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20042009Session document
FINAL
A6-0359/2007
{05/10/2007}05.10.2007
***I
REPORT
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 C60245/2006 2006/0136(COD))
{ENVI}Committee on the Environment, Public Health and Food Safety
Rapporteur: Hiltrud Breyer
Draftswoman (*):
Anja Weisgerber, Committee on the Internal Market and Consumer Protection
Draftsman (*):
Kysti Virrankoski, Committee on Agriculture and Rural Development
(*) Procedure with associated committees - Rule 47 of the Rules of Procedure
TITLE \* MERGEFORMAT PR_COD_1am
Symbols for procedures * Consultation procedure
majority of the votes cast
**I Cooperation procedure (first reading)
majority of the votes cast
**II Cooperation procedure (second reading)
majority of the votes cast, to approve the common position
majority of Parliaments component Members, to reject or amend the common position
*** Assent procedure
majority of Parliaments component Members except in cases covered by Articles105, 107, 161 and 300 of the EC Treaty and Article7 of the EU Treaty
***I Codecision procedure (first reading)
majority of the votes cast
***II Codecision procedure (second reading)
majority of the votes cast, to approve the common position
majority of Parliaments component Members, to reject or amend the common position
***III Codecision procedure (third reading)
majority of the votes cast, to approve the joint text
(The type of procedure depends on the legal basis proposed by the Commission.)
Amendments to a legislative textIn amendments by Parliament, amended text is highlighted in bold italics. Highlighting in normal italics is an indication for the relevant departments showing parts of the legislative text for which a correction is proposed, to assist preparation of the final text (for instance, obvious errors or omissions in a given language version). These suggested corrections are subject to the agreement of the departments concerned.
CONTENTS
Page
TOC \t "PageHeading;1" DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION PAGEREF _Toc179343164 \h 5
EXPLANATORY STATEMENT PAGEREF _Toc179343165 \h 131
OPINION OF THE COMMITTEE ON LEGAL AFFAIRS ONTHELEGALBASIS PAGEREF _Toc179343166 \h 134
OPINION of the Committee on Industry, Research and Energy PAGEREF _Toc179343167 \h 146
OPINION of the Committee on the Internal Market and Consumer Protection (*) PAGEREF _Toc179343168 \h 166
OPINION of the COMMITTEE ON AGRICULTURE AND RURAL DEVELOPMENT (*) PAGEREF _Toc179343169 \h 203
PROCEDURE PAGEREF _Toc179343170 \h 263
(*) Procedure with associated committees - Rule 47 of the Rules of Procedure
DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION
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 C60245/2006 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 Articles37(2) and 152(4)(b) of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C60245/2006),
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 (A60359/2007),
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 CommissionAmendments 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, Justification
According to Recital 8 of the proposal, the purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment. The choice of the legal basis should reflect the aim and the purpose of the regulation. A dual legal basis shall be used only if several objectives are pursued, which are inseparably linked, which is the case in the present proposal.
Article 37 was used in 1991, when the Treaty did not yet provide for a specific legal basis for protection of human health and the environment. It is not anymore appropriate to be used here.
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, 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. However, the main principles of Directive 79/117/EEC should be maintained in this Regulation.Justification
It is necessary that the content of the repealed directive is taken up in the new act.
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 4
Recital 7
(7) Plant protection products can also have non-beneficial effects on plant production. Their use may involve risks and hazards for humans, animals and the environment, especially if placed on the market without having been officially tested and authorised and if incorrectly used. Therefore, harmonised rules should be adopted on the placing on the market of plant protection products.(7) Pesticides can also have non-beneficial effects on plant production. Their use may involve harm, risks, intrinsic hazards and short and long-term adverse impacts for humans, animals and the environment, especially, but not only, if placed on the market without having been officially tested and authorised and if incorrectly used. Therefore, harmonised rules should be adopted on the placing of pesticides on the market. (This amendment applies to the whole legislative text. The term "pesticides" will be used throughout the adopted text, including the title.)Justification
The term 'plant protection products' used throughout the proposal, including the title, is inappropriate as many members of the public will not be familiar with this terminology. Therefore its continued use could lead to confusion amongst members of the public/consumers. The word pesticides is the correct word to use. Plant protection products should be replaced with pesticides and in the relevant places pesticide products' throughout the text of this Regulation.
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.Justification
Embryos, foetuses and nursing women should be explicitly mentioned, in order to put more emphasis on development neurotoxicological effects (see Grandjean P, Landrigran, P: The Lancet Vol 368 Issue 9553 (2006), p. 2167)
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 purposes1, 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.Justification
In line with the requirement in the Protocol on the Protection and Welfare of Animals that the Community and the Member States pay full regard to the welfare requirements of animals in formulating and implementing policies, it should be included that animal testing is kept to an absolute minimum and carried out only as a last resort, and that the use of alternatives is promoted. This is also in line with the requirements under REACH.
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 non-acceptability 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.Justification
As in other areas of European health and environment policy, manufacturer responsibility should also apply to plant protection products and their active substances.
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. Justification
The vast majority of animal test methods have never been validated to modern standards, and in many cases their relevance and reliability are in doubt. The promotion of non animal test methods is important for the protection of human health, as well as to prevent animal suffering.
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 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.(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 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.Justification
This is to guarantee that new and old substances that have been included on the positive list since 1991 (Annex 1 of Directive 91/414) are regularly reviewed and their hazard assessed.
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 policy1 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).Justification
Directive 2000/60/EC sets quality standards for chemicals in groundwater and surface water, among them plant protection products. If these quality standards are not met, there must be a direct feedback-mechanism to amend or withdraw the approval of an active substance, in line with the existing feedback-mechanism to Directive 2000/60/EC in the authorisation of chemicals (REACH).
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.Justification
The proposal does include incentives for the use of products with a low risk profile. But the definition does not say which substances should be eligible. Article 22 comes up with a very broad definition that is likely to be interpreted in a number of different ways. But businesses need clarity and legal certainty, especially in view of the costly investment in research that is involved in developing new substances.
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.Justification
It is supposed to be society that designates what is an acceptable risk and so if society feels that a risk is not acceptable, then what is considered acceptable is redefined and the risk assessed accordingly. Therefore risks can only be deemed acceptable by all relevant Stakeholders. This must include representatives of rural residents and communities, farmers groups, (both organic and conventional) and environmental and consumer groups as well as the public in general.
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).Justification
Member States should not be forced to accept pesticides which pollute ground water or cause unnecessary risks and hazards for humans, animals and the environment in conflict with their national environmental and health policies. Member states should be allowed to take regional conditions into account before authorising plant protection products.
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.Justification
Consistent with the change proposed by the rapporteur in Article 26 to adopt this review in co-decision.
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.Justification
The public has a right to know information on the risks and potential adverse impacts of co-formulants. Therefore all co-formulants that are included in pesticide products must be publicly available and not subject to commercial confidentiality.
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. Justification
The risk assessment shall prove that a pesticide has no harmful effect on human health and the environment. Evaluating the potential benefit for plant production shall be a separate step in the procedure.
Member States should not be forced to accept pesticides which do not present a clear benefit, pollute ground water and water resources or are in conflict with their national environmental and health policies and National Pesticides Action Plans.
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. Justification
The division into authorization zones is not appropriate as conditions in the proposed zones are often not comparable. Authorizations should be granted only at Member State level but notified to other Member States. Within a reasonable time period, notified Member States should be obliged to confirm, reject or restrict the authorization pursuant their specific national situation.
The proposed zonal authorisation of plant protection products is henceforth changed to a system of mutual recognition similar to the one included in the Biocides Directive.
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.Justification
The priority should always be given to non-chemical methods of pest management as the only truly preventative and sustainable solution which is more in line with the objectives for sustainable crop protection, than the reliance on complex chemicals designed to kill plants, insects or other forms of life, which cannot be classified as sustainable. Member States need to promote and encourage the widespread adoption of 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. All studies and data relevant for toxicological and ecotoxicological assessment of plant protection products should be made available to the public.Justification
The public should be given access to all particulars and scientific documentation submitted in connection with applications for authorization according to the rules on access to information and participation.
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.Justification
It should be clarified that data protection should be limited also in order to avoid animal testing.
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.Justification
As other studies than those on vertebrates may also prevent animal testing they should be included here as well.
In order to facilitate data sharing it is necessary to establish one central database with all the information on tests and studies carried out previously for the purposes of this Regulation, managed by the EFSA. Applicants would then have to consult only one database before carrying out any tests or studies.
This would also increase transparency of the procedure.
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 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.(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 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. Justification
All the various population subgroups at risk of exposure to pesticides must be protected. This includes professional and non-professional users, residents, bystanders, workers, specific vulnerable groups and consumers, directly or indirectly exposed through air, food, feed, water and the environment. All the relevant exposure factors must be included in the exposure calculations for each group when exposure and risk assessments are undertaken.
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.Justification
The risk of pesticides means hazard not only to the users but also to the public, therefore advertisements must not mislead the public regarding pesticides and pesticide products must not mislead users or the public.
Amendment 27
Recital 36
(36) Provisions on record keeping and information about the use of plant protection products should be established in order to raise the level of protection of human and animal health and the environment by ensuring the traceability of potential exposure, to increase the efficiency of monitoring and control and to reduce the costs of monitoring water quality.(36) Provisions on acreage- and crop specific record keeping and information about the use of plant protection products should be established and made publicly available and be directly available upon request to interested parties, such as residents and bystanders, in order to raise the level of protection of human and animal health and the environment by ensuring the traceability of potential exposure, to increase the efficiency of monitoring and control and to reduce the costs of monitoring water quality. The information gathered should also be used for a "pesticide passport" to ensure traceability of pesticide applications in the food chain and in water resources. In view of the possibility of chronic long-term health effects, these records should be kept for at least 30 years.Justification
This would increase transparency. Making available the data in the form of a pesticide passport, which contains information on all pesticides used on a given product, would create additional incentive for reducing the use of pesticides. Such a passport is requested by several large retailers in order to be able to meet consumer demand.
The availability this information is vital for the correct assessment and treatment of anyone who suffers adverse health effects therefore members of the public should be entitled to access the information on the chemicals they are exposed to, such as their doctors or other medical advisors. In view of any chronic long-term health effects then these records need to be kept at least for 30 years.
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. Justification
There should be a level playing field as regards access to the market for different operators. This would foster innovation and the development of new products, as well as resulting in improvements to existing ones. It will also be good for competition within the market and lead to more products being 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.Justification
Consistent with the change proposed by the rapporteur in Article 65 to adopt these provisions under co-decision.
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 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.(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 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).Justification
To ensure coherence between all related legislation.
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 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. Justification
This amendment is necessary to bring the text into line with the provisions of the new decision on comitology.
Amendment 34
Article 1
Subject matterSubject matter and purposeThis 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.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.6. Member States may not be prevented from applying the precautionary principle in restricting or prohibiting pesticides.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.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.Justification
The purpose, objective and basic principles of the Regulation should be laid down in Article 1, not only in the recitals of the Regulation.
Paragraph 6 is to make the provisions of this Regulation minimum rules, thereby enabling individual Member States to make further progress with the development of pesticides.
Paragraphs 7 and 8 are important to ensure that the achievements secured in the groundwater directive are carried over into this Regulation in order to safeguard drinking water.
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. Justification
It should be emphasized that the provisions foreseen in the present regulation are designed to reduce harmful effects of synthetic plant protection products and are not in all cases suited for assessing risks and the potential impact of biological control substances. In order to take account of the specific properties of such products, a regulation on biological control products should be foreseen.
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;Justification
Clarification.
Amendment 37
Article 3, point 2 a (new)
(2a) 'active substances'Substances, including all 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; Justification
This definition is needed in order to make sure that when evaluating an active substance, all metabolites present in a given product will be included. This definition is similar to the definition given in Directive 91/414/EEC.
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;Justification
The definition of the term 'preparations' should cover not just mixtures (composite substances which can easily be separated into their component parts by simple physical means (using filter paper, mechanical separation, centrifugation) but also solutions (homogeneous substances), which have different properties.
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, genotoxic or skin sensitizing capabilities should be regarded as a substance of concern; Justification
Substances of concern must include any substance that has the potential to cause any adverse effect on human or animal health or the environment. This includes any substances with carcinogenic, mutagenic, endocrine disrupting, neurotoxic, immunotoxic, reprotoxic, genotoxic or skin sensitizing capabilities.
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; Justification
This regulation should not only deal with active substances and plant protection products as such, but also include provisions on "articles" that might contain such substances (e.g. textiles). The definition proposed here is identical to the definition adopted under REACH.
Amendment 41
Article 3, point 4 b (new)
(4b) advertisementA 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; Justification
Necessary for enforcement purposes.
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;Justification
Clarification.
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;Justification
A definition is needed for clarity of provisions relating to low risk active substances and plant protection products.
Amendment 44
Article 3, point 9
(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;(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, as well as imports, shall be deemed to constitute placing on the market for the purposes of this Regulation; Justification
Imported products must comply with all criteria set in this regulation.
Amendment 45
Article 3, point 9 a (new)
(9a) parallel tradeThe 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;Justification
There is a need for a clear definition and a minimum set of community harmonized rules regulating the placing of PPPs on the market through parallel trade.
Amendment 46
Article 3, point 9 b (new)
(9b) identicalPlant protection products shall be considered as identical when they: share a common origin, have been manufactured by the same company or by an associated undertaking or under licence (producer identity), and 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;Justification
Related to parallel trade rules: the simplified procedure for placing Plant protection products on the market through parallel trade should only apply when the imported product is identical to the authorized product, hence the proposed definition.
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;Justification
The definition of health given by the WHO should be included as it relates to the objective and other relevant provisions of this Regulation.
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;Justification
Vulnerable groups must receive particular attention in the authorisation procedure and should therefore be defined in Article 3 of this Regulation.
Amendment 50
Article 3, point 14
(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;
(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 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 agro-ecosystems 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;Justification
The definition of integrated pest management (IPM) should not only include aspects of plant protection, but also management aspects linked to the choice of adapted varieties, crop rotation and nutrient strategy, which can considerably reduce the need to use plant protection products.
Amendment 51
Article 3, point 14 a (new)
(14a) non-chemical methods of plant protection and pest and crop managementThe 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;Justification
The priority should always be given to non-chemical methods of pest management as the only truly preventative and sustainable solution which is more in line with the objectives for sustainable crop protection, than the reliance on complex chemicals designed to kill plants, insects or other forms of life, which cannot be classified as sustainable. Member States need to promote and encourage the widespread adoption of non-chemical alternatives to plant protection and pest and crop management.
Amendment 52
Article 3, point 17
(17) 'zone'deletedGroup 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;Justification
The proposed definition is misleading because it refers to zones in Annex I which do not have relatively similar agriculture, plant health and environmental conditions. The proposed zoning system undermines the national authorisation and it is not in line with the EC principle of proportionality and subsidiarity because it is going beyond what is necessary to speeding up the decision making process These objectives can be reached by amending the mutual recognition system without the concept of zoning.
In addition, water management conditions can differ within the three proposed zones..
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; Justification
Optimum efficacy is a biased term. It is therefore better to ensure that only the minimum quantity is used. Good Plant Protection Practice is much broader than the current definition that just includes considerations regarding the application of pesticides (see definition of Integrated Pest Management above). It is therefore necessary to clarify the definition as only referring to Plant Protection Products.
The only real solution to eliminate the adverse impacts of pesticides on public health, animals, wildlife and wider environment is to take a preventative and truly sustainable approach by prioritising non-chemical methods of plant protection and pest and crop management.
To provide for optimum plant protection while minimising risks to human and animal health and to the environment, it is essential to avoid the build-up of resistance. If resistance occurs, this may create the need to use plant protection products with a greater impact on human and animal health and on the environment. Prevention of the build-up of resistance therefore needs to be included in the definition of good plant protection practice
Amendment 54
Article 3, point 20 a (new)
(20a) Good Experimental PracticePractice in accordance with Directive 2004/10/EC;Justification
Definition of the term used in Chapter V.
Amendment 55
Article 3, point 21
(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. (21) 'Data protection'
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.Justification
It should be included here that the owner of a test or study cannot prevent it being used by another person where this would avoid animal testing.
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. Justification
There should be a definition of rapporteur Member State.
Amendment 57
Article 3, point 21 b (new)
(21b) tests and studiesInvestigation 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;Justification
Test and study reports terminology is used repeatedly throughout this regulation. There is a need to insert a definition that includes not only study reports but also other information relevant to a risk assessment.
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.Justification
The word unacceptable is nowhere precisely defined.
Amendment 59
Article 3, point 21 d (new)
(21d) minor usesFor 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 or on seed.Justification
Definition of the term minor uses used in Article 49.
Amendment 60
Article 4, paragraph 1
1. An active substance shall be approved in accordance with Annex II, if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance will fulfil the conditions provided for in paragraphs 2 and 3.1. An active substance or a metabolite in the use-phase shall be approved in accordance with Annex II, if it may be proven, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance will fulfil the conditions provided for in paragraphs 2 and 3. These conditions have to be used as cut-off criteria.Justification
Cut-off criteria will be used for the exclusion of active substances and there is a risk that mitigation measures will prove inadequate to protect human health and the environment against intrinsic hazards of certain substances. This will bring the Regulation in line with advanced policy assessment tools for chemical substances, such as the POPs Convention. Moreover, metabolites should be considered on the same base as an active substance since people are exposed to these possibly very toxic metabolites.
Amendment 61
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, such as pregnant and nursing women, embryos and foetuses, infants and children, or animal health, taking into account known cumulative and synergistic effects when the methods to assess such effects are available, or on groundwater;Justification
All the various population subgroups at risk of exposure to pesticides must be protected. This includes professional and non-professional users, residents, bystanders, workers, specific vulnerable groups and consumers, directly or indirectly exposed through air, food, feed, water and the environment. Given that agricultural pesticides are often used in mixtures, the potential adverse health effects of mixtures, including any synergistic effects, must be assessed prior to their approval.
Amendment 62
Article 4, paragraph 2, point (c)
(c) for residues which are of toxicological or environmental significance, there shall be methods in general use for measuring them.(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. The residues shall be detectable with the common multi-residue methods as applied by EU reference laboratories.Justification
Given the risks and adverse impacts of pesticides use, there should be methods in general use to measure residues of all authorized substances. These methods need to be sufficiently sensitive with respect to any technically detectable levels that could be present in any environmental and biological media. This includes any particles, droplets and vapours present in the air , residues transported on pollen or crop dust (e.g. at harvest), spreading of contaminated soil, long-range transportation of pesticides, as well as residues in water, food and feed etc.
This amendment introduces two dimensions into this article. Firstly, that for all authorised pesticides there shall be methods available to identify residues. This is currently not the case, as standard laboratory equipment is capable of identifying only a limited number of substances residues. Secondly, the methods used to assess health effects should be sufficiently sensitive, with respect to levels of concern in various environmental and biological media, in order not to overlook effects that are not detected by methods in general use.
Amendment 63
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 such as pregnant and nursing women, embryos and foetuses, infants and children, 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 where the methods to assess such effects are available; or on surface water and groundwater;Justification
All the various subgroups at risk of exposure to pesticides must be protected, particularly residents, who can be regularly exposed to pesticides from various sources, which include long term exposure to airborne pesticides, exposure to vapours, which can occur days, weeks, even months after application, reactivation, precipitation, pesticides transported from outdoor applications and redistributed indoors, as well as long-range transportation, as pesticides can travel in the air for miles.
The use of the term groundwater on its own makes it more difficult to take account of the cumulative effects.
Any assessment of the state of surface water, which plant protection products enter, should cover all of the hydrosphere, i.e. both surface and groundwater.
Rain, particularly torrential rain, results in the leaching of various substances contained in the soil, including plant protection products. As a result of surface run-off, those substances enter surface water and, through a process of infiltration, 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;
(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;(ii) its impact on non-target species;(ii) its impact on non-target species, including on the behaviour of those species;(iii) its impact on biodiversity.(iii) its impact on biodiversity and the ecosystem;(iiia) its destructive impact on species threatened with extinction.Justification
Many pesticides have indirect effects on the ecosystem, i.e. through food chain effects (reduced bird population in agro-ecosystems due to massive reduction of prey insects). These effects should be taken into account as far as possible.
Special attention should also be given to the environmental effects due to long-range environmental transportation of plant protection products, e.g. in the Arctic region.
Too often mortality alone is studied and not effects on behaviour. This must therefore be specified.
Habitats of species threatened with extinction which appear on the Red List are to be found in many parts of Europe.
Pesticides and other plant protection products are a threat to birds in particular, given that they migrate and feed in many different areas where spraying and other treatments involving pesticides, among other substances, may take place. Feeding by rare species of animal in contaminated areas could bring about the extinction of those species.
Amendment 65
Article 4, paragraph 4
4. For approval of an active substance, paragraphs 1, 2 and 3 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance. 4. For approval of an active substance, paragraphs 1, 2 and 3 shall be deemed to be satisfied where this has been established with respect to the full range of representative uses of at least three plant protection products containing that active substance.Justification
All normal conditions under which plant protection products could be used should be taken into account for approval of a substance.
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Amendment 66
Article 4 a (new)
Animal testingIn 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.Justification
The promotion of intelligent testing strategies and compulsory data sharing can significantly reduce the number of animals used.
Amendment 67
Article 6, point (e)
(e) manner of application;(e) manner and conditions of application;Justification
The directive should cover not just the manner in which plant protection products are used but also the conditions under which they are used.
The last point in this article does refer to 'particular conditions', but no mention is made to typical conditions of use.
Amendment 68
Article 6, point (i)a (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;Justification
Specific uses, which are incompatible with good practices like IPM, should be restricted.
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. Justification
Industry should not be entitled to choose a rapporteur Member State. Applications should be sent to the Authority and Member States should decide amongst themselves who to become the rapporteur Member State. Disagreement should be solved in comitology, on the basis of objective criteria.
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.
Justification
Article 70 of this Regulation requires compliance of measures in conformity with this Regulation to be without prejudice to general civil and criminal liability in the Member States of the producer. The amendment seeks to establish a level playing field for all producers, including the ones established in a jurisdiction outside the Community.
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. Justification
The same provision applies to assessments under Directive 91/414/EEC and has a considerable influence on the speed and quality of the assessment reports on active substances.
Amendment 72
Article 8, paragraph 1, point (a)
(a) Data with respect to one or more representative uses on a widely grown crop in each zone of at least one plant protection product containing the active substance, demonstrating that the requirements of Article 4 are met; where the data submitted do not cover all zones or concern a crop which is not widely grown, justification for this approach;(a) data with respect to the full range of representative uses on a widely grown crop in each Member State of at least three plant protection products containing the active substance, including products for seed coating if this use is foreseen, demonstrating that the requirements of Article 4 are met; where the data submitted do not cover all Member States or concern a crop which is not widely grown, justification for this approach; Justification
Substances used for seed coating (for example fipronil and imidaclopride) have been documented to carry acute toxicity for bees, which have not been foreseen in the risk assessment. It is therefore necessary to introduce this provision in the Regulation.
Zoning is not appropriate for authorisation purposes, since climatic, biological and aquatic conditions in the various countries are not comparable in the proposed zones.
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;Justification
The provisions on data requirements are an essential part of the approval procedure, which should regulated in a legislative procedure, not by a comitology decision.
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;Justification
Dossiers with incomplete or wrong information should be rejected.
The provisions on data requirements are an essential part of the approval procedure, which should regulated in a legislative procedure, not by a comitology decision.
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;Justification
In order to facilitate that animal testing for the purposes of this Regulation is kept to an absolute minimum, applications should also be required to provide a justification of the steps taken to avoid animal testing in general.
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. Justification
All available data must be submitted and assessed.
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.Justification
Clarification of the wording. The adoption of a regulation on the data requirements in the advisory procedure should be limited to a mere transfer of existing requirements. This ensures that the necessary basis for the evaluation of active substances is provided following the transition from the current directive to the new regulation. Modifications should be limited to drafting changes, all the more that the data requirements should be adopted in co-decision in the very near future (see amendment to Article 75), as they represent an essential element of the regulation.
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. Justification
The applicant must have the obligation to collect and summarise all scientific literature on the substance. This will benefit unexpected effects in bees that are not detected in the risk assessment but are widely documented in the scientific literature.
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.Justification
The period of time to add to the missing elements should be specified.
The notified Member States shall respect the same levels of data protection and confidentiality as the rapporteur Member State.
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 expected to meet the requirements of Article 4.1. 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 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.
The Member State may consult 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. Justification
Starting the evaluation of available information before the dossier is complete will speed up access of new, innovative products to the market. Therefore it should not take more than eight months for the rapporteur Member State to issue its review report once the evaluation of the current active substances under Directive 91/414/EEC is completed.
There needs to be a mechanism for claiming data protection for additional information.
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.Justification
In order to ensure a high level of protection for human health and the environment, it is advisable to reduce as far as possible the duration of the approval procedure for new active substances, safeners, synergists and co-formulants (without prejudice to the evaluation criteria). This will enable new plant protection products with a lower impact on human and animal health and the environment to be put into use more quickly.
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. Justification
The transparency of the procedure should be increased
Amendment 83
Article 12, paragraph 2, subparagraph 2
Where appropriate, the Authority shall address in its conclusion the risk mitigation options identified in the draft assessment report. 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.Justification
If more time to conclude consultations is required the extension of the captioned period should be clearly indicated.
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. Justification
EFSA plays a key role in the assessment of active substances, as it will adopt a conclusion on its approval or not. It is important to ensure that EFSA has enough time to perform a rigorous assessment. Currently, EFSA has 10 months to adopt a conclusion. The Commission proposes to shorten this period to 3 months. This may occur at the expense of a proper assessment. There should therefore be flexibility to "stop the clock" when EFSA needs additional information. This information should then be assessed by the rapporteur Member State, as it is most familiar with the dossier.
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. Justification
EFSA plays a key role in the assessment of active substances, as it will adopt a conclusion on its approval or not. It is important to ensure that EFSA has enough time to perform a rigorous assessment. In some cases, EFSA might need to consult experts to ensure this. This may require extra time. There should therefore be flexibility to "stop the clock" when EFSA needs to organise the consultation of experts.
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 Article 12.1. 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. Justification
The Commission does not need half a year to draft a report on a fully examined dossier. The procedure needs to be accelerated.
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.Justification
The transparency of the procedure should be increased.
In order to ensure a high level of protection for human health and the environment, it is advisable to reduce as far as possible the duration of the approval procedure for new active substances, safeners, synergists and co-formulants (without prejudice to the evaluation criteria). This will enable new plant protection products with a lower impact on human and animal health and the environment to be put into use more quickly.
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;Justification
This amendment is necessary to bring the text into line with the provisions of the new decision on comitology. The transparency of the procedure should be increased. Therefore the inclusion of approved substances in an Annex of the Regulation should be maintained.
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.Justification
The transparency of the procedure should be increased. Therefore the inclusion of approved substances in an Annex of the Regulation should be maintained.
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.Justification
In the proposed text the renewal of the authorisation by the Member State follows the renewal of the active substance (Article 43(6)). This implies that also the authorisation would in principle be unlimited in time, after the first renewal. This is contrary to the precautionary principle and to the principle that decisions are made in the light of current scientific and technical knowledge, as is laid down in Article 4(10) of the proposed text, and the principle that a high standard of protection must be ensured (recital 21).
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;Justification
In order to ensure that animal testing for the purposes of this Regulation is kept to an absolute minimum, measures to facilitate this should also be included in the programme.
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 Article18.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 Article18.Justification
This amendment is necessary to bring the text into line with the provisions of the new decision on comitology.
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.Justification
Not more than one year should be granted for using up stocks of the plant protection product. Beyond this period, producers should ensure the safe removal and disposal of their product.
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. Justification
To ensure transparency in the process and align the proposal to the precautionary principle. The amendment also seeks to ensure that decisions take into account current scientific and technical knowledge, as it is laid down in Article 4(1) of the proposed text and the principle that a high standard of protection must be ensured, as stipulated in recital 21.
Amendment 98
Article 21, paragraph 1, subparagraphs 2 a and 2 b (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.The approval shall be reviewed for the ten active substances most often found to be present above the maximum residue level (MRL) in the annual monitoring reports on pesticide residues published by the Commission. Where the same substance is found repeatedly on that list, the approval shall be withdrawn. Justification
While the Commission can launch a review for a given substance at any time, it should be made clear that requests for review can also be initiated by other institutions or stakeholders.
It is essential that, in cases of non-compliance with the objectives of Directive 2000/60/EC, it is possible to reconsider the approval of the substance. Moreover, this direct feedback mechanism between Directive 2000/60/EC and this Regulation will also provide an extra incentive for producers to seriously consider their responsibilities in terms of product stewardship.
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). Justification
This amendment is necessary to bring the text into line with the provisions of the new decision on comitology.
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. Justification
It is essential that in case of non-compliance with the objectives of Directive 2000/60/EC for a substance, it is possible to reconsider the approval of the substance. The procedure should be in line with the provisions of the new decision on comitology.
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 15years, 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 15years, where it will have no adverse effect on human and animal health and the environment, as provided for in Article 46(1). Justification
To clarify that active substances that have no adverse effect on humans, animals or the environment can be considered as low-risk.
Amendment 102
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,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.Justification
There is a need to lay down clear and objective criteria to define which substances can claim to have a low risk profile. There is no definition for this in the proposal. To encourage research for less harmful substances and products, it is important to provide businesses with clarity and legal certainty on what exactly is meant by a low risk profile. The criteria listed here are partly taken from the biocides directive, 98/8/EC. With these criteria 25% to 30% of active substances would be considered as low risk.
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). Justification
The use of plant protection substances based on biological control agents offers excellent prospects for the protection of human and animal health and of the environment and should be fully supported. In view of their low-risk nature, such biological control agents have great potential benefits. Since plant protection based on biological control agents often has a relatively small area of application, a 15-year approval period is necessary in order to promote sufficient research and development for such plant protection products.
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 which1. 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: Justification
No unlimited authorisations shall be foreseen in the Regulation for basic substances. Similarly to active substances, they should be subject to a regular review in line with the latest scientific information and data.
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.Justification
The risk assessment procedure shall be mandatory also for basic substances.
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.Justification
Bearing in mind that the approval for other substances is 10 years and substitution is by existing alternatives in the market, 7 years for the authorisation of candidates for substitution is clearly excessive. In Sweden, for example, a programme for the substitution of pesticides was completed giving 5 years as a deadline for finding alternatives. Substituting plant protection products by non-chemical alternatives should be the first priority.
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. Justification
Safeners and synergists shall be assessed in relation to different active substances with which they are combined.
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 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.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.Justification
The provisions for reviewing existing synergists and safeners shall not be left to a comitology decision, but shall be established in a legislative procedure based on the Treaty.
Amendment 109
Article 27
ProhibitionCo-Formulants1. 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).Justification
Co-formulants can have an impact on human health and the environment. They should therefore be approved and included on a positive list, like safeners and synergists (see Article 25), in line with provisions of the new decision on comitology.
Good practice should be assumed, but can not be taken for granted. Instead, realistic conditions of use should be foreseen in line with the current provisions included in the test guidelines in Directive 91/414, where consideration must be given to practical conditions of use and realistic conditions of use.
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.Justification
Co-formulants used in plant protection products should not be subject to double regulation under REACH.
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;Justification
The Regulation aims at having high standards for authorisation. Plant protection products authorised specifically for research and development purposes should not be placed on the market.
Amendment 112
Article 28 a (new)
Article 28a
Parallel imports1. Notwithstanding the provisions of Article 28(1), a plant protection product may be placed on the market and used in a Member State without being authorised there if the person wishing to market the plant protection product is in possession of a marketability certificate for the plant protection product issued by that Member State.2. Member States shall issue a marketability certificate within the meaning of paragraph 1 for a plant protection product upon request, provided the plant protection product to be imported from another Member State has already been authorised in another Member State and a reference product which is compositionally equivalent is authorised in the importing state (parallel imports).3. Compositional equivalence within the meaning of this Article shall be deemed to exist where imported and reference products contain the same active substances in comparable amounts with equivalent minimum purity levels and with certain impurities of the same type and equivalent maximum levels and have a matching formulation type. As regards other aspects of composition, differences are permissible provided these qualitative or quantitative differences in the co-formulants have no impact on biological efficacy, the plants to be treated or human beings, animals or nature. The criteria and the procedure for verifying compositional equivalence may be regulated in greater detail under the advisory procedure referred to in Article 76(2). 4. The application for the issue of a marketability certificate shall contain the following information: the Member State of origin of the plant protection product to be imported; the name and address of the importer; the designation under which the imported plant protection product is to be marketed in the importing country; the designation and approval number in the Member State of origin of the plant protection product to be imported; the name and address of the authorisation holder in the Member State of origin; the original instructions with which the plant protection product to be imported is marketed in the Member State of origin; the designation and instructions with which the imported plant protection product is to be marketed; the designation and authorisation number of the reference product; the name of the authorisation holder of the reference product.5. A plant protection product for which a marketability certificate has been issued shall be used in the same manner as the reference product.6. The marketability certificate shall apply for the duration of the authorisation of the reference product. If the authorisation holder of the reference product applies, pursuant to Article 44(1), for authorisation to be withdrawn and if the requirements under Article 29 continue to be met, the validity of the marketing certificate shall end one year after the revocation of the authorisation, and, at the latest, when the authorisation has expired.7. The provisions of Articles 43, 45 and 53(4) and Chapter VII shall apply, mutatis mutandis, to parallel imports.Justification
The Commissions proposal contains no rules on parallel imports of plant protection products. However, legal provisions are urgently needed at EU level in order to put an end to the existing legal uncertainty. Conflicting court decisions and the variety of approaches taken to parallel imports by the Member States mean that the proposal must be supplemented by rules on parallel imports.
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;Justification
See justification on Amendment to Article 27 above.
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;Justification
Different formulations vary considerably in risk - e.g. powder compared to granule formulation and formulation containing organic solvent compared to water soluble emulsions. If it can be avoided, the formulation in itself should not increase the risk involved with the use of a specific plant protection product. The proposed text would help ensure that the formulation with the lowest possible risk is used when a product is placed on the market.
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;Justification
The Uniform principles are a key element in the authorisation process.
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; Justification
This is in line with the earlier amendment suggested at Article 4, paragraph 2, point c and the related justification.
Methods to detect all residues of active substances should be sufficiently sensitive with respect to levels of concern in various environmental and biological media in order not to overlook effects that are not easily detected by methods in general use.
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].Justification
Member States should not be forced to accept pesticides which pollute ground water or cause unnecessary risks and hazards for humans, animals and the environment in conflict with their national environmental and health policies. Member states should be allowed to take regional conditions into account before authorising plant protection products.
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.deletedJustification
Considering that pesticide products often contain a number of different substances potentially altering the action of an active ingredient/substance within the formulation, it cannot be assumed that all different products and formulations containing an specific synergist or safener which is included in the review programme referred to in Article 26 will have no harmful effects on humans and animals or the environment. The potential adverse health must be assessed prior to their authorization to establish that there will be no harmful effects on humans and animals.
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).Justification
This amendment is necessary to bring the text into line with the provisions of the new decision on comitology.
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.Justification
The Uniform Principles shall not be established by the Comitology procedure. In 1996 the European Parliament had to go to Court because the first Uniform Principles which were established by the Commission did not comply with Directive 91/414. The Court (case C-303/94) confirmed the Parliaments position and the Principles were changed, especially for drinking water criteria. The Regulation establishing the new Uniform Principles should be adopted by the European Parliament and the Council in an adequate legislative procedure, and not by Comitology.
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.Justification
It shall be made clear that the interaction between different substances is taken into account in the authorisation process. It is not sufficient to look at the involved substances separately.
The amendment is mainly meant to clarify. It is already indirectly mentioned in Article 25 paragraph 2 in connection with Article 8 paragraph 1 point a), Article 29 paragraph 4 and in the uniform principles.
Amendment 122
Article 30, title and paragraph 1
ContentsContents 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. Justification
The authorisation form should be standardised and identical for the Member States.
Amendment 123
Article 30, paragraph 2
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;(d) the obligation to inform any residents and neighbours who could be exposed to the spray drift and other sources of exposure.Justification
Conditions for specific requirements and restrictions should be clarified. This amendment deems the authorisation in line with other provisions in this Regulation. The conditions and principles of Integrated Pest Management and informing residents and neighbours should be formulated as a minimum.
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.Justification
Conditions for specific requirements and restrictions should be clarified.
Amendment 125
Article 30, paragraph 3, introductory part
3. The requirements referred to in paragraph 2 may include:3. The requirements referred to in paragraph 2 should include:
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;Justification
All the various population subgroups at risk of exposure to pesticides must be protected. This includes professional and non-professional users, residents, bystanders, workers, specific vulnerable groups and consumers, directly or indirectly exposed through air, food, feed, water and 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, childrens playgrounds etc. Justification
The statutory conditions of use in the approval for all pesticides should contain detailed requirements for any prohibition of pesticide use in and around areas used by the general public or by sensitive population, such as residential areas, parks, public gardens, sports grounds, school grounds, childrens playgrounds etc.
Amendment 128
Article 32, paragraphs 1 and 2
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.Justification
In the proposed text, only the Member States where an application for authorisation is submitted are informed about the application. This is different in the current Directive 91/414, where the applicant has to inform every Member state by sending a complete dossier.
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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.Justification
Clearly safeners, synergists, co-formulants and adjuvants are added to enhance or modify the effect of the active substance, making the combined effect different from the added-on effect of the individual substances. Therefore, the combined effect should also be evaluated.
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;Justification
In order to facilitate that animal testing for the purposes of this Regulation is kept to an absolute minimum, applications should also be required to provide a justification of the steps taken to avoid animal testing in general.
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).Justification
In the proposed text, only the Member States where an application for authorisation is submitted are informed about the application. This is different in the current Directive 91/414, where the applicant has to inform every Member state by sending a complete dossier.
Amendment 133
Article 32, paragraph 5 a (new)
5a. 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.Justification
A solution not requiring much time or administration work is to inform or notify all the other Member States about the application and by giving those Member States the possibility to request a complete dossier. Furthermore the Member States shall have the right to give their comments to the Member State evaluating the dossier. This contributes to the quality of the evaluation and to the uniformity of the evaluation in all countries.
Amendment 135
Article 34 a (new)
Article 34 aDatabase of the AuthorityUpon 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).Justification
Conform the last subparagraph of Article 9(3) and Article 10. Linked to Amendments of Recital 32 and Articles 54(1), 57(1) and (2) and 58(-1). In order to facilitate data sharing it is necessary to establish one central database with all the information on tests and studies carried out previously for the purposes of this Regulation, managed by the Authority. Applicants would then have to consult only one database before carrying out any tests or studies. The information referred to in Article 32(3)(c) should also be publicly available to ensure transparency in relation to the steps taken by applicants to avoid animal testing.
Amendment 136
Article 35, paragraph 1, subparagraphs 1 and 2
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.Justification
The investment in placing new products on the market is substantial, especially for SMEs, and a predictable decision making system is required to give certainty to the investing companies. Changing the rules after the time of application is inappropriate and discourages investment by companies. The proposed wording in the second part ensures legal certainty in case of legal disputes. Realistic conditions can be evaluated and measured and can allow courts to rule on the basis of measurable facts.
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.Justification
EU-wide authorisation is required in order, finally, to establish a functioning internal market for plant protection products. Changes should therefore also be made to the text.
Amendment 138
Article 35, paragraph 2
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.Justification
Following the rapporteur's Amendment 86, the division into authorization zones is not appropriate as conditions in the proposed zones are often incomparable. Authorizations should be granted only at Member State level but notified to other Member States. Within a reasonable time period of 180 days, notified Member States should be obliged to confirm, reject or restrict the authorization pursuant their specific national situation.
Amendment 139
Article 35, paragraph 3
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).Justification
Use and potential problems of use may vary considerably between Member States, even those belonging to the same zone. Member States should therefore be able to foresee additional conditions and restrictions of use.
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. Justification
Specifying the time periods is necessary in order to lay down the procedures.
Amendment 141
Article 37, paragraph 4, subparagraph 1
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 paragraph3.4. 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 paragraph3.Justification
We need to secure the fastest possible authorisation procedure compatible with a high protection of human health and the environment. This means, however, that if Member States are to take full account of the relevant and specific circumstances within their territory before authorising or refusing to authorise a product authorised in another Member State - rather than automatically approve the authorisation from another Member State - 90 days is inadequate.
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Amendment 142
Article 37, paragraph 5
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.Justification
This amendment is necessary to bring the text into line with the provisions of the new decision on comitology.
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).
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* 12 months after the entry into force of this Regulation.Justification
A system of work sharing should be put in place to facilitate the decision making process of Member States that authorise the same product within the EU.
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.Justification
A central body, the Authority should keep track of the various authorisations granted to substances in the different Member States.
Amendment 145
Article 38, paragraph 2
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.Justification
A system of work sharing should be put in place to facilitate the decision making process of Member States that authorise the same product within the EU.
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.Justification
A system of work sharing should be put in place to facilitate the decision making process of Member States that authorise the same product within the EU.
Amendment 147
Article 39, paragraph 1
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.Justification
The division into authorization zones is not appropriate as conditions in the proposed zones are often incomparable. Authorizations should be granted only at Member State level but notified to other Member States. Within a reasonable time period, notified Member States should be obliged to confirm, reject or restrict the authorization pursuant their specific national situation.
The assumption of the Commission seems to be that the climatologic and environmental conditions in all greenhouses and in all cases of post-harvest treatment are relatively similar. As this is not the case, this part of the article should be deleted.
Amendment 148
Article 40, paragraph 1
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.Justification
The principle of mutual recognition must leave room for Member States to adapt authorisations to their specific situation, by setting additional conditions for use or, in duly substantiated cases, to refuse authorisation of a given product.
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.Justification
In line with the rapporteur's report, the principle of mutual recognition must leave room for Member States to decide whether an authorisation should be granted on the basis of the country specific conditions. In order to make the legislation as clear as possible, this should be stated in the relevant Article 40, which concerns authorisation under the heading of mutual recognition.
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.Justification
See the justification to the amendment to Article 40, paragraph 1 a (new).
The amendment replace the zoning system as laid down in the Commission proposal and will give more discretion to Member States without incurring any unnecessary duplication of work and a slower decision-making process.
Amendment 151
Article 40, paragraph 2
2. By way of derogation from paragraph 1 and subject to Community law, additional conditions may be imposed with respect to the requirements referred to in Article 30(3).2. Additional conditions may be imposed with respect to the requirements referred to in Article 30(3).Justification
See the justification to the amendment to Article 40, paragraph 1 a (new)
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. Justification
See the justification to the amendment to Article 40, paragraph 1 a (new)
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).Justification
If necessary, Member States should have the full information available before deciding on authorisation of a specific product.
Amendment 154
Article 41, paragraph 2
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.Justification
We need to secure the fastest possible authorisation procedure compatible with a high protection of human health and the environment. This means, however, that if Member States are to take full account of the relevant and specific circumstances within their territory before authorising or refusing to authorise a product authorised in another Member State - rather than automatically approve the authorisation from another Member State - 90 days is inadequate.
Amendment 155
Chapter III, Section 1, Subsection 4, title
RENEWAL AND WITHDRAWALRENEWAL, AMENDMENT AND WITHDRAWALJustification
A better reflection of the content of the subsection.
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;Justification
Clarification regarding the data to be protected after the renewal of the active substance authorization.
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;Justification
Clarification regarding the data to be protected after the renewal of the active substance authorization.
Amendment 158
Article 42, paragraph 5
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). Justification
This amendment is necessary to bring the text into line with the provisions of the new decision on comitology.
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.Justification
It is essential that in case of non-compliance with the objectives of Directive 2000/60/EC for a substance, it is possible to reconsider the authorisation of the product. Moreover this direct feedback mechanism between Directive 2000/60/EC and this Regulation will also provide an extra incentive for producer to seriously consider their responsibilities in terms of product stewardship.
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.Justification
In the proposed text an important provision from Directive 91/414 Article 4(6) is missing. This Article states that the authorisation shall be modified if it is established that on the basis of developments in scientific and technical knowledge the manner of use and amount used can be modified. This obligation keeps the authorisation conditions up to date with scientific developments and is an example of a practical application of the precautionary principle.
Amendment 161
Article 43, paragraph 4
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.Justification
Where the reasons for withdrawal, amendment or not renewing the authorization are related to the protection of human and animal health and the environment then the sale and use of such pesticides should cease with immediate effect.
Amendment 163
Article 45 a (new)
Article 45aDisposal and destruction of unauthorised plant protection productsNotwithstanding 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. Justification
Stocks of obsolete pesticides pose serious hazards to human health and the environment in many Member States and third countries. The producers shall be required to assure safe disposal and destruction of these hazardous substances.
Amendment 164
Article 45 b (new)
Article 45bImportsImported 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. Justification
In order both to protect human health and the competitiveness of the European industry, imported non-food materials or articles should not contain active substances that have not been approved in the EU.
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;Justification
To clarify that only products containing active substances that have no adverse effect on humans, animals or the environment can be considered as low-risk active substances.
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.Justification
Zoning is not appropriate for authorisation purposes, since climatic, biological and aquatic conditions in the various countries are not comparable in the proposed zones.
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 90-day 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 90-day period shall be extended by the additional time limit granted by the Member State. The total period may not exceed four months.Justification
Clear time limits must be set for all measures under the Regulation.
Amendment 168
Article 46 a (new)
Article 46aPlacing on the market and usingreduced risk plant protection products1. 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).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.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.4. Unless stated otherwise, all the provisions of this Regulation relating to authorisations shall apply.Justification
To encourage the development of less harmful plant protection products, this introduces a new category of low-risk plant protection products that present a lower risk than current products on the market and contain at least one low-risk active substance. This category of plant protection products should receive certain advantages such as a longer period of data protection and tax exemption.
Amendment 169
Article 48, paragraph 1, introductory part and points (a) and (b)
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 equally effective authorised plant protection product, or an equally effective 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 non-chemical 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;Justification
Substitution should be the back-bone of a modern authorisation policy.
Products that contain a candidate for substitution shall not be approved by Member States if there are safer alternatives or methods available for a given crop. The proposed deadline of five years will speed up the revision process and give incentive for innovation.During the comparative assessment process it has to be ensured that a possible alternative shows equivalent efficacy in treating the pest problem. Otherwise farmers would be left without adequate means to protect their harvest.
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.Justification
Non-chemical methods and practises of crop management and pest prevention must also be taken into consideration in the provisions for substitution.
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.Justification
Although all products might be liable for substitution, Member States have limited resources and therefore priority in comparative assessment and substitution shall be given to candidates for substitution.
Amendment 172
Article 48, paragraph 3
3. Member States shall repeat the comparative assessment provided for in paragraph1 regularly and at the latest four years after authorisation or renewal of the authorisation was granted.3. Member States shall repeat the comparative assessment provided for in paragraph 1 only once and at the latest four years after authorisation or renewal of the authorisation was granted.Based on the results of that comparative assessment, Member States shall maintain, withdraw or amend the authorisation.Based on the results of the first comparative assessment, Member States shall maintain, withdraw or amend the authorisation. After the second comparative assessment, Member States shall withdraw the authorisation.Justification
Candidates for substitution should not be allowed on the market indefinitely but should be removed after the second comparative assessment.
Amendment 173
Article 48, paragraph 4
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. Justification
The proposed deadline of two years will speed up the process of substitution and give incentive for innovation.
Amendment 174
Article 49, paragraph 1
1. For the purpose of this Article, 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 to meet an exceptional need.1. For the purpose of this Article, 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 (not more than 0,1 % of the agricultural area of the Member State) or on a widely grown crop to meet an exceptional need.Justification
Minor uses are considered now every crop which is not a major crop (cerea l s , m a i z e ) . A p p l e s a r e g r o w n o n 3 0 0 . 0 0 0 h a i n E U 1 5 , a b o u t 0 . 2 5 % o f t h e a g r i c u l t u r a l a r e a .
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