Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (Text with EEA relevance)Text with EEA relevance

• Published date: 11 June 2011
• Subject Matter: Legislazione fitosanitaria,Legislación fitosanitaria,Législation phytosanitaire
• Official Gazette Publication: Gazzetta ufficiale dell’Unione europea, L 155, 11 giugno 2011,Diario Oficial de la Unión Europea, L 155, 11 de junio de 2011,Journal officiel de l’Union européenne, L 155, 11 juin 2011

02011R0546 — EN — 21.11.2022 — 002.001

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►B COMMISSION REGULATION (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (Text with EEA relevance) (OJ L 155 11.6.2011, p. 127)

Amended by:

		Official Journal
		No	page	date
M1	COMMISSION REGULATION (EU) 2018/676 of 3 May 2018	L 114	8	4.5.2018
►M2	COMMISSION REGULATION (EU) 2022/1441 of 31 August 2022	L 227	70	1.9.2022

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▼B

COMMISSION REGULATION (EU) No 546/2011

of 10 June 2011

implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products

(Text with EEA relevance)

Article 1

The uniform principles for evaluation and authorisation of plant protection products provided for in Article 29(6) 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.

▼M2

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ANNEX

GENERAL INTRODUCTION

1. GENERAL PRINCIPLES

1.1. The objective of the principles developed in this Annex is to ensure a high level of protection of human and animal (species normally fed and kept by humans or food-producing animals) health and the environment in evaluations and decisions by Member States with regard to authorisation of plant protection products, implementing the requirements of Article 29(1)(e) in conjunction with Article 4(3) and Article 29(1)(f), (g) and (h) of Regulation (EC) No 1107/2009. For the purpose of this Annex, the following definitions apply:

(1)

‘efficacy’ means a measure concerning the overall effect of the application of a plant protection product on the agricultural system in which it is used (i.e. which includes positive effects of treatment in performing the desired plant protection activity and negative effects such as development of resistance, phytotoxicity or reduction of qualitative or quantitative yield);

(2)

‘relevant impurity’ means a chemical impurity that is of concern for human health, animal health or the environment;

(3)

‘storage stability’ means the capacity of a plant protection product to maintain the initial properties and the specified content during the storage period under established storage conditions.

1.2. In evaluating applications for granting authorisations Member States shall:

(a)

—

ensure that dossiers supplied are in accordance with the requirements of the Annex to Commission Regulation (EU) No 284/2013 ( 1 ), at the latest at the time of finalisation of the evaluation for the purpose of decision-making, without prejudice, where relevant, to Articles 33, 34 and 59 of Regulation (EC) No 1107/2009,

—

ensure that the data submitted by the applicant are acceptable in terms of quantity, quality, consistency and reliability and sufficient to permit a proper evaluation of the dossier,

—

evaluate, where relevant, justifications submitted by the applicant for not supplying certain data;

(b)

take into account the data concerning the active substance in the plant protection product of the Annex to Commission Regulation (EU) No 283/2013 ( 2 ), submitted for the purpose of approval of the active substance under Regulation (EC) No 1107/2009, and the results of the evaluation of those data, without prejudice, where relevant, to the provisions of Article 33(3) and of Articles 34 and 59 of Regulation (EC) No 1107/2009;

(c)

take into consideration other relevant technical or scientific information with regard to the efficacy of the plant protection product or to the potentially adverse effects of the plant protection product its components or its residues, where relevant.

1.3. Where, in the specific principles on evaluation, reference is made to the data of the Annex to Regulation (EU) No 283/2013 this shall be understood as being the data referred to in point 1.2(b) of this Annex.

1.4. Where the data and information provided are sufficient to permit completion of the evaluation for one of the proposed uses, Member States shall evaluate applications and make a decision for the proposed use.

Taking account of justifications provided and with the benefit of any subsequent clarifications, Member States shall reject applications for granting authorisations for which the data gaps are such that it is not possible to finalise the evaluation and to make a reliable decision for at least one of the proposed uses.

1.5. During the process of evaluation and decision-making, Member States shall cooperate with the applicants in order to resolve any questions on the dossier quickly or to identify at an early stage any additional studies necessary for a technically complete dossier that allows for a proper evaluation, or to amend any proposed conditions for the use of the plant protection product or to modify its nature or its composition in order to ensure full compliance with the requirements of this Annex and more generally with the provisions of Regulation (EC) No 1107/2009.

1.6. During the process of evaluation and decision-making, Member States shall base their assessment on scientific principles, preferably recognised at international level, and this process shall be made with the benefit of expert advice.

1.7. Member States shall take into account those guidance documents applicable at the date of the submission of the application for the authorisation.

2. EVALUATION, GENERAL PRINCIPLES

2.1. Having regard to current scientific and technical knowledge, Member States shall evaluate the information referred to in point 1.2, and in particular:

(a)

identify the risks arising, assess their significance and the expected exposure, and make a judgement as to the likely risks to humans, animals or the environment;

(b)

assess efficacy in terms of effectiveness (including possible development of resistance or cross-resistance of the target organism(s)) and adverse effects (including phytotoxicity/pathogenicity) on crops (including treated crops, succeeding crops and adjacent crops) of the plant protection product for each use for which authorisation is sought.

2.2. Member States shall evaluate the quality and the methodology of tests, especially where there are no standardised test methods, as well as the following characteristics of the methods described, when available:

relevance; representativeness; sensitivity; specificity; reproducibility.

2.3. In interpreting the results of evaluations, Member States shall take into consideration and report possible elements of uncertainty in the information obtained during the evaluation, in order to ensure that the chances of failing to detect adverse effects or of underestimating their importance are reduced to a minimum. The decision-making process shall be examined to identify critical decision points or items of data for which uncertainties could lead to a false classification of risk.

2.4. In accordance with Article 29 of Regulation (EC) No 1107/2009, Member States shall ensure that evaluations carried out have regard to the proposed practical conditions of use and, in particular, to the purpose of use, the application dose, the application method, frequency and timing of applications, and the nature and composition of the plant protection product.

In accordance with the requirements for proper use as set out in Article 55 of Regulation (EC) No 1107/2009, Member States shall take into account the provisions of Directive 2009/128/EC of the European Parliament and of the Council ( 3 ) and, in particular, the principles of integrated pest management.

2.5. In the evaluation, Member States shall consider the agricultural, plant health or environmental (including climatic) conditions in the areas of use.

2.6. Where specific principles in Section 1 of Part A or Section 1 of Part B (as applicable) provide for the use of calculation models in the evaluation of a plant protection product, those models shall:

(a)

make a best possible estimation in an appropriate way of all relevant processes involved taking into account realistic parameters and assumptions;

(b)

be submitted to an evaluation as referred to in point 2.3;

(c)

be reliably validated with measurements carried out under circumstances relevant for the use of the model;

(d)

be relevant to the conditions in the area of use;

(e)

in cases the models have not been validated, be supported with details indicating how the model calculates estimates provided, and explanations of all the inputs to the model and details of how they have been derived.

2.7. Where metabolites are referred to in the specific principles, only those that are relevant for the proposed criterion shall be taken into consideration. For Part A this concerns also degradation or reaction products. For Part B this concerns what is defined as ‘metabolites of concern’.

3. DECISION-MAKING, GENERAL...