PURPOSE : to lay down new harmonised EU rules for plant protection products, which aim to reinforce the protection of public health and the environment, support sustainable development in agriculture, reduce animal testing, boost competitiveness for producers and increase availability of plant protection products for farmers.
PROPOSED ACT : Regulation of the European Parliament and of the Council.
CONTENT : the use of plant protection products (PPP) may involve risks and hazards for humans, animals and the environment, especially if placed on the market without having been officially tested and authorized and if incorrectly used. Therefore harmonized rules should be adopted on the placing on the market of PPP.
This proposal follows extensive consultations with Member States and stakeholders over the past 5 years, as well as a comprehensive impact assessment. The proposed Regulation is fully in line with the overall Commission strategy on pesticides, and will complement the Commission’s proposal for a Directive on the sustainable use of pesticides (refer to COD/2006/0132).
The proposed Regulation replaces Directive 91/414/EEC concerning the placing of plant protection products on the market and repeals Council Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances. In a nutshell, it consists of the following elements:
- establishment at EU level of a positive list of active substances, safeners, synergists and a negative list of co-formulants;
- the time-span for the approval of active substances is shortened, with strict deadlines laid out for Member States, the European Food Safety Authority and the Commission;
- authorisations of active substances will no longer have to be renewed every 10 years (just once, after the first 10 year period), in order to avoid a backlog of unnecessary applications which have already been found to be acceptable for use. However, a review of an authorisation can still be carried out at any time if new concerns arise about its safety;
- the EU will be divided into 3 zones with similar climatic and ecological features, and plant protection products authorised by any one Member State will automatically be cleared for use in the other Member States in that particular zone;
- national authorities will still be allowed, however, to impose specific national risk mitigation measures if deemed necessary;
- data protection rules are also simplified, to allow more transparency, greater competition and a level playing field for small and medium sized producers, while ensuring that this does not hamper innovation;
- provisions on packaging, labelling and advertising;
- obligation to keep records and to carry out controls;
- establishment of criteria for approval of active substances, safeners or synergists.
The proposal also includes new provisions which aim to protect human health, animal welfare and the environment:
- the safety evaluations of active substances will be founded on strict criteria, also based on health considerations and the effects on the environment (e.g. persistence in the environment);
- the European Food Safety Authority (EFSA) has a central role in the evaluation procedure;
- control measures are reinforced in the Commission’s proposal, and farmers and other professional users will have to keep records of their use of plant protection products. These will have to be made available on request to the drinking water industry and neighbours;
- avoid repetition of testing on vertebrates
- protect non-professional users.
For further information concerning the financial implications of this measure, please refer to the financial statement.