Assessment of the Equivalence of Technical Materials - European ...

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Contents1 Implementing schedule ...................................................................................................... 32 Introduction ........................................................................................................................ 33 Legal basis.......................................................................................................................... 34 Approach ............................................................................................................................ 45 Definitions.......................................................................................................................... 46 Evaluation of equivalence of technical materials (Tier I) .................................................. 56.1 Data requirements ...................................................................................................... 56.2 Evaluation process...................................................................................................... 56.3 Decision-making ........................................................................................................ 66.4 Reporting.................................................................................................................... 67 Evaluation of equivalence of technical materials (Tier II)................................................. 67.1 Toxicity ...................................................................................................................... 67.1.1 Data requirements .............................................................................................. 67.1.2 Evaluation process.............................................................................................. 77.1.3 Decision-making ................................................................................................ 97.1.4 Reporting.......................................................................................................... 107.2 Ecotoxicity ............................................................................................................... 107.2.1 Data requirements and evaluation process....................................................... 107.2.2 Decision making............................................................................................... 13Appendix I Flow chart and time table on the procedure for the assessment of theequivalence of new sources of technical materials according to Article 38 Regulation (EC) No1107/2009 (The numbering corresponds to the explanation given on the next page).............. 16Appendix Ib: Evaluation and decision making scheme in the perspective of toxicologicalassessment ...................................................................................................................... 19Appendix II Aide-memoire for sources of information that can be used to assess the toxicHAZARD of impurities............................................................................................................ 20Appendix III Impurities of known toxicological concern................................................. 22Appendix V How to judge what is an acceptable upper limit concentration for an impurityof toxicological concern........................................................................................................... 27Appendix VI Example calculations for applying the generic approach for assessingecotoxicological equivalence ................................................................................................... 29Appendix VII Evaluation report.......................................................................................... 302
1 Implementing scheduleThis amended guidance document should be implemented as from 13 July 2012.2 IntroductionAs a general principle for the same active substance the level of hazard posed for health andenvironmental protection must be comparable for different sources of technical material. Thisdocument only addresses the hazard of technical materials. If the hazard is considered to begreater for the new source than the reference source, then an appropriate risk assessmentshould be conducted for the new source to determine whether plant protection productscontaining the new technical material will fulfil the safety requirements laid down in Article4(2) and (3) of Regulation (EC) No 1107/2009.This guidance document is intended to establish a harmonised procedure for assessing theequivalence of different sources of technical material versus the reference source according tothe provisions stipulated in Article 38 of Regulation (EC) No 1107/2009.Any change concerning the source of the technical material after the authorisation of a plantprotection product is dealt with by Article 45 (2). The assessment of the change (e.g. newsource, amended specification, amended manufacturing process, amended manufacturinglocation) has to be conducted according to the procedure stipulated in Article 38 and thisguidance document.The purpose is to apply harmonised hazard assessment criteria to a certain technical materialwhich was not completely toxicologically and/or ecotoxicologically tested according toAnnex II of Directive 91/414/EEC. By the comparison of the specification(s) which havebeen concluded and agreed on for the reference source(s) with the correspondingspecifications for new sources or changes to those already assessed, technical materials can beconsidered as equivalent or not equivalent regarding their hazard potential or certain data gapscan be identified where further toxicological and ecotoxicological testing is needed.This paper does not address:• Technical materials that are micro-organisms• Technical materials that are poorly-defined chemical compositions/mixtures, e.g. plantextracts, animal products and their derivatives3 Legal basisThe legal basis for this guidance document is the Regulation (EC) No 1107/2009 as lastamended. However, the guidance document can also be used for assessments that have to beconducted according to Directive 91/414/EEC. The given references to the requirements ofAnnex II and VI of 91/414/EEC have to be regarded as valid as long as the data requirementsare not adopted as stipulated in Article 78, paragraph 1 (b) and (c) of Regulation (EC) No1107/2009. If necessary the guidance document will be amended accordingly.3
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Page 31 and 32: TABLE OF CONTENTS1 STATEMENT OF THE
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