New EU Pesticide Legislation Moves Forward

The new legislation has to be formally adopted by the Council, and it will enter into force later this year. Together with the end of the review programme of existing active substances, the Commission will have met its objective to make sure that efficient plant protection is achieved with safer products.

14/01/09 The European Parliament has adopted in second reading a Regulation to replace the current legislation on plant protection products, based on a Commission proposal from 2006. The European Commission said that the new legislation will increase the protection of human health and the environment, will lead to a better protection of agricultural production and will extend and deepen the single market of plant protection products.

Commissioner A. Vassiliou said: "This is certainly a very good way for the European Parliament and the Council to start the New Year – by improving the protection of human health and of the environment. The new legislation will also benefit our farmers, as it ensures their own protection through specific measures such as the promotion of safer products."

The European Commission said that the new Regulation will facilitate innovation by establishing clear criteria for approval of substances. Rules are proposed to ensure an open and competitive market. The existing legislation is improved and simplified, in particular in terms of approval procedures.

The new Regulation confirms the importance that the European Commission gives to a high level of protection of human health and the environment, while at the same time harmonises further the availability of plant protection products. Moreover it intends to favour competition and reduce administrative burden for all stakeholders.

The text contains provisions on the following main issues:
•  criteria for approval of active substances
•  inspection and monitoring on production, storage, transport and use of plant protection products
•  a simplified evaluation and authorization procedure
•  the role of the European Food Safety Authority (EFSA)
•  data protection – data sharing
•  mutual recognition for plant protection products
•  informing on the use of plant protection products to neighbours
•  reduction of tests on vertebrates

The Commission welcomes the work done by the European Parliament and the Council as all objectives targeted by the initial proposal have been maintained in the text resulting from the co-decision process.

The new legislation has to be formally adopted by the Council, and it will enter into force later this year. Together with the end of the review programme of existing active substances, the Commission will have met its objective to make sure that efficient plant protection is achieved with safer products.

Plant protection products, or pesticides (insecticides, fungicides, herbicides), are chemical formulations containing an active substance and other ingredients. They are important for the protection of plants and crops in agriculture, horticulture, forestry and gardening.

Active substances are chemicals used in plant protection products and are the essential component which enables the plant protection product to protect the plant against insects or fungi which destroy plants. There are currently around 500 active substances on the EU market.

Active substances are approved at EU-level, while plant protection products containing these substances are authorised at Member State level.

The Regulation which has now been agreed replaces Directive 91/414/EEC. It covers the authorisation, use and control of plant protection products. It lays down a comprehensive risk assessment and authorisation procedure for active substances and products containing these substances.

Each active substance has to be proven safe in terms of human health, including residues in the food chain, animal health and the environment, in order to be allowed to be marketed. Producers are responsible for providing comprehensive dossiers to this end, based on scientific data. An EU positive list of active substances is being established, and Member States may only authorise plant protection products containing active substances included in this positive list.

Active substances that have been banned from use in the EU are currently listed in Council Directive 79/117/EEC. Plant protection products containing these active substances may not be placed on the market or used in the EU. The new Regulation repeals Directive 79/117/EEC , in order to avoid confusion between banned and non-approved active substances, neither of which are allowed to be used in the EU. Only active substances on the EU positive list will be permitted for use, to the exclusion of all others.

In 2005, Regulation 396/2005 entered into force, setting maximum residue levels of pesticides in food and feed throughout the EU (see IP/04/543). In addition to harmonised upper legal limits for pesticides found on food and feed, this Regulation sets out strict monitoring and reporting requirements to ensure that these limits are being respected in all Member States.

Plant protection products are also subject to certain chemical and environmental rules, for example, provisions under the Water Framework Directive.

In 2001, the Commission submitted a progress report on Directive 91/414 to the Council and Parliament, which looked at how the legislation was functioning and where it could be improved. The Commission concluded that a reform of the legislation was necessary in order to address certain identified needs and weaknesses. These included the need to further reinforce human health and environmental protection, harmonise the availability of plant protection products between farmers in different Member States, increase transparency, boost the competitiveness of the EU chemical industry, avoid duplication of animal testing and define the role of the European Food Safety Authority (EFSA).

Following consideration of the progress report, the Council and Parliament called on the Commission to bring forward proposals for new legislation on the marketing of plant protection products, also adding some of their own requests for the future, in particular on the exclusion of certain categories of hazardous substances. Before drawing up and finalising the draft Regulation, the Commission undertook extensive consultations with all interested stakeholders and carried out an impact assessment.

The new Regulation perpetuates the harmonised authorisation system for active substances used in plant protection products originally set out in Directive 91/414/EEC.

The applicant must submit a comprehensive dossier on the substance, with full information on the nature and composition of the substance, details of tests carried out on crops and plants, safety data, means of detection etc. to a “rapporteur” Member State. This Member State is then responsible for carrying out a full evaluation of the substance and submitting a draft assessment report to the Commission, other Member States and the European Food Safety Authority (EFSA).

On the basis of this assessment report, EFSA organises a peer review of the evaluation with the other Member States and presents its conclusion to the Commission. On the basis of these conclusions the Commission decides whether or not to put forward, through Comitology procedure, a proposal to approve the active substance and add it to the EU positive list of active substances.

The approval of an active substance for use in plant protection products may be subject to conditions and restrictions in order to fully ensure human, animal and environmental protection. These may include restrictions on means of application of plant protection products containing the active substance, crops to which they can be applied, limitation of use to professional users, monitoring after use and other risk mitigation measures.

Under the new Regulation, the existing procedure is updated, simplified, and clearer criteria for approval of active substances are laid down. The central role that the EFSA plays in the evaluation process is clearly defined. Once an active substance has been approved at EU level, it may then be used in plant protection products.

The European Crop Protection Association said the plant protection industry looks forward to more and better science in the wake of the European Parliament’s majority support for its pesticide regulatory package. “Once we enter the implementation phase of the process, we intend to help make sure that the path that is followed is based on fact, not fear,” said Friedhelm Schmider, Director General of the European Crop Protection Association.  “We hope that we are now leaving behind a period of sensational claims and that the approach to the application of this legislation will be one of great care and due diligence.”

The Association noted that pest management products are used to fight insects, fungus, disease and weeds in all forms of agriculture including organic.  They are essential to producing and preserving the food supply.  The banning criteria (cut-offs) are of major concern to industry and the whole European food chain. European farmers have already lost 60% of the substances previously available in 1991. 

“Now the question arises of what further losses are in store for both the farmer’s pest fighting portfolio and  European food production as a result of the legislation,” added Schmider.  “To some extent the loss of more useful substances without a scientific rationale could be avoided during 2nd reading. We will work with European policy makers and our partners in the food chain to support a sensible implementation of the remaining provisions of concern. The decision-making so far has been done in the absence of a comprehensive impact assessment, which would certainly be very helpful in ensuring that the next steps are the right ones to safely secure Europe’s food supply.”

While the adoption of cut-off criteria remains of great concern to industry, other areas of the new legislation, such as the new rules on parallel trade and national provisional authorisations, are hailed by ECPA.

“This legislation is largely welcomed by industry because it formalizes with our long standing commitment to the safe, environmentally sound use of our products,” said Schmider.  “We can see very clearly that the key to the continued sustainable use of plant protection products lies in further risk reduction.”

Industry recognizes that all actions directed to this aim should be both ecologically and economically viable, rendering agriculture sustainable and food production secure in Europe.  ECPA applauds the focus on elements that contribute to these goals, such as the regular inspection of equipment, education and training of users, and integrated pest management.  “We also appreciate that the measures can be adapted to meet different national needs.”

However, Schmider indicated that it is industry’s firm position that arbitrary use reduction is neither an appropriate means of risk reduction nor a promoter of sustainable practices. “Indeed, there is no direct systematic link between the amount of product used (whether measured in total quantity or number of treatments) and the risk involved. It is crucial that this perspective be considered when establishing national action plans on the sustainable use of plant protection products.”