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I.
INTRODUCTION
The Rapporteur, Mrs. Hiltrud BREYER (Greens/EFA - DE), presented a report consisting of 253
amendments (amendments 1-253) to the proposal for a Regulation on behalf of the Committee on
the Environment, Public Health and Food Safety. In addition, various political groups tabled a
further 53 amendments (amendments 254-306).
II. DEBATE
The debate, which took place on 22 October 2007, was a joint debate which covered four legislative
proposals. For a summary of the joint debate, please see document 14183/07.
III. VOTE The parliament adopted 247 amendments when it voted in plenary on the following day, 23 October
2007.
(i) adopted amendments which the Commission can accept, or accept subject to rewording
These were amendments 9, 11, 20, 22, 26, 29, 31-33, 36, 41, 43, 45, 49, 51, 56-57, 64, 67, 75, 78-
79, 82, 84, 92-93, 96, 107, 114, 119, 124, 130-131, 140, 145, 153, 155-157, 159-160, 167, 170, 181,
184, 190, 195-197, 201, 203, 206, 212-213, 215, 217, 220, 274, 286 and 301.
(ii) adopted amendments which the Commission can accept in principle or in part These were amendments 5-7, 10, 14, 18-19, 21, 24-25, 34, 39, 46, 50, 53-54, 59, 62, 66, 76-77, 80,
87, 89, 94-95, 98-100, 108-109, 115-116, 121-122, 133-134, 136, 149, 163, 169, 175-177, 180, 183,
188-189, 199, 209, 218, 225, 244, 248, 251-252, 296-297, 300 and 305.
(ii) adopted amendment which the Commission cannot accept These were amendments 1-3, 8, 12-13, 15-17, 23, 28, 30, 35, 37-38, 40, 42, 44, 47-48, 52, 55, 58,
68-71, 73-74, 81, 83, 85-86, 88, 90-91, 97, 101, 103-106, 110-111, 113, 117-118, 120, 126-129,
132, 135, 137-139, 141-144, 146-148, 150, 152, 154, 158, 161-162, 164-166, 168, 171, 173, 179,
185-187, 191-192, 194, 198, 202, 204-205, 207-208, 210-211, 214, 216, 219, 221-224, 226-230,
232, 235-242, 245-246, 249-250, 253, 255, 267, 276, 281, 287, 293, 295, 299 and 303-304.
The text of the amendments adopted and the European Parliament's legislative resolution are
annexed to this note.
____________________
ANNEX
(23.10.2007)
P6_TA-PROV(2007)0445
The placing of plant protection products on the market ***I
European Parliament legislative resolutionof 23 October 2007 on the proposal for a regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market (COM(2006)0388 C6-0245/2006 2006/0136(COD))
(Codecision procedure: first reading)
The European Parliament,
having regard to the Commission proposal to the European Parliament and the Council (COM(2006)0388), having regard to Article 251(2) and Articles 37(2) and 152(4)(b) of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C6-0245/2006), having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis, having regard to Rules 51 and 35 of its Rules of Procedure, having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy, the Committee on the Internal Market and Consumer Protection and the Committee on Agriculture and Rural Development (A6-0359/2007), 1. Approves the Commission proposal as amended; 2. Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text; 3. Instructs its President to forward its position to the Council and Commission.
Text proposed by the Commission Amendments by Parliament Amendment 1
Citation 1
Having regard to the Treaty establishing the European Community, and in particular Articles 37 (2) and 152 (4)(b) thereof, Having regard to the Treaty establishing the European Community, and in particular Articles 152 (4)(b) and 175 (1) thereof, Amendment 2
Recital 4
(4) By way of simplification, the new act should also repeal Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances. (4) By way of simplification, this Regulation should also repeal Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances. However, the main principles of Directive 79/117/EEC should be maintained in this Regulation. Amendment 3
Recital 6 a (new)
(6a) Various types of crop are of significance in the Community for both large scale and small scale production. These various types of production should be protected by allowing the use of different plant protection products.
Amendment 5
Recital 8
(8) The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment. Particular attention should be paid to the protection of vulnerable groups of the population, including pregnant women, infants and children. The precautionary principle should be applied and ensure that industry demonstrates that substances or products produced or placed on the market do not adversely affect human health or the environment. (8) The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment, and at the same time to ensure the competitiveness of European agriculture. Particular attention should be paid to the protection of vulnerable groups of the population, including pregnant and nursing women, embryos and foetuses, infants and children. The precautionary principle should be applied and ensure that industry demonstrates that substances or products produced or placed on the market
do not adversely affect human health or the environment and are not suspected of doing so.
Amendment 6
Recital 8 a (new)
(8a) In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation should be undertaken only as a last resort. This Regulation, and the legislation establishing data requirements for active substances, plant protection products, safeners and synergists, should ensure that testing on vertebrate animals is minimised and that double testing is avoided, and promote the use of non animal test methods and intelligent testing strategies. Existing results from tests on vertebrate animals must be shared in the process of developing new plant protection products. In accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes
1
,tests on vertebrate animals
must also be replaced, restricted or refined. Implementation of this Regulation must where possible be based on the use of appropriate alternative testing methods. Not later than ...*, the Commission must review the rules on the data protection of results from tests on vertebrate animals and where necessary change those rules.
___________________ 1
OJ L 358, 18.12.1986, p. 1. Directive as amended
by Directive 2003/65/EC of the European Parliament and of the Council (OJ L 230, 16.9.2003, p. 32).
Seven years after the entry into force of
this Regulation.
Amendment 7
Recital 9
(9) Substances should only be included in plant protection products where it has been demonstrated that they present a clear benefit for plant production and they are not expected to have any harmful effect on human or animal health or any unacceptable influence on the environment. In order to achieve the same level of protection in all Member States, the decision on acceptability or non-acceptability of such substances should be taken at Community level. (9) Substances should only be included in plant protection products where it has been demonstrated that they present a clear benefit for plant production and it has been established that they will not have any harmful effect on human or animal health or any unacceptable influence on the environment. In order to achieve a high and identical level of protection in all Member States, the decision on acceptability or nonacceptability of such substances should be taken at Community level. Amendment 8
Recital 9 a (new)
(9a) To apply the 'polluter pays' principle, the Commission should examine how manufacturers of plant protection products or of the active substances they contain should be appropriately involved in dealing with or rectifying harm to human health or to the environment which may result from the use of plant protection products. Amendment 9 Recital 11 a (new)
(11a) The development of non animal in vitro (test tube) test methods should be promoted in order to produce safety data more relevant to humans than results of animal studies currently in use. Amendment 10
Recital 13
(13) In the interest of safety, the approval period for active substances should be limited in time. The approval period should be proportional to the possible risks inherent in the use of such substances. Experience gained from the actual use of plant protection products containing the substances concerned and any (13) In the interest of safety, the approval period for active substances should be limited in time. The approval period should be proportional to the possible risks inherent in the use of such substances and should be limited to a maximum of 15 years for low risk substances, 5 years for candidates for substitution and 10 years
developments in science and technology should be taken into account when any decision regarding the renewal of an approval is taken. After the first renewal, such substances should only be reviewed further where there are indications that they no longer meet the requirements of this Regulation. for other substances. Experience gained from the actual use of plant protection products containing the substances concerned and any developments in science and technology should be taken into account when any decision regarding the renewal of an approval is taken. After the first renewal, a regular review of substances should take place. Amendment 11
Recital 14
(14) The possibility of amending or withdrawing the approval of an active substance in cases where the criteria for approval are no longer satisfied should be provided for. (14) The possibility of amending or withdrawing the approval of an active substance in cases where the criteria for approval are no longer satisfied or where compliance with Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy 1
and its daughter
directives may be compromised, should be provided for.
_______________________________________
1
OJ L 327, 22.12.2000, p. 1. Directive as
amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).
Amendment 12
Recital 15 a (new)
(15a) To encourage the development of plant protection products, incentives must be incorporated for placing on the market products with a low risk profile or a risk profile that is lower than that of products already on the market. Clear and objective criteria must be laid down to define which products may claim such a profile.
Amendment 13
Recital 16
(16) Certain substances which are not predominantly used as a plant protection product may be of value for plant protection, but the economic interest of applying for approval may be limited. Therefore, specific provisions should ensure that such substances, as far as their risks are acceptable, may also be approved for plant protection use. (16) Certain substances which are not predominantly used as a plant protection product may be of value for plant protection, but the economic interest of applying for approval may be limited. Therefore, specific provisions should ensure that such substances, as far as their risks are deemed acceptable by all relevant stakeholders, may also be approved for plant protection use. Amendment 14
Recital 17
(17) Some active substances may only be acceptable when extensive risk mitigation measures are taken. Such substances should be identified at Community level. Member States should regularly re examine whether plant protection products containing such active substances can be replaced by plant protection products containing active substances which require less risk mitigation. (17) Some active substances of particular concern, which are currently approved, should be identified at Community and national level as candidates for substitution. Member States should examine plant protection products containing such active substances with the aim of replacing them by plant protection products containing active substances which require significantly less or no risk mitigation or by alternative non chemical agricultural practices and methods of crop protection. After a positive check, active substances should be replaced immediately. Amendment 15
Recital 17 a (new)
(17a) Member States should be entitled to prohibit or not authorise plant protection products in order to take account of their specific natural, agricultural or climatic conditions, or if the use of these products would be in conflict with their action plan to reduce the risks associated with, and dependence on, the use of pesticides (National Pesticide Action Plan).
Amendment 16
Recital 18
(18) In addition to active substances, plant protection products may contain safeners or synergists for which similar rules should be provided. The technical rules necessary for the review of such substances should be established. Substances currently on the market should only be reviewed after those provisions have been established. (18) In addition to active substances, plant protection products may contain safeners or synergists for which similar legislation should be provided. The provisions necessary for the review of such substances should be established on the basis of a legislative proposal from the Commission. Substances currently on the market should only be reviewed after those provisions have been established. Amendment 17
Recital 19
(19) Plant protection products may also contain co-formulants. It is appropriate to provide a list of co-formulants which should not be included in plant protection products. (19) Plant protection products may also contain co-formulants. It is appropriate to adopt and make publicly available a positive list of co-formulants which may be included in plant protection products and the reasons therefor. This information should be available to the public. Details of all co formulants that are included in plant protection products must also be available to the public. Amendment 18
Recital 21
(21) The provisions governing authorisation must ensure a high standard of protection. In particular, when granting authorisations of plant protection products, the objective of protecting human or animal health and the environment should take priority over the objective of improving plant production. Therefore, it should be demonstrated, before plant protection products are placed on the market, that they present a clear benefit for plant production and do not have any harmful effect on human or animal health or any unacceptable influence on the environment. (21) The provisions governing authorisation must ensure a high standard of protection. In particular, when granting authorisations of plant protection products, the objective of protecting human or animal health and the environment and water resources should take priority over the objective of improving plant production. Therefore, it should be demonstrated, before plant protection products are placed on the market, that they do not have any harmful effect on human health, including that of vulnerable groups, or animal health or any unacceptable influence on the environment and on water resources. Member States should be entitled to prohibit or not
authorise plant protection products that do not present a clear benefit for plant production in the specific conditions of their territory.
Amendment 19
Recital 24
(24) To avoid any duplication of work, to reduce the administrative burden for industry and for Member States and to ensure more harmonised availability of plant protection products, authorisations granted by one Member State should be accepted by other Member States where ecological and climatic conditions are comparable. Therefore, the European Union should be divided in authorisation zones with comparable conditions in order to facilitate such mutual recognition.(24) To avoid unnecessary duplication of work, to reduce the administrative burden for industry and for Member States and to facilitate more harmonised availability of plant protection products, authorisations granted by one Member State should be notified to other Member States. Member States should be entitled to confirm, reject or restrict the authorisation granted by another Member State on the basis of their specific agricultural needs or to maintain a higher protection level in line with their National Pesticide Action Plan.
Amendment 295
Recital 24 a (new)
(24a) Good administrative co operation between Member States should be increased during all steps of the authorisation procedure and should be facilitated by a European Helpdesk.
Amendment 20
Recital 26
(26) In exceptional cases, Member States should be permitted to authorise plant protection products not complying with the conditions provided for in this Regulation, where it is necessary to do so because of a danger or threat to plant production which cannot be contained by any other means. Such authorisations should be reviewed at Community level. (26) In exceptional cases, it should be permitted to authorise plant protection products not complying with the conditions provided for in this Regulation, where it is necessary to do so because of a danger or threat to plant production and ecosystems which cannot be contained by any other means. Such temporary authorisations should be reviewed at Community level.
Amendment 21
Recital 28
(28) In order to ensure a high level of protection of human health and the environment, plant protection products should be used properly having regard to the principles of integrated pest management. The Council shall include in the statutory management requirement referred to in Annex III of Regulation (EC) No 1782/2003 the principles of integrated pest management, including good plant protection practice and good environmental practice. A transitional period should therefore be foreseen to allow Member States to put in place the necessary structures to enable users of plant protection products to apply the principles of integrated pest management. (28) In order to ensure a high level of protection of human health and the environment, plant protection products should be used properly, according to their authorisation, having regard to the principles of integrated pest management and giving priority to non chemical and natural alternatives wherever possible. The Council shall include in the statutory management requirement referred to in Annex III of Regulation (EC) No 1782/2003 the principles of integrated pest management, including good plant protection practice and non chemical methods of plant protection and pest and crop management. A transitional period should therefore be foreseen to allow Member States to put in place the necessary structures to enable users of plant protection products to apply the principles of integrated pest management and non chemical alternatives to plant protection and pest and crop management. Amendment 22
Recital 29
(29) A system of exchange of information should be established. Member States should make available to each other, the Authority and the Commission the particulars and scientific documentation submitted in connection with applications for authorisation of plant protection products. (29) A system of exchange of information should be established. Member States should make available to each other, the Authority and the Commission the particulars and scientific documentation submitted in connection with applications for authorisation of plant protection products. Studies and data relevant for toxicological and ecotoxicological assessment of plant protection products should be made available to the public.
Amendment 23
Recital 31
(31) Studies represent a major investment. This investment should be protected in order to stimulate research. For this reason, studies lodged by one applicant with a Member State should be protected against use by another applicant. This protection should, however, be limited in time in order to allow competition. It should also be limited to studies which are genuinely necessary for regulatory purposes, to avoid applicants artificially extending the period of protection by submitting new studies which are not necessary. (31) Studies represent a major investment. This investment should be protected in order to stimulate research. For this reason, studies, other than those involving tests on vertebrate animals and other studies that may prevent animal testing, lodged by one applicant with a Member State should be protected against use by another applicant. This protection should, however, be limited in time in order to allow competition. It should also be limited to studies which are genuinely necessary for regulatory purposes, to avoid applicants artificially extending the period of protection by submitting new studies which are not necessary. Amendment 24
Recital 32
(32) Rules should be laid down to avoid duplication of tests and studies. In particular, repetition of studies involving vertebrates should be prohibited. In this context, there should be an obligation to allow access to studies on vertebrates on reasonable terms. In order to allow operators to know what studies have been carried out by others, Member States should keep a list of such studies even where they are not covered by the above system of compulsory access. (32) Rules should be laid down to avoid duplication of tests and studies. In particular, repetition of studies involving vertebrates should be prohibited. In this context, there should be an obligation to allow access to studies on vertebrates and other studies that may prevent animal testing. In order to allow operators to know what studies have been carried out by others, Member States should forward to the Authority all such studies even
where they are not covered by the above system of compulsory access. The Authority should establish a central database for such studies.
Amendment 25
Recital 34
(34) Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of (34) Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of
dangerous preparations applies to the classification, packaging and labelling of pesticides. However, to further improve the protection of users of plant protection products, of consumers of plants and plant products and of the environment, further specific rules are appropriate which take account of the specific conditions of use of plant protection products. dangerous preparations applies to the classification, packaging and labelling of pesticides. However, to further improve the protection of users of plant protection products, of residents and bystanders who could be exposed to pesticides from crop spraying, of consumers of plants and plant products and of the environment, it is appropriate to adopt specific legislation on the basis of a legislative proposal from the Commission which takes account of the specific conditions of use of plant protection products. Amendment 26
Recital 35
(35) To ensure that advertisements do not mislead users of plant protection products, it is appropriate to provide rules on the advertising of those products. (35) To ensure that advertisements do not mislead users of plant protection products or the public, it is appropriate to provide rules on the advertising of those products. Amendment 28
Recital 37
(37) Provisions on control and inspection arrangements with regard to the marketing and use of plant protection products should ensure correct, safe and harmonised implementation of the requirements laid down in this Regulation in order to achieve a high level of protection of both human and animal health and the environment. (37) Member States should carry out controls and inspections with regard to the marketing and use of plant protection products to ensure compliance with the requirements laid down in this Regulation in order to achieve a high level of protection of both human and animal health and the environment. Amendment 29
Recital 37 a (new)
(37a) Operators must have the same opportunities in respect of market access, in particular so that small and medium sized enterprises can operate, in order to ensure that sufficient safe and effective plant protection products are available to farmers.
Amendment 30
Recital 38
(38) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules provides for control measures for the use of plant protection products at all stages of the production of food, including record keeping on the use of plant protection products. Similar rules should apply to the storage and use of plant protection products not covered by Regulation (EC) No 882/2004. (38) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules provides for control measures for the use of plant protection products at all stages of the production of food, including record keeping on the use of plant protection products. Similar rules should be established on the basis of a legislative proposal from the Commission for the storage and use of plant protection products not covered by Regulation (EC) No 882/2004. Amendment 31
Recital 38 a (new)
(38a) The bureaucratic burden on farmers should be as limited as possible. Amendment 32
Recital 39
(39) Close coordination should be ensured with other(39) The measures provided for in this Regulation should apply without prejudice to existing Community legislation, in particular Directive [...] of the European Parliament and of the Council of ... establishing a framework for Community action to achieve a sustainable use of pesticides Community legislation, in
particular Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residues levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC, and Community legislation on the protection of workers and anyone concerned with the contained use and deliberate release of genetically modified organisms.
1
, Directive 2000/60/EC of the
European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy
2
, Regulation (EC) No 396/2005 of
the European Parliament and of the Council of 23 February 2005 on maximum residues levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC, and Community legislation on the protection of workers and anyone concerned with the
contained use and deliberate release of genetically modified organisms.
_______________ 1
OJ L ...
2
OJ L 327, 22.12.2000, p. 1. Directive as
amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).
Amendment 33
Recital 46 a (new)
(46 a) In particular, the Commission should be empowered to approve active substances, to renew or review their approval, to approve co formulants, to adopt harmonised methods to determine the nature and quantity of active substances, safeners and synergists, and where appropriate of relevant impurities and co formulants, to establish rules for resolving disagreement between Member States on the assessment of equivalence, to adopt guidelines on the organisation of compliance checks at the renewal of an authorisation, to adopt detailed rules for allowing derogations from authorisation of plant protection products for research and development, implementing measures to ensure uniform application of record keeping on production, storage and use of plant protection products, technical or other guidance documents for the implementation of this Regulation and the list of approved active substances. Since those measures are of general scope and are designed to amend non essential elements of this Regulation or to supplement it by the addition of non essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Amendment 34
Article 1
Subject matter Subject matter and purpose This Regulation lays down rules for the authorisation of plant protection products in commercial form and for their placing on the market, use and control within the Community. 1. This Regulation lays down rules for the authorisation of plant protection products in commercial form and for their placing on the market, use and control within the Community. This Regulation lays down both rules for the approval of active substances, safeners and synergists, which plant protection products contain or consist of, and rules for adjuvants and co-formulants. 2. This Regulation lays down both rules for the approval of active substances, safeners and synergists, which plant protection products contain or consist of, and rules for adjuvants and co-formulants. 3. The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment. 4. This Regulation is based on the precautionary principle in order to ensure that substances or products placed on the market do not adversely affect human health or the environment.
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5.The purpose of this Regulation is furthermore to harmonise the rules on the placing on the market of plant protection products in order to harmonise the availability of plant protection products between farmers in different Member States.
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6.Member States may not be prevented from applying the precautionary principle in restricting or prohibiting pesticides.
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7.Member States may establish any pesticide free zones they deem necessary in order to safeguard drinking water resources. Such pesticide free zones may cover the entire Member State.
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8.Member States may impose a ban on the use and marketing of EU authorised pesticides where they are found in measurable quantities outside the root zone.
Amendment 35
Article 2, paragraph 2
-
2.This Regulation shall apply to substances, including micro-organisms and viruses, having general or specific action against harmful organisms or on plants, parts of plants or plant products, hereinafter 'active substances'. 2. This Regulation shall apply to substances, including micro-organisms and viruses, having general or specific action against harmful organisms or on plants, parts of plants or plant products, hereinafter 'active substances'. It shall, however, cease to apply to micro organisms, viruses, pheromones and biological products once a specific regulation on biological control products has been adopted. Amendment 36
Article 3, point 2
(2) 'substances' (2) 'substances' Chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process; Chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process used; Amendment 37
Article 3, point 2 a (new)
(2a) 'active substances'
Substances, including their metabolites present in the use phase, micro organisms and viruses, having general or specific action against target organisms or on plants, parts of plants or plant products;
Amendment 38
Article 3, point 3
(3) 'preparations' (3) 'preparations' Mixtures composed of two or more substances intended for use as a plant protection product or as an adjuvant; Mixtures or solutions composed of two or more substances, at least one of which is an active substance, intended for use as a plant protection product or as an adjuvant;
Amendment 39
Article 3, point 4
(4) 'substance of concern' (4) 'substance of concern' 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. Any substance which has an inherent capacity to cause an adverse effect on humans, animals or the environment. Such substances include, but are not limited to, substances classified as dangerous in accordance with Directive 67/548/EEC, and present in the plant protection product at a concentration leading the product to be regarded as dangerous within the meaning of Article 3 of Directive 1999/45/EC; Such substances include, but are not limited to, substances classified as dangerous in accordance with Directive 67/548/EEC, and regarded as dangerous within the meaning of Article 3 of Directive 1999/45/EC. Any substance that has or potentially has either carcinogenic, mutagenic, endocrine disrupting, neurotoxic, immunotoxic, reprotoxic or genotoxic capabilities should be regarded as a substance of concern; Amendment 40
Article 3, point 4 a (new)
(4a) 'article'
An object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition;
Amendment 41
Article 3, point 4 b (new)
(4b) `advertisement'
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;
Amendment 42
Article 3, point 5
(5) 'plants' (5) 'plants' Live plants and live parts of plants, including fresh fruit, vegetables and seeds; Live plants and live parts of plants, together with seeds for sowing, in particular: fresh fruit, vegetables, flowers, leaves, shoots, living pollen, seedlings, bulbs and roots; Amendment 43
Article 3, point 7 a (new)
(7a) 'low risk'
Of a nature considered inherently unlikely to cause an adverse effect on humans, animals or the environment; Amendment 44
Article 3, point 9
(9) 'placing on the market' (9) 'placing on the market' The holding of a plant protection product 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. Release for free circulation of a plant protection product into the territory of the Community shall be deemed to constitute placing on the market for the purposes of this Regulation; The holding of a plant protection product 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. Release for free circulation of a plant protection product into the territory of the Community, as well as imports, shall be deemed to constitute placing on the market for the purposes of this Regulation; Amendment 45
Article 3, point 9 a (new)
(9a) "parallel trade"
The import of a plant protection product from a Member State where the product has been authorised under the conditions of Directive 91/414/EEC or this Regulation with the intention of placing it on the market in the importing Member State where the plant protection product or an identical reference product has been authorised under the conditions of Directive 91/414/EEC or this Regulation;
Amendment 46
Article 3, point 9 b (new)
(9b) "identical"
Plant protection products shall be considered as identical when they: i) share a common origin, ii) have been manufactured by the same company or by an associated undertaking or under licence ("producer identity"), and
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iii)have at least been manufactured according to the same formulation, using the same active ingredient, and have the same effect, having due regard in particular to differences which may exist in conditions relating to agriculture, human health, plant health and the environment, in particular climatic conditions; Amendment 47
Article 3, point 11 a (new)
(11a) 'importer'
A person importing plant protection products for commercial purposes; Amendment 48
Article 3, point 13 a (new)
(13a) 'health'
A state of complete physical, mental and social well being, and not merely the absence of disease or infirmity;
Amendment 49
Article 3, point 13 b (new)
(13b) 'vulnerable groups'
Persons needing specific consideration when assessing the acute and chronic health effects of plant protection products. These include pregnant and nursing women, embryos and foetuses, infants and children, the elderly, people who are ill and those taking medication, workers and residents subject to high pesticide exposure over the long term;
Amendment 50
Article 3, point 14
(14) 'integrated pest management' (14) 'integrated pest management' Careful consideration of all available pest control techniques and subsequent integration of appropriate measures that discourage the development of pest populations and keep plant protection products and other forms of intervention to levels that are economically justified and reduce or minimise risks to human health and the environment. Integrated pest management emphasises the growth of a healthy crop with the least possible disruption to agro-ecosystems and encourages natural pest control mechanisms;Careful consideration of all available pest control techniques and subsequent integration of appropriate measures that discourage the development of pest populations and keep plant protection products and other forms of intervention to levels that are economically and ecologically justified and reduce or minimise risks to human health and the environment. Integrated pest management emphasises the growth of a healthy crop with the least possible disruption to agroecosystems by giving priority to preventive crop growing measures and the use of adapted varieties and of non chemical methods of plant protection and crop management;
Amendment 51
Article 3, point 14 a (new)
(14a) `non chemical methods of plant protection and pest and crop management'
The use of pest control and management techniques that do not have chemical properties. Non chemical methods of plant protection and pest and crop management include rotation, physical and mechanical control and natural predator management;
Amendment 52
Article 3, point 17
(17) 'zone' deleted Group of Member States, as defined in Annex I, for which it is assumed that the agricultural, plant health and environmental (including climatic) conditions are relatively similar;
Amendment 53
Article 3, point 18
(18) 'Good Plant Protection Practice' (18) 'Good Practice for the Use of Plant Protection Products' Practice whereby the treatments with plant protection products applied to a given crop, in conformity with the conditions of their authorised uses, are selected, dosed and timed to ensure optimum efficacy with the minimum quantity necessary, taking due account of local conditions and of the possibilities for cultural and biological control; Practice whereby the treatments with plant protection products applied to a given crop, in conformity with the conditions of their authorised uses, are selected, dosed and timed to ensure that only the minimum quantity necessary is used, taking due account of local conditions, of the need to prevent the build up of resistance and of the possibilities for cultural and biological control, and giving priority to non chemical methods of plant protection and pest and crop management; Amendment 54
Article 3, point 20 a (new)
(20a) `Good Experimental Practice'
Practice in accordance with Directive 2004/10/EC;
Amendment 55
Article 3, point 21
(21) 'Data protection' (21) 'Data protection' A test or study report is covered by data protection where its owner has the right to prevent it being used for the benefit of another person. A test or study report, other than those involving tests on vertebrate animals and other tests or studies that may prevent animal testing, is covered by data protection where its owner has the right to prevent it being used for the benefit of another person. Amendment 56
Article 3, point 21 a (new)
(21a) 'rapporteur Member State'
The Member State which agrees to assume the responsibility for assessing the active substances, or safeners, or synergists. It is required to carry out this task in a professional manner and to publish an
impact assessment report within a specified period.
Amendment 57
Article 3, point 21 b (new)
(21b) `tests and studies'
Investigation or experiment 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;
Amendment 58
Article 3, point 21 c (new)
(21c) `unacceptable effect on the environment'
Any effect that may alter biodiversity and biotopes, inter alia via a disruption to certain species which could ultimately lead to their becoming extinct. Amendment 59
Article 3, point 21 d (new)
(21d) `minor uses'
For the purpose of this Regulation, minor use of a plant protection product in a particular Member State means the use of that product on a crop which is not widely grown in that Member State or on a widely grown crop in order to meet a limited or sporadic and exceptional need.
Amendment 296
Article 4, paragraph 2, point (a)
(a) they shall not have any harmful effects on human health, including vulnerable groups, or animal health, taking into account known cumulative and synergistic effects when the methods to assess such effects are available, or on ground water; (a) they shall not have any harmful effects on human health, in particular that of users who are in direct contact with the products, residents, bystanders and vulnerable groups, or animal health, taking into account known cumulative and synergistic effects, or on groundwater; Amendment 255
Article 4, paragraph 2, point (b)
(b) they shall not have any unacceptable effect on the environment; (b) they shall not have any unacceptable effect on the environment taking into account cumulative and synergistic effects and all relevant exposure routes to organisms in the environment; methods to assess such effects will be presented by the European Food Safety Authority; Amendment 62
Article 4, paragraph 2, point (c)
(c) for residues which are of toxicological or environmental significance(c) for residues of all approved substances, there shall be standardised methods in general use for measuring them which are sufficiently sensitive with respect to any technically detectable levels that could be present in any environmental and biological media , there shall
be methods in general use for measuring them.
. The residues shall be
detectable with the common multi residue methods as applied by EU reference laboratories.
Amendment 297
Article 4, paragraph 3, point (b)
(b) it shall have no immediate or delayed harmful effect on human or animal health, directly or through drinking water, food, feed or air, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects where the methods to assess such effects are available; or on groundwater; (b) it shall have no immediate or delayed harmful effect on human health, in particular that of residents and bystanders and vulnerable groups, or animal health, directly or through drinking water, food, feed or air, including in locations distant from its use following long range transportation, or consequences in the workplace or through other indirect effects, taking into account cumulative and
synergistic effects; or on surface water and groundwater;
Amendment 64
Article 4, paragraph 3, point (e)
(e) it shall have no unacceptable effects on the environment, having particular regard to the following considerations: (e) it shall have no unacceptable effects on the environment, having particular regard to the following considerations: (i) its fate and distribution in the environment, particularly contamination of surface waters, including estuarine and coastal waters, drinking water, groundwater, air and soil, taking into account locations distant from its use following long range environmental transportation;
(i) its fate and distribution in the environment, particularly contamination of surface waters, including estuarine and coastal waters, drinking water, groundwater, air and soil;
(ii) its impact on non-target species, including on the behaviour of those species;
(ii) its impact on non-target species;
(iii) its impact on biodiversity and the ecosystem;
(iii) its impact on biodiversity.
(iiia) its destructive impact on species threatened with extinction.
Amendment 66
Article 4 a (new)
Animal testing
In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort. The use of non animal tests and intelligent testing strategies shall be promoted, and duplicate vertebrate animal testing shall be prohibited.
Amendment 67
Article 6, point (e)
(e) manner of application; (e) manner and conditions of application;
Amendment 68
Article 6, point (ia) (new)
(ia) restrictions or prohibitions for uses not compatible with integrated pest management schemes, or even detrimental to these schemes such as chemical soil treatment;
Amendment 69
Article 7, paragraph 1, subparagraph 1
-
1.The Authority shall be responsible for coordinating the approval procedure.
In doing so, the Authority shall rely on the competent authorities of Member States.
-
1.An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to a Member State (hereinafter referred to as `rapporteur Member State') together with a complete and a summary dossier, as provided for in Article 8(1) and (2), or a letter of access to such dossiers or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4. An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to the Authority together with a complete and a summary dossier, as provided for in Article 8(1) and (2), or a letter of access to such dossiers or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4. The Authority shall inform the competent authorities of the Member States of the applications it has received.
A Member State may choose an active substance for which an application for approval has been received by the Authority, with the aim of becoming the competent authority for the purposes of Articles 9 and 11 (hereinafter referred to as `rapporteur Member State').
In cases where two or more Member States have expressed an interest in becoming the rapporteur Member State and they cannot agree who should be the competent authority, the rapporteur Member State shall be determined in accordance with the regulatory procedure referred to in Article 76(3).
The decision shall be based on objective criteria such as geographic, agricultural and climatic conditions, especially with regard to the target organisms, the performance and impartiality of the competent authority and the reference laboratory, and the absence of interests linked to the producing companies. Amendment 70
Article 7, paragraph 1 a (new)
1a. A natural or legal person established outside the Community who submits an application shall appoint a natural or legal person established in the Community to fulfil, as his only representative, the obligations on producers under this Regulation.
Amendment 71
Article 7, paragraph 1 b (new)
1b. Assessment of an application may be performed by a number of Member States together under the co rapporteur system. Amendment 73
Article 8, paragraph 1, point (b)
(b) for each point of the data requirements for the active substance referred to in Article 75(1)(b), 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; (b) for each point of the data requirements for the active substance referred to in paragraph 3, 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;
Amendment 74
Article 8, paragraph 1, point (c)
(c) for each point of the data requirements for the plant protection product referred to in Article 75(1)(b), 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 referred to in Article 4 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, resulting from the proposed limited range of representative uses of the active substance, may lead to restrictions in the approval;(c) for each point of the data requirements for the plant protection product referred to in paragraph 3, 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 referred to in Article 4 for one or more plant protection products which are representative of the uses referred to in point (a), taking into account the fact that any data gaps in the dossier, as provided for in paragraph 2, resulting from the proposed limited range of representative uses of the active substance, shall lead to non approval of the active substance;
Amendment 75
Article 8, paragraph 1, point (c a) (new)
(ca) for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplicative testing on vertebrate animals; Amendment 76
Article 8, paragraph 2
-
2.The complete dossier shall contain the full text of the individual test and study reports concerning all the information referred to in points (b) and (c) of paragraph 1. It shall not contain any reports of tests or studies involving the deliberate administration of the active substance or the plant protection product to humans. 2. The complete dossier shall contain the full text of the individual test and study reports concerning all the information referred to in points (b) and (c) of paragraph 1.
Amendment 77
Article 8, paragraph 3, subparagraph 2
The data requirements referred to in Article 8(1) shall be defined in Regulations adopted in accordance with the procedure referred to in Article 76(2), incorporating the requirements for active substances and plant protection products in Annexes II and III to Directive 91/414/EEC with any necessary modifications. Similar data requirements shall be defined for safeners and synergists in accordance with the procedure referred to in Article 76(3). The data requirements referred to in paragraph 1 shall be laid down in Regulations adopted in accordance with the advisory procedure referred to in Article 76(2), transferring the requirements for active substances and plant protection products in Annexes II and III to Directive 91/414/EEC with any modifications necessary due to the change from a directive to a regulation. Similar data requirements shall be defined for safeners and synergists in accordance with the procedure referred to in Article 251 of the Treaty. Amendment 78
Article 8, paragraph 3 a (new)
3a. All scientific peer reviewed open literature on the active substance and its metabolites regarding negative side effects on health, the environment and non target species shall be added by the applicant to the dossier.
Amendment 79
Article 9, paragraph 2, subparagraph 1
-
2.Where one or more of the elements provided for in Article 8 are missing, the Member State shall inform the applicant, setting a time period for their submission. 2. Where one or more of the elements provided for in Article 8 are missing, the Member State shall inform the applicant, setting a time period of no longer than three months for their submission. Article 7(3) shall apply. Amendment 80
Article 11, paragraph 1
-
1.Within twelve months of the date of the notification provided for in the first subparagraph of Article 9(3), the rapporteur Member State shall prepare and submit to the Authority a report (hereafter called "draft assessment report") assessing whether the active substance can be 1. The rapporteur Member State may start the evaluation of test and study reports as soon as they are submitted by the applicant, including before the date of the notification provided for in the first subparagraph of Article 9(3). Within twelve months of the date of the notification provided for in the
expected to meet the requirements of Article 4. first subparagraph of Article 9(3), the rapporteur Member State shall prepare and submit to the Authority a report (hereafter called "draft assessment report") assessing whether the active substance can be expected to meet the requirements of Article 4. Where the Member State needs additional information, it shall set a time period for the applicant to supply it. In that case, the twelve-month period shall be extended by the additional time period granted by the Member State. It shall inform the Commission and the Authority. Where the Member State needs additional information, it shall set a reasonable time period for the applicant to supply it along with any claims for data protection pursuant to Article 56. In that case, the twelve-month period shall be extended by the additional time period granted by the Member State. It shall inform the Commission and the Authority. When supplying additional information, the applicant shall at the same time submit any claims for data protection pursuant to Article 56. Article 7(3) shall apply. The Member State may consult the Authority.
The Member State may consult the Authority.
Amendment 81
Article 12, paragraph 1, subparagraph 3
The Authority shall allow a period of ninety days for the submission of written comments. The Authority shall allow a period of sixty days for the submission of written comments. Amendment 82
Article 12, paragraph 2, subparagraph 1
-
2.The Authority shall adopt a conclusion on whether the active substance can be expected to meet the requirements of Article 4 within ninety days of the end of the period provided for in paragraph 1 of this Article and communicate it to the applicant, the Member States and the Commission. 2. The Authority shall adopt a conclusion on whether the active substance can be expected to meet the requirements of Article 4 within ninety days of the end of the period provided for in paragraph 1 of this Article, with due justification, including a reference to the consideration of any public comments, and communicate it to the applicant, the Member States and the Commission. The conclusion shall be published by the Authority within one week after its adoption.
Amendment 83
Article 12, paragraph 2, subparagraph 2
Article 12, paragraph 2, subparagraph 2 Where the Authority needs additional consultations with experts as provided for in paragraph 1, it shall set a time period for concluding the consultations. In that case, the ninety day period shall be extended by the additional period granted by the Authority. It shall inform the Commission and the Member States. Where appropriate, the Authority shall address in its conclusion the risk mitigation options identified in the draft assessment report.
Amendment 84
Article 12, paragraph 3, subparagraph 1
-
3.Where the Authority needs additional information, it shall set a time period for the applicant to supply it. In that case, the ninety day period provided for in paragraph 2 shall be extended by the additional period granted by the Authority. It shall inform the Commission and the Member States. 3. Where the Authority needs additional information, it shall set a time period for the applicant to supply it. In that case, the sixty day period provided for in paragraph 2 shall be extended by the additional period granted by the Authority and by the time necessary for the evaluation of that information by the rapporteur Member State in its draft assessment report. The Authority shall inform the Commission and the Member States. Amendment 85
Article 12, paragraph 3, subparagraph 1 a (new)
Where the Authority needs to organise consultations of experts, the ninety day period provided for in paragraph 2 shall be extended by the time necessary for these consultations. It shall inform the Commission and the Member States.
Amendment 86
Article 13, paragraph 1, subparagraph 1
-
1.Within six months of receiving the conclusion provided for in Article 12(2) from the Authority, the Commission shall present a report, (herinafter referred to as "the review report", to the Committee referred to in Article 76(1), taking into account the draft assessment report by the Rapporteur Member State under Article 11 and the conclusion of the Authority under 1. Within three months of receiving the conclusion provided for in Article 12(2) from the Authority, the Commission shall present a report, (herinafter referred to as "the review report", to the Committee referred to in Article 76(1), taking into account the draft assessment report by the Rapporteur Member State under Article 11 and the conclusion of the Authority under
Article 12. Article 12. Amendment 87
Article 13, paragraph 1, subparagraph 2
The applicant shall be given the possibility to submit comments on the review report. The applicant and any others who have submitted written comments under the procedure provided for in Article 12 (1) shall be given the opportunity to submit comments on the review report.
The review report shall be available to the public and forwarded to the European Parliament.
Amendment 88
Article 13, paragraph 2, introduction and point (a)
-
2.On the basis of the review report provided for in paragraph 1, other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 are relevant, a Regulation shall be adopted in accordance with the procedure referred to in Article 76(3), providing that: 2. On the basis of the review report provided for in paragraph 1, other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 are relevant, a Regulation with due justification shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 76(3a), providing that: (a) an active substance is approved, subject to conditions and restrictions, as referred to in Article 6, where appropriate; (a) an active substance is approved, subject to conditions and restrictions, as referred to in Article 6, where appropriate, and included in Annex IIa; Amendment 89
Article 13, paragraph 3
-
3.The Commission shall maintain a list of approved active substances. 3. The Commission shall maintain an updated list of approved active substances in Annex IIa and publish this list on the Internet. Amendment 90
Article 14, paragraph 2
-
2.The renewal shall be for an unlimited period of time. 2. The approval may be renewed once or repeatedly for a period not exceeding 10 years.
Amendment 91
Article 15, paragraph 1
-
1.The application provided for in Article 14 shall be submitted by a producer of the active substance to a Member State, with a copy to the other Member States, the Commission and the Authority, no later than three years before the expiry of the first approval. 1. The application provided for in Article 14 shall be submitted by a producer of the active substance to the Member State concerned, with a copy to the other Member States, the Commission and the Authority, no later than three years before the expiry of the first approval. Amendment 92
Article 18, point (b)
(b) the necessary data to be submitted; (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; Amendment 93
Article 19
A Regulation, adopted in accordance with the procedure referred to in Article 76(3), shall set out the provisions necessary for the implementation of the renewal and review procedure, including, where relevant, the implementation of a programme of work, as provided for in Article 18. A Regulation, adopted in accordance with the regulatory procedure with scrutiny referred to in Article 76(3a), shall set out the provisions necessary for the implementation of the renewal and review procedure, including, where relevant, the implementation of a programme of work, as provided for in Article 18. Amendment 94
Article 20, paragraph 1, introductory part
-
1.A Regulation shall be adopted in accordance with the procedure referred to in Article 76(3), providing that: 1. A Regulation with due justification shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 76(3a), providing that:
Amendment 95
Article 20, paragraph 2
-
2.Where the reasons for not renewing the approval permit it, the Regulation referred to in paragraph 1 shall provide for a grace period for using up stocks of the plant protection products concerned, which will be such that it does not interfere with the normal period of use of the plant protection product. 2. Where the reasons for not renewing the approval do not concern the protection of health or the environment, the Regulation referred to in paragraph 1 shall provide for a grace period for using up stocks of the plant protection products concerned, which shall be not longer than one year. Past this period, producers shall ensure the removal and safe disposal of the remaining stocks. Amendment 96
Article 20, paragraph 2 a (new)
2a. In the event of a ban or the withdrawal of the approval on health or environmental grounds, the plant protection product concerned shall be disposed of immediately. Amendment 97
Article 21, paragraph 1, subparagraph 1
-
1.The Commission may review the approval of an active substance at any time. 1. The Commission may review the approval of an active substance at any time and shall give due consideration to requests for review from a Member State, the European Parliament and other stakeholders, based on current scientific and technical knowledge and monitoring data. Amendment 98
Article 21, paragraph 1, subparagraph 2 a (new)
The Commission shall review the approval of an active substance where there are indications that the achievement of the objectives established in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC may be compromised.
Amendment 99
Article 21, paragraph 3, subparagraph 1
-
3.Where the Commission concludes that the criteria referred to in Article 4 are no longer satisfied, or the further information required in accordance with point (f) of Article 6 has not been provided, a Regulation to withdraw or amend the approval shall be adopted in accordance with the procedure referred to in Article 76(3). 3. Where the Commission concludes that the criteria referred to in Article 4 are no longer satisfied, or the further information required in accordance with point (f) of Article 6 has not been provided, a Regulation to withdraw or amend the approval shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 76(3a). Amendment 100
Article 21, paragraph 3 a (new)
3a. Where the Commission concludes that the objectives of reducing pollution from priority substances established in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC cannot be met, a Regulation to withdraw or amend the approval shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 76(3a) of this Regulation. Amendment 101
Article 22, paragraph 1
-
1.By way of derogation from Article 5, an active substance complying with the criteria provided for in Article 4 shall be approved for a period not exceeding 15 years, where it may be expected that plant protection products containing that substance will pose only a low risk to human and animal health and the environment, as provided for in Article 46(1). 1. By way of derogation from Article 5, an active substance complying with the criteria provided for in Article 4 shall be approved for a period not exceeding 15 years, where it will have no adverse effect on human and animal health and the environment, as provided for in Article 46(1).
Amendment 301
Article 22, paragraph 1, subparagraph 1 a (new)
This derogation shall not apply to any active substance classified in accordance with Directive 67/548/EEC as:
carcinogenic,
mutagenic, toxic to reproduction,
sensitising chemicals,
or to substances that are qualified as:
persistent with a half life of more than 60 days,
endocrine disrupters appearing on the EU
list of suspected endocrine disrupters,
toxic,
bioaccumulative and non readily
degradable.
*
No later than ..., the Commission shall review and if necessary specify the criteria for treating an active substance as a low risk substance and, if appropriate, submit proposals.
*
One year after the entry into force of this Regulation.
Amendment 103
Article 22, paragraph 1 a (new)
1a. Notwithstanding Article 5, active substances based on biological control agents which comply with the criteria of Article 4 shall be given approval for a period not exceeding 15 years where plant protection products containing such biological control agents are expected to present only a low risk to human and animal health and the environment as defined in Article 46(1).
Amendment 104
Article 23, paragraph 1, introductory part
-
1.Basic substances shall be approved in accordance with paragraphs 2 to 6. By way of derogation from Article 5, the approval shall be for an unlimited period of time. For the purpose of those paragraphs, a basic substance is an active substance which 1. Basic substances shall be approved in accordance with paragraphs 2 to 6. For the purpose of those paragraphs, a basic substance is an active substance which: Amendment 274
Article 23, paragraph 1, subparagraph 1 a (new)
For the purpose of this Regulation, an active substance which fulfils the criteria of a 'foodstuff' as defined in Article 2 of Regulation (EC) No 178/2002* shall be considered as a basic substance.
Regulation (EC) No 178/2002 of the *
European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
Amendment 105
Article 23, paragraph 2
-
2.By way of derogation from Article 5, a basic substance shall be approved where any relevant evaluations carried out in accordance with other Community legislation, regulating the use of that substance for purposes other than as a plant protection product, show that the substance has neither an immediate or delayed harmful effect on human or animal health nor an unacceptable effect on the environment. 2. A basic substance shall be approved in accordance with Article 4 and where any relevant evaluations carried out in accordance with other Community legislation, regulating the use of that substance for purposes other than as a plant protection product, show that the substance has neither an immediate or delayed harmful effect on human or animal health nor an unacceptable effect on the environment, provided that each point of the data requirements for active substances contained in plant protection products is given and the same decision making procedures apply.
Amendment 106
Article 24, paragraph 1, subparagraph 1
-
1.By way of derogation from Article 5 and Article 14(2), an active substance complying with the criteria provided for in Article 4 shall be approved for a period not exceeding seven years, where other already approved active substances are significantly less toxic for consumers or operators or present significantly fewer risks for the environment. The assessment shall take account of the criteria laid down in point 4 of Annex II. 1. By way of derogation from Article 5 and Article 14(2), an active substance complying with the criteria provided for in Article 4 shall be approved once for a period not exceeding five years, where other already approved active substances or alternative agricultural methods or practices are significantly less toxic for consumers or operators or present significantly fewer risks for the environment. The assessment shall take account of the criteria laid down in point 4 of Annex II. Amendment 107
Article 25, paragraph 1 a (new)
1a. For approval of a safener or synergist, paragraph 1 shall be deemed to be satisfied where compliance with Article 4 has been established with respect to one or more representative uses of at least one plant protection product for every different active substance the safener or synergist is combined with. Amendment 108
Article 26
Within 5 years of the entry into force of this Regulation, a Regulation shall be adopted in accordance with the procedure referred to in Article 76(3) establishing a programme of work for the gradual review of synergists and safeners on the market when that Regulation enters into force. The regulation shall include the establishment of data requirements, notification, evaluation, assessment and decisionmaking procedures It shall require interested parties to submit all the necessary data to the Commission, the Authority and the Member States within a specified time period. Within 2 years of the entry into force of this Regulation, a Regulation shall be adopted in accordance with the procedure referred to in Article 251 of the Treaty establishing a programme of work for the gradual review of synergists and safeners on the market when that Regulation enters into force. The regulation shall include the establishment of data requirements, including measures to minimise animal testing, notification, evaluation, assessment and decision-making procedures. It shall require interested parties to submit all the necessary data to the Commission, the Authority and the Member States within a specified time period.
Amendment 109
Article 27
ProhibitionCo Formulants 1. A co-formulant shall be prohibited where it has been established that:1. A co-formulant shall be approved where it has been established that: (a) its residues, consequent on application consistent with good plant protection practice, have a harmful effect on human or animal health or on groundwater or an unacceptable effect on the environment; or (a) the co formulant or its residues, consequent on application consistent with realistic conditions of use, do not have a harmful effect on human or animal health or on groundwater or an unacceptable effect on the environment; and (b) its use, consequent on application consistent with good plant protection practice and having regard to realistic normal conditions of use, has a harmful effect on human or animal health or an unacceptable effect on plants, plant products or the environment. (b) its use, consequent on application consistent with good plant protection product practice and having regard to realistic conditions of use, does not have a harmful effect on human or animal health or an unacceptable effect on plants, plant products or the environment. 2. Co-formulants prohibited pursuant to paragraph 1 shall be included in Annex III in accordance with the procedure referred to in Article 76(3). 2. Co-formulants approved pursuant to paragraph 1 shall be included in Annex III in accordance with the regulatory procedure with scrutiny referred to in Article 76(3a). Amendment 110
Article 27, paragraph 2 a (new)
2a. Where a co formulant is used in a plant protection product authorised under this Regulation, its specific use in plant protection products shall be considered as being registered in accordance with Article 15 (1) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
1
.
____________
1
OJ L 396, 30.12.2006, p. 1. Corrected in OJ L 136,
29.5.2007, p. 3.
Amendment 111
Article 28, paragraph 2, point (b)
(b) placing on the market and use of plant protection products for research or development purposes in accordance with Article 51; (b) use of plant protection products for research or development purposes in accordance with Article 51; Amendment 113
Article 29, paragraph 1, point (c)
(c) its co-formulants have not been prohibited under Article 27; (c) its co-formulants have been approved under Article 27; Amendment 114
Article 29, paragraph 1, point (c a) (new)
(ca) its (technical) formulation is such that user exposure or other risks are limited as much as possible without compromising the functioning of the product;
Amendment 115
Article 29, paragraph 1, point (e a) (new)
(ea) all metabolites of the active substance(s) present in the use phase have been determined and comply with criteria of the uniform principles referred to in paragraph 6;
Amendment 116
Article 29, paragraph 1, point (f)
(f) its residues, resulting from authorised uses, and which are of toxicological, ecotoxicological or environmental significance, can be determined by appropriate methods in general use; (f) its residues, resulting from authorised uses, can be determined by standardised methods in general use in all Member States, which are sufficiently sensitive with respect to any technically detectable levels that could be present in any environmental and biological media. The residues shall be detectable with the common multi residue methods as applied by EU reference laboratories;
Amendment 117
Article 29, paragraph 1, point (h a) (new)
(ha) its authorisation does not counteract the national plans developed under Directive 2007/XXX/EC [establishing a framework for Community action to achieve a sustainable use of pesticides].
Amendment 118
Article 29, paragraph 2
-
2.By way of derogation from point (a) of paragraph 1, a Member State may, during a period of 5 years following the adoption of the programme of work referred to in Article 26 authorise the placing on the market in its territory of plant protection products containing synergists and safeners which are not approved, but which are included in that programme.deleted Amendment 119
Article 29, paragraph 5
-
5.With respect to point (e) of paragraph 1, harmonised methods may be adopted in accordance with the procedure referred to in Article 76(3). 5. With respect to point (e) of paragraph 1, harmonised methods may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 76(3a). Amendment 120
Article 29, paragraph 6
-
6.Uniform principles for evaluation and authorisation of plant protection products shall be defined in Regulations adopted in accordance with the procedure referred to in Article 76(2), incorporating the requirements in Annex VI to Directive 91/41 4/EEC with any necessary modifications. 6. Uniform principles for evaluation and authorisation of plant protection products shall be defined in a Regulation of the European Parliament and of the Council, incorporating the requirements in Annex VI to Directive 91/414/EEC with any necessary modifications.
Amendment 121
Article 29, paragraph 6, subparagraph 1 a (new)
The uniform principles shall take due account of the interaction between the active substance, safeners, synergists and co formulants.
Amendment 281
Article 29, paragraph 6 a (new)
6a. By way of derogation from paragraph 1(a), Member States may pre authorise a product evaluated by a rapporteur Member State on the basis of the criteria set out in this Regulation. A pre authorisation may be granted for a period of not more than three years if, two and a half years after submission of the application pursuant to Article 7(1), no decision has yet been taken on the authorisation of the active substance. A Member State may start its evaluation regarding a pre authorisation as soon as there is evidence that the deadlines for the substance authorisation will not be met. The pre authorisation shall be restricted to specific crops:
(a) that have been evaluated by the rapporteur Member State, and where the rapporteur Member State considers that the use on these crops is safe, that the active substance can satisfy the requirements of Article 4(2) and (3) and that the plant protection product satisfies the requirements of Article 29(1) (b) to (g); and
(b) where MRLs have been set in line with Regulation (EC) No 396/2005, and included in Annex II or III to that Regulation.
Amendment 122
Article 30, title and paragraph 1
Contents Contents of the authorisation 1. The authorisation shall define the crops on which and the purposes for which the plant protection product may be used. 1. The authorisation, which shall use a standardised form, shall define the crops on which and the purposes for which the plant protection product may be used. Amendment 305
Article 30, paragraph 2
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2.The authorisation shall set out the requirements relating to the placing on the market and use of the plant protection product. Those requirements shall include the conditions of use necessary to comply with the conditions and requirements provided for in the Regulation approving the active substances, safeners and synergists. The authorisation shall include a classification of the plant protection product for the purpose of Directive 1999/45/EC. 2. The authorisation shall set out the requirements relating to the placing on the market and use of the plant protection product. Those requirements shall as a minimum include: (a) the conditions of use necessary to comply with the conditions and requirements provided for in the Regulation approving the active substances, safeners and synergists and the requirements and conditions for plant protection products set out in Article 4(3); (b) a classification of the plant protection product pursuant to Directive 1999/45/EC;
(c) indications for proper use according to the principles of Integrated Pest Management as defined in Article 3, to apply from 2012 onwards.
Amendment 124
Article 30, paragraph 2, subparagraph 1 a (new)
These requirements shall in any case cover:
the maximum dose per hectare in each application;
the period between the last application
and harvest;
the number of applications per year. Amendment 126
Article 30, paragraph 3, point (a)
(a) a restriction of the product with respect to the distribution and use of the plant protection product to protect the health of the distributors, users and workers concerned; (a) a restriction of the product with respect to the distribution and use of the plant protection product to protect the health of the distributors, users, workers, residents, bystanders and consumers concerned, animal health or the environment; Amendment 127
Article 30, paragraph 3, point (b a) (new)
(ba) any restrictions or prohibitions of pesticide use in and around areas used by the general public or by sensitive population groups, such as residential areas, parks, public gardens, sports grounds, school grounds, children's playgrounds etc.
Amendment 303
Article 30, paragraph 3, point (b b) (new)
(bb) other restrictions or conditions relevant to the issue of an authorisation and to the use of the plant protection product, particularly where these are intended to protect the health of distributors, users, workers, residents, bystanders and consumers or animal health or the environment. Amendment 128
Article 32, paragraphs 1 and 2
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1.A person who wishes to place a plant protection product on the market shall apply for an authorisation, in person or via a representative, to each Member State where the plant protection product is intended to be placed on the market. 1. A person who wishes to place a plant protection product on the market shall apply for an authorisation, in person or via a representative, to each Member State where the plant protection product is intended to be placed on the market.
The person who wishes to place a plant protection product on the market shall notify the Commission. This notification shall include the information referred to in paragraph 2 and the summary dossier referred in paragraph 3(a). 2. The application shall include the following: 2. The application shall include the following: (a) a list of the zones and the Member States where the applicant has made an application; (a) a list of the Member States where the applicant has made an application; (b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned;
(c) a certified copy of any authorisations already granted for that plant protection product in a Member State.(c) a certified copy of any authorisations already granted for that plant protection product in a Member State. Amendment 129
Article 32, paragraph 3, point (b)
(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; and (b) for each active substance, safener and synergist, co formulant and adjuvant 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, co formulant and adjuvant, as well as a complete and summary dossier on the combined effect of the active substance(s), safener(s) and synergist(s), co formulant(s) and adjuvant(s) contained in the plant protection product. Amendment 130
Article 32, paragraph 3, point (c)
(c) for each test or study involving vertebrate animals, a justification of the steps taken to avoid duplicative testing; (c) for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplicative testing on vertebrate animals;
Amendment 131
Article 32, paragraph 5, subparagraph 2
On request, the applicant shall provide the Member State with samples of the plant protection product and analytical standards of its ingredients. On request, the applicant shall provide the Member States involved in the assessment with samples of the plant protection product and analytical standards of its ingredients. Amendment 132
Article 32, paragraph 5 a (new)
5a. On request, the applicant shall provide any other Member States with the complete dossier referred to in paragraph 3(a).
Amendment 133
Article 32, paragraph 5 b (new)
5b. Application forms shall be standard in all Member States.
Amendment 134
Article 34
The application shall be examined by the Member State proposed by the applicant, unless another Member State in the same zone agrees to examine it. The Member State which will examine the application shall inform the applicant. The application shall be examined by the Member State where the applicant submits the application, unless another Member State volunteers to examine it. The Member State which will examine the application shall inform the applicant. At the request of the Member State examining the application, the other Member States in the same zone to which an application has been submitted shall cooperate to ensure a fair division of the workload. At the request of the Member State examining the application, the other Member States shall cooperate to ensure a fair division of the workload. The other Member States within the zone to which an application has been submitted shall refrain from proceeding with the file pending assessment by the Member State examining the application. The other Member States shall have the right to send their comments to the Member State examining the application.
Amendment 135
Article 34 a (new)
Article 34 a
Database of the Authority
Upon being informed which Member State will examine the application, the applicant shall immediately forward to the Authority the complete and the summary dossiers referred to in Article 32(3)(a) and (b) and the information referred to in Article 32(3)(c).
The Authority shall without delay make available to the public the summary dossiers, excluding any information which is confidential under Article 60, and the information referred to in Article 32(3)(c).
Amendment 136
Article 35, paragraph 1, subparagraphs 1 and 2
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1.The Member State examining the application shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge. 1. The Member State examining the application shall make an independent, objective and transparent assessment in the light of the accepted scientific and technical guidelines and requirements existing at the time of application without prejudice to Article 21. It shall apply the uniform principles for evaluation and authorisation of plant protection products, referred to in Article 29(6), to establish whether the plant protection product meets the requirements provided for in Article 29, where used in accordance with Article 52, and under all realistic normal conditions of use, and the consequences of its use under the authorised conditions. It shall apply the uniform principles for evaluation and authorisation of plant protection products, referred to in Article 29(6), to establish whether the plant protection product meets the requirements provided for in Article 29, where used in accordance with Article 52, and under all realistic conditions of use, and the consequences of its use under the authorised conditions.
Amendment 137
Article 35, paragraph 1, subparagraph 3
The Member State examining the application shall make available its assessment to the other Member States within the same zone to which an application has been made. The Member State examining the application shall make available its assessment to the other Member States. Amendment 138
Article 35, paragraph 2
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2.The Member States concerned shall grant or refuse authorisations accordingly on the basis of the conclusions of the assessment of the Member State examining the application as provided for in Articles 30 and 31. The Member States shall authorise the plant protection product concerned under the same conditions, including classification for the purpose of Directive 1999/45/EC, as the Member State examining the application. 2. Without prejudice to Articles 30 and 31, where a plant protection product has already been authorised in one Member State, the other Member States shall decide whether and under which conditions to authorise the plant protection product concerned within 180 days of receiving an application. Amendment 139
Article 35, paragraph 3
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3.By way of derogation from paragraph 2 and subject to Community law, additional conditions may be imposed with respect to the requirements referred to in Article 30(3). 3. By way of derogation from paragraph 2 and subject to Community law: (a) Member States may subject approval to specific conditions and restriction of use, if there is substantiated, scientific evidence that due to specific conditions of use, use patterns, nutritional habits or other relevant circumstances the conditions and restriction in the original authorisation are not sufficient;
(b) additional conditions may be imposed with respect to the requirements referred to in Article 30(3).
Amendment 140
Article 36, paragraph 1, subparagraph 2
Where the Member State needs additional information, it shall set a time period for the applicant to supply it. In that case, the twelve-month period shall be extended by the additional time period granted by the Member State. Where the Member State needs additional information, it shall set a time period for the applicant to supply it. In that case, the twelve-month period shall be extended by the additional time period granted by the Member State, which may not exceed four months. Amendment 141
Article 37, paragraph 4, subparagraph 1
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4.Where the Member States concerned do not reach agreement within 90 days the Member State examining the application for authorisation shall submit the matter to the Commission. A decision on whether the conditions referred to in Article 29(1)(b) are complied with shall be adopted in accordance with the procedure referred to in Article 76(2). The 90 day period begins on the date on which the Member State examining the application for authorisation informed the rapporteur Member State that it does not agree with the conclusion of the latter, in accordance with paragraph 3. 4. Where the Member States concerned do not reach agreement within 180 days the Member State examining the application for authorisation shall submit the matter to the Commission. A decision on whether the conditions referred to in Article 29(1)(b) are complied with shall be adopted in accordance with the regulatory procedure referred to in Article 76(3). The 180 day period begins on the date on which the Member State examining the application for authorisation informed the rapporteur Member State that it does not agree with the conclusion of the latter, in accordance with paragraph 3. Amendment 142
Article 37, paragraph 5
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5.Detailed rules for the implementation of paragraphs 1 to 4 may be established in accordance with the procedure referred to in Article 76(3), after consultation of the Authority. 5. Detailed rules for the implementation of paragraphs 1 to 4 may be established in accordance with the regulatory procedure with scrutiny referred to in Article 76(3a), after consultation of the Authority.
Amendment 143
Article 38, paragraph 1, subparagraph 1 a (new)
Not later than ...*, the Commission shall present a proposal introducing a standardised format for the documentation provided for in points (a), (b) and (c). _____ * 12 months after the entry into force of this Regulation.
Amendment 144
Article 38, paragraph 1 a (new)
1a. Member States shall, without delay, make available to the Authority a file containing the documentation provided for in points (a), (b) and (c) of paragraph 1. The Authority shall maintain a register in which all authorisations in the different Member States are registered.
Amendment 145
Article 38, paragraph 2
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2.On request, Member States shall, without delay, make available to the other Member States, the Authority and the Commission a file containing the documentation provided for in points (a), (b) and (c) of paragraph 1. 2. To facilitate the decision making process described in Article 35(2), Member States having granted an authorisation shall, without delay, make available to the other Member States and the Commission a file containing the documentation provided for in points (a), (b) and (c) of paragraph 1 of this Article. Amendment 146
Article 38, paragraph 2 a (new)
2a. Within 12 weeks of a decision on the authorisation of a plant protection product, Member States shall make available a record of the administrative decision as referred to in point (c) of paragraph 1 on a public web site.
Amendment 147
Article 39, paragraph 1
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1.The holder of an authorisation may apply for an authorisation for the same plant protection product and for the same use in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases: 1. The holder of an authorisation may apply for an authorisation for the same plant protection product and for the same use in another Member State under the mutual recognition procedure provided for in this subsection.
(a) the authorisation was granted by a Member State (reference Member State)which belongs to the same zone; or
(b) the authorisation was granted by a Member State for use in greenhouses or as post harvest treatment, regardless of the zone to which the reference Member State belongs.
Amendment 148
Article 40, paragraph 1
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1.The Member State to which an application under Article 39 is submitted shall authorise the plant protection product concerned under the same conditions including classification for the purpose of Directive 1999/45, as the reference Member State. 1. The Member State to which an application under Article 39 is submitted shall examine thoroughly the assessment undertaken by the reference Member State against the circumstances in its own territory. Amendment 149
Article 40, paragraphs 1 a and 1 b (new)
1a. The Member State shall grant the authorisation under conditions relevant to that Member State or refuse to grant the authorisation if Article 29 is not fulfilled in that Member State.
1b. The authorisation may be subject to provisions resulting from the implementation of other measures in accordance with Community law, relating to the conditions for distribution and use of plant protection products intended to protect the health of the distributors, users and workers concerned.
Amendment 150
Article 40, paragraph 1 c (new)
1c. The authorisation may be subject to additional requirements when relevant agricultural, plant health and environmental (including climatic) conditions in the Member State make these requirements necessary in order to comply with Article 29.
These use conditions should in any case cover:
the dose per hectare in each application;
the period between the last application
and harvest;
the number of applications per year;
prescription of the need of spraying;
the level of danger/risk for human health (cumulative effects);
protection of groundwater and
biodiversity.
Amendment 152
Article 40, paragraph 2 a (new)
2a. Where a Member State believes a plant protection product authorised by another Member State cannot meet the requirements set out in Article 29 or would counteract the objectives of its National Pesticide Action Plan, and consequently proposes to refuse the authorisation, it shall notify the Commission, the other Member States and the applicant.
Amendment 153
Article 41, paragraph 1, point (c a) (new)
(ca) at the request of the Member State a complete dossier as required in Article 32(3).
Amendment 154
Article 41, paragraph 2
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2.The Member State to which an application under Article 39 is submitted shall decide on the application within 90 days. 2. The Member State to which an application under Article 39 is submitted shall decide on the application within 180 days. Amendment 155
Chapter III, Section 1, Subsection 4, title
RENEWALANDWITHDRAWAL RENEWAL, AMENDMENTAND WITHDRAWAL
Amendment 156
Article 42, paragraph 3, point (a)
(a) any new information required as a result of amendments in data requirements or criteria; (a) any new information referred to in the renewal Regulation, as mentioned in Article 20, or required as a result of amendments in data requirements or criteria; Amendment 157
Article 42, paragraph 3, point (b)
(b) justification 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; (b) justification 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 the approval; Amendment 158
Article 42, paragraph 5
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5.Guidelines on the organisation of compliance checks may be established in accordance with the procedure referred to in Article 76(2). 5. Guidelines on the organisation of compliance checks may be established in accordance with the regulatory procedure with scrutiny referred to in Article 76(3a).
Amendment 159
Article 43, paragraph 1 a (new)
1a. Member States shall review an authorisation where there are indications that the achievement of the objectives established in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC may be compromised.
Amendment 160
Article 43, paragraph 3, point (c a) (new)
(ca) on the basis of developments in scientific and technical knowledge the manner of use and amounts used can be modified.
Amendment 161
Article 43, paragraph 4
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4.Where a Member State withdraws or amends an authorisation in accordance with paragraph 3, it shall immediately inform the holder of the authorisation, the other Member States, the Authority and the Commission. The other Member States belonging to the same zone shall withdraw or amend the authorisation accordingly. Article 45 shall apply where appropriate. 4. Where a Member State withdraws or amends an authorisation in accordance with paragraph 3, it shall immediately inform the holder of the authorisation, the other Member States, the Authority and the Commission. Amendment 162
Article 45, paragraph 2
Where the reasons for withdrawal, amendment or not renewing the authorisation permit, grace periods for using up stocks of the plant protection products concerned shall be such that they do not interfere with the normal period of use of the plant protection product. Where the reasons for withdrawal, amendment or not renewing the authorisation are not related to the protection of human and animal health or the environment, grace periods for using up stocks of the plant protection products concerned shall be granted for a period not longer than one season. If the reasons for withdrawal, amendment or not renewing the authorisation are related to the protection of human and animal health or the environment then there shall be no
time period for using up stocks of the plant protection products concerned and all sales and use of such products shall cease with immediate effect once the decision of withdrawal or non renewal has been taken.
Amendment 163
Article 45 a (new)
Article 45a
Disposal and destruction of unauthorised
plant protection products
Notwithstanding the provisions of Article 45, stocks of unauthorised plant protection products shall be safely disposed of and destroyed under the responsibility of the former authorisation holder. Amendment 164
Article 45 b (new)
Article 45b
Imports
Imported non food materials or articles shall not contain residues of active substances that have not been approved in accordance with the provisions of this Regulation.
Amendment 165
Article 46, paragraph 1, point (a a) (new)
(aa) the low risk active substances contained in it have no adverse effect on humans, animals or the environment; Amendment 166
Article 46, paragraph 3, subparagraph 2
The period shall be 60 days where an authorisation has already been granted for the same low-risk plant protection product by another Member State located in the same zone. The period shall be 60 days where an authorisation has already been granted for the same low-risk plant protection product by another Member State.
Amendment 167
Article 46, paragraph 3, subparagraph 3
Where the Member State needs additional information, it shall set a time limit for the applicant to supply it. In that case, the 90day period shall be extended by the additional time limit granted by the Member State. Where the Member State needs additional information, it shall set a time limit for the applicant to supply it. In that case, the 90day period shall be extended by the additional time limit granted by the Member State. The total period may not exceed four months. Amendment 168
Article 46 a (new)
Article 46a
Placing on the market and using
reduced risk plant protection products
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1.Notwithstanding Article 29, a plant protection product shall be authorised as a reduced risk product if it satisfies the following requirements:
(a) at least one of the active substances that it contains is a substance as defined in Article 22 ("Low risk active substances");
(b) all the active substances, protective substances and synergistic products with a low risk that it contains are approved in accordance with Chapter II;
(c) it entails, in the light of scientific or technical knowledge, considerably fewer risks to human or animal health or the environment than a comparable plant protection product that is already authorised;
(d) it is sufficiently active;
(e) it complies with Article 29(1)(b), (c) and (e) to (h).
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2.Applicants for authorisation of a reduced risk plant protection product must demonstrate that it meets the conditions in paragraph 1 and enclose with the application a detailed and a summary dossier for each point of the details required for the active substance and the plant protection product.
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3.The Member State shall decide within 120 days whether to approve an application for authorisation for a reduced risk plant protection product.
This period shall be 90 days if another Member State from the same zone has already granted authorisation for the same reduced risk plant protection product.
If the Member State requires additional information, it shall set a deadline by which the applicant must provide the information. In such a case the period of 120 days shall be extended by the additional period that the Member State has granted.
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4.Unless stated otherwise, all the provisions of this Regulation relating to authorisations shall apply.
Amendment 169
Article 48, paragraph 1, introductory part and points (a) and (b)
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1.Member States shall not authorise a plant protection product containing a candidate for substitution where a comparative assessment weighing up the risks and benefits, as set out in Annex IV, shows that: 1. Member States shall not authorise for use in a given crop a plant protection product either containing a candidate for substitution or posing a higher risk where a comparative assessment weighing up the risks and benefits, as set out in Annex IV, shows that: (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; (a) for the uses specified in the application an authorised plant protection product, or a non-chemical control or prevention method, having equivalent efficacy is already
authorised and is significantly safer for human or animal health or the environment;
(b) the plant protection product or nonchemical control or prevention method referred to in point (a) does not present significant economic or practical disadvantages; (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;
Amendment 170
Article 48, paragraph 1, point (c)
(c) the chemical diversity of the active substances is adequate to minimise the occurrence of resistance in the target organism. (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. Amendment 171
Article 48, paragraph 1, subparagraph 1 a (new)
While Member States shall not authorise any plant protection product where a comparative assessment shows the existence of safer alternatives, priority in comparative assessment and substitution shall be given to candidates for substitution. Amendment 173
Article 48, paragraph 4
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4.Where a Member State decides to withdraw or amend an authorisation pursuant to paragraph 3, that withdrawal or amendment shall take effect four years after the decision of the Member State or at the end of the approval period of the candidate for substitution where that period ends earlier. 4. Where a Member State decides to withdraw or amend an authorisation pursuant to paragraph 3, that withdrawal or amendment shall take effect two years after the decision of the Member State or at the end of the approval period of the candidate for substitution where that period ends earlier. Amendment 175
Article 49, paragraph 2 a (new)
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2.Member States may, after authorisation by the Commission, adopt specific measures to facilitate the submission of applications to extend the authorisation for and the submission of applications relating to minor uses.
Amendment 176
Article 49, paragraph 3, point (d)
(d) the documentation and information to support an extension of use has been submitted by the persons or bodies referred to in paragraph 2. (d) the documentation and information to support an extension of use has been submitted by the persons or bodies referred to in paragraph 2. The studies necessary in order to determine maximum residue levels may be carried out by scientific institutes or official bodies. Amendment 177
Article 49, paragraph 4, subparagraph 1 a (new)
Extensions on the basis of this Article shall be separately identified and separate reference shall be made to liability restrictions.
Amendment 179
Article 49, paragraph 5
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5.When Member States grant an extension of authorisation for a minor use, they shall inform the authorisation holder and request him to change the labelling accordingly. 5. When Member States grant an extension of authorisation for a minor use, they shall inform the authorisation holder, who shall change the labelling accordingly. Where the authorisation holder declines, the Member States shall ensure that users are fully and specifically informed as to instructions for use, by means of an official publication or an official website. Where the authorisation holder declines, the Member States shall ensure that users are fully and specifically informed as to instructions for use, by means of an official publication or an official website. The label shall indicate that such uses have not been evaluated for efficacy or phytotoxicity. Without prejudice to Article 70, the authorisation holder shall not be liable for any losses arising from use in accordance with extensions of authorisation.
Amendment 180
Article 49, paragraph 6
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6.Member States shall establish and regularly update a list of minor uses. 6. Member States shall establish and regularly update a list of minor uses. This list shall be made available to the public through official websites of the Member State and of the Commission. .
Amendment 276
Article 49, paragraph 6 a (new)
6a. The Commission shall, not later than ...
*
, present a proposal to the European
Parliament and the Council for establishing a European promotion fund for minor uses. The Fund shall also be entitled to finance additional residue tests for minor uses.
________
*
One year after the entry into force of this
Regulation.
Amendment 286
Article 49 a (new)
Article 49a
Parallel trade
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1.A plant protection product that is authorised in one Member State (Member State of origin) may, subject to an application for a parallel trade permit, be introduced, placed on the market and used in another Member State (Member State of introduction), if that Member State determines that the plant protection product is identical in composition to a plant protection product already authorised in the Member State of introduction (reference product). The application shall be submitted to the regulatory authority in the Member State of introduction (competent authority).
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2.A parallel trade permit shall be granted within 90 working days after receiving a complete application. Member States shall on request provide each other with the information necessary to assess identicality within 10 working days of receiving the request. The procedure for granting a parallel trade permit shall be interrupted from the day the request for information is sent to the competent authority of the Member State of origin until the complete information required is delivered to the competent authority. 3. Member States shall grant a parallel trade permit under a simplified procedure if the plant protection product to be introduced is identical to the reference product in specification and content of the active substances, safeners and synergists, in type of formulation and in composition of the plant protection product. 4. Active substances, safeners and synergists shall be considered as identical in terms of paragraph 3 if: (a) they have been manufactured by the same company or by an associated undertaking or under licence according to the same manufacturing process; and
(b) they have either the same specification, or specifications approved to be equivalent under the procedure referred to in Article 37.
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5.The plant protection product to be introduced and the reference product shall be considered as identical in composition in terms of paragraph 3 if:
(a) the co formulants are identical in all respects; or
(b) varying co formulants do not have more harmful effects within the meaning of Article 4(3) with due regard, in particular, to differences which may exist in conditions relating to agriculture, plant health and the environment, in particular climatic conditions, relevant to the use of the product.
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6.The criteria and the procedures for evaluating to what extent the compositions are identical may be described in detail in accordance with the procedure referred to in Article 76(3).
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7.The application for a parallel trade permit shall include the following:
Member State of origin,
name and address of the applicant,
name and address of a contact person in
the Member State of introduction, if the applicant is not established there,
name to be given to the plant protection
product to be distributed in the Member State of introduction,
name and registration number of the
plant protection product in the Member State of origin,
name and address of the authorisation
holder in the Member State of origin,
original 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. The competent authority may require a translation of the relevant parts of the original instructions for use,
name and registration number of the
reference product,
name and address of the authorisation
holder of the reference product,
a draft label for the product intended to be placed on the market,
a sample of the product which is intended
to be introduced if it is considered as necessary by the competent authority.
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8.The applicant for a parallel trade permit may demonstrate by means of all available and accessible information that the plant protection product intended to be introduced is identical in terms of paragraphs 3, 4 and 5 to the reference product.
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9.A plant protection product for which a parallel trade permit has been issued is to be placed on the market and used in accordance with the provisions of the authorisation of the reference product. To meet the requirements of Article 29 and to facilitate monitoring and controls in terms of Article 65 the competent authority may lay down additional requirements for the product to be introduced. 10. The parallel trade permit shall be valid for the duration of authorisation of the reference product. If the authorisation holder of the reference product applies for a withdrawal of authorisation in accordance with Article 44(1) and the requirements of Article 29 are still fulfilled, the validity of the parallel trade permit will expire by the date on which the authorisation of the reference product would normally have expired.
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11.Without prejudice to specific provisions in this Article, Articles 43 to 45, 52 and 53(4) and Chapters VI to X shall apply to parallel traded plant protection products correspondingly.
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12.Without prejudice to Article 43 a parallel trade permit may be withdrawn if
the authorisation of the introduced plant
protection product is withdrawn in the Member State of origin for reasons of safety or efficacy,
the parallel trade permit is misused by the
applicant to introduce or place on the market plant protection products which are not authorised in any Member State.
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13.Where, with regard to the criteria provided for in paragraphs 3, 4 and 5, the assessment carried out by the Member State of introduction shows that the product intended to be introduced is not identical in terms of paragraph 3, 4 or 5 to the reference product, the Member State of introduction may only grant the authorisation required for placing on the market and use in accordance with Article 28.
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14.The provisions of this Article do not apply to plant protection products which are authorised in the Member State of origin pursuant to Article 50 or 51. Amendment 181
Article 50, title
Agricultural emergency situations Emergency authorisations Amendment 183
Article 51, paragraph 1, subparagraph 1
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1.By way of derogation from Article 28, experiments or tests for research or development purposes involving the release into the environment of an unauthorised plant protection product may be carried out if the Member State in whose territory the experiment or test is to be carried out has assessed the available data and granted an authorisation for trial purposes. The authorisation may limit the quantities to be used and the areas to be treated and may impose further conditions to prevent any harmful effects on human or animal health or any unacceptable adverse effect on the environment, such as the need to prevent entry into the food chain of feed and food containing residues unless a relevant provision has already been established under Regulation (EC) No 396/2005. 1. By way of derogation from Article 28, experiments or tests for research or development purposes involving the release into the environment of an unauthorised plant protection product may be carried out if the Member State in whose territory the experiment or test is to be carried out has assessed the available data and granted an authorisation for trial purposes. Any such experiments or tests must be very strictly controlled to ensure that there will be no immediate or delayed harmful effect on human health, including residents and bystanders and vulnerable groups, such as babies, children, pregnant women, the elderly, people who are ill and those taking medication, or animal health, directly or through drinking water, food, feed or air, including in locations distant from its use following long range transportation, or consequences in the workplace or through other indirect effects, taking into account cumulative and synergistic effects; or on groundwater. The authorisation may limit the quantities to be used and the areas to be treated and may impose further conditions to prevent any harmful effects on human or animal health or any unacceptable adverse effect on the environment, such as the need to prevent entry into the food chain of feed and food containing residues unless a relevant provision has already been established under Regulation (EC) No 396/2005.
Amendment 184
Article 51, paragraph 4
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4.Detailed rules for the application of this Article, in particular the maximum quantities of plant protection products that may be released during experiments or tests and the minimum data to be submitted in accordance with paragraph 2, may be adopted in accordance with the procedure referred to in Article 76(3). 4. Detailed rules for the application of this Article, in particular the maximum quantities of plant protection products that may be released during experiments or tests and the minimum data to be submitted in accordance with paragraph 2, may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 76(3a). Amendment 185
Article 52
Plant protection products shall be used properly. Plant protection products shall be used properly. Proper use shall include compliance with the conditions established in accordance with Article 30 and specified on the labelling, and application of the principles of good plant protection practice as well as, whenever possible, the principles of integrated pest management and good environmental practice. Proper use shall include compliance with the conditions established in accordance with Article 30 and specified on the labelling, and application of the principles of good plant protection practice as well as, whenever possible, the principles of integrated pest management. At the latest by 1 January 2014 proper use of plant protection products shall comply with the principles of integrated pest management, including good plant protection practice and good environmental practise. At the latest by 1 January 2014 proper use of plant protection products shall comply with the principles of integrated pest management, including good plant protection practice and good environmental practise. Detailed rules for the application of this Article including minimum requirements for these principles may be adopted in accordance with the procedure referred to in Article 76(2). Detailed rules for the application of this Article including minimum requirements for these principles may be adopted in accordance with the regulatory procedure referred to in Article 76(3).
Amendment 186
Article 53, paragraph 1, subparagraph 1
-
1.The holder of an authorisation for a plant protection product shall immediately notify the Member States that granted an authorisation of any new information concerning that plant protection product, or an active substance, safener or synergist contained in the plant protection product, which suggests that the plant protection product has harmful effects which might mean that the plant protection product or the active substance, safener or synergist no longer complies with the criteria set out in Articles 29 and 4 respectively. 1. The holder of an authorisation for a plant protection product shall immediately notify the Member States of any new information concerning that plant protection product, or an active substance, safener or synergist contained in the plant protection product, which suggests that the plant protection product has harmful effects which might mean that the plant protection product or the active substance, safener or synergist no longer complies with the criteria set out in Articles 29 and 4 respectively. Amendment 187
Article 53, paragraph 1, subparagraph 2
In particular, potentially harmful effects of that plant protection product, or of residues of an active substance, safener or synergist contained in it, on human or animal health or on groundwater, or their potentially unacceptable effects on plants or plant products or the environment shall be notified. In particular, potentially harmful effects of that plant protection product, or of residues of an active substance, safener or synergist contained in it, on human or animal health or on surface water and groundwater, or their potentially unacceptable effects on plants or plant products and other parts of the environment shall be notified. Amendment 188
Article 53, paragraph 1, subparagraph 3
To this end the authorisation holder shall record and report all suspected adverse reactions in humans related to the use of the plant protection product. To this end the authorisation holder shall record and report all suspected adverse reactions in humans, in animals and the environment related to the use of the plant protection product.
Amendment 189
Article 53, paragraph 3, subparagraph 1
-
3.The first Member State which granted an authorisation within each zone shall evaluate the information received and inform the other Member States, belonging to the same zone, where it decides to withdraw or amend the authorisation under Article 43. 3. The Member State receiving such notification shall immediately pass it on to the other Member States. Without prejudice to the right of Member States to adopt interim protective measures, the Member State which granted an authorisation shall evaluate the information received and inform the other Member States, where it decides to withdraw or amend the authorisation under Article 43. Amendment 190
Article 53, paragraph 4
-
4.The holder of an authorisation for a plant protection product shall report annually to the competent authority of the Member State which authorised his plant protection product any available information relating to the lack of expected efficacy, the development of resistance and to any unexpected effect on plants, plant products or the environment. 4. The holder of an authorisation for a plant protection product shall report annually to the competent authorities of the Member States any available information relating to the lack of expected efficacy, the development of resistance and to any unexpected effect on plants, plant products or the environment. Amendment 191
Article 54, paragraph 1, introduction
1.Member States shall keep information electronically available to the public on plant protection products authorised or withdrawn in accordance with this Regulation, containing at least: 1.Member States shall forward to the Authority, who shall make electronically available to the public, information on plant protection products authorised or withdrawn in accordance with this Regulation, containing at least: Amendment 192
Article 54, paragraph 1, points (e a) and (e b) (new)
(ea) the Member State(s) where the plant protection product has been authorised,
(eb) information on basic environmental and health risks,
Amendment 287
Article 56, paragraph 1, subparagraphs 3 and 4
Where a report is protected, it may not be used, by the Member State which received it, for the benefit of other applicants for plant protection products, except as provided in paragraph 2, in Article 59 or in Article 77. Where a report is protected, it may be used, by the Member State which received it, for the benefit of other applicants for pesticides, except as provided in paragraph 2, in Article 59 or in Article 77. The period of data protection is ten years starting at the date of the first authorisation in that Member State, except as provided in paragraph 2, in Article 59 or in Article 77. That period is extended to 12 years for plant protection products covered by Article 46. The period of data protection shall be ten years starting at the date of the first authorisation in that Member State, except as provided in paragraph 2, in Article 59 or in Article 77. That period shall be extended to 15 years for pesticides covered by Article 46 and 12 years for those covered by Article 46a. Amendment 194
Article 56, paragraph 1, subparagraph 5
A study shall not be protected if it was only necessary for the renewal or review of an authorisation. A study submitted for the renewal or review of an authorisation shall not be protected except where required for the purposes of amending the legislation. Amendment 195
Article 56, paragraph 1, subparagraph 5 a (new)
Data protection shall also apply to third parties who submit tests and study reports for the purpose of minor uses.
Amendment 196
Article 56, paragraph 1 a (new)
1a. The data protection period for the product concerned shall be extended if the first applicant applies for authorisation for derived plant protection products for restricted uses as defined in Article 49(1). The data protection period shall be extended by three months for each new product for limited use. The data protection period may be extended by a maximum of three years.
Amendment 197
Article 56, paragraph 3, introductory part
-
3.Data protection under paragraph 1 shall 3. Data protection under paragraph 1 shall only be granted where the first applicant has claimed data protection at the time of submitting the dossier and has provided to the Member State concerned for each test or study report the following information: only be granted where the first applicant has claimed data protection at the time of submitting the dossier or further information and has provided to the Member State concerned for each test or study report the following information: Amendment 198
Article 56, paragraph 3, point (a)
(a) justification that the test and study reports submitted are necessary for the first authorisation, renewal or review, or for the amendment of the authorisation of a plant protection product; or as a result of changes to legislation;
(a) justification that the test and study reports submitted are necessary for the first authorisation, or for the amendment of the authorisation of a plant protection product;
Amendment 199
Article 56, paragraph 3 a (new)
3a. By way of derogation from paragraph 1, where tests and study reports have already been used to grant authorisation to another product and the period of protection has not yet expired, those reports shall be protected for the remaining period.
Amendment 299
Article 57, paragraphs 1 and 2
-
1.For each active substance, safener and synergist, rapporteur Member States shall keep, and make available to any interested party upon request, a list of the test and study reports necessary for first approval, amendment of approval conditions or renewal of the approval. 1. For each active substance, safener and synergist, rapporteur Member States shall forward to the Authority, who shall make available to the public at the moment of publishing the draft assessment report according to the provisions of Article 12, a list of the test and study reports necessary for first approval, amendment of approval conditions or renewal of the approval and a summary of the results of the tests and study reports to establish the efficacy of the substance and its harmlessness to humans, animals, plants and the environment.
-
2.For each plant protection product which they authorise, Member States shall keep and make available to any interested party upon request: 2. For each plant protection product which they authorise, Member States shall forward to the Authority, who shall make available to the public, at the moment of publishing the draft assessment report according to the provisions of Article 12: (a) a list of the test and study reports necessary for first authorisation, amendment of the authorisation conditions or renewal of the authorisation; and (a) a list of the test and study reports necessary for first authorisation, amendment of the authorisation conditions or renewal of the authorisation; (b) a list of test and study reports for which protection is claimed under Article 56 and any justifications submitted in accordance with that Article. (b) a list of test and study reports for which protection is claimed under Article 56 and any justifications submitted in accordance with that Article; and (ba) a summary of the results of the tests and study reports to establish the efficacy of the product and its harmlessness to humans, animals, plants and the environment. Amendment 201
Article 58, paragraph - 1 (new)
-
1.Any persons intending to seek an authorisation for a plant protection product shall, before carrying out tests or studies, consult the database referred to in Articles 34a, 54 and 57.
Amendment 202
Article 58, paragraph 1, subparagraph 1
-
1.Any persons intending to seek an authorisation for a plant protection product shall, before carrying out tests or studies, enquire of the competent authority of the Member State to which they intend to make an application whether an authorisation has already been granted in that Member State for a plant protection product containing the same active substance, safener or synergist. Such enquiry shall include consultation of the information available pursuant to Article 54. 1. Any persons intending to seek, renew or review an authorisation for a plant protection product shall, before carrying out tests or studies, inform the competent authority of the Member State to which they intend to make an application that an authorisation has already been granted in that or another Member State for a plant protection product containing the same active substance, safener or synergist, referring to the relevant information in the database.
Amendment 203
Article 58, paragraph 2
-
2.The competent authority of the Member State, where satisfied that the prospective applicant intends to apply for an authorisation, shall provide him with the name and address of the holder or holders of previous relevant authorisations and shall at the same time inform the holders of the authorisations of the name and address of the applicant. 2. The competent authority of the Member State, where satisfied that the prospective applicant intends to apply for an authorisation, or the renewal or review thereof, shall provide him with the name and address of the holder or holders of previous relevant authorisations and shall at the same time inform the holders of the authorisations of the name and address of the applicant. Amendment 204
Article 58, paragraph 3
-
3.The prospective applicant for the authorisation and the holder or holders of relevant authorisations shall take all reasonable steps to reach agreement on the sharing of any test and study reports protected under Article 56 that are required by the applicant for authorisation of a plant protection product. 3. The prospective applicant for the authorisation, or the renewal or review thereof, and the holder or holders of relevant authorisations shall take all reasonable steps to reach agreement on the sharing of any test and study reports protected under Article 56 that are required by the applicant for the authorisation, or the renewal or review, of a plant protection product. Such an agreement may be replaced by submission of the matter to an arbitration board and acceptance of the arbitration order. In an endeavour to ensure that the costs of sharing the information are determined in a fair, transparent and non discriminatory way, the Commission may, in accordance with the regulatory procedure referred to in Article 76(3), adopt cost sharing guidelines based on those principles.
Amendment 205
Article 58, paragraph 3 a (new)
3a. Where the Member State considers that a monopoly might be created, and the prospective applicant and the holder or holders of the authorisations for plant protection products containing the same active substance, safener, or synergist cannot reach agreement on the sharing of any tests and studies involving vertebrate animals, the prospective applicant shall inform the competent authority of the Member State to that effect. The two parties shall nevertheless agree which courts and tribunals have jurisdiction for the purposes of the second subparagraph of Article 59(3).
Amendment 206
Article 59, paragraph 1
-
1.Tests and studies involving vertebrate animals shall not be repeated for the purposes of this Regulation. Any person intending to perform tests and studies involving vertebrate animals shall take the necessary measures to verify that those tests and studies have not already been performed or initiated. 1. Tests and studies involving vertebrate animals shall not be repeated for the purposes of this Regulation. Any person intending to perform tests and studies involving vertebrate animals shall take the necessary measures to verify that those tests and studies have not already been performed or initiated, in particular by consulting the database. Amendment 207
Article 59, paragraph 2
-
2.The prospective applicant and the holder or holders of the relevant authorisations shall make every effort to ensure that they share tests and studies involving vertebrate animals. The costs of sharing the test and study reports shall be determined in a fair, transparent and non-discriminatory way. The prospective applicant is only required to share in the costs of information he is required to submit to meet the authorisation requirements. 2. The prospective applicant and the holder or holders of the relevant authorisations shall make every effort to ensure that they share tests and studies involving vertebrate animals. The costs of sharing the test and study reports shall be determined in a fair, transparent and non-discriminatory way. The prospective applicant is required to share in the costs that accrue during the full process of generating the information he is required to submit to meet the authorisation requirements.
Amendment 208
Article 59, paragraph 3 a (new)
3a. Not later than ...*, the Commission shall carry out a review of the provisions in this Regulation concerning data protection for tests and studies involving vertebrate animals. The Commission shall submit this assessment, and any proposed amendments for limiting the data protection with regard to animal experiments, to the European Parliament and the Council.
______________________ * Seven years after the entry into force of this Regulation.
Amendment 209
Article 60, paragraph 1 a (new)
1a. An opportunity to comment shall be given to the applicant before the competent authority adopts a decision as to the confidentiality of the data, which shall be binding on all Member States, the Authority and the Commission. The decision, which must be notified to the applicant, shall contain an adequate justification. The applicant shall have the right to challenge such decision in court before it is implemented, with a view to having the assessments and decision made by the competent authority reviewed by the court and to preventing disclosure of the data in question. Amendment 210
Article 60, paragraph 2, point (c a) (new)
(ca) names and addresses of institutions and persons involved in testing on vertebrate animals.
Amendment 211
Article 60, paragraph 2 a (new)
2a. For test data, including study reports, which have been provided by an applicant to support a decision to authorise or amend a plant protection product under this Regulation, such data may be viewed by interested parties in specific locations identified by the Commission, the Authority or the Member States. Such data shall not be made public through the provision of copies or through any other means of publication (including electronic publication).
Amendment 212
Article 62, paragraph 1, subparagraph 2
That Regulation shall also contain standard phrases for special risks and safety precautions which supplement the phrases provided for by Directive 1999/45/EC. It shall incorporate the text of the Annexes IV and V to Directive 91/414/EEC with any necessary modifications. That Regulation shall also contain standard phrases for special risks and safety precautions which supplement the phrases provided for by Directive 1999/45/EC. It shall transfer the text of the Annexes IV and V to Directive 91/414/EEC with any modifications necessary due to the change from a directive to a regulation. Amendment 213
Article 62, paragraph 2
-
2.Member States may require samples or mock-ups of the packaging and drafts of labels and leaflets to be submitted. 2. Member States may require samples or mock-ups of the packaging and drafts of labels and leaflets to be submitted for examination before an authorisation is granted.
Amendment 214
Article 62, paragraph 3 a (new)
3a. Food products which do not comply with the provisions of Commission Directive 2006/125/EC of 5 December 2006 on processed cereal based foods and baby foods for infants and young children
1
, shall be labelled "not suitable
for infants and young children".
1
OJ L 339, 6.12.2006, p. 16. Amendment 215
Article 63, paragraph 2 a (new)
2a. Member States may prohibit or restrict the advertising of plant protection products in certain media.
Amendment 216
Article 64, paragraph 1
-
1.Producers, suppliers, distributors and professional users of plant protection products shall keep records of the plant protection products they produce, store or use. 1. Producers, suppliers, distributors and professional users of plant protection products shall keep records of the plant protection products they produce, store or use for at least 10 years after the end of production or use. They shall make the relevant information contained in these records available to the competent authority on request. They shall also keep this information available for neighbours or the drinking water industry who request access to it. They shall make the information contained in these records available to the competent authority. They shall also keep this information available for neighbours and residents, retailers or the drinking water industry who request direct access to it. The information on all applications of plant protection products on a given agricultural product shall be provided to retailers and wholesalers in the form of a pesticide passport.
Amendment 217
Article 64, paragraph 1 a (new)
1a. Producers of plant protection products shall undertake post registration monitoring. They shall notify the competent authorities of any relevant information and keep the information available to relevant stakeholders on request.
Amendment 218
Article 64, paragraph 2
-
2.Authorisation holders shall provide the competent authorities of the Member States with all data relating to the volume of sales of plant protection products. 2. Producers of plant protection products shall inform the competent authorities about the amounts produced of a given
substance or product,
the amounts of a given substance or
product delivered to processors or wholesalers within the EU,
the amounts exported of a given
substance or product.
This information shall be assessed and published by the competent authorities.
Amendment 219
Article 64, paragraph 3
-
3.Implementing measures to ensure the uniform application of paragraphs 1 and 2 may be adopted in accordance with the procedure referred to in Article 76(3). 3. Implementing measures to ensure the uniform application of paragraphs 1 and 2 may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 76(3a).
Amendment 220
Article 65, paragraph 1
Member States shall carry out official controls in order to enforce compliance with this Regulation. They shall finalise and transmit to the Commission, a report on the scope and the results of these controls within six months of the end of the year to which the reports relate. Member States shall carry out official controls in order to enforce compliance with this Regulation. These controls shall include controls on the farm, in order to verify compliance with use restrictions. Member States shall finalise and transmit to the Commission a report on the scope and the results of these controls within six months of the end of the year to which the reports relate. Amendment 221
Article 65, paragraph 3
A Regulation, adopted in accordance with the procedure referred to in Article 76(3), shall set out provisions for the controls on the production, packaging, labelling, storage, transport, marketing, formulation and use of plant protection products. That Regulation shall contain provisions equivalent to Articles 1 to 13, 26, 27(1), 27(4)(a) and (b) and 27(5) to (12), 28, 29, 32 to 45, 51, 53, 54, 66 and to Annexes I, II, III, VI, and VII to Regulation (EC) No 882/2004. It shall also contain provisions concerning the collection of information and reporting on suspected poisonings and shall detail the information to be made available in response to medical demand. A Regulation, adopted in accordance with the procedure referred to in Article 251 of the Treaty, shall set out provisions for the controls on the production, packaging, labelling, storage, transport, marketing, formulation and use of plant protection products. That Regulation shall contain provisions equivalent to Articles 1 to 13, 26, 27(1), 27(4)(a) and (b) and 27(5) to (12), 28, 29, 32 to 45, 51, 53, 54, 66 and to Annexes I, II, III, VI, and VII to Regulation (EC) No 882/2004. It shall also contain provisions concerning the collection of information and reporting on suspected poisonings and shall detail the information to be made available in response to medical demand. Amendment 222
Article 70 a (new)
Article 70 a Fund for safe disposal of obsolete pesticides
Producers and authorisation holders shall contribute to a fund covering the costs associated with the disposal and destruction of stocks of obsolete pesticides in Member States and third countries. The contribution to the fund shall be distributed in a fair and transparent manner.
Amendment 223
Article 71, paragraph 1
-
1.Member States may recover the costs associated with any work they carry out arising from obligations under this Regulation, by means of fees or charges. 1. Member States may recover the costs associated with any work they carry out in connection with approvals or authorisations within the scope of, or arising from obligations under, this Regulation, by means of fees or charges. Amendment 224
Article 74
The Commission may, in accordance with the procedure referred to in Article 76(2), adopt or amend technical and other guidance documents for the implementation of this Regulation. The Commission may ask the Authority to prepare or to contribute to such guidance documents. The Commission may, in accordance with the regulatory procedure with scrutiny referred to in Article 76(3a), adopt or amend technical and other guidance documents for the implementation of this Regulation. The Commission may ask the Authority to prepare or to contribute to such guidance documents. The Authority may initiate the preparation or revision of guidance documents for the risk assessment of active substances.
Amendment 225
Article 75, paragraph 1
1.The following shall be adopted in accordance with the procedure referred to in Article 76(3): 1. The measures needed to implement this Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 76(3). Not later than ...*, the Commission shall present legislative proposals based on Article 251 of the Treaty on: (a) amendments to the Annexes, taking into account current scientific and technical knowledge;
(b) the Regulations on data requirements for active substances and for plant protection products, as referred to in Article 8(1)(b) and (c), taking into account scientific and technical knowledge; (b) the data requirements for active substances and for plant protection products, as referred to in Article 8(1)(b) and (c), including measures to minimise animal testing, in particular the use of non animal testing methods and intelligent testing strategies, taking into account 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 scientific and technical knowledge; (c) uniform principles for evaluation and authorisation of plant protection products, as referred to in Article 29(6), taking into account scientific and technical knowledge; (d) amendments to the Regulation containing the requirements of the labelling of plant protection products as referred to in Article 62(1); (d) requirements of the labelling of plant protection products as referred to in Article 62(1).
(e) the measures needed to implement this Regulation.
_____________________
-
*Two years after entry into force of this Regulation.
Amendment 226
Article 75, paragraph 2
-
2.In accordance with the procedure referred to in Article 76(2), a Regulation shall be adopted containing the list of active substances included in Annex I to Directive 91/414/EEC. Those substances shall be deemed to have been approved under this Regulation. 2. In accordance with the regulatory procedure with scrutiny referred to in Article 76(3a), a Regulation shall be adopted containing the list of active substances included in Annex I to Directive 91/414/EEC. Those substances shall be deemed to have been approved under this Regulation. Amendment 227
Article 76, paragraph 3 a (new)
3a. Where reference is made to this paragraph, Article 5a (1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Amendment 228
Article 76, paragraph 4 a (new)
4a. The meetings of the Committee and its Working Groups shall be open to Members of the European Parliament on request.
Amendment 229
Article 78
Article 78deleted Derogation for safeners and synergists
By way of derogation from Article 28(1), a Member State may, for a period of five years following the adoption of the programme referred to in Article 26 authorise the placing on the market in its territory of plant protection products containing safeners and synergists which have not been approved, where they are included in that programme.
Amendment 267
Article 80, paragraph 2
The Commission shall within 18 months after its entry into force adopt the following Regulations: The Commission shall within 18 months after its entry into force adopt the following Regulations: - A Regulation containing the list of the active substances already approved at the moment of publication of that Regulation - A Regulation containing the list of the active substances already approved at the moment of publication of that Regulation - A Regulation on data requirements for active substances, as referred to in Article 8(1)(b) - A Regulation on data requirements for active substances, as referred to in Article 8(1)(b) - A Regulation on data requirements for plant protection products, as referred to in Article 8(1)(c) - A Regulation on data requirements for plant protection products, as referred to in Article 8(1)(c) A Regulation on uniform principles for risk assessment for plant protection products, as referred to in Article 35
-
-A Regulation containing the requirements of the labelling of plant protection products as referred to in Article 62(1).- A Regulation containing the requirements of the labelling of plant protection products as referred to in Article 62(1). The Commission shall within 6 months after its entry into force adopt the following Regulation: A Regulation on uniform principles for risk assessment for plant protection products, as referred to in Article 35.
Amendment 230
Annex I
Annex deleted
Amendment 232
Annex II, point 3.2
An active substance shall only be approved where it has been established for a limited range of representative uses that the plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic normal conditions of use is sufficiently effective. This requirement shall be evaluated in the light of the uniform principles for evaluation and authorisation of plant protection products referred to in the second paragraph of Article 35. An active substance shall only be approved where it has been established for an extensive range of representative uses that the plant protection product, consequent on application consistent with good plant protection product practice and having regard to realistic conditions of use, is sufficiently effective. This requirement shall be evaluated in the light of the uniform principles for evaluation and authorisation of plant protection products referred to in the second paragraph of Article 35. Amendment 300
Annex II, point 3.6
3.6.1. Where relevant, an ADI, AOEL and ARfD shall be established. When establishing such values a sufficient safety margin shall be ensured taking into account the type and severity of effects and the vulnerability of specific groups of the population. 3.6.1. Where relevant, an ADI, AOEL and ARfD shall be established. When establishing such values an appropriate safety margin of at least 100 shall be ensured taking into account the type and severity of effects, possible combination effects and the vulnerability of specific groups of the population particularly at risk. 3.6.2. An active substance shall only be approved, if, on the basis of assessment of higher tier genotoxicity testing carried out in accordance with the data requirements for the active substances and the plant protection products and other available data and information, it is not classified, in accordance with the provisions of Directive 67/548/EEC, as mutagen category 1 or 2 unless the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use is negligible. 3.6.2. An active substance shall only be approved if, on the basis of assessment of higher tier genotoxicity testing carried out in accordance with the data requirements for the active substances and the plant protection products and other available data and information including a review of the scientific literature, it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as a mutagen category 1 or 2. Such active substances may only be approved if the exposure of humans to that active substance in a plant protection product, under realistic conditions of use, is negligible, as the product is used in closed systems or in other conditions excluding
contact with humans and where residues of the active substance concerned on food and feed do not exceed the limit of determination using the most sensitive methods.
3.6.3. An active substance shall only be approved, if, on the basis of assessment of carcinogenicity testing carried out in accordance with the data requirements for the active substances and the plant protection products and other available data and information, it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as carcinogen category 1 or 2 unless the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use is negligible. 3.6.3. An active substance shall only be approved if, on the basis of assessment of carcinogenicity testing carried out in accordance with the data requirements for the active substances and the plant protection products and other available data and information including a review of the scientific literature, it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as a carcinogen
category 1 or 2. Such active substances may only be approved if the exposure of humans to that active substance in a plant protection product, under realistic conditions of use, is negligible, as the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance concerned on food and feed do not exceed the limit of determination using the most sensitive methods.
3.6.4. An active substance shall only be approved, if, on the basis of assessment of reproductive toxicity testing carried out in accordance with the data requirements for the active substances and the plant protection products and other available data and information, it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as toxic for reproduction category 1 or 2 unless the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use is negligible. 3.6.4. An active substance shall only be approved if, on the basis of assessment of reproductive toxicity testing carried out in accordance with the data requirements for the active substances and the plant protection products and other available data and information including a review of the scientific literature, it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as toxic for reproduction category 1 or 2. Such active substances may only be approved if the exposure of humans to that active substance in a plant protection product, under realistic conditions of use, is negligible, as the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance concerned on food and feed do not exceed the limit of determination using the most sensitive methods.
3.6.5. An active substance shall only be approved, if, on the basis of the assessment of Community or internationally agreed test guidelines it is not considered to have endocrine disrupting properties that may be of toxicological significance in humans unless the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use, is negligible. 3.6.5. An active substance shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information including a review of the scientific literature it is not considered to have endocrine disrupting properties that are suspected to be of toxicological significance in humans including when exposure is likely to happen during embryonic/foetal life and/or during childhood, taking due account of likely combination effects. Such active substances may only be approved if the exposure of humans to that active substance in a plant protection product, under realistic conditions of use, is negligible, as the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance concerned on food and feed do not exceed the limit of determination using the most sensitive methods. 3.6.5a. An active substance shall only be approved if, on the basis of the assessment or other available data and information including a review of the scientific literature, it is not considered to cause a risk of developmental neurotoxic or immunotoxic properties in humans, taking into account exposure during embryonic/foetal life and/or during childhood as well as likely combination effects. Such active substances may only be approved if the exposure of humans to that active substance in a plant protection product, under realistic conditions of use, is negligible, as the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance concerned on food and feed do not exceed the limit of determination using the most sensitive methods.
Amendment 304
Annex II, point 3.7.1, introductory part and points (a) and (b)
3.7.1. An active substance shall only be approved where it is not considered to be a persistent organic pollutant. 3.7.1. An active substance shall only be approved where it, and its transformation products or residues, are not considered to be persistent organic pollutants. A persistent organic pollutant is defined as follows: A persistent organic pollutant is defined as follows: (a) Persistence: (a) Persistence: (i) Evidence that its DT50 in water is greater than two months, or that its DT50 in soil is greater than six months, or that its DT50 in sediment is greater than six months; and (i) Evidence that its DT50 in water is greater than two months, or that its DT50 in soil is greater than six months, or that its DT50 in sediment is greater than six months; (ia) Evidence that the active substance is otherwise sufficiently persistent to justify its exclusion from Annex I to Directive 91/414/EEC, or to be considered in the context of the POPs Convention; or (b) Bio-accumulation: (b) Bio-accumulation: (i) Evidence that its bio-concentration factor or bio accumulation factor in aquatic species is greater than 5,000 or, in the absence of such data, that the log Ko/w is greater than 5; (i) Evidence that its bio-concentration factor or bio accumulation factor in aquatic species is greater than 2,000 or, in the absence of such data, that the log Ko/w or the log Ko/a is greater than 5; (ii) Evidence that a chemical presents other reasons for concern, such as high bioaccumulation in other non-target species, high toxicity or ecotoxicity; and (ii) Evidence that a chemical presents other reasons for concern, such as high bioaccumulation in other non-target species, high toxicity or ecotoxicity; or
(iia) Monitoring data in biota indicating that the bio accumulation potential of the active substance is sufficient to be considered under the POPs Convention;
Amendment 235
Annex II, point 3.7.2, introduction, subparagraph 1
3.7.2. An active substance shall only be approved if it is not considered to be a persistent, bioaccumulating and toxic (PBT) substance. 3.7.2. An active substance shall only be approved if it, and its transformation products or residues, are not considered to be persistent, bioaccumulating and toxic (PBT) substances.
Amendment 236
Annex II, point 3.7.2.1, subparagraph 2 a (new)
It also fulfils the persistence criterion where there is evidence that the substance is otherwise sufficiently persistent to be of concern.
Amendment 237
Annex II, point 3.7.2.2, subparagraph 2 a (new)
It also fulfils the bioaccumulation criterion when there is evidence of high bioaccumulation in other species, or monitoring data in biota indicate that the bioaccumulation potential of the chemical is sufficient to be of concern.
Amendment 238
Annex II, point 3.7.2.3, indent 2
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-the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2, or 3), or - the substance is classified as carcinogenic (category 1, 2 or 3), mutagenic (category 1, 2 or 3), or toxic for reproduction (category 1, 2, or 3), or Amendment 239
Annex II, point 3.7.3, introduction, subparagraph 1
An active substance shall not be An active substance shall not be 3.7.3. 3.7.3. considered as complying with Article 4 where it is very persistent, very bioaccumulating (vPvB). considered as complying with Article 4 where it, or its transformation products or residues, are very persistent, very bioaccumulating (vPvB). Amendment 240
Annex II, point 3.7.3.1.
An active substance fulfils the very persistence criterion where:An active substance fulfils the very persistent criterion (vP ) where there is evidence that:
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-the half-life in marine, fresh- or estuarine water is higher than 60 days, or - the half-life in marine, fresh- or estuarine water is higher than 60 days, or
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-the half-life in marine, fresh- or estuarine water sediment is higher than 180 days, or - 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. - the half-life in soil is higher than 180 days. It also fulfils the very persistent criterion where there is evidence that the substance is otherwise sufficiently highly persistent to be of concern. Amendment 241
Annex II, point 3.7.3.2., subparagraphs 1 a and 1 b (new)
Assessment of bioaccumulation shall be based on measured data on bioconcentration in aquatic species. Data from both freshwater and marine water species can be used.
It also fulfils the very bioaccumulative criterion when there is evidence of very high bioaccumulation in other species, or monitoring data in biota indicate that the bioaccumulation potential of the chemical is sufficient to be of concern.
Amendment 242 Annex II, point 3.8.1
3.8.1. An active substance shall only be considered as complying with Article 4 if the risk assessment demonstrates risks to be acceptable in accordance with the criteria laid down in the uniform principles for evaluation and authorisation of plant protection products referred to in Article 35 under realistic proposed conditions of use of a plant protection product containing the active substance. The assessment must take into account the severity of effects, the uncertainty of the data, and the number of organism groups which the active substance is expected to affect adversely by the intended use. 3.8.1. An active substance shall only be considered as complying with Article 4 if the risk assessment demonstrates risks to be acceptable in accordance with the criteria laid down in the uniform principles for evaluation and authorisation of plant protection products referred to in Article 35 under realistic proposed conditions of use of a plant protection product containing the active substance. The assessment must take into account the severity of effects on biodiversity, the uncertainty of the data, and the number of organism groups which the active substance is expected to affect adversely by the intended use.
Amendment 244
Annex II, point 3.8.2 a (new)
3.8.2a. An active substance shall only be approved, if, on the basis of the assessment of Community or internationally agreed test guidelines and other available data and information including a review of the scientific literature, it is not considered to be toxic for bees and has a Hazard Quotient (HQ) lower than 50.
Amendment 245
Annex II, point 3.9
An active substance shall only be approved if, where relevant, a residue definition can be established for the purposes of risk assessment and for enforcement purposes. An active substance shall only be approved if a residue definition can be established and analytical methods in general use are capable of detecting them for the purposes of risk assessment and for enforcement purposes. Amendment 246
Annex II, point 3.9 a (new)
3.9a. Food chain effects
An active substance shall only be approved if its impact on the food chain of higher organisms is considered to be acceptable on the basis of a scientifically approved risk assessment methodology and, if approved, the assessed impact on the ecosystem is reduced through a system of mitigation and compensation.
Amendment 293
Annex II, point 3.9 b (new)
3.9b. Substances on the list of priority hazardous substances for water policy annexed to Directive 2000/60/EC should not be approved.
Amendment 248
Annex II, point 4
An active substance shall be approved as a candidate for substitution pursuant to Article 24 where: An active substance shall be defined as a candidate for substitution pursuant to Article 24 where any of the following conditions are met: - its ADI, ARfD or AOEL is significantly lower than those of the majority of the approved active substances; - its ADI, ARfD or AOEL is lower than those of the majority of the approved active substances, taking into account residents, bystanders and the most vulnerable population groups; - it meets two of the criteria to be considered as a PBT substance; - it meets one of the criteria to be considered as a PBT substance;
it is prone to leaching to groundwater; - there are reasons for concern linked to the nature of the critical effects which, in combination with the use/exposure patterns, amount to situations of use that could still cause concern, even with very restrictive risk management measures(such as extensive personal protective equipment or very large buffer zones); - there are reasons for concern linked to the nature of the critical effects and properties which may give rise to very restrictive risk management measures (such as extensive personal protective equipment or very large buffer zones);
it has potentially endocrine disrupting,
neurotoxic or immunotoxic properties, in adults or during development, on the basis of assessment and other available data and information including a review of scientific literature;
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-it contains a significant proportion of non-active isomers. - it contains a significant proportion of non-active isomers. Amendment 249
Annex II a (new)
Annex II a
List of active substances approved for inclusion in plant protection products Amendment 250
Annex III, title
List of co-formulants which are not accepted for inclusion in plant protection products List of co-formulants, safeners and synergists approved for inclusion in plant protection products
Amendment 251
Annex IV, point 1
A comparative assessment shall be performed by Member States when evaluating an application for authorisation for a plant protection product containing an active substance approved as a candidate for substitution. A comparative assessment shall be performed by Member States when evaluating an application for authorisation for a plant protection product. In this process, priority shall be given to plant protection products containing an active substance approved as a candidate for substitution. Where refusal or withdrawal of an authorisation of a plant protection product in favour of an alternative plant protection product is considered (hereinafter `substitution'), the alternative must, in the light of scientific and technical knowledge, show significantly lower risk to health or the environment. An assessment of the alternative plant protection product shall be performed to demonstrate whether it can be used with similar effect on the target organism and without significant economic and practical disadvantages to the user or not. Where refusal or withdrawal of an authorisation of a plant protection product in favour of an alternative plant protection product is considered (hereinafter `substitution'), the alternative must, in the light of scientific and technical knowledge, show significantly lower risk to health or the environment. An assessment of the alternative plant protection product shall be performed to demonstrate whether it can be used with similar effect on the target organism and without significant economic and practical disadvantages to the user or not. Further conditions for refusal or withdrawal of an authorisation are: Further conditions for refusal or withdrawal of an authorisation are: (a) substitution shall be applied only where the chemical diversity of the active substances is sufficient to minimise the occurrence of resistance in the target organism; (a) substitution shall be applied only where the diversity of the active substances and other non chemical methods of crop protection and pest prevention is sufficient to minimise the occurrence of resistance in the target organism; (b) substitution shall be applied only to active substances which, where used in authorised plant protection products, present a significantly higher level of risk to human health or the environment; (b) substitution may be applied by Member States to all active substances which, where used in authorised plant protection products, present a higher level of risk to human health or the environment. (c) substitution shall be applied only after allowing for the possibility, where necessary, of acquiring experience from use in practice, where not already available.
Amendment 252
Annex IV, point 2
A significant difference in risk shall be identified on a case-by-case basis by the competent authorities. The properties of the active substance, and the possibility of exposure of different population subgroups (professional or non-professional users, bystanders, workers, residents, specific vulnerable groups or consumers) directly or indirectly through food, feed, water or the environment shall be taken into account. Other factors such as the stringency of imposed restrictions on use and prescribed personal protective equipment must also be considered. A significant difference in risk, especially for health risks, shall be identified on a case-by-case basis by the competent authorities, taking into account known cumulative and synergistic effects. The properties of the active substance, and the possibility of exposure of different population subgroups (professional or nonprofessional users, bystanders, workers, residents, specific vulnerable groups or consumers) directly or indirectly through food, feed, water or the environment shall be taken into account. Other factors such as the stringency of imposed restrictions on use and prescribed personal protective equipment must also be considered. For the environment, a factor of at least 10 between the Predicted Environmental Concentration (PEC) and the Predicted No Effect Concentration (PNEC) ratios of different active substances is considered a significant difference in risk. For the environment, taking into account known cumulative and synergistic effects, a factor of at least 3 between the Predicted Environmental Concentration (PEC) and the Predicted No Effect Concentration (PNEC) ratios of different active substances is considered a significant difference in risk. Amendment 253
Annex IV, point 3, subparagraph 2 a (new)
The comparative assessment shall take authorised minor uses into account.
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