ECPA (pictured left): Little consideration appears to have been given to the impact of Directive 91/414

The European Crop Protection Association (ECPA) has expressed concern over MEPs' efforts to introduce stricter legislation as part of the forthcoming revision of the EU agrochemical registration Directive (91/414). Little consideration appears to have been given to the impact of Directive 91/414, the ECPA says. Out of the 1,100 active ingredients on the market in 1991, only some 300 will be left once the EU review of existing ais is completed, it points out.

A draft report containing 484 proposed amendments to the European Commission's proposals for updating Directive 91/414 will be put to the vote by the European Parliament's Environment Committee on July 17th. The Environment Committee is taking the lead in parliamentary discussions on the European Commission's proposals. The Committee received suggested amendments from the Parliament's Agriculture, Internal Market and Industry Committees earlier this year (Agrow No 520, p 7).

A group of 13 amendments seek to strengthen the contentious proposal to exclude ais based on their hazardous properties. The ECPA reiterates its strong opposition to this idea. Instead, it supports an alternative group of eight amendments that delete the original proposals and suggest that hazard criteria should be used to determine ais that are candidates for substitution. Such a system would be in line with the new EU chemical registration rules and would ensure that products of concern are substituted and removed from the market when suitable alternatives are available, the ECPA says.

While comparative assessment and product substitution is a controversial issue for the industry, the ECPA acknowledges the political support for this measure. Nevertheless, it opposes a group of 13 amendments that seek to: extend comparative assessment to all products; impose comparative assessment at the level of geographical zones; cut the approval period of substitution candidate ais from seven to five years; and cut phase-out periods of candidate ais from four to two years.

Industry only supports comparative assessment at the farmer level, at which economic and practical disadvantages must be considered, the ECPA stresses. Forcing approvals to be reviewed every five years would lead to a substantial increase in administrative burden, it adds. Instead, the ECPA supports amendments that would award full ten-year approvals to ais that are substitution candidates.

The ECPA expresses concern at amendments seeking to overturn the Commission's proposal for a zonal registration system for products containing approved ais in Annex I of Directive 91/414. The ECPA supports the zonal concept, which would encourage worksharing between member states and the mutual recognition of authorisations. Its view is in contrast to the draft report's author, Environment Committee member Hiltrid Breyer, who says that she "does not consider ... zonal licensing ... to be useful".

"Dividing the EU into arbitrary zones does not in any way meet environmental or nature-conservancy criteria," Ms Breyer says. Instead, she calls for EU member states to retain the option "of going beyond the Community standard" and making their own approval decisions. She supports amendments allowing member states to impose their own bans on ais. The ECPA disagrees with these proposed changes and prefers others that would merely amend the text to specify that member states have the right to take local conditions into account when approving products.

A wide range of 19 proposed amendments concern data protection provisions. The Commission's proposals would remove protection from data used to renew or review approvals. The ECPA welcomes amendments that would restore protection to necessary data for the first authorisation, renewal or review. It also supports changes that would provide compensation in cases of compulsory sharing of data to reduce animal tests.

However, seven of the 19 amendments seek to remove data protection from all studies that could help prevent further animal testing, and provide open access for competitors to such studies. The ECPA argues that the removal of data protection would reduce the incentive to develop new products.

Other amendments relating to research and development provide more favourable outcomes to the ECPA. These include amendments to: require rapporteur member states to complete draft assessment reports on new ais within eight months, instead of 12; and allow the Commission to grant provisional approvals of new ais. The ECPA had previously warned that the Commission's original proposal to remove national provisional approvals would delay market introductions by three years. Other parliamentary amendments welcomed by the industry include changes to ease procedures for extending approvals to minor crops.

The ECPA praises the "clear view" given by the Parliament that the revision of Directive 91/414 must include harmonised rules on the parallel import of pesticides. A group of seven amendments introduces provisions for parallel imports, which must be identical to reference products already approved in the importing country.

Elsewhere, Ms Breyer is keen to incorporate the aims of other proposed legislation, such as the thematic strategy on sustainable pesticide use, into Directive 91/414. The strategy foresees the compulsory introduction of IPM standards into agriculture. IPM standards should be incorporated into the definitions and measures of "good technical practice" and "proper handling of pesticides" in Directive 91/414, she says. "In addition, these conditions should become a compulsory component of the licensing process by 2012 instead of 2014," she adds.

MORE NEWS ON EU LEGISLATION

EU decides Annex 1 renewal rules - 11/07/07
MEPs vote for agrochemical cuts - 28/06/07
EU defends 91/414 reform proposals - 07/06/07
MEPs seek ai controls in water - 25/05/07

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