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1. Evaluation 1.1. During the process of evaluation and decision-making provided for in Articles 4 to 21, the rapporteur Member State and the Authority shall cooperate with applicants to resolve any questions on the dossier quickly or to identify at an early stage any further explanations or additional studies necessary for the evaluation of the dossier, including information to eliminate the need for a restriction of the approval, 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 satisfaction of the requirements of this Regulation.

1.2. The evaluation by the Authority and the rapporteur Member State must be based on scientific principles and be made with the benefit of expert advice.

1.3. During the process of evaluation and decision-making provided for in Articles 4 to 21, Member States and the Authority shall take into consideration any further guidance developed in the framework of the Standing Committee on the Food Chain and Animal Health for the purposes of refining, where relevant, the risk assessments.

2. General decision-making criteria 2.1. Article 4 shall only be considered as complied with, where, on the basis of the dossier submitted, authorisation in at least one Member State is expected to be possible for at least one plant protection product containing that active substance for at least one of the representative uses.

2.2. Submission of further informationIn principle an active substance, safener or synergist shall only be approved where a complete dossier is submitted. In exceptional cases an active substance, safener or synergist may be approved even though certain information is still to be submitted where:

(a) the data requirements have been amended or refined after the submission of the dossier; or (b) the information is considered to be confirmatory in nature, as required to increase confidence in the decision.

2.3. Restrictions on approvalWhere necessary, the approval may be subject to conditions and restrictions as referred to in Article 6. Where the rapporteur Member State considers that the dossier provided lacks certain information, to the effect that the active substance could only be approved subject to restrictions, it shall contact the applicant at an early stage to obtain more information which may possibly enable these restrictions to be removed.

3. Criteria for the approval of an active substance 3.1. Dossier The dossiers submitted pursuant to Article 7(1) shall contain the information needed to establish, where relevant, Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level (AOEL) and Acute Reference Dose (ARfD). In the case of an active substance, safener or synergist for which one or more representative uses includes use on feed or food crops or leads indirectly to residues in food or feed, the dossier submitted pursuant to Article 7(1) shall contain the information necessary to carry out a risk assessment and for enforcement purposes. The dossier shall in particular:

(a) permit any residue of concern to be defined;

(b) reliably predict the residues in food and feed, including succeeding crops, on the basis of information provided in accordance with the data requirements for active substances;

(c) reliably predict, where relevant, the corresponding residue level reflecting the effects of processing and/or mixing;

(d) permit a maximum residue level to be defined and to be determined by appropriate methods in general use for the commodity and, where appropriate, for products of animal origin where the commodity or parts of it is fed to animals;

(e) permit, where relevant, concentration or dilution factors due to processing and/or mixing to be defined. The dossier submitted pursuant to Article 7(1) shall be sufficient to permit, where relevant, an estimate of the fate and distribution of the active substance in the environment, and its impact on non-target species.

3.2. Efficacy

An active substance alone or associated with a safener or synergist shall only be approved where it has been established for one or more representative uses that the plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use is sufficiently effective. This requirement shall be evaluated in accordance with the uniform principles for evaluation and authorisation of plant protection products referred to in Article 29(6).

3.3. Relevance of metabolites Where applicable the documentation submitted shall be sufficient to permit the establishment of the toxicological, ecotoxicological or environmental relevance of metabolites.

3.4. Composition of the active substance, safener or synergist 3.4.1. For chemical active substances, safeners and synergists, the specification shall define the minimum degree of purity, the identity and maximum content of impurities and, where relevant, of isomers/diastereo-isomers and additives, and the content of impurities of toxicological, ecotoxicological or environmental concern within acceptable limits.

3.4.2. For chemical active substances, safeners and synergists, the specification shall be in compliance with the relevant Food and Agriculture Organisation specification as appropriate, where such specification exists. However, where necessary for reasons of protection of human or animal health or the environment, stricter specifications may be adopted.

3.4.3. Active substances that are micro-organisms shall be deposited at an internationally recognised culture collection and shall have an accession number. The species’ name of the micro-organisms shall be identified unequivocally, based on the latest scientific information, and the micro-organisms shall be named at the strain level, including any other designation which may be relevant (e.g. isolate level, if relevant for viruses). It shall be indicated whether or not the micro-organisms are wild types, spontaneous or induced mutants, or genetically modified organisms.

3.4.4. For active substances that are micro-organisms, the specification shall define the minimum and maximum content of the micro-organism, the identity and content of relevant contaminating micro-organisms, metabolites of concern and impurities of toxicological, ecotoxicological or environmental concern within acceptable limits.

3.5. Methods of analysis 3.5.1. The methods of analysis of chemical active substances, safeners or synergists as manufactured and of determination of impurities of toxicological, ecotoxicological or environmental concern or which are present in quantities greater than 1 g/kg in the active substance, safener or synergist as manufactured, shall have been validated and shown to be sufficiently specific, correctly calibrated, accurate and precise.

3.5.2. The methods of residue analysis for chemical active substances and relevant metabolites in plant, animal and environmental matrices and drinking water, as appropriate, shall have been validated and shown to be sufficiently sensitive with respect to the levels of concern.

3.5.3. The evaluation shall have been carried out in accordance with the uniform principles for evaluation and authorisation of plant protection products referred to in Article 29(6).

3.5.4. For active substances that are micro-organisms, the methods of analysis to identify and quantify them, and relevant contaminating micro-organisms, shall have been validated and shown to be sufficiently specific, correctly calibrated, accurate and precise.

3.5.5. For active substances that are micro-organisms, the methods of analysis of metabolites of concern and relevant impurities shall have been validated and shown to be sufficiently specific, correctly calibrated, accurate and precise.

3.6. Impact on human health 3.6.1. Where relevant, an ADI, AOEL and ARfD shall be established. When establishing such values an appropriate safety margin of at least 100 shall be ensured taking into account the type and severity of effects and the vulnerability of specific groups of the population. When the critical effect is judged of particular significance, such as developmental neurotoxic or immunotoxic effects, an increased margin of safety shall be considered, and applied if necessary.

3.6.2. An active substance, safener or synergist shall only be approved if, on the basis of assessment of higher tier genotoxicity testing carried out in accordance with the data requirements for the active substances, safeners or synergists and other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as mutagen category 1A or 1B.

3.6.3. An active substance, safener or synergist shall only be approved, if, on the basis of assessment of carcinogenicity testing carried out in accordance with the data requirements for the active substances, safener or synergist and other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogen category 1A or 1B, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with Article 18(1)(b) of Regulation (EC) No 396/2005.