1
LAW ON PLANT PROTECTION PRODUCTS
I. MAIN PROVISIONS
Scope of Regulation
Article 1
This Law shall govern the registration, control, circulation, importation, and application of plant protection products in agriculture and forestry, the tasks of public interest in the area of plant protection products, and other issues relevant for plant protection products.
Plant Protection Products
Article 2
Plant protection products, for the purpose of this Law, shall be:
1) Plant protection products;
2) Products of general use for plant protection;
3) Ancillary plant protection products;
4) Other plant protection products which contain one or more basic substances (hereinafter referred to as: other products).
Plant protection products, for the purpose of this Law, shall be deemed to be also plant protection products which are used in organic production and the plant protection products which contain or are composed of genetically modified organisms, or which are obtained from them, provided that the intentional introduction into the environment, placement into circulation or transit of such organisms is allowed based on the assessment of risk to the environment and human health, in accordance with the law governing genetically modified organisms.
Meaning of Terms
Article 3
Terms used in this Law shall have the following meaning:
1) Active substance shall mean a substance or a microorganism, including viruses, which has a general or specific effect on harmful organisms, plants, parts of plant or plant organisms;
2) Plants shall be deemed to be live plants and live parts of plants, including fresh fruit and seeds;
3) Plant products shall mean the products of plant origin in unprocessed state or having undergone simple reprocessing through milling, drying or pressing, excluding plants referred to in item 2) of this Article;
4) Distributor shall mean a legal person or entrepreneur that engages in circulation of plant protection products without altering their characteristics;
5) Good agricultural practice shall mean the performance of agricultural activities in a manner enabling the management of agricultural land and reproductive
material with respect of the natural characteristics of the agricultural area concerned and optimal combination of agrotechnical measures with the aim of conserving natural fertility of the agricultural land and preventing excessive pollution of the environment, excessive use of plant nutrition products and soil enrichment products and plant protection products, to ensure that the produced plants or plant products intended for consumption contain the least possible level of residue;
6) Animals shall mean those animal species which fall within the species usually fed, kept or consumed by humans;
7) Environment shall mean the water, air, soil, flora, fauna and their mutual relations;
8) Integrated plant protection shall mean rational application of a combination of biological, biotechnological, chemical, agrotechnical or enrichment measures for plant cultivation, where the application of chemical products is limited to the lowest possible extent necessary for maintenance of the population of harmful organisms below the level which may cause economically unacceptable damage;
9) Uniform principles shall mean the uniform criteria for assessment of active substance and/or basic substance and plant protection products, and for decision making in accordance with the contemporary international methodology;
10) Waiting period shall mean the final deadline for the application of plant protection products before harvesting;
11) User shall mean a legal person, entrepreneur or natural person that applies the plant protection products;
12) List of approved active substances and basic substances (hereinafter referred to as: the List of Approved Substances) shall mean an inventory of active substances and/or basic substances approved for use in plant protection products, which is adjusted to the list of active substances and basic substances in the territory of the European Union;
13) List of prohibited active substances and basic substances (hereinafter referred to as: the List of Prohibited Substances) shall mean an inventory of active substances and/or basic substances prohibited for use in plant protection products, which is adjusted to the list of active substances and basic substances in the territory of the European Union;
14) Maximum allowed quantity of residue shall mean the largest quantity of the plant protection products residue, expressed in mg/kg of the tested product;
15) Basic substance shall mean a substance which was not originally produced as a plant protection product but which manifests a certain biological activity;
16) Residues of plant protection products shall mean one or more active substances or basic substances or other substances, including their metabolites and products derived by their disintegration or reaction, which are present on plants or in plants, or on products of plant origin or in products of plant origin, or in edible products of animal origin, or anywhere in the environment (air, water, soil), and which result from the application of plant protection products;
17) Ancillary plant protection product shall mean a product containing one or more substances of natural or synthetic origin in its final form, which is used together with a plant protection product;
18) Preparation shall mean a mixture or a solution of substances intended to be used as a plant protection product, of which at least one substance is active substance;
19) Plant protection product shall mean an active substance or a preparation containing one or more active substances in its final form, which is intended for:
-Protection of plants or plant products from harmful organisms, or for prevention of any effects of harmful organisms;
-Affecting the life processes of plants in a manner different from the effects of the plant nutrition products such as plant development and growth regulators;
-Protection of plant products during warehousing, applied before or after harvesting, except for preserving agents;
-Destruction of unwanted plants or parts thereof.
20) product of general use for plant protection shall mean a preparation, other product or ancillary product prepared for direct application on small surfaces, the application of which does not present any danger for users and does not require wearing any personal protective gear;
21) Manufacturer shall mean a legal person or entrepreneur engaged in the production of plant protection products;
22) Circulation shall mean any supply of plant protection products, with or without compensation, including the importation in the territory of the Republic of Serbia, excluding warehousing for the purpose of exportation from the customs territory of the Republic of Serbia or warehousing for the purpose of their safe disposal;
23) Registration of plant protection products shall mean a procedure based on which a decision is issued permitting production, placement into circulation and application of plant protection products;
24) Substance shall mean a chemical element or its compounds, which appear in nature or as a result of a production process, including any impurities resulting from the production process;
25) Technical product shall mean a material containing active substance and impurities resulting from its production, and which may also contain a necessary quantity of additives;
26) Transit shall mean any transportation of the shipment across the territory of the Republic of Serbia;
27) Importation of plant protection products (hereinafter referred to as: the importation) shall mean any introduction of shipment to the territory of the Republic of Serbia, excluding transit;
28) Application appliances shall mean machines, apparatus and equipment, including their integral parts, which are designed for proper application of preparations, products of general use and ancillary plant protection products in the open or in closed space, as well as for the treatment of seed;
29) Harmful organisms shall mean organisms of plant or animal kingdom, viruses, bacteria, mycoplasma (phytoplasma) and other pathogenic organisms harmful for plant and plant products.
Application of Other Regulations
Article 4
A plant protection product, active substance and/or basic substance contained in the plant protection product may be produced, placed into circulation and applied in the territory of the Republic of Serbia if it is registered or entered in the List of Approved Substances in accordance with this Law and regulation enacted within the framework of it, and classified, packaged, labeled and accompanied with a safety paper, declaration and the instructions for use in accordance with this Law and regulations adopted based on this Law and in accordance with regulations enacted within the framework of it.
The plant protection products which are not registered in the Republic of Serbia, as well as the active substances and/or basic substances contained in plant protection products, but which are not entered in the List of Approved Substances, may be produced and warehoused in the Republic of Serbia, or imported and transported across the territory of the Republic of Serbia only if they are intended for placement into circulation in the country to which they are being exported.
Plant protection products shall be classified, packed, and mark in accordance with this Law and regulations adopted on the basis of it in accordance with the rules that regulate chemicals that are applied on the content and delivery of the security list.
Plant protection products, active substance and/or basic substances which are placed into circulation contrary to the provisions of this Law and regulations adopted based on this Law, as well as the plant protection products packaging shall be deemed to be waste.
The testing of properties and effects of active substances and/or basic substances and plant protection products on the health of humans, animals and the environment must be conducted in the laboratories which are in conformity with the guidelines of good laboratory practice, in accordance with the law governing medicines and medical devices.
II. NATIONAL REFERENCE LABORATORY AND PERFORMANCE OF THE TASKS OF PUBLIC INTEREST
National Reference Laboratory
Article 5
The work of laboratory testing and related activities in the field of plant protection is executed by the National reference laboratory, established by the law which regulates the food safety.
Tasks of Public Interest
Article 6
Tasks of public interest in the area of registration, placement into circulation and application of plant protection products and application appliances shall include the following scientific and expert tasks:
1) Testing of plant protection products, active substances and basic substances in the registration procedure;
2) Assessment of plant protection products, active substances and basic substances in the registration procedure;
3) Monitoring the residues of plant protection products in food and feed and the environment;
4) Scientific and expert support in decision making in the plant protection products registration procedure and determination of the maximum allowed quantity of residues;
5) Laboratory testing of samples of plant protection products taken in the procedure of inspection control with the aim of checking chemical and physical properties;
6) Control testing of application appliances;
7) Applied and other research in the area of plant protection products;
8) Development, establishment and application of new procedures in the good practice in plant protection and good agricultural practice;
9) Introduction of international standards in testing of the efficiency of plant protection products;
10) Professional training for the persons responsible for warehousing, placement into circulation and application of plant protection products and application appliances;
11) Records of the consumption, application of plant protection products and outstanding quantity of plant protection products;
12) Preparing the scientific basis for legal drafting in the area of plant protection products;
13) Other tasks in the area of plant protection products.
Public Bid for the Performance of the Tasks of Public Interest Article 7
The tasks of public interest in the area of plant protection products, may be assigned to legal persons through a public bid (hereinafter referred to as: the Legal Person Performing the Tasks of Public Interest) which shall be announced by the ministry responsible for agriculture (hereinafter referred to as: the Ministry) and published in the „Official Gazette of the Republic of Serbia”.
The performance of tasks of public interest referred to in Article 6 paragraph 1 items 1), 2), 3) and 5) may, based on the public bid, be assigned for a period of at least five years.
Public bid referred to in paragraph 1 of this Article shall include:
1) The tasks of public interest in the area of plant protection products for which the competition is being announced;
2) The period for which the performance of tasks of public interest is being assigned;
3) Evidence of compliance with the requirements in respect of technical and professional capacity, or accreditation, namely quality assurance in the organization and implementation of work in the laboratory and in the field, depending on the type of testing;
4) Criteria for the selection of the Legal Person Performing the Tasks of Public Interest;
5) Deadline for adoption and publication of the decision on selection of the Legal Person Performing the Tasks of Public Interest;
6) Manner of informing about the results of competition.
The public bid referred to in paragraph 1 of this Article shall be conducted by a commission established by the Minister.
The decision on selection of the Legal Person Performing the Tasks of Public Interest shall be issued by the Minister.
The results of competition shall be published in the „Official Gazette of the Republic of Serbia”.
Contract on Performance of the Tasks of Public Interest
Article 8
Based on the decision on selection of the Legal Person Performing the Tasks of Public Interest, the Ministry and the legal person who has been assigned the performance of tasks of public interest in the area of plant protection products shall conclude a contract which shall define, in particular:
1) The tasks of public interest which are subject of contract;
2) The responsible person who will perform specific tasks;
3) The methods, manner and procedure for performance of specific tasks;
4) Mutual rights, obligations and responsibilities;
5) Period for which the contract is concluded;
6) Manner of funding and price for the performance of specific tasks;
7) Control of the performance of specific tasks;
8) Termination of the contract;
9) Reasons for the termination of the contract;
10) Notice period for the termination of the contract.
Uniform Methods, Criteria and Guidelines for Performance of the Tasks of Public Interest Article 9
The Reference Laboratory shall organize and establish the application of uniform methods, criteria and guidelines for the performance of the tasks of public interest in the territory of the Republic of Serbia which are performed by the Legal Persons Performing the Tasks of Public Interest.
The Legal Persons Performing the Tasks of Public Interest shall perform the tasks of public interest in accordance with uniform methods, criteria and guidelines referred to in paragraph 1 of this Article.
III. REGISTRATION OF PLANT PROTECTION PRODUCTS
1. Registration Procedure
Applicant
Article 10
The Ministry shall register plant protection products based on the application for registration of plant protection products submitted by the manufacturer.
A manufacturer which has corporate domicile in the Republic of Serbia may submit the application for registration of plant protection products if it is entered in the Register of Economic Operators in accordance with the law governing the registration of economic operators and if it holds the evidence on compliance with the requirements for production of plant protection products in accordance with the regulations governing environmental protection.
A manufacturer which does not have corporate domicile in the Republic of Serbia shall submit the application for registration of plant protection products through an agent or a representative office established in the Republic of Serbia.
The agent of the manufacturer referred to in paragraph 3 of this Article must be entered in the Register of Economic Operators in accordance with the law governing the registration of economic operators and must have a contract on agency services which shall in particular define and ensure the liability for any damage arising from the application of plant protection products in the territory of the Republic of Serbia.
The representative office of the manufacturer referred to in paragraph 3 of this Article must be entered in the Register of Economic Operators in accordance with the law governing the registration of economic operators and the law governing foreign trade.
Application for Registration
Article 11
The manufacturer shall submit with the application for registration of plant protection products the following:
1) The documentation for assessment of active substances and/or basic substances contained in the plant protection products;
2) The documentation for assessment of plant protection products;
3) The sample of plant protection products, active substances and/or basic substances and other ingredients in plant protection products, in the original packaging;
4) The evidence on compliance with the requirements referred to in Article 10 paragraphs 2, 4 and 5.
The Minister shall prescribe the form and the content of the application for registration of plant protection products.
Documentation for Assessment of
Active Substances and/or Basic Substances
Article 12
Documentation for the assessment of active substances and/or basic substances shall in particular contain the data about:
1) The identity of manufacturer;
2) The identity of active substances and/or basic substances;
3) The results of testing of physical and chemical properties;
4) Additional properties for active substances and/or basic substances, particularly related to the application, the operating mechanism, the manner of handling, warehousing and security measures;
5) Analytical methods for testing of active substances and/or basic substances and residues;
6) The results of toxicological and metabolitic testing of active substances and/or basic substances;
7) The residues of active substances and/or basic substances in plants and on plants or products of plant origin, food and feed;
8) The results of testing of the destiny and behavior of active substances and/or basic substances in the environment;
9) The results of ecotoxicological testing.
If a plant protection products contain any active substance and/or basic substance that is already entered in the List of Approved Substances, such active substance and/or basic substance shall not be reassessed and, in such an event:
1) the manufacturer shall not be obliged to submit the documentation referred to in paragraph 1 of this Article, other than the evidence related to the identity of the active substance and/or basic substance;
2) the Ministry shall consider the conditions under which the active substance and/or basic substance has been entered in the List of Approved Substances and determine whether there are any significant differences between the purity level and content and characteristics of the impurities of the active substance and/or basic substance in comparison with the composition of the active substance and/or basic substance established in the documentation based on which such active substance and/or basic substance has been entered in the List of Approved Substances.
If, due to the nature of a plant protection product or its proposed application, it is not necessary to submit some of the data referred to in paragraph 1 of this Article, and if the testing of active substances and/or basic substances is not scientifically necessary or technically viable, the manufacturer shall provide written explanation thereof.
The Minister shall prescribe the content and the manner of handling the documentation referred to in paragraph 1 of this Article and the methods for testing of active substances and/or basic substances.
Documentation for Assessment of Plant Protection Products Article 13
Documentation for assessment of plant protection products shall in particular contain the data on:
1) The identity of the manufacturer;
2) The identity of the plant protection products;
3) The results of testing of physical, chemical and technical properties of plant protection products;
4) The application and efficiency of the plant protection product;
5) Additional properties for plant protection products;
6) Analytical methods for testing of plant protection products and residues;
7) The results of toxicological testing of plant protection products;
8) The residues of plant protection products in the treated plants, or on the treated plants, plant products, food and feed;
9) The results of testing of the destiny and behavior of plant protection products in the environment;
10) The results of ecotoxicological testing.
If, due to the nature of a plant protection product or its proposed application, it is not necessary to submit some of the data referred to in paragraph 1 of this Article, and if the examination of plant protection products is not scientifically necessary or technically viable, the manufacturer shall submit written explanation thereof.
The Minister shall prescribe the content and the manner of handling the documentation referred to in paragraph 1 of this Article and the methods for testing of plant protection products.
Assessment of Active Substances, Basic Substances and Plant Protection Products
Article 14
The assessment of active substances and/or basic substances and the plant protection products shall be performed by the Ministry.
Exceptionally, the assessment of active substances and/or basic substances and plant protection products may also be performed by the Legal Person Performing the Tasks of Public Interest.
If, in the assessment procedure referred to in paragraphs 1 and 2 of this Article, it is established that additional data are required, the Ministry must request the manufacturer to supplement the documentation, taking into account the efficiency of the procedure.
The Minister shall prescribe the elements for the assessment of active substances and/or basic substances and plant protection products, as well as for the decision making.
Registration of Plant Protection Products
Article 15
The Ministry shall register plant protection products if, based on the assessment referred to in Article 14 of this Law, it has established:
1) That active substance and/or basic substance is entered or can be entered in the List of Approved Substances;
2) That plant protection products, taking into account the scientific and technical knowledge, depending on the intended use:
-have satisfactory efficiency,
-do not have unacceptable effect on plants or plant products,
-do not have unacceptable effect on the environment,
-do not have a harmful effect on the health of humans or animals, directly or indirectly through the drinking water, food or feed,
-do not cause unnecessary suffering to the harmful vertebrates which are being suppressed;
3) That the nature and composition of active substance, basic substance, impurities and other substances in plant protection products may be determined using the prescribed methods;
4) That the physical and chemical properties of plant protection products are determined and that they are considered acceptable for the purposes of relevant application and warehousing;
5) That the residues of plant protection products of toxicological and ecotoxicological significance may be determined using relevant methods;
6) The maximum allowed quantity of residues in agricultural products;
7) Waiting periods for the requested intended use.
Plant protection products may also be registered for application on non-agricultural surfaces if the manufacturer submits along with the application for registration of plant protection products the documentation referred to in Article 12 paragraphs 1 and 3 and Article 13 paragraphs 1 and 2 of this Law, and if the requirements referred to in paragraph 1 items 1) to 5) of this Article are met.
Recognition of Registration
Article 16
A manufacturer may submit an application for registration of plant protection products based on the registration performed in some other country, namely it may submit an application requesting that the tests and examinations performed in the procedure of registration of plant protection products in some other country are not repeated in the Republic of Serbia.
The application referred to in paragraph 1 of this Article shall be submitted to the Ministry.
The Minister shall issue a decision on approval of the application referred to in paragraph 1 of this Article if:
1) The active substance and/or basic substance contained in the plant protection products are entered in the List of Approved Substances;
2) The plant protection products are registered in accordance with uniform principles;
3) it is found, during the proposed application of plant protection products, that there is a comparability of the requirements significant for the application of plant protection products in the country in which they have been registered and the requirements in the Republic of Serbia, in the context of agricultural production, health status of plants and the environment, including the climatic conditions.
In deciding on the application referred to in paragraph 1 of this Article, the Ministry may:
1) with the consent of the manufacturer, define an alteration of the proposed application of plant protection products, with the aim of excluding all incomparable conditions in agricultural production, protection of plants or the environment, including the climatic conditions in the Republic of Serbia, provided the requirements referred to in Article 15 paragraph 1 item 2) of this Law are met;
2) Define the limitations in the application of plant protection products due to the differences in dietary habits of the population in the Republic of Serbia, with the aim of preventing the exposure of consumers to the residues of plant protection products in excess of the allowed daily intake;
3) Define the special requirements for placing into circulation and application of plant protection products, safety at work when applying plant protection products, as well as the users of plant protection products.
The Minister shall issue a decision on rejection of the application referred to in paragraph 1 of this Article when the requirements referred to in paragraph 3 of this Article are not met.
The decision of the Minister referred to in paragraphs 3 and 5 shall be final and an administrative dispute may be instigated against it.
Prevention of Retesting on Vertebrates
Article 17
If an active substance and/or basic substance are entered in the List of Approved Substances, with the aim of preventing the retesting on vertebrates, the manufacturer shall, before submitting an application for registration, submit to the Ministry a request for obtaining data, specifically:
1) Whether the plant protection product which shall be subject of the application for the registration of plant protection products is already registered in the Republic of Serbia;
2) The name and address of the manufacturer of plant protection product if an identical plant protection product is already registered.
Along with the request for obtaining data, the manufacturer shall submit a written statement that it intends to register a plant protection product and that it has access to the data referred to in Articles 12 and 13 of this Law.
Upon receipt of the request referred to in paragraph 1 of this Article and the statement referred to in paragraph 2 of this Article, the Ministry shall submit to the manufacturer intending to register a plant protection product the data about the name and address of the manufacturer of the registered identical plant protection product, and, at the same time, notify the manufacturer of the registered identical plant protection product about the name and address of the manufacturer intending to register the plant protection product.
The manufacturer of the registered identical plant protection product and the manufacturer intending to register the plant protection product shall undertake all measures to jointly use the data and to notify the Ministry in writing about the manner in which they will jointly use the data.
Data Protection
Article 18
In the registration procedure, the Ministry and the Legal Person Performing the Tasks of Public Interest shall not use the data from the documentation referred to in Articles 12 and 13 of this Law in favor of other manufacturers, specifically the data about:
1) Active substance and/or basic substance, unless:
-The manufacturer that has first submitted an application for the registration of plant protection products has issued a written consent that the manufacturer that subsequently submitted an application for registration may use such documentation;
-At least ten years have elapsed since the active substance was first entered in the List of Approved Substances;
2) The plant protection product, unless: -The manufacturer that has first submitted an application for registration of plant protection products has issued a written consent that the manufacturer that subsequently submitted an application may use such documentation;
-At least ten years have elapsed since the registration of the plant protection product.
Confidential Data
Article 19
The Ministry shall keep all the data which the manufacturer has submitted for the purpose of registering the plant protection products as confidential.
If the manufacturer defines that it does not consider the data it has submitted for the purpose of registering plant protection products as confidential, in whole or in part, it shall notify the Ministry thereof.
The data not considered confidential shall be:
1) The name and content of all active substances and/or basic substances in plant protection products;
2) The name of plant protection products;
3) The minimum content of active substance and/or basic substance in the technical product;
4) The maximum content of impurities of toxicological and ecotoxicological significance;
5) The name of other substances classified as dangerous;
6) The physical and chemical properties of active substance, basic substance and plant protection products;
7) The manners for preventing harmful effect of the active substance, basic substance and plant protection products;
8) The summary of the testing results of active substance and/or basic substance and plant protection products;
9) Recommended procedures and safety measures for alleviation of the risk in handling, warehousing, transportation, fire and other hazards;
10) Methods for the determination of the content of active substance and/or basic substance, impurities and other ingredients in the active substance and/or basic substance and plant protection products, as well as the methods for determination of residues;
11) Methods of safety disposal of active substance and/or basic substance, plant protection products and packaging;
12) Procedures of decontamination in the event of spillage or leakage;
13) Data about the emergency action and treatment.
2. Decision on the Registration of Plant Protection Products
Content of the Decision on Registration of Plant Protection Products
Article 20
Decision on registration of plant protection products (hereinafter referred to as: the decision on registration) shall be issued by the Minister based on the results of the assessment of active substance and/or basic substance and the results of the assessment of plant protection products.
The decision on registration shall refer to the plant protection products and the manufacturer.
The decision on registration shall contain in particular:
1) The trade name of plant protection products;
2) The composition of plant protection products;
3) The data on the application of plant protection products;
4) The classification and marks for labeling the plant protection products;
5) The places of sale;
6) The waiting period;
7) The maximum allowed quantity of residues in food.
The evaluation of active substances or basic substances and means for plant protection from paragraph 1 of this Article must be completed no later than one year from date of application for the registration of plant protection products. The period for issuing the decision on registration shall commence on the completion date of the assessment of active substance and/or basic substance and plant protection products.
The decision on registration shall be final and an administrative dispute may be instigated against it.
The Ministry shall keep the List of Approved Substances, the List of Prohibited Substances and the List of Plant Protection Products based on the issued decisions on registration of plant protection products which are published annually in the „Official Gazette of the Republic of Serbia”.
The Minister shall prescribe the content and the manner of keeping the List of Approved Substances, the List of Prohibited Substances and the List of Plant Protection Products referred to in paragraph 6 of this Article.
Application of Plant Protection Products for Small Crops and for Purposes of Lesser Importance
Article 21
The state authorities, scientific and research organizations in the area of agriculture and forestry, the users of plant protection products or their associations and the manufacturers may submit to the Ministry a request for application of the registered plant protection products for the purposes which are not indicated in the decision on registration.
The request referred to in paragraph 1 of this Article may be submitted for small crops and for the purposes of lesser importance.
Along with the request referred to in paragraph 1 of this Article, the data and/or documentation which explains the request for the application of plant protection products for small crops and for the purposes of lesser importance shall be submitted.
The application of plant protection products for small crops and for purposes of lesser importance may be approved if the assessment of plant protection products is completed and if the requirements referred to in Article 15 paragraph 1 items 1) and 2) of this Law are met.
The application of plant protection products for small crops and purposes of lesser importance shall be approved by the decision of the Minister.
The decision of the Minister referred to in paragraph 5 of this Article shall be final and an administrative dispute may be instigated against it.
The persons referred to in paragraph 1 of this Article shall notify the users of plant protection products about the application of plant protection products for small crops and purposes of lesser importance in the additional instructions for use, which is approved by the Ministry.
The Minister shall specify the list of small crops and purposes of lesser importance.
Validity Period, Extension of the Registration Validity and Reassessment of the Documentation for Registration Article 22
The decision on registration shall be issued for the period of maximum ten years and it may be extended upon a decision of the Minister.
The manufacturer shall submit an application for extension of the registration validity to the Ministry at the latest 12 months before the expiry of the period for which it has been issued.
The validity period of registration shall be extended if it is established that the registered plant protection products meet the requirements for registration referred to in Article 15 of this Law. The Ministry may, ex officio, review the decision on registration with the aim of verifying the fulfillment of the requirements referred to in Article 15 of this Law and, for these purposes, demand that the manufacturer of registered plant protection products or the persons referred to in Article 21 paragraph 1 of this Law to submit the additional documentation and/or the data necessary for reassessment.
The period for which the decision on registration has been issued may also be extended if it is necessary to obtain additional documentation and conduct reassessment in the procedure of extension of registration and/or review of the decision on registration.
The decision on extension of the validity of decision on registration shall be final and an administrative dispute may be instigated against it.
Cancellation of the Decision on Registration, Prohibitions and Restrictions
Article 23
The decision on registration shall be canceled and circulation and application of registered plant protection products shall be prohibited or restricted by a decision of the Minister, if:
1) It is found that some of the requirements for registration of plant protection product referred to in Article 15 of this Law are no longer met;
2) It is found that the data based on which the decision on registration was issued are incorrect or misleading;
3) within a specified period, the manufacturer fails to eliminate the deficiencies found in process of control of plant protection products, and such deficiencies may cause the change in characteristics of plant protection products in relation to the characteristics specified in the decision on registration;
4) the period for which the decision on registration was issued has expired and the manufacturer has not submitted an application for extension of the decision on registration within the period referred to in Article 22 paragraph 2 of this Law;
5) The manufacturer of registered products submits an application for cancellation of the decision on registration.
Decision from paragraph 1 this Article sets the date in which the plant protection products can be in circulated for sales and application of existing stocks, and that the deadline cannot be longer than 18 months from the date of the issuance of the decision.
The period referred to in paragraph 1 of this Article shall be specified in the decision on cancellation of the decision on registration on a case by case basis.
The manufacturers, importers and distributors shall undertake all the necessary measures for withdrawing from circulation the stocks of plant protection products within the period specified in the decision from paragraph 1 of this Article.
The decision of the Minister referred to in paragraph 1 of this Article shall be final and an administrative dispute may be instigated against it.
The Minister shall prescribe the manner of handing the stocks of plant protection products.
Amendment of the Decision on Registration
Article 24
If, based on new scientific and technical knowledge, the use of substances contained in plant protection products is restricted or the manner and the quantity of application of plant protection products is modified, the Minister may issue a decision on amendment of the decision on registration.
If the manufacturer of registered plant protection products submits an application for amendment of the decision on registration, the Minister may issue a decision on amendment of the decision on registration where the requirements referred to in Article 15 of this Law are met.
In the event referred to in paragraph 2 of this Article, the Ministry may request the documentation referred to in Articles 12 and 13 of this Law and the samples necessary for assessment of justifiability of the amendment of the decision on registration.
Notwithstanding paragraph 3 of this Article, the reassessment of plant protection products shall not be required for the amendment of the decision on registration due to minor changes which have no effect on the health of humans and animals and the environment.
Minor changes which have no effect on human health and the environment in the context of paragraph 4 of this Article shall be deemed to be the change of the trade name of plant protection products, change of the name of the manufacturer, agent or representative office, change of the composition which is, in accordance with international standards, deemed to be a minor change without a change of the content of active substance and/or basic substance.
In the event referred to in paragraph 4 of this Article, the manufacturer of registered products shall submit the evidence of the occurrence of minor changes along with the application for amendment of the decision on registration.
The decision of the Minister on the amendment of the decision on registration shall be final and an administrative dispute may be instigated against it.
Provisional Registration
Article 25
A preparation and/or ancillary plant protection product that contain a new active substance shall be registered based on the decision on provisional registration of preparation and/or ancillary plant protection product, which is issued by the Minister if the requirements referred to in Article 15 paragraph 1 items 2) to 7) of this Law are met.
Decision on provisional registration of preparation and/or ancillary plant protection product shall be issued for the period of maximum three years.
The decision on provisional registration shall define maximum allowed quantities of residue in agricultural products, taking into account the proposed application of the preparation and/or ancillary plant protection product.
If a preparation and/or ancillary plant protection product that contain a new active substance no longer meet the requirements referred to in Article 15 paragraph 1 items 2) to 7) of this Law, the Minister shall issue a decision on cancellation of the decision on provisional registration of preparation and/or ancillary plant protection product.
The decision on provisional registration shall also be cancelled upon a substantiated application of the holder of the registration of a preparation and/or ancillary plant protection product.
In the event referred to in paragraphs 4 and 5 of this Article, a preparation and/or ancillary product that contain a new active substance may be circulated for maximum 18 months from the date of issuance of the decision on cancellation of the decision on provisional registration of preparation and/or ancillary plant protection product, with the aim of selling and using the existing stocks.
Decision from paragraphs 4 and 5 of this Article shall determine the date in which the preparation and ancillary plant protection products that contain a new active ingredient can be circulated for sales and application of existing stocks, whereby the deadline cannot be longer than 18 months from the date of the adoption of the decision.
The manufacturers, importers and distributors shall undertake all necessary measures for withdrawing from the circulation any stocks of the preparation and/or ancillary plant protection product within the period specified in the decision from paragraph 4 and 5 of this Article.
The decision from paragraph 4 and 5 of this Article shall be final and an administrative dispute may be instigated against them.
The Minister shall prescribe the manner of handling the stocks of preparation and/or ancillary plant protection product.
3. Testing of Non-Registered Plant Protection Products and Active Substances and/or Basic Substances Not Included in the List of Approved Substances and the Application of Non-Registered Plant Protection Products
Testing for the Research or Development Purposes
Article 26
Testing of non-registered plant protection products and active substances and/or basic substances not entered in the List of Approved Substances for the research or development purposes that are conducted in the environment may be conducted only on the basis of a decision on approval of testing for the research or development purposes, which is issued by the Minister.
Exceptionally, for testing of non-registered plant protection products and active substances and/or basic substances not entered in the List of Approved Substances for the research or development purposes, the decision referred to in paragraph 1 of this Article shall not be necessary if they are not released into the environment.
The request for the testing of non-registered plant protection products and active substances and/or basic substances not entered in the List of Approved Substances for the research or development purposes may be submitted by scientific and research organizations in the area of plant protection products.
Along with the application for testing referred to in paragraph 3 of this Article the documentation containing data based on which it is possible to assess the effects on the health of humans and animals or any harmful and/or adverse effect on the environment shall be submitted.
The decision from paragraph 1 of this Article shall be final and an administrative dispute may be instigated against it.
The Minister shall prescribe the content and the form of the application for testing of non-registered plant protection products and active substances and/or basic substances not entered in the List of Approved Substances for the research or development purposes.
Application of Non-Registered Plant Protection Products in Emergency Cases
Article 27
In the event of unforeseeable danger which may be caused by harmful organisms and which cannot be suppressed or reduced in an appropriate manner by the application of registered plant protection products and other measures, or due to the shortage of registered plant protection products on the market, the Minister may issue a decision approving the application of plant protection products that are not registered for the limited and controlled application.
The decision referred to in paragraph 1 of this Article shall be issued ex officio or at the request of a party.
The party referred to in paragraph 2 of this Article shall submit to the Ministry, along with the request for placement into circulation and application of the plant protection products that are not registered, the data and/or documentation verifying that plant protection products have been registered in some other country.
The decision referred to in paragraph 1 of this Article shall be final and an administrative dispute may be instigated against it.
The Minister shall prescribe the form of the request for application of plant protection products that are not registered.
4. Control of Plant Protection Products after the Registration
Post-Registration Control
Article 28
Registered plant protection products shall be subject to control (hereinafter
referred to as: post-registration control).
Post-registration control shall include:
1) Testing of chemical and physical properties of the samples of registered plant protection products taken in the production, circulation, importation and/or from the users;
2) testing of the residues of plant protection products in plants and/or on plants, plant products, prescribed objects, food of plant origin, feed and the environment, and in particular in the underground and surface waters, irrigation water and soil.
Post-Registration Control Program
Article 29
The Minister shall adopt the Annual Post-Registration Control Program.
Annual Post-registration Control Program shall contain: the plan of sample taking; the type and number of samples; the manner of taking and testing of samples; the facilities from which the sample is taken; the dynamics of sample taking; the measures to be undertaken when it is determined that the chemical and physical properties of plant protection product are not in conformity with the issued decision on registration and/or when it is found that the residues of plant protection products exceed the prescribed maximum allowed quantities.
The funds for implementation of the Annual Post-Registration Control Program shall be provided from the budget of the Republic of Serbia.
Notification about the Possible Harmful Effects
Article 30
The manufacturer shall without delay notify the Ministry and the users of plant protection products about possible harmful effects of plant protection products and/or residues of plant protection products on the health of humans and animals, on the surface and underground waters or on the environment, as well as about any new insights concerning the possible limitations to the alteration of crops.
Mandatory notification referred to in paragraph 1 of this Article shall also apply to the users of plant protection products who, during the application, establish that plant protection products have harmful effect on the health of humans or animals, or surface and underground waters or the environment.
IV. CIRCULATION OF PLANT PROTECTION PRODUCTS
Requirements for Circulation
Article 31
Registered plant protection products may be placed into circulation if they are placed in a packaging safe to human health and the environment.
Packaging of plant protection products must have a declaration and instruction for use with the data contained in the decision on registration, in the Serbian language, that are clear, unambiguous and legible, so that they cannot be erased or removed.
The declaration and instructions for use of plant protection products must indicate the specific marks of risks and warnings for humans and the environment.
Circulation of plant protection products may be performed by a distributor that is entered in the Register of Economic Operators in accordance with the law governing the registration of economic operators and entered in the Register of Distributors and Importers of Plant Protection Products (hereinafter referred to as: the Register of Distributors and Importers), which is kept by the Ministry.
The Minister shall prescribe the content of the declaration and instructions for use of plant protection products, specific marks of risk and warnings for humans and the environment, as well as the manner of handling the emptied plant protection products packaging.
Entry in the Register of Distributors and Importers
Article 32
Entry in the Register of Distributors and Importers shall be conducted based on the application submitted to the Ministry by the distributor.
A distributor shall be entered in the Register of Distributors and Importers if it meets the requirements in respect of facilities, equipment and professional capacity of employees.
The Minister shall issue a decision on entry in the Register of Distributors and Importers.
The decision from paragraph 3 of this Article shall be final and an administrative dispute may be instigated against it.
The Minister shall prescribe the form and the content of the application for entry in the Register of Distributors and Importers, and requirements in respect of facilities, equipment and professional capacity of employees referred to in paragraph 2 of this Article.
Register of Distributors and Importers
Article 33
The Register of Distributors and Importers shall in particular contain:
1) Number of the entry in the Register of Distributors and Importers;
2) Number from the Register of Economic Operators;
3) Name, corporate domicile and code of business activity;
4) Fiscal identification number;
5) Facilities and places of sale.
The Register of Distributors and Importers shall be kept in electronic format and may be linked with other registers and databases kept by the Ministry.
The data from the Register of Distributors and Importers shall be publicly available.
The distributor shall notify any change in the data entered in the Register of Distributors and Importers to the Ministry within 30 days after the day the change occurred.
Plant protection products may be sold only in the facilities and places of sale entered in the Register of Distributors and Importers.
The Minister shall prescribe the content of the Register of Distributors and Importers.
Removal from the Register of Distributors and Importers
Article 34
A distributor shall be removed from the Register of Distributors and Importers if:
1) it no longer meets the requirements referred to in Article 31 paragraph 4 and Article 32 paragraph 2 of this Law;
2) It fails to notify the change of data within the period referred to in Article 33 paragraph 4 of this Law;
3) It submits an application for removal from the Register of Distributors and Importers.
Removal from the Register of Distributors and Importers shall be conducted based on the decision issued by the Minister.
The decision from paragraph 2 of this Article shall be final and an administrative dispute may be instigated against it.
Circulation of Particularly Dangerous Plant Protection Products
Article 35
A registered plant protection product which is classified in a specific class of danger (hereinafter referred to as: particularly dangerous) shall not be intended for general use and may not be released for free circulation.
Decision referred to in paragraph 1 of this Article may be issued to a distributor entered in the Register of Distributors and Importers that meets the requirements in respect of facilities, equipment, education degree and professional capacity of employees.
Decision referred to in paragraph 1 shall be final and an administrative dispute may be instigated against it.
The Minister shall prescribe the requirements in respect of facilities, equipment and education degree of employees referred to in paragraph 2 of this Article.
The Minister shall, with the consent of the minister responsible for environmental protection, prescribe the program for professional education of employees referred to in paragraph 2 of this Article.
Transportation and Warehousing of Plant Protection Products Article 36
Plant protection product may be transported and warehoused in a manner that does not adversely affect the life and health of humans and animals and the environment, and in the conditions ensuring the maintenance of unaltered physical and chemical properties and the fitness for application of plant protection products.
It shall be prohibited to sell, warehouse or transport plant protection products in the same premises with the food or feed.
The persons warehousing the plant protection products must have a professional capacity for the performance of such tasks.
The Minister shall, with the consent of the minister responsible for environmental protection, prescribe the requirements and the manner of warehousing the plant protection products, as well as the program of professional education of persons performing the warehousing of plant protection products.
Plant Protection Products with the Expired ‘Use Before’ Date Article 37
It shall be prohibited to place into circulation the plant protection products whose ‘use before’ date has expired.
Plant protection products whose ‘use before’ date has expired may be applied only if, based on the relevant sample testing, it is found that chemical and physical characteristics of the samples are identical to the conditions specified in the decision on registration.
The Minister shall issue a decision approving the application of plant protection products whose ‘use before’ date has expired.
The decision of the Minister referred to in paragraph 3 shall be final and an administrative dispute may be instigated against it.
Advertising of Plant Protection Products
Article 38
Registered plant protection products may be advertised and exhibited in accordance with the intended use specified in the decision on registration.
The Minister shall, with the consent of the minister responsible for trade, prescribe the manner of advertising and exhibiting the registered plant protection products.
V. IMPORTATION OF PLANT PROTECTION PRODUCTS, ACTIVE
SUBSTANCES AND/OR BASIC SUBSTANCES
Requirements for Importation of Plant Protection Products,
Active Substances and/or Basic Substances
Article 39
Registered plant protection products may be imported in the Republic of Serbia.
Active substances and/or basic substances entered in the List of Approved Substances and used for the production of registered plant protection products may be imported in the Republic of Serbia.
The importation of registered plant protection products may be performed by a legal person or entrepreneur that is entered in the Register of Economic Operators in accordance with the law governing the registration of economic operators and entered in the Register of Distributors and Importers.
The importation of active substances and/or basic substances that are entered in the List of Approved Substances and used for the production of registered plant protection products may be performed by a manufacturer which has corporate domicile in the Republic of Serbia.
Provisions of this Article shall not apply to the importation of plant protection products and active substances and/or basic substances referred to in Article 4 paragraph 2 of this Law.
Border Crossings
Article 40
Importation and transit of plant protection products and active substances and/or basic substances (hereinafter referred to as: the shipment) may be performed through border crossings with organized phytosanitary inspection and which comply with the hygienic-technical and operational requirements.
Notwithstanding paragraph 1 of this Article, the importation of shipments may be performed through a border crossing without organized phytosanitary inspection which is, by the decision of the Minister, temporarily opened for this purpose.
If a shipment arrives to the border crossing which is not designated for the performance of phytosanitary control, the customs authority shall refer such shipment to the nearest border crossing with organized phytosanitary inspection.
The Minister shall designate the border crossings referred to in paragraph 2 of this Article.
The Minister shall prescribe the hygienic-technical and operational requirements to be met by the border crossings referred to in paragraphs 1 and 2 of this Article.
Control and Sampling of the Shipment on Importation
Article 41
The shipments on importation shall be subject to:
1) Control that includes: identification of the shipment, control of the documentation, packaging, means of transportation and shipment, and
2) Sampling.
The importer or customs agent shall:
1) Notify the arrival of shipment to the phytosanitary inspector;
2) submit an application for control of the shipment within the prescribed period;
3) provide for the conditions necessary for the performance of shipment control;
4) Implement all the measures instructed by the phytosanitary inspector.
Customs authority may not undertake any actions prescribed by the rules of a relevant customs procedure, with the exception of the shipments in transit, before the phytosanitary inspector completes the shipment control and sampling.
For the shipments in transit with reloading in the territory of the Republic of Serbia, the customs agent shall be obliged to notify the arrival of the shipment to the phytosanitary inspector, for the purpose of its recording.
The Minister shall prescribe the requirements and the manner of performing the shipment control and sampling, the manner of submitting samples and the number and size of samples for the purpose of testing, the manner of notifying the arrival of shipment, the form and content of the application for shipment control and the conditions to be provided by the importers for the purpose of performing phytosanitary control.
Control of Shipments in the Customs Office of Destination
Article 42
If it is not possible to perform shipment control and/or sampling at the border crossing in accordance with this Law, the shipment control and/or sampling may be performed at the specific places within the Republic of Serbia, in the customs office of destination.
In the event referred to in paragraph 1 of this Article, the phytosanitary inspector shall issue a decision on transportation based on which the shipment is allowed to pass to the customs office of destination, where such shipment shall remain under the customs supervision until the shipment control and/or sampling is completed, namely its importation approved or rejected.
Any relocation, opening, dividing or sampling of the shipment referred to in paragraph 2 of this Article shall be prohibited.
Approval and Prohibition of Importation
Article 43
Phytosanitary inspector shall submit the samples taken from the shipment to the Legal Person Performing the Tasks of Public Interest for the purpose of testing of chemical and physical properties.
If the results of control and/or laboratory testing are in accordance with the prescribed requirements, the phytosanitary inspector shall issue a decision approving the importation of shipment.
If the results of control and/or laboratory testing are not in accordance with the prescribed requirements, the phytosanitary inspector shall issue a decision prohibiting the importation of the shipment and order its return or temporary seizure.
Against the decision referred to in paragraphs 2 and 3 of this Article an appeal may be lodged with the Minister within eight days from the day of submitting the decision.
The appeal shall not stay the execution of the decision.
The decision of the Minister on the appeal shall be final and an administrative dispute may be instigated against it.
The temporarily seized shipment shall be treated in accordance with the law governing the conditions for performance of the circulation of goods, performance of services in the circulation of goods and inspection supervision.
VI. APPLICATION OF PLANT PROTECTION PRODUCTS
Requirements for the Application of Plant Protection Products Article 44
Plant protection products must be applied:
1) in accordance with the decision on registration, namely in accordance with the decision referred to in Article 21 of this Law or decision referred to in Article 26 of this Law, as well as the decision referred to in Article 27 of this Law;
2) In accordance with the declaration and instructions for use;
3) In accordance with the principles of good agricultural practice and integral plant protection;
4) In accordance with its intended use and focused on suppression target;
5) In a manner that does not adversely affect health of humans and animals and unnecessarily increase their exposure to the products;
6) In a manner that is not harmful to the environment.
The data referred to in paragraph 1 items 1) and 2) of this Article must be available to the user of products.
The Minister shall prescribe the elements of integral plant protection.
Prohibition of the Application of Plant Protection Products Article 45
It shall be prohibited to apply the plant protection products: 1) In a manner that would cause contamination of the facilities and premises used by people or used for raising and keeping of animals;
2) In a manner that would cause contamination of waters and surfaces bordering with the treated surfaces;
3) For suppression of untargeted organisms, disruption of their habitat, and/or prevention of their expansion in the context of plant protection measures;
4) Within the water protection zones for water sources and water supply for the population;
5) Poisonous for the bees, from the aircraft;
6) Poisonous for the bees during the plant flowering period;
7) In the protected natural areas;
8) That contains active substance and/or basic substances entered in the List of Prohibited Substances.
Notwithstanding paragraph 1 items 4) and 7) of this Article, plant protection products may be used only in the event of the suppression of quarantine or regulated non-quarantine harmful organisms or other harmful organisms, based on the consent of the Ministry in case from paragraph 1 item 4 of this Article, that is under the ministry responsible for environmental protection, under the conditions referred to paragraph 1 item 7 of this Article. In case of the application of plant protection products in protected areas, after obtaining the consent of the competent Ministry for the Environment referred to in paragraph 2 of this Article, legal persons who made the application plant protection products must inform the manager of protected natural areas on the implementation of the following plant protection products at least 48 hours before applying.
Notwithstanding paragraph 1 item 6) of this Article, plant protection products may be applied only in the event of the suppression of harmful organisms from the prescribed lists or in the event of treating the plants, plant products and prescribed objects under the conditions referred to in Article 49 of this Law.
Obligations of the Users of Plant Protection Products
Article 46
The user of plant protection products must have a professional capacity for the application of such products.
The user of plant protection products shall be responsible for all activities and precautionary measures in respect of the application of plant protection products, which are related to the health of humans and animals and the environment.
The user of plant protection products shall notify the owners of the parcels of land bordering the parcel of land that is to be treated, at least 24 hours before commencement of the application of plant protection products.
The user of plant protection products shall submit to the Ministry the data about harvest of plants which he performs before the expiry of the waiting period.
Plants and plant products referred to in paragraph 4 of this Article, after the harvest, must be warehoused separately from other plants and plant products and may not be used or placed into circulation as food before they are tested and their safety is determined in accordance with the law governing food safety.
The Minister shall prescribe the program of professional capacity building of the users of plant protection products.
Application of Particularly Dangerous Plant Protection Products
Article 47
Registered plant protection products that are classified as particularly dangerous are not intended for general use and may not be applied by any person not holding the decision on the approval of application, which is issued by the Minister.
The decision referred to in paragraph 1 of this Article may be issued to a legal person or entrepreneur that meets the requirements in respect of facilities, equipment, education degree and professional capacity of employees.
The application of registered plant protection products referred to in paragraph 1 of this Article must be notified to the Ministry and the local self-government authority at least 48 hours before the treatment, except in the event of a sudden occurrence of harmful organisms, when the treatment may be notified immediately before the application.
A notification of the application of registered protection products referred to in paragraph 1 of this Article shall contain the data about:
1) Location on which the plant protection product shall be applied;
2) Name of the plant protection product;
3) Quantity and concentration of the application of the plant protection product which will be applied;
4) Manner of application of the plant protection product;
5) Date and, if possible, time of the application of the plant protection product;
6) anticipated duration of application;
7) Name and address of a legal person or entrepreneur that shall perform the application, with the data on the name and surname and address of the employees that will directly perform the application.
The decision of the Minister referred to in paragraph 1 of this Article shall be final and an administrative dispute may be instigated against it.
The Minister shall prescribe the requirements in respect of the facilities, equipment and education degree referred to in paragraph 2 of this Article.
The Minister, with the consent of the minister responsible for environmental protection, shall prescribe the program of professional capacity building referred to in paragraph 2 of this Article.
Application of Plant Protection Products from the Aircraft
Article 48
The application of plant protection products from aircraft shall be allowed only for such plant protection products for which it was assessed in the registration procedure that they may be applied from aircraft and if this method of application is allowed by the decision on registration.
The application of plant protection products from aircraft must be notified to the local self-government authority by the person applying such products at the least 48 hours before the commencement of treatment.
Local self-government authority shall inform the bee keepers or their associations, the users of hunting grounds, the managers or owners, users and lessees of land in the protected natural areas and the persons registered for production and fish farming, fertilized fish eggs and fish young of the notification of the application of plant protection products.
Protection of Bees, Vertebrates and Aquatic Organisms
Article 49
Plant protection products which are poisonous for bees may be applied under the following conditions:
1) that the persons applying plant protection products have notified, 48 hours before the treatment, bee keepers, their associations and local self-government authorities about the pending application of plant protection products, indicating the application method, with the aim of undertaking the relevant measures of protection;
2) That bee societies are located at a distance of at least five kilometers from the site of treatment, so that bee societies can be relocated into a zone that is safe for bees.
Upon receiving the notification referred to in paragraph 1 item 1) of this Article, bee keepers, their associations and local self-government authorities shall undertake relevant measures of protection, in accordance with local conditions, on the sites where bee societies are located or where grazing lands are located which are visited by bees and in which bees fly in very large numbers, and forward the data on the undertaken measures to the persons applying the plant protection products that are poisonous for bees, at their request.
The plant protection products which are particularly dangerous for land vertebrates may be applied only if the users of hunting grounds, the managers or owners, users and lessees of land in the protected natural areas and the Ministry are notified about their pending application at the least 72 hours before the treatment, with the aim of undertaking the relevant measures of protection.
The plant protection products which are classified and labeled by the mark for the risk to the aquatic environment and aquatic organisms may be applied only at a distance not less than one kilometer from the aquatic surfaces, thus excluding any possibility of their direct contact with or shift to the aquatic surfaces by the wind or rain.
The Minister shall, with the consent of the minister responsible for environmental protection, prescribe the requirements for the protection of bees, vertebrates and aquatic organisms and other untargeted organisms in the course of application of plant protection products.
Application Appliances
Article 50
Application appliances may be placed into circulation and used if, in accordance with their intended use, they provide safe and efficient application and safety for operators, working and living environment.
The application appliances placed into circulation and the application appliances in use must be subject to control testing and visibly designated by a mark.
The Minister shall prescribe the manner of labeling and the content of the mark of application appliances.
Control Testing
Article 51
Appliances for the application that are used and placed on the market must be subjected to control testing and visibly marked label. Control testing, for the purposes of this Law, shall mean the verification of the good technical condition and functionality of application appliances and individual operating parts, the assessment of the functioning of individual operating parts and application appliances as a whole, as well as the assessment of the risk which their use may present to the operator and the working and living environment.
Control testing of application appliances shall be performed by the Legal Person Performing the Tasks of Public Interest.
The Legal Person Performing the Tasks of Public Interest shall, upon the completion of control testing, issue a certificate on the functionality of the application appliance, label the application appliance with the mark and keep records of the control testing.
The Legal Person Performing the Tasks of Public Interest shall submit to the Ministry, on a three-month basis, the data from the records of control testing.
The Minister shall prescribe the method of control testing, deadlines for control testing, the content of the certificate on functionality of application appliances, form for the records of control testing, as well as the application appliances for which control testing is not required.
Products Residues
Article 52
The residues of products in food and feed may not be present in the quantities exceeding the maximum allowed quantity.
The food and feed for which it is determined that the residues of products exceed the maximum allowed quantity of residues must be destroyed or their use for human or animal consumption otherwise prevented.
The Minister shall, with the consent of the minister responsible for health, prescribe the maximum allowed quantities of residues in food and feed, and food and feed for which the maximum allowed quantities of residues are to be determined.
The Minister shall prescribe the sampling and testing methods for the purpose of determining residues in food and feed.
VII. SERVICES RELATED TO PLANT PROTECTION PRODUCTS
Service Providers
Article 53
Services related to the plant protection products, for the purposes of this Law, shall include:
1) Consultancy services related to the provision of recommendations for the suppression of
harmful organisms on plants, plant products and prescribed objects using plant protection
products;
2) Operational services related to the implementation of measures for suppression of
harmful organisms using plant protection products.
The services related to the plant protection products may be performed by a legal person or entrepreneur that is entered in the Register of Economic Operators in accordance with the law governing registration of economic operators and that is entered in the Register of Service Providers in the Area of Plant Protection Products (hereinafter referred to as: the Register of Service Providers), which is kept by the Ministry.
Entry in the Register of Service Providers
Article 54
Entry in the Register of Service Providers shall be conducted on the basis of an application submitted by the service provider to the Ministry.
A service provider shall be entered in the Register of Service Providers if it complies with the requirements in respect of facilities, equipment and professional capacity of employees, and if employing at least one bachelor of engineering in plant protection and/or one master of engineering with a license to provide services related to plant protection products.
The Minister shall issue a decision verifying compliance with the requirements referred to in paragraph 2 of this Article.
The Minister shall issue a decision on entry in the Register of Service Providers.
The decision of the Minister referred to in paragraphs 3 and 4 of this Article shall be final and an administrative dispute may be instigated against it.
The Minister shall prescribe the requirements in respect of the facilities, equipment and professional capacity building program for the employees, as well as the form and content of the application referred to in paragraph 1 of this Article.
Register of Service Providers
Article 55
The Register of Service Providers shall in particular include:
1) Number of the entry in the Register of Service Providers;
2) Number from the Register of Economic Operators;
3) Name, corporate domicile and code of business activity;
4) Fiscal identification number.
The Register of Service Providers shall be kept in electronic format and it may be linked with other registers and databases kept by the Ministry.
The data from the Register of Service Providers shall be publicly available.
Service provider shall be obliged to notify the Ministry of any change in the data entered in the Register of Service Providers within 30 days from the day the change has occurred.
The Minister shall prescribe the content of the Register of Service Providers.
Removal from the Register of Service Providers
Article 56
A service provider shall be removed from the Register of Service Providers
if:
1) It no longer complies with the requirements referred to in Articles 53 paragraph 2 and 54 paragraph 2 of this Law;
2) It fails to notify the change in data referred to in Article 55 paragraph 4 of this Law within the deadline;
3) It submits an application for the removal from the Register of Service Providers.
Removal from the Register of Service Providers shall be conducted based on a decision issued by the Minister.
The decision of the Minister referred to in paragraph 2 of this Article shall be final and an administrative dispute may be instigated against it.
License for Provision of Services Related to Protection Products
Article 57
The Ministry shall issue license for provision of services related to plant protection products for the period of three years.
License for provision of services related to plant protection products shall be issued to a person who is a bachelor of engineering in plant protection and/or a master of engineering, who has been performing the tasks related to plant protection products for at least three years and who has successfully passed the exam in the area of plant protection products (hereinafter referred to as: the license holder).
Professional examinations in the area of plant protection products shall be taken before a commission established by the Minister.
The decision on license referred to in paragraph 1 of this Article shall be final and an administrative dispute may be instigated against it.
The Minister shall prescribe the program and the manner of taking the professional examination, the form of the application for taking the professional examinations, the form of the minutes on taking the professional examinations and the form of the certificate stating that the professional examinations have been successfully passed.
Renewal of the License for Provision of Services
Article 58
License for provision of services related to plant protection products may be renewed based on the application of the license holder, at the least 90 days before the expiry of the validity of such license.
License for provision of services related to plant protection products may be renewed based on:
1) Verification of the expert knowledge of the holder of license for provision of services related to plant protection products;
2) Verification of the performance of the holder of license for provision of services related to plant protection products in the period for which the license was issued.
Decision from paragraph 1 of this Article shall be final and administrative dispute may be instigated against it.
The Minister shall prescribe the manner and procedure for verifying the expert knowledge and verifying the performance of the holder of license for provision of services related to plant protection products.
Withdrawal of License for Provision of Services
Article 59
License for provision of services related to plant protection products shall be withdrawn:
1) At the request of the license holder;
2) If the license holder has been penalized for an offense prescribed by this Law.
Decision referred to in paragraph 1 of this Article shall be final and administrative dispute may be instigated against it.
Records on Licenses for Provision of Services Article 60
The Ministry shall keep the records on the issued, renewed and withdrawn licenses.
The Minister shall prescribe the manner of keeping the records referred to in paragraph 1 of this Article.
VIII. EXPERT COUNCIL FOR PLANT PROTECTION PRODUCTS
Setting up
Article 61
For the purpose of considering the professional matters, providing the expert opinions and participating in the execution of projects related to plant protection products, the Minister shall, in accordance with the regulations governing state administration, issue a decision establishing a special working group – the Expert Council for Plant Protection Products (hereinafter referred to as: the Expert Council).
Members of the Expert Council may not be in the conflict of interest with the manufacturers of plant protection products, the Reference Laboratory and the Legal Person Performing the Tasks of Public Interest.
The members of the Expert Council must sign the statement on nonexistence of the conflict of interest.
Tasks of the Expert Council
Article 62
The Expert Council shall consider the professional matters, provide expert opinion and take part in the execution of the projects related to:
1) Procedure of the registration of plant protection products;
2) Testing of plant protection products;
3) Application of plant protection products;
4) Plans and specific programs related to plant protection products;
5) Provision of recommendations for the professional capacity building of employees;
6) Provision of recommendations for drafting the legislation related to plant protection products;
7) Performance of other necessary tasks in connection with the plant protection products.
IX. PROFESSIONAL EDUCATION
Further Education
Article 63
Persons employed with the Ministry that perform tasks related to plant protection products, as well as the persons employed with the Reference Laboratory and the Legal Person Performing the Tasks of Public Interest shall be subject to the prescribed verification of professional knowledge within programs adopted by the Ministry.
X. RECORDS, DATA COLLECTION AND EXCHANGE
Record-Keeping and Reporting
Article 64
A manufacturer which has corporate domicile in the Republic of Serbia, distributor, user of plant protection products and services provider shall be obliged to keep records of the plant protection products.
A manufacturer which has corporate domicile in the Republic of Serbia shall keep records about the quantity of:
1) The plant protection products produced warehoused and placed into circulation, for each production series;
2) The active substances and/or basic substances procured;
3) The plant protection products, active substances and/or basic substances withdrawn from the circulation.
Distributor shall keep records of the quantity of the plant protection products procured, sold and withdrawn from the circulation.
The user of plant protection products shall keep records of each treatment of plants, plant products and prescribed objects.
Services provider shall keep records of the services provided.
The data from the records referred to in paragraphs 2, 3 and 5 of this Article shall be submitted to the Ministry twice a year for the current year, by March 31 and by September 30.
The data from the records referred to in paragraph 4 of this Article shall be submitted to the Ministry by March 31 of current year for the preceding calendar year.
The records from paragraphs 2, 3, 4 and 5 of this Article shall be kept for at least five years.
The Minister shall prescribe the form, content and manner of keeping the records from paragraphs 2, 3, 4 and 5 of this Article
Data Collection and Communication
Article 65
For the purpose of analyzing and monitoring the circulation and application of plant protection products and efficient supervision over the circulation and application of plant protection products, the Ministry shall collect the data on plant protection products, residues of plant protection products and application appliances, which are necessary for the setting up and maintaining of databases and record-keeping.
The databases referred to in paragraph 1 of this Article must be linked with the Register of Agricultural Households that is kept by the Ministry.
Information System
Article 66
The Ministry shall set up and maintain the information systems related to plant protection products.
Reference Laboratory, Legal Person Performing the Tasks of Public Interest, as well as the manufacturer which has corporate domicile in the Republic of Serbia, distributor, user of plant protection products and services provider shall submit the records they are keeping to the Ministry, for the purpose of their harmonization and linking with the information system of the Ministry.
The Ministry shall ensure the harmonization and linking of the information system related to plant protection products with other domestic and international information systems related to plant protection products.
Setting up and maintaining of the information system related to plant protection products shall be funded from the budget of the Republic of Serbia.
Data Exchange
Article 67
The Ministry shall obtain, use and exchange data from the databases and records kept by the state administration authorities, local self-government authorities, institutions, manufacturers and distributors of plant protection products, as well as other authorized persons, in accordance with the regulations governing the right of access to the information of public importance and data protection, and particularly the data related to the area of dangerous substances and environmental polluters and ecologically significant regions.
Personal data from the databases and records referred to in paragraph 1 of this Article may be requested and communicated only by the responsible authorities, in accordance with the law governing the protection of personal data.
The Ministry may communicate data from the databases and registers kept by other state administration authorities or local self-government authorities provided such type of data is necessary for performance of activities of the Ministry prescribed by this Law.
The Ministry may communicate data from the databases and registers kept by the public institutions responsible for acute poisoning and other effects of the products and Legal Persons Performing the Tasks of Public Interest, provided such type of data is necessary for performance of activities of the Ministry.
International Exchange of Information
Article 68
The Ministry shall perform the international exchange of information, which shall particularly include the information about:
1) registered plant protection products;
2) Active substances and/or basic substances;
3) The cessation of validity of the decision on registration;
4) The prohibitions and restrictions of the circulation and application of plant protection products;
5) The list of border crossings through which importation may take place;
6) The systematic monitoring of residue;
7) Shipments which, due to noncompliance with the provisions of this Law, are prohibited for importation at the request of international bodies and organizations;
8) Other data concerning the plant protection products, active substances and basic substances.
In the exchange of information referred to in paragraph 1 of this Article, compliance must be ensured with the agreements binding for the Republic of Serbia and the rules of EU Member States, the Code of the Food and Agriculture Organization of the United Nations (FAO), the rules of the European and Mediterranean Plant Protection Organization (EPPO), the World Trade Organization (WTO), as well as other relevant regional and international institutions and organizations.
XI. FUNDS FOR IMPLEMENTATION OF THE LAW
Article 69
The funds for the performance of the tasks of public interest shall be provided from the budget of the Republic of Serbia.
Article 70
Legal person, entrepreneur or shall pay a compensation for:
1) The registration and/or assessment of the plant protection product, active substance and/or basic substance;
2) The control, sampling and laboratory testing of samples of plant protection products performed at their request;
3) The control, sampling and laboratory testing of the products residue in food, feed and the environment performed at their request;
4) The control for the issuance of a decision on approval of testing of nonregistered plant protection products for the research and development purposes;
5) The control of shipments on importation;
6) The control for the purpose of verifying the compliance with the requirements for the performance of circulation;
7) The control for the purpose of verifying the compliance with the requirements for issuance of the decision for approval of the circulation of particularly dangerous plant protection products;
8) The testing of plant protection products whose “use before” date has expired with aim of its application;
9) The control for the purpose of verifying the compliance with the requirements for issuance of the decision on approval of the application of dangerous plant protection products;
10) The control testing of application appliances and issuance of the certificate of functionality and the mark;
11) The control for the purpose of defining the requirements for provision of services;
Natural person shall pay compensation for:
1) The control, sampling and laboratory testing of samples of plant protection products performed at their request;
2) The control, sampling and laboratory testing of the products residue in food, feed and the environment performed at their request;
3) The control for the purpose of verifying the compliance with the requirements for issuance of the decision for approval of the circulation of particularly dangerous plant protection products;
4) The issuance of licenses for the provision of services in the area of plant protection products;
5) Professional training and testing and issuance of certificates.
The funds obtained from the compensations referred to in paragraph 1 of this Article shall be the revenue of the Republic of Serbia and shall be kept on the separate account in the budget of the Republic of Serbia.
The level of compensations referred to in paragraph 1 of this Article shall be specified by the Government.
Article 71
The costs of the administrative procedure shall be borne by the applicant, in particular for:
1) The issuance of the decision on registration;
2) The cancellation of the decision on registration, at its request;
3) The amendment of the decision on registration due to minor changes in the formulation of plant protection products;
4) The decision on approval of testing of non-registered plant protection product or active substance and/or basic substance not entered in the List of Approved Substances for the research or development purposes;
5) The decision on approval of the application of non-registered plant protection product in the cases of emergency;
6) The request for the control of shipment on importation;
7) The entry in the Register of Distributors and Importers;
8) The entry in the Register of Service Providers;
9) The removal from the Register of Distributors and Importers, at its request;
10) The removal from the Register of Service Providers, at its request;
11) The submittal of data.
The funds referred to in paragraph 1 of this Article shall be paid by the applicant to a relevant account for payment of public revenues of the budget of the Republic of Serbia.
The level of costs shall be determined in accordance with the regulations on the compensation for the costs in the administrative procedure.
XII. SUPERVISION
Inspection Supervision
Article 72
Inspection supervision over the application of the provisions of this Law and regulations adopted based on this Law shall be performed by the Ministry through phytosanitary inspectors.
The tasks of the phytosanitary inspector related to plant protection products may be performed by a bachelor engineer of plant protection and/or master engineer, who has at least three years of working experience and who has successfully passed the state professional examination.
Identification Document, Mark and the Uniform
Article 73
In the performance of inspection supervision tasks, the phytosanitary inspector must have the official identification document and the uniform, and phytosanitary inspector at the border must also have a special mark.
The Minister shall prescribe the form and content of the official identification document, the appearance of uniform and shape of the mark referred to in paragraph 1 of this Article, as well as the manner of keeping records of the issued identification documents.
Rights and Duties of the Phytosanitary Inspector
Article 74
In performance of the inspection supervision tasks, the phytosanitary inspector shall have the right and duty to:
1) check whether the plant protection product is registered for placement into circulation in the territory of the Republic of Serbia and whether the active substance and/or basic substance is entered in the List of Approved Substances, in accordance with this Law;
2) check whether the plant protection products that are not registered in the Republic of Serbia and whether active substances and/or basic substances that are not entered in the List of Approved Substances, which are produced and warehoused in the Republic of Serbia or imported and transported in the Republic of Serbia or from the Republic of Serbia, are intended for placement into circulation in the country of export;
3) Check whether contractual obligations referred to in Article 8 of this Law are fulfilled;
4) Check whether a plant protection product is placed into circulation or applied in accordance with the decision referred to in Article 21 paragraph 5 of this Law;
5) Check whether the users of plant protection products are notified in an adequate manner of the application of plant protection products for small crops and purposes of lesser importance;
6) check whether a plant protection product is circulated after the prescribed period referred to in Article 23 paragraph 2 of this Law.;
7) Check whether a preparation or ancillary product is circulated after the prescribed period referred to in Article 25 paragraphs 6 this Law;
8) Check whether the stocks of plant protection products, preparations or ancillary plant protection products are handled in appropriate manner;
9) check whether the manufacturer, importer or distributor undertakes all necessary measures for withdrawing plant protection products from the circulation in accordance with Article 23 paragraph 1 and Article 25 paragraphs 4 and 5 of this Law;
10) check whether the plant protection product that are not registered, or the active substance and/or basic substance that is not entered in the List of Approved Substances are tested in accordance with the decision on approval of testing for the research or development purposes referred to in Article 26 paragraph 1 of this Law;
11) Check whether the plant protection product is applied in accordance with the decision on application of non-registered plant protection products in the cases of emergency referred to in Article 27 of this Law;
12) take the samples of plant protection products, plants, plant products, and prescribed objects, without compensation, as well as waters and soil for the purpose of testing;
13) check whether the manufacturer without delay has informed the Ministry and the users about the possible harmful consequences of the plant protection products, that is residues of plant protection products for the health of humans and animals, surface and underground water or the environment, as well as new insights about the possible limitations of the crops rotation 14) check the compliance with requirements in respect of packaging, declaration and instructions for use of plant protection products in accordance with Article 32 paragraph 2 of this Law;
15) Check whether the distributor/ importer, is entered in the Register of Distributors and Importers in accordance with Article 32 paragraph 2of this Law;
16) Check whether distributor/importer entered in the Register of Distributors and Importers complies with the requirements for obtaining approval for circulation of particularly dangerous plant protection products in accordance with Article 36 of this Law;
17) Check whether the sale, warehousing or transportation of plant protection products is conducted in accordance with the provisions of Article 36 of this Law;
18) Check whether the person who performs warehousing of plant protection products complies with the requirements in accordance with Article 36 paragraph 3 of this Law;
19) check whether the plant protection products whose “use before” period has expired are in the circulation;
20) Check whether plant protection products are advertised and exhibited in accordance with Article 38 of this Law;
21) check whether importation is performed in accordance with Article 38 of this Law;
22) Check whether importation and transit are performed at border crossings referred to in Article 40 of this Law;
23) perform the control and sampling of shipments in accordance with Articles 41 and 42 of this Law;
24) Check the performance of obligations of the importer and customs agent in accordance with Article 41 paragraph 2;
25) Check whether plant protection products are applied in accordance with Articles 44 and 45, and whether the user performs the obligations referred to in Article 46 paragraphs 2 and 3 of this Law;
26) check whether the user submits to the Ministry the data about the harvest before the expiry of the waiting period, and whether it warehouses such plants or plant products separately from other plants and plant products or places them into circulation before testing and determining their safety;
27) check whether the legal person or entrepreneur complies with the requirements for obtaining the approval for application of particularly dangerous plant protection products;
28) Check whether the application of plant protection products is performed in accordance with Article 47 paragraph 3, Articles 48 and 49 of this Law;
29) Check the compliance with the requirements for placement into circulation and use of application appliances referred to in Article 51 paragraph 1 of this Law;
30) check whether food and feed contain the residue of plant protection products;
31) check whether services provider is entered in the Register of Services Providers in accordance with Article 54 of this Law;
32) Check the operation of the holder of license for provision of services related to plant protection products;
33) check whether records and submittal of data from records are conducted in accordance with Article 64 of this Law;
34) check whether the records are kept in accordance with this Law;
35) Check whether the compensations for performed phytosanitary control of shipments in circulation are paid;
36) Control the implementation of measures pursuant to this Law.
Measures Instructed by the Phytosanitary Inspector
Article 75
In the performance of tasks referred to in Article 74 of this Law, the phytosanitary inspector may:
1) prohibit the production, placement into circulation and application of the plant protection product if it is not registered, circulation and application of plant protection products which are banned or limited by the decision referred to in Article 23 paragraph 1 of this Law and plant protection product if its “use before” date has expired;
2) prohibit the production, placement into circulation and application of the plant protection product if it is not declared and labeled, and if it is not applied in conformity with the requirements from the decision on registration;
3) Prohibit the application of the plant protection product which is harmful for bees, when the product is not applied in accordance with Article 49 of this Law;
4) order appropriate measures, if it is found in official testing that product residue in plants or on plants, plant products and prescribed objects exceeds the prescribed maximum allowed quantity of residue;
5) prohibit testing of non-registered plant protection product or active substance and/or basic substance not entered in the List of Approved Substances, when the requirements are not met for the approval of testing of non-registered plant protection product or active substance and/or basic substance not entered in the List of Approved Substances for the research or development purposes or other requirements prescribed by this Law and regulations adopted based on this Law;
6) propose to the Ministry cancellation of the decision on registration of the plant protection product;
7) temporarily prohibit placement into circulation and application of plant protection products, and/or their series (charges, lots) for which it is suspected that they do not comply with the requirements specified in the decision on registration, until the completion of testing;
8) prohibit placement into circulation and application of plant protection products which do not meet the requirements specified in the decision on registration;
9) temporarily seize plant protection product which is produced, placed into circulation or applied contrary to the requirements prescribed by this Law and regulations adopted based on this Law;
10) order safe disposal or destruction of flawed plant protection products;
11) Temporarily prohibit placement into circulation or use of application appliances and order their control testing;
12) order the Legal Persons Performing the Tasks of Public Interest and services providers to eliminate the deficiencies within a specified period, in order to ensure compliance with this Law and regulations adopted based on this Law;
13) Prohibit the performance of activity in the domain of plant protection products until the requirements for performance of such activity are met;
14) prohibit the Legal Persons Performing the Tasks of Public Interest to perform their activity for the period of three months, if they do not perform the testing in accordance with the requirements, standards and methods prescribed by this Law and regulations adopted based on this Law;
15) Prohibit performing of the business activity for the period of three months to the persons that fail to allow inspection control or to submit the required data, the documentation they have available or in any other manner prevent inspection control;
16) Prohibit the importation, order the return to the sender or temporarily seize the shipment, if the requirements prescribed by this Law and regulations adopted based on this Law are not met;
17) Instigate criminal or offense proceedings before the responsible authorities against persons that have violated the provisions of this Law and the regulations adopted based on this Law.
Phytosanitary inspector shall issue a decision to specify the measures referred to in paragraph 1 of this Article.
Phytosanitary inspector may determine in a decision referred to in paragraph 2 of this Article, whereby the production, application and placement into circulation of the plant protection product is prohibited, that such a product be kept by the person with whom it was found.
Decision referred to in paragraph 2 of this Article shall also specify the conditions for its keeping.
Obligations of Persons Subject to
Inspection Supervision
Article 76
The manufacturer, distributor, importer, user of plant protection products and services provider which are subject to inspection supervision shall be obliged to allow such supervision, provide the data and notifications and provide the conditions for the unimpeded operation of the phytosanitary inspector.
The persons referred to in paragraph 1 of this Article shall be obliged to, within a specified period, at the request of phytosanitary inspector, submit or prepare data and the material necessary for the performance of inspection supervision tasks.
The period referred to in paragraph 2 of this Article must be appropriate for the type of request.
Responsibility for Settlement of Appeals
Article 77
Against the decision of phytosanitary inspector an appeal may be filed with the Minister within eight days from the day of submitting the decision. The Minister shall decide on the appeal within 30 days from the day of submitting the appeal.
The appeal shall not stay the execution of the decision.
The decision of the Minister on the appeal referred to in paragraph 1 of this Article shall be final and an administrative dispute may be instigated against it.
XIII. PENAL PROVISIONS
Criminal Offense
Article 78
Anyone who produces, places into circulation or applies a non-registered plant protection product or active substance and/or basic substance which is entered in the List of Prohibited Substances, or produces, places into circulation or applies a product for which the prohibition of production, placement into circulation or application is in place, and thus causes harmful effects to human health and the environment, shall be punished by imprisonment of up to one year.
If, due to the action referred to in paragraph 1 of this Article, a significant damage has occurred, the offender shall be punished by the imprisonment of up to three years.
If the action referred to in paragraph 1 of this Article is committed unintentionally, the offender shall be fined or punished by the imprisonment of up to one year.
Commercial Offense
Article 79
A legal person shall be fined in the amount of RSD 700,000 to RSD 3,000,000 for commercial offence if:
1) It performs the tasks of public interest and does not hold a contract, or performs them contrary to the contract (Articles 7 and 8);
2) It uses data contrary to the prescribed requirements referred to in Article 18 of this Law;
3) It does not perform placement of plant protection products into circulation and application thereof in accordance with the decision on registration (Article 20);
4) it conducts testing of non-registered plant protection products or active substances and/or basic substances not entered in the List of Approved Substances without the decision on approval of testing for the research or development purposes or contrary to that decision (Article 26);
5) In the events provided in Article 27 of this Law, it applies the plant protection product that is not registered without a decision on approval of the application of non-registered plant protection product;
6) It places into circulation a plant protection product whose “use before” date has expired contrary to Article 37 paragraphs 1 and 3 of this Law;
7) It applies a plant protection product whose “use before” date has expired contrary to Article 37 paragraph 2 of this Law;
8) It applies plant protection product contrary to Article 44 of this Law, or contrary to the prohibition of application of plant protection products referred to in Article 45 of this Law;
9) it applies plant protection product and does not comply with the requirements for the application of products referred to in Article 46 paragraph 1 of this Law or, when applying the plant protection product, fails to undertake all necessary activities and measures referred to in Article 46 paragraphs 2 and 3 of this Law;
10) it fails to submit to the Ministry the data about any harvesting that it undertakes before expiry of the waiting period in accordance with Article 46 paragraph 4 of this Law or if, after harvesting, warehouses plants or plant products treated before expiry of the waiting period together with other plants or plant products or places them into circulation before testing and determination of their safety contrary to Article 46 paragraph 5 of this Law;
11) It applies the plant protection product without holding the decision on approval of the application of particularly dangerous plant protection product (Article 47 paragraph 1);
12) It applies the plant protection product contrary to the provisions of Article 48 paragraphs 1 and 2 of this Law;
13) it applies the plant protection product which is poisonous for bees contrary to the provision of Article 49 paragraph 1 of this Law,;
14) It applies plant protection products which are classified and marked with the mark for the risk to the aquatic environment and aquatic organisms contrary to the provision of Article 49 paragraph 3 of this Law;
15) The food and feed it places into circulation contains the residue of products above the maximum allowed quantity (Article 52 paragraph 1);
16) It provides services without being entered in the Register of Services Providers (Article 53);
17) It fails to act pursuant to the decision of the phytosanitary inspector, in accordance with this Law (Article 75).
For the commercial offense referred to in paragraph 1 of this Article, a responsible person within the legal person shall also be fined in the amount of RSD 70,000 to RSD 200,000.
For the actions referred to in paragraph 1 of this Article, in addition to the fine, legal person may also be imposed a protective measure of prohibition of performing certain business activity, or the responsible person may be imposed a protective measure of prohibition of performing certain duties, in the duration of six months to seven years.
Offense of a Legal Person
Article 80
A legal person shall be fined in the amount of RSD 500,000 to RSD 1,000,000 for the offense if:
1) it provides incorrect data in procedure of registration of the plant protection product (Articles 12 and 13, Article 21 paragraph 4, Article 24 paragraph 3, Article 25);
2) It performs testing on vertebrates contrary to Article 17 paragraphs 1 and 2 of this Law;
3) it applies plant protection products for the purposes other than those specified in the decision on registration, without the decision on approval of the application of plant protection products for small crops and purposes of lesser importance (Article 21 paragraph 5);
4) It fails to, through additional instructions, inform the users of plant protection products on approval of the application plant protection products for small crops and purposes of lesser importance (Article 21 paragraph 7);
5) It fails to withdraw from the circulation plant protection products within the period referred to in Article 23 paragraph 1 and Article 25 paragraphs 4 and 5 of this Law;
6) It fails to handle the stocks of plant protection products in accordance with Article 23 paragraph 3 and Article 25 paragraph 7 of this Law;
7) it provides incorrect data in the procedure of issuing the decision on approval of testing of non-registered plant protection products or active substances and/or basic substances not entered in the List of Approved Substances for the research or development purposes, or in the procedure of issuing the decision on approval of application of non-registered plant protection products in the cases of emergency (Articles 26 and 27);
8) It fails to notify the Ministry and the users about possible harmful effects of plant protection products (Article 30);
9) It packages, declares, provides instructions for use, advertises or exhibits plant protection product contrary to Article 31 paragraph 3 and Article 38 of this Law;
10) It performs circulation of plant protection products without being entered in the Register of Distributors and Importers in accordance with Article 32 of this Law;
11) it performs circulation of plant protection products without the decision on approval of circulation of particularly dangerous plant protection products referred to in Article 35 paragraph 1 of this Law;
12) It sells, warehouses or transports the plant protection product contrary to Article 36 paragraph 2 of this Law;
13) It fails to provide that warehousing of plant protection product is conducted by a person with the professional capacity for performance of such tasks (Article 36 paragraph 3);
14) It imports the plant protection product through the border crossing other than the one designated by the Minister (Article 40 paragraphs 1 and 2);
15) It imports a shipment without the control and sampling (Article 41 paragraph 1);
16) it performs a relocation, opening or division of a shipment for which customs supervision was designated, by the decision on transportation, until the completion of control and/or sampling and/or approval or rejection of its importation (Article 42 paragraphs 2 and 3);
17) It places into circulation or uses the application appliances contrary to Article 51 paragraph 1 of this Law;
18) It fails to keep records and fails to provide data from the records in accordance with Article 64 of this Law.
A responsible person within the legal person shall also be fined in the amount of RSD 20,000 to RSD 50,000 for the offense referred to in paragraph 1 of this Article.
Offense of an Entrepreneur
Article 81
An entrepreneur that acts as referred to in Article 79 paragraph 1 item 3) and items 5), 6), 7), 8), 9), 10), 11), 12), 13), 14), 15), 16) and 17) of this Law shall be fined in the amount of RSD 300,000 to RSD 500,000 for the offense.
Article 82
An entrepreneur that acts as referred to in Article 80 paragraph 1 items 1), 2), 3), 4), 5), 6), 7), 8), 9), 10), 11), 12), 13), 14), 15), 16), 17) and 18) of this Law shall be fined in the amount of RSD 100,000 to RSD 400,000 for the offense.
Offense of a Natural Person
Article 83
A natural person that acts as referred to in Article 79 paragraph 1 items 7), 8), 9), 10), 11), 12), 13), 14), 15) and 17) of this Law shall be fined in the amount of RSD 35,000 to RSD 50,000 for the offense, as well as if: 1) It applies plant protection product contrary to the prohibitions or restrictions referred to in Article 23 paragraphs 1, 2 and 3 of this Law; 2) It provides services related to plant protection products without a license for provision of services referred to in Article 57 paragraph 1 of this Law.
Article 84
A natural person that acts as referred to in Article 80 paragraph 1 items 3), 4), 17) and 18) of this Law, as well as if it fails to inform the Ministry that a plant protection product is harmful to the health of humans or animals, surface waters or underground waters or the environment in accordance with Article 30 paragraph 2 of this Law shall be fined in the amount of RSD 5,000 to RSD 30,000 for the offense.
XIV. TRANSITIONAL AND FINAL PROVISIONS
Deadline for Harmonization of Business Operations
Article 85
The manufacturer, distributor, importer, user of plant protection products and the services provider shall harmonize their business operations with the provisions of this Law within three years from the day this Law comes into force.
Decisions on Issuance of License for Placement of Pesticides into Circulation
Article 86
The decisions on issuance of license for placement of pesticides into circulation that were issued based on the Law on Plant Protection („Official Gazette of FRY”, No. 24/98 and 26/98-correction and „Official Gazette of RS”, No. 101/05-other law) shall apply until the expiry of the validity period specified in such decisions, and five years from the day this Law comes into force at the latest.
The decisions on issuance of provisional license for placement of pesticides into circulation that were issued based on the Law on Plant Protection („Official Gazette of FRY”, No. 24/98 and 26/98-correction and „Official Gazette of RS”, No. 101/05-other law) shall apply until the expiry of the validity period specified in such decisions, and one year from the day this Law comes into force at the latest.
Performance of the Tasks of Public Interest until the Announcement of Public Bid
Article 87
Legal person that is, based on the Law on Plant Protection („Official Gazette of FRY”, No. 24/98 and 26/98-correction and „Official Gazette of RS”, No. 101/05-other law), authorized for testing of pesticides and control of the pesticide equipment and application appliances, shall continue to perform the tasks for which it was authorized until the completion of the competition for performance of the tasks of public interest, which shall be implemented in accordance with this Law.
Application of By-Laws
Article 88
The regulations to be adopted based on the authorizations referred to in this Law shall be adopted within three years from the day this Law comes into force. Until the adoption of regulations referred to in paragraph 1 of this Article, the regulations adopted based on the Law on Plant Protection („Official Gazette of FRY”, No. 24/98 and 26/98-correction and „Official Gazette of RS”, No. 101/05-other law) shall apply, excluding the provisions of such regulations which are not in accordance with this Law.
Abolishing of Previous Laws
Article 89
On the day this Law comes into force, the provisions of the Law on Plant Protection („Official Gazette of FRY”, No. 24/98 and 26/98-correction and „Official Gazette of RS”, No. 101/05-other law) shall cease to apply in the part governing pesticides, except provision form Article 88 paragraph 3 of this Law.
On the date of entry into force of this law provisions of the Regulations on the line for the production of pesticides (“Official Gazette of the FRY, number 68/01) will cease to apply.
Coming into Force of the Law
Article 90
This Law shall come into force eight days from the day of its publication in the „Official Gazette of the Republic of Serbia”, except for provisions from Article 11 to 25 which will apply from 31st of December 2013.