Pesticides Update - January 2009

New Pesticides Regulation approved by European Parliament

On 13 January 2009 the European Parliament approved the much-debated new Regulation on plant protection products. Once this comes into force, and subject to certain transitional measures, this Regulation will replace Directive 91/414/EEC concerning the placing of plant protection products on the market and repeal Council Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances.

Important elements in the new Regulation include:

• ban of substances meeting certain (hazard-based) cut-off criteria
• comparative assessment and substitution of products with safer alternatives new rules on data protection
• new provisions on packaging, labelling, advertising and Parallel Imports
• obligation to keep records which will be available to third parties upon request via the Competent Authorities
• simplified procedures for low-risk substances and products
• division of the EU in three zones based on climatic, agricultural and ecological conditions (north, centre and south), with compulsory mutual recognition within each zone as the basic rule. Individual States will however have flexibility to adopt additional conditions or restrictions on the use of pesticides approved within their zone

Amongst these elements, the banning of substances based on hazard-based cut-off criteria was probably the most heavily debated. These criteria were introduced to accelerate the review process while achieving a high level of protection of human health and the environment. It is expected that more than 20 substances will be banned due to the shift from risk-based to hazard-based criteria. According to a list put together by the Swedish Chemicals Agency in September 2008, the following 23 pesticides will be banned as a result of the cut-off criteria:

Amitrol, Ioxynil, Glufosinate, Linuron, Molinate, Pendimethalin, Tepraloxydim, Tralkoxydim, Carbendazim, Dinocap, Epoxiconazole, Flumioxazin, Flusilazole, Iprodion, Mancozeb, Maneb, Metconazole, Quinoxyfen, Tebuconazole, Bifenthrin, Lufenuron, Thiacloprid and Flurprimidol.

These are principally CMR (carcinogenic, mutagenic or toxic to reproduction), ED (endocrine-disruptors), PBT (persistent, bioaccumulative and toxic) or vPvB (very persistent and very bioaccumulative).

The rules on data protection have also been changed with mandatory data sharing systems for vertebrate studies. Test and study reports are protected for a period of 10 years (which can be extended up to 13 or 15 years in special cases, e.g. low-risk plant protection products or minor crops). The new rules also grant 30 months of protection to data used for the renewal of plant protection product authorisations.

After formal approval by the Agriculture and Fisheries Council, which is scheduled for March or April 2009, the new Regulation will be published in the Official Journal and enter into force twenty days after this publication. This new legislation will gradually supersede existing laws on pesticides. Pesticides which are placed on the market under the current legislation will remain available until their existing authorisation expires.

For further information or questions, please contact Claudio Mereu.