Plant Protection Products 

The Council and the European Parliament recently adopted a Regulation on plant protection products (PPPs), which is currently awaiting publication in the EU’s Official Journal. The Regulation will ban a number of PPPs currently in use, while also providing a comprehensive list of products that are authorised for use in the European Union.

Background

PPPs have been subject to increasing amounts of controversy in the past few years due to their perceived negative effect on human health and the environment. Governments have therefore come under increasing pressure to ban a number of these products and more strictly regulate others.

Council Directive 79/117/EEC of 21 December 1978 was the first piece of EU legislation to establish a list of prohibited and authorised substances for use in PPPs within the EU. The scope of this Directive was expanded in 1991, with the adoption of Council Directive 91/414/EEC. Following a progress report on the functioning of Directive 91/414/EEC, the Commission decided that reform was needed in a number of areas including:

·         protection of public health and the environment;

·         support for sustainable development in agriculture;

·         reduction of animal testing;

·         boosting competitiveness for producers and increasing the availability of plant protection products for farmers;

·         improving the functioning of the internal market;

·         increasing transparency;

·         defining the role of the European Food Safety Authority (EFSA);

·         simplifying the rules for low risk substances and products while strengthening the rules for substances with the potential to cause harm.

The Commission therefore proposed this Regulation, in conjunction with a Thematic Strategy and a Framework Directive on pesticides, to address the weaknesses identified in Council Directive 91/414/EEC.

Aim of the Regulation

The principle objectives of the Regulation are:

·         to establish a European Community positive list of active substances, safeners, synergists and a negative list of co-formulants;

·         establish predictable, efficient and consistent criteria for the approval of active substances, safeners or synergists;

·         to provide for the authorisation of PPPs at Member State level, with the time-span for approval shortened;

·         to create separate and administratively simple provisions for substances or products considered low risk to public health and the environment.

Authorisation

The authorisation procedure for PPPs under the new Regulation strengthens the role of the European Food Safety Authority (EFSA), which is mandated to conduct independent scientific reviews of authorisations. The aim is to ensure consistency in the evaluations procedure. While EFSA is responsible for risk assessments, it is the Commission which performs the risk management role and takes the final decision on active substances. Provisions have also been included that aim to ensure the transparency of the evaluation process.

Zoning

The Regulation also establishes a system of three geographical zones (North, Central and South), each of which has similar climatic and ecological features.  This will be done in order to avoid the duplication of work and to reduce the administrative burden for industry and EU Member States. Authorisations granted by one Member State will therefore be accepted by other Member States where agricultural, plant health and environmental (including climatic) conditions are comparable.

Moreover, where identical plant protection products are authorised in different Member States, a simplified procedure for granting a parallel trade permit is provided for in this Regulation, in order to facilitate the trade between Member States of such products.

Packaging, Labelling and Marketing

Rules on the advertisement of PPPs have been laid down in this Regulation in order to ensure that users of PPPs and members of the public are not mislead. Moreover, Member States may prohibit or restrict the advertising of plant protection products in certain media, subject to EU law. Advertisements will not be allowed to visually depict potentially dangerous practices, such as mixing or application of PPPs without sufficient protective clothing, nor any use of PPPs near food or children.

Research and Intellectual Property Protection

The Regulation also establishes a system for exchanging information. Member States will be expected to make the particulars and scientific documentation submitted in connection with applications for authorisation of plant protection products available to each other, the Commission and the EFSA.

Studies will be protected from the potential infringement of intellectual property. Tests and studies, which will be subject to obligatory data sharing, lodged by one applicant with a Member State will be protected against use by another applicant. This protection will, however, be limited in time in order to allow competition. It will also be limited to studies which are genuinely necessary for regulatory purposes, to avoid applicants artificially extending the period of protection by submitting new studies which are not necessary.