The European Commission has published Regulation No 284/2013 on the data requirements for plant protection products and Regulation No 283/2013 on the data requirements for active substances. Alongside these two new Regulations the Commission has also published two corresponding Communications which identify the guidance notes that are applicable to the various sections of the new Regulations.
As we mentioned in our previous bulletin of 18 July 2011 titled 'New Pesticides Regulation enters into Force in Europe', an applicant who wishes to place an active substance or a plant protection product on the market in the EU must first submit for the purposes of authorisation a complete dossier on the active substance/plant protection product. The new Communications will assist products or importers in preparing their active substance/plant protection product dossiers for submission.
The new rules have been created to take into account current scientific and technical knowledge of active substances/plant protection products. The overall effect of these new rules, according to the Commission, will be the removal of active substances and plant protection products that are unsafe for human health or the environment.
The two Communications provide guidance on the information relating to test methods and other information that must be included in the dossier.
The new rules come into force on 1 January 2014 for active substances. The rules in relation to plant protection products do not come into force until 1 January 2016 provided however that the dossier for at least one active substance contained therein was submitted by 31 December 2015.
The text of the new Regulations and Communications can be found here:
Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
Commission Communication in framework of Regulation No 283/2013 sets out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
Commission Communication in framework of Regulation No 284/2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
