Annex II

02009R1107-20210327 → 02009R1107-20221121

ANNEX II Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II 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 … 419 unchanged words … 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; 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. The 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. The 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 the chemical active substance, safener substances, safeners or synergist 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 the chemical active substance 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 has 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 … 1,156 unchanged words … be determined in the light of current scientific knowledge and under consideration of internationally agreed guidelines; (4) adverse effects that are non-specific secondary consequences of other toxic effects shall not be considered for the identification of the substance as endocrine disruptor. 3.6.6. Active substances that are micro-organisms shall only be approved if, on the basis of the assessment carried out on the information provided in accordance with the data requirements, it is concluded that the strain of the micro-organism is not pathogenic to humans. In addition: (a) viruses shall only be approved if, on the basis of the assessment carried out on the information provided in accordance with the data requirements, it is concluded that the isolate of the virus is not infective to humans; (b) strains of bacteria shall only be approved if, on the basis of the assessment carried out on the information provided in accordance with the data requirements, it is concluded that they do not have any known, functional and transferable gene coding for resistance to relevant antimicrobial agents as defined in accordance with the data requirements. 3.7. Fate and behaviour in the environment 3.7.1. An active substance, safener or synergist shall only be approved where it is not considered to be a persistent organic pollutant (POP). A substance that fulfils all three of the criteria of the points … 2,014 unchanged words … a micro-organism, emitted and used by plants, animals and other organisms for communication, shall be considered as being of low- risk where it does not correspond to any of points (a) to (d) of point 5.1.1. 5.2. Micro-organisms 5.2.1. An active substance which that is a micro-organism other than a virus may be considered as being a low-risk active substance unless its susceptibility to at least two classes of low-risk unless at strain level it antimicrobial agents has demonstrated multiple resistance to anti-microbials used in human or veterinary medicine. not been demonstrated. 5.2.2. Baculoviruses shall An active substance that is a virus may be considered as being of a low-risk active substance unless at strain level they have it is: (a) a baculovirus with demonstrated adverse effects on non-target insects. insects; or (b) a non-virulent variant of a plant pathogen with demonstrated adverse effects on non-target plants.