Placing on the market and use of plant protection products under Article 45(1) of the Plant Protection Act (PPA) and Regulation (ЕC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives Nos 79/117/EEC and 91/414/EEC.

Regulation authorising the placing on the market and the use of plant protection products

The draft aims to establish the procedure and the conditions for authorising the placing on the market, use, renewal of authorisation, amendment, withdrawal or termination of authorisation for the placing on the market and use of plant protection products (PPPs). The draft also lays down the national measures necessary to implement Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309 of 24 November 2009) (Regulation (EC) No 1107/2009).

The Bulgarian Food Safety Agency (BFSA) shall perform the activities relating to the authorisation of plant protection products (PPPs), save for the performance of evaluations for which product assessment reports must be prepared. An evaluation of plant protection products for which an assessment report must be prepared shall be performed by the Centre for Risk Assessment of the Food Chain (CRAFC). The draft determines the scope of the evaluation of plant protection products. The application procedure for authorisation, renewal or termination of authorisation and the manner of coordination between the BFSA and the CRAFC have been laid down.

The draft introduces criteria for the designation of professional and non-professional categories of use of plant protection products. A requirement is laid down stipulating that plant protection products, for which different persons have submitted applications, be authorised under different trade names. Where a trade name has already been used or for which an application has been submitted, an application for that trade name may be submitted again in the event of an authorisation of another product of another applicant, provided that written

consent or agreement with the previous holder of the authorisation for the placing on the market and use of the PPP is submitted.

The draft lays down the conditions and the procedure for amendment of an authorisation for placing on the market and use of the plant protection products in accordance with Article 55(1) PPA and Articles 33-39 of Regulation (EC) No 1107/2009, and lays down the conditions and the procedure for:

- authorising the placing on the market and the use of plant protection products under Article 57 PPA and Articles 40-42 of Regulation No 1107/2009 and the procedure for authorising, placing on the market and use of low-risk PPPs pursuant to Article 58 PPA and Article 47 of Regulation No 1107/2009;

- the requirements for the placing on the market and use of the PPP for minor uses according to Article 51 of Regulation (EC) No 1107/2009 are laid down;

- authorising the placing on the market and the use for parallel trade pursuant to Article 61 PPA and Article 52 of Regulation (EC) No 1107/2009;

- authorising PPPs for limited and controlled use pursuant to Article 62 PPA and Article 53 of Regulation (EC) No 1107/2009;

- authorising PPPs for research and/or development activities, pursuant to Article 64 PPA and Article 54 of Regulation (EC) No 1107/2009.

The conditions and the procedure for amendment, withdrawal or termination of the authorisations for placing on the market and use of PPPs under Articles 67, 68 and 69 PPA and Articles 44 and 45 of Regulation (EC) No 1107/2009, and the procedure for setting grace periods for disposal, storage, placing on the market and use have been laid down.

In order to clarify the used terms, ‘Additional Provisions’ set out definitions of the terms: ‘quarantine period’, ‘minor change in the composition of PPP’, ‘approved active substance’, ‘official translation’, ‘reference product’, ‘South zone’, ‘South-East zone’, ‘South Europe and the Mediterranean’.