substantial equiva- lence is a key step in the procedure for assessment of the safety of genetically modified foods, it is not a safety assessment in itself. In order to ensure clarity, transpar- ency and a harmonised framework for authorisation of genetically modified food, this notification procedure should be abandoned in respect of genetically modified foods.

(7) Feed consisting of or containing genetically modified organisms (GMOs) has so far been authorised, subject to the authorisation procedure provided by Council Direc- tive 90/220/EEC of 23 April 1990 (6) and Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (7); no authorisation procedure exists for feed produced from GMOs; a single, efficient and transparent Commu- nity authorisation procedure for feed consisting of, containing or produced from GMOs should be estab- lished.

(8) The provisions of this Regulation should also apply to feed intended for animals which are not destined for food production.

(5) OJ L 43, 14.2.1997, p. 1. (6) OJ L 117, 8.5.1990, p. 15. Directive repealed by Directive 2001/

18/EC. (7) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Council

Decision 2002/811/EC (OJ L 280, 18.10.2002, p. 27).

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(9) The new authorisation procedures for genetically modi- fied food and feed should include the new principles introduced in Directive 2001/18/EC. They should also make use of the new framework for risk assessment in matters of food safety set up by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down proce- dures in matters of food safety (1). Thus, genetically modified food and feed should only be authorised for placing on the Community market after a scientific evaluation of the highest possible standard, to be under- taken under the responsibility of the European Food Safety Authority (Authority), of any risks which they present for human and animal health and, as the case may be, for the environment. This scientific evaluation should be followed by a risk management decision by the Community, under a regulatory procedure ensuring close cooperation between the Commission and the Member States.

(10) Experience has shown that authorisation should not be granted for a single use, when a product is likely to be used both for food and feed purposes; therefore such products should only be authorised when fulfilling authorisation criteria for both food and feed.

(11) Under this Regulation, authorisation may be granted either to a GMO to be used as a source material for production of food or feed and products for food and/or feed use which contain, consist of or are produced from it, or to foods or feed produced from a GMO. Thus, where a GMO used in the production of food and/or feed has been authorised under this Regulation, foods and/or feed containing, consisting of or produced from that GMO will not need an authorisation under this Regulation, but will be subject to the requirements referred to in the authorisation granted in respect of the GMO. Furthermore, foods covered by an authorisation granted under this Regulation will be exempted from the requirements of Regulation (EC) No 258/97 concerning novel foods and novel food ingredients, except where they fall under one or more of the categories referred to in Article 1(2)(a) of Regulation (EC) No 258/97 in respect of a characteristic which has not been considered for the purpose of the authorisation granted under this Regulation.

(12) Council Directive 89/107/EEC of 21 December 1988 on the approximation of laws of the Member States concerning food additives authorised for use in food- stuffs intended for human consumption (2) provides for authorisation of additives used in foodstuffs. In addition

(1) OJ L 31, 1.2.2002, p. 1. (2) OJ L 40, 11.2.1989, p. 27. Directive as amended by Directive 94/

34/EC of the European Parliament and of the Council (OJ L 237, 10.9.1994, p. 1).

to this authorisation procedure, food additives containing, consisting of or produced from GMOs should fall also within the scope of this Regulation for the safety assessment of the genetic modification, while the final authorisation should be granted under the procedure referred to in Directive 89/107/EEC.

(13) Flavourings falling within the scope of Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production (3) which contain, consist of or are produced from GMOs should also fall within the scope of this Regulation for the safety assessment of the genetic modi- fication.

(14) Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (4) provides for an approval procedure for feed materials produced using different technologies that may pose risk to human or animal health and the environment. These feed materials containing, consisting of or produced from GMOs should fall instead within the scope of this Regulation.

(15) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (5), provides for an authorisation procedure for placing on the market addi- tives used in feedingstuffs. In addition to this authorisa- tion procedure, feed additives containing, consisting of or produced from GMOs should also fall within the scope of this Regulation.

(16) This Regulation should cover food and feed produced ‘from’ a GMO but not food and feed ‘with’ a GMO. The determining criterion is whether or not material derived from the genetically modified source material is present in the food or in the feed. Processing aids which are only used during the food or feed production process are not covered by the definition of food or feed and, therefore,

(3) OJ L 184, 15.7.1988, p. 61. Directive as amended by Commission Directive 91/71/EEC (OJ L 42, 15.2.1991, p. 25).

(4) OJ L 213, 21.7.1982, p. 8. Directive as last amended by Directive 1999/20/EC (OJ L 80, 25.3.1999, p. 20).

(5) OJ L 270, 14.12.1970, p. 1. Directive as last amended by Regula- tion (EC) No 1756/2002 (OJ L 265, 3.10.2002, p. 1).

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are not included in the scope of this Regulation. Nor are food and feed which are manufactured with the help of a genetically modified processing aid included in the scope of this Regulation. Thus, products obtained from animals fed with genetically modified feed or treated with genetically modified medicinal products will be subject neither to the authorisation requirements nor to the labelling requirements referred to in this Regulation.

(17) In accordance with Article 153 of the Treaty, the Community is to contribute to promoting the right of consumers to information. In addition to other types of information to the public provided for in this Regula- tion, the labelling of products enables the consumer to make an informed choice and facilitates fairness of trans- actions between seller and purchaser.

(18) Article 2 of Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of food- stuffs (1) provides that labelling must not mislead the purchaser as to the characteristics of the foodstuff and among other things, in particular, as to its nature, iden- tity, properties, composition, method of production and manufacturing.

(19) Additional requirements for the labelling of genetically modified foods are laid down in Regulation (EC) No 258/97, in Council Regulation (EC) No 1139/98 of 26 May 1998 concerning the compulsory indication, on the labelling of certain foodstuffs produced from genetically modified organisms, of particulars other than those provided for in Directive 79/112/EEC (2) and in Commis- sion Regulation (EC) No 50/2000 of 10 January 2000 on the labelling of foodstuffs and food ingredients containing additives and flavourings that have been genetically modified or have been produced from geneti- cally modified organisms (3).

(20) Harmonised labelling requirements should be laid down for genetically modified feed to provide final users, in particular livestock farmers, with accurate information on the composition and properties of feed, thereby enabling the user to make an informed choice.

(21) The labelling should include objective information to the effect that a food or feed consists of, contains or is produced from GMOs. Clear labelling, irrespective of the detectability of DNA or protein resulting from the genetic modification in the final product, meets the demands expressed in numerous surveys by a large majority of consumers, facilitates informed choice and precludes potential misleading of consumers as regards methods of manufacture or production.

(1) OJ L 109, 6.5.2000, p. 29. Directive as amended by Commission Directive 2001/101/EC (OJ L 310, 28.11.2001, p. 19).

(2) OJ L 159, 3.6.1998, p. 4. Regulation as amended by Commission Regulation (EC) No 49/2000 (OJ L 6, 11.1.2000, p. 13).

(3) OJ L 6, 11.1.2000, p. 15.

(22) In addition, the labelling should give information about any characteristic or property which renders a food or feed different from its conventional counterpart with respect to composition, nutritional value or nutritional effects, intended use of the food or feed and health implications for certain sections of the population, as well as any characteristic or property which gives rise to ethical or religious concerns.

(23) Regulation (EC) No 1830/2003 of the European Parlia- ment and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (4) ensures that rele- vant information concerning any genetic modification is available at each stage of the placing on the market of GMOs and food and feed produced therefrom and should thereby facilitate accurate labelling.

(24) Despite the fact that some operators avoid using geneti- cally modified food and feed, such material may be present in minute traces in conventional food and feed as a result of adventitious or technically unavoidable presence during seed production, cultivation, harvest, transport or processing. In such cases, this food or feed should not be subject to the labelling requirements of this Regulation. In order to achieve this objective, a threshold should be established for the adventitious or technically unavoidable presence of genetically modified material in foods or feed, both when the marketing of such material is authorised in the Community and when this presence is tolerated by virtue of this Regulation.

(25) It is appropriate to provide that, when the combined level of adventitious or technically unavoidable presence of genetically modified materials in a food or feed or in one of its components is higher than the set threshold, such presence should be indicated in accordance with this Regulation and that detailed provisions should be adopted for its implementation. The possibility of estab- lishing lower thresholds, in particular for foods and feed containing or consisting of GMOs or in order to take into account advances in science and technology, should be provided for.

(26) It is indispensable that operators strive to avoid any acci- dental presence of genetically modified material not authorised under Community legislation in food or feed. However, in order to ensure the practicability and feasi- bility of this Regulation, a specific threshold, with the possibility of establishing lower levels in particular for

(4) See page 24 of this Official Journal.

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GMOs sold directly to the final consumer, should be established as a transitional measure for minute traces in food or feed of this genetically modified material, where the presence of such material is adventitious or techni- cally unavoidable and provided that all specific condi- tions set in this Regulation are met. Directive 2001/18/ EC should be amended accordingly. The application of this measure should be reviewed in the context of the general review of the implementation of this Regulation.

(27) In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to demonstrate to the competent autho- rities that they have taken appropriate steps to avoid the presence of the genetically modified food or feed.

(28) Operators should avoid the unintended presence of GMOs in other products. The Commission should gather information and develop on this basis guidelines on the coexistence of genetically modified, conventional and organic crops. Moreover, the Commission is invited to bring forward, as soon as possible, any further necessary proposal.

(29) The traceability and labelling of GMOs at all stages of placing on the market, including the possibility of estab- lishing thresholds, is ensured by Directive 2001/18/EC and Regulation (EC) No 1830/2003.

(30) It is necessary to establish harmonised procedures for risk assessment and authorisation that are efficient, time- limited and transparent, and criteria for evaluation of the potential risks arising from genetically modified foods and feed.

(31) In order to ensure a harmonised scientific assessment of genetically modified foods and feed, such assessments should be carried out by the Authority. However, as specific acts or omissions on the part of the Authority under this Regulation could produce direct legal effects on applicants, it is appropriate to provide for the possi- bility of an administrative review of such acts or omis- sions.

(32) It is recognised that, in some cases, scientific risk assess- ment alone cannot provide all the information on which a risk management decision should be based, and that other legitimate factors relevant to the matter under consideration may be taken into account.

(33) Where the application concerns products containing or consisting of a genetically modified organism, the appli- cant should have the choice of either supplying an authorisation for the deliberate release into the environ- ment already obtained under part C of Directive 2001/ 18/EC, without prejudice to the conditions set by that authorisation, or of applying for the environmental risk assessment to be carried out at the same time as the safety assessment under this Regulation. In the latter case, it is necessary for the evaluation of the environ- mental risk to comply with the requirements referred to in Directive 2001/18/EC and for the national competent authorities designated by Member States for this purpose to be consulted by the Authority. In addition, it is appro- priate to give the Authority the possibility of asking one of these competent authorities to carry out the environ- mental risk assessment. It is also appropriate, in accor- dance with Article 12(4) of Directive 2001/18/EC, for the national competent authorities designated under the said Directive in all cases concerning GMOs and food and/or feed containing or consisting of a GMO to be consulted by the Authority before it finalises the envir- onmental risk assessment.

(34) In the case of GMOs to be used as seeds or other plant- propagating materials falling within the scope of this Regulation, the Authority should be under an obligation to delegate the environmental risk assessment to a national competent authority. Nonetheless, authorisa- tions under this Regulation should be without prejudice to the provisions of Directives 68/193/EEC (1), 2002/53/ EC (2) and 2002/55/EC (3), which provide in particular for the rules and the criteria for the acceptance of vari- eties and their official acceptance for inclusion in common catalogues; nor should they affect the provi- sions of Directives 66/401/EEC (4), 66/402/EEC (5), 68/ 193/EEC, 92/33/EEC (6), 92/34/EEC (7), 2002/54/EC (8), 2002/55/EC, 2002/56/EC (9) or 2002/57/EC (10) which regulate in particular the certification and the marketing of seeds and other plant-propagating materials.

(1) OJ L 93, 17.4.1968, p. 15. Directive as last amended by Directive 2002/11/EC (OJ L 53, 23.2.2002, p. 20).

(2) OJ L 193, 20.7.2002, p. 1. (3) OJ L 193, 20.7.2002, p. 33. (4) OJ 125, 11.7.1966, p. 2298/66. Directive as last amended by Direc-

tive 2001/64/EC (OJ L 234, 1.9.2001, p. 60). (5) OJ 125, 11.7.1966, p. 2309/66. Directive as last amended by Direc-

tive 2001/64/EC. (6) OJ L 157, 10.6.1992, p. 1. Directive as last amended by Regulation

(EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1). (7) OJ L 157, 10.6.1992, p. 10. Directive as last amended by Regula-

tion (EC) No 806/2003. (8) OJ L 193, 20.7.2002, p. 12. (9) OJ L 193, 20.7.2002, p. 60. Directive amended by Commission

Decision 2003/66/EC (OJ L 25, 30.1.2003, p. 42). (10) OJ L 193, 20.7.2002, p. 74. Directive amended by Commission

Directive 2003/45/EC (OJ L 138, 5.6.2003, p. 40).

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(35) It is necessary to introduce, where appropriate and on the basis of the conclusions of the risk assessment, post- market monitoring requirements for the use of geneti- cally modified foods for human consumption and for the use of genetically modified feed for animal consump- tion. In the case of GMOs, a monitoring plan concerning environmental effects is compulsory under Directive 2001/18/EC.

(36) To facilitate controls on genetically modified food and feed, applicants for authorisation should propose appro- priate methods for sampling, identification and detec- tion, and deposit samples of the genetically modified food and feed with the Authority; methods of sampling and detection should be validated, where appropriate, by the Community reference laboratory.

(37) Technological progress and scientific developments should be taken into account when implementing this Regulation.

(38) Food and feed falling within the scope of this Regulation which have been lawfully placed on the Community market before the date of application of this Regulation should continue to be allowed on the market, subject to the transmission to the Commission by the operators of information concerning the risk assessment, methods for sampling, identification and detection as appropriate, including the transmission of samples of the food and feed and their control samples within six months after the date of application of this Regulation.

(39) A register of genetically modified food and feed authorised under this Regulation should be established, including product specific information, studies which demonstrate the safety of the product, including, where available, references to independent and peer-reviewed studies, and to methods for sampling, identification and detection. Non-confidential data should be made avail- able to the public.

(40) In order to stimulate research and development into GMOs for food and/or feed use, it is appropriate to protect the investment made by innovators in gathering the information and data supporting an application under this Regulation. This protection should however be limited in time in order to avoid the unnecessary repetition of studies and trials which would be against the public interest.

(41) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (1).

(1) OJ L 184, 17.7.1999, p. 23.

(42) Provision should be made for consultation of the European Group on Ethics in Science and New Technol- ogies established by Commission Decision of 16 December 1997, or any other appropriate body estab- lished by the Commission, with a view to obtaining advice on ethical issues regarding the placing on the market of genetically modified food or feed. Such consultations should be without prejudice to the compe- tence of Member States as regards ethical issues.

(43) In order to provide a high level of protection of human life and health, animal health and welfare, environment and consumer interests in relation to genetically modi- fied food and feed, requirements arising from this Regu- lation should apply in a non-discriminatory manner to products originating in the Community and imported from third countries, in accordance with the general principles referred to in Regulation (EC) No 178/2002. The content of this Regulation takes account of the international trade commitments of the European Communities and of the requirements of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity as regards importer obligations and notifica- tion.

(44) Certain instruments of Community law should be repealed and others amended as a result of this Regula- tion.

(45) The implementation of this Regulation should be reviewed in the light of experience gained in the short term, and the impact of the application of this Regula- tion on human and animal health, consumer protection, consumer information and the functioning of the internal market should be monitored by the Commis- sion,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

OBJECTIVE AND DEFINITIONS

Article 1

Objective

The objective of this Regulation, in accordance with the general principles laid down in Regulation (EC) No 178/2002, is to:

(a) provide the basis for ensuring a high level of protection of human life and health, animal health and welfare, environ- ment and consumer interests in relation to genetically modified food and feed, whilst ensuring the effective func- tioning of the internal market;

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(b) lay down Community procedures for the authorisation and supervision of genetically modified food and feed;

(c) lay down provisions for the labelling of genetically modi- fied food and feed.

Article 2

Definitions

For the purposes of this Regulation:

1. the definitions of ‘food’, ‘feed’, ‘final consumer’, ‘food busi- ness’ and ‘feed business’ given in Regulation (EC) No 178/ 2002 shall apply;

2. the definition of ‘traceability’, laid down in Regulation (EC) No 1830/2003;

3. ‘operator’ means the natural or legal person responsible for ensuring that the requirements of this Regulation are met within the food businesses or feed businesses under its control;

4. the definitions of ‘organism’, ‘deliberate release’ and ‘envir- onmental risk assessment’ referred to in Directive 2001/ 18/EC shall apply;

5. ‘genetically modified organism’ or ‘GMO’ means a geneti- cally modified organism as defined in Article 2(2) of Direc- tive 2001/18/EC, excluding organisms obtained through the techniques of genetic modification listed in Annex I B to Directive 2001/18/EC;

6. ‘genetically modified food’ means consisting of or produced from GMOs;

food containing,

7. ‘genetically modified feed’ means consisting of or produced from GMOs;

feed containing,

8. ‘genetically modified organism for food use’ means a GMO that may be used as food or as a source material for the production of food;

9. ‘genetically modified organism for feed use’ means a GMO that may be used as feed or as a source material for the production of feed;

10. ‘produced from GMOs’ means derived, in whole or in part, from GMOs, but not containing or consisting of GMOs;

11. ‘control sample’ means the GMO or its genetic material (positive sample) and the parental organism or its genetic material that has been used for the purpose of the genetic modification (negative sample);

12. ‘conventional counterpart’ means a similar food or feed produced without the help of genetic modification and for which there is a well-established history of safe use;

13. ‘ingredient’ means ‘ingredient’ as referred to in Article 6(4) of Directive 2000/13/EC;

14. ‘placing on the market’ means the holding of food or feed for the purpose of sale, including offering for sale, or any other form of transfer, whether free of charge or not, and the sale, distribution and other forms of transfer them- selves.

15. ‘pre-packaged food’ means any single item for presentation as such consisting of a food and the packaging into which it was put before being offered for sale, whether such packaging encloses the food completely or only partially, provided that the contents cannot be altered without opening or changing the packaging.

16. ‘mass caterer’ means ‘mass caterer’ as referred to in Article 1 of Directive 2000/13/EC.

CHAPTER II

GENETICALLY MODIFIED FOOD

Se c t i on 1

A ut h ori sat i o n an d su p e rvi si on

Article 3

Scope

1. This Section shall apply to:

(a) GMOs for food use;

(b) food containing or consisting of GMOs;

(c) food produced from or containing ingredients produced from GMOs.

2. Where necessary, it may be determined in accordance with the procedure referred to in Article 35(2) whether a type of food falls within the scope of this Section.

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Article 4

Requirements

1. Food referred to in Article 3(1) must not:

(a) have adverse effects on human health, animal health or the environment;

(b) mislead the consumer;

(c) differ from the food which it is intended to replace to such an extent that its normal consumption would be nutrition- ally disadvantageous for the consumer.

2. No person shall place on the market a GMO for food use or food referred to in Article 3(1) unless it is covered by an authorisation granted in accordance with this Section and the relevant conditions of the authorisation are satisfied.

3. No GMO for food use or food referred to in Article 3(1) shall be authorised unless the applicant for such authorisation has adequately and sufficiently demonstrated that it satisfies the requirements of paragraph 1 of this Article.

4. The authorisation referred to in paragraph 2 may cover:

(a) a GMO and foods containing or consisting of that GMO as well as foods produced from or containing ingredients produced from that GMO; or

(b) food produced from a GMO as well as foods produced from or containing that food;

(c) an ingredient produced from a GMO as well as food containing that ingredient.

5. An authorisation as referred to in paragraph 2 shall not be granted, refused, renewed, modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation.

6. The applicant for an authorisation as referred to in para- graph 2 and, after the authorisation is granted, the authorisa- tion-holder or his representative, shall be established in the Community.

7. Authorisation under this Regulation shall be without prejudice to Directive 2002/53/EC, Directive 2002/55/EC and Directive 68/193/EEC.

Article 5

Application for authorisation

1. To obtain the authorisation referred to in Article 4(2), an application shall be submitted in accordance with the following provisions.

2. The application shall be sent to the national competent authority of a Member State.

(a) The national competent authority:

(i) shall acknowledge receipt of the application in writing to the applicant within 14 days of its receipt. The acknowledgement shall state the date of receipt of the application;

(ii) shall inform without delay the European Food Safety Authority (hereinafter referred to as the Authority); and

(iii) shall make the application and any supplementary information supplied by the applicant available to the Authority.

(b) The Authority

(i) shall inform without delay the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them;

(ii) shall make the summary of the dossier referred to in paragraph 3(1) available to the public.

3. The application shall be accompanied by the following:

(a) the name and the address of the applicant;

(b) the designation of the food, and its specification, including the transformation event(s) used;

(c) where applicable, the information to be provided for the purpose of complying with Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (hereinafter referred to as the Cartagena Protocol);

(d) where applicable, a detailed description of the method of production and manufacturing;

(e) a copy of the studies, including, where available, indepen- dent, peer-reviewed studies, which have been carried out and any other material which is available to demonstrate that the food complies with the criteria referred to in Article 4(1);

(f) either an analysis, supported by appropriate information and data, showing that the characteristics of the food are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics and to the criteria specified in Article 13(2)(a), or a proposal for labelling the food in accordance with Article 13(2)(a) and (3);

(g) either a reasoned statement that the food does not give rise to ethical or religious concerns, or a proposal for labelling it in accordance with Article 13(2)(b);

(h) where appropriate, the conditions for placing on the market the food or foods produced from it, including specific conditions for use and handling;

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(i) methods for detection, sampling (including references to existing official or standardised sampling methods) and identification of the transformation event and, where applicable, for the detection and identification of the trans- formation event in the food and/or in foods produced from it;

(j) samples of the food and their control samples, and infor- mation as to the place where the reference material can be accessed;

(k) where appropriate, a proposal for post-market monitoring regarding use of the food for human consumption;

(l) a summary of the dossier in a standardised form.

4. In the case of an application relating to a GMO for food use, references to ‘food’ in paragraph 3 shall be interpreted as referring to food containing, consisting of or produced from the GMO in respect of which an application is made.

5. In the case of GMOs or food containing or consisting of GMOs, the application shall also be accompanied by:

(a) the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC or, where the placing on the market of the GMO has been authorised under part C of Directive 2001/18/EC, a copy of the authorisation decision;

(b) a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan; this dura- tion may be different from the proposed period for the consent.

In such case, Articles 13 to 24 of Directive 2001/18/EC shall not apply.

6. Where the application concerns a substance, the use and placing on the market of which is subject, under other provi- sions of Community law, to its inclusion on a list of substances registered or authorised to the exclusion of others, this must be stated in the application and the status of the substance under the relevant legislation must be indicated.

7. The Commission, having first consulted the Authority, shall establish, in accordance with the procedure referred to in Article 35(2), implementing rules for the application of this Article, including rules concerning the preparation and the presentation of the application.

8. Before the date of application of this Regulation, the Authority shall publish detailed guidance to assist the applicant in the preparation and the presentation of the application.

Article 6

Opinion of the Authority

1. In giving its opinion, the Authority shall endeavour to respect a time limit of six months as from the receipt of a valid application. Such time limit shall be extended whenever the Authority seeks supplementary information from the applicant as provided for in paragraph 2.

2. The Authority or a national competent authority through the Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specific time limit.

3. In order to prepare its opinion the Authority:

(a) shall verify that the particulars and documents submitted by the applicant are in accordance with Article 5 and examine whether the food complies with the criteria referred to in Article 4(1);

(b) may ask the appropriate food assessment body of a Member State to carry out a safety assessment of the food in accordance with Article 36 of Regulation (EC) No 178/ 2002;

(c) may ask a competent authority designated in accordance with Article 4 of Directive 2001/18/EC to carry out an environmental risk assessment; however, if the application concerns GMOs to be used as seeds or other plant-propa- gating material, the Authority shall ask a national compe- tent authority to carry out the environmental risk assess- ment;

(d) shall forward to the Community reference laboratory referred to in Article 32 the particulars referred to in Article 5(3)(i) and (j). The Community reference laboratory shall test and validate the method of detection and identifi- cation proposed by the applicant;

(e) shall, in verifying the application of Article 13(2)(a), examine the information and data submitted by the appli- cant to show that the characteristics of the food are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics.

4. In the case of GMOs or food containing or consisting of GMOs, the environmental safety requirements referred to in Directive 2001/18/EC shall apply to the evaluation to ensure that all appropriate measures are taken to prevent the adverse effects on human and animal health and the environment which might arise from the deliberate release of GMOs. During evaluation of requests for the placing on the market of products consisting of or containing GMOs, the national competent authority within the meaning of Directive 2001/18/ EC designated by each Member State for this purpose shall be consulted by the Authority. The competent authorities shall have three months after the date of receiving the request within which to make their opinion known.

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5. In the event of an opinion in favour of authorising the food, the opinion shall also include the following particulars:

(a) the name and address of the applicant;

(b) the designation of the food, and its specification;

(c) where applicable, the information required under Annex II to the Cartagena Protocol;

(d) the proposal for the labelling of the food and/or foods produced from it;

(e) where applicable, any conditions or restrictions which should be imposed on the placing on the market and/or specific conditions or restrictions for use and handling, including post-market monitoring requirements based on the outcome of the risk assessment and, in the case of GMOs or food containing or consisting of GMOs, condi- tions for the protection of particular ecosystems/environ- ment and/or geographical areas;

(f) the method, validated by the Community reference labora- tory, for detection, including sampling, identification of the transformation event and, where applicable, for the detec- tion and identification of the transformation event in the food and/or in foods produced from it; an indication of where appropriate reference material can be accessed;

(g) where appropriate, the monitoring plan referred to in Article 5(5)(b).

6. The Authority shall forward its opinion to the Commis- sion, the Member States and the applicant, including a report describing its assessment of the food and stating the reasons for its opinion and the information on which this opinion is based, including the opinions of the competent authorities when consulted in accordance with paragraph 4.

7. The Authority, in conformity with Article 38(1) of Regu- lation (EC) No 178/2002, shall make its opinion public, after deletion of any information identified as confidential in accor- dance with Article 30 of this Regulation. The public may make comments to the Commission within 30 days from such publication.

Article 7

Authorisation

1. Within three months after receiving the opinion of the Authority, the Commission shall submit to the Committee referred in Article 35 a draft of the decision to be taken in respect of the application, taking into account the opinion of the Authority, any relevant provisions of Community law and other legitimate factors relevant to the matter under considera- tion. Where the draft decision is not in accordance with the opinion of the Authority, the Commission shall provide an explanation for the differences.

2. Any draft decision which envisages the granting of authorisation shall include the particulars referred to in Article 6(5), the name of the authorisation-holder and, where appro- priate, the unique identifier attributed to the GMO as referred to in the Regulation (EC) No 1830/2003.

3. A final decision on the application shall be adopted in accordance with the procedure referred to in Article 35(2).

4. The Commission shall without delay inform the applicant of the decision taken and publish details of the decision in the Official Journal of the European Union.

5. The authorisation granted in accordance with the proce- dure referred to in this Regulation shall be valid throughout the Community for 10 years and shall be renewable in accordance with Article 11. The authorised food shall be entered in the Register referred to in Article 28. Each entry in the Register shall mention the date of authorisation and shall include the particulars referred to in paragraph 2.

6. The authorisation under this Section shall be without prejudice to other provisions of Community law governing the use and placing on the market of substances which may only be used if they are included in a list of substances registered or authorised to the exclusion of others.

7. The granting of authorisation shall not lessen the general civil and criminal liability of any food operator in respect of the food concerned.

8. References made in parts A and D of Directive 2001/18/ EC to GMOs authorised under part C of that Directive shall be considered as applying equally to GMOs authorised under this Regulation.

Article 8

Status of existing products

1. By way of derogation from Article 4(2), products falling within the scope of this Section which have been lawfully placed on the market in the Community before the date of application of this Regulation may continue to be placed on the market, used and processed provided that the following conditions are met:

(a) in the case of products placed on the market under Direc- tive 90/220/EEC before the entry into force of Regulation (EC) No 258/97 or in accordance with the provisions referred to in Regulation (EC) No 258/97, operators responsible for placing on the market the products concerned shall, within six months after the date of applica- tion of this Regulation, notify the Commission of the date on which they were first placed on the market in the Community;

(b) in the case of products which have been lawfully placed on the market in the Community but are not covered by point (a), operators responsible for placing on the market the products concerned shall, within six months after the date of application of this Regulation, notify the Commission that the products were placed on the market in the Community before the date of application of this Regula- tion.

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2. The notification referred to in paragraph 1 shall be accompanied by the particulars mentioned in Article 5(3) and (5), as appropriate, which the Commission shall forward to the Authority and the Member States. The Authority shall forward to the Community reference laboratory the particulars referred to in Article 5(3)(i) and (j). The Community reference labora- tory shall test and validate the method of detection and identifi- cation proposed by the applicant.

3. Within one year from the date of application of this Regulation and after verification that all the information required has been submitted and examined, the products concerned shall be entered in the Register. Each entry in the Register shall include the particulars referred to in Article 7(2) as appropriate and, in the case of the products referred to in paragraph 1(a), shall mention the date on which the products concerned were first placed on the market.

4. Within nine years from the date on which the products referred to in paragraph 1(a) were first placed on the market, but in no case earlier than three years after the date of applica- tion of this Regulation, operators responsible for placing them on the market shall submit an application in accordance with Article 11, which shall apply mutatis mutandis.

Within three years from the date of application of this Regula- tion, operators responsible for placing on the market products referred to in paragraph 1(b) shall submit an application in accordance with Article 11, which shall apply mutatis mutandis.

5. Products referred to in paragraph 1 and food containing them or produced from them shall be subject to the provisions of this Regulation, in particular Articles 9, 10 and 34, which shall apply mutatis mutandis.

6. Where the notification and accompanying particulars referred to in paragraphs 1 and 2 are not supplied within the period specified or are found to be incorrect, or where an application is not submitted as required by paragraph 4 within the period specified, the Commission, acting in accordance with the procedure referred to in Article 35(2), shall adopt a measure requiring the product concerned and any products derived from it to be withdrawn from the market. Such a measure may provide for a limited period of time within which existing stocks of the product may be used up.

7. In the case of authorisations not issued to a specific holder, the operator who imports, produces or manufactures the products referred to in this Article shall submit the infor- mation or the application to Commission.

8. Detailed rules for implementing this Article shall be adopted in accordance with the procedure referred to in Article 35(2).

Article 9

Supervision

1. After an authorisation has been issued in accordance with this Regulation, the authorisation-holder and parties concerned shall comply with any conditions or restrictions which have

been imposed in the authorisation and shall in particular make sure that products not covered by the authorisation are not placed on the market as food or feed. Where post-market monitoring as referred to in Article 5(3)(k) and/or monitoring as referred to in Article 5(5)(b) has been imposed on the authorisation-holder, the authorisation-holder shall ensure that it is carried out and shall submit reports to the Commission in accordance with the terms of the authorisation. The monitoring reports referred to shall be made accessible to the public after deletion of any information identified as confidential in accor- dance with Article 30.

2. If the authorisation-holder proposes to modify the terms of the authorisation, the authorisation-holder shall submit an application in accordance with Article 5(2). Articles 5, 6 and 7 shall apply mutatis mutandis.

3. The authorisation-holder shall forthwith inform the Commission of any new scientific or technical information which might influence the evaluation of the safety in use of the food. In particular, the authorisation-holder shall forthwith inform the Commission of any prohibition or restriction imposed by the competent authority of any third country in which the food is placed on the market.

4. The Commission shall make the information supplied by the applicant available to the Authority and the Member States without delay.

Article 10

Modification, suspension and revocation of authorisations

1. On its own initiative or following a request from a Member State or from the Commission, the Authority shall issue an opinion on whether an authorisation for a product referred to in Article 3(1) still meets the conditions set by this Regulation. It shall forthwith transmit this opinion to the Commission, the authorisation-holder and the Member States. The Authority, in conformity with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public, after deletion of any information identified as confidential in accordance with Article 30 of this Regulation. The public may make comments to the Commission within 30 days from such publication.

2. The Commission shall examine the opinion of the Authority as soon as possible. Any appropriate measures shall be taken in accordance with Article 34. If appropriate, the authorisation shall be modified, suspended or revoked in accor- dance with the procedure referred to in Article 7.

3. Articles 5(2), 6 and 7 shall apply mutatis mutandis.

Article 11

Renewal of authorisations

1. Authorisations under this Regulation shall be renewable for 10-year periods, on application to the Commission by the authorisation-holder at the latest one year before the expiry date of the authorisation.

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2. The application shall be accompanied by the following:

(a) a copy of the authorisation for placing the food on the market;

(b) a report on the results of the monitoring, if so specified in the authorisation;

(c) any other new information which has become available with regard to the evaluation of the safety in use of the food and the risks of the food to the consumer or the environment;

(d) where appropriate, a proposal for amending or comple- menting the conditions of the original authorisation, inter alia the conditions concerning future monitoring.

3. Articles 5(2), 6 and 7 shall apply mutatis mutandis.

4. Where, for reasons beyond the control of the authorisa- tion-holder, no decision is taken on the renewal of an authori- sation before its expiry date, the period of authorisation of the product shall automatically be extended until a decision is taken.

5. The Commission, having first consulted the Authority, may establish, in accordance with the procedure referred to in Article 35(2), implementing rules for the application of this Article, including rules concerning the preparation and the presentation of the application.

6. The Authority shall publish detailed guidance to assist the applicant in the preparation and the presentation of its applica- tion.

S e c t i on 2

L ab e l l i n g

Article 12

Scope

1. This Section shall apply to foods which are to be deliv- ered as such to the final consumer or mass caterers in the Community and which:

(a) contain or consist of GMOs; or

(b) are produced from or contain ingredients produced from GMOs.

2. This Section shall not apply to foods containing material which contains, consists of or is produced from GMOs in a proportion no higher than 0,9 per cent of the food ingredients considered individually or food consisting of a single ingre- dient, provided that this presence is adventitious or technically unavoidable.

3. In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to supply evidence to satisfy the competent authorities that they have taken appropriate steps to avoid the presence of such material.

4. Appropriate lower thresholds may be established in accordance with the procedure referred to in Article 35(2) in particular in respect of foods containing or consisting of GMOs or in order to take into account advances in science and tech- nology.

Article 13

Requirements

1. Without prejudice to the other requirements of Commu- nity law concerning the labelling of foodstuffs, foods falling within the scope of this Section shall be subject to the following specific labelling requirements:

(a) where the food consists of more than one ingredient, the words ‘genetically modified’ or ‘produced from genetically modified (name of the ingredient)’ shall appear in the list of ingredients provided for in Article 6 of Directive 2000/13/ EC in parentheses immediately following the ingredient concerned;

(b) where the ingredient is designated by the name of a cate- gory, the words ‘contains genetically modified (name of organism)’ or ‘contains (name of ingredient) produced from genetically modified (name of organism)’ shall appear in the list of ingredients;

(c) where there is no list of ingredients, the words ‘genetically modified’ or ‘produced from genetically modified (name of organism)’ shall appear clearly on the labelling;

(d) the indications referred to in (a) and (b) may appear in a footnote to the list of ingredients. In this case they shall be printed in a font of at least the same size as the list of ingredients. Where there is no list of ingredients, they shall appear clearly on the labelling;

(e) where the food is offered for sale to the final consumer as non-pre-packaged food, or as pre-packaged food in small containers of which the largest surface has an area of less than 10 cm2, the information required under this para- graph must be permanently and visibly displayed either on the food display or immediately next to it, or on the packa- ging material, in a font sufficiently large for it to be easily identified and read.

2. In addition to the labelling requirements referred to in paragraph 1, the labelling shall also mention any characteristic or property, as specified in the authorisation, in the following cases:

(a) where a food is different from its conventional counterpart as regards the following characteristics or properties:

(i) composition;

(ii) nutritional value or nutritional effects;

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(iii) intended use of the food;

(iv) implications for the health of certain sections of the population;

(b) where a food may give rise to ethical or religious concerns.

3. In addition to the labelling requirements referred to in paragraph 1 and as specified in the authorisation, the labelling of foods falling within the scope of this Section which do not have a conventional counterpart shall contain appropriate information about the nature and the characteristics of the foods concerned.

Article 14

Implementing measures

1. Detailed rules for implementing this Section, amongst other things regarding the measures necessary for operators to comply with the labelling requirements, may be adopted in accordance with the procedure referred to in Article 35(2).

2. Specific rules concerning the information to be given by mass caterers providing food to the final consumer may be adopted in accordance with the procedure referred to in Article 35(2).

In order to take into account the specific situation of mass caterers, such rules may provide for adaptation of the require- ments of Article 13(1)(e).

CHAPTER III

GENETICALLY MODIFIED FEED

S e c t i on 1

A uthori sat ion an d sup e rvisi on

Article 15

Scope

1. This Section shall apply to:

(a) GMOs for feed use;

(b) feed containing or consisting of GMOs;

(c) feed produced from GMOs.

2. Where necessary, it may be determined in accordance with the procedure referred to in Article 35(2) whether a type of feed falls within the scope of this Section.

Article 16

Requirements

1. Feed referred to in Article 15(1) must not:

(a) have adverse effects on human health, animal health or the environment;

(b) mislead the user;

(c) harm or mislead the consumer by impairing the distinctive features of the animal products;

(d) differ from feed which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for animals or humans.

2. No person shall place on the market, use or process a product referred to in Article 15(1) unless it is covered by an authorisation granted in accordance with this Section and the relevant conditions of the authorisation are satisfied.

3. No product referred to in Article 15(1) shall be authorised unless the applicant for such authorisation has adequately and sufficiently demonstrated that it satisfies the requirements of paragraph 1 of this Article.

4. The authorisation referred to in paragraph 2 may cover:

(a) a GMO and feed containing or consisting of that GMO as well as feed produced from that GMO; or

(b) feed produced from a GMO as well as feeds produced from or containing that feed.

5. An authorisation as referred to in paragraph 2 shall not be granted, refused, renewed, modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation.

6. The applicant for an authorisation as referred to in para- graph 2 and, after the authorisation is granted, the authorisa- tion-holder or his representative, shall be established in the Community.

7. Authorisation under this Regulation shall be without prejudice to Directive 2002/53/EC, Directive 2002/55/EC and Directive 68/193/EEC.

Article 17

Application for authorisation

1. To obtain the authorisation referred to in Article 16(2), an application shall be submitted in accordance with the following provisions.

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2. The application shall be sent to the national competent authority of a Member State.

(a) The national competent authority:

(i) shall acknowledge receipt of the application in writing to the applicant within 14 days of its receipt. The acknowledgement shall state the date of receipt of the application;

(ii) shall inform the Authority without delay; and

(iii) shall make the application and any supplementary information supplied by the applicant available to the Authority.

(b) The Authority:

(i) shall inform without delay the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them;

(ii) shall make the summary of the dossier referred to in paragraph 3(1) available to the public.

3. The application shall be accompanied by the following:

(a) the name and the address of the applicant;

(b) the designation of the feed and its specification, including the transformation event(s) used;

(c) where applicable, the information to be provided for the purpose of complying with Annex II to the Cartagena Protocol;

(d) where applicable, a detailed description of the method of production and manufacturing and intended uses of the feed;

(e) a copy of the studies including, where available, indepen- dent, peer-reviewed studies, which have been carried out and any other material which is available to demonstrate that the feed complies with the criteria referred to in Article 16(1), and, in particular for feed falling within the scope of Directive 82/471/EEC, the information required under Council Directive 83/228/EEC of 18 April 1983 on the fixing of guidelines for the assessment of certain products used in animal nutrition (1);

(f) either an analysis, supported by appropriate information and data, showing that the characteristics of the feed are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics and to the criteria specified in Article 25(2)(c), or a proposal for labelling the feed in accordance with Article 25(2)(c) and (3);

(g) either a reasoned statement that the feed does not give rise to ethical or religious concerns, or a proposal for labelling it in accordance with Article 25(2)(d);

(h) where appropriate, the conditions for placing the feed on the market, including specific conditions for use and hand- ling;

(1) OJ L 126, 13.5.1983, p. 23.

(i) methods for detection, sampling (including references to existing official or standardised sampling methods) and identification of the transformation event and, where applicable, for the detection and identification of the trans- formation event in the feed and/or in the feed produced from it;

(j) samples of the feed and their control samples and informa- tion as to the place where the reference material can be accessed;

(k) where appropriate, a proposal for post-market monitoring for the use of the feed for animal consumption;

(l) a summary of the dossier in a standardised form.

4. In the case of an application relating to a GMO for feed use, references to ‘feed’ in paragraph 3 shall be interpreted as referring to feed containing, consisting of or produced from the GMO in respect of which an application is made.

5. In the case of GMOs or feed containing or consisting of GMOs, the application shall also be accompanied by:

(a) the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC or, where the placing on the market of the GMOs has been authorised under part C of Directive 2001/18/EC, a copy of the authorisation decision;

(b) a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan; this dura- tion may be different from the proposed period for the consent.

In such case, Articles 13 to 24 of Directive 2001/18/EC shall not apply.

6. Where the application concerns a substance, the use and placing on the market of which is subject under other provi- sions of Community law to its inclusion on a list of substances registered or authorised to the exclusion of others, this must be stated in the application and the status of the substance under the relevant legislation must be indicated.

7. The Commission, having first consulted the Authority, shall establish, in accordance with the procedure referred to in Article 35(2), implementing rules for the application of this Article, including rules concerning the preparation and the presentation of the application.

8. Before the date of application of this Regulation, the Authority shall publish detailed guidance to assist the applicant in the preparation and the presentation of the application.

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Article 18

Opinion of the Authority

1. In giving its opinion, the Authority shall endeavour to comply with a time limit of six months as from the receipt of a valid application. Such time limit shall be extended whenever the Authority seeks supplementary information from the appli- cant as provided in paragraph 2.

2. The Authority or a national competent authority through the Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specific time limit.

3. In order to prepare its opinion, the Authority:

(a) shall verify that the particulars and documents submitted by the applicant are in accordance with Article 17, and examine whether the feed complies with the criteria laid down in Article 16(1);

(b) may ask the appropriate feed assessment body of a Member State to carry out a safety assessment of the feed in accor- dance with Article 36 of Regulation (EC) No 178/2002;

(c) may ask a competent authority designated in accordance with Article 4 of Directive 2001/18/EC to carry out an environmental risk assessment; however, if the application concerns GMOs to be used as seeds or other plant-propa- gating material, the Authority shall ask a national compe- tent authority to carry out the environmental risk assess- ment;

(d) shall forward to the Community reference laboratory the particulars referred to in Article 17(3)(i) and (j). The Community reference laboratory shall test and validate the method of detection and identification proposed by the applicant;

(e) shall, in verifying the application of Article 25(2)(c), examine the information and data submitted by the appli- cant to show that the characteristics of the feed are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics.

4. In the case of GMOs or feed containing or consisting of GMOs, the environmental safety requirements referred to in Directive 2001/18/EC shall apply to the evaluation to ensure that all appropriate measures are taken to prevent the adverse effects on human and animal health and the environment which might arise from the deliberate release of GMOs. During evaluation of requests for the placing on the market of products consisting of or containing GMOs, the national competent authority within the meaning of Directive 2001/18/ EC, designated by each Member State for this purpose shall be consulted by the Authority. The competent authorities shall have three months after the date of receiving the request within which to make their opinion known.

5. In the event of an opinion in favour of authorising the feed, the opinion shall also include the following particulars:

(a) the name and address of the applicant;

(b) the designation of the feed, and its specification;

(c) where applicable, the information required under Annex II to the Cartagena Protocol;

(d) the proposal for the labelling of the feed;

(e) where applicable, any conditions or restrictions which should be imposed on the placing on the market and/or specific conditions or restrictions for use and handling, including post-market monitoring requirements based on the outcome of the risk assessment and, in the case of GMOs or feed containing or consisting of GMOs, condi- tions for the protection of particular ecosystems/environ- ment and/or geographical areas;

(f) the method, validated by the Community reference labora- tory, for detection, including sampling, identification of the transformation event and, where applicable, for the detec- tion and identification of the transformation event in the feed and/or in feed produced from it; an indication of where appropriate reference material can be accessed;

(g) where appropriate, the monitoring plan as referred to in Article 17(5)(b).

6. The Authority shall forward its opinion to the Commis- sion, the Member States and the applicant, including a report describing its assessment of the feed and stating the reasons for its opinion and the information on which this opinion is based, including the opinions of the competent authorities when consulted in accordance with paragraph 4.

7. The Authority, in conformity with Article 38(1) of Regu- lation (EC) No 178/2002, shall make its opinion public, after deletion of any information identified as confidential in accor- dance with Article 30 of this Regulation. The public may make comments to the Commission within 30 days from such publication.

Article 19

Authorisation

1. Within three months after receiving the opinion of the Authority, the Commission shall submit to the Committee referred in Article 35 a draft of the decision to be taken in respect of the application, taking into account the opinion of the Authority, any relevant provisions of Community law and other legitimate factors relevant to the matter under considera- tion. Where the draft decision is not in accordance with the opinion of the Authority, the Commission shall provide an explanation for the differences.

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2. Any draft decision which envisages the granting of authorisation shall include the particulars referred to in Article 18(5), the name of the authorisation-holder and, where appro- priate, the unique identifier attributed to the GMO as referred to in Regulation (EC) No 1830/2003.

3. A final decision on the application shall be adopted in accordance with the procedure referred to in Article 35(2).

4. The Commission shall without delay inform the applicant of the decision taken and publish details of the decision in the Official Journal of the European Union.

5. The authorisation granted in accordance with the proce- dure referred to in this Regulation shall be valid throughout the Community for 10 years and shall be renewable in accordance with Article 23. The authorised feed shall be entered in the Register referred to in Article 28. Each entry in the Register shall mention the date of authorisation and shall include the particulars referred to in paragraph 2.

6. The authorisation under this Section shall be without prejudice to other provisions of Community law governing the use and placing on the market of substances which may only be used if they are included in a list of substances registered or authorised to the exclusion of others.

7. The granting of authorisation shall not lessen the general civil and criminal liability of any feed operator in respect of the feed concerned.

8. References made in parts A and D of Directive 2001/18/ EC to GMOs authorised under part C of that Directive shall be considered as applying equally to GMOs authorised under this Regulation.

Article 20

Status of existing products

1. By way of derogation from Article 16(2), products falling within the scope of this Section which have been lawfully placed on the market in the Community before the date of application of this Regulation may continue to be placed on the market, used and processed provided that the following conditions are met:

(a) in the case of products which have been authorised under Directives 90/220/EEC or 2001/18/EC, including use as feed, under Directive 82/471/EEC, which are produced from GMOs, or under Directive 70/524/EEC, which contain, consist of or are produced from GMOs, operators responsible for placing on the market the products concerned shall, within six months after the date of applica- tion of this Regulation, notify the Commission of the date on which they were first placed on the market in the Community;

(b) in the case of products which have been lawfully placed on the market in the Community but which are not referred to in point (a), operators responsible for placing on the market

in the Community the products concerned shall, within six months after the date of application of this Regulation, notify the Commission that the products were placed on the market in the Community before the date of application of this Regulation.

2. The notification referred to in paragraph 1 shall be accompanied by the particulars mentioned in Article 17(3) and (5), as appropriate, which the Commission shall forward to the Authority and the Member States. The Authority shall forward to the Community reference laboratory the particulars referred to in Article 17(3)(i) and (j). The Community reference labora- tory shall test and validate the method of detection and identifi- cation proposed by the applicant.

3. Within one year from the date of application of this Regulation and after verification that all the information required has been submitted and examined, the products concerned shall be entered in the Register. Each entry in the Register shall include the particulars referred to in Article 19(2) as appropriate and, in the case of the products referred to in paragraph 1(a), shall mention the date on which the products concerned were first placed on the market.

4. Within nine years from the date on which the products referred to in paragraph 1(a) were first placed on the market, but in no case earlier than three years after the date of applica- tion of this Regulation, operators responsible for placing them on the market shall submit an application in accordance with Article 23, which shall apply mutatis mutandis.

Within three years from the date of application of this Regula- tion, operators responsible for placing on the market products referred to in paragraph 1(b) shall submit an application in accordance with Article 23, which shall apply mutatis mutandis.

5. Products referred to in paragraph 1 and feed containing them or produced from them shall be subject to the provisions of this Regulation, in particular Articles 21, 22 and 34, which shall apply mutatis mutandis.

6. Where the notification and accompanying particulars referred to in paragraphs 1 and 2 are not supplied within the period specified or are found to be incorrect, or where an application is not submitted as required by paragraph 4 within the period specified, the Commission, acting in accordance with the procedure laid down in Article 35(2), shall adopt a measure requiring the product concerned and any products derived from it to be withdrawn from the market. Such a measure may provide for a limited period of time within which existing stocks of the product may be used up.

7. In the case of authorisations not issued to a specific holder, the operator who imports, produces or manufactures the products referred to in this Article shall submit the infor- mation or the application to the Commission.

8. Detailed rules for implementing this Article shall be adopted in accordance with the procedure referred to in Article 35(2).

L 268/16 EN Official Journal of the European Union 18.10.2003

Article 21

Supervision

1. After an authorisation has been issued in accordance with this Regulation, the authorisation-holder and the parties concerned shall comply with any conditions or restrictions which have been imposed in the authorisation and shall in particular make sure that products not covered by the authori- sation are not placed on the market as food or feed. Where post-market monitoring as referred to in Article 17(3)(k) and/or monitoring as referred to in Article 17(5)(b) has been imposed on the authorisation-holder, the authorisation-holder shall ensure that it is carried out and shall submit reports to the Commission in accordance with the terms of the authorisation. The monitoring reports referred to shall be made accessible to the public after deletion of any information identified as confi- dential in accordance with Article 30.

2. If the authorisation-holder proposes to modify the terms of the authorisation, the authorisation-holder shall submit an application in accordance with Article 17(2). Articles 17, 18 and 19 shall apply mutatis mutandis.

3. The authorisation-holder shall forthwith inform the Commission of any new scientific or technical information which might influence the evaluation of the safety in use of the feed. In particular, the authorisation-holder shall forthwith inform the Commission of any prohibition or restriction imposed by the competent Authority of any third country in which the feed is placed on the market.

4. The Commission shall make the information supplied by the applicant available to the Authority and the Member States without delay.

Article 22

Modification, suspension and revocation of authorisations

1. On its own initiative or following a request from a Member State or from the Commission, the Authority shall issue an opinion on whether an authorisation for a product referred to in Article 15(1) still meets the conditions set by this Regulation. It shall forthwith transmit this opinion to the Commission, the authorisation-holder and the Member States. The Authority, in conformity with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public, after deletion of any information identified as confidential in accordance with Article 30 of this Regulation. The public may make comments to the Commission within 30 days from such publication.

2. The Commission shall examine the opinion of the Authority as soon as possible. Any appropriate measures shall be taken in accordance with Article 34. If appropriate, the authorisation shall be modified, suspended or revoked in accor- dance with the procedure referred to in Article 19.

3. Articles 17(2), 18 and 19 shall apply mutatis mutandis.

Article 23

Renewal of authorisations

1. Authorisations under this Regulation shall be renewable for 10-year periods, on application to the Commission by the authorisation-holder at the latest one year before the expiry date of the authorisation.

2. The application shall be accompanied by the following particulars and documents:

(a) a copy of the authorisation for placing the feed on the market;

(b) a report on the results of the monitoring, if so specified in the authorisation;

(c) any other new information which has become available with regard to the evaluation of the safety in use of the feed and the risks of the feed to animals, humans or the envir- onment;

(d) where appropriate, a proposal for amending or comple- menting the conditions of the original authorisation, inter alia the conditions concerning future monitoring.

3. Articles 17(2), 18 and 19 shall apply mutatis mutandis.

4. Where, for reasons beyond the control of the authorisa- tion-holder, no decision is taken on the renewal of an authori- sation before its expiry date, the period of authorisation of the product shall automatically be extended until a decision is taken.

5. The Commission, having first consulted the Authority, may establish, in accordance with the procedure referred to in Article 35(2), implementing rules for the application of this Article, including rules concerning the preparation and the presentation of the application.

6. The Authority shall publish detailed guidance to assist the applicant in the preparation and the presentation of its application.

Se c t i on 2

L ab e l l i n g

Article 24

Scope

1. This Section shall apply to feed referred to in Article 15(1).

2. This Section shall not apply to feed containing material which contains, consists of or is produced from GMOs in a proportion no higher than 0,9 per cent of the feed and of each feed of which it is composed, provided that this presence is adventitious or technically unavoidable.

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3. In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to supply evidence to satisfy the competent authorities that they have taken appropriate steps to avoid the presence of such materials.

4. Appropriate lower thresholds may be established in accordance with the procedure referred to in Article 35(2), in particular in respect of feed containing or consisting of GMOs, or in order to take into account advances in science and tech- nology.

Article 25

Requirements

1. Without prejudice to the other requirements of Commu- nity law concerning the labelling of feed, feed referred to in Article 15(1) shall be subject to the specific labelling require- ments laid down below.

2. No person shall place a feed referred to in Article 15(1) on the market unless the particulars specified below are shown, in a clearly visible, legible and indelible manner, on an accom- panying document or, where appropriate, on the packaging, on the container or on a label attached thereto.

Each feed of which a particular feed is composed shall be subject to the following rules:

(a) for the feeds referred to in Article 15(1) (a) and (b), the words ‘genetically modified (name of the organism)’ shall appear in parentheses immediately following the specific name of the feed.

Alternatively, these words may appear in a footnote to the list of feed. It shall be printed in a font of at least the same size as the list of feed;

(b) for the feed referred to in Article 15(1)(c), the words ‘produced from genetically modified (name of the organism)’ shall appear in parentheses immediately following the specific name of the feed.

Alternatively, these words may appear in a footnote to the list of feed. It shall be printed in a font of at least the same size as the list of feed;

(c) as specified in the authorisation, any characteristic of the feed referred to in Article 15(1) such as those indicated hereunder, which is different from its conventional counter- part:

(i) composition;

(ii) nutritional properties;

(iii) intended use;

(iv) implications for the health of certain species or cate- gories of animals;

(d) as specified in the authorisation, any characteristic or prop- erty where a feed may give rise to ethical or religious concerns.

3. In addition to the requirements referred to in paragraph 2(a) and (b) and as specified in the authorisation, the labelling or accompanying documents of feed falling within the scope of this Section which does not have a conventional counterpart shall contain appropriate information about the nature and the characteristics of the feed concerned.

Article 26

Implementing measures

Detailed rules for implementing this Section, amongst other things regarding the measures necessary for operators to comply with the labelling requirements, may be adopted in accordance with the procedure referred to in Article 35(2).

CHAPTER IV

COMMON PROVISIONS

Article 27

Products likely to be used as both food and feed

1. Where a product is likely to be used as both food and feed, a single application under Articles 5 and 17 shall be submitted and shall give rise to a single opinion from the Authority and a single Community decision.

2. The Authority shall consider whether the application for authorisation should be submitted both as food and feed.

Article 28

Community register

1. The Commission shall establish and maintain a Commu- nity register of genetically modified food and feed, hereinafter referred to as ‘the Register’.

2. The Register shall be made available to the public.

Article 29

Public access

1. The application for authorisation, supplementary infor- mation from the applicant, opinions from the competent authorities designated in accordance with Article 4 of Directive 2001/18/EC, monitoring reports and information from the authorisation holder, excluding confidential information, shall be made accessible to the public.

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2. The Authority shall apply the principles of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (1) when hand- ling applications for access to documents held by the Authority.

3. Member States shall handle applications for access to documents received under this regulation in accordance with Article 5 of Regulation (EC) No 1049/2001.

Article 30

Confidentiality

1. The applicant may indicate which information submitted under this Regulation it wishes to be treated as confidential on the ground that its disclosure might significantly harm its competitive position. Verifiable justification must be given in such cases.

2. Without prejudice to paragraph 3, the Commission shall determine, after consultation with the applicant, which infor- mation should be kept confidential and shall inform the appli- cant of its decision.

3. Information relating to the following shall not be considered confidential:

(a) name and composition of the GMO, food or feed referred to in Articles 3(1) and 15(1) and, where appropriate, indi- cation of the substrate and the micro-organism;

(b) general description of the GMO and the name and address of the authorisation-holder;

(c) physico-chemical and biological characteristics of the GMO, food or feed referred to in Articles 3(1) and 15(1);

(d) effects of the GMO, food or feed referred to in Articles 3(1) and 15(1) on human and animal health and on the environ- ment;

(e) effects of the GMO, food or feed referred to in Articles 3(1) and 15(1) on the characteristics of animal products and its nutritional properties;

(f) methods for detection, including sampling and identifica- tion of the transformation event and, where applicable, for the detection and identification of the transformation event in the food or feed referred to in Articles 3(1) and 15(1);

(g) information on waste treatment and emergency response.

4. Notwithstanding paragraph 2, the Authority shall on request supply the Commission and Member States with all information in its possession.

(1) OJ L 145, 31.5.2001, p. 43.

5. The use of the detection methods and the reproduction of the reference materials, provided under Article 5(3) and 17(3) for the purpose of applying this Regulation to the GMOs, food or feed to which an application refers, shall not be restricted by the exercise of intellectual property rights or otherwise.

6. The Commission, the Authority and the Member States shall take the necessary measures to ensure appropriate confi- dentiality of the information received by them under this Regu- lation except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment.

7. If an applicant withdraws or has withdrawn an applica- tion, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information, including research and development information, as well as information as to the confidentiality of which the Commission and the applicant disagree.

Article 31

Data protection

The scientific data and other information in the application dossier required under Article 5(3) and (5) and Article 17(3) and (5) may not be used for the benefit of another applicant for a period of 10 years from the date of authorisation, unless the other applicant has agreed with the authorisation-holder that such data and information may be used.

On the expiry of this 10-year period, the findings of all or part of the evaluation conducted on the basis of the scientific data and information contained in the application dossier may be used by the Authority for the benefit of another applicant if the applicant can demonstrate that the food or feed for which it is seeking authorisation is essentially similar to a food or feed already authorised under this Regulation.

Article 32

Community reference laboratory

The Community reference laboratory and its duties and tasks shall be those referred to in the Annex.

National reference laboratories may be established in accor- dance with the procedure referred to in Article 35(2).

Applicants for authorisation of genetically modified food and feed shall contribute to supporting the costs of the tasks of the Community reference laboratory and the European Network of GMO laboratories mentioned in the Annex.

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The contributions from applicants shall not exceed the costs incurred in carrying out the validation of detection methods.

Detailed rules for implementing this Article, the Annex and any changes to it may be adopted in accordance with the procedure referred to in Article 35(2).

Article 33

Consultation with the European Group on Ethics in Science and New Technologies

1. The Commission, on its own initiative or at the request of a Member State, may consult the European Group on Ethics in Science and New Technologies or any other appropriate body it might establish, with a view to obtaining its opinion on ethical issues.

2. The Commission shall make these opinions available to the public.

Article 34

Emergency measures

Where it is evident that products authorised by or in accor- dance with this Regulation are likely to constitute a serious risk to human health, animal health or the environment, or where, in the light of an opinion of the Authority issued under Article 10 or Article 22, the need to suspend or modify urgently an authorisation arises, measures shall be taken under the proce- dures provided for in Articles 53 and 54 of Regulation (EC) No 178/2002.

Article 35

Committee procedure

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, set up by Article 58 of Regulation (EC) No 178/2002, hereinafter referred to as the ‘Committee’.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. The Committee shall adopt its rules of procedure.

Article 36

Administrative review

Any decision taken under, or failure to exercise, the powers vested in the Authority by this Regulation may be reviewed by the Commission on its own initiative or in response to a request from a Member State or from any person directly and individually concerned.

To this effect a request shall be submitted to the Commission within two months from the day on which the party concerned became aware of the act or omission in question.

The Commission shall take a decision within two months requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to act.

Article 37

Repeals

The following Regulations shall be repealed with effect from the date of application of this Regulation:

— Regulation (EC) No 1139/98,

— Regulation (EC) No 49/2000,

— Regulation (EC) No 50/2000.

Article 38

Amendments to Regulation (EC) No 258/97

Regulation (EC) No 258/97 is hereby amended with effect from the date of application of this Regulation as follows:

1. The following provisions shall be deleted:

— Article 1(2)(a) and (b),

— Article 3(2), second subparagraph, and (3),

— Article 8(1)(d),

— Article 9.

2. In Article 3, the first sentence of paragraph 4 shall be replaced by the following:

‘4. By way of derogation from paragraph 2, the proce- dure referred to in Article 5 shall apply to foods or food ingredients referred to in Article 1(2)(d) and (e) which, on the basis of the scientific evidence available and generally recognised or on the basis of an opinion delivered by one of the competent bodies referred to in Article 4(3), are substan- tially equivalent to existing foods or food ingredients as regards their composition, nutritional value, metabolism, intended use and the level of undesirable substances contained therein.’

Article 39

Amendment to Directive 82/471/EEC

The following paragraph shall be added to Article 1 of Direc- tive 82/471/EEC with effect from the date of application of this Regulation:

‘3. This Directive does not apply to products which act as direct or indirect protein sources that fall within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (*).

(*) OJ L 268, 18.10.2003, p. 1.’

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Article 40

Amendments to Directive 2002/53/EC

Directive 2002/53/EC is hereby amended with effect from the date of application of this Regulation as follows:

1. Article 4(5) shall be replaced by the following:

‘5. Further, when material derived from a plant variety is intended to be used in food falling within the scope of Article 3, or in feed falling within the scope of Article 15 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (*), the variety shall be accepted only if it has been approved in accordance with that Regulation.

(*) OJ L 268, 18.10.2003, p. 1.’

2. Article 7(5) shall be replaced by the following:

‘5. Member States shall ensure that a variety intended to be used in food or feed as defined in Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety (*) is accepted only if it has been authorised under the relevant legislation.

(*) OJ L 31, 1.2.2002, p. 1.’

Article 41

Amendments to Directive 2002/55/EC

Directive 2002/55/EC is hereby amended with effect from the date of application of this Regulation as follows:

1. Article 4(3) shall be replaced by the following:

‘3. Further, when material derived from a plant variety is intended to be used in food falling within the scope of Article 3, or in feed falling within the scope of Article 15 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (*), the variety shall be accepted only if it has been approved in accordance with that Regulation.

(*) OJ L 268, 18.10.2003, p. 1.’

2. Article 7(5) shall be replaced by the following:

‘5. Member States shall ensure that a variety intended to be used in food or feed as defined in Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing

the European Food Safety Authority, and laying down procedures in matters of food safety (*) is accepted only if it has been authorised under the relevant legislation.

(*) OJ L 31, 1.2.2002, p. 1.’

Article 42

Amendment to Directive 68/193/EEC

Article 5ba(3) of Directive 68/193/EEC shall be replaced by the following wording with effect from the date of application of this Regulation:

‘3. (a) Where products derived from vine-propagating material are intended to be used as or in food falling within the scope of Article 3 or as or in a feed falling within the scope of Article 15 of Regu- lation (EC) No 1829/2003 of the European Parlia- ment and of the Council of 22 September 2003 on genetically modified food and feed (*), the vine variety concerned shall be accepted only if it has been authorised pursuant to the said Regulation.

(b) Member States shall ensure that a vine variety, from the propagating material of which products were derived intended for use in food and feed pursuant to Articles 2 and 3 of Regulation (EC) No 178/ 2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety (**) shall be accepted only if it has been authorised pursuant to the relevant legislation.

(*) OJ L 268, 18.10.2003, p. 1. (**) OJ L 31, 1.2.2002, p. 1.’

Article 43

Amendments to Directive 2001/18/EC

Directive 2001/18/EC is hereby amended with effect from the date of entry into force of this Regulation, as follows:

1. The following Article shall be inserted:

‘Article 12a

Transitional measures for adventitious or technically unavoidable presence of genetically modified organisms having benefited from a favourable risk evaluation

1. Placing on the market of traces of a GMO or combina- tion of GMOs in products intended for direct use as food or feed or for processing shall be exempted from Articles 13 to

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21 provided that they meet the conditions referred to in Article 47 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (*).

2. This Article shall be applicable for a period of three years after the date of application of Regulation (EC) No 1829/2003.

(*) OJ L 268, 18.10.2003, p. 1.’

2. The following Article shall be inserted:

‘Article 26a

Measures to avoid the unintended presence of GMOs

1. Member States may take appropriate measures to avoid the unintended presence of GMOs in other products.

2. The Commission shall gather and coordinate informa- tion based on studies at Community and national level, observe the developments regarding coexistence in the Member States and, on the basis of the information and observations, develop guidelines on the coexistence of genetically modified, conventional and organic crops.’

Article 44

Information to be provided in accordance with the Cartagena Protocol

1. Any authorisation, renewal, modification, suspension or revocation of authorisation of a GMO, food or feed referred to in Articles 3(1)(a) or (b) or 15(1)(a) or (b) shall be notified by the Commission to the Parties to the Cartagena Protocol through the biosafety clearing house in accordance with Article 11(1) or Article 12(1) of the Cartagena Protocol, as the case may be.

The Commission shall provide a copy of the information, in writing, to the national focal point of each Party that informs the Secretariat in advance that it does not have access to the biosafety clearing house.

2. The Commission shall also process requests for additional information made by any Party in accordance with Article 11(3) of the Cartagena Protocol and shall provide copies of the laws, regulations and guidelines in accordance with Article 11(5) of that Protocol.

Article 45

Penalties

The Member States shall lay down the rules on penalties applic- able to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are imple-

mented. The penalties provided for must be effective, propor- tionate and dissuasive. The Member States shall notify those provisions to the Commission six months after the date of entry into force of this Regulation at the latest and shall notify it without delay of any subsequent amendment affecting them.

Article 46

Transitional measures for requests, labelling and notifications

1. Requests submitted under Article 4 of Regulation (EC) No 258/97 before the date of application of this Regulation shall be transformed into applications under Chapter II, Section 1 of this Regulation where the initial assessment report provided for under Article 6(3) of Regulation (EC) No 258/97 has not yet been forwarded to the Commission, as well as in all cases where an additional assessment report is required in accordance with Article 6(3) or (4) of Regulation (EC) No 258/97. Other requests submitted under Article 4 of Regulation (EC) No 258/ 97 before the date of application of this Regulation shall be processed under the provisions of Regulation (EC) No 258/97, notwithstanding Article 38 of this Regulation.

2. The labelling requirements referred to in this Regulation shall not apply to products, the manufacturing process of which has commenced before the date of application of this Regulation, provided that these products are labelled in accor- dance with the legislation applicable to them before the date of application of this Regulation.

3. Notifications concerning products including their use as feed submitted under Article 13 of Directive 2001/18/EC before the date of application of this Regulation shall be trans- formed into applications under Chapter III, Section 1 of this Regulation where the assessment report provided for in Article 14 of Directive 2001/18/EC has not yet been sent to the Commission.

4. Requests submitted for products referred to in Article 15(1)(c) of this Regulation under Article 7 of Directive 82/471/ EEC before the date of application of this Regulation shall be transformed into applications under Chapter III, Section 1 of this Regulation.

5. Requests submitted for products referred to in Article 15(1) of this Regulation under Article 4 of Directive 70/524/ EEC before the date of application of this Regulation shall be supplemented by applications under Chapter III, Section 1 of this Regulation.

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Article 47

Transitional measures for adventitious or technically unavoidable presence of genetically modified material

which has benefited from a favourable risk evaluation

1. The presence in food or feed of material which contains, consists of or is produced from GMOs in a proportion no higher than 0,5 % shall not be considered to be in breach of Article 4(2) or Article 16(2), provided that:

(a) this presence is adventitious or technically unavoidable;

(b) the genetically modified material has benefited from a favourable opinion from the Community Scientific Committee(s) or the Authority before the date of applica- tion of this Regulation;

(c) the application for its authorisation has not been rejected in accordance with the relevant Community legislation; and

(d) detection methods are publicly available.

2. In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to demonstrate to the competent authorities that they have taken appropriate steps to avoid the presence of such materials.

3. The thresholds referred to in paragraph 1 may be lowered in accordance with the procedure referred to in Article 35(2), in particular for GMOs sold directly to the final consumer.

4. Detailed rules for implementing this Article shall be adopted in accordance with the procedure referred to in Article 35(2).

5. This Article shall remain applicable for a period of three years after the date of application of this Regulation.

Article 48

Review

1. No later than 7 November 2005 and in the light of experience gained, the Commission shall forward to the European Parliament and to the Council a report on the imple- mentation of this Regulation and in particular of Article 47, accompanied, where appropriate, by any suitable proposal. The report and any proposal shall be made accessible to the public.

2. Without prejudice to the powers of national authorities, the Commission shall monitor the application of this Regula- tion and its impact on human and animal health, consumer protection, consumer information and the functioning of the internal market and, if necessary, will bring forward proposals at the earliest possible date.

Article 49

Entry into force

This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.

It shall apply from six months after the date of publication of this Regulation.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 22 September 2003.

For the European Parliament For the Council

The President The President P. COX R. BUTTIGLIONE

18.10.2003 EN Official Journal of the European Union L 268/23

ANNEX

DUTIES AND TASKS OF THE COMMUNITY REFERENCE LABORATORY

1. The Community reference laboratory referred to in Article 32 is the Commission's Joint Research Centre.

2. For the tasks outlined in this Annex, the Commission's Joint Research Centre shall be assisted by a consortium of national reference laboratories, which will be referred to as the ‘European Network of GMO laboratories’.

3. The Community reference laboratory shall be responsible, in particular, for:

— reception, preparation, storage, maintenance and distribution to national reference laboratories of the appropriate positive and negative control samples,

— testing and validation of the method for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food or feed,

— evaluating the data provided by the applicant for authorisation for placing the food or feed on the market, for the purpose of testing and validation of the method for sampling and detection,

— submitting full evaluation reports to the Authority.

4. The Community reference laboratory shall play a role in dispute settlements between Member States concerning the results of the tasks outlined in this Annex.

 Reglamento (CE) N° 1829/2003 del Parlamento Europeo y del Consejo, de 22 de septiembre de 2003, sobre alimentos y piensos modificados genéticamente

I

(Actos cuya publicación es una condición para su aplicabilidad)

REGLAMENTO (CE) No 1829/2003 DEL PARLAMENTO EUROPEO Y DEL CONSEJO de 22 de septiembre de 2003

sobre alimentos y piensos modificados genéticamente

(Texto pertinente a efectos del EEE)

EL PARLAMENTO EUROPEO Y EL CONSEJO DE LA UNIÓN EUROPEA,

Visto el Tratado constitutivo de la Comunidad Europea, y en particular sus artículos 37 y 95 y la letra b) del apartado 4 de su artículo 152,

Vista la propuesta de la Comisión (1),

Visto el dictamen del Comité Económico y Social Europeo (2),

Visto el dictamen del Comité de las Regiones (3),

De conformidad con el procedimiento establecido en el artículo 251 del Tratado (4),

Considerando lo siguiente:

(1) La libre circulación de alimentos y piensos seguros y saludables constituye un aspecto esencial del mercado interior y contribuye notablemente a la salud y el bien- estar de los ciudadanos, al tiempo que favorece sus inte- reses sociales y económicos.

(2) Al aplicar las políticas comunitarias debe garantizarse un nivel elevado de protección de la vida y la salud de las personas.

(3) A fin de proteger la salud humana y la sanidad animal, los alimentos y piensos que contienen o están compuestos por organismos modificados genéticamente o han sido producidos a partir de ellos (denominados en lo sucesivo alimentos y piensos modificados genéticamente) deben someterse a una evaluación de la seguridad mediante un procedimiento comunitario antes de ser comercializados en la Comunidad.

(4) Las diferencias existentes entre las disposiciones legales, reglamentarias y administrativas nacionales en relación con la evaluación y la autorización de alimentos y piensos modificados genéticamente pueden obstaculizar su libre circulación y crear las condiciones para una competencia desigual y desleal.

(5) En el Reglamento (CE) no 258/97 del Parlamento Europeo y del Consejo, de 27 de enero de 1997, sobre nuevos alimentos y nuevos ingredientes alimentarios (5) se estableció un procedimiento de autorización aplicable a los alimentos modificados genéticamente en el que participan los Estados miembros y la Comisión. Este procedimiento debe simplificarse y hacerse más transpa- rente.

(6) El Reglamento (CE) no 258/97 establece asimismo un procedimiento de notificación en relación con alimentos nuevos esencialmente equivalentes a alimentos ya exis- tentes. Si bien la equivalencia sustancial es un paso clave en el proceso de evaluación de la seguridad de los alimentos modificados genéticamente, no constituye en sí misma una evaluación de la seguridad. Para garantizar que la autorización de los alimentos modificados genéti- camente tenga lugar de una manera clara, transparente y armonizada, debe abandonarse dicho procedimiento de notificación en relación con estos alimentos.

(7) Los piensos que contienen o están compuestos por orga- nismos modificados genéticamente (OMG) han estado sujetos hasta ahora al procedimiento de autorización que establecen la Directiva 90/220/CEE del Consejo, de 23 de abril de 1990 (6) y la Directiva 2001/18/CE del Parla- mento Europeo y del Consejo, de 12 de marzo de 2001, sobre la liberación intencional en el medio ambiente de organismos modificados genéticamente (7). No existe ningún procedimiento de autorización para los piensos producidos a partir de OMG; debe establecerse, por tanto, un procedimiento de autorización comunitario único, eficaz y transparente que se aplique a los piensos que contengan o estén compuestos por OMG o se hayan producido a partir de ellos.

(8) Las disposiciones del presente Reglamento deben apli- carse también a los piensos para animales no destinados a la producción alimentaria.

18.10.2003 L 268/1Diario Oficial de la Unión EuropeaES

(1) DO C 304 E de 30.10.2001, p. 221. (2) DO C 221 de 17.9.2002, p. 114. (3) DO C 278 de 14.11.2002, p. 31. (4) Dictamen del Parlamento Europeo de 3 de julio de 2002 (no publi-

cado aún en el Diario Oficial), Posición Común del Consejo de 17 de marzo de 2003 (DO C 113 E de 13.5.2003, p. 31), Decisión del Parlamento Europeo de 2 de julio de 2003 (no publicada aún en el Diario Oficial) y Decisión del Consejo de 22 de julio de 2003.

(5) DO L 43 de 14.2.1997, p. 1. (6) DO L 117 de 8.5.1990, p. 15; Directiva derogada por la Directiva

2001/18/CE. (7) DO L 106 de 17.4.2001, p. 1; Directiva cuya última modificación la

constituye la Decisión 2002/811/CE del Consejo (DO L 280 de 18.10.2002, p. 27).

(9) Los nuevos procedimientos de autorización de alimentos y piensos modificados genéticamente deben incorporar los nuevos principios introducidos en la Directiva 2001/ 18/CE. Además, deben hacer uso del nuevo marco para la evaluación del riesgo en cuestiones de seguridad alimentaria establecido por el Reglamento (CE) no 178/ 2002 del Parlamento Europeo y del Consejo, de 28 de enero de 2002, por el que se establecen los principios y los requisitos generales de la legislación alimentaria, se crea la Autoridad Europea de Seguridad Alimentaria y se fijan procedimientos relativos a la seguridad alimen- taria (1). Así pues, la comercialización en la Comunidad de alimentos y piensos modificados genéticamente sólo debe autorizarse tras haberse llevado a cabo, bajo responsabilidad de la Autoridad Europea de Seguridad Alimentaria (denominada en lo sucesivo la Autoridad), una evaluación científica, del mayor nivel posible, de cualquier riesgo que presenten para la salud humana y la sanidad animal y, según el caso, para el medio ambiente. A esta evaluación científica debe seguir una decisión de gestión del riesgo adoptada por la Comunidad de acuerdo con un procedimiento reglamentario que asegure una cooperación estrecha entre la Comisión y los Estados miembros.

(10) La experiencia ha demostrado que no debe concederse autorización para un único uso cuando un producto puede utilizarse como alimento y como pienso. Por lo tanto, estos productos sólo deben autorizarse si cumplen tanto los criterios de autorización aplicables a los alimentos como los aplicables a los piensos.

(11) En virtud del presente Reglamento, la autorización puede concederse a un OMG que se vaya a utilizar como materia prima para la producción de alimentos o piensos, o a los productos con fines de alimentación humana o animal que contienen o están compuestos por ese organismo o han sido producidos a partir de él, o bien a los alimentos o los piensos producidos a partir de un OMG. Así, si el OMG utilizado en la producción de alimentos o piensos ha sido autorizado conforme al presente Reglamento, los alimentos y los piensos que contengan o estén compuestos por este OMG o hayan sido producidos a partir de él no necesitan una autoriza- ción con arreglo al presente Reglamento, pero están sujetos a los requisitos establecidos en la autorización concedida al OMG en cuestión. Además, los alimentos cubiertos por una autorización concedida conforme al presente Reglamento están exentos de los requisitos esta- blecidos en el Reglamento (CE) no 258/97 sobre nuevos alimentos y nuevos ingredientes alimentarios, salvo que entren en una o varias de las categorías que se establecen en la letra a) del apartado 2 del artículo 1 de dicho Reglamento en relación con una característica que no haya sido tomada en consideración para la autorización concedida en virtud del presente Reglamento.

(12) La Directiva 89/107/CEE del Consejo, de 21 de diciembre de 1988, relativa a la aproximación de las legislaciones de los Estados Miembros sobre los aditivos

alimentarios autorizados en los productos alimenticios destinados al consumo humano (2), regula la autoriza- ción de aditivos utilizados en productos alimenticios. Además de someterse a este procedimiento de autoriza- ción, los aditivos alimentarios que contienen o están compuestos por OMG o han sido producidos a partir de OMG deben entrar también en el ámbito de aplicación del presente Reglamento por lo que se refiere a la evalua- ción de la seguridad de la modificación genética, si bien la autorización final debe concederse conforme al proce- dimiento establecido en la citada Directiva 89/107/CEE.

(13) Los aromatizantes que entran en el ámbito de aplicación de la Directiva 88/388/CEE del Consejo, de 22 de junio de 1988, relativa a la aproximación de las legislaciones de los Estados miembros en el ámbito de los aromas que se utilizan en los productos alimenticios y de los mate- riales de base para su producción (3), que contienen o están compuestos por OMG o han sido producidos a partir de OMG deben entrar también en el ámbito de aplicación del presente Reglamento por lo que se refiere a la evaluación de la seguridad de la modificación gené- tica.

(14) La Directiva 82/471/CEE del Consejo, de 30 de junio de 1982, relativa a determinados productos utilizados en la alimentación animal (4), contiene disposiciones sobre un procedimiento de aprobación de productos utilizados en la alimentación animal producidos mediante diversas tecnologías que pueden presentar riesgos para la salud humana, la sanidad animal y el medio ambiente. Los productos que contienen o están compuestos por OMG o han sido producidos a partir de OMG deben, sin embargo, entrar en el ámbito de aplicación del presente Reglamento.

(15) La Directiva 70/524/CEE del Consejo, de 23 de noviembre de 1970, sobre los aditivos en la alimenta- ción animal (5), contiene disposiciones sobre un procedi- miento de autorización para la comercialización de aditivos utilizados en piensos. Además de someterse a este procedimiento de autorización, los aditivos para piensos que contienen o están compuestos por OMG o han sido producidos a partir de OMG deben entrar también en el ámbito del presente Reglamento.

(16) El presente Reglamento debe aplicarse a los alimentos y los piensos producidos «a partir de» un OMG, pero no a los alimentos y los piensos «con» un OMG. El criterio determinante es si en el alimento o el pienso está presente algún material derivado del material de partida modificado genéticamente. Los auxiliares tecnológicos utilizados únicamente durante el proceso de producción del alimento o el pienso no entran en la definición de alimento o pienso y, por lo tanto, tampoco en el ámbito de aplicación del presente Reglamento. Tampoco entran en el ámbito de aplicación del presente Reglamento los alimentos y los piensos que se han fabricado con ayuda de un auxiliar tecnológico modificado genéticamente.

18.10.2003L 268/2 Diario Oficial de la Unión EuropeaES

(1) DO L 31 de 1.2.2002, p. 1.

(2) DO L 40 de 11.2.1989, p. 27; Directiva modificada por la Directiva 94/34/CE del Parlamento Europeo y del Consejo (DO L 237 de 10.9.1994, p. 1).

(3) DO L 184 de 15.7.1988, p. 61; Directiva modificada por la Direc- tiva 91/71/CEE de la Comisión (DO L 42 de 15.2.1991, p. 25).

(4) DO L 213 de 21.7.1982, p. 8; Directiva cuya última modificación la constituye la Directiva 1999/20/CE (DO L 80 de 25.3.1999, p. 20).

(5) DO L 270 de 14.12.1970, p. 1; Directiva cuya última modificación la constituye el Reglamento (CE) no 1756/2002 (DO L 265 de 3.10.2002, p. 1).

Así, los productos obtenidos a partir de animales alimen- tados con piensos modificados genéticamente o tratados con productos veterinarios modificados genéticamente no estarán sujetos ni a los requisitos de autorización ni a los requisitos de etiquetado establecidos en el presente Reglamento.

(17) De acuerdo con el artículo 153 del Tratado, la Comu- nidad contribuirá a promover el derecho de los consumi- dores a la información. Además de los otros tipos de información al público que establece el presente Regla- mento, el etiquetado de los productos permite a los consumidores elegir con conocimiento de causa y contri- buye a que las transacciones entre vendedor y comprador sean justas.

(18) El artículo 2 de la Directiva 2000/13/CE del Parlamento Europeo y del Consejo, de 20 de marzo de 2000, relativa a la aproximación de las legislaciones de los Estados miembros en materia de etiquetado, presentación y publicidad de los productos alimenticios (1), establece que el etiquetado no debe inducir a error al comprador con respecto a las características del producto alimen- ticio y, en particular, a su naturaleza, identidad, cuali- dades, composición y modo de obtención y fabricación.

(19) Existen requisitos adicionales de etiquetado de los alimentos modificados genéticamente en el Reglamento (CE) no 258/97, en el Reglamento (CE) no 1139/98 del Consejo, de 26 de mayo de 1998, relativo a la indicación obligatoria, en el etiquetado de determinados productos alimenticios fabricados a partir de organismos modifi- cados genéticamente, de información distinta de la prevista en la Directiva 79/112/CEE (2), y en el Regla- mento (CE) no 50/2000 de la Comisión, de 10 de enero de 2000, relativo al etiquetado de los productos alimen- ticios e ingredientes alimentarios que contienen aditivos y aromas modificados genéticamente o producidos a partir de organismos modificados genéticamente (3).

(20) Deben establecerse unos requisitos armonizados de etiquetado para los piensos modificados genéticamente, para ofrecer al usuario final, en particular a los gana- deros, una información precisa sobre la composición y las propiedades de los piensos que permita al usuario realizar una elección informada.

(21) En el etiquetado debe informarse de manera objetiva de que el alimento o el pienso contiene o está compuesto por OMG o ha sido producido a partir de OMG. Un etiquetado claro, al margen de la detectabilidad del ADN o la proteína resultantes de la modificación genética en el producto final, responde a los deseos expresados por la gran mayoría de los consumidores en numerosas encuestas, permite elegir con conocimiento de causa y descarta la posibilidad de que los consumidores se vean inducidos a error por lo que respecta al método de fabri- cación o producción.

(22) Las etiquetas deben dar asimismo información de cual- quier característica o propiedad que haga que el alimento o el pienso sean diferentes a sus homólogos convencionales por lo que se refiere a la composición, el valor o los efectos nutricionales, el uso al que están destinados o los efectos sobre la salud de determinados sectores de la población, así como cualquier caracterís- tica o propiedad que genere inquietudes de orden ético o religioso.

(23) El Reglamento (CE) no 1830/2003 del Parlamento Europeo y del Consejo, de 22 de septiembre de 2003, relativo a la trazabilidad y al etiquetado de organismos modificados genéticamente y a la trazabilidad de alimentos y piensos producidos a partir de éstos y por el que se modifica la Directiva 2001/18/CE (4) garantiza que la información pertinente con respecto a la modifi- cación genética esté disponible en todas las fases de la comercialización de OMG y de alimentos y piensos producidos a partir de OMG, y debe, por tanto, facilitar un correcto etiquetado.

(24) A pesar de que algunos operadores evitan el uso de alimentos y piensos modificados genéticamente, pueden aparecer trazas diminutas en los alimentos y los piensos convencionales como consecuencia de una presencia accidental o técnicamente inevitable en el momento de la producción de la semilla, el cultivo, la cosecha, el transporte o la transformación. En estos casos, el alimento o el pienso no debe estar sujeto a los requisitos de etiquetado establecidos en el presente Reglamento; para ello, debe fijarse un umbral de presencia accidental o técnicamente inevitable de materiales modificados genéticamente en los alimentos o los piensos, tanto cuando la comercialización de dicho material esté autori- zada en la Comunidad como cuando su presencia se tolere en virtud del presente Reglamento.

(25) Conviene establecer que cuando el nivel combinado de la presencia accidental o técnicamente inevitable del material modificado genéticamente en un alimento o pienso o en uno de sus componentes sea superior al umbral establecido, dicha presencia se indique con arreglo a lo dispuesto en el presente Reglamento y que se adopten disposiciones detalladas para su aplicación. Debe preverse la posibilidad de establecer umbrales más bajos, en especial para los alimentos y piensos que contengan o consistan en OMG o con objeto de tener en cuenta los avances científicos y tecnológicos.

(26) Es indispensable que los operadores se esfuercen por evitar la presencia accidental de material modificado genéticamente no autorizado con arreglo a la legislación comunitaria en los alimentos y los piensos. Sin embargo,

18.10.2003 L 268/3Diario Oficial de la Unión EuropeaES

(1) DO L 109 de 6.5.2000, p. 29; Directiva modificada por la Directiva 2001/101/CE de la Comisión (DO L 310 de 28.11.2001, p. 19).

(2) DO L 159 de 3.6.1998, p. 4; Reglamento modificado por el Regla- mento (CE) no 49/2000 de la Comisión (DO L 6 de 11.1.2000, p. 13).

(3) DO L 6 de 11.1.2000, p. 15. (4) Véase la página 24 del presente Diario Oficial.

para garantizar que el presente Reglamento sea practi- cable y viable, debe establecerse un umbral específico, con la posibilidad de establecer niveles inferiores, en especial para los OMG vendidos directamente al consu- midor final, como medida transitoria aplicable a trazas diminutas, presentes en alimentos o piensos, de dichos materiales modificados genéticamente, cuando su presencia sea accidental o técnicamente inevitable, y siempre que se cumplan todas las condiciones específicas que establece el presente Reglamento. La Directiva 2001/18/CE debe modificarse en consecuencia. La apli- cación de esta medida debe revisarse en el contexto de la revisión general de la aplicación del presente Regla- mento.

(27) Para determinar que la presencia de estos materiales es accidental o técnicamente inevitable, los operadores deben poder demostrar a las autoridades competentes que han adoptado las medidas apropiadas para evitar la presencia de alimentos o piensos modificados genética- mente.

(28) Los operadores deben impedir la presencia accidental de OMG en otros productos. La Comisión debe recoger información y desarrollar, basándose en dicha informa- ción, orientaciones sobre la coexistencia de cultivos modificados genéticamente, cultivos convencionales y cultivos biológicos. Además, se invita a la Comisión a que presente, lo antes posible, cualquier otra propuesta necesaria.

(29) La trazabilidad y el etiquetado de los OMG en todas las fases de su comercialización, incluida la posibilidad de establecer umbrales, se garantizan mediante la Directiva 2001/18/CE y el Reglamento (CE) no 1830/2003.

(30) Es necesario establecer procedimientos armonizados de evaluación del riesgo y de autorización que sean eficaces, rápidos y transparentes, y criterios para la evaluación de los riesgos potenciales derivados de los alimentos y piensos modificados genéticamente.

(31) A fin de garantizar una evaluación científica armonizada de los alimentos y piensos modificados genéticamente, ésta debe ser efectuada por la Autoridad. Sin embargo, dado que los actos u omisiones de actuar específicos por parte de la Autoridad, con arreglo al presente Regla- mento, podrían tener consecuencias jurídicas directas para los solicitantes, es conveniente ofrecer la posibilidad de una revisión administrativa de dichos actos u omisiones.

(32) Es un hecho reconocido que, en algunos casos, la evalua- ción científica del riesgo no puede por sí sola propor- cionar toda la información en la que debe basarse una

decisión de gestión del riesgo, y que pueden tenerse en cuenta otros factores legítimos relevantes para el asunto sometido a consideración.

(33) Cuando la solicitud se refiera a productos que contengan o consistan en OMG, el solicitante debe tener la posibi- lidad de elegir entre presentar una autorización de libera- ción intencional en el medio ambiente ya obtenida con arreglo a la parte C de la Directiva 2001/18/CE, sin perjuicio de las condiciones establecidas por dicha auto- rización, o solicitar que se lleve a cabo la evaluación del riesgo para el medio ambiente en el mismo momento que la evaluación de la seguridad con arreglo al presente Reglamento. En este último caso, es necesario que la evaluación del riesgo para el medio ambiente respete las exigencias que establece la Directiva 2001/18/CE y que la Autoridad consulte a las autoridades nacionales competentes designadas por los Estados miembros con este fin. Además, es conveniente dar a la Autoridad la posibilidad de solicitar a una de dichas autoridades competentes que lleve a cabo la evaluación del riesgo para el medio ambiente. Asimismo es conveniente, en consonancia con el apartado 4 del artículo 12 de la Directiva 2001/18/CE, que la Autoridad consulte a las autoridades nacionales competentes designadas con arreglo a dicha Directiva en todos los casos relativos a OMG y a alimentos o piensos que contengan o consistan en un OMG antes de que finalice la evaluación del riesgo para el medio ambiente.

(34) En el caso de OMG que hayan de utilizarse como semi- llas u otras plántulas y material de multiplicación que estén cubiertos por el presente Reglamento, la Autoridad debe delegar la evaluación del riesgo para el medio ambiente en una autoridad nacional competente. No obstante, las autorizaciones concedidas con arreglo al presente Reglamento deben ser sin perjuicio de las disposiciones de las Directivas 68/193/CEE (1), 2002/53/ CE (2) y 2002/55/CE (3), que establecen en especial las normas y criterios para la aceptación de las variedades y su aceptación oficial para ser incluidas en catálogos comunes, y de las disposiciones de las Directivas 66/ 401/CEE (4), 66/402/CEE (5), 68/193/CEE, 92/33/CEE (6), 92/34/CEE (7), 2002/54/CE (8), 2002/55/CE, 2002/56/ CE (9) y 2002/57/CE (10), que regulan en particular la certificación y la comercialización de semillas y otras plántulas y material de multiplicación.

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(1) DO L 93 de 17.4.1968, p. 15; Directiva cuya última modificación la constituye la Directiva 2002/11/CE (DO L 53 de 23.2.2002, p. 20).

(2) DO L 193 de 20.7.2002, p. 1. (3) DO L 193 de 20.7.2002, p. 33. (4) DO 125 de 11.7.1966, p. 2298/66; Directiva cuya última modifica-

ción la constituye la Directiva 2001/64/CE (DO L 234 de 1.9.2001, p. 60).

(5) DO 125 de 11.7.1966, p. 2309/66; Directiva cuya última modifica- ción la constituye la Directiva 2001/64/CE.

(6) DO L 157 de 10.6.1992, p. 1; Directiva cuya última modificación la constituye el Reglamento (CE) no 806/2003 (DO L 122 de 16.5.2003, p. 1).

(7) DO L 157 de 10.6.1992, p. 10. Directiva cuya última modificación la constituye el Reglamento (CE) no 806/2003.

(8) DO L 193 de 20.7.2002, p. 12. (9) DO L 193 de 20.7.2002, p. 60; Directiva modificada por la Deci-

sión 2003/66/CE de la Comisión (DO L 25 de 30.1.2003, p. 42). (10) DO L 193 de 20.7.2002, p. 74; Directiva cuya última modificación

la constituye la Directiva 2003/45/CE de la Comisión (DO L 138 de 5.6.2003, p. 40).

(35) Es necesario introducir, cuando sea procedente y con base en las conclusiones de la evaluación del riesgo, requisitos sobre el seguimiento postcomercialización del uso de los alimentos modificados genéticamente desti- nados a la alimentación humana y del uso de los piensos modificados genéticamente destinados a la alimentación animal. En el caso de los OMG, la Directiva 2001/18/CE obliga a aplicar un plan de seguimiento en relación con los efectos medioambientales.

(36) Para facilitar los controles sobre los alimentos y piensos modificados genéticamente, los solicitantes de autoriza- ción deben proponer métodos adecuados de muestreo, identificación y detección, y depositar muestras del alimento o el pienso modificado genéticamente ante la Autoridad. Cuando proceda, los métodos de muestreo y detección deben ser validados por el laboratorio comuni- tario de referencia.

(37) A la hora de aplicar el presente Reglamento deben tenerse en cuenta los progresos tecnológicos y los avances científicos.

(38) Los alimentos y piensos cubiertos por el presente Regla- mento que hayan sido puestos en el mercado comuni- tario legalmente antes de la fecha de aplicación del presente Reglamento deben seguir siendo permitidos en el mercado, a condición de que los operadores propor- cionen a la Comisión, en los seis meses siguientes a la fecha de aplicación del presente Reglamento, informa- ción sobre la evaluación del riesgo y sobre los métodos de muestreo, identificación y detección, según corres- ponda, incluyendo la transmisión de muestras de los alimentos y los piensos, así como muestras de control.

(39) Debe crearse un registro de los alimentos y piensos modificados genéticamente autorizados conforme al presente Reglamento, en el que deben figurar datos específicos sobre el producto, estudios que demuestren su seguridad, incluida, si está disponible, una referencia a estudios independientes y revisados por otros especia- listas de muestreo, identificación y detección, y a los métodos respectivos. Toda la información que no sea confidencial debe ponerse a disposición del público.

(40) Para impulsar la investigación y el desarrollo sobre los OMG con fines de alimentación humana o animal, conviene proteger la inversión realizada por las personas innovadoras al recoger la información y los datos en que han apoyado la solicitud presentada conforme al presente Reglamento. No obstante, esta protección debe tener una duración limitada, a fin de evitar una repeti- ción innecesaria de estudios y ensayos que iría en perjuicio del interés público.

(41) Las medidas necesarias para la ejecución del presente Reglamento deben aprobarse con arreglo a la Decisión 1999/468/CE del Consejo, de 28 de junio de 1999, por la que se establecen los procedimientos para el ejercicio de las competencias de ejecución atribuidas a la Comi- sión (1).

(42) Deben incluirse las disposiciones necesarias para la consulta al Grupo europeo de ética de la ciencia y de las nuevas tecnologías, creado por Decisión de la Comisión de 16 de diciembre de 1997, o a cualquier otro orga- nismo apropiado establecido por la Comisión, a fin de recibir su asesoramiento con respecto a las cuestiones éticas relacionadas con la comercialización de alimentos o piensos modificados genéticamente, sin perjuicio de las competencias de los Estados miembros en cuestiones de ética.

(43) A fin de proporcionar un nivel elevado de protección de la vida y la salud de las personas, de la sanidad y el bien- estar de los animales, del medio ambiente y de los inte- reses de los consumidores en relación con los alimentos y los piensos modificados genéticamente, es preciso que los requisitos establecidos en el presente Reglamento se apliquen de forma no discriminatoria a los productos originarios de la Comunidad y a los importados de terceros países, de conformidad con los principios gene- rales establecidos en el Reglamento (CE) no 178/2002. El presente Reglamento tiene debidamente en cuenta los compromisos comerciales internacionales de las Comu- nidades Europeas y los requisitos del Protocolo de Carta- gena sobre Seguridad de la Biotecnología del Convenio sobre la Diversidad Biológica, por lo que respecta a las obligaciones de los importadores y a la notificación.

(44) Algunos actos comunitarios deben ser derogados y otros modificados como consecuencia del presente Regla- mento.

(45) La puesta en práctica del presente Reglamento debe revi- sarse a la vista de la experiencia adquirida a corto plazo y la Comisión debe hacer el seguimiento de las repercu- siones de la aplicación del presente Reglamento en la salud humana y en la sanidad animal, la protección del consumidor, la información del consumidor y el funcio- namiento del mercado interior.

HAN ADOPTADO EL PRESENTE REGLAMENTO:

CAPÍTULO I

OBJETIVO Y DEFINICIONES

Artículo 1

Objetivo

El objetivo del presente Reglamento, con arreglo a los princi- pios generales contenidos en el Reglamento (CE) no 178/2002, es:

a) sentar las bases para asegurar un nivel elevado de protección de la vida y la salud de las personas, de la sanidad y el bien- estar de los animales, del medio ambiente y de los intereses de los consumidores en relación con los alimentos y piensos modificados genéticamente, al tiempo que se asegura el funcionamiento eficaz del mercado interior;

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(1) DO L 184 de 17.7.1999, p. 23.

b) establecer procedimientos comunitarios para la autorización y supervisión de los alimentos y piensos modificados genéti- camente;

c) establecer disposiciones relativas al etiquetado de los alimentos y piensos modificados genéticamente.

Artículo 2

Definiciones

A efectos del presente Reglamento:

1) Se aplicarán las definiciones de alimento, pienso, consumidor final, empresa alimentaria y empresa de piensos contenidas en el Reglamento (CE) no 178/2002.

2) Se aplicará la definición de trazabilidad establecida en el Reglamento (CE) no 1830/2003.

3) Se entenderá por operador la persona física o jurídica responsable de asegurar el cumplimiento de los requisitos del presente Reglamento en las empresas alimentarias o empresas de piensos bajo su control.

4) Se aplicarán las definiciones de organismo, liberación inten- cional y evaluación del riesgo para el medio ambiente estable- cidas en la Directiva 2001/18/CE.

5) Se entenderá por organismo modificado genéticamente u OMG un organismo modificado genéticamente tal como se define en el punto 2 del artículo 2 de la Directiva 2001/ 18/CE, con exclusión de los organismos obtenidos mediante las técnicas de modificación genética enumeradas en el anexo I B de la Directiva 2001/18/CE.

6) Alimentos modificados genéticamente son aquellos que contienen o están compuestos por OMG o han sido produ- cidos a partir de ellos.

7) Piensos modificados genéticamente son aquellos que contienen o están compuestos por OMG o han sido producidos a partir de ellos.

8) Organismo modificado genéticamente destinado a la alimenta- ción humana es aquel OMG que puede utilizarse como alimento o como material de partida para la producción de alimentos.

9) Organismo modificado genéticamente destinado a la alimenta- ción animal es aquel OMG que puede utilizarse como pienso o como material de partida para la producción de piensos.

10) Producido a partir de OMG es el derivado total o parcial- mente de OMG, pero sin contener o estar compuesto por OMG.

11) Muestra de control es el OMG o su material genético (muestra positiva) y el organismo parental, o el material genético de éste, que se ha utilizado para la modificación genética (muestra negativa).

12) Homólogo convencional es cualquier alimento o pienso similar producido sin la ayuda de modificación genética y para el cual existe un historial de uso seguro bien docu- mentado.

13) Ingrediente es el ingrediente al que se refiere el apartado 4 del artículo 6 de la Directiva 2000/13/CE.

14) Comercialización es la tenencia de alimentos o piensos con el propósito de venderlos; se incluye la oferta de venta o cualquier otra forma de transferencia, ya sea a título oneroso o gratuito, así como la venta, distribución u otra forma de transferencia.

15) Alimento preenvasado es un artículo unitario para la presen- tación como tal, integrado por un alimento y el envase en el que haya sido colocado antes de ponerlo en venta y que lo cubra de forma total o parcial, de manera que el conte- nido no pueda modificarse sin abrir o alterar el envase.

16) Colectividades son las colectividades mencionadas en el artículo 1 de la Directiva 2000/13/CE.

CAPÍTULO II

ALIMENTOS MODIFICADOS GENÉTICAMENTE

Se cc i ón 1

A ut o ri zac i ó n y su p e rvi si ón

Artículo 3

Ámbito de aplicación

1. La presente sección se aplicará a:

a) los OMG destinados a la alimentación humana;

b) los alimentos que contengan o estén compuestos por OMG;

c) los alimentos que se hayan producido a partir de OMG o que contengan ingredientes producidos a partir de estos organismos.

2. Cuando sea necesario, podrá determinarse, de confor- midad con el procedimiento mencionado en el apartado 2 del artículo 35, si un tipo de alimento entra en el ámbito de aplica- ción de la presente sección.

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Artículo 4

Requisitos

1. Los alimentos contemplados en el apartado 1 del artículo 3 no deberán:

a) tener efectos negativos sobre la salud humana, la sanidad animal o el medio ambiente;

b) inducir a error al consumidor;

c) diferenciarse de los alimentos que están destinados a susti- tuir de tal manera que su consumo normal resulte desventa- joso, desde el punto de vista nutricional, para los consumi- dores.

2. No se comercializará un OMG destinado a la alimenta- ción humana o un alimento de los contemplados en el apartado 1 del artículo 3 a menos que estén cubiertos por una autoriza- ción concedida de acuerdo con lo dispuesto en la presente sección y cumplan las condiciones pertinentes establecidas en dicha autorización.

3. No se autorizará ningún OMG destinado a la alimenta- ción humana o un alimento de los contemplados en el apartado 1 del artículo 3 a menos que el solicitante de la autorización haya demostrado adecuada y suficientemente que cumplen lo dispuesto en el apartado 1 del presente artículo.

4. La autorización a que se hace referencia en el apartado 2 podrá aplicarse a:

a) un OMG y a los alimentos que lo contengan o estén compuestos por él, así como a los alimentos producidos a partir de dicho OMG o con ingredientes producidos a partir de él;

b) alimentos producidos a partir de un OMG, así como a los alimentos que contengan o hayan sido producidos a partir de ese alimento;

c) un ingrediente producido a partir de un OMG, así como a los alimentos que contengan ese ingrediente.

5. La autorización a que se hace referencia en el apartado 2 no será concedida, denegada, renovada, modificada, suspendida o revocada más que por las razones y conforme a los procedi- mientos establecidos en el presente Reglamento.

6. El solicitante de la autorización a que se hace referencia en el apartado 2 y, una vez concedida ésta, el titular de la misma o su representante, deberá estar establecido en la Comu- nidad.

7. La autorización contemplada en el presente Reglamento se concederá sin perjuicio de lo establecido en las Directivas 2002/53/CE, 2002/55/CE y 68/193/CEE.

Artículo 5

Solicitud de autorización

1. Para obtener la autorización a que se hace referencia en el apartado 2 del artículo 4, deberá presentarse una solicitud con arreglo a las disposiciones siguientes.

2. La solicitud se enviará a la autoridad nacional competente del Estado miembro.

a) La autoridad nacional competente:

i) enviará por escrito al solicitante un acuse de recibo de la solicitud en los 14 días siguientes a la recepción de la misma, en el que deberá figurar la fecha de la recepción de la solicitud,

ii) informará sin demora a la Autoridad Europea de Segu- ridad Alimentaria, denominada en lo sucesivo la Auto- ridad, y

iii) pondrá dicha solicitud y cualquier información comple- mentaria que el solicitante le haya transmitido a disposi- ción de la Autoridad.

b) La Autoridad:

i) informará sin demora a los demás Estados miembros y a la Comisión de la solicitud y pondrá a su disposición dicha solicitud y cualquier información complementaria que el solicitante le haya transmitido,

ii) pondrá a disposición del público el resumen del expe- diente previsto en la letra l) del apartado 3.

3. La solicitud deberá ir acompañada de lo siguiente:

a) nombre y dirección del solicitante;

b) denominación del alimento y características del mismo, en especial la operación u operaciones de transformación prac- ticadas;

c) cuando proceda, la información requerida en el anexo II del Protocolo de Cartagena sobre Seguridad de la Biotecnología del Convenio sobre la Diversidad Biológica, denominado en lo sucesivo Protocolo de Cartagena;

d) cuando proceda, una descripción detallada del método de obtención y fabricación;

e) una copia de los estudios llevados a cabo, incluidos, si los hubiera, estudios independientes y revisados por otros espe- cialistas, y cualquier otro material disponible para demostrar que el alimento cumple los criterios establecidos en el apar- tado 1 del artículo 4;

f) bien un análisis apoyado por la información y los datos apropiados, que muestre que las características del alimento no difieren de las de su homólogo convencional, teniendo en cuenta las tolerancias aplicadas a las variaciones naturales de dichas características y los criterios especificados en la letra a) del apartado 2 del artículo 13, o bien una propuesta de etiquetado del alimento de acuerdo con la letra a) del apartado 2 del artículo 13 y con el apartado 3 de ese mismo artículo;

g) bien una declaración motivada de que el alimento no genera inquietudes de orden ético o religioso, o bien una propuesta de etiquetado de acuerdo con la letra b) del apartado 2 del artículo 13;

h) cuando proceda, las condiciones de comercialización del alimento o de los alimentos producidos a partir de él, incluidas las condiciones específicas de utilización y mani- pulación;

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i) métodos de detección, muestreo (con inclusión de referen- cias a métodos de muestreo existentes oficiales o normali- zados) e identificación de la transformación, y, cuando sean aplicables, de detección e identificación de la transformación en el alimento y/o en los alimentos producidos a partir de él;

j) muestras del alimento y sus muestras de control, e informa- ción sobre el lugar en que se puede acceder al material de referencia;

k) cuando proceda, una propuesta de seguimiento postcomer- cialización del uso del alimento para el consumo humano;

l) un resumen del expediente en formato normalizado.

4. En el caso de una solicitud relacionada con un OMG destinado a la alimentación humana, las referencias a «alimento» del apartado 3 se interpretarán como referencias a un alimento que contiene o está compuesto por el OMG para el que se hace la solicitud o ha sido producido a partir de él.

5. En el caso de los OMG o de los alimentos que contienen o están compuestos por OMG, la solicitud irá también acompa- ñada de lo siguiente:

a) el expediente técnico completo que ofrezca la información que exigen los anexos III y IV de la Directiva 2001/18/CE, así como la información y las conclusiones de la evaluación del riesgo llevada a cabo conforme a los principios estable- cidos en el anexo II de la citada Directiva, o una copia de la decisión de autorización en caso de que la comercialización del OMG se haya autorizado conforme a la parte C de la citada Directiva;

b) un plan de seguimiento de los efectos medioambientales conforme con el anexo VII de la Directiva 2001/18/CE, que incluya una propuesta de duración del propio plan; la dura- ción del plan de seguimiento podrá ser diferente del período de validez propuesto para la autorización.

En este caso, no se aplicarán los artículos 13 a 24 de la Direc- tiva 2001/18/CE.

6. Cuando la solicitud se refiera a una sustancia cuya utiliza- ción y comercialización estén sujetas, con arreglo a otras dispo- siciones de Derecho comunitario, a su inclusión en una lista de sustancias registradas o autorizadas con exclusión de otras, deberá hacerse constar así en la solicitud, e indicarse en ella la situación de la sustancia en virtud de la legislación aplicable.

7. La Comisión, previa consulta a la Autoridad, establecerá normas de desarrollo del presente artículo de conformidad con el procedimiento mencionado en el apartado 2 del artículo 35, incluidas normas para la preparación y la presentación de la solicitud.

8. Antes de la fecha de aplicación del presente Reglamento, la Autoridad publicará instrucciones detalladas para asistir al solicitante en la preparación y presentación de la solicitud.

Artículo 6

Dictamen de la Autoridad

1. La Autoridad procurará emitir su dictamen en un plazo de seis meses a partir de la recepción de una solicitud válida. Este plazo se ampliará cuando la Autoridad pida información complementaria al solicitante, con arreglo a lo dispuesto en el apartado 2.

2. Cuando proceda, la Autoridad o una autoridad nacional competente, por mediación de la Autoridad, podrá pedir al soli- citante que complemente, en un plazo determinado, la informa- ción que acompaña a la solicitud.

3. Para preparar su dictamen, la Autoridad:

a) verificará que la información y la documentación presen- tadas por el solicitante son conformes a lo dispuesto en el artículo 5 y determinará si el alimento cumple los criterios establecidos en el apartado 1 del artículo 4;

b) podrá pedir al organismo encargado de la evaluación de alimentos en un Estado miembro que evalúe la seguridad del alimento, de conformidad con el artículo 36 del Regla- mento (CE) no 178/2002;

c) podrá pedir a la autoridad competente designada de acuerdo con el artículo 4 de la Directiva 2001/18/CE que realice una evaluación del riesgo para el medio ambiente; si la solicitud se refiere a OMG que deban utilizarse como semillas u otras plántulas y material de multiplicación, la Autoridad deberá pedir a una autoridad nacional competente que lleve a cabo la evaluación del riesgo para el medio ambiente;

d) remitirá al laboratorio comunitario de referencia a que se refiere el artículo 32 lo dispuesto en las letras i) y j) del apartado 3 del artículo 5. Dicho laboratorio comunitario de referencia probará y validará el método de detección e iden- tificación propuesto por el solicitante;

e) a fin de verificar la aplicación de lo dispuesto en la letra a) del apartado 2 del artículo 13, examinará la información y los datos presentados por el solicitante para demostrar que las características del alimento no difieren de las de su homólogo convencional, teniendo en cuenta las tolerancias aplicadas a las variaciones naturales de esas características.

4. En el caso de los OMG o de los alimentos que contienen o están compuestos por OMG, se aplicarán a la evaluación los requisitos de seguridad medioambiental establecidos en la Directiva 2001/18/CE, a fin de garantizar que se toman todas las medidas adecuadas para evitar los efectos perjudiciales que la liberación intencional de OMG podría tener para la salud humana, la sanidad animal o el medio ambiente. Durante la evaluación de las solicitudes para comercializar productos que estén compuestos por OMG o los contengan, la Autoridad consultará a la autoridad nacional competente en el sentido de la Directiva 2001/18/CE designada por cada Estado miembro para este fin. Las autoridades competentes dispondrán de tres meses tras la fecha de recepción de la solicitud para dar a conocer su dictamen.

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5. En caso de dictamen favorable a la autorización del alimento, este dictamen incluirá además lo siguiente:

a) el nombre y la dirección del solicitante;

b) la denominación y las características del alimento;

c) cuando proceda, la información requerida en el anexo II del Protocolo de Cartagena;

d) la propuesta de etiquetado del alimento o de los alimentos producidos a partir de él;

e) cuando proceda, las condiciones o restricciones que deberían imponerse a la comercialización y/o las condi- ciones o restricciones específicas de utilización y manipula- ción, así como los requisitos de seguimiento postcomerciali- zación basados en los resultados de la evaluación del riesgo y, en el caso de los OMG o de los alimentos que contienen o están compuestos por OMG, las condiciones para la protección de ecosistemas o del medio ambiente y zonas geográficas particulares;

f) el método de detección, validado por el laboratorio de refe- rencia comunitario, que incluya el muestreo, la identifica- ción de la transformación y, cuando proceda, de detección e identificación de la transformación en el alimento y/o en los alimentos producidos a partir de él; indicación del lugar en que pueda accederse a material de referencia pertinente;

g) cuando proceda, el plan de seguimiento al que se refiere la letra b) del apartado 5 del artículo 5.

6. La Autoridad enviará su dictamen a la Comisión, a los Estados miembros y al solicitante, junto con un informe en el que describa la evaluación efectuada del alimento e indique las razones y la información sobre las que se base el dictamen, incluidos los dictámenes de las autoridades competentes cuando se les consulte de conformidad con lo que dispone el apartado 4.

7. La Autoridad, con arreglo a lo dispuesto en el apartado 1 del artículo 38 del Reglamento (CE) no 178/2002, hará público su dictamen tras haber eliminado cualquier dato que se consi- dere confidencial de conformidad con el artículo 30 del presente Reglamento. Cualquier persona podrá remitir sus comentarios a la Comisión en los 30 días siguientes a la publi- cación del dictamen.

Artículo 7

Autorización

1. En el plazo de tres meses tras la recepción del dictamen de la Autoridad, la Comisión presentará al Comité a que se refiere el artículo 35 un proyecto de la decisión que deberá adoptarse respecto de la solicitud, teniendo en cuenta el dictamen de la Autoridad, cualesquiera disposiciones perti- nentes de la legislación comunitaria y otros factores legítimos relativos al asunto considerado. Cuando el proyecto de decisión no sea conforme al dictamen de la Autoridad, la Comisión motivará las diferencias.

2. En el caso de un proyecto de decisión que prevea la concesión de una autorización, dicho proyecto de decisión deberá incluir los detalles mencionados en el apartado 5 del

artículo 6, el nombre del titular de la autorización y, cuando resulte apropiado, el identificador único atribuido al OMG mencionado en el Reglamento (CE) no 1830/2003.

3. Se adoptará una decisión final sobre la solicitud de conformidad con el procedimiento mencionado en el apartado 2 del artículo 35.

4. La Comisión comunicará inmediatamente al solicitante la decisión que se haya adoptado y publicará una información sobre esta decisión en el Diario Oficial de la Unión Europea.

5. La autorización concedida conforme al procedimiento establecido en el presente Reglamento será válida en toda la Comunidad por un período de 10 años renovable de acuerdo con el artículo 11. El alimento autorizado será inscrito en el registro a que se refiere el artículo 28. Cada entrada de ese registro mencionará la fecha de autorización e incluirá lo dispu- esto en el apartado 2.

6. La autorización concedida en virtud de la presente sección se entenderá sin perjuicio de otras disposiciones de Derecho comunitario por las que se rijan el uso y la comerciali- zación de sustancias que sólo pueden ser utilizadas si se incluyen en una lista de sustancias registradas o autorizadas con exclusión de otras.

7. La concesión de la autorización no disminuirá en modo alguno la responsabilidad civil y penal general del operador del sector de los alimentos en relación con el alimento en cuestión.

8. Las referencias que se hacen en las partes A y D de la Directiva 2001/18/CE a los OMG autorizados con arreglo a lo dispuesto en la parte C de dicha Directiva se considerarán válidas igualmente para los OMG autorizados en virtud del presente Reglamento.

Artículo 8

Situación de los productos existentes

1. No obstante lo dispuesto en el apartado 2 del artículo 4, los productos que entren en el ámbito de aplicación de la presente sección y hayan sido legalmente comercializados en la Comunidad antes de la fecha de aplicación del presente Regla- mento podrán seguir comercializándose, utilizándose y trans- formándose siempre que se cumplan las siguientes condiciones:

a) en el caso de productos que hayan sido comercializados con arreglo a la Directiva 90/220/CEE antes de la entrada en vigor del Reglamento (CE) no 258/97, o bien conforme a lo dispuesto por dicho Reglamento, los operadores responsa- bles de la comercialización de los productos en cuestión notificarán a la Comisión, en los seis meses siguientes a la fecha de aplicación del presente Reglamento, la fecha en que dichos productos se comercializaron por primera vez en la Comunidad;

b) en el caso de productos que hayan sido legalmente comer- cializados en la Comunidad, pero que no se encuentren contemplados en la letra a), los operadores responsables de la comercialización de los productos en cuestión notificarán a la Comisión, en los seis meses siguientes a la fecha de apli- cación del presente Reglamento, que los productos fueron comercializados en la Comunidad antes de la fecha de apli- cación del presente Reglamento.

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2. La notificación a que se refiere el apartado 1 irá acompa- ñada por la información indicada en los apartados 3 y 5 del artículo 5, según proceda, información que la Comisión trans- mitirá a la Autoridad y a los Estados miembros. La Autoridad transmitirá al laboratorio comunitario de referencia los datos mencionados en las letras i) y j) del apartado 3 del artículo 5. El laboratorio comunitario de referencia probará y validará el método de detección e identificación propuesto por el solici- tante.

3. En el plazo de un año tras la fecha de aplicación del presente Reglamento, y una vez que se haya verificado que se ha presentado y examinado toda la información requerida, los productos en cuestión serán inscritos en el registro. Cada entrada del registro incluirá lo dispuesto en el apartado 2 del artículo 7, si procede, y en el caso de los productos contem- plados en la letra a) del apartado 1, mencionará la fecha en que los productos se comercializaron por primera vez.

4. En los nueve años siguientes a la fecha en que los productos contemplados en la letra a) del apartado 1 se comer- cializaron por primera vez, pero en ningún caso antes de tres años desde la fecha de aplicación del presente Reglamento, los operadores responsables de su comercialización presentarán una solicitud conforme al artículo 11, que se aplicará mutatis mutandis.

En los tres años siguientes a la fecha de aplicación del presente Reglamento, los operadores responsables de la comercialización de productos contemplados en la letra b) del apartado 1 presen- tarán una solicitud conforme al artículo 11, que se aplicará mutatis mutandis.

5. Los productos contemplados en el apartado 1 y los alimentos que los contengan o se hayan producido a partir de ellos estarán sometidos a lo dispuesto en el presente Regla- mento, en particular en sus artículos 9, 10 y 34, que se apli- carán mutatis mutandis.

6. Si la notificación, así como la información y documenta- ción que deben acompañarla mencionadas los apartados 1 y 2, no se presentan en el plazo estipulado o resultan ser inco- rrectas, o si la solicitud no se presenta como exige el apartado 4 en el plazo previsto, la Comisión, de conformidad con el procedimiento mencionado en el apartado 2 del artículo 35, adoptará una medida por la que se exija la retirada del mercado del producto en cuestión y de todos sus derivados. En esa medida podrá preverse un período de tiempo limitado durante el cual puedan agotarse las existencias del producto.

7. Si las autorizaciones no se han concedido a un titular concreto, será el operador que importe, produzca o fabrique los productos contemplados en el presente artículo el que presente a la Comisión la información o la solicitud.

8. Las normas de desarrollo del presente artículo se adop- tarán de conformidad con el procedimiento mencionado en el apartado 2 del artículo 35.

Artículo 9

Supervisión

1. Una vez que se haya concedido la autorización conforme al presente Reglamento, su titular y las partes interesadas deberán cumplir todas las condiciones o restricciones que se

hayan impuesto en ella, y en particular garantizar que los productos no incluidos en la autorización no se comercialicen como alimentos o piensos. Si se ha impuesto al titular de la autorización un plan de seguimiento postcomercialización según la letra k) del apartado 3 del artículo 5 y/o un plan de seguimiento según la letra b) del apartado 5 del artículo 5, el titular de la autorización deberá asegurarse de que el plan se lleva a cabo y presentar informes a la Comisión conforme a lo establecido en la autorización. Dichos informes de seguimiento, excluyendo toda información confidencial con arreglo a lo dispuesto en el artículo 30, serán accesibles al público.

2. Si el titular de la autorización se propone modificar los términos de la misma, deberá presentar la correspondiente soli- citud con arreglo al apartado 2 del artículo 5. Los artículos 5, 6 y 7 se aplicarán mutatis mutandis.

3. El titular de la autorización informará inmediatamente a la Comisión de cualquier nuevo dato científico o técnico que pudiera influir en la evaluación de la seguridad en relación con el uso del alimento. En particular, el titular de la autorización deberá informar inmediatamente a la Comisión de cualquier prohibición o restricción impuesta por la autoridad competente de un tercer país en el que se comercialice el alimento.

4. La Comisión pondrá rápidamente a disposición de la Autoridad y de los Estados miembros la información facilitada por el solicitante.

Artículo 10

Modificación, suspensión y revocación de autorizaciones

1. Por propia iniciativa o a petición de un Estado miembro o de la Comisión, la Autoridad emitirá un dictamen sobre si una autorización para un producto contemplado en el apartado 1 del artículo 3 todavía cumple las condiciones del presente Reglamento, y lo enviará inmediatamente a la Comisión, al titular de la autorización y a los Estados miembros. La Auto- ridad, con arreglo a lo dispuesto en el apartado 1 del artículo 38 del Reglamento (CE) no 178/2002, hará público su dictamen tras haber eliminado cualquier dato que se considere confiden- cial, de conformidad con el artículo 30 del presente Regla- mento. Cualquier persona podrá remitir sus comentarios a la Comisión en los 30 días siguientes a la publicación del dictamen.

2. La Comisión examinará el dictamen de la Autoridad lo antes posible. Se adoptarán las medidas apropiadas con arreglo al artículo 34. Si procede, se modificará, suspenderá o revocará la autorización de conformidad con el procedimiento estable- cido en el artículo 7.

3. El apartado 2 del artículo 5 y los artículos 6 y 7 se apli- carán mutatis mutandis.

Artículo 11

Renovación de autorizaciones

1. Las autorizaciones concedidas conforme al presente Reglamento serán renovables por períodos de 10 años, mediante una solicitud que el titular deberá presentar a la Comisión, a más tardar un año antes de que expire su autoriza- ción.

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2. La solicitud deberá ir acompañada de lo siguiente:

a) una copia de la autorización para comercializar el alimento;

b) un informe de los resultados del seguimiento, si así se espe- cifica en la autorización;

c) cualquier otro nuevo dato disponible con respecto a la evaluación de la seguridad de uso del alimento y a los riesgos que presente el alimento para los consumidores o el medio ambiente;

d) cuando proceda, una propuesta para modificar o comple- mentar las condiciones de la autorización original, entre otras las relacionadas con el futuro seguimiento.

3. El apartado 2 del artículo 5 y los artículos 6 y 7 se apli- carán mutatis mutandis.

4. Si, por razones que escapan al control del titular de la autorización, no se toma ninguna decisión con respecto a su renovación antes de la fecha de expiración, la autorización del producto se prorrogará automáticamente hasta que se adopte una decisión.

5. La Comisión, tras consultar a la Autoridad, podrá esta- blecer, de conformidad con el procedimiento mencionado en el apartado 2 del artículo 35, normas de desarrollo para la aplica- ción del presente artículo, incluidas normas sobre la prepara- ción y presentación de la solicitud.

6. La Autoridad publicará instrucciones detalladas para ayudar al solicitante en la preparación y presentación de la soli- citud.

Se cci ón 2

E t i qu e t ad o

Artículo 12

Ámbito de aplicación

1. La presente sección se aplicará a los alimentos que vayan a suministrarse como tales al consumidor final o a las colectivi- dades en la Comunidad y que:

a) contengan o estén compuestos por OMG, o

b) se hayan producido a partir de OMG o contengan ingre- dientes producidos a partir de estos organismos.

2. La presente sección no se aplicará a los alimentos que contengan material que, a su vez, contenga o esté compuesto por OMG o haya sido producido a partir de estos organismos, siempre que el contenido de dicho material no supere el 0,9 % de los ingredientes del alimento considerados individualmente o de los alimentos consistentes en un solo ingrediente, y a condición de que esta presencia sea accidental o técnicamente inevitable.

3. Para determinar que la presencia de este material es acci- dental o técnicamente inevitable, los operadores deberán poder proporcionar pruebas a las autoridades competentes que les demuestren de manera satisfactoria que han adoptado las medidas apropiadas para evitar la presencia de dicho material.

4. En su caso, podrán fijarse umbrales adecuados más bajos de conformidad con el procedimiento mencionado en el apar- tado 2 del artículo 35, en particular respecto de los alimentos que contengan o consistan en OMG o con objeto de tomar en consideración los avances de la ciencia y la tecnología.

Artículo 13

Requisitos

1. Sin perjuicio de otros requisitos de Derecho comunitario relativos al etiquetado de los productos alimenticios, los alimentos que entren en el ámbito de aplicación de la presente sección estarán sujetos a los siguientes requisitos específicos en materia de etiquetado:

a) si el alimento está compuesto por más de un ingrediente, en la lista de ingredientes establecida por el artículo 6 de la Directiva 2000/13/CE figurará entre paréntesis, inmediata- mente después del ingrediente en cuestión, el texto «modifi- cado genéticamente» o «producido a partir de [nombre del ingrediente] modificado genéticamente»;

b) si el ingrediente viene designado por el nombre de una cate- goría, en la lista de ingredientes figurará el texto «contiene [nombre del organismo] modificado genéticamente» o «contiene [nombre del ingrediente] producido a partir de [nombre del organismo] modificado genéticamente»;

c) a falta de una lista de ingredientes, en el etiquetado figurará claramente el texto «modificado genéticamente» o «produ- cido a partir de [nombre del organismo] modificado genéti- camente»;

d) las indicaciones mencionadas en las letras a) y b) podrán figurar en una nota al pie de la lista de ingredientes. En este caso se imprimirán en letra de tamaño al menos igual que la lista de ingredientes. Cuando no haya lista de ingredientes, figurarán claramente en la etiqueta;

e) si el alimento se ofrece para su venta al consumidor final como alimento no preenvasado o como alimento preenva- sado en pequeños recipientes cuya mayor superficie consiste en un área de menos de 10 cm2, la información exigida en el presente apartado deberá exhibirse visible y permanente- mente, bien en el expositor del alimento, bien inmediata- mente al lado, o en el envase, en un tipo de letra lo suficien- temente grande para su fácil identificación y lectura.

2. Además de los requisitos de etiquetado establecidos en el apartado 1, la etiqueta deberá mencionar cualquier caracterís- tica o propiedad que se especifique en la autorización, en los siguientes casos:

a) cuando el alimento sea diferente de su homólogo conven- cional por lo que respecta a las siguientes características o propiedades:

i) composición,

ii) valor o efectos nutricionales,

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iii) uso para el que está destinado,

iv) repercusiones para la salud de determinados sectores de la población;

b) cuando el alimento pueda generar inquietudes de orden ético o religioso.

3. Además de los requisitos de etiquetado establecidos en el apartado 1 y especificados en la autorización, el etiquetado de los alimentos que entren en el ámbito de la presente sección y no tengan homólogo convencional incluirán la información pertinente acerca de su naturaleza y sus características.

Artículo 14

Medidas de ejecución

1. Las medidas de ejecución para aplicar la presente sección, relativas entre otras cosas a las medidas necesarias para que los operadores cumplan los requisitos de etiquetado, podrán adop- tarse de conformidad con el procedimiento mencionado en el apartado 2 del artículo 35.

2. Podrán adoptarse normas específicas relativas a la infor- mación que deben facilitar las colectividades que suministran alimentos al consumidor final de conformidad con el procedi- miento mencionado en el apartado 2 del artículo 35.

Para tener en cuenta la situación específica de dicho sector, tales normas podrán disponer la adaptación de los requisitos de la letra e) del apartado 1 del artículo 13.

CAPÍTULO III

PIENSOS MODIFICADOS GENÉTICAMENTE

Se cci ón 1

A ut o rizaci ón y sup e rvisi ón

Artículo 15

Ámbito de aplicación

1. La presente sección se aplicará a:

a) los OMG destinados a la alimentación animal;

b) los piensos que contengan o estén compuestos por OMG;

c) los piensos producidos a partir de OMG.

2. Cuando sea necesario, podrá determinarse, de confor- midad con el procedimiento mencionado en el apartado 2 del artículo 35, si un tipo de pienso entra en el ámbito de la presente sección.

Artículo 16

Requisitos

1. Los piensos contemplados en el apartado 1 del artículo 15 no deberán:

a) tener efectos negativos sobre la salud humana, la sanidad animal o el medio ambiente;

b) inducir a error al usuario;

c) perjudicar o inducir a error al consumidor menoscabando las características distintivas de los productos animales;

d) diferenciarse de los piensos que están destinados a sustituir de tal manera que su consumo normal resulte desventajoso, desde el punto de vista nutricional, para los animales o las personas.

2. No se comercializará, utilizará o transformará ningún producto contemplado en el apartado 1 del artículo 15 a menos que esté cubierto por una autorización concedida de acuerdo con lo dispuesto en la presente sección y cumpla las condiciones pertinentes establecidas en dicha autorización.

3. No se autorizará ningún producto contemplado en el apartado 1 del artículo 15 a menos que el solicitante de la auto- rización haya demostrado adecuada y suficientemente que cumple lo dispuesto en el apartado 1 del presente artículo.

4. La autorización a que se hace referencia en el apartado 2 podrá aplicarse a:

a) un OMG y a los piensos que lo contengan o estén compuestos por OMG, así como a los piensos producidos a partir de OMG;

b) los piensos producidos a partir de un OMG y a los piensos que contengan o estén producidos a partir de aquéllos.

5. La autorización a que se hace referencia en el apartado 2 no será concedida, denegada, renovada, modificada, suspendida o revocada más que por las razones y conforme a los procedi- mientos establecidos en el presente Reglamento.

6. El solicitante de la autorización a que se hace referencia en el apartado 2 y, una vez concedida ésta, el titular de la misma o su representante deberán estar establecidos en la Comunidad.

7. La autorización contemplada en el presente Reglamento se concederá sin perjuicio de lo establecido en las Directivas 2002/53/CE, 2002/55/CE y 68/193/CEE.

Artículo 17

Solicitud de autorización

1. Para obtener la autorización a que se hace referencia en el apartado 2 del artículo 16, deberá presentarse una solicitud con arreglo a las disposiciones siguientes.

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2. La solicitud se enviará a la autoridad nacional competente del Estado miembro.

a) La autoridad nacional competente:

i) enviará por escrito al solicitante un acuse de recibo de la solicitud en los 14 días siguientes a la recepción de la misma, en el que deberá figurar la fecha de la recepción de la solicitud,

ii) informará sin demora a la Autoridad, y

iii) pondrá dicha solicitud y cualquier información comple- mentaria que el solicitante le haya transmitido a disposi- ción de la Autoridad.

b) La Autoridad:

i) informará sin demora a los demás Estados miembros y a la Comisión de la solicitud y pondrá a su disposición dicha solicitud y cualquier información complementaria que el solicitante le haya transmitido,

ii) pondrá a disposición del público el resumen del expe- diente a que se refiere la letra l) del apartado 3.

3. La solicitud deberá ir acompañada de lo siguiente:

a) nombre y dirección del solicitante;

b) denominación del pienso y características del mismo, en especial la operación u operaciones de transformación prac- ticadas;

c) cuando proceda, la información requerida en el anexo II del Protocolo de Cartagena;

d) cuando proceda, una descripción detallada del método de obtención y fabricación y de los usos a los que está desti- nado el pienso;

e) una copia de los estudios llevados a cabo, incluidos, si los hubiera, estudios independientes y revisados por otros espe- cialistas, y cualquier otro material disponible para demostrar que el pienso cumple los criterios establecidos en el apar- tado 1 del artículo 16 y, en particular para los piensos que entran en el ámbito de aplicación de la Directiva 82/471/ CEE, la información exigida por la Directiva 83/228/CEE del Consejo, de 18 de abril de 1983, relativa a la fijación de directrices para la valoración de determinados productos utilizados en los alimentos para animales (1);

f) bien un análisis apoyado por la información y los datos apropiados, que muestre que las características del pienso no difieren de las de su homólogo convencional, teniendo en cuenta las tolerancias aplicadas a las variaciones naturales de dichas características y los criterios especificados en la letra c) del apartado 2 del artículo 25, o bien una propuesta de etiquetado del pienso de acuerdo con la letra c) del apar- tado 2 del artículo 25 y con el apartado 3 de ese mismo artículo;

g) bien una declaración motivada de que el pienso no genera inquietudes de orden ético o religioso, o bien una propuesta de etiquetado de acuerdo con la letra d) del apartado 2 del artículo 25;

h) cuando proceda, las condiciones de comercialización del pienso, incluidas las condiciones específicas de utilización y manipulación;

i) métodos de detección, muestreo (con inclusión de referen- cias a métodos de muestreo existentes oficiales o normali- zados) e identificación de la transformación, y, cuando sean aplicables, de detección e identificación de la transformación en el pienso y/o en los piensos producidos a partir de él;

j) muestras del pienso y sus muestras de control, e informa- ción sobre el lugar en que se puede acceder al material de referencia;

k) cuando proceda, una propuesta de seguimiento postcomer- cialización del uso del pienso para el consumo animal;

l) un resumen del expediente en formato normalizado.

4. En el caso de una solicitud relacionada con un OMG destinado a la alimentación animal, las referencias a «pienso» del apartado 3 se interpretarán como referencias a un pienso que contiene o está compuesto por el OMG para el que se hace la solicitud o ha sido producido a partir de él.

5. En el caso de los OMG y de los piensos que contienen o están compuestos por OMG, la solicitud irá también acompa- ñada de lo siguiente:

a) el expediente técnico completo que ofrezca la información que exigen los anexos III y IV de la Directiva 2001/18/CE, así como la información y las conclusiones de la evaluación del riesgo llevada a cabo conforme a los principios estable- cidos en el anexo II de la citada Directiva, o una copia de la decisión de autorización en caso de que la comercialización del OMG se haya autorizado conforme a la parte C de la citada Directiva;

b) un plan de seguimiento de los efectos medioambientales conforme al anexo VII de la Directiva 2001/18/CE, que incluya una propuesta de duración del propio plan; la dura- ción del plan de seguimiento podrá ser diferente del período de validez propuesto para la autorización.

En este caso, no se aplicarán los artículos 13 a 24 de la Directiva 2001/18/CE.

6. Cuando la solicitud se refiera a una sustancia cuya utiliza- ción y comercialización estén sujetas, con arreglo a otras dispo- siciones de Derecho comunitario, a su inclusión en una lista de sustancias registradas o autorizadas con exclusión de otras, deberá hacerse constar así en la solicitud, e indicarse en ella la situación de la sustancia en virtud de la legislación aplicable.

7. La Comisión, previa consulta a la Autoridad, establecerá normas de desarrollo del presente artículo de conformidad con el procedimiento mencionado en el apartado 2 del artículo 35, incluidas normas para la preparación y la presentación de la solicitud.

8. Antes de la fecha de aplicación del presente Reglamento, la Autoridad publicará instrucciones detalladas para asistir al solicitante en la preparación y presentación de la solicitud.

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(1) DO L 126 de 13.5.1983, p. 23.

Artículo 18

Dictamen de la Autoridad

1. La Autoridad procurará emitir su dictamen en un plazo de seis meses a partir de la recepción de una solicitud válida. Este plazo se ampliará cuando la Autoridad pida información complementaria al solicitante, con arreglo a lo dispuesto en el apartado 2.

2. Cuando proceda, la Autoridad o una autoridad nacional competente, por mediación de la Autoridad, podrá pedir al soli- citante que complemente, en un plazo determinado, la informa- ción que acompaña a la solicitud.

3. Para preparar su dictamen, la Autoridad:

a) verificará que la información y la documentación presen- tadas por el solicitante son conformes a lo dispuesto en el artículo 17 y determinará si los piensos cumplen los crite- rios establecidos en el apartado 1 del artículo 16;

b) podrá pedir al organismo encargado de la evaluación del pienso en un Estado miembro que evalúe la seguridad de los piensos, de conformidad con el artículo 36 del Reglamento (CE) no 178/2002;

c) podrá pedir a la autoridad competente designada de acuerdo con el artículo 4 de la Directiva 2001/18/CE que realice una evaluación del riesgo para el medio ambiente; sin embargo, si la solicitud se refiere a OMG que deban utilizarse como semillas u otras plántulas y material de multiplicación, la Autoridad deberá pedir a una autoridad nacional compe- tente que lleve a cabo la evaluación del riesgo para el medio ambiente;

d) remitirá al laboratorio comunitario de referencia lo dispu- esto en las letras i) y j) del apartado 3 del artículo 17. Dicho laboratorio comunitario de referencia probará y validará el método de detección e identificación propuesto por el solici- tante;

e) a fin de verificar la aplicación de lo dispuesto en la letra c) del apartado 2 del artículo 25, examinará la información y los datos presentados por el solicitante para demostrar que las características del pienso no difieren de las de su homó- logo convencional, teniendo en cuenta las tolerancias apli- cadas a las variaciones naturales de esas características.

4. En el caso de los OMG y los piensos que contienen o están compuestos por OMG, se aplicarán a la evaluación los requisitos de seguridad medioambiental establecidos en la Directiva 2001/18/CE, a fin de garantizar que se toman todas las medidas adecuadas para evitar los efectos perjudiciales que la liberación intencional de OMG podría tener sobre la salud humana, la sanidad animal y el medio ambiente. Durante la evaluación de las solicitudes para comercializar productos que estén compuestos por OMG o los contengan, la Autoridad consultará a la autoridad nacional competente en el sentido de la Directiva 2001/18/CE designada por cada Estado miembro para este fin. Las autoridades competentes dispondrán de tres meses tras la fecha de recepción de la solicitud para dar a conocer su dictamen.

5. En caso de dictamen favorable a la autorización del pienso, este dictamen incluirá además lo siguiente:

a) el nombre y la dirección del solicitante;

b) la denominación y las características del pienso;

c) cuando proceda, la información requerida en el anexo II del Protocolo de Cartagena;

d) la propuesta de etiquetado del pienso;

e) cuando proceda, las condiciones o restricciones que deberían imponerse a la comercialización y/o las condi- ciones o restricciones específicas de utilización y manipula- ción, así como los requisitos de seguimiento postcomerciali- zación basados en los resultados de la evaluación del riesgo y, en el caso de los OMG o de los piensos que contienen o están compuestos por OMG, las condiciones para la protec- ción de ecosistemas o del medio ambiente y zonas geográ- ficas particulares;

f) el método de detección, validado por el laboratorio comuni- tario de referencia, que incluya el muestreo, la identificación de la transformación y, cuando proceda, de detección e identificación de la transformación en el pienso y/o en los piensos producidos a partir de él; indicación del lugar en que pueda accederse a material de referencia pertinente;

g) cuando proceda, el plan de seguimiento al que se refiere la letra b) del apartado 5 del artículo 17.

6. La Autoridad enviará su dictamen a la Comisión, a los Estados miembros y al solicitante, junto con un informe en el que describa la evaluación efectuada del pienso e indique las razones y la información sobre las que se base el dictamen, incluidos los dictámenes de las autoridades competentes cuando se les consulte de conformidad con lo que dispone el apartado 4.

7. La Autoridad, con arreglo a lo dispuesto en el apartado 1 del artículo 38 del Reglamento (CE) no 178/2002, hará público su dictamen tras haber eliminado cualquier dato que se consi- dere confidencial de conformidad con el artículo 30 del presente Reglamento. Cualquier persona podrá remitir sus comentarios a la Comisión en los 30 días siguientes a la publi- cación del dictamen.

Artículo 19

Autorización

1. En el plazo de tres meses tras la recepción del dictamen de la Autoridad, la Comisión presentará al Comité a que se refiere el artículo 35 un proyecto de la decisión que deberá adoptarse respecto de la solicitud, teniendo en cuenta el dictamen de la Autoridad, cualesquiera disposiciones perti- nentes de la legislación comunitaria y otros factores legítimos relativos al asunto considerado. Cuando el proyecto de decisión no sea conforme al dictamen de la Autoridad, la Comisión motivará las diferencias.

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2. En el caso de un proyecto de decisión que prevea la concesión de una autorización, dicho proyecto de decisión deberá incluir los detalles mencionados en el apartado 5 del artículo 18, el nombre del titular de la autorización y, cuando resulte apropiado, el identificador único atribuido al OMG mencionado en el Reglamento (CE) no 1830/2003.

3. Se adoptará una decisión final sobre la solicitud de conformidad con el procedimiento mencionado en el apartado 2 del artículo 35.

4. La Comisión comunicará inmediatamente al solicitante la decisión que se haya adoptado y publicará una información sobre esta decisión en el Diario Oficial de la Unión Europea.

5. La autorización concedida conforme al procedimiento establecido en el presente Reglamento será válida en toda la Comunidad por un período de 10 años renovable de acuerdo con el artículo 23. El pienso autorizado será inscrito en el registro a que se refiere el artículo 28. Cada entrada de ese registro mencionará la fecha de autorización e incluirá lo dispu- esto en el apartado 2.

6. La autorización concedida en virtud de la presente sección se entenderá sin perjuicio de otras disposiciones de Derecho comunitario por las que se rijan el uso y la comerciali- zación de sustancias que sólo pueden ser utilizadas si se incluyen en una lista de sustancias registradas o autorizadas con exclusión de otras.

7. La concesión de la autorización no disminuirá en modo alguno la responsabilidad civil y penal general del operador del sector de los piensos en relación con el pienso en cuestión.

8. Las referencias que se hacen en las partes A y D de la Directiva 2001/18/CE a los OMG autorizados con arreglo a lo dispuesto en la parte C de dicha Directiva se considerarán válidas igualmente para los OMG autorizados en virtud del presente Reglamento.

Artículo 20

Situación de los productos existentes

1. No obstante lo dispuesto en el apartado 2 del artículo 16, los productos que entren en el ámbito de aplicación de la presente sección y se hayan comercializado legalmente en la Comunidad antes de la fecha de aplicación del presente Regla- mento podrán seguir comercializándose, utilizándose y trans- formándose siempre que se cumplan las siguientes condiciones:

a) en el caso de los productos que hayan sido autorizados en virtud de la Directiva 90/220/CEE o de la Directiva 2001/ 18/CE, incluso para su utilización como piensos en virtud de la Directiva 82/471/CEE y que se hayan producido a partir de OMG, o en virtud de la Directiva 70/524/CEE, que contengan o estén compuestos por OMG o hayan sido producidos a partir de ellos, los operadores responsables de la comercialización de los productos en cuestión notificarán a la Comisión, en un plazo de seis meses a partir de la fecha de aplicación del presente Reglamento, la fecha en que comenzaron a comercializarse los productos en la Comu- nidad;

b) en el caso de los productos que se hayan comercializado legalmente en la Comunidad, pero que no se encuentren contemplados en la letra a), los operadores responsables de

la comercialización de los productos en cuestión en la Comunidad notificarán a la Comisión, en un plazo de seis meses a partir de la fecha de aplicación del presente Regla- mento, que los productos se comercializaron en la Comu- nidad antes de la fecha de aplicación del presente Regla- mento.

2. La notificación a que hace referencia el apartado 1 irá acompañada por la información indicada en los apartados 3 y 5 del artículo 17, según proceda, que la Comisión transmitirá a la Autoridad y a los Estados miembros. La Autoridad trans- mitirá al laboratorio comunitario de referencia la información a que se refiere las letras i) y j) del apartado 3 del artículo 17. El laboratorio comunitario de referencia probará y validará el método de detección e identificación propuesto por el solici- tante.

3. En el plazo de un año a partir de la fecha de aplicación del presente Reglamento, y una vez que haya verificado que se ha presentado y examinado toda la información requerida, los productos en cuestión serán inscritos en el registro. Cada entrada del registro incluirá lo dispuesto en el apartado 2 del artículo 19, según proceda, y en el caso de los productos a que se hace referencia en la letra a) del apartado 1 indicará la fecha en que los productos de que se trate comenzaron a comerciali- zarse.

4. En el plazo de nueve años a partir de la fecha en que los productos a que se hace referencia en la letra a) del apartado 1 comenzaron a comercializarse, pero en ningún caso antes de tres años desde la fecha de aplicación del presente Reglamento, los operadores responsables de su comercialización presentarán una solicitud conforme al artículo 23, que se aplicará mutatis mutandis.

En el plazo de tres años a partir de la fecha de aplicación del presente Reglamento, los operadores responsables de comercia- lizar los productos a que se hace referencia en la letra b) del apartado 1 presentarán una solicitud conforme al artículo 23, que se aplicará mutatis mutandis.

5. Los productos contemplados en el apartado 1 y los piensos que los contengan o se hayan producido a partir de ellos estarán sometidos a lo dispuesto por el presente Regla- mento, y en particular por sus artículos 21, 22 y 34, que se aplicarán mutatis mutandis.

6. Si la notificación, así como la información y documenta- ción que deben acompañarla mencionadas en los apartados 1 y 2, no se presentan en el plazo especificado o resultan ser inco- rrectas, o si la solicitud no se presenta como exige el apartado 4 en el plazo previsto, la Comisión, de conformidad con el procedimiento mencionado en el apartado 2 del artículo 35, adoptará una medida por la que se exija la retirada del mercado del producto en cuestión y de todos sus derivados. En esa medida podrá preverse un período de tiempo limitado durante el cual puedan agotarse las existencias del producto.

7. Si las autorizaciones no se han concedido a un titular concreto, será el operador que importe, produzca o fabrique los productos contemplados en el presente artículo el que presente a la Comisión la información o la solicitud.

8. Las normas de desarrollo del presente artículo se adop- tarán de conformidad con el procedimiento mencionado en el apartado 2 del artículo 35.

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Artículo 21

Supervisión

1. Una vez que se haya concedido la autorización conforme al presente Reglamento, su titular y las partes interesadas deberán cumplir todas las condiciones o restricciones que se hayan impuesto en ella y, en particular, garantizar que los productos no incluidos en la autorización no se comercialicen como alimentos o piensos. Si se ha impuesto al titular de la autorización un plan de seguimiento postcomercialización según la letra k) del apartado 3 del artículo 17 y/o un plan de seguimiento según la letra b) del apartado 5 del artículo 17, el titular de la autorización deberá asegurarse de que el plan se lleva a cabo y presentar informes a la Comisión conforme a lo establecido en la autorización. Dichos informes de seguimiento, excluyendo toda información confidencial con arreglo a lo dispuesto en el artículo 30, serán accesibles al público.

2. Si el titular de la autorización se propone modificar los términos de la misma, deberá presentar la correspondiente soli- citud con arreglo al apartado 2 del artículo 17. Los artículos 17, 18 y 19 se aplicarán mutatis mutandis.

3. El titular de la autorización informará inmediatamente a la Comisión de cualquier nuevo dato científico o técnico que pudiera influir en la evaluación de la seguridad en relación con el uso del pienso. En particular, el titular de la autorización deberá informar inmediatamente a la Comisión de cualquier prohibición o restricción impuesta por la autoridad competente de un tercer país en el que se comercialice el pienso.

4. La Comisión pondrá rápidamente a disposición de la Autoridad y de los Estados miembros toda la información facili- tada por el solicitante.

Artículo 22

Modificación, suspensión y revocación de autorizaciones

1. Por propia iniciativa o a petición de un Estado miembro o de la Comisión, la Autoridad emitirá un dictamen sobre si una autorización para un producto mencionado en el apartado 1 del artículo 15 todavía cumple las condiciones del presente Reglamento, y lo enviará inmediatamente a la Comisión, al titular de la autorización y a los Estados miembros. La Auto- ridad, con arreglo a lo dispuesto en el apartado 1 del artículo 38 del Reglamento (CE) no 178/2002, hará público su dictamen tras haber eliminado cualquier dato que se considere confiden- cial de conformidad con el artículo 30 del presente Regla- mento. Cualquier persona podrá remitir sus comentarios a la Comisión en los 30 días siguientes a la publicación del dictamen.

2. La Comisión examinará el dictamen de la Autoridad lo antes posible. Se adoptarán las medidas apropiadas con arreglo al artículo 34. Si procede, se modificará, suspenderá o revocará la autorización de conformidad con el procedimiento estable- cido en el artículo 19.

3. El apartado 2 del artículo 17 y los artículos 18 y 19 se aplicarán mutatis mutandis.

Artículo 23

Renovación de autorizaciones

1. Las autorizaciones concedidas conforme al presente Reglamento serán renovables por períodos de 10 años, mediante una solicitud que el titular deberá presentar a la Comisión, a más tardar un año antes de que expire su autoriza- ción.

2. La solicitud deberá ir acompañada de lo siguiente:

a) una copia de la autorización para comercializar el pienso;

b) un informe de los resultados del seguimiento, si así se espe- cifica en la autorización;

c) cualquier otro nuevo dato disponible con respecto a la evaluación de la seguridad de uso del pienso y a los riesgos que presente el pienso para los animales, las personas o el medio ambiente;

d) cuando proceda, una propuesta para modificar o comple- mentar las condiciones de la autorización original, entre otras las relacionadas con el futuro seguimiento.

3. El apartado 2 del artículo 17 y los artículos 18 y 19 se aplicarán mutatis mutandis.

4. Si, por razones que escapan al control del titular de la autorización, no se toma ninguna decisión con respecto a su renovación antes de la fecha de expiración, el período de auto- rización del producto se prorrogará automáticamente hasta que se adopte una decisión.

5. La Comisión, tras consultar a la Autoridad, podrá esta- blecer, de conformidad con el procedimiento mencionado en el apartado 2 del artículo 35, normas de desarrollo para la aplica- ción del presente artículo, incluidas normas sobre la prepara- ción y presentación de la solicitud.

6. La Autoridad publicará instrucciones detalladas para ayudar al solicitante en la preparación y presentación de la soli- citud.

Se cc i ón 2

E t i qu e t a d o

Artículo 24

Ámbito de aplicación

1. La presente sección se aplicará a los piensos contem- plados en el apartado 1 del artículo 15.

2. La presente sección no se aplicará a los piensos que contengan material que, a su vez, contenga o esté compuesto por OMG o haya sido producido a partir de estos organismos en una proporción que no supere el 0,9 % del pienso y de cada uno de los alimentos para animales de que esté compuesto, y a condición de que su presencia sea accidental o técnicamente inevitable.

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3. Para determinar que la presencia de este material es acci- dental o técnicamente inevitable, los operadores deberán poder proporcionar pruebas a las autoridades competentes que les demuestren de manera satisfactoria que han adoptado las medidas apropiadas para evitar la presencia de dicho material.

4. En su caso, podrán fijarse umbrales adecuados más bajos de conformidad con el procedimiento mencionado en el apar- tado 2 del artículo 35, en particular respecto de los piensos que contengan o consistan en OMG o con objeto de tomar en consideración los avances de la ciencia y la tecnología.

Artículo 25

Requisitos

1. Sin perjuicio de otros requisitos de Derecho comunitario relativos al etiquetado de los piensos, los piensos contemplados en el apartado 1 del artículo 15 estarán sujetos a los requisitos específicos en materia de etiquetado que se exponen a conti- nuación.

2. Toda persona que desee comercializar los piensos contemplados en el apartado 1 del artículo 15 deberá hacer lo necesario para que los datos especificados a continuación figuren de manera claramente visible, legible e indeleble en un documento adjunto o, cuando corresponda, en el envase, el contenedor o en una etiqueta colocada en ellos.

Todo alimento para animales del que esté compuesto un pienso concreto estará sujeto a las normas siguientes:

a) en el caso de los piensos mencionados en las letras a) y b) del apartado 1 del artículo 15, las palabras «[nombre del organismo] modificado genéticamente» aparecerán entre paréntesis inmediatamente a continuación del nombre específico del pienso.

A modo de alternativa, dichas palabras podrán figurar en una nota al pie de la lista de piensos, impresa en letra de tamaño al menos igual que la lista de piensos;

b) en el caso de los piensos contemplados en la letra c) del apartado 1 del artículo 15, las palabras «producidos a partir de [nombre del organismo] modificado genéticamente» aparecerán entre paréntesis inmediatamente a continuación del nombre específico del pienso.

A modo de alternativa, dichas palabras podrán figurar en una nota al pie de la lista de piensos, impresa en letra de tamaño al menos igual que la lista de piensos;

c) la etiqueta deberá mencionar cualquier característica del pienso contemplada en el apartado 1 del artículo 15 que se especifique en la autorización, como las enumeradas a conti- nuación, que sea diferente de su homólogo convencional:

i) composición,

ii) propiedades nutricionales,

iii) uso para el que está destinado,

iv) repercusiones para la sanidad de determinadas especies o categorías de animales;

d) la etiqueta deberá mencionar cualquier característica o propiedad del pienso que se especifique en la autorización que pueda generar inquietudes de orden ético o religioso.

3. Además de los requisitos establecidos en las letras a) y b) del apartado 2 y especificados en la autorización, las etiquetas o documentos que acompañen a los piensos que entren en el ámbito de la presente sección y no tengan homólogo conven- cional incluirán la información pertinente acerca de su natura- leza y sus características.

Artículo 26

Medidas de ejecución

Las medidas de ejecución para aplicar la presente sección, rela- tivas entre otras cosas a las medidas necesarias para que los operadores cumplan los requisitos de etiquetado, podrán adop- tarse de conformidad con el procedimiento mencionado en el apartado 2 del artículo 35.

CAPÍTULO IV

DISPOSICIONES COMUNES

Artículo 27

Productos que pueden ser utilizados como alimento y como pienso

1. Cuando resulte probable que un producto se utilice como alimento y como pienso, se presentará una única solicitud conforme a los artículos 5 y 17, sobre la cual la Autoridad emitirá un único dictamen y la Comunidad tomará una única decisión.

2. La Autoridad examinará si conviene que una solicitud de autorización se presente al mismo tiempo para alimento y para pienso.

Artículo 28

Registro comunitario

1. La Comisión creará y mantendrá un registro comunitario de alimentos y piensos modificados genéticamente, denomi- nado en lo sucesivo registro.

2. El registro deberá ser de acceso público.

Artículo 29

Acceso del público

1. La solicitud de autorización, la información complemen- taria transmitida por el solicitante, los dictámenes de las autori- dades competentes designadas con arreglo al artículo 4 de la Directiva 2001/18/CE, los informes de seguimiento y la infor- mación transmitida por el titular de la autorización, excluida la información de carácter confidencial, serán accesibles al público.

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2. Al tramitar solicitudes de acceso a los documentos que obren en su poder, la Autoridad aplicará los principios conte- nidos en el Reglamento (CE) no 1049/2001 del Parlamento Europeo y el Consejo, de 30 de mayo de 2001, relativo al acceso del público a los documentos del Parlamento Europeo, del Consejo y de la Comisión (1).

3. Los Estados miembros tramitarán las solicitudes de acceso a los documentos que se les haya transmitido con arreglo al presente Reglamento de conformidad con el artículo 5 del Reglamento (CE) no 1049/2001.

Artículo 30

Confidencialidad

1. El solicitante podrá indicar qué datos de los presentados en virtud del presente Reglamento desea que reciban un trata- miento confidencial porque su revelación pudiera perjudicar seriamente su posición competitiva. En dichos casos, deberá aportar una justificación verificable.

2. Sin perjuicio de lo dispuesto en el apartado 3, la Comi- sión determinará, tras consultar al solicitante, qué información debe mantenerse confidencial, e informará de su decisión al solicitante.

3. No se considerará confidencial la siguiente información:

a) el nombre y la composición del OMG, alimento o pienso contemplados en el apartado 1 del artículo 3 y en el apar- tado 1 del artículo 15 y, cuando proceda, la indicación del sustrato y del microorganismo;

b) la descripción general del OMG y el nombre y la dirección del titular de la autorización;

c) las características fisicoquímicas y biológicas del OMG, el alimento o el pienso contemplados en el apartado 1 del artículo 3 y en el apartado 1 del artículo 15;

d) los efectos que tiene en la salud humana, en la sanidad animal y en el medio ambiente el OMG, el alimento o el pienso contemplados en el apartado 1 del artículo 3 y en el apartado 1 del artículo 15;

e) los efectos que tiene en las características de los productos animales y sus propiedades nutricionales el OMG, el alimento o el pienso contemplados en el apartado 1 del artículo 3 y en el apartado 1 del artículo 15;

f) los métodos de detección, incluidos el muestreo y la identifi- cación de la operación de transformación, y, si procede, de detección e identificación de la operación de transformación en el alimento o el pienso contemplados en el apartado 1 del artículo 3 y en el apartado 1 del artículo 15;

g) información sobre el tratamiento de residuos y actuación en caso de emergencia.

4. No obstante lo dispuesto en el apartado 2, la Autoridad facilitará a la Comisión y a los Estados miembros toda la infor- mación que esté en su poder si así se le solicita.

5. El uso de los métodos de detección y la reproducción de los materiales de referencia contemplados en el apartado 3 del artículo 5 y en el apartado 3 del artículo 17 a efectos de la apli- cación del presente Reglamento a los OMG, los alimentos o los piensos a que se refiera una solicitud no estarán limitados por el ejercicio de los derechos de propiedad intelectual ni de ninguna otra forma.

6. La Comisión, la Autoridad y los Estados miembros adop- tarán las medidas necesarias para garantizar la confidencialidad de la información recibida en virtud de lo dispuesto en el presente Reglamento, salvo que se trate de información que las circunstancias obliguen a hacer pública para proteger la salud humana, la sanidad animal o el medio ambiente.

7. Si un solicitante retira o ha retirado una solicitud, la Autoridad, la Comisión y los Estados miembros respetarán la confidencialidad de la información comercial e industrial, incluida la relativa a la investigación y el desarrollo, así como aquella con respecto a cuya confidencialidad la Comisión y el solicitante no se hayan puesto de acuerdo.

Artículo 31

Protección de datos

Los datos científicos y demás información contenida en el expe- diente de solicitud conforme a los apartados 3 y 5 del artículo 5 y los apartados 3 y 5 del artículo 17 no podrán ser utilizados en provecho de otro solicitante durante un período de diez años contado a partir de la fecha de autorización, salvo que el otro solicitante haya acordado con el titular de la autorización el uso de esos datos y esa información.

Al concluir ese período de 10 años, los resultados de parte o de la totalidad de la evaluación llevada a cabo sobre la base de los datos científicos y demás información contenida en el expe- diente de solicitud podrán ser utilizados por la Autoridad en provecho de otro solicitante, siempre que éste pueda demostrar que el alimento o el pienso para el que solicita la autorización es, en esencia, similar a uno ya autorizado en virtud del presente Reglamento.

Artículo 32

Laboratorio comunitario de referencia

El laboratorio comunitario de referencia, así como sus compe- tencias y tareas, serán los establecidos en el anexo.

Podrán designarse laboratorios nacionales de referencia de conformidad con el procedimiento mencionado en el apartado 2 del artículo 35.

Los solicitantes de autorizaciones relativas a alimentos y piensos modificados genéticamente contribuirán a sufragar los costes de las tareas del laboratorio comunitario de referencia y de la red europea de laboratorios OMG a que se refiere el anexo.

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(1) DO L 145 de 31.5.2001, p. 43.

Las contribuciones de los solicitantes no serán superiores a los costes efectuados para validar los métodos de detección.

Podrán adoptarse normas de desarrollo del presente artículo, del anexo, así como modificaciones del mismo, de conformidad con el procedimiento mencionado en el apartado 2 del artículo 35.

Artículo 33

Consulta al Grupo europeo de ética de la ciencia y de las nuevas tecnologías

1. La Comisión, por propia iniciativa o a petición de un Estado miembro, podrá consultar al Grupo europeo de ética de la ciencia y de las nuevas tecnologías o a cualquier otro orga- nismo apropiado que establezca, a fin de recabar su dictamen con respecto a cuestiones éticas.

2. La Comisión hará que estos dictámenes sean accesibles al público.

Artículo 34

Medidas de emergencia

Cuando sea evidente que productos autorizados por el presente Reglamento o de acuerdo con lo dispuesto en él pueden consti- tuir un riesgo grave para la salud humana, la sanidad animal o el medio ambiente, o cuando, a la luz de un dictamen de la Autoridad formulado de conformidad con los artículos 10 y 22, resulte necesario suspender o modificar urgentemente una autorización, se tomarán medidas con arreglo a los procedi- mientos previstos en los artículos 53 y 54 del Reglamento (CE) no 178/2002.

Artículo 35

Comité

1. La Comisión estará asistida por el Comité permanente de la cadena alimentaria y de sanidad animal creado por el artículo 58 del Reglamento (CE) no 178/2002, denominado en lo suce- sivo el Comité.

2. En los casos en que se haga referencia al presente apar- tado, serán de aplicación los artículos 5 y 7 de la Decisión 1999/468/CE, observando lo dispuesto en su artículo 8.

El plazo contemplado en el apartado 6 del artículo 5 de la Decisión 1999/468/CE queda fijado en tres meses.

3. El Comité aprobará su reglamento interno.

Artículo 36

Revisión administrativa

Las decisiones tomadas o la falta de actuación de la Autoridad en virtud de las competencias que le confiere el presente Regla- mento podrán ser objeto de una revisión administrativa por parte de la Comisión, a iniciativa propia o a petición de un Estado miembro o de cualquier persona directa e individual- mente afectada.

A tal fin se presentará una solicitud a la Comisión en un plazo de dos meses a partir de la fecha en que la parte afectada tenga conocimiento de la acción u omisión de que se trate.

La Comisión adoptará una decisión en el plazo de dos meses exigiendo, si procede, a la Autoridad que retire su decisión, o que remedie su falta de actuación.

Artículo 37

Derogaciones

Quedarán derogados los siguientes Reglamentos con efectos a partir de la fecha de aplicación del presente Reglamento:

— Reglamento (CE) no 1139/98,

— Reglamento (CE) no 49/2000,

— Reglamento (CE) no 50/2000.

Artículo 38

Modificaciones del Reglamento (CE) no 258/97

Con efectos a partir de la fecha de aplicación del presente Reglamento, el Reglamento (CE) no 258/97 queda modificado como sigue:

1) Se suprimen las siguientes disposiciones: — las letras a) y b) del apartado 2 del artículo 1, — el segundo párrafo del apartado 2 del artículo 3 y el

apartado 3 del artículo 3, — la letra d) del apartado 1 del artículo 8, — el artículo 9.

2) La primera frase del apartado 4 del artículo 3 se sustituye por el texto siguiente: «4. No obstante lo dispuesto en el apartado 2, el procedi- miento contemplado en el artículo 5 se aplicará a los alimentos o ingredientes alimentarios mencionados en las letras d) y e) del apartado 2 del artículo 1 que, a tenor de los datos científicos disponibles y reconocidos de forma general o de un dictamen emitido por uno de los orga- nismos competentes contemplados en el apartado 3 del artículo 4, sean sustancialmente equivalentes a alimentos o a ingredientes alimentarios existentes en lo que se refiere a su composición, valor nutricional, metabolismo, uso al que están destinados y a su contenido de sustancias indesea- bles.».

Artículo 39

Modificación de la Directiva 82/471/CEE

Con efectos a partir de la fecha de aplicación del presente Reglamento, en el artículo 1 de la Directiva 82/471/CEE se añade el apartado 3 siguiente:

«3. La presente Directiva no se aplicará a los productos que actúen directa o indirectamente como fuentes proteí- nicas que entren en el ámbito de aplicación del Reglamento (CE) no 1829/2003 del Parlamento Europeo y del Consejo, de 22 de septiembre de 2003, sobre alimentos y piensos modificados genéticamente (*).

(*) DO L 268 de 18.10.2003, p. 1.».

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Artículo 40

Modificaciones de la Directiva 2002/53/CE

Con efectos a partir de la fecha de aplicación del presente Reglamento, la Directiva 2002/53/CE queda modificada como sigue:

1) El apartado 5 del artículo 4 se sustituye por el texto siguiente:

«5. Además, si un material derivado de una variedad de planta va a ser utilizado en un alimento que entre en el ámbito de aplicación del artículo 3 del Reglamento (CE) no 1829/2003 del Parlamento Europeo y del Consejo, de 22 de septiembre de 2003, sobre alimentos y piensos modificados genéticamente (*), o en un pienso que entre en el ámbito de aplicación del artículo 15 de dicho Reglamento, sólo se aceptará esa variedad de planta si ha sido aprobada de conformidad con el Reglamento citado.

(*) DO L 268 de 18.10.2003, p. 1.».

2) El apartado 5 del artículo 7 se sustituye por el texto siguiente:

«5. Los Estados miembros se asegurarán de que la variedad que vaya a utilizarse en alimentos o en piensos definidos en los artículos 2 y 3 del Reglamento (CE) no 178/ 2002 del Parlamento Europeo y del Consejo, de 28 de enero de 2002, por el que se establecen los principios y los requi- sitos generales de la legislación alimentaria, se crea la Auto- ridad Europea de Seguridad Alimentaria y se fijan procedi- mientos relativos a la seguridad alimentaria (*), sólo se acepte si ha sido autorizada con arreglo a la legislación pertinente.

(*) DO L 31 de 1.2.2002, p. 1.».

Artículo 41

Modificaciones de la Directiva 2002/55/CE

Con efectos a partir de la fecha de aplicación del presente Reglamento, la Directiva 2002/55/CE queda modificada como sigue:

1) El apartado 3 del artículo 4 se sustituye por el texto siguiente:

«3. Además, si un material derivado de una variedad de planta va a ser utilizado en un alimento que entre en el ámbito de aplicación del artículo 3 del Reglamento (CE) no 1829/2003 del Parlamento Europeo y del Consejo, de 22 de septiembre de 2003, sobre alimentos y piensos modificados genéticamente (*), o en un pienso que entre en el ámbito de aplicación del artículo 15 de dicho Reglamento, sólo se aceptará esa variedad de planta si ha sido aprobada de conformidad con el Reglamento citado.

(*) DO L 268 de 18.10.2003, p. 1.».

2) El apartado 5 del artículo 7 se sustituye por el texto siguiente:

«5. Los Estados miembros se asegurarán de que la variedad que vaya a utilizarse en alimentos o piensos defi- nidos en los artículos 2 y 3 del Reglamento (CE) no 178/ 2002 del Parlamento Europeo y del Consejo, de 28 de enero

de 2002, por el que se establecen los principios y los requi- sitos generales de la legislación alimentaria, se crea la Auto- ridad Europea de Seguridad Alimentaria y se fijan procedi- mientos relativos a la seguridad alimentaria (*), sólo se acepte si ha sido autorizada con arreglo a la legislación pertinente.

(*) DO L 31 de 1.2.2002, p. 1.».

Artículo 42

Modificación de la Directiva 68/193/CEE

Con efectos a partir de la fecha de aplicación del presente Reglamento, el apartado 3 del artículo 5 terbis de la Directiva 68/193/CEE se sustituye por el texto siguiente:

«3. a) Cuando vayan a utilizarse productos derivados de materiales de multiplicación de la vid como alimentos o ingredientes de éstos incluidos en el ámbito de aplicación del artículo 3 del Reglamento (CE) no 1829/2003 del Parlamento Europeo y del Consejo, de 22 de septiembre de 2003, sobre alimentos y piensos modificados genéticamente (*), o como piensos o ingredientes de éstos incluidos en el ámbito de aplicación del artículo 15 de dicho Reglamento, la variedad de vid de que se trate se admitirá únicamente si ha sido autorizada de conformidad con el Reglamento citado.

b) Los Estados miembros velarán por que las varie- dades de vid de cuyos materiales de multiplicación se hayan derivado productos que vayan a utilizarse en alimentos y en piensos con arreglo a los artículos 2 y 3 del Reglamento (CE) no 178/2002 del Parla- mento Europeo y del Consejo, de 28 de enero de 2002, por el que se establecen los principios y los requisitos generales de la legislación alimentaria, se crea la Autoridad Europea de Seguridad Alimentaria y se fijan procedimientos relativos a la seguridad alimentaria (**), sólo se acepten si han sido autori- zadas con arreglo a la legislación pertinente.

(*) DO L 268 de 18.10.2003, p. 1. (**) DO L 31 de 1.2.2002, p. 1.».

Artículo 43

Modificaciones de la Directiva 2001/18/CE

Con efectos a partir de la fecha de entrada en vigor del presente Reglamento, la Directiva 2001/18/CE queda modificada como sigue:

1) Se inserta el artículo 12 bis siguiente:

«Artículo 12 bis

Medidas transitorias aplicables a la presencia accidental o técnicamente inevitable de organismos modificados genéticamente cuya evaluación de riesgo haya sido favorable

1. La comercialización de trazas de OMG o de combina- ciones de OMG en productos destinados a un uso directo como alimentos o piensos o a una ulterior transformación

18.10.2003L 268/20 Diario Oficial de la Unión EuropeaES

quedarán exceptuados de la aplicación de los artículos 13 a 21, siempre que cumplan las condiciones previstas en el artículo 47 del Reglamento (CE) no 1829/2003 del Parla- mento Europeo y del Consejo, de 22 de septiembre de 2003, sobre alimentos y piensos modificados genética- mente (*).

2. El presente artículo se aplicará durante un periodo de tres años tras la fecha de aplicación del Reglamento (CE) no 1829/2003.

(*) DO L 268 de 18.10.2003, p. 1.».

2) Se inserta el artículo 26 bis siguiente:

«Artículo 26 bis

Medidas para impedir la presencia accidental de OMG

1. Los Estados miembros podrán adoptar las medidas adecuadas para impedir la presencia accidental de OMG en otros productos.

2. La Comisión recogerá y coordinará la información basada en estudios a escala comunitaria y nacional, observará la evolución relativa a la coexistencia de cultivos en los Estados miembros, y, sobre la base de dicha informa- ción y observación, elaborará orientaciones sobre la coexis- tencia de cultivos modificados genéticamente, cultivos convencionales y cultivos biológicos.».

Artículo 44

Información que ha de proporcionarse de acuerdo con el Protocolo de Cartagena

1. La Comisión notificará a las Partes en el Protocolo de Cartagena, conforme al apartado 1 del artículo 11 o al apartado 1 del artículo 12 de dicho Protocolo, a través del Centro de Intercambio de Información sobre Seguridad de la Biotecno- logía, toda autorización, renovación, modificación, suspensión o revocación de la autorización de un OMG, alimento o pienso contemplados en las letras a) o b) del apartado 1 del artículo 3 y en las letras a) o b) del apartado 1 del artículo 15.

La Comisión proporcionará por escrito una copia de la infor- mación al centro focal nacional de cada Parte que haya comu- nicado previamente a la Secretaría que no tiene acceso al Centro de Intercambio de Información sobre Seguridad de la Biotecnología.

2. Asimismo, la Comisión tramitará las solicitudes de infor- mación adicional que haga cualquier Parte conforme al apar- tado 3 del artículo 11 del citado Protocolo, y proporcionará copias de las leyes, las reglamentaciones y las directrices conforme al apartado 5 del artículo 11 de dicho Protocolo.

Artículo 45

Sanciones

Los Estados miembros establecerán el régimen de sanciones aplicable al incumplimiento de lo dispuesto por el presente Reglamento y adoptarán todas las medidas necesarias para

asegurar su aplicación. Las sanciones fijadas deberán ser eficaces, proporcionadas y disuasorias. Los Estados miembros notificarán esas normas a la Comisión a más tardar a los seis meses de la entrada en vigor del presente Reglamento, y le comunicarán de inmediato cualquier modificación posterior.

Artículo 46

Medidas transitorias aplicables a las solicitudes, el etique- tado y las notificaciones

1. Las solicitudes presentadas en virtud del artículo 4 del Reglamento (CE) no 258/97 antes de la fecha de aplicación del presente Reglamento se convertirán en solicitudes conforme a la sección 1 del capítulo II de éste último si aún no se ha enviado a la Comisión el informe de evaluación inicial previsto por el apartado 3 del artículo 6 del citado Reglamento (CE) no 258/97, así como en todos los casos en los que se requiera un informe de evaluación complementaria conforme a los apar- tados 3 o 4 de su artículo 6. Las demás solicitudes presentadas en virtud del artículo 4 del Reglamento (CE) no 258/97 antes de la fecha de aplicación del presente Reglamento se tramitarán de conformidad con el Reglamento (CE) no 258/97, sin perjuicio de lo dispuesto en el artículo 38 del presente Regla- mento.

2. Los requisitos de etiquetado establecidos en el presente Reglamento no se aplicarán a los productos cuyo proceso de fabricación haya comenzado con anterioridad a la fecha de apli- cación del presente Reglamento, siempre que dichos productos hayan sido etiquetados con arreglo a la legislación aplicable con anterioridad a la fecha de aplicación del presente Regla- mento.

3. Las notificaciones relativas a productos que pueden utili- zarse también como piensos presentadas en virtud del artículo 13 de la Directiva 2001/18/CE antes de la fecha de aplicación del presente Reglamento se convertirán en solicitudes conforme a la sección 1 del capítulo III de este último si aún no se ha enviado a la Comisión el informe de evaluación previsto por el artículo 14 de la citada Directiva.

4. Las solicitudes relativas a productos contemplados en la letra c) del apartado 1 del artículo 15 del presente Reglamento presentadas en virtud del artículo 7 de la Directiva 82/471/CEE antes de la fecha de aplicación del presente Reglamento se convertirán en solicitudes conforme a la sección 1 del capítulo III de este último.

5. Las solicitudes relativas a productos contemplados en el apartado 1 del artículo 15 del presente Reglamento presentadas en virtud del artículo 4 de la Directiva 70/524/CEE antes de la fecha de aplicación del presente Reglamento se complemen- tarán con solicitudes conforme a la sección 1 del capítulo III de este último.

18.10.2003 L 268/21Diario Oficial de la Unión EuropeaES

Artículo 47

Medidas transitorias aplicables a la presencia accidental o técnicamente inevitable de material modificado genética-

mente cuya evaluación de riesgo haya sido favorable

1. La presencia en un alimento o en un pienso de material que contenga o esté compuesto por OMG o haya sido produ- cido a partir de estos organismos, en una proporción que no supere el 0,5 %, no se considerará como una infracción de lo dispuesto en el apartado 2 del artículo 4 o en el apartado 2 del artículo 16, a condición de que:

a) esa presencia sea accidental o técnicamente inevitable;

b) el material modificado genéticamente haya recibido el dictamen favorable del comité o comités científicos de la Comunidad o de la Autoridad antes de la fecha de aplica- ción del presente Reglamento;

c) no se haya denegado la solicitud de autorización del mismo en virtud de la legislación comunitaria pertinente, y

d) los métodos de detección estén a disposición del público.

2. Para determinar que la presencia de ese material es acci- dental o técnicamente inevitable, los operadores deberán poder demostrar a las autoridades competentes que han adoptado las medidas apropiadas para evitar su presencia.

3. El umbral mencionado en el apartado 1 podrá reducirse de conformidad con el procedimiento mencionado en el apar- tado 2 del artículo 35, en particular para los OMG vendidos directamente al consumidor final.

4. Las normas de desarrollo del presente artículo se adop- tarán de conformidad con el procedimiento mencionado en el apartado 2 del artículo 35.

5. El presente artículo será aplicable durante un período de tres años tras la fecha de aplicación del presente Reglamento.

Artículo 48

Revisión

1. A más tardar el 7 de noviembre de 2005, y a la luz de la experiencia adquirida, la Comisión presentará al Parlamento Europeo y al Consejo un informe sobre la aplicación del presente Reglamento, y en particular de su artículo 47, acom- pañado, si procede, de las propuestas adecuadas. El informe y cualquier posible propuesta serán accesibles al público.

2. Sin perjuicio de las competencias de las autoridades nacionales, la Comisión vigilará la aplicación del presente Reglamento y sus repercusiones para la salud humana, la sanidad animal, la protección e información de los consumi- dores y el funcionamiento del mercado interior, y si es nece- sario presentará propuestas lo antes posible.

Artículo 49

Entrada en vigor

El presente Reglamento entrará en vigor a los veinte días de su publicación en el Diario Oficial de la Unión Europea.

Será aplicable seis meses después de la fecha de su publicación.

El presente Reglamento será obligatorio en todos sus elementos y directamente aplicable en cada Estado miembro.

Hecho en Bruselas, el 22 de septiembre de 2003.

Por el Parlamento Europeo

El Presidente P. COX

Por el Consejo

El Presidente R. BUTTIGLIONE

18.10.2003L 268/22 Diario Oficial de la Unión EuropeaES

ANEXO

COMPETENCIAS Y TAREAS DEL LABORATORIO COMUNITARIO DE REFERENCIA

1. El laboratorio comunitario de referencia al que se refiere el artículo 32 es el Centro Común de Investigación de la Comisión.

2. En las tareas que se enumeran en este anexo, el Centro Común de Investigación de la Comisión estará asistido por un consorcio de laboratorios nacionales de referencia, al que se denominará red europea de laboratorios OMG.

3. El laboratorio comunitario de referencia será responsable, en particular, de:

— recibir, preparar, almacenar, conservar y distribuir a los laboratorios nacionales de referencia las correspondientes muestras de control, positivas y negativas,

— probar y validar el método de detección, incluidos el muestreo y la identificación de la operación de transforma- ción, y, si procede, la detección e identificación de la operación de transformación en el alimento o pienso,

— evaluar los datos proporcionados por el solicitante de la autorización para comercializar el alimento o el pienso, con el fin de probar y validar el método de muestreo y detección,

— presentar a la Autoridad informes de evaluación completos.

4. El laboratorio comunitario de referencia intervendrá para resolver las controversias entre Estados miembros relacio- nadas con los resultados de las tareas establecidas en el presente anexo.

18.10.2003 L 268/23Diario Oficial de la Unión EuropeaES

 Regulation (EC) No. 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed

18.10.2003 EN Official Journal of the European Union L 268/1

I

(Acts whose publication is obligatory)

REGULATION (EC) No 1829/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2003

on genetically modified food and feed

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Com- munity, and in particular Articles 37, 95 and Article 152(4)(b) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Economic and Social Committee (2),

Having regard to the opinion of the Committee of the Regions (3),

Acting in accordance with the procedure referred to in Article 251 of the Treaty (4),

Whereas:

(1) The free movement of safe and wholesome food and feed is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.

(2) A high level of protection of human life and health should be ensured in the pursuit of Community policies.

(3) In order to protect human and animal health, food and feed consisting of, containing or produced from geneti- cally modified organisms (hereinafter referred to as genetically modified food and feed) should undergo a safety assessment through a Community procedure before being placed on the market within the Commu- nity.

(1) OJ C 304 E, 30.10.2001, p. 221. (2) OJ C 221, 17.9.2002, p. 114. (3) OJ C 278, 14.11.2002, p. 31. (4) Opinion of the European Parliament of 3 July 2002 (not yet

published in the Official Journal), Council Common Position of 17 March 2003 (OJ C 113 E, 13.5.2003, p. 31), Decision of the European Parliament of 2 July 2003 (not yet published in the Offi- cial Journal) and Council Decision of 22 July 2003.

(4) Differences between national laws, regulations and administrative provisions concerning the assessment and authorisation of genetically modified food and feed may hinder their free movement, creating conditions of unequal and unfair competition.

(5) An authorisation procedure involving Member States and the Commission has been established for genetically modified foods in Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredi- ents (5). This procedure should be streamlined and made more transparent.

(6) Regulation (EC) No 258/97 also provides for a notifica- tion procedure for novel foods which are substantially equivalent to existing foods. Whilst substantial equiva- lence is a key step in the procedure for assessment of the safety of genetically modified foods, it is not a safety assessment in itself. In order to ensure clarity, transpar- ency and a harmonised framework for authorisation of genetically modified food, this notification procedure should be abandoned in respect of genetically modified foods.

(7) Feed consisting of or containing genetically modified organisms (GMOs) has so far been authorised, subject to the authorisation procedure provided by Council Direc- tive 90/220/EEC of 23 April 1990 (6) and Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (7); no authorisation procedure exists for feed produced from GMOs; a single, efficient and transparent Commu- nity authorisation procedure for feed consisting of, containing or produced from GMOs should be estab- lished.

(8) The provisions of this Regulation should also apply to feed intended for animals which are not destined for food production.

(5) OJ L 43, 14.2.1997, p. 1. (6) OJ L 117, 8.5.1990, p. 15. Directive repealed by Directive 2001/

18/EC. (7) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Council

Decision 2002/811/EC (OJ L 280, 18.10.2002, p. 27).

L 268/2 EN Official Journal of the European Union 18.10.2003

(9) The new authorisation procedures for genetically modi- fied food and feed should include the new principles introduced in Directive 2001/18/EC. They should also make use of the new framework for risk assessment in matters of food safety set up by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down proce- dures in matters of food safety (1). Thus, genetically modified food and feed should only be authorised for placing on the Community market after a scientific evaluation of the highest possible standard, to be under- taken under the responsibility of the European Food Safety Authority (Authority), of any risks which they present for human and animal health and, as the case may be, for the environment. This scientific evaluation should be followed by a risk management decision by the Community, under a regulatory procedure ensuring close cooperation between the Commission and the Member States.

(10) Experience has shown that authorisation should not be granted for a single use, when a product is likely to be used both for food and feed purposes; therefore such products should only be authorised when fulfilling authorisation criteria for both food and feed.

(11) Under this Regulation, authorisation may be granted either to a GMO to be used as a source material for production of food or feed and products for food and/or feed use which contain, consist of or are produced from it, or to foods or feed produced from a GMO. Thus, where a GMO used in the production of food and/or feed has been authorised under this Regulation, foods and/or feed containing, consisting of or produced from that GMO will not need an authorisation under this Regulation, but will be subject to the requirements referred to in the authorisation granted in respect of the GMO. Furthermore, foods covered by an authorisation granted under this Regulation will be exempted from the requirements of Regulation (EC) No 258/97 concerning novel foods and novel food ingredients, except where they fall under one or more of the categories referred to in Article 1(2)(a) of Regulation (EC) No 258/97 in respect of a characteristic which has not been considered for the purpose of the authorisation granted under this Regulation.

(12) Council Directive 89/107/EEC of 21 December 1988 on the approximation of laws of the Member States concerning food additives authorised for use in food- stuffs intended for human consumption (2) provides for authorisation of additives used in foodstuffs. In addition

(1) OJ L 31, 1.2.2002, p. 1. (2) OJ L 40, 11.2.1989, p. 27. Directive as amended by Directive 94/

34/EC of the European Parliament and of the Council (OJ L 237, 10.9.1994, p. 1).

to this authorisation procedure, food additives containing, consisting of or produced from GMOs should fall also within the scope of this Regulation for the safety assessment of the genetic modification, while the final authorisation should be granted under the procedure referred to in Directive 89/107/EEC.

(13) Flavourings falling within the scope of Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production (3) which contain, consist of or are produced from GMOs should also fall within the scope of this Regulation for the safety assessment of the genetic modi- fication.

(14) Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (4) provides for an approval procedure for feed materials produced using different technologies that may pose risk to human or animal health and the environment. These feed materials containing, consisting of or produced from GMOs should fall instead within the scope of this Regulation.

(15) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (5), provides for an authorisation procedure for placing on the market addi- tives used in feedingstuffs. In addition to this authorisa- tion procedure, feed additives containing, consisting of or produced from GMOs should also fall within the scope of this Regulation.

(16) This Regulation should cover food and feed produced ‘from’ a GMO but not food and feed ‘with’ a GMO. The determining criterion is whether or not material derived from the genetically modified source material is present in the food or in the feed. Processing aids which are only used during the food or feed production process are not covered by the definition of food or feed and, therefore,

(3) OJ L 184, 15.7.1988, p. 61. Directive as amended by Commission Directive 91/71/EEC (OJ L 42, 15.2.1991, p. 25).

(4) OJ L 213, 21.7.1982, p. 8. Directive as last amended by Directive 1999/20/EC (OJ L 80, 25.3.1999, p. 20).

(5) OJ L 270, 14.12.1970, p. 1. Directive as last amended by Regula- tion (EC) No 1756/2002 (OJ L 265, 3.10.2002, p. 1).

18.10.2003 EN Official Journal of the European Union L 268/3

are not included in the scope of this Regulation. Nor are food and feed which are manufactured with the help of a genetically modified processing aid included in the scope of this Regulation. Thus, products obtained from animals fed with genetically modified feed or treated with genetically modified medicinal products will be subject neither to the authorisation requirements nor to the labelling requirements referred to in this Regulation.

(17) In accordance with Article 153 of the Treaty, the Community is to contribute to promoting the right of consumers to information. In addition to other types of information to the public provided for in this Regula- tion, the labelling of products enables the consumer to make an informed choice and facilitates fairness of trans- actions between seller and purchaser.

(18) Article 2 of Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of food- stuffs (1) provides that labelling must not mislead the purchaser as to the characteristics of the foodstuff and among other things, in particular, as to its nature, iden- tity, properties, composition, method of production and manufacturing.

(19) Additional requirements for the labelling of genetically modified foods are laid down in Regulation (EC) No 258/97, in Council Regulation (EC) No 1139/98 of 26 May 1998 concerning the compulsory indication, on the labelling of certain foodstuffs produced from genetically modified organisms, of particulars other than those provided for in Directive 79/112/EEC (2) and in Commis- sion Regulation (EC) No 50/2000 of 10 January 2000 on the labelling of foodstuffs and food ingredients containing additives and flavourings that have been genetically modified or have been produced from geneti- cally modified organisms (3).

(20) Harmonised labelling requirements should be laid down for genetically modified feed to provide final users, in particular livestock farmers, with accurate information on the composition and properties of feed, thereby enabling the user to make an informed choice.

(21) The labelling should include objective information to the effect that a food or feed consists of, contains or is produced from GMOs. Clear labelling, irrespective of the detectability of DNA or protein resulting from the genetic modification in the final product, meets the demands expressed in numerous surveys by a large majority of consumers, facilitates informed choice and precludes potential misleading of consumers as regards methods of manufacture or production.

(1) OJ L 109, 6.5.2000, p. 29. Directive as amended by Commission Directive 2001/101/EC (OJ L 310, 28.11.2001, p. 19).

(2) OJ L 159, 3.6.1998, p. 4. Regulation as amended by Commission Regulation (EC) No 49/2000 (OJ L 6, 11.1.2000, p. 13).

(3) OJ L 6, 11.1.2000, p. 15.

(22) In addition, the labelling should give information about any characteristic or property which renders a food or feed different from its conventional counterpart with respect to composition, nutritional value or nutritional effects, intended use of the food or feed and health implications for certain sections of the population, as well as any characteristic or property which gives rise to ethical or religious concerns.

(23) Regulation (EC) No 1830/2003 of the European Parlia- ment and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (4) ensures that rele- vant information concerning any genetic modification is available at each stage of the placing on the market of GMOs and food and feed produced therefrom and should thereby facilitate accurate labelling.

(24) Despite the fact that some operators avoid using geneti- cally modified food and feed, such material may be present in minute traces in conventional food and feed as a result of adventitious or technically unavoidable presence during seed production, cultivation, harvest, transport or processing. In such cases, this food or feed should not be subject to the labelling requirements of this Regulation. In order to achieve this objective, a threshold should be established for the adventitious or technically unavoidable presence of genetically modified material in foods or feed, both when the marketing of such material is authorised in the Community and when this presence is tolerated by virtue of this Regulation.

(25) It is appropriate to provide that, when the combined level of adventitious or technically unavoidable presence of genetically modified materials in a food or feed or in one of its components is higher than the set threshold, such presence should be indicated in accordance with this Regulation and that detailed provisions should be adopted for its implementation. The possibility of estab- lishing lower thresholds, in particular for foods and feed containing or consisting of GMOs or in order to take into account advances in science and technology, should be provided for.

(26) It is indispensable that operators strive to avoid any acci- dental presence of genetically modified material not authorised under Community legislation in food or feed. However, in order to ensure the practicability and feasi- bility of this Regulation, a specific threshold, with the possibility of establishing lower levels in particular for

(4) See page 24 of this Official Journal.

L 268/4 EN Official Journal of the European Union 18.10.2003

GMOs sold directly to the final consumer, should be established as a transitional measure for minute traces in food or feed of this genetically modified material, where the presence of such material is adventitious or techni- cally unavoidable and provided that all specific condi- tions set in this Regulation are met. Directive 2001/18/ EC should be amended accordingly. The application of this measure should be reviewed in the context of the general review of the implementation of this Regulation.

(27) In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to demonstrate to the competent autho- rities that they have taken appropriate steps to avoid the presence of the genetically modified food or feed.

(28) Operators should avoid the unintended presence of GMOs in other products. The Commission should gather information and develop on this basis guidelines on the coexistence of genetically modified, conventional and organic crops. Moreover, the Commission is invited to bring forward, as soon as possible, any further necessary proposal.

(29) The traceability and labelling of GMOs at all stages of placing on the market, including the possibility of estab- lishing thresholds, is ensured by Directive 2001/18/EC and Regulation (EC) No 1830/2003.

(30) It is necessary to establish harmonised procedures for risk assessment and authorisation that are efficient, time- limited and transparent, and criteria for evaluation of the potential risks arising from genetically modified foods and feed.

(31) In order to ensure a harmonised scientific assessment of genetically modified foods and feed, such assessments should be carried out by the Authority. However, as specific acts or omissions on the part of the Authority under this Regulation could produce direct legal effects on applicants, it is appropriate to provide for the possi- bility of an administrative review of such acts or omis- sions.

(32) It is recognised that, in some cases, scientific risk assess- ment alone cannot provide all the information on which a risk management decision should be based, and that other legitimate factors relevant to the matter under consideration may be taken into account.

(33) Where the application concerns products containing or consisting of a genetically modified organism, the appli- cant should have the choice of either supplying an authorisation for the deliberate release into the environ- ment already obtained under part C of Directive 2001/ 18/EC, without prejudice to the conditions set by that authorisation, or of applying for the environmental risk assessment to be carried out at the same time as the safety assessment under this Regulation. In the latter case, it is necessary for the evaluation of the environ- mental risk to comply with the requirements referred to in Directive 2001/18/EC and for the national competent authorities designated by Member States for this purpose to be consulted by the Authority. In addition, it is appro- priate to give the Authority the possibility of asking one of these competent authorities to carry out the environ- mental risk assessment. It is also appropriate, in accor- dance with Article 12(4) of Directive 2001/18/EC, for the national competent authorities designated under the said Directive in all cases concerning GMOs and food and/or feed containing or consisting of a GMO to be consulted by the Authority before it finalises the envir- onmental risk assessment.

(34) In the case of GMOs to be used as seeds or other plant- propagating materials falling within the scope of this Regulation, the Authority should be under an obligation to delegate the environmental risk assessment to a national competent authority. Nonetheless, authorisa- tions under this Regulation should be without prejudice to the provisions of Directives 68/193/EEC (1), 2002/53/ EC (2) and 2002/55/EC (3), which provide in particular for the rules and the criteria for the acceptance of vari- eties and their official acceptance for inclusion in common catalogues; nor should they affect the provi- sions of Directives 66/401/EEC (4), 66/402/EEC (5), 68/ 193/EEC, 92/33/EEC (6), 92/34/EEC (7), 2002/54/EC (8), 2002/55/EC, 2002/56/EC (9) or 2002/57/EC (10) which regulate in particular the certification and the marketing of seeds and other plant-propagating materials.

(1) OJ L 93, 17.4.1968, p. 15. Directive as last amended by Directive 2002/11/EC (OJ L 53, 23.2.2002, p. 20).

(2) OJ L 193, 20.7.2002, p. 1. (3) OJ L 193, 20.7.2002, p. 33. (4) OJ 125, 11.7.1966, p. 2298/66. Directive as last amended by Direc-

tive 2001/64/EC (OJ L 234, 1.9.2001, p. 60). (5) OJ 125, 11.7.1966, p. 2309/66. Directive as last amended by Direc-

tive 2001/64/EC. (6) OJ L 157, 10.6.1992, p. 1. Directive as last amended by Regulation

(EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1). (7) OJ L 157, 10.6.1992, p. 10. Directive as last amended by Regula-

tion (EC) No 806/2003. (8) OJ L 193, 20.7.2002, p. 12. (9) OJ L 193, 20.7.2002, p. 60. Directive amended by Commission

Decision 2003/66/EC (OJ L 25, 30.1.2003, p. 42). (10) OJ L 193, 20.7.2002, p. 74. Directive amended by Commission

Directive 2003/45/EC (OJ L 138, 5.6.2003, p. 40).

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(35) It is necessary to introduce, where appropriate and on the basis of the conclusions of the risk assessment, post- market monitoring requirements for the use of geneti- cally modified foods for human consumption and for the use of genetically modified feed for animal consump- tion. In the case of GMOs, a monitoring plan concerning environmental effects is compulsory under Directive 2001/18/EC.

(36) To facilitate controls on genetically modified food and feed, applicants for authorisation should propose appro- priate methods for sampling, identification and detec- tion, and deposit samples of the genetically modified food and feed with the Authority; methods of sampling and detection should be validated, where appropriate, by the Community reference laboratory.

(37) Technological progress and scientific developments should be taken into account when implementing this Regulation.

(38) Food and feed falling within the scope of this Regulation which have been lawfully placed on the Community market before the date of application of this Regulation should continue to be allowed on the market, subject to the transmission to the Commission by the operators of information concerning the risk assessment, methods for sampling, identification and detection as appropriate, including the transmission of samples of the food and feed and their control samples within six months after the date of application of this Regulation.

(39) A register of genetically modified food and feed authorised under this Regulation should be established, including product specific information, studies which demonstrate the safety of the product, including, where available, references to independent and peer-reviewed studies, and to methods for sampling, identification and detection. Non-confidential data should be made avail- able to the public.

(40) In order to stimulate research and development into GMOs for food and/or feed use, it is appropriate to protect the investment made by innovators in gathering the information and data supporting an application under this Regulation. This protection should however be limited in time in order to avoid the unnecessary repetition of studies and trials which would be against the public interest.

(41) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (1).

(1) OJ L 184, 17.7.1999, p. 23.

(42) Provision should be made for consultation of the European Group on Ethics in Science and New Technol- ogies established by Commission Decision of 16 December 1997, or any other appropriate body estab- lished by the Commission, with a view to obtaining advice on ethical issues regarding the placing on the market of genetically modified food or feed. Such consultations should be without prejudice to the compe- tence of Member States as regards ethical issues.

(43) In order to provide a high level of protection of human life and health, animal health and welfare, environment and consumer interests in relation to genetically modi- fied food and feed, requirements arising from this Regu- lation should apply in a non-discriminatory manner to products originating in the Community and imported from third countries, in accordance with the general principles referred to in Regulation (EC) No 178/2002. The content of this Regulation takes account of the international trade commitments of the European Communities and of the requirements of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity as regards importer obligations and notifica- tion.

(44) Certain instruments of Community law should be repealed and others amended as a result of this Regula- tion.

(45) The implementation of this Regulation should be reviewed in the light of experience gained in the short term, and the impact of the application of this Regula- tion on human and animal health, consumer protection, consumer information and the functioning of the internal market should be monitored by the Commis- sion,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

OBJECTIVE AND DEFINITIONS

Article 1

Objective

The objective of this Regulation, in accordance with the general principles laid down in Regulation (EC) No 178/2002, is to:

(a) provide the basis for ensuring a high level of protection of human life and health, animal health and welfare, environ- ment and consumer interests in relation to genetically modified food and feed, whilst ensuring the effective func- tioning of the internal market;

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(b) lay down Community procedures for the authorisation and supervision of genetically modified food and feed;

(c) lay down provisions for the labelling of genetically modi- fied food and feed.

Article 2

Definitions

For the purposes of this Regulation:

1. the definitions of ‘food’, ‘feed’, ‘final consumer’, ‘food busi- ness’ and ‘feed business’ given in Regulation (EC) No 178/ 2002 shall apply;

2. the definition of ‘traceability’, laid down in Regulation (EC) No 1830/2003;

3. ‘operator’ means the natural or legal person responsible for ensuring that the requirements of this Regulation are met within the food businesses or feed businesses under its control;

4. the definitions of ‘organism’, ‘deliberate release’ and ‘envir- onmental risk assessment’ referred to in Directive 2001/ 18/EC shall apply;

5. ‘genetically modified organism’ or ‘GMO’ means a geneti- cally modified organism as defined in Article 2(2) of Direc- tive 2001/18/EC, excluding organisms obtained through the techniques of genetic modification listed in Annex I B to Directive 2001/18/EC;

6. ‘genetically modified food’ means consisting of or produced from GMOs;

food containing,

7. ‘genetically modified feed’ means consisting of or produced from GMOs;

feed containing,

8. ‘genetically modified organism for food use’ means a GMO that may be used as food or as a source material for the production of food;

9. ‘genetically modified organism for feed use’ means a GMO that may be used as feed or as a source material for the production of feed;

10. ‘produced from GMOs’ means derived, in whole or in part, from GMOs, but not containing or consisting of GMOs;

11. ‘control sample’ means the GMO or its genetic material (positive sample) and the parental organism or its genetic material that has been used for the purpose of the genetic modification (negative sample);

12. ‘conventional counterpart’ means a similar food or feed produced without the help of genetic modification and for which there is a well-established history of safe use;

13. ‘ingredient’ means ‘ingredient’ as referred to in Article 6(4) of Directive 2000/13/EC;

14. ‘placing on the market’ means the holding of food or feed for the purpose of sale, including offering for sale, or any other form of transfer, whether free of charge or not, and the sale, distribution and other forms of transfer them- selves.

15. ‘pre-packaged food’ means any single item for presentation as such consisting of a food and the packaging into which it was put before being offered for sale, whether such packaging encloses the food completely or only partially, provided that the contents cannot be altered without opening or changing the packaging.

16. ‘mass caterer’ means ‘mass caterer’ as referred to in Article 1 of Directive 2000/13/EC.

CHAPTER II

GENETICALLY MODIFIED FOOD

Se c t i on 1

A ut h ori sat i o n an d su p e rvi si on

Article 3

Scope

1. This Section shall apply to:

(a) GMOs for food use;

(b) food containing or consisting of GMOs;

(c) food produced from or containing ingredients produced from GMOs.

2. Where necessary, it may be determined in accordance with the procedure referred to in Article 35(2) whether a type of food falls within the scope of this Section.

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Article 4

Requirements

1. Food referred to in Article 3(1) must not:

(a) have adverse effects on human health, animal health or the environment;

(b) mislead the consumer;

(c) differ from the food which it is intended to replace to such an extent that its normal consumption would be nutrition- ally disadvantageous for the consumer.

2. No person shall place on the market a GMO for food use or food referred to in Article 3(1) unless it is covered by an authorisation granted in accordance with this Section and the relevant conditions of the authorisation are satisfied.

3. No GMO for food use or food referred to in Article 3(1) shall be authorised unless the applicant for such authorisation has adequately and sufficiently demonstrated that it satisfies the requirements of paragraph 1 of this Article.

4. The authorisation referred to in paragraph 2 may cover:

(a) a GMO and foods containing or consisting of that GMO as well as foods produced from or containing ingredients produced from that GMO; or

(b) food produced from a GMO as well as foods produced from or containing that food;

(c) an ingredient produced from a GMO as well as food containing that ingredient.

5. An authorisation as referred to in paragraph 2 shall not be granted, refused, renewed, modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation.

6. The applicant for an authorisation as referred to in para- graph 2 and, after the authorisation is granted, the authorisa- tion-holder or his representative, shall be established in the Community.

7. Authorisation under this Regulation shall be without prejudice to Directive 2002/53/EC, Directive 2002/55/EC and Directive 68/193/EEC.

Article 5

Application for authorisation

1. To obtain the authorisation referred to in Article 4(2), an application shall be submitted in accordance with the following provisions.

2. The application shall be sent to the national competent authority of a Member State.

(a) The national competent authority:

(i) shall acknowledge receipt of the application in writing to the applicant within 14 days of its receipt. The acknowledgement shall state the date of receipt of the application;

(ii) shall inform without delay the European Food Safety Authority (hereinafter referred to as the Authority); and

(iii) shall make the application and any supplementary information supplied by the applicant available to the Authority.

(b) The Authority

(i) shall inform without delay the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them;

(ii) shall make the summary of the dossier referred to in paragraph 3(1) available to the public.

3. The application shall be accompanied by the following:

(a) the name and the address of the applicant;

(b) the designation of the food, and its specification, including the transformation event(s) used;

(c) where applicable, the information to be provided for the purpose of complying with Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (hereinafter referred to as the Cartagena Protocol);

(d) where applicable, a detailed description of the method of production and manufacturing;

(e) a copy of the studies, including, where available, indepen- dent, peer-reviewed studies, which have been carried out and any other material which is available to demonstrate that the food complies with the criteria referred to in Article 4(1);

(f) either an analysis, supported by appropriate information and data, showing that the characteristics of the food are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics and to the criteria specified in Article 13(2)(a), or a proposal for labelling the food in accordance with Article 13(2)(a) and (3);

(g) either a reasoned statement that the food does not give rise to ethical or religious concerns, or a proposal for labelling it in accordance with Article 13(2)(b);

(h) where appropriate, the conditions for placing on the market the food or foods produced from it, including specific conditions for use and handling;

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(i) methods for detection, sampling (including references to existing official or standardised sampling methods) and identification of the transformation event and, where applicable, for the detection and identification of the trans- formation event in the food and/or in foods produced from it;

(j) samples of the food and their control samples, and infor- mation as to the place where the reference material can be accessed;

(k) where appropriate, a proposal for post-market monitoring regarding use of the food for human consumption;

(l) a summary of the dossier in a standardised form.

4. In the case of an application relating to a GMO for food use, references to ‘food’ in paragraph 3 shall be interpreted as referring to food containing, consisting of or produced from the GMO in respect of which an application is made.

5. In the case of GMOs or food containing or consisting of GMOs, the application shall also be accompanied by:

(a) the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC or, where the placing on the market of the GMO has been authorised under part C of Directive 2001/18/EC, a copy of the authorisation decision;

(b) a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan; this dura- tion may be different from the proposed period for the consent.

In such case, Articles 13 to 24 of Directive 2001/18/EC shall not apply.

6. Where the application concerns a substance, the use and placing on the market of which is subject, under other provi- sions of Community law, to its inclusion on a list of substances registered or authorised to the exclusion of others, this must be stated in the application and the status of the substance under the relevant legislation must be indicated.

7. The Commission, having first consulted the Authority, shall establish, in accordance with the procedure referred to in Article 35(2), implementing rules for the application of this Article, including rules concerning the preparation and the presentation of the application.

8. Before the date of application of this Regulation, the Authority shall publish detailed guidance to assist the applicant in the preparation and the presentation of the application.

Article 6

Opinion of the Authority

1. In giving its opinion, the Authority shall endeavour to respect a time limit of six months as from the receipt of a valid application. Such time limit shall be extended whenever the Authority seeks supplementary information from the applicant as provided for in paragraph 2.

2. The Authority or a national competent authority through the Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specific time limit.

3. In order to prepare its opinion the Authority:

(a) shall verify that the particulars and documents submitted by the applicant are in accordance with Article 5 and examine whether the food complies with the criteria referred to in Article 4(1);

(b) may ask the appropriate food assessment body of a Member State to carry out a safety assessment of the food in accordance with Article 36 of Regulation (EC) No 178/ 2002;

(c) may ask a competent authority designated in accordance with Article 4 of Directive 2001/18/EC to carry out an environmental risk assessment; however, if the application concerns GMOs to be used as seeds or other plant-propa- gating material, the Authority shall ask a national compe- tent authority to carry out the environmental risk assess- ment;

(d) shall forward to the Community reference laboratory referred to in Article 32 the particulars referred to in Article 5(3)(i) and (j). The Community reference laboratory shall test and validate the method of detection and identifi- cation proposed by the applicant;

(e) shall, in verifying the application of Article 13(2)(a), examine the information and data submitted by the appli- cant to show that the characteristics of the food are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics.

4. In the case of GMOs or food containing or consisting of GMOs, the environmental safety requirements referred to in Directive 2001/18/EC shall apply to the evaluation to ensure that all appropriate measures are taken to prevent the adverse effects on human and animal health and the environment which might arise from the deliberate release of GMOs. During evaluation of requests for the placing on the market of products consisting of or containing GMOs, the national competent authority within the meaning of Directive 2001/18/ EC designated by each Member State for this purpose shall be consulted by the Authority. The competent authorities shall have three months after the date of receiving the request within which to make their opinion known.

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5. In the event of an opinion in favour of authorising the food, the opinion shall also include the following particulars:

(a) the name and address of the applicant;

(b) the designation of the food, and its specification;

(c) where applicable, the information required under Annex II to the Cartagena Protocol;

(d) the proposal for the labelling of the food and/or foods produced from it;

(e) where applicable, any conditions or restrictions which should be imposed on the placing on the market and/or specific conditions or restrictions for use and handling, including post-market monitoring requirements based on the outcome of the risk assessment and, in the case of GMOs or food containing or consisting of GMOs, condi- tions for the protection of particular ecosystems/environ- ment and/or geographical areas;

(f) the method, validated by the Community reference labora- tory, for detection, including sampling, identification of the transformation event and, where applicable, for the detec- tion and identification of the transformation event in the food and/or in foods produced from it; an indication of where appropriate reference material can be accessed;

(g) where appropriate, the monitoring plan referred to in Article 5(5)(b).

6. The Authority shall forward its opinion to the Commis- sion, the Member States and the applicant, including a report describing its assessment of the food and stating the reasons for its opinion and the information on which this opinion is based, including the opinions of the competent authorities when consulted in accordance with paragraph 4.

7. The Authority, in conformity with Article 38(1) of Regu- lation (EC) No 178/2002, shall make its opinion public, after deletion of any information identified as confidential in accor- dance with Article 30 of this Regulation. The public may make comments to the Commission within 30 days from such publication.

Article 7

Authorisation

1. Within three months after receiving the opinion of the Authority, the Commission shall submit to the Committee referred in Article 35 a draft of the decision to be taken in respect of the application, taking into account the opinion of the Authority, any relevant provisions of Community law and other legitimate factors relevant to the matter under considera- tion. Where the draft decision is not in accordance with the opinion of the Authority, the Commission shall provide an explanation for the differences.

2. Any draft decision which envisages the granting of authorisation shall include the particulars referred to in Article 6(5), the name of the authorisation-holder and, where appro- priate, the unique identifier attributed to the GMO as referred to in the Regulation (EC) No 1830/2003.

3. A final decision on the application shall be adopted in accordance with the procedure referred to in Article 35(2).

4. The Commission shall without delay inform the applicant of the decision taken and publish details of the decision in the Official Journal of the European Union.

5. The authorisation granted in accordance with the proce- dure referred to in this Regulation shall be valid throughout the Community for 10 years and shall be renewable in accordance with Article 11. The authorised food shall be entered in the Register referred to in Article 28. Each entry in the Register shall mention the date of authorisation and shall include the particulars referred to in paragraph 2.

6. The authorisation under this Section shall be without prejudice to other provisions of Community law governing the use and placing on the market of substances which may only be used if they are included in a list of substances registered or authorised to the exclusion of others.

7. The granting of authorisation shall not lessen the general civil and criminal liability of any food operator in respect of the food concerned.

8. References made in parts A and D of Directive 2001/18/ EC to GMOs authorised under part C of that Directive shall be considered as applying equally to GMOs authorised under this Regulation.

Article 8

Status of existing products

1. By way of derogation from Article 4(2), products falling within the scope of this Section which have been lawfully placed on the market in the Community before the date of application of this Regulation may continue to be placed on the market, used and processed provided that the following conditions are met:

(a) in the case of products placed on the market under Direc- tive 90/220/EEC before the entry into force of Regulation (EC) No 258/97 or in accordance with the provisions referred to in Regulation (EC) No 258/97, operators responsible for placing on the market the products concerned shall, within six months after the date of applica- tion of this Regulation, notify the Commission of the date on which they were first placed on the market in the Community;

(b) in the case of products which have been lawfully placed on the market in the Community but are not covered by point (a), operators responsible for placing on the market the products concerned shall, within six months after the date of application of this Regulation, notify the Commission that the products were placed on the market in the Community before the date of application of this Regula- tion.

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2. The notification referred to in paragraph 1 shall be accompanied by the particulars mentioned in Article 5(3) and (5), as appropriate, which the Commission shall forward to the Authority and the Member States. The Authority shall forward to the Community reference laboratory the particulars referred to in Article 5(3)(i) and (j). The Community reference labora- tory shall test and validate the method of detection and identifi- cation proposed by the applicant.

3. Within one year from the date of application of this Regulation and after verification that all the information required has been submitted and examined, the products concerned shall be entered in the Register. Each entry in the Register shall include the particulars referred to in Article 7(2) as appropriate and, in the case of the products referred to in paragraph 1(a), shall mention the date on which the products concerned were first placed on the market.

4. Within nine years from the date on which the products referred to in paragraph 1(a) were first placed on the market, but in no case earlier than three years after the date of applica- tion of this Regulation, operators responsible for placing them on the market shall submit an application in accordance with Article 11, which shall apply mutatis mutandis.

Within three years from the date of application of this Regula- tion, operators responsible for placing on the market products referred to in paragraph 1(b) shall submit an application in accordance with Article 11, which shall apply mutatis mutandis.

5. Products referred to in paragraph 1 and food containing them or produced from them shall be subject to the provisions of this Regulation, in particular Articles 9, 10 and 34, which shall apply mutatis mutandis.

6. Where the notification and accompanying particulars referred to in paragraphs 1 and 2 are not supplied within the period specified or are found to be incorrect, or where an application is not submitted as required by paragraph 4 within the period specified, the Commission, acting in accordance with the procedure referred to in Article 35(2), shall adopt a measure requiring the product concerned and any products derived from it to be withdrawn from the market. Such a measure may provide for a limited period of time within which existing stocks of the product may be used up.

7. In the case of authorisations not issued to a specific holder, the operator who imports, produces or manufactures the products referred to in this Article shall submit the infor- mation or the application to Commission.

8. Detailed rules for implementing this Article shall be adopted in accordance with the procedure referred to in Article 35(2).

Article 9

Supervision

1. After an authorisation has been issued in accordance with this Regulation, the authorisation-holder and parties concerned shall comply with any conditions or restrictions which have

been imposed in the authorisation and shall in particular make sure that products not covered by the authorisation are not placed on the market as food or feed. Where post-market monitoring as referred to in Article 5(3)(k) and/or monitoring as referred to in Article 5(5)(b) has been imposed on the authorisation-holder, the authorisation-holder shall ensure that it is carried out and shall submit reports to the Commission in accordance with the terms of the authorisation. The monitoring reports referred to shall be made accessible to the public after deletion of any information identified as confidential in accor- dance with Article 30.

2. If the authorisation-holder proposes to modify the terms of the authorisation, the authorisation-holder shall submit an application in accordance with Article 5(2). Articles 5, 6 and 7 shall apply mutatis mutandis.

3. The authorisation-holder shall forthwith inform the Commission of any new scientific or technical information which might influence the evaluation of the safety in use of the food. In particular, the authorisation-holder shall forthwith inform the Commission of any prohibition or restriction imposed by the competent authority of any third country in which the food is placed on the market.

4. The Commission shall make the information supplied by the applicant available to the Authority and the Member States without delay.

Article 10

Modification, suspension and revocation of authorisations

1. On its own initiative or following a request from a Member State or from the Commission, the Authority shall issue an opinion on whether an authorisation for a product referred to in Article 3(1) still meets the conditions set by this Regulation. It shall forthwith transmit this opinion to the Commission, the authorisation-holder and the Member States. The Authority, in conformity with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public, after deletion of any information identified as confidential in accordance with Article 30 of this Regulation. The public may make comments to the Commission within 30 days from such publication.

2. The Commission shall examine the opinion of the Authority as soon as possible. Any appropriate measures shall be taken in accordance with Article 34. If appropriate, the authorisation shall be modified, suspended or revoked in accor- dance with the procedure referred to in Article 7.

3. Articles 5(2), 6 and 7 shall apply mutatis mutandis.

Article 11

Renewal of authorisations

1. Authorisations under this Regulation shall be renewable for 10-year periods, on application to the Commission by the authorisation-holder at the latest one year before the expiry date of the authorisation.

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2. The application shall be accompanied by the following:

(a) a copy of the authorisation for placing the food on the market;

(b) a report on the results of the monitoring, if so specified in the authorisation;

(c) any other new information which has become available with regard to the evaluation of the safety in use of the food and the risks of the food to the consumer or the environment;

(d) where appropriate, a proposal for amending or comple- menting the conditions of the original authorisation, inter alia the conditions concerning future monitoring.

3. Articles 5(2), 6 and 7 shall apply mutatis mutandis.

4. Where, for reasons beyond the control of the authorisa- tion-holder, no decision is taken on the renewal of an authori- sation before its expiry date, the period of authorisation of the product shall automatically be extended until a decision is taken.

5. The Commission, having first consulted the Authority, may establish, in accordance with the procedure referred to in Article 35(2), implementing rules for the application of this Article, including rules concerning the preparation and the presentation of the application.

6. The Authority shall publish detailed guidance to assist the applicant in the preparation and the presentation of its applica- tion.

S e c t i on 2

L ab e l l i n g

Article 12

Scope

1. This Section shall apply to foods which are to be deliv- ered as such to the final consumer or mass caterers in the Community and which:

(a) contain or consist of GMOs; or

(b) are produced from or contain ingredients produced from GMOs.

2. This Section shall not apply to foods containing material which contains, consists of or is produced from GMOs in a proportion no higher than 0,9 per cent of the food ingredients considered individually or food consisting of a single ingre- dient, provided that this presence is adventitious or technically unavoidable.

3. In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to supply evidence to satisfy the competent authorities that they have taken appropriate steps to avoid the presence of such material.

4. Appropriate lower thresholds may be established in accordance with the procedure referred to in Article 35(2) in particular in respect of foods containing or consisting of GMOs or in order to take into account advances in science and tech- nology.

Article 13

Requirements

1. Without prejudice to the other requirements of Commu- nity law concerning the labelling of foodstuffs, foods falling within the scope of this Section shall be subject to the following specific labelling requirements:

(a) where the food consists of more than one ingredient, the words ‘genetically modified’ or ‘produced from genetically modified (name of the ingredient)’ shall appear in the list of ingredients provided for in Article 6 of Directive 2000/13/ EC in parentheses immediately following the ingredient concerned;

(b) where the ingredient is designated by the name of a cate- gory, the words ‘contains genetically modified (name of organism)’ or ‘contains (name of ingredient) produced from genetically modified (name of organism)’ shall appear in the list of ingredients;

(c) where there is no list of ingredients, the words ‘genetically modified’ or ‘produced from genetically modified (name of organism)’ shall appear clearly on the labelling;

(d) the indications referred to in (a) and (b) may appear in a footnote to the list of ingredients. In this case they shall be printed in a font of at least the same size as the list of ingredients. Where there is no list of ingredients, they shall appear clearly on the labelling;

(e) where the food is offered for sale to the final consumer as non-pre-packaged food, or as pre-packaged food in small containers of which the largest surface has an area of less than 10 cm2, the information required under this para- graph must be permanently and visibly displayed either on the food display or immediately next to it, or on the packa- ging material, in a font sufficiently large for it to be easily identified and read.

2. In addition to the labelling requirements referred to in paragraph 1, the labelling shall also mention any characteristic or property, as specified in the authorisation, in the following cases:

(a) where a food is different from its conventional counterpart as regards the following characteristics or properties:

(i) composition;

(ii) nutritional value or nutritional effects;

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(iii) intended use of the food;

(iv) implications for the health of certain sections of the population;

(b) where a food may give rise to ethical or religious concerns.

3. In addition to the labelling requirements referred to in paragraph 1 and as specified in the authorisation, the labelling of foods falling within the scope of this Section which do not have a conventional counterpart shall contain appropriate information about the nature and the characteristics of the foods concerned.

Article 14

Implementing measures

1. Detailed rules for implementing this Section, amongst other things regarding the measures necessary for operators to comply with the labelling requirements, may be adopted in accordance with the procedure referred to in Article 35(2).

2. Specific rules concerning the information to be given by mass caterers providing food to the final consumer may be adopted in accordance with the procedure referred to in Article 35(2).

In order to take into account the specific situation of mass caterers, such rules may provide for adaptation of the require- ments of Article 13(1)(e).

CHAPTER III

GENETICALLY MODIFIED FEED

S e c t i on 1

A uthori sat ion an d sup e rvisi on

Article 15

Scope

1. This Section shall apply to:

(a) GMOs for feed use;

(b) feed containing or consisting of GMOs;

(c) feed produced from GMOs.

2. Where necessary, it may be determined in accordance with the procedure referred to in Article 35(2) whether a type of feed falls within the scope of this Section.

Article 16

Requirements

1. Feed referred to in Article 15(1) must not:

(a) have adverse effects on human health, animal health or the environment;

(b) mislead the user;

(c) harm or mislead the consumer by impairing the distinctive features of the animal products;

(d) differ from feed which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for animals or humans.

2. No person shall place on the market, use or process a product referred to in Article 15(1) unless it is covered by an authorisation granted in accordance with this Section and the relevant conditions of the authorisation are satisfied.

3. No product referred to in Article 15(1) shall be authorised unless the applicant for such authorisation has adequately and sufficiently demonstrated that it satisfies the requirements of paragraph 1 of this Article.

4. The authorisation referred to in paragraph 2 may cover:

(a) a GMO and feed containing or consisting of that GMO as well as feed produced from that GMO; or

(b) feed produced from a GMO as well as feeds produced from or containing that feed.

5. An authorisation as referred to in paragraph 2 shall not be granted, refused, renewed, modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation.

6. The applicant for an authorisation as referred to in para- graph 2 and, after the authorisation is granted, the authorisa- tion-holder or his representative, shall be established in the Community.

7. Authorisation under this Regulation shall be without prejudice to Directive 2002/53/EC, Directive 2002/55/EC and Directive 68/193/EEC.

Article 17

Application for authorisation

1. To obtain the authorisation referred to in Article 16(2), an application shall be submitted in accordance with the following provisions.

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2. The application shall be sent to the national competent authority of a Member State.

(a) The national competent authority:

(i) shall acknowledge receipt of the application in writing to the applicant within 14 days of its receipt. The acknowledgement shall state the date of receipt of the application;

(ii) shall inform the Authority without delay; and

(iii) shall make the application and any supplementary information supplied by the applicant available to the Authority.

(b) The Authority:

(i) shall inform without delay the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them;

(ii) shall make the summary of the dossier referred to in paragraph 3(1) available to the public.

3. The application shall be accompanied by the following:

(a) the name and the address of the applicant;

(b) the designation of the feed and its specification, including the transformation event(s) used;

(c) where applicable, the information to be provided for the purpose of complying with Annex II to the Cartagena Protocol;

(d) where applicable, a detailed description of the method of production and manufacturing and intended uses of the feed;

(e) a copy of the studies including, where available, indepen- dent, peer-reviewed studies, which have been carried out and any other material which is available to demonstrate that the feed complies with the criteria referred to in Article 16(1), and, in particular for feed falling within the scope of Directive 82/471/EEC, the information required under Council Directive 83/228/EEC of 18 April 1983 on the fixing of guidelines for the assessment of certain products used in animal nutrition (1);

(f) either an analysis, supported by appropriate information and data, showing that the characteristics of the feed are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics and to the criteria specified in Article 25(2)(c), or a proposal for labelling the feed in accordance with Article 25(2)(c) and (3);

(g) either a reasoned statement that the feed does not give rise to ethical or religious concerns, or a proposal for labelling it in accordance with Article 25(2)(d);

(h) where appropriate, the conditions for placing the feed on the market, including specific conditions for use and hand- ling;

(1) OJ L 126, 13.5.1983, p. 23.

(i) methods for detection, sampling (including references to existing official or standardised sampling methods) and identification of the transformation event and, where applicable, for the detection and identification of the trans- formation event in the feed and/or in the feed produced from it;

(j) samples of the feed and their control samples and informa- tion as to the place where the reference material can be accessed;

(k) where appropriate, a proposal for post-market monitoring for the use of the feed for animal consumption;

(l) a summary of the dossier in a standardised form.

4. In the case of an application relating to a GMO for feed use, references to ‘feed’ in paragraph 3 shall be interpreted as referring to feed containing, consisting of or produced from the GMO in respect of which an application is made.

5. In the case of GMOs or feed containing or consisting of GMOs, the application shall also be accompanied by:

(a) the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC or, where the placing on the market of the GMOs has been authorised under part C of Directive 2001/18/EC, a copy of the authorisation decision;

(b) a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan; this dura- tion may be different from the proposed period for the consent.

In such case, Articles 13 to 24 of Directive 2001/18/EC shall not apply.

6. Where the application concerns a substance, the use and placing on the market of which is subject under other provi- sions of Community law to its inclusion on a list of substances registered or authorised to the exclusion of others, this must be stated in the application and the status of the substance under the relevant legislation must be indicated.

7. The Commission, having first consulted the Authority, shall establish, in accordance with the procedure referred to in Article 35(2), implementing rules for the application of this Article, including rules concerning the preparation and the presentation of the application.

8. Before the date of application of this Regulation, the Authority shall publish detailed guidance to assist the applicant in the preparation and the presentation of the application.

L 268/14 EN Official Journal of the European Union 18.10.2003

Article 18

Opinion of the Authority

1. In giving its opinion, the Authority shall endeavour to comply with a time limit of six months as from the receipt of a valid application. Such time limit shall be extended whenever the Authority seeks supplementary information from the appli- cant as provided in paragraph 2.

2. The Authority or a national competent authority through the Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specific time limit.

3. In order to prepare its opinion, the Authority:

(a) shall verify that the particulars and documents submitted by the applicant are in accordance with Article 17, and examine whether the feed complies with the criteria laid down in Article 16(1);

(b) may ask the appropriate feed assessment body of a Member State to carry out a safety assessment of the feed in accor- dance with Article 36 of Regulation (EC) No 178/2002;

(c) may ask a competent authority designated in accordance with Article 4 of Directive 2001/18/EC to carry out an environmental risk assessment; however, if the application concerns GMOs to be used as seeds or other plant-propa- gating material, the Authority shall ask a national compe- tent authority to carry out the environmental risk assess- ment;

(d) shall forward to the Community reference laboratory the particulars referred to in Article 17(3)(i) and (j). The Community reference laboratory shall test and validate the method of detection and identification proposed by the applicant;

(e) shall, in verifying the application of Article 25(2)(c), examine the information and data submitted by the appli- cant to show that the characteristics of the feed are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics.

4. In the case of GMOs or feed containing or consisting of GMOs, the environmental safety requirements referred to in Directive 2001/18/EC shall apply to the evaluation to ensure that all appropriate measures are taken to prevent the adverse effects on human and animal health and the environment which might arise from the deliberate release of GMOs. During evaluation of requests for the placing on the market of products consisting of or containing GMOs, the national competent authority within the meaning of Directive 2001/18/ EC, designated by each Member State for this purpose shall be consulted by the Authority. The competent authorities shall have three months after the date of receiving the request within which to make their opinion known.

5. In the event of an opinion in favour of authorising the feed, the opinion shall also include the following particulars:

(a) the name and address of the applicant;

(b) the designation of the feed, and its specification;

(c) where applicable, the information required under Annex II to the Cartagena Protocol;

(d) the proposal for the labelling of the feed;

(e) where applicable, any conditions or restrictions which should be imposed on the placing on the market and/or specific conditions or restrictions for use and handling, including post-market monitoring requirements based on the outcome of the risk assessment and, in the case of GMOs or feed containing or consisting of GMOs, condi- tions for the protection of particular ecosystems/environ- ment and/or geographical areas;

(f) the method, validated by the Community reference labora- tory, for detection, including sampling, identification of the transformation event and, where applicable, for the detec- tion and identification of the transformation event in the feed and/or in feed produced from it; an indication of where appropriate reference material can be accessed;

(g) where appropriate, the monitoring plan as referred to in Article 17(5)(b).

6. The Authority shall forward its opinion to the Commis- sion, the Member States and the applicant, including a report describing its assessment of the feed and stating the reasons for its opinion and the information on which this opinion is based, including the opinions of the competent authorities when consulted in accordance with paragraph 4.

7. The Authority, in conformity with Article 38(1) of Regu- lation (EC) No 178/2002, shall make its opinion public, after deletion of any information identified as confidential in accor- dance with Article 30 of this Regulation. The public may make comments to the Commission within 30 days from such publication.

Article 19

Authorisation

1. Within three months after receiving the opinion of the Authority, the Commission shall submit to the Committee referred in Article 35 a draft of the decision to be taken in respect of the application, taking into account the opinion of the Authority, any relevant provisions of Community law and other legitimate factors relevant to the matter under considera- tion. Where the draft decision is not in accordance with the opinion of the Authority, the Commission shall provide an explanation for the differences.

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2. Any draft decision which envisages the granting of authorisation shall include the particulars referred to in Article 18(5), the name of the authorisation-holder and, where appro- priate, the unique identifier attributed to the GMO as referred to in Regulation (EC) No 1830/2003.

3. A final decision on the application shall be adopted in accordance with the procedure referred to in Article 35(2).

4. The Commission shall without delay inform the applicant of the decision taken and publish details of the decision in the Official Journal of the European Union.

5. The authorisation granted in accordance with the proce- dure referred to in this Regulation shall be valid throughout the Community for 10 years and shall be renewable in accordance with Article 23. The authorised feed shall be entered in the Register referred to in Article 28. Each entry in the Register shall mention the date of authorisation and shall include the particulars referred to in paragraph 2.

6. The authorisation under this Section shall be without prejudice to other provisions of Community law governing the use and placing on the market of substances which may only be used if they are included in a list of substances registered or authorised to the exclusion of others.

7. The granting of authorisation shall not lessen the general civil and criminal liability of any feed operator in respect of the feed concerned.

8. References made in parts A and D of Directive 2001/18/ EC to GMOs authorised under part C of that Directive shall be considered as applying equally to GMOs authorised under this Regulation.

Article 20

Status of existing products

1. By way of derogation from Article 16(2), products falling within the scope of this Section which have been lawfully placed on the market in the Community before the date of application of this Regulation may continue to be placed on the market, used and processed provided that the following conditions are met:

(a) in the case of products which have been authorised under Directives 90/220/EEC or 2001/18/EC, including use as feed, under Directive 82/471/EEC, which are produced from GMOs, or under Directive 70/524/EEC, which contain, consist of or are produced from GMOs, operators responsible for placing on the market the products concerned shall, within six months after the date of applica- tion of this Regulation, notify the Commission of the date on which they were first placed on the market in the Community;

(b) in the case of products which have been lawfully placed on the market in the Community but which are not referred to in point (a), operators responsible for placing on the market

in the Community the products concerned shall, within six months after the date of application of this Regulation, notify the Commission that the products were placed on the market in the Community before the date of application of this Regulation.

2. The notification referred to in paragraph 1 shall be accompanied by the particulars mentioned in Article 17(3) and (5), as appropriate, which the Commission shall forward to the Authority and the Member States. The Authority shall forward to the Community reference laboratory the particulars referred to in Article 17(3)(i) and (j). The Community reference labora- tory shall test and validate the method of detection and identifi- cation proposed by the applicant.

3. Within one year from the date of application of this Regulation and after verification that all the information required has been submitted and examined, the products concerned shall be entered in the Register. Each entry in the Register shall include the particulars referred to in Article 19(2) as appropriate and, in the case of the products referred to in paragraph 1(a), shall mention the date on which the products concerned were first placed on the market.

4. Within nine years from the date on which the products referred to in paragraph 1(a) were first placed on the market, but in no case earlier than three years after the date of applica- tion of this Regulation, operators responsible for placing them on the market shall submit an application in accordance with Article 23, which shall apply mutatis mutandis.

Within three years from the date of application of this Regula- tion, operators responsible for placing on the market products referred to in paragraph 1(b) shall submit an application in accordance with Article 23, which shall apply mutatis mutandis.

5. Products referred to in paragraph 1 and feed containing them or produced from them shall be subject to the provisions of this Regulation, in particular Articles 21, 22 and 34, which shall apply mutatis mutandis.

6. Where the notification and accompanying particulars referred to in paragraphs 1 and 2 are not supplied within the period specified or are found to be incorrect, or where an application is not submitted as required by paragraph 4 within the period specified, the Commission, acting in accordance with the procedure laid down in Article 35(2), shall adopt a measure requiring the product concerned and any products derived from it to be withdrawn from the market. Such a measure may provide for a limited period of time within which existing stocks of the product may be used up.

7. In the case of authorisations not issued to a specific holder, the operator who imports, produces or manufactures the products referred to in this Article shall submit the infor- mation or the application to the Commission.

8. Detailed rules for implementing this Article shall be adopted in accordance with the procedure referred to in Article 35(2).

L 268/16 EN Official Journal of the European Union 18.10.2003

Article 21

Supervision

1. After an authorisation has been issued in accordance with this Regulation, the authorisation-holder and the parties concerned shall comply with any conditions or restrictions which have been imposed in the authorisation and shall in particular make sure that products not covered by the authori- sation are not placed on the market as food or feed. Where post-market monitoring as referred to in Article 17(3)(k) and/or monitoring as referred to in Article 17(5)(b) has been imposed on the authorisation-holder, the authorisation-holder shall ensure that it is carried out and shall submit reports to the Commission in accordance with the terms of the authorisation. The monitoring reports referred to shall be made accessible to the public after deletion of any information identified as confi- dential in accordance with Article 30.

2. If the authorisation-holder proposes to modify the terms of the authorisation, the authorisation-holder shall submit an application in accordance with Article 17(2). Articles 17, 18 and 19 shall apply mutatis mutandis.

3. The authorisation-holder shall forthwith inform the Commission of any new scientific or technical information which might influence the evaluation of the safety in use of the feed. In particular, the authorisation-holder shall forthwith inform the Commission of any prohibition or restriction imposed by the competent Authority of any third country in which the feed is placed on the market.

4. The Commission shall make the information supplied by the applicant available to the Authority and the Member States without delay.

Article 22

Modification, suspension and revocation of authorisations

1. On its own initiative or following a request from a Member State or from the Commission, the Authority shall issue an opinion on whether an authorisation for a product referred to in Article 15(1) still meets the conditions set by this Regulation. It shall forthwith transmit this opinion to the Commission, the authorisation-holder and the Member States. The Authority, in conformity with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public, after deletion of any information identified as confidential in accordance with Article 30 of this Regulation. The public may make comments to the Commission within 30 days from such publication.

2. The Commission shall examine the opinion of the Authority as soon as possible. Any appropriate measures shall be taken in accordance with Article 34. If appropriate, the authorisation shall be modified, suspended or revoked in accor- dance with the procedure referred to in Article 19.

3. Articles 17(2), 18 and 19 shall apply mutatis mutandis.

Article 23

Renewal of authorisations

1. Authorisations under this Regulation shall be renewable for 10-year periods, on application to the Commission by the authorisation-holder at the latest one year before the expiry date of the authorisation.

2. The application shall be accompanied by the following particulars and documents:

(a) a copy of the authorisation for placing the feed on the market;

(b) a report on the results of the monitoring, if so specified in the authorisation;

(c) any other new information which has become available with regard to the evaluation of the safety in use of the feed and the risks of the feed to animals, humans or the envir- onment;

(d) where appropriate, a proposal for amending or comple- menting the conditions of the original authorisation, inter alia the conditions concerning future monitoring.

3. Articles 17(2), 18 and 19 shall apply mutatis mutandis.

4. Where, for reasons beyond the control of the authorisa- tion-holder, no decision is taken on the renewal of an authori- sation before its expiry date, the period of authorisation of the product shall automatically be extended until a decision is taken.

5. The Commission, having first consulted the Authority, may establish, in accordance with the procedure referred to in Article 35(2), implementing rules for the application of this Article, including rules concerning the preparation and the presentation of the application.

6. The Authority shall publish detailed guidance to assist the applicant in the preparation and the presentation of its application.

Se c t i on 2

L ab e l l i n g

Article 24

Scope

1. This Section shall apply to feed referred to in Article 15(1).

2. This Section shall not apply to feed containing material which contains, consists of or is produced from GMOs in a proportion no higher than 0,9 per cent of the feed and of each feed of which it is composed, provided that this presence is adventitious or technically unavoidable.

18.10.2003 EN Official Journal of the European Union L 268/17

3. In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to supply evidence to satisfy the competent authorities that they have taken appropriate steps to avoid the presence of such materials.

4. Appropriate lower thresholds may be established in accordance with the procedure referred to in Article 35(2), in particular in respect of feed containing or consisting of GMOs, or in order to take into account advances in science and tech- nology.

Article 25

Requirements

1. Without prejudice to the other requirements of Commu- nity law concerning the labelling of feed, feed referred to in Article 15(1) shall be subject to the specific labelling require- ments laid down below.

2. No person shall place a feed referred to in Article 15(1) on the market unless the particulars specified below are shown, in a clearly visible, legible and indelible manner, on an accom- panying document or, where appropriate, on the packaging, on the container or on a label attached thereto.

Each feed of which a particular feed is composed shall be subject to the following rules:

(a) for the feeds referred to in Article 15(1) (a) and (b), the words ‘genetically modified (name of the organism)’ shall appear in parentheses immediately following the specific name of the feed.

Alternatively, these words may appear in a footnote to the list of feed. It shall be printed in a font of at least the same size as the list of feed;

(b) for the feed referred to in Article 15(1)(c), the words ‘produced from genetically modified (name of the organism)’ shall appear in parentheses immediately following the specific name of the feed.

Alternatively, these words may appear in a footnote to the list of feed. It shall be printed in a font of at least the same size as the list of feed;

(c) as specified in the authorisation, any characteristic of the feed referred to in Article 15(1) such as those indicated hereunder, which is different from its conventional counter- part:

(i) composition;

(ii) nutritional properties;

(iii) intended use;

(iv) implications for the health of certain species or cate- gories of animals;

(d) as specified in the authorisation, any characteristic or prop- erty where a feed may give rise to ethical or religious concerns.

3. In addition to the requirements referred to in paragraph 2(a) and (b) and as specified in the authorisation, the labelling or accompanying documents of feed falling within the scope of this Section which does not have a conventional counterpart shall contain appropriate information about the nature and the characteristics of the feed concerned.

Article 26

Implementing measures

Detailed rules for implementing this Section, amongst other things regarding the measures necessary for operators to comply with the labelling requirements, may be adopted in accordance with the procedure referred to in Article 35(2).

CHAPTER IV

COMMON PROVISIONS

Article 27

Products likely to be used as both food and feed

1. Where a product is likely to be used as both food and feed, a single application under Articles 5 and 17 shall be submitted and shall give rise to a single opinion from the Authority and a single Community decision.

2. The Authority shall consider whether the application for authorisation should be submitted both as food and feed.

Article 28

Community register

1. The Commission shall establish and maintain a Commu- nity register of genetically modified food and feed, hereinafter referred to as ‘the Register’.

2. The Register shall be made available to the public.

Article 29

Public access

1. The application for authorisation, supplementary infor- mation from the applicant, opinions from the competent authorities designated in accordance with Article 4 of Directive 2001/18/EC, monitoring reports and information from the authorisation holder, excluding confidential information, shall be made accessible to the public.

L 268/18 EN Official Journal of the European Union 18.10.2003

2. The Authority shall apply the principles of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (1) when hand- ling applications for access to documents held by the Authority.

3. Member States shall handle applications for access to documents received under this regulation in accordance with Article 5 of Regulation (EC) No 1049/2001.

Article 30

Confidentiality

1. The applicant may indicate which information submitted under this Regulation it wishes to be treated as confidential on the ground that its disclosure might significantly harm its competitive position. Verifiable justification must be given in such cases.

2. Without prejudice to paragraph 3, the Commission shall determine, after consultation with the applicant, which infor- mation should be kept confidential and shall inform the appli- cant of its decision.

3. Information relating to the following shall not be considered confidential:

(a) name and composition of the GMO, food or feed referred to in Articles 3(1) and 15(1) and, where appropriate, indi- cation of the substrate and the micro-organism;

(b) general description of the GMO and the name and address of the authorisation-holder;

(c) physico-chemical and biological characteristics of the GMO, food or feed referred to in Articles 3(1) and 15(1);

(d) effects of the GMO, food or feed referred to in Articles 3(1) and 15(1) on human and animal health and on the environ- ment;

(e) effects of the GMO, food or feed referred to in Articles 3(1) and 15(1) on the characteristics of animal products and its nutritional properties;

(f) methods for detection, including sampling and identifica- tion of the transformation event and, where applicable, for the detection and identification of the transformation event in the food or feed referred to in Articles 3(1) and 15(1);

(g) information on waste treatment and emergency response.

4. Notwithstanding paragraph 2, the Authority shall on request supply the Commission and Member States with all information in its possession.

(1) OJ L 145, 31.5.2001, p. 43.

5. The use of the detection methods and the reproduction of the reference materials, provided under Article 5(3) and 17(3) for the purpose of applying this Regulation to the GMOs, food or feed to which an application refers, shall not be restricted by the exercise of intellectual property rights or otherwise.

6. The Commission, the Authority and the Member States shall take the necessary measures to ensure appropriate confi- dentiality of the information received by them under this Regu- lation except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment.

7. If an applicant withdraws or has withdrawn an applica- tion, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information, including research and development information, as well as information as to the confidentiality of which the Commission and the applicant disagree.

Article 31

Data protection

The scientific data and other information in the application dossier required under Article 5(3) and (5) and Article 17(3) and (5) may not be used for the benefit of another applicant for a period of 10 years from the date of authorisation, unless the other applicant has agreed with the authorisation-holder that such data and information may be used.

On the expiry of this 10-year period, the findings of all or part of the evaluation conducted on the basis of the scientific data and information contained in the application dossier may be used by the Authority for the benefit of another applicant if the applicant can demonstrate that the food or feed for which it is seeking authorisation is essentially similar to a food or feed already authorised under this Regulation.

Article 32

Community reference laboratory

The Community reference laboratory and its duties and tasks shall be those referred to in the Annex.

National reference laboratories may be established in accor- dance with the procedure referred to in Article 35(2).

Applicants for authorisation of genetically modified food and feed shall contribute to supporting the costs of the tasks of the Community reference laboratory and the European Network of GMO laboratories mentioned in the Annex.

18.10.2003 EN Official Journal of the European Union L 268/19

The contributions from applicants shall not exceed the costs incurred in carrying out the validation of detection methods.

Detailed rules for implementing this Article, the Annex and any changes to it may be adopted in accordance with the procedure referred to in Article 35(2).

Article 33

Consultation with the European Group on Ethics in Science and New Technologies

1. The Commission, on its own initiative or at the request of a Member State, may consult the European Group on Ethics in Science and New Technologies or any other appropriate body it might establish, with a view to obtaining its opinion on ethical issues.

2. The Commission shall make these opinions available to the public.

Article 34

Emergency measures

Where it is evident that products authorised by or in accor- dance with this Regulation are likely to constitute a serious risk to human health, animal health or the environment, or where, in the light of an opinion of the Authority issued under Article 10 or Article 22, the need to suspend or modify urgently an authorisation arises, measures shall be taken under the proce- dures provided for in Articles 53 and 54 of Regulation (EC) No 178/2002.

Article 35

Committee procedure

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, set up by Article 58 of Regulation (EC) No 178/2002, hereinafter referred to as the ‘Committee’.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. The Committee shall adopt its rules of procedure.

Article 36

Administrative review

Any decision taken under, or failure to exercise, the powers vested in the Authority by this Regulation may be reviewed by the Commission on its own initiative or in response to a request from a Member State or from any person directly and individually concerned.

To this effect a request shall be submitted to the Commission within two months from the day on which the party concerned became aware of the act or omission in question.

The Commission shall take a decision within two months requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to act.

Article 37

Repeals

The following Regulations shall be repealed with effect from the date of application of this Regulation:

— Regulation (EC) No 1139/98,

— Regulation (EC) No 49/2000,

— Regulation (EC) No 50/2000.

Article 38

Amendments to Regulation (EC) No 258/97

Regulation (EC) No 258/97 is hereby amended with effect from the date of application of this Regulation as follows:

1. The following provisions shall be deleted:

— Article 1(2)(a) and (b),

— Article 3(2), second subparagraph, and (3),

— Article 8(1)(d),

— Article 9.

2. In Article 3, the first sentence of paragraph 4 shall be replaced by the following:

‘4. By way of derogation from paragraph 2, the proce- dure referred to in Article 5 shall apply to foods or food ingredients referred to in Article 1(2)(d) and (e) which, on the basis of the scientific evidence available and generally recognised or on the basis of an opinion delivered by one of the competent bodies referred to in Article 4(3), are substan- tially equivalent to existing foods or food ingredients as regards their composition, nutritional value, metabolism, intended use and the level of undesirable substances contained therein.’

Article 39

Amendment to Directive 82/471/EEC

The following paragraph shall be added to Article 1 of Direc- tive 82/471/EEC with effect from the date of application of this Regulation:

‘3. This Directive does not apply to products which act as direct or indirect protein sources that fall within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (*).

(*) OJ L 268, 18.10.2003, p. 1.’

L 268/20 EN Official Journal of the European Union 18.10.2003

Article 40

Amendments to Directive 2002/53/EC

Directive 2002/53/EC is hereby amended with effect from the date of application of this Regulation as follows:

1. Article 4(5) shall be replaced by the following:

‘5. Further, when material derived from a plant variety is intended to be used in food falling within the scope of Article 3, or in feed falling within the scope of Article 15 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (*), the variety shall be accepted only if it has been approved in accordance with that Regulation.

(*) OJ L 268, 18.10.2003, p. 1.’

2. Article 7(5) shall be replaced by the following:

‘5. Member States shall ensure that a variety intended to be used in food or feed as defined in Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety (*) is accepted only if it has been authorised under the relevant legislation.

(*) OJ L 31, 1.2.2002, p. 1.’

Article 41

Amendments to Directive 2002/55/EC

Directive 2002/55/EC is hereby amended with effect from the date of application of this Regulation as follows:

1. Article 4(3) shall be replaced by the following:

‘3. Further, when material derived from a plant variety is intended to be used in food falling within the scope of Article 3, or in feed falling within the scope of Article 15 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (*), the variety shall be accepted only if it has been approved in accordance with that Regulation.

(*) OJ L 268, 18.10.2003, p. 1.’

2. Article 7(5) shall be replaced by the following:

‘5. Member States shall ensure that a variety intended to be used in food or feed as defined in Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing

the European Food Safety Authority, and laying down procedures in matters of food safety (*) is accepted only if it has been authorised under the relevant legislation.

(*) OJ L 31, 1.2.2002, p. 1.’

Article 42

Amendment to Directive 68/193/EEC

Article 5ba(3) of Directive 68/193/EEC shall be replaced by the following wording with effect from the date of application of this Regulation:

‘3. (a) Where products derived from vine-propagating material are intended to be used as or in food falling within the scope of Article 3 or as or in a feed falling within the scope of Article 15 of Regu- lation (EC) No 1829/2003 of the European Parlia- ment and of the Council of 22 September 2003 on genetically modified food and feed (*), the vine variety concerned shall be accepted only if it has been authorised pursuant to the said Regulation.

(b) Member States shall ensure that a vine variety, from the propagating material of which products were derived intended for use in food and feed pursuant to Articles 2 and 3 of Regulation (EC) No 178/ 2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety (**) shall be accepted only if it has been authorised pursuant to the relevant legislation.

(*) OJ L 268, 18.10.2003, p. 1. (**) OJ L 31, 1.2.2002, p. 1.’

Article 43

Amendments to Directive 2001/18/EC

Directive 2001/18/EC is hereby amended with effect from the date of entry into force of this Regulation, as follows:

1. The following Article shall be inserted:

‘Article 12a

Transitional measures for adventitious or technically unavoidable presence of genetically modified organisms having benefited from a favourable risk evaluation

1. Placing on the market of traces of a GMO or combina- tion of GMOs in products intended for direct use as food or feed or for processing shall be exempted from Articles 13 to

18.10.2003 EN Official Journal of the European Union L 268/21

21 provided that they meet the conditions referred to in Article 47 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (*).

2. This Article shall be applicable for a period of three years after the date of application of Regulation (EC) No 1829/2003.

(*) OJ L 268, 18.10.2003, p. 1.’

2. The following Article shall be inserted:

‘Article 26a

Measures to avoid the unintended presence of GMOs

1. Member States may take appropriate measures to avoid the unintended presence of GMOs in other products.

2. The Commission shall gather and coordinate informa- tion based on studies at Community and national level, observe the developments regarding coexistence in the Member States and, on the basis of the information and observations, develop guidelines on the coexistence of genetically modified, conventional and organic crops.’

Article 44

Information to be provided in accordance with the Cartagena Protocol

1. Any authorisation, renewal, modification, suspension or revocation of authorisation of a GMO, food or feed referred to in Articles 3(1)(a) or (b) or 15(1)(a) or (b) shall be notified by the Commission to the Parties to the Cartagena Protocol through the biosafety clearing house in accordance with Article 11(1) or Article 12(1) of the Cartagena Protocol, as the case may be.

The Commission shall provide a copy of the information, in writing, to the national focal point of each Party that informs the Secretariat in advance that it does not have access to the biosafety clearing house.

2. The Commission shall also process requests for additional information made by any Party in accordance with Article 11(3) of the Cartagena Protocol and shall provide copies of the laws, regulations and guidelines in accordance with Article 11(5) of that Protocol.

Article 45

Penalties

The Member States shall lay down the rules on penalties applic- able to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are imple-

mented. The penalties provided for must be effective, propor- tionate and dissuasive. The Member States shall notify those provisions to the Commission six months after the date of entry into force of this Regulation at the latest and shall notify it without delay of any subsequent amendment affecting them.

Article 46

Transitional measures for requests, labelling and notifications

1. Requests submitted under Article 4 of Regulation (EC) No 258/97 before the date of application of this Regulation shall be transformed into applications under Chapter II, Section 1 of this Regulation where the initial assessment report provided for under Article 6(3) of Regulation (EC) No 258/97 has not yet been forwarded to the Commission, as well as in all cases where an additional assessment report is required in accordance with Article 6(3) or (4) of Regulation (EC) No 258/97. Other requests submitted under Article 4 of Regulation (EC) No 258/ 97 before the date of application of this Regulation shall be processed under the provisions of Regulation (EC) No 258/97, notwithstanding Article 38 of this Regulation.

2. The labelling requirements referred to in this Regulation shall not apply to products, the manufacturing process of which has commenced before the date of application of this Regulation, provided that these products are labelled in accor- dance with the legislation applicable to them before the date of application of this Regulation.

3. Notifications concerning products including their use as feed submitted under Article 13 of Directive 2001/18/EC before the date of application of this Regulation shall be trans- formed into applications under Chapter III, Section 1 of this Regulation where the assessment report provided for in Article 14 of Directive 2001/18/EC has not yet been sent to the Commission.

4. Requests submitted for products referred to in Article 15(1)(c) of this Regulation under Article 7 of Directive 82/471/ EEC before the date of application of this Regulation shall be transformed into applications under Chapter III, Section 1 of this Regulation.

5. Requests submitted for products referred to in Article 15(1) of this Regulation under Article 4 of Directive 70/524/ EEC before the date of application of this Regulation shall be supplemented by applications under Chapter III, Section 1 of this Regulation.

L 268/22 EN Official Journal of the European Union 18.10.2003

Article 47

Transitional measures for adventitious or technically unavoidable presence of genetically modified material

which has benefited from a favourable risk evaluation

1. The presence in food or feed of material which contains, consists of or is produced from GMOs in a proportion no higher than 0,5 % shall not be considered to be in breach of Article 4(2) or Article 16(2), provided that:

(a) this presence is adventitious or technically unavoidable;

(b) the genetically modified material has benefited from a favourable opinion from the Community Scientific Committee(s) or the Authority before the date of applica- tion of this Regulation;

(c) the application for its authorisation has not been rejected in accordance with the relevant Community legislation; and

(d) detection methods are publicly available.

2. In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to demonstrate to the competent authorities that they have taken appropriate steps to avoid the presence of such materials.

3. The thresholds referred to in paragraph 1 may be lowered in accordance with the procedure referred to in Article 35(2), in particular for GMOs sold directly to the final consumer.

4. Detailed rules for implementing this Article shall be adopted in accordance with the procedure referred to in Article 35(2).

5. This Article shall remain applicable for a period of three years after the date of application of this Regulation.

Article 48

Review

1. No later than 7 November 2005 and in the light of experience gained, the Commission shall forward to the European Parliament and to the Council a report on the imple- mentation of this Regulation and in particular of Article 47, accompanied, where appropriate, by any suitable proposal. The report and any proposal shall be made accessible to the public.

2. Without prejudice to the powers of national authorities, the Commission shall monitor the application of this Regula- tion and its impact on human and animal health, consumer protection, consumer information and the functioning of the internal market and, if necessary, will bring forward proposals at the earliest possible date.

Article 49

Entry into force

This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.

It shall apply from six months after the date of publication of this Regulation.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 22 September 2003.

For the European Parliament For the Council

The President The President P. COX R. BUTTIGLIONE

18.10.2003 EN Official Journal of the European Union L 268/23

ANNEX

DUTIES AND TASKS OF THE COMMUNITY REFERENCE LABORATORY

1. The Community reference laboratory referred to in Article 32 is the Commission's Joint Research Centre.

2. For the tasks outlined in this Annex, the Commission's Joint Research Centre shall be assisted by a consortium of national reference laboratories, which will be referred to as the ‘European Network of GMO laboratories’.

3. The Community reference laboratory shall be responsible, in particular, for:

— reception, preparation, storage, maintenance and distribution to national reference laboratories of the appropriate positive and negative control samples,

— testing and validation of the method for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food or feed,

— evaluating the data provided by the applicant for authorisation for placing the food or feed on the market, for the purpose of testing and validation of the method for sampling and detection,

— submitting full evaluation reports to the Authority.

4. The Community reference laboratory shall play a role in dispute settlements between Member States concerning the results of the tasks outlined in this Annex.


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