1107 - PappasLaw Attorneys at Law in Brussels

1 1107 vademecum 2015by Hans Mattaar nd editionMarch 2015 i Preface The 1107 Vademecum1 seems to have filled a gap: a very small A5-sized gap in many a briefcase and purse, and a much bigger gap in the working life of the European regulatory professional. In many offices, both in industry and competent authorities, copies found their way to every desk, and the vademecum is spotted on meeting tables where it sits at hand to help experts untangling the knots of Regulation (EC) No 1107 /20092. Since the publication of the first edition of the vademecum in March 2014, the core legal text saw little change, but one or two new (revisions of) Guidance Documents were published every month.

2 Comparative Assessment will soon become part of the authorisation process for products containing Candidates for Substitution, and the renewal of approved substances will now have to pass the hurdle of approval criteria. This second edition of the vademecum contains information on the status of all approved chemical substances, updated information on the renewal programme, and helpful information that will guide you in finding the most recent versions of the appropriate Guidance Document for the issues you are dealing with. When is a substance up for renewal?

3 Is it a candidate for substitution? You find it all in the 1107 vademecum . And of course you will find updated information on the EU decision-making process, the qualified majority voting system, the meeting schedule of the PAFF meetings for 2015, and many other bits of useful European and Brussels information. The 1107 vademecum is now also available in an electronic version3, fully hyperlinked to help you jumping back and forth between the different articles and paragraphs, or to take you directly to other regulations and Directives that are linked to Regulation 1107 / 2009 .

4 For more printed copies of the vademecum for your colleagues please contact me at Pappas & Associates4. Hans Mattaar, Senior Advisor, Pap pas & Associates Copyright Notice: the integral text of Regulation (EC) No 1107 / 2009 that you find in this vademecum is not a photocopy from the Official Journal, but a duplicated, consolidated word-processed verbatim5. We have thoroughly edited and checked the text, and we have tried to maintain as much as possible the look and feel of the published text in the Official Journal. We remind you that only European Union documents published in the Official Journal of the European Union are deemed authentic.

5 1 Latin: go with me 2 OJ L 309, , p. 1. 3 The PDF-version of the 1107 vademecum can be downloaded from the Pappas & Associates website: 4 Contact Hans Mattaar at at +31 611 929 009 or at +32 2 2315 704 5 European Union, ii Pappas & Associates Pappas & Associates is a law firm located in the heart of the European Quarter in Brussels , specialised in European Law. Its "legal diversity" is based on its particular structure bringing together lawyers and regulatory experts, as well as on its European network. In the field of crop protection, Pappas & Associates has a broad experience both at European and Member State level, combining regulatory, scientific, political and legal strategies.

6 Be it litigation, arbitration or policy advice in the field of European policies, namely in the fields of Competition (Anti-trust, State Aids), Internal Market or Health and Consumer Protection, Pappas & Associates is your privileged defender and adviser. Contact us at: Tel: +32 (0)2 2315 704 Fax: +32 (0)2 2315 708 Email: or Address: Pappas & Associates, Attorneys at Law Rue Stevin 49-51 B-1000 Brussels Belgium Access: Metro: lines 1 and 5, station Maelbeek Bus: lines 22, 59, 64, stop Livingstone Car: Rue Stevin, corner Avenue Livingstone, P-disk or paid parking nearby iii Table of Contents Preface.

7 I Pappas & Associates .. ii Table of Contents .. iii Introduction .. 1 2-Step system and harmonisation .. 1 Mutual Recognition and zonal system .. 1 Review & Renewal Programmes .. 1 AIR 1 .. 2 AIR 2 .. 2 AIR 3 .. 2 Guidance Documents .. 3 Schematic overview Procedural Guidance Documents.. 4 EU Decision-making .. 5 Introduction .. 5 Co-decision .. 6 Comitology .. 6 Standing Committee on the Plants, Animals, Food and Feed .. 7 Qualified Majority Voting .. 7 Since 1 November 2014 .. 7 The old voting system .. 7 Regulatory Procedure ( implementing acts ).

8 8 Regulatory Procedure with scrutiny ( delegated acts ) .. 9 Lists and Tables .. 9 List of approved substances with dates, RMS, CfS listing, Air listing, CMR class .. 9 Guidance Documents listed by year/number .. 17 Main text of the 25 1107 vademecum 1 Introduction Regulation 1107 / 2009 is the framework legislation setting out the rules and procedures regarding the placing on the market of plant protection products. The Regulation replaces the previous framework Directive 91/414/EEC. Although the Regulation entered into force on 14 June 2011, some of the provisions of Directive 91/414 continue to apply, mainly for processes that started already before the entry into force of the Regulation1.

9 2-Step system and harmonisation The Regulation describes the general proces for placing plant protection products on the market. This process consists of two steps: first the active substance(s) of a plant protection product must be approved at the European level, then as a second step the plant protection product must be authorised at the Member State level. The approval process focuses on a review of the intrinsic properties of the active substances, drafted by an allocated Rapporteur Member State, peer reviewed by all other Member States, and finally scrutinised by the EFSA2.

10 The resulting commonly agreed endpoints allow the Member States to conduct risk assessments using the same input parameters, with commonly agreed risk assessment methodologies, and to decide on the granting of authorisations on the bases of the Uniform Principles, which are also laid down by the Regulation3. Mutual Recognition and zonal system In order to reduce the workload for the individual Member States, and to improve harmonisation, the Regulation also lays down rules for Mutual Recognition. Because the environmental conditions, necessary for risk assessments, vary considerably from the Scandinavian to the Meditarranean countries, the Regulation establishes 3 (climatic/ regulatory) zones: North, Central and South (see Figure 1, the three zones).