Loi sur les organismes génétiquement modifiés, Serbie, WIPO Lex

Texte(s) princip(al)(aux)

Serbe Zakon O Genetički Modifikovanim Organizmima

Anglais Law on Genetically Modified Organisms

I. GENERAL PROVISIONS
- Article 1
- Article 2
- Article 3
- Article 4
- Article 5
- Article 6
- Article 7
- Article 8
II. PROCEDURE FOR ISSUING APPROVAL
- Article 9
- Article 10
- Article 11
- Article 12
- Article 13
- Article 14
- Article 15
- Article 16
- Article 17
- Article 18
III. REQUIREMENTS FOR USE IN CLOSED SYSTEMS AND FOR DELIBERATE RELEASE INTO THE ENVIRONMENT OF GMOs
- 1. Requirements for Use in Closed Systems
- 2. Requirements for Deliberate Release into the Environment
IV. HANDLING, PACKAGING AND TRANSPORT OF GMO AND GMO PRODUCTS
V. REGISTER OF GMO AND GMO PRODUCTS AND LICENSE REGISTER
- 1. Register of GMOs and GMO products
  - Article 32
  - Article 33
- 2. Licenses Register
VI. SUPERVISION
VII. PENAL PROVISIONS
VIII. TRANSITIONAL AND FINAL PROVISIONS

LAW ON GENETICALLY MODIFIED ORGANISMS¹

I. GENERAL PROVISIONS

Scope of Regulation Article 1

This Law shall govern the procedure for issuing approvals for use in closed systems, for deliberate release into the environment, for placing on the market or for transit of genetically modified organisms and products containing genetically modified organisms, conditions for use in closed systems and for deliberate release into the environment of genetically modified organisms, handling, packaging and transport of genetically modified organisms and products containing genetically modified organisms, as well as other issues of importance for genetically modified organisms and products containing genetically modified organisms.

Ban on trade Article 2

No genetically modified organisms or product containing genetically modified organisms can be traded or grown for commercial use at the territory of the Republic of Serbia.

Article 3

Agriculture products of non-animal origin are not considered genetically modified organism if contain up to 0.9% threshold of genetically modified organism and impurities of genetically modified organisms.

Seed and reproductive material are not considered genetically modified organisms if contain up to 0.1% threshold of genetically modified organisms and impurities of genetically modified organisms.

Definitions of Terms Article 4

Terms as used in this Law shall have the following meaning: 1) genetic material shall mean part of a plant, animal, fungus, microorganism, virus or viroid containing hereditary information; 2) a genetically modified organism shall mean an organism whose genetic material has been modified through methods of modern biotechnology; 3) an incident shall mean any event leading to uncontrolled release of a genetically modified organism into the environment, resulting from use in closed systems, deliberate release

¹Law on Genetically Modified Organisms was adopted by the National Parliament of the Republic of Serbia on May 29, 2009 and published in the Official Gazette of the Republic of Serbia No. 41/09.

into the environment or placing on the market of a genetically modified organism that may represent an immediate or delayed hazard for the human life and health and the environment;

4) user shall mean a legal person, entrepreneur or natural person using genetically modified organism or product containing genetically modified organism in closed systems and on the occasion of deliberate release into the environment ;

5) methods of modern biotechnology shall mean in vitro techniques of nucleic acids, including recombinant deoxyribonucleic acid (DNA) and direct introduction of nucleic acids into cells or organelles and cell fusion beyond the taxonomic level of family overcoming natural reproductive or recombinant barriers and that are not techniques used in traditional breeding and selection (classical methods);

6) living modified organism shall mean any genetically modified organism or product containing genetically modified organism capable of reproduction and transfer of genetic material, including a sterile organism capable of growth;

7) monitoring shall mean planned and systematic monitoring and supervision of genetically modified organisms, their use in closed systems, monitoring of the procedure of deliberate release into the environment and monitoring and supervising the environment where a genetically modified organism was deliberately released, as well as potential harmful effects on the environment and human health;

8) deliberate release into the environment shall mean: -contained release of a genetically modified organism for the purpose of carrying out experiments, demonstration experiments and development of new varieties;

9) unintended release into the environment shall mean accidental release of a living modified organism into the environment due to an unforeseen event, accident, improper handling, storing, etc.;

10) authorized laboratory shall mean a legal person carrying out testing of genetically modified organisms and products containing genetically modified organisms;

11) product containing genetically modified organism shall mean any product consisting of, or containing, or derived from one or several genetically modified organisms, regardless of the degree of processing;

12) risk assessment shall mean a scientific assessment carried out under the “case by case” procedure involving identification of potential harmful effects of genetically modified organisms or products containing genetically modified organisms for human health and the environment which may arise during use in closed systems, deliberate release into the environment, placing on the market or transit. In risk assessment the precaution principle must be obeyed;

13) handling shall mean final processing, reprocessing and storing of genetically modified organisms or products containing genetically modified organisms;

14) developerdeveloper shall mean a legal person, entrepreneur or natural person creating a genetically modified organism or product containing genetically modified organism;

15) use in closed systems shall mean any operation whereby genetically modified organisms or products containing genetically modified organisms are grown, reproduced, stored, transported, disposed of, destroyed or in any other manner used in the area separated by physical barriers, or where a combination of physical, chemical or biological barriers prevents the contact of genetically modified organisms with the outside world and their effect on the environment.

Exemptions from Application Article 5

The provisions of this Law shall not apply to the product containing genetically modified organism (hereinafter referred to as: the GMO product) which is not a living modified organism (hereinafter referred to as: the LMO) and is not used as food, feed, medicine or auxiliary medicine.

The provisions of this Law shall not apply to genetically modified microorganisms and to GMO products which are not LMOs, if they are intended for medical use and if their use is governed entirely by other regulations.

Expert Council for Biological Safety Article 6

For the purposes of examining professional issues and providing expert opinion referring to genetically modified organisms (hereinafter referred to as: GMOs), the minister responsible for agriculture (hereinafter referred to as: the Minister), in accordance with regulations governing state administration, shall issue a decision to establish a special working group – the Expert Council for Biological Safety (hereinafter referred to as: the Expert Council).

Activities of the Expert Council Article 7

The Expert Council shall:

1) assess the accuracy of data in the application submitted in order to obtain approval for use in closed systems, for deliberate release into the environment, based on the accompanying documents, whereby the data from global practices is used;

2) carry out risk assessment for deliberate release into the environment,

3) provide expert opinion to the ministry responsible for agriculture (hereinafter referred to as: the Ministry) on fulfillment of the requirements for granting the license for use in closed systems;

4) provide expert opinion to the Ministry on fulfillment of the requirements for granting the

approval for deliberate release into the environment, 5) examine the results of deliberate release into the environment; 6) examine proposals for amending regulations on GMOs; 7) examine other expert opinions concerning GMOs and GMO products.

The Expert Council shall operate under the “case by case” procedure, and in its activities it shall be guided by data based on scientific knowledge and observe the precautionary principle.

The Expert Council shall issue the Rules of Procedure.

Conflict of Interest Article 8

The Expert Council member who is family-related, or business and/or financially-related to the applicant may not participate in the decision making process in the course of Expert Council providing its opinion.

II. PROCEDURE FOR ISSUING APPROVAL

Approval

Article 9

The approval shall be issued for use in closed systems, for deliberate release into the environment, of GMOs and GMO products.

Application Article 10

The procedure for issuing approval for use in closed systems, for deliberate release into the environment shall be initiated based on the application submitted by the developerdeveloper, user or their authorized representative in the Republic of Serbia (hereinafter referred to as: the applicant).

The application shall contain:

1) GMO description;

2) business name, corporate domicile and address of the legal person or entrepreneur, name,

domicile and personal identification number of the natural person, or the name and

address of their authorized representative;

3) location where GMO is released into the environment;

4) plan and methods of supervision of GMOs and GMO products, as well as plan of measures

in case of an incident;

5) risk assessment with regard to human health and the environment.

The application shall also be submitted in case a GMO results from cross-breeding of two or more GMOs by applying traditional methods.

The application shall be submitted to the Ministry, and the approval in the form of a decision shall be issued by the Minister.

The Minister shall prescribe the contents and form of the application for use in closed systems, for deliberate release into the environment, of GMOs and GMO products, as well as the manner of protection of confidential data in the application.

Correcting Deficiencies in the Application Article 11

If the application does not contain the data referred to in Article 10 of this Law, the Ministry shall

inform the applicant to correct the identified deficiencies within the period of 30 days.

If the applicant fails to correct the deficiencies within the specified period, the application shall be refused.

Confidential Data Article 12

The applicant may identify certain data in the application as confidential.

The confidential data shall be kept by all persons with access to confidential data for the period of 10 years from the date of the application submission.

The confidential data shall not be deemed to be data referred to in Article 10, paragraph 2, items 1) to 5) of this Law, nor the data already available to the public.

It shall be prohibited to use the data from one application on the experiments undertaken for risk assessment purposes in other applications without the written approval of the data owner within the period of 10 years from the day the experiment was carried out.

The data identified as confidential shall remain confidential when the applicant withdraws the application.

The Minister shall determine the list of persons with access to confidential data and prescribe the manner of treating, keeping and exchange of data between the persons granted access to confidential data.

Authorized Laboratory Article 13

The testing of GMOs and GMO products for the purposes of identifying and quantifying the genetic modification shall be carried out by the laboratory authorized by the Ministry.

The authorization shall be granted by the decision of the Minister.

The Minister shall revoke the authorization if it is found that the authorized laboratory fails to meet the prescribed requirements, or that the authorization was granted based on incorrect and false data.

The Minister shall prescribe the requirements that must be fulfilled by the authorized laboratory concerning the facilities, technical equipment and human resources, as well as methods used for testing of GMOs and GMO products.

Testing and Report on Testing Performed Article 14

The applicant shall submit to the authorized laboratory a certain quantity of the material for the

purposes of GMOs and GMO products testing, at the request of the Ministry, during the consideration of the application or following the obtaining of the approval.

The authorized laboratory, on completing the testing referred to in paragraph 1 of this Article, shall prepare the report and submit it to the Ministry.

The authorized laboratory and its employees shall keep the data specified as confidential, as well as the results obtained through testing, in accordance with this Law.

The Minister shall prescribe the manner and deadlines for reporting referred to in paragraph 2 of this Article.

Informing the Public Article 15

Following the receipt of the application, the Ministry shall make available to the public the contents of the application in at least one daily newspaper distributed on the entire territory of the Republic of Serbia, and through electronic media.

The Ministry shall organize and administer the public discussion lasting up to 30 days from the day of making the application contents available to the public.

The opinion of the Expert Council and the final decision with the rationale shall be published by the Ministry in at least one daily newspaper distributed on the entire territory of the Republic of Serbia and through electronic media.

Issuing the Decision Article 16

Based on the opinion of the Expert Council, and taking into account the relevant public comments, as well as the report of the authorized laboratory in case the report was requested, the Minister shall issue the decision approving the use in closed systems, deliberate release into the environment specifying the safety measures and the duration of the approval.

In case the requirements specified by this Law for contained use, deliberate release into the environment have not been met, the Minister shall issue the decision refusing the application of the applicant.

The decision of the Minister referred to in paragraphs 1 and 2 of this Article shall be final.

If the responsible state administration authority, following the issuance of the decision approving deliberate release into the environment, finds that the developer, user or their authorized representative in the Republic of Serbia no longer meets the requirements prescribed for the granting of the approval, it shall order to the persons in question to undertake relevant measures, and, where appropriate, by way of a decision, temporarily or permanently revoke the approval.

The decision of the Minister referred to in paragraph 4 of this Article shall be final.

Renewal of the Approval Article 17

The applicant shall submit the application for renewal of the approval to the Ministry six months prior to the expiry of the approval.

The application referred to in paragraph 1 of this Article shall contain:

1) a copy of the approval subject to the renewal request;

2) report on the monitoring results;

3) new information related to the assessment of risk for human health and the environment;

By the time of issuance of the new decision, the applicant may continue with the use in closed systems, deliberate release into the environment.

The Minister shall prescribe the contents of the application for renewal of approval for use in closed systems, for deliberate release into the environment.

Article 18

If this Law does not regulate the procedure of approval issuance, the provisions of the law governing general administrative procedure shall apply mutatis mutandis.

III. REQUIREMENTS FOR USE IN CLOSED SYSTEMS AND FOR DELIBERATE RELEASE INTO THE ENVIRONMENT OF GMOs

1. Requirements for Use in Closed Systems

License Article 19

The approval for the use of GMOs in closed systems shall be issued to the legal person in the form of a license.

The license referred to in paragraph 1 of this Article shall be issued for one or several levels of risk.

The legal person must establish an expert body for the assessment of the risk for the use in closed systems and meet the requirements regarding the human resources, facilities and technical equipment prescribed by this Law and regulations adopted on the basis of this Law.

The Minister shall prescribe the requirements for the work of the expert bodies related to risk assessment, as well as the requirements that must be met by legal persons with regard to human resources, facilities and technical equipment.

Risk Level Classification Article 20

The use in closed systems shall be classified into four levels of risk:

1) use with negligible risk – level one;

2) use with minor risk – level two;

3) use with significant risk – level three;

4) use with high risk – level four.

Classification into certain risk levels shall be carried out on the basis of the undertaken safety measures in line with the requirements prescribed by this Law and the regulations adopted on the basis of this Law.

The Minister shall prescribe the criteria for risk classification, measures in case of an incident, manner of handling the GMOs at certain risk levels, the manner of disposing of the resulting waste, and other requirements for use in closed systems at a particular level of risk.

Revoking the License Article 21

If the legal person ceases to meet the requirements referred to in Articles 19 and 20 of this Law, its license for use in closed systems may be temporarily revoked.

The Minister shall issue the decision on suspending the license, order the removal of deficiencies and specify the period of 60 days from the day of the submission of the decision for the removal of deficiencies.

The license for use in closed systems shall be permanently revoked if the legal person fails to remove the deficiencies due to which the license has been suspended.

The Minister shall issue a decision permanently revoking the license.

The decision of the Minister shall be final.

2. Requirements for Deliberate Release into the Environment

Cross-Border Movement of LMOs Article 22

For each cross-border movement of LMOs whereby they are deliberately released into the environment for the purposes of performing experiments, demonstration experiments and development of new varieties, all the obligations under the Cartagena Protocol on Biosafety to the Convention on Biological Diversity that refer to the first cross-border movement for the purpose of deliberate release into the environment shall apply.

Monitoring Plan, Plan of Measures in Case of an Incident and Risk Assessment Article 23

The monitoring plan that is submitted by the applicant along with the application for deliberate release of GMOs into the environment shall also contain the manner of waste disposal.

The Minister shall prescribe the manner of preparing the monitoring plan and methods of monitoring GMOs, the manner of preparing the plan of measures in case of an incident, and the contents of risk assessment for deliberate release into the environment.

Data or Results of Deliberate Release into the Environment of the Other Applicant Article 24

In the application, the applicant may refer to the data or results of the deliberate release into the environment submitted to the Ministry by a different applicant, provided the applicant has obtained the written consent of the other applicant.

Duty of the Applicant Article 25

If the data on any modification or unintended modification of the GMO becomes available to the applicant during the time that the Ministry is considering the application or after the issuance of the approval for deliberate release into the environment, and such data may affect the assessed risk for human health and the environment, the applicant shall:

1) undertake the necessary measures for the protection of human health and the environment; 2) inform the Ministry of the new data that may affect the assessed risk for human health and the environment; 3) adjust the measures for case of an incident stated in the application or the approval for the purposes of the protection of human health and the environment.

If the data on any modification or unintended modification of the GMO that may significantly affect the assessment of risk for human health and the environment becomes available to the Ministry, the Ministry shall make such data available to the public and order the developer, user or their authorized representative in the Republic of Serbia to:

1) stop the deliberate release into the environment; 2) cease the deliberate release into the environment until the conditions for the deliberate release into the environment are adjusted.

Issuing One Approval Article 26

The applicant may be allowed the deliberate release into the environment on the same location or on different locations for the same purpose by issuing one approval.

Report on the Results of Deliberate Release into the Environment Article 27

During and on completion of the deliberate release into the environment, within the periods specified in the approval, the developer, user or their authorized representative in the Republic of Serbia shall submit to the Ministry the report on the results of the deliberate release into the environment in a written or electronic form.

The Minister shall prescribe the contents and form of the report on the results of the deliberate release into the environment.

IV. HANDLING, PACKAGING AND TRANSPORT OF GMO AND GMO PRODUCTS

Content of Documentation Accompanying GMOs and GMO Products during Handling, Packaging and Transport Article 28

During handling, packaging and transport, including transit over the whole territory of the Republic of Serbia, the GMOs and GMO products shall be accompanied by the documentation which must contain the data clearly indicating that they are GMOs and GMO products.

For use in closed systems, the documentation must contain the conditions and requirements for safe handling, transport and use, the place for obtaining information, including the name and address of the person or institution that has been consigned the GMO.

For deliberate release into the environment, the documentation must include identity and the appropriate characteristics of the GMOs and GMO products, conditions for safe handling, storage, transport and use, as well as the place for obtaining information.

The Minister shall prescribe the manner of handling, packaging and transport of GMOs and GMO products.

Informing the Ministry Article 29

Legal persons, entrepreneurs and natural persons are obliged to inform the Ministry when transporting genetically modified organisms or products from genetically modified organisms via the whole territory of the Republic of Serbia, in accordance with this law and other regulations.

Waste Disposal Article 30

The developer, user or their authorized representative in the Republic of Serbia shall destroy the waste containing, consisting of or derived from GMOs, as well as the waste resulting from the use of GMOs in such a manner that the GMOs are no longer capable of reproducing and transferring genetic material to other organisms.

The developer, user or their authorized representative in the Republic of Serbia is obliged to inform the Ministry about the date of when waste was destroyed.

Liability for Damage Article 31

The developer, user or their authorized representative in the Republic of Serbia shall be liable for damage arising from its direct or indirect activity related to GMOs or GMO products, causing harmful effect for human health and the environment, in accordance with this Law and other regulations.

V. REGISTER OF GMO AND GMO PRODUCTS AND LICENSE REGISTER

1. Register of GMOs and GMO products

Entry in the Register of GMOs and GMO Products Article 32

GMOs and GMO products for which the approval for deliberate release into the environment, for placing on the market, or for transit have been issued, shall be entered in the Register of GMOs and GMO products (hereinafter referred to as: the Register).

The data from the Register shall be public.

The Register shall be kept by the Ministry in electronic form and it may be linked with the other bases and registers of the Ministry.

The data identified as confidential in accordance with this Law and other regulations may not be entered into the Register.

The Minister shall prescribe more closely the contents and manner of keeping the Register.

Deletion from the Register Article 33

GMOs and GMO products shall be deleted from the Register if the period specified in the decision for deliberate release into the environment expires.

The Minister shall issue the decision on deletion from the Register.

The decision of the Minister referred to in paragraph 2 of this Article shall be final.

2. Licenses Register

Entry in the Licenses Register Article 34

Legal persons having obtained the license for use in closed systems shall be entered in the Licenses Register.

The data from the Licenses Register shall be public.

The Licenses Register shall be kept by the Ministry in electronic form and it may be linked with other electronic bases and registers of the Ministry.

The Minister shall prescribe the contents and manner of keeping the Licenses Register.

Deletion from the Licenses Register Article 35

A legal person shall be deleted from the Licenses Register:

1) if its license has been permanently revoked;

2) if it fails to submit a new application on the expiry of the period referred to in Article 17,

paragraph 1 of this Law;

3) based on the substantiated request.

Lists to Be Published Article 36

The Minister shall determine the List of GMOs and GMO Products for Which the Approvals for Deliberate Release into the Environment have been issued, and the List of Legal Persons Granted the License for Use in Closed Systems, which are published in the “Official Gazette of the Republic of Serbia”.

VI. SUPERVISION

Article 37

The supervision of the implementation of the provisions of this Law and the regulations adopted based on this Law shall be carried out by the Ministry.

The inspection supervision of the implementation of the provisions of this Law and the regulations adopted based on this Law shall be carried out by the Ministry through phytosanitary and veterinary inspectors.

The supervision of work of the authorized laboratory in performing delegated activities of testing of GMOs and GMO products shall be carried out by the Ministry, in accordance with regulations governing state administration.

Rights and Duties of Phytosanitary Inspectors Article 38

When performing the activities of inspection supervision, phytosanitary inspectors shall have the

right and duty to: 1) control the use in closed systems, deliberate release into the environment for which the approval was issued; 2) control whether the authorized laboratory meets the requirements for testing GMOs and

GMO products; 3) control the safety measures on deliberate release into the environment; 4) control the implementation of plan of measures and monitoring plan on deliberate release

into the environment 5) control the manner of keeping records and the documentation accompanying the GMOs

and GMO products; 6) take samples for testing GMOs and GMO products; 7) take samples to check the presence of prohibited GMOs or GMO products; 8) check disposal of waste containing, consisting of, derived from or resulting from the use of

GMOs.

Measures Ordered by Phytosanitary Inspectors Article 39

When performing the activities referred to in Article 40 of this Law, phytosanitary inspectors may: 1) prohibit use in closed systems, deliberate release into the environment of GMOs and GMO products; 2) order undertaking of urgent measures for the protection of human health and the

environment; 3) order the destruction of GMOs and GMO products that have not been approved; 4) order the destruction of waste containing, consisting of, derived from, or resulting from

the use of GMOs; 5) order the undertaking of other measures, based on the authorizations under this Law.

The measures referred to in paragraph 1 of this Article shall be ordered by a decision of the phytosanitary inspector.

Rights and Duties of Veterinary Inspectors Article 40

When performing the activities of inspection supervision, veterinary inspectors shall have the

right and duty to: 1) take samples for testing GMOs and GMO products; 2) take samples to detect the presence of GMOs and GMO products that have not been

approved; 3) control the manner of keeping records and the documentation accompanying the GMOs and GMO products; 4) control disposal of waste containing, consisting of, derived from, or resulting from the use of GMOs.

Measures Ordered by Veterinary Inspectors Article 41

When performing the activities referred to in Article 40 of this Law, veterinary inspectors may:

1) order the destruction of GMOs and GMO products that have not been approved;

2) order the destruction of waste containing, consisting of, derived from, or resulting from

the use of GMOs;

3) order the undertaking of other measures based on the authorizations under this Law.

The measures referred to in paragraph 1 of this Article shall be ordered by a decision from the veterinary inspectors.

Responsibility for Deciding on Appeals Article 42

The decisions of the phytosanitary and veterinary inspectors may be appealed to the Minister within eight days of the day of delivery of the decision.

The appeal shall not stay the execution of the decision.

Testing and Testing Costs Article 43

If there is suspicion that GMOs and GMO products are used contrary to the provisions of this Law, the phytosanitary or veterinary inspector shall request the developer, user or their authorized representative in the Republic of Serbia to present the relevant approvals.

If the developer, user or their authorized representative in the Republic of Serbia does not hold the approval, the phytosanitary or veterinary inspector shall prohibit the use in closed systems, deliberate release into the environment of GMOs and GMO products, and deliver the sample of GMOs and GMO products to the authorized laboratory for analysis.

If the analysis demonstrate that the GMO and GMO product have not been approved, the phytosanitary or veterinary inspector shall issue the decision prohibiting use in closed systems, deliberate release into the environment and the GMO and GMO product sample shall be destroyed.

The costs of the analysis and the destruction of the GMO and GMO product shall be borne by the developer, user or their authorized representative in the Republic of Serbia.

The costs of the testing under the inspector’s order shall be borne by the applicant.

Funds for Enforcing this Law Article 44

The applicant shall pay the republic administrative fee for the procedure of considering the application for use in closed systems, for deliberate release into the environment.

The funds referred to in paragraph 1 of this Article shall be revenues of the Budget of the Republic of Serbia.

VII. PENAL PROVISIONS

1. Criminal Offense

Article 45

The person that, contrary to the provisions of this Law, commences the use of GMOs and GMO products in closed systems, deliberate release into the environment, placing on the market or transit, or disposes of them into the environment and thus causes harmful consequences for human health and the environment, shall be punished for a criminal offense by imprisonment of up to three years.

The GMOs and GMO products referred to in paragraph 1 of this Article shall be confiscated and destroyed at the expense of the person having committed the criminal offense.

2. Commercial Offense

Article 46

The legal person shall be fined in the amount from RSD 500,000 to 3,000,000 for a commercial offense if it commences the use of GMOs and GMO products in closed systems, deliberate release into the environment, placing on the market or transit, without obtaining the approval of the Ministry (Article 9).

For a commercial offense referred to in paragraph 1 of this Article, the responsible person within the legal person shall also be fined in the amount from RSD 50,000 to 200,000.

For the actions referred to in paragraph 1 of this Article, in addition to the fine, the protective measure may be ordered prohibiting the legal person to perform certain economic activity, or the protective measure prohibiting the responsible person within the legal person from performing certain duties in the duration from six months to seven years.

The GMOs and GMO products referred to in paragraph 1 of this Article shall be confiscated and destroyed at the expense of the person having committed the commercial offense.

3. Misdemeanors Committed by Legal Persons

Article 47

A legal person shall be fined in the amount from RSD 200,000 to 1,000,000 for a misdemeanor: 1) if it fails to keep confidential data for the period of 10 years after the date of the submission of the application (Article 12, paragraph 2); 2) if it uses the data from one application on the experiments performed for risk assessment in other applications without the written approval of the owner of the data within the period of 10 years from the date the experiment was performed (Article12, paragraph 4); 3) if it carries out the testing of GMOs and GMO products without the authorization of the Ministry (Article 13); 4) if it fails to prepare the report following the completed testing of the GMOs and GMO products and to submit it to the Ministry (Article 14, paragraph 2); 5) if it fails to submit the application for approval renewal within the prescribed period, and continues operation (Article 17, paragraph 1); 6) if it engages in use in closed systems without having the license for a certain degree of risk (Article 19); 7) if it fails to notify the Ministry of the data on any change or unintentional modification of the GMO while the Ministry is considering the application or after issuing the approval for deliberate release into the environment (Article 24, paragraph 1); 8) if it fails to submit to the Ministry the report on the results of the deliberate release into the environment (Article 25, paragraph 1); 9) if the documentation accompanying GMOs and GMO products in handling, packaging and transport does not contain the data referred to in Article 28 of this Law; 10) if it fails to destroy the waste containing, consisting of or derived from GMOs and the waste resulting from the use of GMOs (Article 30).

For a misdemeanor referred to in paragraph 1 of this Article the responsible person within a legal person shall also be fined in the amount from RSD 10,000 to 50,000.

4. Misdemeanors Committed by Entrepreneurs Article 48

An entrepreneur shall be fined for a misdemeanor in the amount from RSD 250,000 to 500,000: 1) if it fails to keep confidential data for the period of 10 years after the date of the submission of application (Article12, paragraph 2); 2) if it uses the data from one application on the experiments performed for risk assessment in other applications without the written approval of the data owner within the period of 10 years from the date when the experiment was performed (Article 12, paragraph 4); 3) if it fails to submit the application for approval renewal within the prescribed period, and continues operation (Article 17, paragraph 1); 4) if it engages in use in closed systems without having the license for a particular degree of risk (Article 19); 5) if it fails to notify the Ministry of the data on any change or unintentional modification of the GMO while the Ministry is considering the application or after issuing the approval (Article 25, paragraph 1); 6) if it fails to submit to the Ministry the report on the results of the deliberate release into the environment (Article 27, paragraph 1); 7) if the documentation accompanying GMOs and GMO products in handling, packaging and

transport fails to contain the data referred to in Article 28 of this Law; 8) if it fails to destroy the waste containing, consisting of or derived from GMOs and the waste resulting from the use of GMOs (Article 30).

5. Misdemeanors Committed by Natural Persons Article 49

A natural person shall be fined for a misdemeanor in the amount from RSD 30,000 to 50,000: 1) if it engages in deliberate release into the environment without obtaining approval (Article

9); 2) if it fails to observe the plan of measures in case of an incident (Article 10); 3) if the documentation accompanying GMOs and GMO products in handling, packaging and

transport fails to contain the data referred to in Article 28 of this Law; 4) if it fails to destroy the waste containing, consisting of derived from GMOs and the waste resulting from the use of GMOs (Article 30).

VIII. TRANSITIONAL AND FINAL PROVISIONS

Deadline for Aligning Business Operations Article 50

The developer, user or their authorized representative in the Republic of Serbia shall align its business operations with the provisions of this Law within six months from the day this Law comes into force at the latest.

Adoption of By-laws Article 51

By-laws prescribed by this Law shall be adopted within six months from the day this Law comes into force.

Until the adoption of by-laws referred to in paragraph 1 of this Article, the by-laws adopted based on the Law on Genetically Modified Organisms (“Official Gazette of FRY”, no. 21/01 and “Official Gazette of RS”, no. 101/05-other law) shall apply, unless they are contrary to this Law.

Cessation of Effect of the Previous Law Article 52

On the day this Law comes into force, the Law on Genetically Modified Organisms (“Official Gazette of FRY”, no. 21/01 and “Official Gazette of RS”, no. 101/05-other law) shall cease to apply.

Coming into Force of the Law Article 53

This Law shall come into force on the eighth day from the day of its publication in the “Official Gazette of the Republic of Serbia”.

ZAKON

O GENETIČKI MODIFIKOVANIM ORGANIZMIMA

("Sl. glasnik RS", br. 41/2009)

I OSNOVNE ODREDBE

Predmet uređivanja

Član 1

Ovim zakonom uređuje se postupak za izdavanje odobrenja za upotrebu u zatvorenim sistemima i za namerno uvođenje u životnu sredinu genetički modifikovanih organizama i proizvoda od genetički modifikovanih organizama, uslovi za upotrebu u zatvorenim sistemima i za namerno uvođenje u životnu sredinu genetički modifikovanih organizama, rukovanje, pakovanje i prevoz genetički modifikovanih organizama i proizvoda od genetički modifikovanih organizama, kao i druga pitanja od značaja za genetički modifikovane organizme i proizvode od genetički modifikovanih organizama.

Zabrana stavljanja u promet

Član 2

Nijedan modifikovan živi organizam kao ni proizvod od genetički modifikovanog organizma ne može da se stavi u promet, odnosno gaji u komercijalne svrhe na teritoriji Republike Srbije.

Član 3

Genetički modifikovan organizam ne smatra se poljoprivredni proizvod biljnog porekla koji količinski sadrži do 0,9% primesa genetički modifikovanog organizma i primesa poreklom od genetički modifikovanog organizma.

Semenski i reproduktivni materijal ne smatraju se genetički modifikovanim organizmima ukoliko količinski sadrže do 0,1% primesa genetički modifikovanog organizma i primesa poreklom od genetički modifikovanog organizma.

Značenje pojmova

Član 4

Pojedini pojmovi upotrebljeni u ovom zakonu imaju sledeće značenje:

1) genetički materijal je deo biljke, životinje, gljive, mikroorganizma, virusa ili viroida koji sadrži naslednu informaciju;

2) genetički modifikovan organizam je organizam čiji je genetički materijal promenjen metodama savremene biotehnologije;

3) incident je svaki događaj koji dovodi do nekontrolisanog oslobađanja genetički modifikovanog organizma u životnu sredinu, a do koga dolazi prilikom upotrebe u zatvorenim sistemima i namernog uvođenja u životnu sredinu genetički modifikovanog organizma, koji može predstavljati neposrednu ili odloženu opasnost za život i zdravlje ljudi i životnu sredinu;

4) korisnik je pravno lice, preduzetnik ili fizičko lice koje upotrebljava genetički modifikovan organizam ili proizvod od genetički modifikovanog organizma u zatvorenim sistemima i prilikom namernog uvođenja u životnu sredinu;

5) metode savremene biotehnologije jesu in vitro tehnike nukleinskih kiselina, uključujući i rekombinantnu dezoksiribonukleinsku kiselinu (DNK) i direktno unošenje nukleinskih kiselina u ćelije ili organele i fuzija ćelija iznad taksonomskog nivoa familije, koje prevazilaze prirodne reproduktivne ili rekombinacione barijere i nisu tehnike koje se koriste u tradicionalnom oplemenjivanju i selekciji (klasične metode);

6) modifikovani živi organizam (living modified organism) je svaki genetički modifikovan organizam ili proizvod od genetički modifikovanog organizma koji je sposoban za razmnožavanje i prenos genetičkog materijala, uključujući i sterilni organizam koji je sposoban za rast;

7) monitoring je planirano i sistematsko praćenje i nadziranje genetički modifikovanog organizma, njegove upotrebe u zatvorenim sistemima, praćenje postupka namernog uvođenja u životnu sredinu, praćenje i nadziranje životne sredine u koju je genetički modifikovan organizam uveden, kao i mogućih štetnih efekata na životnu sredinu i zdravlje ljudi;

8) namerno uvođenje u životnu sredinu je ograničeno uvođenje genetički modifikovanog organizma radi izvođenja ogleda, demonstracionih ogleda i razvoja novih varijeteta;

9) nenamerno uvođenje u životnu sredinu je slučajno ispuštanje modifikovanog živog organizma u životnu sredinu usled nepredviđenog događaja, nesreće, nepravilnog rukovanja, skladištenja i drugo;

10) ovlašćena laboratorija je pravno lice koje vrši ispitivanje genetički modifikovanog organizma i proizvoda od genetički modifikovanog organizma;

11) proizvod od genetički modifikovanog organizma je svaki proizvod koji se sastoji, odnosno sadrži, odnosno dobijen je od jednog ili više genetički modifikovanih organizama, bez obzira na stepen obrade;

12) procena rizika je naučna procena koja se sprovodi po principu "slučaj po slučaj" koja podrazumeva identifikaciju mogućih štetnih efekata od genetički modifikovanog organizma ili proizvoda od genetički modifikovanog organizma po zdravlje ljudi i životnu sredinu do kojih može doći prilikom upotrebe u zatvorenim sistemima i namernog uvođenja u životnu sredinu. Prilikom procene rizika mora se poštovati princip predostrožnosti;

13) rukovanje je dorada, prerada i skladištenje genetički modifikovanog organizma ili proizvoda od genetički modifikovanog organizma;

14) stvaralac je pravno lice, preduzetnik ili fizičko lice koje stvara genetički modifikovan organizam ili proizvod od genetički modifikovanog organizma;

15) upotreba u zatvorenim sistemima je svaka operacija kojom se genetički modifikovan organizam ili proizvod od genetički modifikovanog organizma uzgaja, razmnožava, skladišti, transportuje, odlaže, uništava ili na bilo koji drugi način koristi u prostoru koji je odvojen fizičkim preprekama ili se kombinacijom fizičkih, hemijskih, odnosno bioloških prepreka onemogućava kontakt genetički modifikovanog organizma sa spoljnim svetom i njihov uticaj na životnu sredinu.

Izuzeci od primene

Član 5

Odredbe ovog zakona ne primenjuju se na proizvod od genetički modifikovanog organizma (u daljem tekstu: proizvod od GMO) koji nije modifikovani živi organizam (u daljem tekstu: LMO) i ne koristi se kao hrana, hrana za životinje, lek ili pomoćno lekovito sredstvo.

Odredbe ovog zakona ne primenjuju se na genetički modifikovan mikroorganizam, kao i na proizvod od GMO koji nije LMO, ako su oni namenjeni za medicinsku upotrebu i ako je njihova upotreba u celini regulisana drugim propisima.

Stručni savet za biološku sigurnost

Član 6

Radi razmatranja stručnih pitanja i davanja stručnih mišljenja koja se odnose na genetički modifikovan organizam (u daljem tekstu: GMO), ministar nadležan za poslove poljoprivrede (u daljem tekstu: ministar), u skladu sa propisima kojima se uređuje državna uprava, rešenjem osniva posebnu radnu grupu - Stručni savet za biološku sigurnost (u daljem tekstu: Stručni savet).

Poslovi Stručnog saveta

Član 7

Stručni savet:

1) procenjuje tačnost podataka iz prijave koja se podnosi za izdavanje odobrenja za upotrebu u zatvorenim sistemima i za namerno uvođenje u životnu sredinu na osnovu priložene dokumentacije, pri čemu se koriste podaci iz svetske prakse;

2) vrši procenu rizika pri namernom uvođenju u životnu sredinu;

3) daje stručno mišljenje ministarstvu nadležnom za poslove poljoprivrede (u daljem tekstu: Ministarstvo) o ispunjenosti uslova za dobijanje dozvole za upotrebu u zatvorenim sistemima;

4) daje stručno mišljenje Ministarstvu o ispunjenosti uslova za davanje odobrenja za namerno uvođenje u životnu sredinu;

5) razmatra rezultate namernog uvođenja u životnu sredinu;

6) razmatra predloge za izmenu propisa o GMO;

7) razmatra druga stručna mišljenja koja se odnose na GMO i proizvode od GMO.

Stručni savet radi po principu "slučaj po slučaj", u svom radu se rukovodi podacima koji su zasnovani na naučnim saznanjima i poštuje princip predostrožnosti.

Stručni savet donosi Poslovnik o svom radu.

Sukob interesa

Član 8

Član Stručnog saveta koji je u srodstvu ili je poslovno, odnosno finansijski u vezi sa podnosiocem prijave ne može da učestvuje u odlučivanju prilikom davanja mišljenja Stručnog saveta.

II POSTUPAK ZA IZDAVANJE ODOBRENJA

Odobrenje

Član 9

Odobrenje se izdaje za upotrebu u zatvorenim sistemima i za namerno uvođenje u životnu sredinu GMO i proizvoda od GMO.

Prijava

Član 10

Postupak za izdavanje odobrenja za upotrebu u zatvorenim sistemima i za namerno uvođenje u životnu sredinu pokreće se na osnovu prijave stvaraoca, korisnika ili njihovog ovlašćenog zastupnika u Republici Srbiji (u daljem tekstu: podnosilac prijave).

Prijava sadrži:

1) opis GMO;

2) poslovno ime, sedište i adresu pravnog lica ili preduzetnika, ime, prebivalište i jedinstveni matični broj građana fizičkog lica, odnosno lično ime i adresu njihovog ovlašćenog zastupnika;

3) lokaciju na kojoj se GMO uvodi u životnu sredinu;

4) plan i metode nadzora GMO i proizvoda od GMO, kao i plan mera za slučaj incidenta;

5) procenu rizika po zdravlje ljudi i životnu sredinu.

Prijava se podnosi i u slučaju kada je GMO dobijen ukrštanjem dva ili više GMO primenom klasičnih metoda.

Prijava se podnosi Ministarstvu, a odobrenje u formi rešenja izdaje ministar.

Ministar bliže propisuje sadržinu i obrazac prijave za upotrebu u zatvorenim sistemima i za namerno uvođenje u životnu sredinu GMO i proizvoda od GMO, kao i način zaštite poverljivih podataka iz prijave.

Otklanjanje nedostataka u prijavi

Član 11

Ako prijava ne sadrži podatke iz člana 10. ovog zakona Ministarstvo će obavestiti podnosioca prijave da u roku od 30 dana otkloni utvrđene nedostatke.

Ako podnosilac prijave u ostavljenom roku ne otkloni nedostatke, prijava će biti odbačena.

Poverljivi podaci

Član 12

Podnosilac prijave može da označi određene podatke u prijavi kao poverljive.

Poverljive podatke dužna su da čuvaju sva lica kojima su poverljivi podaci dostupni 10 godina od dana podnošenja prijave.

Poverljivi podaci nisu podaci iz člana 10. stav 2. tač. 1) do 5) ovog zakona, kao ni oni podaci koji su već dostupni javnosti.

Zabranjeno je koristiti podatke iz jedne prijave o sprovedenim eksperimentima za procenu rizika u drugim prijavama bez pismenog odobrenja vlasnika podataka u roku od 10 godina od dana kada je eksperiment izveden.

Podaci koji su označeni kao poverljivi, ostaju poverljivi i kad podnosilac prijave povuče prijavu.

Ministar određuje spisak lica koja imaju pristup poverljivim podacima i propisuje način postupanja, čuvanja i razmene podataka između lica kojima je dozvoljen pristup poverljivim podacima.

Ovlašćena laboratorija

Član 13

Ispitivanje GMO i proizvoda od GMO u cilju identifikacije i kvantifikacije genetičke modifikacije vrši laboratorija koja je ovlašćena od strane Ministarstva.

Ovlašćenje se izdaje rešenjem ministra.

Ministar oduzima ovlašćenje ako se utvrdi da ovlašćena laboratorija ne ispunjava propisane uslove ili da je ovlašćenje izdato na osnovu netačnih i neistinitih podataka.

Ministar propisuje uslove koje mora da ispunjava ovlašćena laboratorija u pogledu objekta, tehničke opremljenosti i kadrovske osposobljenosti, kao i metode koje se koriste za ispitivanje GMO i proizvoda od GMO.

Ispitivanje i izveštaj o izvršenom ispitivanju

Član 14

Podnosilac prijave dostavlja ovlašćenoj laboratoriji određenu količinu materijala radi ispitivanja GMO i proizvoda od GMO na zahtev Ministarstva u toku razmatranja prijave ili po dobijanju odobrenja.

Ovlašćena laboratorija dužna je da posle izvršenog ispitivanja iz stava 1. ovog člana sačini izveštaj i dostavi ga Ministarstvu.

Ovlašćena laboratorija i zaposleni u njoj dužni su da čuvaju podatke koji su označeni kao poverljivi, kao i rezultate dobijene na osnovu ispitivanja, u skladu sa ovim zakonom.

Ministar propisuje način i rokove za izveštavanje iz stava 2. ovog člana.

Upoznavanje javnosti

Član 15

Po prijemu prijave Ministarstvo stavlja na uvid javnosti sadržinu prijave u najmanje jednom dnevnom listu koji se distribuira na celoj teritoriji Republike Srbije i putem elektronskih medija.

Ministarstvo organizuje i sprovodi javnu raspravu koja traje do 30 dana od dana stavljanja na uvid javnosti sadržine prijave.

Mišljenje Stručnog saveta i konačno rešenje sa obrazloženjem Ministarstvo objavljuje u najmanje jednom dnevnom listu koji se distribuira na celoj teritoriji Republike Srbije i putem elektronskih medija.

Donošenje odluke

Član 16

Na osnovu mišljenja Stručnog saveta, a imajući u vidu i relevantne primedbe javnosti, kao i izveštaj ovlašćene laboratorije ukoliko je izveštaj tražen, ministar donosi rešenje kojim odobrava upotrebu u zatvorenim sistemima, namerno uvođenje u životnu sredinu, određuje mere sigurnosti i vreme trajanja odobrenja.

Ukoliko nisu ispunjeni uslovi propisani ovim zakonom za upotrebu u zatvorenim sistemima i za namerno uvođenje u životnu sredinu ministar donosi rešenje kojim odbija zahtev podnosioca prijave.

Rešenje ministra iz st. 1. i 2. ovog člana je konačno.

Ako nadležni organ državne uprave posle donošenja rešenja kojim se odobrava upotreba u zatvorenim sistemima i namerno uvođenje u životnu sredinu utvrdi da stvaralac, korisnik ili njihov ovlašćen zastupnik u Republici Srbiji više ne ispunjava uslove propisane za dobijanje odobrenja naložiće navedenim licima da preduzmu odgovarajuće mere i rešenjem po potrebi privremeno ili trajno oduzeti odobrenje.

Rešenje ministra iz stava 4. ovog člana je konačno.

Obnavljanje odobrenja

Član 17

Podnosilac prijave dužan je da podnese prijavu za obnavljanje odobrenja Ministarstvu šest meseci pre isteka odobrenja.

Prijava iz stava 1. ovog člana sadrži:

1) kopiju odobrenja čije se obnavljanje traži;

2) izveštaj o rezultatima monitoringa;

3) nove informacije vezane za procenu rizika po zdravlje ljudi i životnu sredinu.

Podnosilac prijave može do donošenja novog rešenja da nastavi upotrebu u zatvorenim sistemima i namerno uvođenje u životnu sredinu.

Ministar bliže propisuje sadržinu prijave za obnavljanje odobrenja za upotrebu u zatvorenim sistemima i za namerno uvođenje u životnu sredinu.

Član 18

Ako ovim zakonom nije uređen postupak za izdavanje odobrenja shodno se primenjuju odredbe zakona kojim se uređuje opšti upravni postupak.

III USLOVI ZA UPOTREBU U ZATVORENIM SISTEMIMA I ZA NAMERNO UVOĐENJE U ŽIVOTNU SREDINU GMO

1. Uslovi za upotrebu u zatvorenim sistemima

Dozvola

Član 19

Odobrenje za upotrebu u zatvorenim sistemima GMO izdaje se pravnom licu u vidu dozvole.

Dozvola iz stava 1. ovog člana izdaje se za jedan ili više stepena rizika.

Pravno lice mora da formira stručno telo za procenu rizika prilikom upotrebe u zatvorenim sistemima i da ispunjava uslove u pogledu stručnog kadra, objekta i tehničke opremljenosti propisane ovim zakonom i propisima donetim na osnovu ovog zakona.

Ministar propisuje uslove za rad stručnih tela za procenu rizika, kao i bliže uslove koje pravno lice mora da ispuni u pogledu stručnog kadra, objekta i tehničke opremljenosti.

Klasifikacija stepena rizika

Član 20

Upotreba u zatvorenim sistemima klasifikuje se u četiri stepena rizika:

1) upotreba uz zanemarljiv rizik - prvi stepen;

2) upotreba uz mali rizik - drugi stepen;

3) upotreba uz značajan rizik - treći stepen;

4) upotreba uz veliki rizik - četvrti stepen.

Klasifikacija u određene stepene rizika vrši se na osnovu preduzetih mera sigurnosti u skladu sa uslovima propisanim ovim zakonom i propisima donetim na osnovu ovog zakona.

Ministar bliže propisuje kriterijume za klasifikaciju rizika, mere za slučaj incidenta, način rukovanja sa GMO kod određenog stepena rizika, način postupanja sa nastalim otpadom i druge uslove za upotrebu u zatvorenim sistemima kod određenog stepena rizika.

Oduzimanje dozvole

Član 21

Ako pravno lice prestane da ispunjava uslove iz čl. 19. i 20. ovog zakona može mu se privremeno oduzeti dozvola za upotrebu u zatvorenim sistemima.

O privremenom oduzimanju dozvole ministar donosi rešenje, nalaže otklanjanje nedostataka i određuje rok od 60 dana od dana dostavljanja rešenja za otklanjanje nedostataka.

Dozvola za upotrebu u zatvorenim sistemima oduzima se trajno ako pravno lice ne otkloni nedostatke zbog kojih je dozvola privremeno oduzeta.

O trajnom oduzimanju dozvole ministar donosi rešenje.

Rešenje ministra je konačno.

2. Uslovi za namerno uvođenje u životnu sredinu

Prekogranični promet LMO

Član 22

Za svaki prekogranični promet LMO koji se namerno uvodi u životnu sredinu radi izvođenja ogleda, demonstracionih ogleda i razvoja novih varijeteta primenjuju se sve obaveze koje se po Kartagena protokolu o biološkoj zaštiti uz Konvenciju o biološkoj raznovrsnosti odnose na prvi prekogranični promet radi namernog uvođenja u životnu sredinu.

Plan nadzora, plan mera za slučaj incidenta i procena rizika

Član 23

Plan nadzora koji podnosilac prijave za namerno uvođenje u životnu sredinu GMO dostavlja uz prijavu obavezno sadrži i način postupanja sa otpadom.

Ministar propisuje način izrade plana nadzora i metode nadzora GMO, način izrade plana mera za slučaj incidenta i sadržinu procene rizika za namerno uvođenje u životnu sredinu.

Podaci, odnosno rezultati namernog uvođenja u životnu sredinu drugog podnosioca

Član 24

Podnosilac prijave može se u prijavi pozvati na podatke ili rezultate namernog uvođenja u životnu sredinu koje je Ministarstvu podneo drugi podnosilac, ako je podnosilac prijave pribavio pismenu saglasnost drugog podnosioca.

Dužnost podnosioca prijave

Član 25

Ako podnosiocu prijave postane dostupan podatak o bilo kojoj izmeni ili nenamernoj promeni GMO za vreme dok Ministarstvo razmatra prijavu ili posle davanja odobrenja za namerno uvođenje u životnu sredinu, a takav podatak može da ima uticaj na procenjeni rizik po zdravlje ljudi i životnu sredinu, podnosilac prijave je dužan da:

1) preduzme neophodne mere za zaštitu zdravlja ljudi i životne sredine;

2) obavesti Ministarstvo o novom podatku koji može da utiče na procenjeni rizik po zdravlje ljudi i životnu sredinu;

3) prilagodi mere za slučaj incidenta navedene u prijavi, odnosno odobrenju u cilju zaštite zdravlja ljudi i životne sredine.

Ako Ministarstvu postane dostupan podatak o bilo kojoj izmeni ili nenamernoj promeni GMO koji može da ima značajan uticaj na procenu rizika po zdravlje ljudi i životnu sredinu, Ministarstvo će taj podatak učiniti dostupnim javnosti i naložiti stvaraocu, korisniku ili njihovom ovlašćenom zastupniku u Republici Srbiji da:

1) obustavi namerno uvođenje u životnu sredinu;

2) prekine namerno uvođenje u životnu sredinu dok ne prilagodi uslove za namerno uvođenje u životnu sredinu.

Izdavanje jednog odobrenja

Član 26

Podnosiocu prijave može se izdavanjem jednog odobrenja dozvoliti namerno uvođenje u životnu sredinu na istom mestu ili na različitim mestima za istu namenu.

Izveštaj o rezultatima namernog uvođenja u životnu sredinu

Član 27

U toku i po završetku namernog uvođenja u životnu sredinu, u rokovima utvrđenim u odobrenju, stvaralac, korisnik ili njihov ovlašćen zastupnik u Republici Srbiji dužan je da podnese Ministarstvu izveštaj o rezultatima namernog uvođenja u životnu sredinu u pismenoj ili elektronskoj formi.

Ministar propisuje sadržinu i obrazac izveštaja o rezultatima namernog uvođenja u životnu sredinu.

IV RUKOVANJE, PAKOVANJE I PREVOZ GMO I PROIZVODA OD GMO

Sadržina dokumentacije koja prati GMO i proizvod od GMO prilikom rukovanja, pakovanja i prevoza

Član 28

Prilikom rukovanja, pakovanja i prevoza, uključujući i prevoz preko cele teritorije Republike Srbije, GMO i proizvod od GMO prati dokumentacija koja mora da sadrži podatke koji jasno ukazuju da se radi o GMO i proizvodu od GMO.

Za upotrebu u zatvorenim sistemima dokumentacija mora da sadrži uslove i zahteve za bezbedno rukovanje, prevoz i upotrebu, mesto za pribavljanje informacija, uključujući ime i adresu pojedinca, odnosno ustanove kojoj je poveren GMO.

Za namerno uvođenje u životnu sredinu dokumentacija mora da sadrži identitet i odgovarajuće karakteristike GMO i proizvoda od GMO, uslove za bezbedno rukovanje, skladištenje, prevoz i korišćenje, kao i mesto za pribavljanje informacija.

Ministar propisuje način rukovanja, pakovanja i prevoza GMO i proizvoda od GMO.

Obaveštavanje Ministarstva

Član 29

Pravno lice, preduzetnik ili fizičko lice dužno je da obavesti Ministarstvo kada prevozi preko cele teritorije Republike Srbije GMO i proizvod od GMO, u skladu sa ovim zakonom i drugim propisima.

Postupanje sa otpadom

Član 30

Stvaralac, korisnik ili njihov ovlašćen zastupnik u Republici Srbiji dužan je da otpad koji sadrži, sastoji se ili je dobijen od GMO, kao i otpad koji je nastao upotrebom GMO uništi uz prisustvo ovlašćenog lica tako da GMO više ne bude sposoban za razmnožavanje i prenos genetičkog materijala na druge organizme.

O uništavanju GMO stvaralac, korisnik ili njihov ovlašćeni zastupnik u Republici Srbiji dužan je da o datumu uništavanja obavesti Ministarstvo.

Odgovornost za štetu

Član 31

Stvaralac, korisnik ili njihov ovlašćen zastupnik u Republici Srbiji odgovoran je za štetu koja nastane njegovom direktnom, odnosno indirektnom aktivnošću vezanom za GMO ili proizvod od GMO, kojom se prouzrokuju štetne posledice po zdravlje ljudi i životnu sredinu, u skladu sa ovim zakonom i drugim propisima.

V REGISTAR GMO I PROIZVODA OD GMO I REGISTAR DOZVOLA

1. Registar GMO i proizvoda od GMO

Upis u Registar GMO i proizvoda od GMO

Član 32

U Registar GMO i proizvoda od GMO upisuje se GMO i proizvod od GMO za koji je izdato odobrenje za namerno uvođenje u životnu sredinu (u daljem tekstu: Registar).

Podaci iz Registra su javni.

Registar vodi Ministarstvo u elektronskoj formi i može se povezivati sa drugim bazama i registrima Ministarstva.

U Registar se ne mogu upisati podaci koji su u skladu sa ovim zakonom i drugim propisima označeni kao poverljivi.

Ministar bliže propisuje sadržinu i način vođenja Registra.

Brisanje iz Registra

Član 33

GMO i proizvod od GMO briše se iz Registra ako istekne vreme određeno rešenjem za namerno uvođenje u životnu sredinu.

Ministar donosi rešenje o brisanju iz Registra.

Rešenje ministra iz stava 2. ovog člana je konačno.

2. Registar dozvola

Upis u Registar dozvola

Član 34

U Registar dozvola upisuju se pravna lica koja su dobila dozvolu za upotrebu u zatvorenim sistemima.

Podaci iz Registra dozvola su javni.

Registar dozvola vodi Ministarstvo u elektronskoj formi i može se povezivati sa drugim bazama i registrima Ministarstva.

Ministar bliže propisuje sadržinu i način vođenja Registra dozvola.

Brisanje iz Registra dozvola

Član 35

Pravno lice briše se iz Registra dozvola:

1) ako mu je trajno oduzeta dozvola;

2) ako ne podnese novu prijavu istekom roka iz člana 17. stav 1. ovog zakona;

3) na osnovu obrazloženog zahteva.

Spiskovi koji se objavljuju

Član 36

Ministar utvrđuje Spisak GMO i proizvoda od GMO za koje je izdato odobrenje za namerno uvođenje u životnu sredinu i Spisak pravnih lica koja su dobila dozvolu za upotrebu u zatvorenim sistemima, koji se objavljuju u "Službenom glasniku Republike Srbije".

VI NADZOR

Član 37

Nadzor nad primenom odredaba ovog zakona i propisa donetih na osnovu ovog zakona vrši Ministarstvo.

Inspekcijski nadzor nad sprovođenjem odredaba ovog zakona i propisa donetih na osnovu ovog zakona Ministarstvo vrši preko fitosanitarnih i veterinarskih inspektora.

Nadzor nad radom ovlašćene laboratorije u obavljanju poverenih poslova ispitivanja GMO i proizvoda od GMO vrši Ministarstvo, u skladu sa propisima kojima se uređuje državna uprava.

Prava i dužnosti fitosanitarnog inspektora

Član 38

U vršenju poslova inspekcijskog nadzora fitosanitarni inspektor ima pravo i dužnost da:

1) proverava upotrebu u zatvorenim sistemima i namerno uvođenje u životnu sredinu za koje je dato odobrenje;

2) proverava da li ovlašćena laboratorija ispunjava uslove za ispitivanje GMO i proizvoda od GMO;

3) proverava mere sigurnosti prilikom namernog uvođenja u životnu sredinu;

4) proverava sprovođenje plana mera i plana nadzora prilikom namernog uvođenja u životnu sredinu;

5) proverava način vođenja evidencije i dokumentaciju koja prati GMO i proizvod od GMO;

6) uzima uzorke za ispitivanje GMO i proizvoda od GMO;

7) uzima uzorke radi utvrđivanja prisustva nedozvoljenih GMO ili proizvoda od GMO;

8) proverava postupanje sa otpadom koji sadrži, sastoji se, dobijen je ili koji je nastao upotrebom GMO.

Mere koje nalaže fitosanitarni inspektor

Član 39

U vršenju poslova iz člana 38. ovog zakona fitosanitarni inspektor može da:

1) zabrani upotrebu u zatvorenim sistemima i namerno uvođenje u životnu sredinu GMO i proizvoda od GMO;

2) naredi hitne mere radi zaštite zdravlja ljudi i životne sredine;

3) naredi uništavanje nedozvoljenih GMO i proizvoda od GMO;

4) naredi uništavanje otpada koji sadrži, sastoji se, dobijen je ili koji je nastao upotrebom GMO;

5) naredi preduzimanje i drugih mera na osnovu ovlašćenja iz ovog zakona.

Mere iz stava 1. ovog člana fitosanitarni inspektor nalaže rešenjem.

Prava i dužnosti veterinarskog inspektora

Član 40

U vršenju poslova inspekcijskog nadzora veterinarski inspektor ima pravo i dužnost da:

1) uzima uzorke za ispitivanje GMO i proizvoda od GMO;

2) uzima uzorke radi utvrđivanja prisustva nedozvoljenih GMO i proizvoda od GMO;

3) proverava način vođenja evidencije i dokumentaciju koja prati GMO i proizvod od GMO;

4) proverava postupanje sa otpadom koji sadrži, sastoji se, dobijen je ili koji je nastao upotrebom GMO.

Mere koje nalaže veterinarski inspektor

Član 41

U vršenju poslova iz člana 40. ovog zakona veterinarski inspektor može da:

1) naredi uništavanje nedozvoljenih GMO i proizvoda od GMO;

2) naredi uništavanje otpada koji sadrži, sastoji se, dobijen je ili koji je nastao upotrebom GMO;

3) naredi preduzimanje i drugih mera na osnovu ovlašćenja iz ovog zakona.

Mere iz stava 1. ovog člana veterinarski inspektor nalaže rešenjem.

Nadležnost za rešavanje po žalbi

Član 42

Protiv rešenja fitosanitarnog i veterinarskog inspektora može se izjaviti žalba ministru u roku od osam dana od dana dostavljanja rešenja.

Žalba ne odlaže izvršenje rešenja.

Ispitivanje i troškovi ispitivanja

Član 43

Ako postoji sumnja da se GMO i proizvod od GMO koristi suprotno odredbama ovog zakona fitosanitarni, odnosno veterinarski inspektor tražiće na uvid od stvaraoca, korisnika ili njihovog ovlašćenog zastupnika u Republici Srbiji odgovarajuće odobrenje.

Ako stvaralac, korisnik ili njihov ovlašćen zastupnik u Republici Srbiji nema odobrenje fitosanitarni, odnosno veterinarski inspektor zabraniće upotrebu u zatvorenim sistemima i namerno uvođenje u životnu sredinu GMO i proizvoda od GMO, a uzorak GMO i proizvoda od GMO dostaviti na analizu ovlašćenoj laboratoriji.

Ako se analizom utvrdi da se radi o nedozvoljenom GMO i proizvodu od GMO fitosanitarni, odnosno veterinarski inspektor donosi rešenje kojim zabranjuje upotrebu u zatvorenim sistemima i namerno uvođenje u životnu sredinu, a uzeti uzorak GMO i proizvoda od GMO uništava.

Troškove analize i uništavanja GMO i proizvoda od GMO snosi stvaralac, korisnik ili njihov ovlašćen zastupnik u Republici Srbiji.

Troškove ispitivanja po nalogu inspektora snosi podnosilac prijave.

Sredstva za sprovođenje ovog zakona

Član 44

Za postupak razmatranja prijave za upotrebu u zatvorenim sistemima i za namerno uvođenje u životnu sredinu podnosilac prijave plaća republičku administrativnu taksu.

Sredstva iz stava 1. ovog člana prihod su budžeta Republike Srbije.

VII KAZNENE ODREDBE

1. Krivično delo

Član 45

Ko protivno odredbama ovog zakona započne da upotrebljava GMO i proizvod od GMO u zatvorenim sistemima, namerno uvodi u životnu sredinu, stavlja u promet, gaji u komercijalne svrhe ili odlaže u životnu sredinu i time prouzrokuje štetne posledice po zdravlje ljudi i životnu sredinu, kazniće se za krivično delo zatvorom do tri godine.

GMO i proizvod od GMO iz stava 1. ovog člana oduzeće se i uništiti o trošku lica koje je izvršilo krivično delo.

2. Privredni prestup

Član 46

Novčanom kaznom od 500.000 do 3.000.000 dinara kazniće se za privredni prestup pravno lice ako započne da upotrebljava GMO i proizvod od GMO u zatvorenim sistemima, namerno uvodi u životnu sredinu, stavi u promet ili gaji u komercijalne svrhe, a nije dobilo odobrenje Ministarstva (član 9).

Za privredni prestup iz stava 1. ovog člana kazniće se novčanom kaznom od 50.000 do 200.000 dinara i odgovorno lice u pravnom licu.

Za radnje iz stava 1. ovog člana, pored novčane kazne, može se izreći i zaštitna mera zabrane pravnom licu da se bavi određenom privrednom delatnošću, odnosno zaštitna mera zabrane odgovornom licu u pravnom licu da vrši određene dužnosti u trajanju od šest meseci do sedam godina.

GMO i proizvod od GMO iz stava 1. ovog člana oduzeće se i uništiti o trošku lica koje je izvršilo privredni prestup.

3. Prekršaj pravnog lica

Član 47

Novčanom kaznom od 200.000 do 1.000.000 dinara kazniće se za prekršaj pravno lice, ako:

1) ne čuva poverljive podatke 10 godina od dana podnošenja prijave (član 12. stav 2);

2) koristi podatke iz jedne prijave o sprovedenim eksperimentima za procenu rizika u drugim prijavama bez pismenog odobrenja vlasnika podataka u roku od 10 godina od dana kada je eksperiment izveden (član 12. stav 4);

3) vrši ispitivanje GMO i proizvoda od GMO bez ovlašćenja Ministarstva (član 13);

4) posle izvršenog ispitivanja GMO i proizvoda od GMO ne sačini izveštaj i ne dostavi ga Ministarstvu (član 14. stav 2);

5) ne podnese prijavu za obnavljanje odobrenja u propisanom roku, a nastavi sa radom (član 17. stav 1);

6) vrši upotrebu u zatvorenim sistemima, a nema dozvolu za određeni stepen rizika (član 19);

7) ne prijavi Ministarstvu podatak o bilo kojoj izmeni ili nenamernoj promeni GMO dok Ministarstvo razmatra prijavu ili posle davanja odobrenja za namerno uvođenje u životnu sredinu (član 25. stav 1);

8) ne podnese Ministarstvu izveštaj o rezultatima namernog uvođenja u životnu sredinu (član 27. stav 1);

9) prilikom rukovanja, pakovanja i prevoza dokumentacija koja prati GMO i proizvod od GMO ne sadrži podatke iz člana 28. ovog zakona;

10) ne uništava otpad koji sadrži, sastoji se ili je dobijen od GMO i otpad koji je nastao upotrebom GMO (član 30).

Za prekršaj iz stava 1. ovog člana kazniće se novčanom kaznom od 10.000 do 50.000 dinara i odgovorno lice u pravnom licu.

4. Prekršaj preduzetnika

Član 48

Novčanom kaznom od 250.000 do 500.000 dinara kazniće se za prekršaj preduzetnik, ako:

1) poverljive podatke ne čuva 10 godina od dana podnošenja prijave (član 12. stav 2);

3) ne podnese prijavu za obnavljanje odobrenja u propisanom roku, a nastavi sa radom (član 17. stav 1);

4) vrši upotrebu u zatvorenim sistemima, a nema dozvolu za određeni stepen rizika (član 19);

5) ne prijavi Ministarstvu podatke o bilo kojoj izmeni ili nenamernoj promeni GMO dok Ministarstvo razmatra prijavu ili posle davanja odobrenja (član 25. stav 1);

6) ne podnese Ministarstvu izveštaj o rezultatima namernog uvođenja u životnu sredinu (član 27. stav 1);

7) prilikom rukovanja, pakovanja i prevoza dokumentacija koja prati GMO i proizvod od GMO ne sadrži podatke iz člana 28. ovog zakona;

8) ne uništava otpad koji sadrži, sastoji se ili je dobijen od GMO i otpad koji je nastao upotrebom GMO (član 30).

5. Prekršaj fizičkog lica

Član 49

Novčanom kaznom od 30.000 do 50.000 dinara kazniće se za prekršaj fizičko lice, ako:

1) namerno uvodi u životnu sredinu, a nije dobilo odobrenje (član 9);

2) se ne pridržava plana mera za slučaj incidenta (član 10);

3) prilikom rukovanja, pakovanja i prevoza dokumentacija koja prati GMO i proizvod od GMO ne sadrži podatke iz člana 28. ovog zakona;

4) ne uništava otpad koji sadrži, sastoji se ili je dobijen od GMO i otpad koji je nastao upotrebom GMO (član 30).

VIII PRELAZNE I ZAVRŠNE ODREDBE

Rok za usklađivanje poslovanja

Član 50

Stvaralac, korisnik ili njihov ovlašćen zastupnik u Republici Srbiji dužan je da svoje poslovanje uskladi sa odredbama ovog zakona najkasnije u roku od šest meseci od dana stupanja na snagu ovog zakona.

Donošenje podzakonskih akata

Član 51

Podzakonski akti propisani ovim zakonom biće doneti u roku od šest meseci od dana stupanja na snagu ovog zakona.

Do donošenja podzakonskih akata iz stava 1. ovog člana primenjivaće se podzakonski akti doneti na osnovu Zakona o genetički modifikovanim organizmima ("Službeni list SRJ", broj 21/01 i "Službeni glasnik RS", broj 101/05 - dr. zakon), ako nisu u suprotnosti sa ovim zakonom.

Prestanak važenja ranijeg zakona

Član 52

Danom stupanja na snagu ovog zakona prestaje da važi Zakon o genetički modifikovanim organizmima ("Službeni list SRJ", broj 21/01 i "Službeni glasnik RS", broj 101/05 - dr. zakon).

Stupanje na snagu zakona

Član 53

Ovaj zakon stupa na snagu osmog dana od dana objavljivanja u "Službenom glasniku Republike Srbije".

Loi sur les organismes génétiquement modifiés, Serbie

Documents disponibles

LAW ON GENETICALLY MODIFIED ORGANISMS1

LAW ON GENETICALLY MODIFIED ORGANISMS¹