# EUR-Lex - 52008PC0578 - EN

Important legal notice

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# 52008PC0578

**Communication from the Commission to the European Parliament pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of a Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market /* COM/2008/0578 final - 0136 /0000 */ **

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[pic] | COMMISSION OF THE EUROPEAN COMMUNITIES |

Brussels, 22.9.2008

COM(2008) 578 final

2006/0136 (COD)

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT

pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of a Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market

(presented by the Commission)

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT

pursuant to the second subparagraph of Article 251 (2) of the EC Treatyconcerning thecommon position of the Council on the adoption of a Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market

1. BACKGROUND

Date of transmission of the proposal to the EP and the Council (document COM((2006)0388 final – 2006/0136(COD): | 19 July 2006 |

Date of the opinion of the European Economic and Social Committee: | 31 May 2007 |

Date of the opinion of the Committee of the Regions | 13 February 2007 |

Date of the opinion of the European Parliament, first reading: | 23 October 2007 |

Date of transmission of the amended proposal: Date of political agreement | 11 March 2008 23 June 2008 |

Date of adoption of the common position: | 15 September 2008 |

2. PURPOSE OF THE COMMISSION PROPOSAL

The proposed Regulation would replace the existing legislation on the placing on the market of plant protection products (Council Directive 91/414/EEC), thoroughly revising the procedures for the safety evaluation of active substances and plant protection products. However, it keeps the two steps procedure of the Directive:

- Approval of active substances at EU level

- Authorisation of plant protection products, containing approved substances, by Member States.

For simplification, it would also repeal Council Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances. The main aim of the proposal is to maintain a high level of protection for humans, animals and the environment; to reduce the administrative burdens of the present approval and authorisation procedures and to achieve a higher level of harmonization.

This proposal should be seen as part of a package together with the Thematic Strategy on the Sustainable Use of Pesticides and the proposal for a Framework Directive, which fills a legal gap in the use phase of pesticides, as well as a proposal for a Regulation on the collection of statistics regarding the placing on the market and the use of plant protection products.

3. COMMENTS ON THE COMMON POSITION

3.1. General comment

The Commission supports the common position as adopted by the Council on 15 September 2008. It is in line with the aims and the approach taken in the Commission's original proposal and reflects the principles of many amendments proposed by the European Parliament.

3.2. Amendments made by the European Parliament at first reading

Amendments accepted by the Commission and which are in line with the common position:

Amendments 5, 14 and 18 of the European Parliament strengthen the statements of recitals 8, 17 and 21 and have been partially incorporated. Recital 8 introduces the safeguard of the competitiveness of European agriculture. In recital 17 a reference to candidates for substitution has been included. Recital 21 introduces a reference to vulnerable groups in the evaluation of any harmful effect on human or animal health.

Amendment 96 on Article 20 on immediate disposal of a plant protection product in case of immediate concerns has been completely incorporated.

Amendment 159 has been incorporated as such in the common position and in the Commission amended proposal. It introduces in Article 43 on the withdrawal or amendment of an authorisation of a plant protection product, the possibility for Member States to review an authorisation when it concludes that the objectives of Directive 2000/60/EC (Water Framework Directive) may not be achieved.

Most elements of the amendments 175 to 180 and 196 on minor uses, aiming to facilitate the authorisations for minor uses, have been accepted by the Commission. The common position incorporated the ones concerning liability and extension of data protection for minor uses. In addition, a definition of minor uses as proposed by amendment 59 has been included in the common position, while in the Commission modified proposal the same is laid down under Article 49 on minor uses.

The introduction of a new Article 49 (a) on parallel trade, as proposed by the European Parliament in amendment 45 and 286, was accepted by the Council and the Commission. However the text of the common position reflects the judgment of the Court of Justice in more recent Cases. Furthermore, the need for controls on parallel trade has been added in Article 65.

Also Amendment 189 has been included as such in the common position and the Commission amended proposal. It introduces in Article 53 the possibility for Member States to adopt interim protective measures when information on potentially harmful effects becomes available.

The Commission accepted to include a definition of "advertisements" in Article 63. This is included in the common position in Article 3.

The common position, in line with the Commission amended proposal, includes in Annex II points 3.6.3 to 3.6.5. a detailed definition of "negligible exposure". This is in line with amendment 300. However the common position excludes completely mutagenic substances, independently from exposure.

Moreover, developmental neurotoxicity and immunotoxic effects, which were proposed by the European Parliament as exclusion criteria, have been included by the common position in the criteria for definition of candidates for substitution, as in the Commission amended proposal. The clarification in amendment 248 that a substance is a candidate for substitution if one of the relevant criteria is fulfilled was also included.

In relation to low risk substances, the common position has incorporated the criteria for exclusion of substances from the definition of "low risk" in line with amendment 301. Such provision has been added in Part 5 of Annex II. One substantial difference concerns "sensitising" substances, as the amendment refers only to "sensitising chemicals", while the Commission in its amended proposal and the common position refer to sensitising in general, covering in this way also micro–organisms . The provision that the Commission shall review and if necessary specify the low risk criteria has been included in Article 22, but without setting the deadline of one year proposed by the European Parliament.

Other amendments which clarify the text or better define procedures have been incorporated. They are included in Article 11 on the preparation of a draft assessment report setting a maximum period of 6 months for submission of additional information, Article 12 on the availability to the public of the conclusions of the Authority, Article 13 on a provision for a public list of approved substances which should be electronically available, Article 27 adding a reference to realistic conditions of use for co-formulants, Article 30 on adding some specific contents of the authorisations concerning application data and Article 36 on the procedure for authorisations of plant protection products setting a maximum period of 6 months for submission of additional information. The provision for Member States to receive a complete dossier on request has been included in Article 41. In Article 62 the need to incorporate the existing labelling requirements of Directive 91/414/EEC into the implementing Commission Regulation on labelling has been introduced.

Amendments not incorporated in the common position, which are nevertheless accepted by the Commission in the amended proposal as such or subject to rewording:

The Parliament proposed to introduce a reference to compliance with Directive 2000/60/EC (Water Framework Directive) in various amendments. The Commission amended proposal endorsed them in recital 14, Article 21 (review of approval), and Article 43 (withdrawal or amendment of an authorisation). Only this latter amendment has been incorporated also in the common position.

The proposed amendments for recitals 34 and 35 have been included or partially included in the amended proposal. They concern protection of residents and bystanders and the need to ensure that advertisements do not mislead the public.

Several amendments strengthen the objective to minimize animal testing. The Commission incorporated most of these amendments (24, 75, 92, 108, 225) in recital 32 and in Articles 8, 18, 26, 59 and 75.

Amendment 34 proposes to clarify in Article 1 the purpose of the Regulation. The Commission accepted to include a reference to the high level of protection, to the precautionary principle and to the harmonisation of availability of plant protection products among European farmers.

Several new definitions, proposed by the European Parliament, have been incorporated in Article 3 such as parallel trade, low risk, rapporteur Member State, test and studies and the definition concerning non chemicals methods of plant protection. This last concept has also been incorporated in the definition of good plant protection practice.

The European Parliament emphasised in various parts of the act the reference to vulnerable groups and amendment 49 introduces a definition of such groups. The Commission has incorporated most of them, as well as the definition of vulnerable groups in Article 3.

In the definition of integrated pest management, a reference to the encouragement of natural pest control mechanisms has been introduced.

Moreover, in the definition of a substance of concern, the Commission included endocrine disrupting properties, neurotoxicity or immunotoxicity, in line with amendment 39 of the European Parliament.

As proposed by the European Parliament, a reference to vulnerable groups, to locations distant from use of a substance following long range environmental transport, its impact on behaviour of non target species and its impact on the ecosystem have been incorporated in the approval criteria in Article 4. In addition it has been clarified that analytical methods shall be standardised and sufficiently sensitive; this has been partially accepted in the common position.

The Commission accepted to include in Article 20 amendment 95 with respect to the period of grace for using up stocks of not approved plant protection products within a maximum period of one year.

Amendment 274 establishes that foodstuffs as defined by Regulation EC No 178/2002 have to be considered as basic substance and such amendment has been directly incorporated in the amended Commission proposal in Article 23.

The European Parliament introduced in Article 64 (Amendment 217) the obligation for producers to undertake post-registration monitoring and the Commission has completely incorporated such provision.

Moreover, Parliament proposed amendment 220 to include in Article 65 on monitoring and controls the need to verify compliance with use restrictions at farm level. Such clarification has been directly included in the amended Commission proposal.

The Commission incorporated partly amendment 248 concerning the criteria for approval as a candidate for substitution (Annex II point 4). A reference to a high potential risk for groundwater and to neurotoxic or immunotoxic properties has been introduced.

Furthermore, in Annex IV part 2 concerning comparative assessment, amendment 252 has been partially incorporated with respect to the consideration of cumulative and synergistic effects for health risk.

Other amendments, which were introduced by the Commission in its amended proposal, concern the requirement in Article 29 that the formulation of a plant protection product should be such that it limits user exposure and other risks without compromising efficacy and the obligation for Member States in Article 49 to keep available on their official website a list of minor uses. In Article 9(2), the Commission proposed 6 months for completion of the dossier if elements are found to be missing, while the common position foresees 3 months.

Comitology

The alignment with Decision 2006/512/EC (on Comitology) was generally endorsed by the Commission amended proposal and by the common position as introduced by Parliament amendments.

Amendments 88, 94, 99, 100, 142, 143, 158, 185, 219, 224, 226, 227 introduce the regulatory procedure with scrutiny in cases where the Commission sees the need for curtailment of time (e.g. efficiency to respect time limits of renewal of approvals, urgency to be applied in case of threat to human or animal health). Moreover, the approval of an active substance is considered by both the common position and the amended proposal as an implementing measure to be adopted in accordance with the normal regulatory procedure.

In some cases, the co-decision procedure is proposed by the Parliament; however the Commission and Council consider the concerned measures (data requirements for safeners and synergists, regulation establishing a program of work, control regulation) of general scope and amending non essential elements of the Regulation. In addition, the Commission considers that the co-decision procedure would not be appropriate for technical provisions which need to be continuously updated. Therefore, they should be adopted in accordance with the regulatory procedure with scrutiny.

Amendment 120 would require the co-decision procedure for the adoption of a Regulation concerning uniform principles incorporating requirements of Annex VI of Directive 91/414/EEC. The Commission and Council consider this as a technical supplement (simple transfer of already existing requirements) to the basic text by the addition of non essential elements and consequently propose the advisory committee.

In a few cases, the Commission included the need for urgency and efficiency provisions. These few cases refer to efficiency to respect time limits of renewal of approvals and urgency to be applied in case of threat to human or animal health.

3.3. New provisions introduced by the Council

The Council added some technical definitions in Article 3, such as professional user, relevant metabolite, impurity etc...

Some additional requirements in relation to the use of plant protection products regarding in particular drinking water have been added in Article 4, which are in line with some of the amendments proposed by the European Parliament in amendment 255.

A derogation to the approval criteria of Annex II has been inserted by the Council under Article 4 (7). It would allow to approve substances which fail to meet specific approval criteria (substances which are not carcinogenic or toxic to reproduction category 2 or endocrine disruptors, as set out in paragraph 3.6.3, 3.6.4, 3.6.5 of 3.8.2 of Annex II).

In Article 14, a time schedule for the renewal of approvals of active substances is introduced (maximum of 15 years or exceptionally, in case of derogations under Article 4(7), a maximum of 5 years).

The Council added for safeners and synergists the obligation for the Commission to define data requirements (Article 25). It provided also that the assessment of equivalence (Article 37) and the approval criteria (Annex II, paragraph 3.6 – 3.9) apply to safeners and synergists and not only to active substances.

The new Article 29a gives Member States the right to grant provisional authorisations under certain conditions (complete dossier, delayed assessment procedure, maximum residue level established). This provision is largely in line with amendment 281 of the European Parliament.

Article 35 clarifies that for the assessment of dossiers in the light of current scientific and technical knowledge, guidance documents as available at the time of application should be used. This is in line with amendment 136 of the European Parliament.

The provisions on mutual recognition and the zonal system (recital 24, articles 35, 39 and 78a and Annex I) have been re-grouped within the text and partly amended. In addition to the Commission proposal, voluntary mutual recognition would be allowed for plant protection products authorised in another zone, for plant protection products containing candidates for substitution (Article 39), for provisional authorisations or for plant protection products containing an active substance approved under the derogation of Article 4(7). For use in seed treatment or in empty rooms/containers, there is obligatory mutual recognition at EU level. Provisions on placing on the market of treated seeds have been introduced in a specific Article.

The Council also added a procedure which allows official or scientific bodies involved in agricultural activities, professional agricultural organisations or professional users to apply for mutual recognition in a Member State, even if no such application is made or supported by the authorisation holder.

The common position maintains compulsory mutual recognition, but a derogation (Article 35(3)) allows adaptation to local conditions and, exceptionally, for the Member States to refuse authorisations due to specific and justified risks to health or the environment which could not be controlled otherwise.

The Council added a provision on seed treatments (new recital 26a and Article 47a), which lays down additional labelling requirements for treated seeds and would empower Member States to restrict the use of treated seeds if they constitute a serious danger because of the plant protection product used to treat the seed.

An additional period of data protection of two years and 6 months is foreseen for studies necessary for the renewal or review of an authorisation (Article 56).

Some changes have been done in Article 60, setting out the rules on confidentiality. These amendments are mostly technical and clarify the difference between the protection of commercial rights of companies and the protection of privacy and integrity of individuals.

The Council has deleted all explicit references of the initial Commission proposal to Regulation (EC) No 882/2004 on monitoring and controls for food and feed in Article 65, to which these controls should be similar, but kept the reference to this Regulation in recital 38.

In Article 78, the Council added provisions setting out derogations for using co-formulants in plant protection products as well as a programme of work for adjuvants .

Article 78a provides a review clause on the functioning of the mutual recognition of authorisation, the zonal system and the criteria for approval, with a report from the Commission within five years.

The Council amended the text in paragraphs 3.6.2 to 3.6.5 and 3.8 of Annex II on the approval criteria. Mutagenic substances of category 1 or 2 can not be approved for the use in plant protection products. Substances which are carcinogenic or toxic to reproduction as well as endocrine disruptors can only be approved if their use only leads to negligible exposure of humans or the environment (the latter only for endocrine disruptors). The concept of negligible exposure for consumers is further defined by a reference to Regulation (EC) No 396/2005 on setting of maximum residue levels.

3.4. Major problems when adopting the common position

Legal base

The Commission proposal is based on Articles 37 and 152 (4) (b), which are both agricultural bases. For the Commission the proposal is agricultural, because without plant protection products, agricultural yields would be affected (recital 6). Art. 37 is the appropriate basis for all rules on the "production and marketing" of agricultural products which contribute to the attainment of one or more objectives of the CAP. The proposal defines what products can be used in the field, so it is clearly linked to agricultural production. Promoting more environmentally friendly forms of agricultural production is also one of the aims of the CAP.

Art. 152 (4) (b) establishes measures in the phytosanitary field which have as direct objective the protection of human health.

The common position adds Article 95 (common market) but deletes Art. 152 (4) (b). The Commission has accepted this compromise but made a written statement.

Data protection Article 56

The Commission proposal provides for data protection period of 10 years. The common position provides that the period can be extended up to 13 years in special cases (e.g. extensions to minor crops). It also provides for 2.5 years of data protection after each renewal of the approval of the active substance.

The additional data protection for extensions of use for minor crops, also proposed by the European Parliament (amendment 196), is not controversial. However, additional data protection at renewal might hamper the market access of generic producers. The Commission did not accept the proposal of the Presidency to give 5 years data protection at renewal but accepted the compromise of 2.5 years. The European Parliament referred in its amendment 194 to protection of additional data required for the purposes of amending the legislation.

Monitoring and Controls Article 65

The Commission has accepted the deletion in Article 65 of the detailed references to Regulation (EC) No 882/2004 on monitoring controls for food and feed. This will give less certainty on the scope for the implementing measures on control and monitoring. However, the common position still refers to Regulation (EC) No 882/2004 in recital 38. Therefore the same objectives are maintained for the implementing measure.

Criteria for approval

The Commission proposal sets criteria for the approval of active substances. The Commission proposed that substances which are carcinogenic, mutagenic or toxic for reproduction category 1 and 2 (classified or to be classified) (category 1: sufficient evidence for concerns in humans; category 2: strong presumption of relevance to humans) or which are endocrine disruptors cannot be approved unless exposure is negligible.

The common position maintains the Commission approach and reinforces the criteria for mutagens, which are completely excluded. Furthermore, carcinogens, substances toxic for reproduction and endocrine disruptors, which could be approved because there is negligible exposure, become candidates for substitution when it comes to the authorisation of plant protection products at Member State level (point 4 of Annex II, indents 5 and 6).

A derogation (Article 4.7) provides that, if there are no other available means to control a serious danger to plant health, it would be possible to approve a substance for a maximum of 5 years even if it does not satisfy the listed criteria. Their use should however be subject to risk mitigation measures to minimise exposure to humans and maximum residue levels in food and feed would be set according to the normal procedures. These substances would also be excluded from obligatory mutual recognition (Article 40 (2) (d)). Substances which are carcinogenic or toxic for reproduction category 1 are excluded from the derogation.

In addition in Article 14 (renewal of approval of substances) it is clarified that renewal of approval of such substances will not be for 15 years (as is the case for other substances) but maximum for 5 years.

The Commission has made a written statement which clarifies how it would apply the derogation.

4. CONCLUSION

The Commission takes the view that the common position fully reflects the key elements of its initial proposal and the spirit of many of the amendments of the European Parliament made in the first reading.

The Commission therefore agrees with the common position as adopted by the Council by qualified majority.

5. STATEMENTS BY THE COMMISSION

The Commission made two written statements which are attached.

ANNEX

STATEMENTS BY THE COMMISSION

(1) "The Commission recognises that the procedure which allows possible approval of an active substance for a maximum period of 5 years, even if it does not satisfy the listed criteria, is a derogation from the standard procedure to approve active substances. The Commission stresses that the derogation would only apply in cases where documented evidence is submitted showing that there are no other available means to control a serious danger to plant health. The approval will be decided by comitology, thus involving all Member States in the evaluation not only of the dossier on the active substance, but equally on the documentation showing that there are no alternatives. Approval which may be proposed will be subject to strict conditions, including risk mitigation measures, which would be part of the approval decision and aim at minimising exposure to humans and the environment."

(2) "The Commission regrets the removal of Article 152.4(b) of the Treaty from the legal basis of the proposal. One of the main aims of the proposal is to achieve a high level of human and animal health and to protect the environment.

In order to allow the legislative process to move forward with a view to the timely adoption of the proposed Regulation, the Commission accepts the common position of the Council given that the substance of the compromise reached, taken as a whole, meets the objectives of the proposal.

Should the European Parliament re-introduce during the second reading Article 152 as one of the legal bases of the proposal, the Commission reserves the right to accept the relevant amendment."