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Brussels, 13 January 2009
What are plant protection 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.
What legislation is in place in the EU with regard to plant protection products?
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.
Why did the Commission propose a new Regulation on plant protection products?
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.
What will be the procedure for approving active substances for use in plant protection products in the EU?
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.
What is the procedure for authorising plant protection products?
Member States are responsible for authorising plant protection products following strict EU criteria laid down for the authorisation process.
These include requirements that the plant protection product contains only active substances approved at EU level, that it has been shown to have no harmful effects on human, animal or environmental health when applied properly and under normal conditions, and, when used on food and feed crops, that it can be used in compliance with EU rules on maximum residue levels for agricultural products.
What changes to the authorisation procedures for active substances and plant protection products are introduced by the Regulation?
For the approval of active substances to be used in plant protection products (and their inclusion in the EU positive list), the Regulation simplifies and speeds up the process, in order to enhance competitiveness in this field.
The Commission, Member States and the EFSA, which are all involved in the EU-level approval process for active substances, will have strict deadlines in which to fulfil their role in the procedure.
Criteria for the approval of active substances (such as health and environmental requirements) are tightened and clarified, which will serve to both strengthen human and animal health protection and also allow industry to have a clear idea of what is required for approval before investing in the development of a new active substance.
The authorisation of plant protection products will continue to be done by national authorities in line with clearly defined EU rules and procedures. However, the new Regulation introduces compulsory mutual recognition of authorisations amongst Member States within the same defined zone, with a degree of flexibility to accommodate local conditions. (see below for zones).
Why did the Commission propose the mutual recognition of plant protection product authorisations between Member States in defined zones within the EU?
Plant protection products must be authorised by each Member State in which they are to be used. This means that the producer must submit multiple applications for authorisation of the same product, while national authorities may be mirroring each others’ work. In addition, exclusively national authorisations of plant protection products can lead to large disparities between one Member State and another in the range of products that farmers can choose from, which may distort intra-EU competition.
The mutual recognition of authorisations will help to avoid the unnecessary duplication of work, speed-up the decision-making process and reduce the fragmentation of the EU market when it comes to plant protection products.
What are the defined zones in which plant protection product authorisations must be mutually recognised?
Three zones have been defined on the basis of relevant factors such as similar climatic, agricultural and ecological conditions. They fall broadly into North, Central and South.
The first zone would include Denmark, Estonia, Latvia, Lithuania, Finland and Sweden. The second would be made up of Belgium, Czech Republic, Germany, Ireland, Luxembourg, Hungary, Netherlands, Austria, Poland, Romania, Slovenia, Slovakia and the UK. The third zone would consist of Bulgaria, Spain, Greece, France, Italy, Cyprus, Malta and Portugal.
Is there the possibility for national authorities not to recognise an authorisation by another Member State in its zone?
The safety evaluation and subsequent authorisation of a plant protection product in one Member State should be a sufficient guarantee of its safety in other Member States included in the same zone. However, if national authorities have evidence that there is a need to provide further protection for human health or the environment, they can add their own risk mitigation measures. In case this would not be sufficient and the use of the product would still pose an unacceptable risk, a Member State could also refuse to recognise an authorisation.
What happens with active substances already on the market? Do they have to be re-evaluated after 10 years?
For active substances on the market when the Regulation enters into force (which will already have been subject to the comprehensive Commission review of all plant protection products on the market), a review of the authorisation will be carried out in the timelines foreseen under the old legislation, using the new criteria laid down in the new Regulation.
What does the new Regulation foresee with regard to substituting certain plant protection products with other plant protection products?
The new Regulation provides for comparative assessment and substitution of certain plant protection products with other substances identified as possible less hazardous alternatives. The aim is to identify, at EU level, active substances of greater risk to human, animal or environmental health, and put them forward as candidates for substitution. Comparative assessments between plant protection products containing such candidates for substitution and alternatives presenting less risk should be carried out at Member State level.
Before authorising plant protection products containing active substances which are candidates for substitution, Member States should verify whether there are viable alternatives which could be used instead. This will contribute to the gradual complete replacement of more hazardous active substances, and plant protection products containing them, with less risky substitutes. If a Member State decides to authorise a plant protection product containing an active substance which is a candidate for substitution, the principle of mutual recognition by other Member States in the zone will not apply.
What provisions are laid down with regard to testing plant protection products on animals?
The new Regulation contains provisions to avoid the duplication of testing of plant protection products on vertebrate animals. This is in line with the Commission’s overall animal welfare goal to reduce unnecessary animal testing.
What monitoring and control measures are laid down in the new Regulation?
Producers, suppliers, distributors and professional users of plant protection products are obliged to keep records of their production and use of these products. (This is already largely provided for under EU hygiene legislation already in place).
The records will have to be made available via the Competent Authorities upon request of third parties. Certain authorisations may require that farmers automatically inform neighbours before using the product.
Member State authorities are responsible for ensuring that the EU rules with regard to the marketing and use of plant protection products are fully and properly enforced, and must report to the Commission on the results of their controls. The Commission will perform audits on Member States to verify that the proper controls are being applied.