Commission Regulation (EU) No 545/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products Text with EEA relevance

• Published date: 11 June 2011
• Subject Matter: Plant health legislation
• Official Gazette Publication: Official Journal of the European Union, L 155, 11 June 2011

11.6.2011 EN Official Journal of the European Union L 155/67

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COMMISSION REGULATION (EU) No 545/2011

of 10 June 2011

implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the first sentence of Article 8(4) thereof,

After consulting the Standing Committee on the Food Chain and Animal Health,

Whereas:

(1) In accordance with Regulation (EC) No 1107/2009 the dossier to be submitted for the approval of an active substance or for the authorisation of a plant protection product is to fulfil the same requirements in respect of the data requirements for the plant protection product as under the previously applicable rules which are set out in Annexes II and III to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (2).

(2) It is therefore necessary for the implementation of Regulation (EC) No 1107/2009 to adopt a regulation containing those data requirements for the plant protection product. Such a regulation is not to include any substantial modification,

HAS ADOPTED THIS REGULATION:

Article 1

The data requirements for the plant protection product provided for in Article 8(1)(c) of Regulation (EC) No 1107/2009 shall be as set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply from 14 June 2011.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 10 June 2011.

For the Commission

The President

José Manuel BARROSO

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(1) OJ L 309, 24.11.2009, p. 1.

(2) OJ L 230, 19.8.1991, p. 1.

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ANNEX

DATA REQUIREMENTS FOR PLANT PROTECTION PRODUCTS, AS PROVIDED FOR IN ARTICLE 8(1)(c) OF REGULATION (EC) No 1107/2009

INTRODUCTION

1. The information required shall:

1.1. include a technical dossier supplying the information necessary for evaluating efficacy and the foreseeable risks, whether immediate or delayed, which the plant protection product may entail for humans, animals and the environment and containing at least the information and results of the studies referred to below;

1.2. where relevant, be generated using test guidelines, in accordance with the latest adopted version, referred to or described in this Annex; in the case of studies initiated before the entry into force of the modification of this Annex, the information shall be generated using suitable internationally or nationally validated test guidelines or, in the absence thereof, test guidelines accepted by the competent authority;

1.3. in the event of a test guideline being inappropriate or not described, or where another one than those referred to in this Annex has been used, include a justification, which is acceptable to the competent authority for the guidelines used. In particular, when reference is made in this Annex to a method laid down in Commission Regulation (EC) No 440/2008 (1) which consists in the transposal of a method developed by an international organisation (e.g. OECD), Member States may accept that the required information is generated in accordance with the latest version of that method if at the initiation of the studies the method under Regulation (EC) No 440/2008 has not yet been updated;

1.4. include when required by the competent authority, a full description of test guidelines used, except if they are referred to or described in this Annex, and a full description of any deviations from them including a justification, which is acceptable to the competent authority, for these deviations;

1.5. include a full and unbiased report of the studies conducted as well as a full description of them or a justification, which is acceptable to the competent authority where: — particular data and information which would not be necessary owing to the nature of the product or its proposed uses, are not provided, or — it is not scientifically necessary, or technically possible to supply information and data;

1.6. where relevant, have been generated in accordance with the requirements of Council Directive 86/609/EEC (2).

2. Tests and analyses

2.1. Tests and analyses must be conducted in accordance with the principles laid down in Directive 2004/10/EC of the European Parliament and of the Council (3) where testing is done to obtain data on the properties and/or safety with respect to human or animal health or the environment.

2.2. Tests and analyses, required under points 6.2 to 6.7 of this Annex, shall be conducted by official or officially recognised testing facilities or organisations which satisfy at least the following requirements: — have at their disposal sufficient scientific and technical staff, having the necessary education, training, technical knowledge and experience for their assigned functions, — have at their disposal suitable items of equipment required for correct performance of the tests and measurements which it claims to be competent to carry out. This equipment shall be properly maintained and calibrated where appropriate before being put into service and thereafter in accordance with an established programme, — have at their disposal appropriate experimental fields and, where necessary glasshouses, growth cabinets or storage rooms. The environment in which the tests are undertaken shall not invalidate its results or adversely effect the required accuracy of measurement, — make available to all relevant personnel operating procedures and protocols used for the trials, — make available, where requested by the competent authority, prior to the commencement of a test, detailed information on it, containing at least its location and the plant protection products included in it, — ensure that the quality of the work performed is appropriate to its type, range, volume and intended purpose, — maintain records of all original observations, calculations and derived data, calibration records and the final test report as long as the product concerned is authorised in the Union.

2.3. Officially recognised testing facilities and organisations, and, where requested, official facilities and organisations shall: — report to the relevant national authority all detailed information necessary to demonstrate that they can satisfy the requirements provided for in point 2.2, — accept at any time the inspections, which each Member State shall regularly organise on its territory in order to verify the compliance with the requirement as laid down in point 2.2.

2.4. By way of derogation from point 2.1, Member States may apply points 2.2 and 2.3, by extension, to tests and analyses performed on their territory in order to obtain data on the properties and/or safety of the preparations with respect to honey-bees and beneficial arthropods other than bees and actually started on or before 31 December 1999.

2.5. By way of derogation from point 2.1, Member States may apply points 2.2 and 2.3, by extension, to supervised residue trials performed on their territory in accordance with Section 8 ‘Residues in or on treated products, food and feed’ with plant protection products containing active substances already on the market on the 26 July 1993 and actually started on or before 31 December 1997.

2.6. By way of derogation from point 2.1, for active substances consisting of micro-organisms or viruses, tests and analyses done to obtain data on the properties and/or safety with respect to other aspects than human health, may have been conducted by official or officially recognised testing facilities or organisations which satisfy at least the requirements under points 2.2 and 2.3 of the introduction to this Annex.

3. The information required shall include the proposed classification and labelling of the plant protection product in accordance with Directive 1999/45/EC of the European Parliament and of the Council (4) or with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (5).

4. In individual cases it may be necessary to require certain information as provided for in the Annex to Commission Regulation (EU) No 544/2011 (6), Part A, for co-formulants. Before such information will be required and before possible new studies have to be performed, all information on the co-formulant, made available to the competent authority, will be considered, in particular when:

— the use of the co-formulant is permitted in food, animal feeding stuffs, medicines or cosmetics in accordance with EU legislation, or

— a safety data sheet is provided for the co-formulant in accordance with Article 31 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (7).

PART A

CHEMICAL PREPARATIONS

1. Identity of the plant protection product

The information provided, taken together with that provided for the active substance(s), must be sufficient to precisely identify preparations and define them in terms of their specification and nature. The information and data referred to, unless otherwise specified, are required for all plant protection...