Joint answer given by Mr Dalli on behalf of the Commission
Written questions : E-0918/10 , P-1123/10
29.3.2010
In order to make it easier for new and innovative plant protection products to enter the market, Article 8(1) of Directive 91/414/EEC[1] on placing plant protection products on the market provides for the possibility to authorise products containing new active substances for a limited time period of three years, if a complete dossier has been submitted and if the Member State authorising the product establishes that the high safety standards of Directive 91/414/EEC are met.
Commission Decision 2009/535/EC[2] recognised in principle the completeness of the data dossier submitted by BASF SE in order to support the inclusion of the active substance with the development code ‘BAS 650F’. This substance has the ISO name ‘ametoctradin’ and is usually referred to under the registered trademark ‘Initium’. Therefore, any Member State can grant provisional authorisations for products containing this substance.
When authorising a plant protection product, a Member State must assess whether the high safety standards for human and animal health and the environment as laid down in the European legislation are met for all uses which are granted. Granting provisional authorisations are not an exemption of this rule, so the safety standards are not compromised. A Member State, when granting provisional authorisations decides to perform the whole risk assessment on its own and can therefore not fully benefit from the worksharing exercise under the peer-review procedure. However, by doing so, Member States can accelerate the entry of innovative products on their market, which might also be safer for consumers and the environment in comparison to other products.
The Commission intends to adopt temporary maximum levels (MRLs)[3] for pesticide residues for ametroctadin (Initium) on the basis of a reasoned opinion issued by the European Food Safety Authority (EFSA) in October 2009[4]. The proposed MRLs in the reasoned opinion were provisional as the peer review had not been finalised. It is based on an evaluation report and information from the draft assessment report of ametoctradin. Both documents are produced by the Netherlands, which are leading (‘rapporteur Member State’) in the peer review organised by EFSA. The proposal has already been voted on the Standing Committee (SCFEAH) and is expected to be published in the Official Journal at the latest in the third quarter of 2010.
- [1] OJ L 230, 19.8.1991.
- [2] OJ L 179, 10.7.2009.
- [3] The procedure for MRL setting is described in Regulation (EC) No 396/2005 of the Parliament and of the Council on maximum residue levels of pesticides in or on food and feed of plant and animal origin, OJ L 70, 16.3.2005.
- [4] European Food Safety Authority; Setting of new MRLs for BAS 650 F in table and wine grapes, potatoes, tomatoes, peppers, cucumbers, courgettes, melons and lettuce. EFSA Journal 2009; 7(10):1367. [28 pp.]. doi:10.2903/j.efsa.2009.1367. Available online: www.efsa.europa.eu