EN

Brussels, 12.7.2006

COM(2006) 388 final

2006/0136 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

concerning the placing of plant protection products on the market

(presented by the Commission)

{SEC(2006) 930}

{SEC(2006) 931}

EXPLANATORY MEMORANDUM

Context of the proposal |

110 | (a) Grounds for and objectives of the proposalOn 26 July 2001, the Commission submitted a progress report to Council and Parliament on the functioning of Directive 91/414/EEC [COM(2001) 444]. The report highlighted a number of areas where the Directive could be improved. The Commission concluded in its report that reform of the current legislation was necessary in order to achieve the following:reinforce the high level of protection of human health and the environment,improve functioning of the internal market,maintain and enhance the competitiveness of the EU chemical industry,harmonise availability of plant protection products between farmers in different Member States,increase transparency,avoid repetition of animal testing,update the procedures in particular to take account of the creation of the European Food Safety Authority,define the role of the European Food Safety Authority. |

120 | (b) General contextBoth Council and the European Parliament, in reacting to the progress report, called on the Commission to bring forward proposals to amend the Directive.The Council moreover called the Commission inter alia to consider rules in order to:avoid repetition of testing on vertebratesprotect non-professional userspresent criteria for approval of active substancesfurther strengthen the rules for substances with a very hazardous profileintroduce a simplified procedure for low risk substances and products. The European Parliament stressed also aspects such as:the principle of comparative assessment and substitutionexclusion of substances with a very hazardous profileincreased transparencyimprovement of mutual recognition by introducing product authorisation zones.Both the European Parliament and the Council called the Commission to propose a thematic strategy for the sustainable use of pesticides and to make further progress on establishing maximum residue levels. |

130 | (c) Existing provisions in the area of the proposalThe Community regulatory framework concerning plant protection products includes:(1) Directive 91/414/EEC of 15 July 1991 concerning the placing on the market of plant protection products which intends to prevent risks at source through a very comprehensive risk assessment procedure of each active substance and the products containing the substance, before they can be authorised for marketing and use.(2) 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, which provides for a list of substances which have been banned in the EU and which may not be included in plant protection products.(3) Regulation (EC) No 396/2005 of the European Parliament and of the Council on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC which sets maximum residue levels (MRLs) of active substances in agricultural produce, thus intending to limit the risks to consumers. In addition, monitoring the respect of MRLs is an important tool to assess whether farmers have correctly applied the instructions and restrictions outlined in the authorisations of plant protection products.(4) Together with this proposed Regulation, a proposal is presented for a Directive of the European Parliament and of the Council establishing a framework for Community action to achieve a sustainable use of pesticides. It intends to cover the use and distribution phase in so far as they are not addressed in the current proposal. |

140 | (d) Consistency with other policiesIn preparing its proposal the Commission has taken into account key elements of the Lisbon strategy in order to extend and deepen the single market, to ensure open and competitive markets inside and outside Europe, to encourage and stimulate investment in research, development and innovation within the EU and to improve regulation and cut red-tape.The Commission has been careful to avoid duplication of the provisions of other legislation, while avoiding loopholes and ensuring that necessary information is made available to other sectors.Certain aspects concerning use and distribution of plant protection products are covered by the proposal for a Directive of the European Parliament and of the Council establishing a framework for Community action to achieve a sustainable use of pesticides. Coherence with the legislation on setting maximum residue limits has been ensured. The proposal will also ensure coherence with two recently adopted Regulations: Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.The proposed provisions are in line with the principles of Regulation (EC) No 1049/2001 of the European Parliament and of the Council regarding public access to European Parliament, Council and Commission documents. |

Consultation of interested parties and impact assessment |

| (a) Consultation of interested parties |

211 | Consultation methods, main sectors targeted and general profile of respondentsFollowing the presentation of the Commission's progress report, there was a wide consensus on the need for reform. Both the Council and the European Parliament clearly favoured development of more effective mechanisms and procedures, to strengthen the criteria for acceptance of substances and products and to ensure that they would be used more safely. Industry welcomed the reflection on more effective evaluation and authorisation procedures. Industry also expressed interest that any new rules on data protection should keep a fair balance between the interests of research and generic companies. Environmental non-governmental organisations (NGOs) and consumer organisations were strongly supportive of the need for change, in particular to increase transparency and to strengthen the criteria for acceptance of active substances.The Commission organised a brainstorming meeting with Member States on 27 February 2002 in which a number of areas were identified as requiring discussion and possible amendment. The Commission subsequently organised a workshop with the Presidency in Corfu in July 2002. Member States, Accession countries, the European Parliament and NGOs were invited to participate, to prepare background papers on each of the topics identified and to suggest other topics important to them. The report of the workshop formed the basis for further discussions. The Commission organised a further meeting with stakeholders in Brussels on 30 January 2004.The objectives of this meeting were (i) to report back to stakeholders on the orientations of the Commission in handling all of the topics discussed at Corfu, (ii) to exchange views on a possible compromise approach to data protection and on centralisation of the system for authorisation of plant protection products and (iii) inform stakeholders on planned next steps in the process. Also the status and plans for the Thematic Strategy on the Sustainable Use of Pesticides were discussed. The Commission consulted stakeholders again by mail on 18 April 2005 on a first draft proposal and a draft impact assessment on which written contributions were made. From 10 March to 10 May 2005 the Commission carried out an Interactive Policy Making consultation with the general public.A further consultation on the impact assessment was organised at a meeting with stakeholders on 25 January 2006.Among the stakeholders consulted were:AUDACE (Association of Users and Distributors of AgroChemicals in Europe)BEUC (Bureau Européen des Unions des Consommateurs)BUAV (British Union Against Vivisection)CEFIC (European Chemical Industry Council)CELCAA (Comité Européen de Liaison des Commerces Agricoles et Agro-Alimentaires)COCERAL (Comité du Commerce des céréales, aliments du bétail, oléagineux, huile d'olive, huiles et graisses et agrofournitures)COLEACP (Europe-Africa-Caribbean-Pacific Liaison Committee)COPA/COGECA (Committee of Professional Agricultural Organisations in the European Union/General Confederation of Agricultural Co-operatives in the European Union)ECCA (The European Crop Care Association)ECPA (The European Crop Protection Association)EEB (European Environmental Bureau)EFTA (European Free Trade Association)ESA (European Seed Association)EPPO (European and Mediterranean Plant Protection Organisation)EUREAU (European Union of National Associations of Water Suppliers and Waste Water Services)EUREPGAP (Euro-Retailer Produce working Group – Good Agricultural Practice)Eurogroup for Animal WelfareFEFAC (Fédération européenne des Fabricants d’Aliments Composés)Freshfel Europe (Forum for the European fresh fruits and vegetables chain)Friends of the EarthIBMA (International Biocontrol Manufacturers Association)Member States of E.U. + Bulgaria, Romania OECD (Organisation for Economic Co-operation and Development)PAN (Pesticides Action Network Europe)UEAPME (Union Européenne de l'Artisanat et des Petites et Moyennes Entreprises)WWF (World Wildlife Fund) |

212 | Summary of responses and how they have been taken into account.A large number of comments were received. The input from stakeholders was considered when preparing the final proposal. The following are the main points that were raised and comments considered as follows:Mutual recognition of authorisations: there was no consensus on the best approach for further harmonization of authorisation of plant protection products. Some stakeholders are opposed because they fear that local conditions can not be taken into account sufficiently, whilst other stakeholders would be in favour of a fully centralized authorisation system. The proposed system is a compromise between the current situation and a fully centralised authorisation. It should avoid unnecessary duplication of work, speed up decision making and ensure a more harmonized availability of plant protection products in the different Member States.Data protection and data sharing: Member States complain that the current system is too complicated and a major administrative burden. The research industry complains that the data protection period is too short and that it should be extended to all data; data sharing is accepted but only for data involving vertebrate animals. The generic industry complains that no fair competition is possible because of data protection, in particular at the 10 year review of an active substance. It is proposed to simplify the system. Data protection for 10 years after the first authorisation is maintained. Provisions on data protection at review of an active substance are removed.Comparative assessment: The European Parliament, some Member States and Environmental and Consumer organisations are very much in favour. Other Member States, industry and farmer organisations are against because they fear that the availability of products will be reduced with subsequent problems to deal with pest resistance; they prefer the principle to be applied at farmer level. The proposed system provides that certain active substances are identified as candidates for substitution and that Member States have to apply comparative assessment and substitution when authorizing plant protection products. The problem of development of resistance will have to be considered before substituting a product. Criteria for approval of active substances: most stakeholders agree that criteria have to be established but do not necessarily agree on the criteria themselves. Such criteria are established in an annex of the proposal, taking into account the high level of protection of human and animal health and of the environment requested by the European Parliament and the Council. The establishment of criteria will also enable industry to take an informed decision before investing in the development of new active substances or to support the renewal of approval of existing active substances. Provisional authorisations: industry and some Member States do not agree with the abolishment of provisional authorisations. The principle of provisional authorisation is however incompatible with Regulation (EC) No 396/2005 which establishes a harmonised Community system for establishing MRLs. Moreover the strict deadlines introduced for assessing an active substance will substantially reduce the period for decision making, which will compensate for the abolishment of provisional authorisations. In addition Member States must already start to evaluate applications for authorisation of plant protection products during the EU evaluation of the active substance.Comments were also raised on several aspects of the proposed Regulation; these comments have been considered and taken into account as far as possible. It should however be noted that views were sometimes totally opposed between stakeholders. |

| (b) Collection and use of expertise |

229 | Internal and external expertise was used to contribute to the impact assessment. |

230 | (c) Impact assessmentThe Commission carried out an impact assessment listed in the Work Programme, whose report is accessible on http://europa.eu.int/comm/dgs/health_consumer/index_en.htm.For each of the main measures proposed, three to five options have been examined with regard to their economic and social impacts and their impacts on health and the environment.I. Provisional authorisationsII. Mutual recognitionIII. Comparative assessmentIV. Data protectionV. Informing neighbours of the use of plant protection products. |

Legal elements of the proposal |

305 | (a) Summary of the proposed actionThe proposed Regulation replaces Directive 91/414/EEC concerning the placing of plant protection products on the market and repeals Council Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances. In a nutshell, it consists of the following elements:Establishment at EU level of a positive list of active substances, safeners, synergists and a negative list of co-formulantsAuthorisation of plant protection products at Member State levelCompulsory mutual recognition of authorisations in Member States belonging to the same authorisation zoneComparative assessment and substitution of products containing substances identified as candidates for substitutionSpecific provisions for basic substances or products containing substances of low concernDetailed rules on data protection and transparencyProvisions on packaging, labelling and advertising Obligation to keep records and to carry out controlsEstablishment of criteria for approval of active substances, safeners or synergists |

310 | (b) Legal basisArticle 37(2) and Article 152(4)(b) |

320 | (c) Subsidiarity principleThe subsidiarity principle applies insofar as the proposal does not fall under the exclusive competence of the Community. |

| The objectives of the proposal cannot be sufficiently achieved by the Member States for the following reason(s). |

321 | Action by Member States only could lead to different levels of protection for human and animal health and for the environment. Recommendations or self-regulations would not guarantee a sufficient level of protection of human health or the environment.It could also risk creating additional burden to industry when different requirements would apply. Competition conditions between farmers would be unequal if availability of plant protection products is very diverse. |

| Community action will better achieve the objectives of the proposal for the following reason(s): |

324 | Only Community action can lead to improvement of the completion of the internal market for plant protection products. |

325 | The large difference in authorisation of existing active substances shows that without further harmonisation the protection levels in Member States may vary a lot. |

327 | A positive list of about 500 active substances needs to be managed. This requires a harmonised and centralised approach. |

| The proposal therefore complies with the subsidiary principle. |

| (d) Proportionality principleThe proposal complies with the proportionality principle for the following reason: |

331 | The proposal fully harmonizes the approval of active substances but leaves it to Member States to authorise plant protection products taking into account harmonised criteria and national conditions. |

332 | The administrative and financial burden is reduced because of:the provision of strict deadlines for decisions at all levels, thus increasing predictability and improving access to the marketincreased worksharing at Member State level for assessing applications for authorisation. |

| (e) Choice of instruments |

341 | Proposed instruments: Regulation. |

342 | Other means would not be adequate for the following reason:The instrument of a Regulation is justified because it ensures that the provisions are implemented at the same time and in the same way in all 25 Member States, reducing as well administrative burden and ensuring clarity for the economic actors. |

Budgetary implication |

401 | The Community may make a financial contribution up to 100% to the establishment of a harmonised policy and system.The appropriations required for the above measures shall be authorised each financial year as part of the budgetary procedure.DG SANCO shall recruit 2 staff for the implementation of the control measures. |

Additional information |

520 | (a) SimplificationThe recast and replacement of Directive 91/414/EEC by a Regulation was foreseen in the Simplification Rolling Programme of the Communication of the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions - Implementing the Community Lisbon programme - A strategy for the simplification of the regulatory environment [COM(2005) 535].The proposal fully implements the objectives of clarifying and improving legibility of legislation and reducing administrative costs. Replacing Directive 91/414/EEC by a Regulation brings clear benefits for the Member States, which will no longer have to transpose approval of substances into national legislation. Stakeholders will also benefit from clearer criteria in the legislation and the fact that the Regulation will significantly shorten the approval time for active substances by providing strict deadlines within which the process must be completed.Administrative procedures for authorisation of plant protection products are simplified. The impact of the new mutual recognition rules applicable to the three zones is positive for public authorities leading to better streamlining, increased efficiency and faster administrative procedures. The new rules on data protection are clear and reduce the administrative burden for industry and public authorities. For industry, obligatory zonal mutual recognition will bring benefits of administative and procedural simplification. The deadlines to grant authorisations are much shorter.Farmers will obtain a quicker and more harmonised availability of plant protection products.The proposal is included in the Commission's Work and Legislative Programme under the reference 2003/SANCO/61. |

520 | (b) Repeal of existing legislationThe adoption of the proposal will lead to the repeal of existing legislation. |

560 | (c) European Economic AreaThe proposed act concerns an EEA matter and should therefore extend to the European Economic Area. |

2006/0136 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

concerning the placing of plant protection products on the market

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 37(2) and 152(4)(b) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee,

Having regard to the opinion of the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty,

Whereas:

(1) Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market [1] provides for rules governing plant protection products and the active substances contained in those products.

(2) In their conclusions on the progress report [2] presented by the Commission under Directive 91/414/EEC, the European Parliament and the Council asked the Commission to review the Directive and identified a number of issues for the Commission to address.

(3) In the light of the experience gained from the application of Directive 91/414/EEC and of recent scientific and technical developments, Directive 91/414/EEC should be replaced.

(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 [3].

(5) To simplify application of the new act and to ensure consistency throughout the Member States, it should take the form of a Regulation.

(6) Plant production has a very important place in the Community. One of the most important ways of protecting plants and plant products against harmful organisms, including weeds, and of improving agricultural production is the use of plant protection products.

(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.

(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.

(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.

(10) In the interest of predictability, efficiency and consistency, a detailed procedure should be laid down for assessing whether an active substance can be approved. The information to be submitted by interested parties for the purposes of approval of a substance should be specified. In view of the amount of work connected with the approval procedure, it is appropriate that the evaluation of such information be performed by a Member State acting as a rapporteur for the Community. To ensure consistency in evaluation, an independent scientific review should be performed by the European Food Safety Authority established by Article 22 of Regulation (EC) No 178/2002 of the European Parliament and the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [4] (hereinafter referred to as ‘the Authority’). It should be clarified that the Authority performs a risk assessment whilst the Commission should perform the risk management and take the ultimate decision on an active substance. Provisions should be included to ensure transparency of the evaluation process.

(11) For ethical reasons, the assessment of an active substance or a plant protection product should not be based on tests or studies involving the deliberate administration of the active substance or plant protection product to humans with the purpose of determining a human No Observed Effect Level of an active substance. Similarly, toxicological studies carried out on humans should not be used to lower the safety margins for active substances or plant protection products.

(12) To speed up the approval of active substances, strict deadlines should be established for the different procedural steps.

(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.

(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.

(15) The evaluation of an active substance may reveal that it presents considerably less of a risk than other substances. In order to favour the inclusion of such a substance in plant protection products, it is appropriate to identify such substances and to facilitate the placing on the market of plant protection products containing them.

(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.

(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.

(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.

(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.

(20) Plant protection products containing active substances can be formulated in many ways and used on a variety of crops, under different agricultural, ecological and climatic conditions. Authorisations for plant protection products should therefore be granted by Member States.

(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.

(22) In the interest of predictability, efficiency and consistency, criteria, procedures and conditions for the authorisation of plant protection products should be harmonised, account being taken of the general principles of protection of human and animal health and the environment.

(23) The active substances contained in a plant protection product can be produced by different manufacturing processes, leading to differences in specifications. Such differences may have safety implications. For efficiency reasons, a harmonised procedure at Community level should be provided for the assessment of those differences.

(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.

(25) The economic interest for industry to apply for an authorisation is limited in certain uses. In order to ensure that diversification of agriculture and horticulture is not jeopardised by the lack of availability of plant protection products, specific rules should be established for minor uses.

(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.

(27) To promote innovation, special rules should be established permitting the use of plant protection products in experiments even where they have not yet been authorised.

(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.

(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.

(30) Adjuvants may be used to increase the efficacy of a plant protection product. Their placing on the market or use should be forbidden where they contain a co-formulant which has been prohibited.

(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.

(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.

(33) As different rules are applied by Member States, the Authority or the Commission in relation to access to and confidentiality of documents, it is appropriate to clarify the provisions concerning access to information contained in the documents in the possession of these authorities and the confidentiality of these documents.

(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 [5] 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.

(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.

(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.

(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.

(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 [6] 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.

(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 [7], and Community legislation on the protection of workers and anyone concerned with the contained use and deliberate release of genetically modified organisms.

(40) It is necessary to establish procedures for the adoption of emergency measures in situations where an approved active substance, a safener, a synergist or a plant protection product is likely to constitute a serious risk to human or animal health or the environment.

(41) Member States should lay down rules on penalties applicable to infringements of this Regulation and should take the measures necessary to ensure that they are implemented.

(42) General civil and criminal liability in the Member States of the manufacturer and, where applicable, of the person responsible for placing the plant protection product on the market or using it should remain applicable.

(43) Member States should have the possibility of recovering the costs of the procedures associated with the application of the Regulation from those seeking to place, or placing, plant protection products on the market and from those applying for the approval of active substances, safeners or synergists.

(44) Member States should designate the necessary national authorities.

(45) The Commission should facilitate the application of this Regulation. Therefore, it is appropriate to provide for the necessary financial resources and the possibility of amending certain provisions of the Regulation in the light of experience or of developing technical notes for guidance.

(46) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [8]. It is appropriate to adopt purely technical, administrative or urgent measures using the advisory committee procedure.

(47) Certain provisions of Directive 91/414/EEC should remain applicable during the transitional period,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter

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.

Article 2

Scope

1. This Regulation shall apply to products, in the form in which they are supplied to the user, consisting of or containing active substances, safeners or synergists, and intended for one of the following uses:

(a) protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for hygiene reasons rather than for the protection of plants or plant products;

(b) influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient;

(c) preserving plant products, insofar as such substances or products are not subject to special Community provisions on preservatives;

(d) destroying undesired plants or parts of plants, except algae;

(e) checking or preventing undesired growth of plants, except algae.

These products are referred to hereinafter as ‘plant protection products’.

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’.

3. This Regulation shall apply to the following:

(a) substances or preparations which are added to a plant protection product to eliminate or reduce phytotoxic effects of the preparation on certain plants, hereinafter ‘safeners’;

(b) substances or preparations which, while showing no or only weak activity in the sense of paragraph 1, can give enhanced activity to the active substance(s) in a plant protection product, hereinafter ‘synergists’;

(c) substances or preparations which are used or intended to be used in a plant protection product or adjuvant, but are neither active substances nor safeners or synergists, hereinafter ‘co-formulants’;

(d) substances or preparations which consist of co-formulants or preparations containing one or more co-formulants, in the form in which they are supplied to the user and placed on the market to be mixed by the user with a plant protection product for the purpose of changing its properties or effects, hereinafter ‘adjuvants’.

Article 3

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1) 'residues'

One or more substances present in or on plants or products of plant origin, edible animal products or elsewhere in the environment and resulting from the use of a plant protection product, including their metabolites, breakdown or reaction products;

(2) 'substances'

Chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process;

(3) 'preparations'

Mixtures composed of two or more substances intended for use as a plant protection product or as an adjuvant;

(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.

Such substances include, but are not limited to, substances classified as dangerous in accordance with Directive 67/548/EEC [9], 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;

(5) 'plants'

Live plants and live parts of plants, including fresh fruit, vegetables and seeds;

(6) 'plant products'

Products in unprocessed state or having undergone only simple preparation, such as milling, drying or pressing, derived from plants, but excluding plants as defined in point (5);

(7) 'harmful organisms'

Any species, strain or biotype belonging to the animal or plant kingdom or pathogenic agent injurious to plants or plant products;

(8) 'animals'

Animals belonging to species normally domesticated, fed, kept or consumed by humans;

(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;

(10) 'authorisation of a plant protection product'

Administrative act by which the competent authority of a Member State authorises the placing on the market of a plant protection product in its territory;

(11) 'producer'

A person who manufactures active substances, safeners, synergists, co-formulants, plant protection products or adjuvants on his own, or who contracts this manufacturing to another party, or a person designated by the manufacturer as his sole representative for the purpose of compliance with this Regulation;

(12) 'letter of access'

A document by which the owner of data protected under this Regulation agrees to the use of such data by the competent authority for the purpose of granting an authorisation of a plant protection product or an approval of an active substance, synergist or safener for the benefit of another person;

(13) 'environment'

Waters (including ground, surface, transitional and coastal), soil, air, land, wild species of fauna and flora, and any interrelationship between them, and any relationship with other living organisms;

(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;

(15) 'micro-organisms'

Any microbiological entity, including lower fungi and viruses, cellular or non-cellular, capable of replication or of transferring genetic material;

(16) 'genetically modified micro-organisms'

Micro-organisms in which the genetic material has been altered within the meaning of Article 2(2) of Directive 2001/18/EC of the European Parliament and of the Council [10];

(17) 'zone'

Group of Member States, as defined in Annex I, for which it is assumed that the agricultural, plant health and environmental (including climatic) conditions are relatively similar;

(18) 'Good Plant Protection Practice'

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;

(19) 'Good Environmental Practice'

Practice in plant protection which includes the handling and application of plant protection products in a way which only contaminates the environment with the smallest amount practicable;

(20) 'Good Laboratory Practice'

Practice as defined by Directive 2004/10/EC [11];

(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.

CHAPTER II

Active substances, safeners, synergists and co-formulants

SECTION 1

active substances

Subsection 1

Requirements and conditions for approval

Article 4

Approval criteria for active substances

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.

2. The residues of the plant protection products, consequent on application consistent with good plant protection practice, shall meet the following requirements:

(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;

(b) they shall not have any unacceptable effect on the environment;

(c) for residues which are of toxicological or environmental significance, there shall be methods in general use for measuring them.

3. The use of the plant protection products, consequent on application consistent with good plant protection practice and having regard to normal conditions of use, shall meet the following requirements:

(a) it shall be sufficiently effective;

(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;

(c) it shall not have any unacceptable effects on plants or plant products;

(d) it shall not cause unnecessary suffering and pain to vertebrates to be controlled;

(e) it shall have no unacceptable effects on the environment, having particular regard to the following considerations:

(i) its fate and distribution in the environment, particularly contamination of surface waters, including estuarine and coastal waters, drinking water, groundwater, air and soil;

(ii) its impact on non-target species;

(iii) its impact on biodiversity.

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.

5. In relation to human health, no data collected on humans shall be used to lower the safety margins resulting from tests or studies on animals.

Article 5

First approval

First approval shall be for a period not exceeding ten years.

Article 6

Conditions and restrictions

Approval may be subject to conditions and restrictions including:

(a) the minimum degree of purity of the active substance;

(b) the nature and maximum content of certain impurities;

(c) restrictions arising from the evaluation of the information referred to in Article 8 taking account of the agricultural, plant health and environmental, including climatic, conditions in question;

(d) type of preparation;

(e) manner of application;

(f) submission of further confirmatory information to Member States and to the European Food Safety Authority, hereinafter ‘the Authority’, where new requirements are established during the evaluation process as a result of new scientific and technical knowledge;

(g) designation of categories of users, such as professional and non-professional;

(h) designation of places where plant protection products containing the active substance may be authorised according to specific conditions;

(i) the need to impose risk mitigation measures and monitoring after use;

(j) any other particular conditions that result from the evaluation of information made available in the context of this Regulation.

Subsection 2

Approval procedure

Article 7

Application

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.

A joint application may be submitted by an association of producers designated by the producers for the purpose of compliance with this Regulation.

2. Within 14 days of receiving the application, the rapporteur Member State shall send the applicant a written acknowledgement, stating the date of receipt.

3. When submitting his application, the applicant may, pursuant to Article 60, request certain parts of the dossiers referred to in paragraph 1 to be kept confidential. He shall explain for each document or each part of a document why it is to be considered as confidential.

He shall at the same time submit any claims for data protection pursuant to Article 56.

After giving the applicant the possibility to submit comments on the decision it plans to adopt, the rapporteur Member State shall decide what information is to be kept confidential. It shall inform the applicant and the Authority of its decision.

Article 8

Dossiers

1. The summary dossier shall include the following:

(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;

(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;

(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;

(d) a checklist demonstrating that the dossier provided for in paragraph 2 is complete;

(e) the reasons why the test and study reports submitted are necessary for first approval of the active substance or for amendments to the conditions of the approval;

(f) an assessment of all information submitted.

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.

3. The format of the summary dossier and the complete dossier shall be established in accordance with the procedure referred to in Article 76(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).

Article 9

Admissibility of the application

1. Within 30 days of receiving the application, the rapporteur Member State shall check whether the dossiers submitted with the application contain all the elements provided for in Article 8, using the checklist referred to in Article 8(1)(d).

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.

Where at the end of that period, the applicant has not submitted the missing elements, the rapporteur Member State shall inform the applicant that the application is inadmissible.

A new application for the same substance may be submitted at any time.

3. Where the dossiers submitted with the application contain all the elements provided for in Article 8, the rapporteur Member State shall notify the applicant, the Commission, the other Member States and the Authority of the admissibility of the application and start assessing the active substance.

After receiving that notification, the applicant shall immediately forward the summary dossier and the complete dossier to the other Member States, the Authority and the Commission.

Article 10

Access to the summary dossier

The Authority shall without delay make the summary dossier referred to in Article 8(1) available to the public, excluding any information which is confidential under Article 60.

Article 11

Draft assessment report

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.

Where the Member State needs additional information, it shall set a time period for the applicant to supply it. In that case, the twelve-months 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.

2. The format of the draft assessment report shall be established in accordance with the procedure referred to in Article 76(2).

Article 12

Conclusion by the Authority

1. The Authority shall circulate the draft assessment report received from the rapporteur Member State to the applicant, the other Member States and the Commission.

It shall make it available to the public, after giving the applicant two weeks to request, pursuant to Article 60, that certain parts of the draft assessment report be kept confidential.

The Authority shall allow a period of ninety days for the submission of written comments.

Where appropriate, the Authority shall organise a consultation of experts, including experts from the rapporteur Member State.

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.

Where appropriate, the Authority shall address in its conclusion the risk mitigation options identified in the draft assessment report.

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.

The Authority may ask the Commission to consult a Community reference laboratory, designated pursuant to Regulation (EC) No 882/2004 for the purposes of verifying whether the analytical method for the determination of the residues proposed by the applicant is satisfactory and meets the requirements of Article 29(1)(f) of this Regulation. The applicant shall, if requested by the Community reference laboratory, provide samples and analytical standards.

4. The Authority shall establish the format for its conclusion which shall include details on the procedure of the evaluation and the properties of the active substance concerned.

Article 13

Approval Regulation

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.

The applicant shall be given the possibility to submit comments on the review report.

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:

(a) an active substance is approved, subject to conditions and restrictions, as referred to in Article 6, where appropriate;

(b) an active substance is not approved; or

(c) the conditions of the approval are amended.

3. The Commission shall maintain a list of approved active substances.

Subsection 3

Renewal and review

Article 14

Renewal of approval

1. On application the approval of an active substance shall be renewed where it is established that the criteria referred to in Article 4 are satisfied.

Article 4 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.

Such renewal of the approval may include conditions and restrictions, as referred to in Article 6.

2. The renewal shall be for an unlimited period of time.

Article 15

Application for renewal

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.

2. When applying for renewal, the applicant shall identify new data he intends to submit and demonstrate that they are necessary, because of data requirements or criteria which were not applicable on first approval of the active substance or because his request is for an amended approval. He shall at the same time submit a timetable of any new and ongoing studies.

The applicant shall identify, giving reasons, the parts of the information submitted that are to be kept confidential in accordance with Article 60.

Article 16

Access to the application for renewal

The Authority shall, without delay, make available to the public the information provided by the applicant under Article 15, excluding any information declared confidential under Article 60.

Article17

Extension of approval period for the duration of the procedure

Where for reasons beyond the control of the applicant it appears that the approval is likely to expire before a decision has been taken on renewal, a Regulation shall be adopted in accordance with the procedure referred to in Article 76(3), postponing the expiry for a period sufficient to examine the application. In particular, such a Regulation shall be adopted where applicants could not give the three years’ notice required under Article 15(1) because the active substance was included in Annex I to Directive 91/414/EEC for a duration which expired less than three years after the date of application of this Regulation.

The length of that period shall be established on the basis of the following:

(a) the time needed to provide the information requested;

(b) the time needed to complete the procedure;

(c) the need to ensure the establishment of a coherent programme of work, as provided for in Article 18.

Article 18

Programme of work

The Commission may establish a programme of work grouping together similar active substances. This programme may require interested parties to submit all the necessary data to the Commission, the Authority and the Member States within a period provided for in the programme.

The programme shall include the following:

(a) the procedures concerning the submission and assessment of applications for renewal of approvals;

(b) the necessary data to be submitted;

(c) the time periods for submission of such data;

(d) rules on the submission of new information;

(e) rules on requests for confidentiality in accordance with Article 60.

Article 19

Implementing measures

A Regulation, adopted in accordance with the procedure referred to in Article 76(3), shall set out the provisions necessary for the implementation of the renewal and review procedure, including, where relevant, the implementation of a programme of work, as provided for in Article 18.

Article 20

Renewal Regulation

1. A Regulation shall be adopted in accordance with the procedure referred to in Article 76(3), providing that:

(a) the approval of an active substance is renewed, where appropriate, subject to conditions and restrictions; or

(b) the approval of an active substance is not renewed.

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.

Article 21

Review of approval

1. The Commission may review the approval of an active substance at any time.

Where it considers that there are indications that the substance no longer satisfies the criteria provided for in Article 4, or further information required in accordance with point (f) of Article 6 has not been provided, it shall inform the Member States, the Authority and the producer of the active substance, setting a time period for the producer to submit its comments.

2. The Commission may ask the Authority for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within 3 months of the request.

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).

Article 20(2) shall apply.

Subsection 4

Derogations

Article 22

Low risk active substances

1. By way of derogation from Article 5, an active substance complying with the criteria provided for in Article 4 shall be approved for a period not exceeding 15 years, where it may be expected that plant protection products containing that substance will pose only a low risk to human and animal health and the environment, as provided for in Article 46(1).

2. Article 4(4) and Articles 6 to 21 shall apply.

Article 23

Approval criteria for basic substances

1. Basic substances shall be approved in accordance with paragraphs 2 to 6. By way of derogation from Article 5, the approval shall be for an unlimited period of time. For the purpose of those paragraphs, a basic substance is an active substance which

(a) is not predominantly used as a plant protection product but

(b) nevertheless has some use as a plant protection product, either directly or in a product consisting of the substance and a simple diluent,

(c) is not a substance of concern, and

(d) is not directly marketed for use as a plant protection product.

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.

3. An application for the approval of a basic substance shall be submitted by any interested party or by a Member State to the Commission.

The application shall be accompanied by the following information:

(a) any evaluations carried out in accordance with other Community legislation regulating the use of the substance; or

(b) information indicating that the substance has neither an immediate or delayed harmful effect on human or animal health nor an unacceptable effect on the environment.

4. The Commission may ask the Authority for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within 3 months of the request.

5. Articles 6 and 13 shall apply.

6. The Commission may review the approval of a basic substance at any time.

Where it considers that there are indications that the substance no longer satisfies the criteria provided for in paragraphs 1 and 2 it shall inform the Member States, the Authority and the interested party, setting a time period for their comments to be submitted.

The Commission shall ask the Authority for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within 3 months of the request.

Where the Commission concludes that the criteria referred to in paragraph 1 are no longer satisfied, a Regulation to withdraw or amend the approval shall be adopted in accordance with the procedure referred to in Article 76(3). Article 20(2) shall apply.

Article 24

Approval criteria for candidates for substitution

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.

Such a substance is referred to hereinafter as a ‘candidate for substitution’.

2. Article 4(4) and Articles 6 to 21 shall apply.

SECTION 2

Safeners and synergists

Article 25

Approval of safeners and synergists

1. A safener or synergist shall be approved, where it complies with Article 4.

2. Articles 5 to 21 shall apply.

Article 26

Safeners and synergists already on the market

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.

SECTION 3

Unacceptable co-formulants

Article 27

Prohibition

1. A co-formulant shall be prohibited 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

(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.

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).

CHAPTER III

Plant protection products

Section 1

Authorisation

Subsection 1

Requirements and contents

Article 28

Authorisation for placing on the market and use

1. A plant protection product shall not be placed on the market or used unless it has been authorised in the Member State concerned in accordance with this Regulation.

2. By way of derogation from paragraph 1, no authorisation shall be required in the following cases:

(a) use of plant protection products containing exclusively one or more basic substances;

(b) placing on the market and use of plant protection products for research or development purposes in accordance with Article 51;

(c) production, storage or movement of a plant protection product intended for use in another Member State, provided that the product is authorised in that Member State and that the Member State of production, storage or movement has put in place inspection requirements to ensure that the plant protection product is not used in its territory.

Article 29

Requirements

1. A plant protection product shall only be authorised where it complies with the following requirements:

(a) its active substances, safeners and synergists have been approved;

(b) where its active substance, safener or synergist is produced by a person or in accordance with a manufacturing process other than that specified in the dossier on the basis of which that substance, safener or synergist was approved, the active substance, safener or synergist contained in the plant protection product does not deviate significantly from the specification included in the Regulation approving that substance, safener or synergist and has no more harmful effects within the meaning of Article 4(2) and (3), due to its impurities, than if it had been produced in accordance with the manufacturing process specified in that dossier;

(c) its co-formulants have not been prohibited under Article 27;

(d) in the light of current scientific and technical knowledge, it complies with the requirements provided for in Article 4(3);

(e) the nature and quantity of its active substances, safeners and synergists and, where appropriate, any toxicologically, ecotoxicologically or environmentally significant impurities and co-formulants can be determined by appropriate methods;

(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;

(g) its physical and chemical properties have been determined and deemed acceptable for the purposes of the appropriate use and storage of the product;

(h) for feed and food crops, where appropriate, the maximum residue levels for the agricultural products affected by the use referred to in the authorisation have been set or modified in accordance with Regulation (EC) No 396/2005.

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.

3. The applicant shall demonstrate that the requirements provided for in paragraph 1 are met.

4. Compliance with the requirements set out in point (b) and points (d) to (g) of paragraph 1 shall be established by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in question and representative of the conditions prevailing in the zone where the product is intended to be used.

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).

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 91/414/EEC with any necessary modifications.

Article 30

Contents

1. The authorisation shall define the crops on which and the purposes for which the plant protection product may be used.

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.

3. The requirements referred to in paragraph 2 may include:

(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;

(b) the obligation to inform any neighbours who could be exposed to the spray drift before the product is used and who have requested to be informed.

Article 31

Duration

1. The period of authorisation shall be laid down in the authorisation. The duration of an authorisation shall be set for as long as all active substances, safeners and synergists contained in the plant protection product are approved.

2. Authorisations may be granted for shorter periods to synchronise the re-evaluation of similar products for the purposes of a comparative assessment of products containing candidates for substitution as provided for in Article 48.

3. After renewal of the approval of an active substance, safener or synergist contained in the plant protection product, an additional authorisation period of nine months shall be granted to allow the examination as provided for in Article 42 to be carried out.

Subsection 2

Procedure

Article 32

Application for authorisation

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.

2. The application shall include the following:

(a) a list of the zones and 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.

3. The application shall be accompanied by the following:

(a) for the plant protection product concerned, a complete and a summary dossier for each point of the data requirements of the plant protection product;

(b) for each active substance, safener and synergist contained in the plant protection product, a complete and a summary dossier for each point of the data requirements of the active substance, safener and synergist; and

(c) for each test or study involving vertebrate animals, a justification of the steps taken to avoid duplicative testing;

(d) the reasons why the test and study reports submitted are necessary for first authorisation or for amendments to the conditions of the authorisation.

4. When submitting his application, the applicant may, pursuant to Article 60, request that certain parts of the dossiers referred to in paragraph 3 are to be kept confidential. He shall explain for each document or each part of a document why it is to be considered as confidential.

He shall at the same time submit any claims for data protection pursuant to Article 56(3).

After giving the applicant the possibility to submit comments on the decision it plans to adopt, the rapporteur Member State shall decide what information is to be kept confidential. It shall inform the applicant and the Authority of its decision

5. Where requested by the Member State the applicant shall submit his application in the national or official languages of that Member State or one of those languages.

On request, the applicant shall provide the Member State with samples of the plant protection product and analytical standards of its ingredients.

Article 33

Exemption

1. Applicants shall be exempted from supplying the test and study reports referred to in Article 32(3) where they demonstrate that they have been granted access in accordance with Article 56, 58 or 59 or that any data protection period has expired.

2. However, applicants to whom paragraph 1 applies shall provide the following information:

(a) the information needed to identify the active substance, safener or synergist, where they have been approved, and to establish whether the conditions for approval are met and comply with Article 29(1)(b), where appropriate;

(b) the data needed to demonstrate that the plant protection product has comparable effects to the plant protection product for which they show access to the protected data.

Article 34

Member State examining the application

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.

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.

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.

Article 35

Examination

1. The Member State examining the application shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge.

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.

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.

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.

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).

Article 36

Time period for examination

1. The Member State examining the application shall decide within twelve months of receiving it whether the requirements for authorisation are met.

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.

2. The time-limits provided for in paragraph 1 shall be suspended while applying the procedure set out in Article 37.

3. For an application for authorisation of a plant protection product containing an active substance not yet approved, Member States shall start the evaluation as soon as it has received the draft assessment report referred to in Article 12(1). In such case the Member State shall decide on the application at the latest within six months of the active substance being approved.

Article 37

Assessment of equivalence under Article 29(1)(b)

1. Where it is necessary to establish whether a plant protection product complies with Article 29(1)(b), this shall be assessed by the Member State which acted as rapporteur for the active substance, safener or synergist as referred to in Article 7(1), hereafter called the rapporteur Member State. The applicant shall submit all necessary data to that Member State.

2. After giving the applicant the opportunity to submit his comments, which the applicant shall also communicate to the Member State examining the application, the rapporteur Member State shall adopt a conclusion which it shall communicate to the Commission, the other Member States and the applicant.

3. Where the Member State examining the application for authorisation does not agree with the conclusion of the rapporteur Member State, it shall inform the applicant, the other Member States and the Commission stating its reasons.

The Member State examining the application for authorisation and the rapporteur Member State shall try to reach agreement on whether Article 29(1)(b) is complied with. They shall provide the applicant with an opportunity to submit his comments.

4. Where the Member States concerned do not reach agreement within 90 days the Member State examining the application for authorisation shall submit the matter to the Commission. A decision on whether the conditions referred to in Article 29(1)(b) are complied with shall be adopted in accordance with the procedure referred to in Article 76(2). The 90-day period begins on the date on which the Member State examining the application for authorisation informed the rapporteur Member State that it does not agree with the conclusion of the latter, in accordance with paragraph 3.

Before such a decision is adopted, the Commission may ask the Authority for an opinion, or for scientific or technical assistance which shall be provided within three months of the request.

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.

Article 38

Reporting and exchange of information on applications for authorisation

1. Member States shall compile a file on each application. Each file shall contain the following:

(a) a copy of the application;

(b) a report containing information on the evaluation of and decision on the plant protection product;

(c) a record of the administrative decisions taken by the Member State concerning the application and the documentation provided for in Article 32(3) together with a summary of the latter.

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.

3. On request, applicants shall provide a copy of the documentation to be submitted with an application pursuant to Article 32(2) and Article 33 to Member States, the Authority and the Commission.

Subsection 3

Mutual recognition of authorisations

Article 39

Mutual recognition

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:

(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.

2. Mutual recognition shall not apply to plant protection products containing a candidate for substitution.

Article 40

Authorisation

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/EC, as the reference Member State.

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).

Article 41

Procedure

1. The application shall be accompanied by:

(a) a certified copy of the authorisation granted by the reference Member State;

(b) a formal statement that the plant protection product is identical to that authorised by the reference Member State;

(c) a summary of the dossier as required in Article 32(3).

2. The Member State to which an application under Article 39 is submitted shall decide on the application within 90 days.

Subsection 4

Renewal and withdrawal

Article 42

Renewal of authorisation

1. An authorisation shall be renewed upon application by the authorisation holder, provided that the conditions provided for in Article 29 are still satisfied.

The application shall be submitted at the latest one year before the expiry of the authorisation except where applicants cannot comply with this deadline because the active substance in question was included in Annex I to Directive 91/414/EEC for a duration which expired less than a year after the date of application of this Regulation.

2. The application shall be accompanied by the following information:

(a) a copy of the authorisation of the plant protection product,

(b) a report on the results of monitoring, where the authorisation was subject to monitoring.

3. Within three months of renewal of the approval of an active substance, safener or synergist contained in the plant protection product, the applicant shall submit the following information:

(a) any new information required as a result of amendments in data requirements or criteria;

(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;

(c) any information required to demonstrate that the plant protection product meets the requirements set out in the Regulation on the renewal of the approval of the active substance, safener or synergist contained in it.

4. Member States shall check that all plant protection products containing the active substance, safener or synergist concerned comply with any conditions and restrictions provided for in the Regulation renewing the approval under Article 20.

The Member State which acted as rapporteur for the active substance, safener or synergist shall coordinate performance of the compliance check and assessment of the results. The compliance check shall be performed within the time period set in the Regulation on the renewal of the approval.

5. Guidelines on the organisation of compliance checks may be established in accordance with the procedure referred to in Article 76(2).

6. Member States shall decide on the renewal of the authorisation at the latest nine months after the renewal of the approval of the active substance, safener or synergist contained in it.

7. Where, for reasons beyond the control of the holder of the authorisation, no decision is taken on the renewal of the authorisation before its expiry, the Member State in question shall extend the authorisation for the period necessary to complete the examination and adopt a decision on the renewal.

Article 43

Withdrawal or amendment of an authorisation

1. Member States may review an authorisation at any time where there are indications that a requirement referred to in Article 29 is no longer satisfied.

2. Where a Member State intends to withdraw or amend an authorisation, it shall inform the authorisation holder and give him the possibility to submit comments.

The Member State may ask the authorisation holder to submit further information.

3. The Member State shall withdraw or amend the authorisation, as appropriate, where:

(a) the requirements referred to in Article 29 are not or are no longer satisfied;

(b) false or misleading information was supplied concerning the facts on the basis of which the authorisation was granted;

(c) a condition included in the authorisation has not been met.

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.

Article 44

Withdrawal or amendment of an authorisation at the request of the authorisation holder

1. An authorisation may be withdrawn or amended at the request of the holder of the authorisation, who shall state the reasons for his request.

2. Amendments may only be granted where it is established that the requirements of Article 29 continue to be satisfied.

Article 45

Grace period

Where a Member State withdraws or amends an authorisation or does not renew it, it may grant a grace period for the disposal, storage, placing on the market and use of existing stocks.

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.

Subsection 5

Special cases

Article 46

Placing on the market and use of low-risk plant protection products

1. Where all the active substances contained in a plant protection product are substances as referred to in Article 22 (‘low-risk active substances’), that product shall, by way of derogation from Article 29, be authorised as a low-risk plant protection product provided it meets the following requirements:

(a) the low-risk active substances, safeners and synergists contained in it have been approved under Chapter II;

(b) it does not contain a substance of concern;

(c) it is sufficiently effective;

(d) it does not cause unnecessary pain and suffering to vertebrates to be controlled;

(e) it complies with Article 29(1)(b), (c) and (e) to (h).

These products are referred to hereinafter as ‘low-risk plant protection products’.

2. An applicant for authorisation of a low-risk plant protection product shall demonstrate that the requirements set out in paragraph 1 are met and shall accompany the application with a complete and summary dossier for each point of the data requirements of the active substance and the plant protection product.

3. The Member State shall decide within 90 days on whether to approve an application for authorisation of a low-risk plant protection product.

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.

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.

4. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply.

Article 47

Placing on the market and use of plant protection products containing

a genetically modified micro-organism

1. A plant protection product which contains a micro-organism falling within the scope of Directive 2001/18/EC shall be examined in respect of the genetic modification in accordance with that Directive, in addition to the assessment under this Chapter.

An authorisation under this Regulation shall not be granted for such a plant protection product unless written consent, as referred to in Article 19 of Directive 2001/18/EC, has been granted for it.

2. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply.

Article 48

Comparative assessment of plant protection products containing candidates for substitution

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:

(a) for the uses specified in the application an authorised plant protection product, or a non-chemical control or prevention method, already exists which is significantly safer for human or animal health or the environment;

(b) the plant protection product or non-chemical control or prevention method referred to in point (a) does not present significant economic or practical disadvantages;

(c) the chemical diversity of the active substances is adequate to minimise the occurrence of resistance in the target organism.

2. By way of derogation from paragraph 1, a plant protection product containing a candidate for substitution shall be authorised without comparative assessment in cases where it is necessary to acquire experience first through using that product in practice.

Such authorisations shall be granted for a period not exceeding three years.

3. Member States shall repeat the comparative assessment provided for in paragraph 1 regularly 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.

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.

5. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply.

Article 49

Extension of authorisations for minor uses

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.

2. The authorisation holder, official or scientific bodies involved in agricultural activities or professional agricultural organisations and professional users may ask for the authorisation of a plant protection product already authorised in the Member State concerned to be extended to minor uses not yet covered by that authorisation.

3. Member States shall extend the authorisation provided that:

(a) the intended use is minor in nature;

(b) the conditions referred to in Article 4(3)(b), (d) and (e) and Article 29(1)(h) are satisfied;

(c) the extension is in the public interest;

(d) the documentation and information to support an extension of use has been submitted by the persons or bodies referred to in paragraph 2.

4. The extension may take the form of an amendment to the existing authorisation or may be a separate authorisation, according to the administrative procedures of the Member State concerned.

5. When Member States grant an extension of authorisation for a minor use, they shall inform the authorisation holder and request him to change the labelling accordingly.

Where the authorisation holder declines, the Member States shall ensure that users are fully and specifically informed as to instructions for use, by means of an official publication or an official website.

6. Member States shall establish and regularly update a list of minor uses.

7. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply.

Subsection 6

Derogations

Article 50

Agricultural emergency situations

1. By way of derogation from Article 28, in special circumstances a Member State may authorise, for a period not exceeding 120 days, the placing on the market of plant protection products, for limited and controlled use, where such a measure appears necessary because of a danger to plant health which cannot be contained by any other reasonable means.

The Member State concerned shall immediately inform the other Member States and the Commission of the measure taken, providing detailed information about the situation and any measures taken to ensure consumer safety.

2. The Commission may ask the Authority for an opinion, or for scientific or technical assistance.

The Authority shall provide its opinion or the results of its work to the Commission within one month of the request.

3. If necessary, a decision shall be taken, in accordance with the procedure referred to in Article 76(3), as to

(a) whether the treated crop may be safely marketed, and

(b) whether and under what conditions the Member State

(i) may extend the duration of the measure or repeat it; or

(ii) shall withdraw or amend its measure.

4. Paragraphs 1 to 3 shall not apply to plant protection products containing or composed of genetically modified micro-organisms.

Article 51

Research and development

1. By way of derogation from Article 28, experiments or tests for research or development purposes involving the release into the environment of an unauthorised plant protection product may be carried out if the Member State in whose territory the experiment or test is to be carried out has assessed the available data and granted an authorisation for trial purposes. The authorisation may limit the quantities to be used and the areas to be treated and may impose further conditions to prevent any harmful effects on human or animal health or any unacceptable adverse effect on the environment, such as the need to prevent entry into the food chain of feed and food containing residues unless a relevant provision has already been established under Regulation (EC) No 396/2005.

The Member State may authorise a programme of experiments or tests in advance or require an authorisation for each experiment or test.

2. An application shall be submitted to the Member State in whose territory the experiment or test is to be conducted, together with a dossier containing all the available data to permit an assessment of possible effects on human or animal health or the possible impact on the environment.

3. An authorisation for trial purposes shall not be granted for experiments or tests involving the release into environment of a genetically modified micro-organism unless such release has been accepted under Directive 2001/18/EC.

4. Detailed rules for the application of this Article, in particular the maximum quantities of plant protection products that may be released during experiments or tests and the minimum data to be submitted in accordance with paragraph 2, may be adopted in accordance with the procedure referred to in Article 76(3).

Section 2

Use and information

Article 52

Use of plant protection products

Plant protection products shall be used properly.

Proper use shall include compliance with the conditions establ