Efficacy Guideline 101- Guidelines for the …

1 Chemicals Regulation Efficacy Guideline 101 04/11/2010. Directorate Guidelines for the preparation of a biological assessment Dossier. COMMISSION 7600/VI/95 rev. 6 (as amended by PSD). OF THE. EUROPEAN COMMUNITIES ---------- Directorate-General for Agriculture ---------- VI B II-1. VERSION AMENDED BY. PSD (now CRD). FOR USE IN THE UK. Guidelines and criteria for the preparation and presentation of data concerning Efficacy as provided in Annex III, parts A and B, section 6 of Directive 91/414/EEC concerning the placing of plant protection products on the market ( biological assessment dossier). Document 7600/VI/95 rev. 6 has recently been issued by the Commission of the European Communities. This version has been amended slightly for use in the UK.

2 The main amendments are: i) different formats are proposed for summary tables (Tables 1 and 2). The examples given are based on formats which have been used successfully by UK applicants in the past. However, they are only examples, and applicants who have existing formats with which both they and PSD (now CRD) are content, should not change their formats just for the sake of it. ii) a diagram which summarises the relationship of Efficacy to Annex I listing of a new active substance and to authorisation of a plant protection product containing that active substance has been included (Diagram 1). iii) The first sentence of point requires a written justification to demonstrate that the target organism is actually harmful or that the intended use is beneficial.

3 For many products this aspect is self- explanatory and CRD does not therefore require the submission of this information for UK applications, we will instead contact applicants in those instances where further information is required. The remainder of the paragraph still applies, for example with plant growth regulators. iv) Point requires a copy of the certificate of Official Recognition' ( OR'). for each testing facility/organisation that generated the Efficacy data. Because CRD administer the UK OR' scheme, copies of certificates are not required for data generated in the UK. Instead, applicants must identify each testing facility/organisation and provide CRD with the relevant certificate numbers. (Note that this may still be achieved by submitting copies of certificates, if desired.

4 For data generated elsewhere in the European Union (EU), appropriate evidence of OR' is still required ( copies of certificates or a statement from the relevant competent authority). When trials were performed outside the EU or before the Directive came into force this must be clearly stated. Page 1 Chemicals Regulation Efficacy Guideline 101 04/11/2010. Directorate Applicants are advised to follow the guidance when compiling biological assessment dossiers (formerly termed Efficacy Overviews' in the UK). The document is complemented by previous guidance issued in the UK, namely: Efficacy overviews - a guide to applicants ( Efficacy Guideline 102);. All CRD's Efficacy Guidelines can be found at: If you have any queries on these Guidelines , please contact CRD.

5 Environment Branch Mallard House Kings Pool Tel: 01904 455763. 3 Peasholme Green Fax: 01904 455711. York YO1 7PX Email: Page 2 Chemicals Regulation Efficacy Guideline 101 04/11/2010. Directorate Guidelines for the preparation of a biological assessment Dossier (BAD). Foreword Directive 91/414/EEC concerning the placing of plant protection products on the market provides in Article 6 (2) and (3) and Article 13 (1) (a) that a dossier satisfying the requirements of Annex III has to be submitted by applicants. These Guidelines are intended to provide guidance to applicants as to the format and presentation of data concerning Efficacy as required in Annex III, parts A and B, section 6 of Directive 91/414/EEC (as amended by Directive 93/71/EEC) for the authorisation of a plant protection product.

6 Commission document 1663/VI/94 Guidelines and criteria for the preparation and presentation of complete dossiers and of Summary dossiers for the inclusion of active substances in Annex I of Directive 91/414/EEC (Article and ) provides guidance on the preparation of a complete dossier for the inclusion of an active substance in Annex I. However, it doesn't provide details for the preparation and presentation of Efficacy data for the authorisation of plant protection products by Member States. The current document intends to fill this gap. In fact it is stated in document 1663/VI/94 that for the purpose of inclusion of an active substance in Annex I, the consideration of Efficacy or of unacceptable effects on plants or plant products does not arise and therefore Annex III dossiers submitted need not include Efficacy study reports.

7 However in the case of applications for the inclusion of new active substances in Annex I, it is envisaged that an application will simultaneously be made for the authorisation of a plant protection product containing the active substance. In such cases, in addition to concise summary information - to be used in the context of inclusion of the active substance in Annex I - a complete overview of Efficacy - to be used in the context of authorisation of the plant protection product concerned - is required as part of the relevant Annex III dossier. Where on particular points of detail, additional or more detailed guidance is required, applicants and other interested parties are advised to contact the designated competent authority of the Member State to which the documentation is to be submitted.

8 General introduction The guidance provided and criteria specified apply to the preparation of the Efficacy data to be included in the complete Annex III dossiers and summary dossiers as to be submitted in accordance with Article 6 (2) and (3) and Article 13 (1) (a) of Directive 91/414/EEC. The aim of this guidance document is to provide applicants with advice on the drafting of the biological assessment Dossier' (the term which has been used to describe the report of Efficacy as provided for in Annex III, chapter 6 of Directive 91/414/EEC) so as to enable the Authorities to evaluate an application for authorisation without the need to refer back to the Page 3 Chemicals Regulation Efficacy Guideline 101 04/11/2010. Directorate applicant except for occasional clarification or further information, thus improving the efficiency and cost-effectiveness of the authorisation process.

9 This document has been conceived as an opinion of the Commission Services and elaborated in co-operation with the Member States. It does not however intend to produce legally binding effects and by its nature does not prejudice any measure taken by a Member State in the implementation of provisions concerned, nor any case law by the European Court of Justice. In particular it should be kept in mind that: i) Those wishing to submit data and information in support of application for an authorisation of a plant protection product are themselves required to summarise, evaluate and assess the data concerned in the light of the relevant evaluative and decision making criteria. They are also required to make proposals for the decision, which in their opinion, reflect the conclusions that can be derived from the data and information concerned.

10 These proposals should be supported with statements as to the rationale used. ii) As well as providing at least two hard copies of the complete dossier, applicants should also provide the summary and assessment documentation in electronic form. In addition, it is desirable that the biological dossier including the study reports be provided in CD-ROM. format. OECD format dossiers CRD is aware that guidance developed within the Standing Committee on Plant Health (SANCO/3989/2001) identified that as from 31 December 2004 all dossiers should be submitted in OECD format on the basis of the OECD dossier guidance. CRD is also aware that there are differences with the OECD format compared to that of the biological assessment Dossier, both in terms of covering all relevant data requirements and also in the presentation format.