New harmonised EU rules for plant protection products, which aim to reinforce the protection of public health and and the environment, support sustainable development in agriculture, reduce animal testing, boost competitiveness for producers and increase availability of plant protection products for farmers, have been proposed by the European Commission today. Among the measures set out in the draft Regulation are shorter and clearer authorisation criteria and streamlined procedures, simplified data protection rules, provisions for the substitution of active substances with safer alternatives and a reduction in testing on vertebrate animals. The proposed legislation will also strengthen the internal market in this area by allowing mutual recognition of of plant protection product authorisations between Member States within the same defined zone. Today’s proposal follows extensive consultations with Member States and stakeholders over the past 5 years, as well as a comprehensive impact assessment.

Markos Kyprianou, Commissioner for Health and Consumer Protection, said, “The proposed Regulation aims to strengthen and improve the rules on pesticides throughout the EU, to the benefit of EU citizens and stakeholders. It will ensure an even higher level of protection for human and animal health and the environment, while also offering more choice to farmers and boosting competitiveness for the industry in this field.“

Simplifying and harmonising

The proposed Regulation aims to streamline and simplify the authorisation procedures for plant protection products, and reduce the administrative burden for all stakeholders. 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. This will help to avoid duplication of work, speed up decision-making and ensure a more harmonised availability of plant protection products in the different Member States. 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.

Protecting human health, animal welfare and the environment

The proposal put forward by the Commission today will increase the level of protection given to human health, animal welfare and the environment, through a series of new provisions. Firstly, 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, which is clearly defined in the proposed Regulation. 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.

In line with the EU’s overall strategy for the sustainable use of pesticides, the proposed Regulation promotes comparative assessment and substitution of certain plant protection products with other substances identified as a safer and viable alternative. The proposed Regulation also introduces a new rule prohibiting the duplication of tests on vertebrate animals, which should reduce animal testing and improve animal welfare in this area.

Next steps

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. It will now be submitted to Council and the European Parliament for adoption. It is foreseen that it will enter into effect in 2008, at a time when the current review of all existing active substances already on the market will have been completed.

For more information, see: http://ec.europa.eu/food/plant/protection/evaluation/index_en.htm
and http://ec.europa.eu/food/plant/protection/evaluation/framework_en.htm