2018/0080/BG
EC/EFTA
BG Bulgaria
  • C00A - AGRICULTURE, FISHING AND FOODSTUFFS
2018-05-25
2018-03-02

Placing on the market and use of plant protection products under Article 57 of the Plant Protection Act (PPA) and Articles 40-42 of 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 on the placing on the market and use of plant protection products

The Bulgarian Food Safety Agency (BFSA) shall perform the activities relating to the authorisation of plant protection products (PPPs), except 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.

Article 15 of the draft lays down the conditions and procedure for amendment of an authorisation to place on the market and use plant protection products in accordance with Article 55(1) PPA and Articles 33-39 of Regulation (EC) No 1107/2009.

Article 20 lays down the conditions and procedure for authorising the placing on the market and use of plant protection products under Article 57 PPA and Articles 40-42 of Regulation No 1107/2009. Article 21 sets out the conditions and procedure for authorising the placing on the market and use of low-risk PPPs pursuant to Article 58 PPA and Article 47 of Regulation No 1107/2009. Article 22 sets out 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.

Article 23 sets out the conditions and procedure for authorising the placing on the market and use for parallel trade according to Article 61 PPA and Article 52 of Regulation No 1107/2009. Article 24 of the draft lays down the procedure for authorising PPP for limited and controlled use according to the requirements of Article 62 PPA and Article 53 of Regulation No 1107/2009. Article 28 lays down the procedure for authorising PPP for research and/or development purposes according to Article 64 PPA and Article 54 of Regulation (EC) No 1107/2009. Article 32 sets out the conditions for authorising finished solutions according to Article 65 PPA, renewal of the authorisation for the placing on the market and use of PPPs according to Article 66 PPA and Article 43 of Regulation No 1107/2009.

The conditions and procedure for amendment, withdrawal and termination of the authorisations for the placing on the market and use of PPPs under Articles 67, 68 and 69 PPA and Articles 44-45 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.

A condition is set out stipulating that plant protection preparations for spray application shall only be approved if they are not categorised in the first category of professional use. In order to clarify the terms used, definitions of the following terms are provided in the section entitled ‘Supplementary provisions’: ‘minor change in the composition of the PPP’, ‘approved active substance’, ‘official translation’, ‘southern and south-eastern zone’, and ‘Southern Europe and the Mediterranean’. The section entitled ‘Final provisions’ contains a requirement to carry out an evaluation for which an assessment report must be prepared for the PPPs that are authorised to be placed on the market and used prior to the draft regulation’s entry into force. The BFSA shall provide the CRAFC with a copy of the relevant information and the necessary documents for the assessment.