Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC
Modified by
- Council Regulation (EU) No 518/2013of 13 May 2013adapting Regulation (EC) No 1107/2009 of the European Parliament and of the Council, by reason of the accession of the Republic of Croatia, 32013R0518, June 10, 2013
- Regulation (EU) No 652/2014 of the European Parliament and of the Councilof 15 May 2014laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material, amending Council Directives 98/56/EC, 2000/29/EC and 2008/90/EC, Regulations (EC) No 178/2002, (EC) No 882/2004 and (EC) No 396/2005 of the European Parliament and of the Council, Directive 2009/128/EC of the European Parliament and of the Council and Regulation (EC) No 1107/2009 of the European Parliament and of the Council and repealing Council Decisions 66/399/EEC, 76/894/EEC and 2009/470/EC, 32014R0652, June 27, 2014
- Commission Regulation (EU) 2017/1432of 7 August 2017amending Regulation (EC) No 1107/2009 of the European Parliament and the Council concerning the placing of plant protection products on the market as regards the criteria for the approval of low-risk active substances(Text with EEA relevance), 32017R1432, August 8, 2017
(a) protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products; (b) influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient; (c) preserving plant products, in so far as such substances or products are not subject to special Community provisions on preservatives; (d) destroying undesired plants or parts of plants, except algae unless the products are applied on soil or water to protect plants; (e) checking or preventing undesired growth of plants, except algae unless the products are applied on soil or water to protect plants.
(a) substances or preparations which are added to a plant protection product to eliminate or reduce phytotoxic effects of the plant protection product on certain plants, referred to as "safeners"; (b) substances or preparations which, while showing no or only weak activity as referred to in paragraph 1, can give enhanced activity to the active substance(s) in a plant protection product, referred to as "synergists"; (c) substances or preparations which are used or intended to be used in a plant protection product or adjuvant, but are neither active substances nor safeners or synergists, referred to as "co-formulants"; (d) substances or preparations which consist of co-formulants or preparations containing one or more co-formulants, in the form in which they are supplied to the user and placed on the market to be mixed by the user with a plant protection product and which enhance its effectiveness or other pesticidal properties, referred to as "adjuvants".
1. "residues" means one or more substances present in or on plants or plant products, edible animal products, drinking water or elsewhere in the environment and resulting from the use of a plant protection product, including their metabolites, breakdown or reaction products; 2. "substances" means chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process; 3. "preparations" means mixtures or solutions composed of two or more substances intended for use as a plant protection product or as an adjuvant; 4. "substance of concern" means any substance which has an inherent capacity to cause an adverse effect on humans, animals or the environment and is present or is produced in a plant protection product in sufficient concentration to present risks of such an effect. Such substances include, but are not limited to, substances meeting the criteria to be classified as hazardous in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixturesOJ L 353, 31.12.2008, p. 1 .5. "plants" means live plants and live parts of plants, including fresh fruit, vegetables and seeds; 6. "plant products" means products of plant origin in an unprocessed state or having undergone only simple preparation, such as milling, drying or pressing, but excluding plants; 7. "harmful organisms" means any species, strain or biotype belonging to the animal kingdom or plant kingdom or pathogenic agent injurious to plants or plant products; 8. "non-chemical methods" means alternative methods to chemical pesticides for plant protection and pest management, based on agronomic techniques such as those referred to in point 1 of Annex III to Directive 2009/128/EC, or physical, mechanical or biological pest control methods; 9. "placing on the market" means the holding for the purpose of sale within the Community, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves, but not the return to the previous seller. Release for free circulation into the territory of the Community shall constitute placing on the market for the purposes of this Regulation; 10. "authorisation of a plant protection product" means an administrative act by which the competent authority of a Member State authorises the placing on the market of a plant protection product in its territory; 11. "producer" means a person who manufactures plant protection products, active substances, safeners, synergists, co-formulants or adjuvants on his own, or who contracts this manufacturing to another party, or a person designated by the manufacturer as his sole representative for the purpose of compliance with this Regulation; 12. "letter of access" means an original document by which the owner of data protected under this Regulation agrees to the use of such data under the specific terms and conditions by the competent authority for the purpose of granting an authorisation of a plant protection product or an approval of an active substance, synergist or safener for the benefit of another applicant; 13. "environment" means waters (including ground, surface, transitional, coastal and marine), sediment, soil, air, land, wild species of fauna and flora, and any interrelationship between them, and any relationship with other living organisms; 14. "vulnerable groups" means persons needing specific consideration when assessing the acute and chronic health effects of plant protection products. These include pregnant and nursing women, the unborn, infants and children, the elderly and workers and residents subject to high pesticide exposure over the long term; 15. "micro-organisms" means any microbiological entity, including lower fungi and viruses, cellular or non-cellular, capable of replication or of transferring genetic material; 16. "genetically modified organisms" means organisms in which the genetic material has been altered within the meaning of Article 2(2) of Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organismsOJ L 106, 17.4.2001, p. 1 .17. "zone" means a group of Member States as defined in Annex I. For the purpose of use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment the zone means all zones defined in Annex I; 18. "good plant protection practice" means a practice whereby the treatments with plant protection products applied to given plants or plant products, in conformity with the conditions of their authorised uses, are selected, dosed and timed to ensure acceptable efficacy with the minimum quantity necessary, taking due account of local conditions and of the possibilities for cultural and biological control; 19. "good laboratory practice" means a practice as defined in point 2.1 of Annex I to Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substancesOJ L 50, 20.2.2004, p. 44 .20. "good experimental practice" means a practice in accordance with the provisions of European and Mediterranean Plant Protection Organisation (EPPO) Guidelines 181 and 152; 21. "data protection" means the temporary right of the owner of a test or study report to prevent it being used for the benefit of another applicant; 22. "rapporteur Member State" means the Member State which undertakes the task of evaluating an active substance, safener or synergist; 23. "tests and studies" means investigations or experiments whose purpose is to determine the properties and behaviour of an active substance or of plant protection products, predict exposure to active substances and/or their relevant metabolites, determine safe levels of exposure and establish conditions for the safe use of plant protection products; 24. "authorisation holder" means any natural or legal person holding an authorisation of a plant protection product; 25. "professional user" means a professional user as defined in Article 3(1) of Directive 2009/128/EC; 26. "minor use" means use of a plant protection product in a particular Member State on plants or plant products which are: (a) not widely grown in that Member State; or (b) widely grown, to meet an exceptional plant protection need;
27. "greenhouse" means a walk-in, static, closed place of crop production with a usually translucent outer shell, which allows controlled exchange of material and energy with the surroundings and prevents release of plant protection products into the environment. For the purpose of this Regulation, closed places of plant production where the outer shell is not translucent (for example, for production of mushrooms or witloof) are also considered as greenhouses; 28. "post-harvest treatment" means treatment of plants or plant products after harvest in an isolated space where no run-off is possible, for example in a warehouse; 29. "biodiversity" means variability among living organisms from all sources, including terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this variability may include diversity within species, between species and of ecosystems; 30. "competent authority" means any authority or authorities of a Member State responsible for carrying out the tasks established under this Regulation; 31. "advertisement" means a means of promoting the sale or use of plant protection products (to anyone other than the authorisation holder, the person placing the plant protection product on the market and their agents) by printed or electronic media; 32. "metabolite" means any metabolite or a degradation product of an active substance, safener or synergist, formed either in organisms or in the environment. A metabolite is deemed relevant if there is a reason to assume that it has intrinsic properties comparable to the parent substance in terms of its biological target activity, or that it poses a higher or comparable risk to organisms than the parent substance or that it has certain toxicological properties that are considered unacceptable. Such a metabolite is relevant for the overall approval decision or for the definition of risk mitigation measures; 33. "impurity" means any component other than the pure active substance and/or variant which is present in the technical material (including components originating from the manufacturing process or from degradation during storage).
(a) they shall not have any harmful effects on human health, including that of vulnerable groups, or animal health, taking into account known cumulative and synergistic effects where the scientific methods accepted by the Authority to assess such effects are available, or on groundwater; (b) they shall not have any unacceptable effect on the environment.
(a) it shall be sufficiently effective; (b) it shall have no immediate or delayed harmful effect on human health, including that of vulnerable groups, or animal health, directly or through drinking water (taking into account substances resulting from water treatment), food, feed or air, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects where the scientific methods accepted by the Authority to assess such effects are available; or on groundwater; (c) it shall not have any unacceptable effects on plants or plant products; (d) it shall not cause unnecessary suffering and pain to vertebrates to be controlled; (e) it shall have no unacceptable effects on the environment, having particular regard to the following considerations where the scientific methods accepted by the Authority to assess such effects are available: (i) its fate and distribution in the environment, particularly contamination of surface waters, including estuarine and coastal waters, groundwater, air and soil taking into account locations distant from its use following long-range environmental transportation; (ii) its impact on non-target species, including on the ongoing behaviour of those species; (iii) its impact on biodiversity and the ecosystem.
(a) the minimum degree of purity of the active substance; (b) the nature and maximum content of certain impurities; (c) restrictions arising from the evaluation of the information referred to in Article 8 taking account of the agricultural, plant health and environmental, including climatic, conditions in question; (d) type of preparation; (e) manner and conditions of application; (f) submission of further confirmatory information to Member States, the Commission and the European Food Safety Authority, (the Authority), where new requirements are established during the evaluation process or as a result of new scientific and technical knowledge; (g) designation of categories of users, such as professional and non-professional; (h) designation of areas where the use of plant protection products, including soil treatment products, containing the active substance may not be authorised or where the use may be authorised under specific conditions; (i) the need to impose risk mitigation measures and monitoring after use; (j) any other particular conditions that result from the evaluation of information made available in the context of this Regulation.
(a) information with respect to one or more representative uses on a widely grown crop in each zone of at least one plant protection product containing the active substance, demonstrating that the approval criteria provided for in Article 4 are met; where the information submitted does not cover all zones or concern a crop which is not widely grown, justification for this approach; (b) for each point of the data requirements for the active substance, the summaries and results of tests and studies, the name of their owner and of the person or institute that has carried out the tests and studies; (c) for each point of the data requirements for the plant protection product, the summaries and results of tests and studies, the name of their owner and of the person or institute that carried out the tests and studies, relevant to the assessment of the criteria provided for in Article 4(2) and (3) for one or more plant protection products which are representative of the uses referred to in point (a), taking into account the fact that data gaps in the dossier, as provided for in paragraph 2 of this Article, resulting from the proposed limited range of representative uses of the active substance, may lead to restrictions in the approval; (d) for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplication of tests and studies on vertebrate animals; (e) a checklist demonstrating that the dossier provided for in paragraph 2 of this Article is complete in view of the uses applied for; (f) the reasons why the test and study reports submitted are necessary for first approval of the active substance or for amendments to the conditions of the approval; (g) where relevant, a copy of an application for a maximum residue level as referred to in Article 7 of Regulation (EC) No 396/2005 or a justification for not supplying such information; (h) an assessment of all information submitted.
(a) an active substance is approved, subject to conditions and restrictions, as referred to in Article 6, where appropriate; (b) an active substance is not approved; or (c) the conditions of the approval are amended.
(a) the time needed to provide the information requested; (b) the time needed to complete the procedure; (c) where appropriate, the need to ensure the establishment of a coherent work programme, as provided for in Article 18.
(a) the procedures concerning the submission and assessment of applications for renewal of approvals; (b) the necessary data to be submitted, including measures to minimise animal testing, in particular the use of non-animal test methods and intelligent testing strategies; (c) the periods for submission of such data; (d) rules on the submission of new information; (e) period for assessment and decision making; (f) the allocation of evaluation of active substances to Member States, taking into account a balance in the responsibilities and work to be done among Member States acting as rapporteurs.
(a) the approval of an active substance is renewed, subject to conditions and restrictions where appropriate; or (b) the approval of an active substance is not renewed.
(a) is not a substance of concern; and (b) does not have an inherent capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects; and (c) is not predominantly used for plant protection purposes but nevertheless is useful in plant protection either directly or in a product consisting of the substance and a simple diluent; and (d) is not placed on the market as a plant protection product.
(a) any evaluations of its possible effects on human or animal health or the environment carried out in accordance with other Community legislation regulating the use of the substance; and (b) other relevant information on its possible effects on human or animal health or the environment.
(a) its residues, consequent on application consistent with good plant protection practice, and having regard to realistic conditions of use, have a harmful effect on human or animal health or on groundwater or an unacceptable effect on the environment; or (b) its use, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, has a harmful effect on human or animal health or an unacceptable effect on plants, plant products or the environment.
(a) use of products containing exclusively one or more basic substances; (b) placing on the market and use of plant protection products for research or development purposes in accordance with Article 54; (c) production, storage or movement of a plant protection product intended for use in another Member State, provided that the product is authorised in that Member State and that the Member State of production, storage or movement has put in place inspection requirements to ensure that the plant protection product is not used in its territory; (d) production, storage or movement of a plant protection product intended for use in a third country provided that the Member State of production, storage or movement has put in place inspection requirements to ensure that the plant protection product is exported from its territory; (e) placing on the market and use of plant protection products for which a parallel trade permit has been granted in accordance with Article 52.
(a) its active substances, safeners and synergists have been approved; (b) where its active substance, safener or synergist is produced by a different source, or by the same source with a change in the manufacturing process and/or manufacturing location: (i) the specification, pursuant to Article 38, does not deviate significantly from the specification included in the Regulation approving that substance, safener or synergist; and (ii) the active substance, safener or synergist has no more harmful effects within the meaning of Article 4(2) and (3) due to its impurities than if it had been produced in accordance with the manufacturing process specified in the dossier that supported the approval;
(c) its co-formulants are not included in Annex III; (d) its technical formulation is such that user exposure or other risks are limited as much as possible without compromising the functioning of the product; (e) in the light of current scientific and technical knowledge, it complies with the requirements provided for in Article 4(3); (f) the nature and quantity of its active substances, safeners and synergists and, where appropriate, any toxicologically, ecotoxicologically or environmentally relevant impurities and co-formulants can be determined by appropriate methods; (g) its residues, resulting from authorised uses, and which are of toxicological, ecotoxicological or environmental relevance, can be determined by appropriate methods in general use in all Member States, with appropriate limits of determination on relevant samples; (h) its physical and chemical properties have been determined and deemed acceptable for the purposes of the appropriate use and storage of the product; (i) for plants or plant products to be used as feed or food, where appropriate, the maximum residue levels for the agricultural products affected by the use referred to in the authorisation have been set or modified in accordance with Regulation (EC) No 396/2005.
(a) the decision on approval could not be finalised within a period of 30 months from the date of admissibility of the application, extended by any additional period set in accordance with Article 9(2), Article 11(3) or Article 12(2) or (3); and (b) pursuant to Article 9 the dossier on the active substance is admissible in relation to the proposed uses; and (c) the Member State concludes that the active substance can satisfy the requirements of Article 4(2) and (3) and that the plant protection product may be expected to satisfy the requirements of Article 29(1)(b) to (h); and (d) maximum residue levels have been established in accordance with Regulation (EC) No 396/2005.
(a) the maximum dose per hectare in each application; (b) the period between the last application and harvest; (c) the maximum number of applications per year.
(a) a restriction with respect to the distribution and use of the plant protection product in order to protect the health of the distributors, users, bystanders, residents, consumers or workers concerned or the environment, taking into consideration requirements imposed by other Community provisions; such restriction shall be indicated on the label; (b) the obligation before the product is used to inform any neighbours who could be exposed to the spray drift and who have requested to be informed; (c) indications for proper use according to the principles of Integrated Pest Management referred to in Article 14 of and Annex III to Directive 2009/128/EC; (d) designation of categories of users, such as professional and non-professional; (e) the approved label; (f) the interval between applications; (g) the period between the last application and consumption of the plant product where applicable; (h) the re-entry interval; (i) the packaging size and material.
(a) a list of intended uses in each zone as indicated in Annex I and the Member States where the applicant has made or intends to make an application; (b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request; (c) where relevant, a copy of any authorisations already granted for that plant protection product in a Member State; (d) where relevant, a copy of any conclusion of the Member State assessing equivalence as referred to in Article 38(2).
(a) for the plant protection product concerned, a complete and a summary dossier for each point of the data requirements of the plant protection product; (b) for each active substance, safener and synergist contained in the plant protection product, a complete and a summary dossier for each point of the data requirements of the active substance, safener and synergist; (c) for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplication of tests and studies on vertebrate animals; (d) the reasons why the test and study reports submitted are necessary for first authorisation or for amendments to the conditions of the authorisation; (e) where relevant a copy of the application for a maximum residue level as referred to in Article 7 of Regulation (EC) No 396/2005 or a justification for not supplying such information; (f) where relevant for an amendment of an authorisation an assessment of all information submitted in accordance with point (h) of Article 8(1); (g) a draft label.
(a) all necessary data for the identification of the plant protection product including its complete composition as well as a declaration that no unacceptable co-formulants are used; (b) the information needed to identify the active substance, safener or synergist, where they have been approved, and to establish whether the conditions for approval are met and comply with point (b) of Article 29(1), where appropriate; (c) on the request of the concerned Member State, the data needed to demonstrate that the plant protection product has comparable effects to the plant protection product for which they show access to the protected data.
(a) a copy of the application; (b) a report containing information on the evaluation of and decision on the plant protection product; the format of the report shall be established in accordance with the advisory procedure referred to in Article 79(2); (c) a record of the administrative decisions taken by the Member State concerning the application and of the documentation provided for in Article 33(3) and Article 34 together with a summary of the latter; (d) the approved label, where applicable.
(a) the authorisation was granted by a Member State (reference Member State) which belongs to the same zone; (b) the authorisation was granted by a Member State (reference Member State) which belongs to a different zone provided that the authorisation for which the application was made is not used for the purpose of mutual recognition in another Member State within the same zone; (c) the authorisation was granted by a Member State for use in greenhouses, or as post-harvest treatment, or for treatment of empty rooms or containers used for storing plant or plant products, or for seed treatment, regardless of the zone to which the reference Member State belongs.
(a) an authorisation under point (b) of Article 40(1) was applied for; (b) it contains a candidate of substitution; (c) Article 30 has been applied; or (d) it contains a substance approved in accordance with Article 4(7).
(a) a copy of the authorisation granted by the reference Member State as well as a translation of the authorisation into an official language of the Member State receiving the application; (b) a formal statement that the plant protection product is identical to that authorised by the reference Member State; (c) a complete or summary dossier as required in Article 33(3) when requested by the Member State; (d) an assessment report of the reference Member State containing information on the evaluation and decision on the plant protection product.
(a) a copy of the authorisation of the plant protection product; (b) any new information required as a result of amendments in data requirements or criteria; (c) evidence that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted or necessary to amend the conditions of approval; (d) any information required to demonstrate that the plant protection product meets the requirements set out in the Regulation on the renewal of the approval of the active substance, safener or synergist contained therein; (e) a report on the monitoring information, where the authorisation was subject to monitoring.
(a) the requirements referred to in Article 29 are not or are no longer satisfied; (b) false or misleading information was supplied concerning the facts on the basis of which the authorisation was granted; (c) a condition included in the authorisation has not been met; (d) on the basis of developments in scientific and technical knowledge, the manner of use and amounts used can be modified; or (e) the authorisation holder fails to comply with the obligations resulting from this Regulation.
(a) the low-risk active substances, safeners and synergists contained in it have been approved under Chapter II; (b) it does not contain a substance of concern; (c) it is sufficiently effective; (d) it does not cause unnecessary pain and suffering to vertebrates to be controlled; (e) it complies with points (b), (c) and (f) to (i) of Article 29(1).
(a) for the uses specified in the application an authorised plant protection product, or a non-chemical control or prevention method, already exists which is significantly safer for human or animal health or the environment; (b) the substitution by plant protection products or non-chemical control or prevention methods referred to in point (a) does not present significant economic or practical disadvantages; (c) the chemical diversity of the active substances, where relevant, or methods and practices of crop management and pest prevention are adequate to minimise the occurrence of resistance in the target organism; and (d) the consequences on minor use authorisations are taken into account.
(a) the intended use is minor in nature; (b) the conditions referred to in points (b), (d) and (e) of Article 4(3) and Article 29(1)(i) are satisfied; (c) the extension is in the public interest; and (d) the documentation and information to support the extension of use has been submitted by the persons or bodies referred to in paragraph 1, especially data on the magnitude of residues and where necessary on the risk assessment to the operator, worker and bystander.
(a) they have been manufactured by the same company or by an associated undertaking or under licence in accordance with the same manufacturing process; (b) they are identical in specification and content to the active substances, safeners and synergists, and in the type of formulation; and (c) they are either the same or equivalent in the co-formulants present and the packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment.
(a) the name and registration number of the plant protection product in the Member State of origin; (b) the Member State of origin; (c) the name and address of the authorisation holder in the Member State of origin; (d) the original label and instructions for use with which the plant protection product to be introduced is distributed in the Member State of origin if it is considered as necessary for the examination by the competent authority of the Member State of introduction. This competent authority may require a translation of the relevant parts of the original instructions for use; (e) the name and address of the applicant; (f) the name to be given to the plant protection product to be distributed in the Member State of introduction; (g) a draft label for the product intended to be placed on the market; (h) a sample of the product which is intended to be introduced if it is considered as necessary by the competent authority of the Member State of introduction; (i) the name and registration number of the reference product.
(a) may or may not extend the duration of the measure or repeat it; or (b) shall withdraw or amend its measure.
(a) the name or business name of the holder of the authorisation and the authorisation number; (b) the trade name of the product; (c) the type of preparation; (d) the name and amount of each active substance, safener or synergist which it contains; (e) the classification, risk and safety phrases in accordance to Directive 1999/45/EC and to the Regulation referred to in Article 65; (f) the use or uses for which it is authorised; (g) the reasons for withdrawal of an authorisation if they are related to safety concerns; (h) the list of minor uses referred to in Article 51(8).
(a) necessary for the authorisation or an amendment of an authorisation in order to allow the use on another crop; and (b) certified as compliant with the principles of good laboratory practice or of good experimental practice.
(a) to test and study reports for which the applicant has submitted a letter of access; or (b) where any period of data protection granted for the test and study reports concerned in relation to another plant protection product has expired.
(a) a list of the test and study reports concerning the active substance, safener or synergist, adjuvant and the plant protection product necessary for first authorisation, amendment of the authorisation conditions or renewal of the authorisation; and (b) a list of test and study reports for which the applicant claimed data protection under Article 59 and any reasons submitted in accordance with that Article.
(a) the method of manufacture; (b) the specification of impurity of the active substance except for the impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant; (c) results of production batches of the active substance including impurities; (d) methods of analysis for impurities in the active substance as manufactured except for methods for impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant; (e) links between a producer or importer and the applicant or the authorisation holder; (f) information on the complete composition of a plant protection product; (g) names and addresses of persons involved in testing on vertebrate animals.
(a) are established in a transparent manner; and (b) correspond to the actual total cost of the work involved except if it is in public interest to lower the fees or charges.
(a) development of a harmonised system, including an appropriate database, for gathering and storing all information concerning active substances, safeners, synergists, co-formulants, plant protection products and adjuvants and for making such information available to the Member States, producers and other interested parties; (b) performance of studies needed to prepare and develop further legislation on the placing on the market and use of plant protection products and adjuvants; (c) performance of studies needed to harmonise procedures, decision-making criteria and data requirements; (d) coordination, if necessary by electronic means, of cooperation between Member States, the Commission and the Authority and measures to facilitate work sharing; (e) development and maintenance of a coordinated electronic submission and evaluation system aimed at promoting electronic document exchange and work sharing between the applicants, the Member States, the Commission and the Authority; (f) development of guidance to facilitate the day-to-day application of this Regulation; (g) travel and subsistence expenses that Member States’ experts incur as a result of the Commission appointing them to assist its experts in the framework of control activities laid down under Article 68; (h) training of control staff; (i) financing of other measures needed to ensure application of the Regulation adopted under Article 68.
(a) amendments to the Annexes, taking into account current scientific and technical knowledge; (b) amendments to the Regulations on data requirements for active substances and for plant protection products, as referred to in points (b) and (c) of Article 8(1), taking into account current scientific and technical knowledge; (c) amendments to the Regulation on uniform principles for evaluation and authorisation of plant protection products, as referred to in Article 29(6), taking into account current scientific and technical knowledge; (d) a Regulation postponing the expiry of the approval period referred to in the second subparagraph of Article 17; (e) a Regulation on data requirements for safeners and synergists referred to in Article 25(3); (f) a Regulation establishing a work programme for safeners and synergists referred to in Article 26; (g) adoption of the harmonised methods referred to in Article 29(4); (h) inclusion of co-formulants in Annex III, as referred to in Article 27(2); (i) extension of the date of application of this Regulation to provisional authorisations, as referred to in Article 30(3); (j) information requirements for parallel trade, as referred to in Article 52(4); (k) rules for the application of Article 54, in particular the maximum quantities of plant protection products to be released; (l) detailed rules for adjuvants, as referred to in Article 58(2); (m) a Regulation containing the requirements of the labelling of plant protection products, as referred to in Article 65(1); (n) a Regulation on controls, as referred to in the third subparagraph of Article 68.
(a) to active substances for which a decision has been adopted in accordance with Article 6(3) of Directive 91/414/EEC before 14 June 2011 ;(b) to active substances listed in Annex I to Regulation (EC) No 737/2007 OJ L 169, 29.6.2007, p. 10 .(c) to active substances for which completeness has been established in accordance with Article 16 of Regulation (EC) No 33/2008 OJ L 15, 18.1.2008, p. 5 .(d) to active substances for which completeness has been established in accordance with Article 6 of Regulation (EC) No 33/2008 before 14 June 2011 .
(a) for a period of five years from the date of their inclusion or approval, for active substances covered by Article 8(2) of Directive 91/414/EEC; (b) for a period of 10 years from the date of their inclusion or approval, for active substances which were not on the market on 26 July 1993 ;(c) for a period of five years from the date of the renewal of the inclusion or renewal of the approval, for active substances whose inclusion in Annex I to Directive 91/414/EEC expires by 24 November 2011 . This provision shall only apply to data necessary for the renewal of the approval and which were certified as compliant with the principles of good laboratory practice by that date.
(a) under Article 4 of Directive 91/414/EEC which are pending in the Member States; or (b) which are due to be amended or withdrawn following an inclusion in Annex I to Directive 91/414/EEC or following an approval in accordance with paragraph 1 of this Article;
(a) a Regulation containing the list of the active substances already approved at the moment of adoption of that Regulation; (b) a Regulation on data requirements for active substances, as referred to in Article 8(1)(b); (c) a Regulation on data requirements for plant protection products, as referred to in Article 8(1)(c); (d) a Regulation on uniform principles for risk assessment for plant protection products, as referred to in Article 36; (e) a Regulation containing the requirements of the labelling of plant protection products, as referred to in Article 65(1).
(a) the data requirements have been amended or refined after the submission of the dossier; or (b) the information is considered to be confirmatory in nature, as required to increase confidence in the decision.
(a) permit any residue of concern to be defined; (b) reliably predict the residues in food and feed, including succeeding crops; (c) reliably predict, where relevant, the corresponding residue level reflecting the effects of processing and/or mixing; (d) permit a maximum residue level to be defined and to be determined by appropriate methods in general use for the commodity and, where appropriate, for products of animal origin where the commodity or parts of it is fed to animals; (e) permit, where relevant, concentration or dilution factors due to processing and/or mixing to be defined.
evidence that its bio-concentration factor or bioaccumulation factor in aquatic species is greater than 5000 or, in the absence of such data, that the partition coefficient n-octanol/water (log Ko/w) is greater than 5, orevidence that the active substance, safener or synergist present other reasons for concern, such as high bioaccumulation in other non-target species, high toxicity or ecotoxicity.
measured levels of the active substance, safener or synergist in locations distant from the sources of its release are of potential concern, monitoring data show that long-range environmental transport of the active substance, safener or synergist, with the potential for transfer to a receiving environment, may have occurred via air, water or migratory species, or environmental fate properties and/or model results demonstrate that the active substance, safener or synergist has a potential for long-range environmental transport through air, water or migratory species, with the potential for transfer to a receiving environment in locations distant from the sources of its release. For an active substance safener or synergist that migrates significantly through the air, its DT50 in air is to be greater than 2 days.
the half-life in marine water is higher than 60 days, the half-life in fresh or estuarine water is higher than 40 days, the half-life in marine sediment is higher than 180 days, the half-life in fresh or estuarine water sediment is higher than 120 days, or the half-life in soil is higher than 120 days.
the long-term no-observed effect concentration for marine or freshwater organisms is less than 0,01 mg/l, the substance is classified as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) pursuant to Regulation (EC) No 1272/2008, or there is other evidence of chronic toxicity, as identified by the classifications STOT RE 1 or STOT RE 2 pursuant to Regulation (EC) No 1272/2008.
the half-life in marine, fresh- or estuarine water is higher than 60 days, the half-life in marine, fresh- or estuarine water sediment is higher than 180 days, or the half-life in soil is higher than 180 days.
will result in a negligible exposure of honeybees, or has no unacceptable acute or chronic effects on colony survival and development, taking into account effects on honeybee larvae and honeybee behaviour.
its ADI, ARfD or AOEL is significantly lower than those of the majority of the approved active substances within groups of substances/use categories, it meets two of the criteria to be considered as a PBT substance, there are reasons for concern linked to the nature of the critical effects (such as developmental neurotoxic or immunotoxic effects) which, in combination with the use/exposure patterns, amount to situations of use that could still cause concern, for example, high potential of risk to groundwater; even with very restrictive risk management measures (such as extensive personal protective equipment or very large buffer zones), it contains a significant proportion of non-active isomers, it is or is to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogen category 1A or 1B, if the substance has not been excluded in accordance with the criteria laid down in point 3.6.3, it is or is to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 1A or 1B if the substance has not been excluded in accordance with the criteria laid down in point 3.6.4, if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information, reviewed by the Authority, it is considered to have endocrine disrupting properties that may cause adverse effects in humans if the substance has not been excluded in accordance with the criteria laid down in point 3.6.5.
(a) it is or has to be classified in accordance with Regulation (EC) No 1272/2008 as any of the following: carcinogenic category 1A, 1B or 2, mutagenic category 1A, 1B or 2, toxic to reproduction category 1A, 1B or 2, skin sensitiser category 1, serious damage to eye category 1, respiratory sensitiser category 1, acute toxicity category 1, 2 or 3, specific Target Organ Toxicant, category 1 or 2, toxic to aquatic life of acute and chronic category 1 on the basis of appropriate standard tests, explosive, skin corrosive, category 1A, 1B or 1C;
(b) it has been identified as priority substance under Directive 2000/60/EC; (c) it is deemed to be an endocrine disruptor; (d) it has neurotoxic or immunotoxic effects.
(a) substitution shall be applied only where other methods or the chemical diversity of the active substances is sufficient to minimise the occurrence of resistance in the target organism; (b) substitution shall be applied only to plant protection products where their use presents a significantly higher level of risk to human health or the environment; and (c) substitution shall be applied only after allowing for the possibility, where necessary, of acquiring experience from use in practice, where not already available.
| Acts amending Directive 91/414/EEC | Deadline for transposition |
|---|---|
| Directive 93/71/EEC | |
| Directive 94/37/EC | |
| Directive 94/79/EC | |
| Directive 95/35/EC | |
| Directive 95/36/EC | |
| Directive 96/12/EC | |
| Directive 96/46/EC | |
| Directive 96/68/EC | |
| Directive 97/57/EC | |
| Directive 2000/80/EC | |
| Directive 2001/21/EC | |
| Directive 2001/28/EC | |
| Directive 2001/36/EC | |
| Directive 2001/47/EC | |
| Directive 2001/49/EC | |
| Directive 2001/87/EC | |
| Directive 2001/99/EC | |
| Directive 2001/103/EC | |
| Directive 2002/18/EC | |
| Directive 2002/37/EC | |
| Directive 2002/48/EC | |
| Directive 2002/64/EC | |
| Directive 2002/81/EC | |
| Directive 2003/5/EC | |
| Directive 2003/23/EC | |
| Directive 2003/31/EC | |
| Directive 2003/39/EC | |
| Directive 2003/68/EC | |
| Directive 2003/70/EC | |
| Directive 2003/79/EC | |
| Directive 2003/81/EC | |
| Directive 2003/82/EC | |
| Directive 2003/84/EC | |
| Directive 2003/112/EC | |
| Directive 2003/119/EC | |
| Regulation (EC) No 806/2003 | — |
| Directive 2004/20/EC | |
| Directive 2004/30/EC | |
| Directive 2004/58/EC | |
| Directive 2004/60/EC | |
| Directive 2004/62/EC | |
| Directive 2004/66/EC | |
| Directive 2004/71/EC | |
| Directive 2004/99/EC | |
| Directive 2005/2/EC | |
| Directive 2005/3/EC | |
| Directive 2005/25/EC | |
| Directive 2005/34/EC | |
| Directive 2005/53/EC | |
| Directive 2005/54/EC | |
| Directive 2005/57/EC | |
| Directive 2005/58/EC | |
| Directive 2005/72/EC | |
| Directive 2006/5/EC | |
| Directive 2006/6/EC | |
| Directive 2006/10/EC | |
| Directive 2006/16/EC | |
| Directive 2006/19/EC | |
| Directive 2006/39/EC | |
| Directive 2006/41/EC | |
| Directive 2006/45/EC | |
| Directive 2006/64/EC | |
| Directive 2006/74/EC | |
| Directive 2006/75/EC | |
| Directive 2006/85/EC | |
| Directive 2006/104/EC | |
| Directive 2006/131/EC | |
| Directive 2006/132/EC | |
| Directive 2006/133/EC | |
| Directive 2006/134/EC | |
| Directive 2006/135/EC | |
| Directive 2006/136/EC | |
| Directive 2007/5/EC | |
| Directive 2007/6/EC | |
| Directive 2007/21/EC | |
| Directive 2007/25/EC | |
| Directive 2007/31/EC | |
| Directive 2007/50/EC | |
| Directive 2007/52/EC | |
| Directive 2007/76/EC | |
| Directive 2008/40/EC | |
| Directive 2008/41/EC | |
| Directive 2008/45/EC | |
| Directive 2008/66/EC |
| Acts amending Directive 79/117/EEC | Deadline for transposition |
|---|---|
| Directive 83/131/EEC | |
| Directive 85/298/EEC | |
| Directive 86/214/EEC | — |
| Directive 86/355/EEC | |
| Directive 87/181/EEC | |
| Directive 87/477/EEC | |
| Directive 89/365/EEC | |
| Directive 90/335/EEC | |
| Directive 90/533/EEC | |
| Directive 91/188/EEC | |
| Regulation (EC) No 807/2003 | — |
| Regulation (EC) No 850/2004 | — |