On 11 June 2011, the Commission published five Regulations implementing Regulation (EU) 1107/2009 concerning the placing on the market of plant protection products (the PPPR) in the EU, applicable as from 14 June 2011.
The five implementing Regulations cover the following:
1. a list of approved active substances;[1]
2. the data requirements for active substances;[2]
3. the data requirements for plant protection products;[3]
4. the uniform principles for evaluation and authorisation (risk assessment) for plant protection products;[4]
5. the labelling requirements for plant protection products.[5]
The Commission adopted these Regulations within the framework of Article 84 of the PPPR, which required the Commission to adopt implementing measures on those points by 14 June 2011. This date is also the date of repeal of the previous Directive on plant protection products (Directive 91/414), as well as the date of application of the new PPPR and its requirements by the EU authorities and the Member States.
However, the PPPR includes transitional measures according to which Directive 91/414 will still be applicable to certain active substances or pesticides products regarding the procedure and the conditions for approval of the active substances (i.e. inclusion of the substance in the Annex), as well as for data protection, approval of pesticides products and labelling requirements. This is notably the case for active substances that were listed in Regulation 737/2007, which laid down the procedure for the renewal of the inclusion of the first group of active substances.
Concerning the five adopted Regulations, Regulation 540/2011 establishes the list of approved active substances (353 active substances are currently included in that list). It transfers the existing list that was included in Annex I of Directive 91/414, since Directive 91/414 was repealed from 14 June 2011. The adoption of this Regulation was immediately followed by two amendments:
- Regulation 541/2011, which divided the new Annex into two parts (Part A, including active substances deemed to have been approved under the new PPPR, namely the existing list of approved substances, and Part B, including active substances that will be approved under the new PPPR) and
- Regulation 542/2011, which modified the entry for carbendazim, in accordance with its recent renewal.
Regulation 544/2011 sets out the data requirements for active substances. It specifies the information that must be submitted by the applicant in its dossier for approval of the active substance, as well as the tests and analysis that must be carried out. A separate section (Part B) concerns requirements relating to micro-organisms, including viruses.
Regulation 545/2011 lays down data requirements for the approval of pesticides products at national level (after inclusion of the active substance contained in the product in the list of approved substances). Micro-organisms are also regulated under a separate section.
Regulation 546/2011 provides uniform principles that must be applied by the national authorities for the evaluation and authorisation of plant protection products and also includes deadlines for reaching decisions. As for the other Regulations, it also includes a separate section on plant protection products containing micro-organisms.
Finally, Regulation 547/2011 covers the labelling requirements for plant protection products. It also includes standard phrases for special risks to human or animal health or to the environment, as well as for safety precautions.
[1] Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances.
[2] Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances.
[3] Commission Regulation (EU) No 545/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products.
[4] Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products.
[5] Commission Regulation (EU) No 547/2011 of 8 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards labelling requirements for plant protection products.
