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Jun. 26, 2008

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Jun. 26, 2008
The European Crop Protection Associations says it is "disillusioned and frustrated" by the decision of EU Agriculture Ministers to support the proposed introduction of hazard-based criteria in the registration of agrochemicals. EU Ministers reached agreement on the proposals this month, which will enable the text to go for a second reading at the European Parliament in the autumn. The ECPA vows to keep up its campaign to demand a full impact assessment before any new rules come into force.
The proposals form part of the European Commission's plans to revise the EU agrochemical registration Directive (91/414). The text agreed at the June meeting is a compromise drawn up by EU and member state officials after Ministers rejected an earlier version of the proposals in May. The latest compromise largely follows the Commission's original plans to introduce hazard-based "cut-off" criteria that would halt the registration process for certain active ingredients. However, it also incorporates derogation from this rule if no alternatives are available.
The proposals would "totally prohibit the marketing and use of substances proven to be carcinogenic, mutagenic and toxic for reproduction", the Slovenian EU presidency says. "In exceptional cases, when available products do not offer sufficiently effective plant protection, other hazardous substances may be used, but only under strictly regulated conditions. This transitional period shall not exceed five years," it adds.
Such an arrangement managed to gain a qualified majority vote by Ministers, although the UK, Ireland, Romania and Hungary abstained, reports Brussels news agency AgraFacts. The UK has expressed strong objections to the plans, arguing that they would result in widespread loss of pesticide products and significant reduction in crop yields.
While the ECPA acknowledges the derogation for certain products that have been shown to be required to deal with serious dangers to plant health, it points out that it is "extremely restricted". It is "unlikely to maintain a number of key crop protection solutions", the ECPA believes.
Slovenian Agriculture Minister Iztok Jarc stresses that, in defining registration criteria for ais, consideration had been given to the influence of agrochemicals on the long-term food supply in the EU. The proposed rules would encourage the replacement of hazardous products with safer ones, he adds. The ECPA has long disputed this view, arguing that the industry cannot bring new ais to market at a sufficient pace to keep up with the potential scale of product losses.
Implementation of such proposals would remove products from the market that have been used safely for years, the ECPA says. "Just because a product has hazardous properties does not mean it is dangerous. Proper risk evaluations of products are required to determine this – taking the dose and actual use into consideration," stresses ECPA director-general Friedhelm Schmider.
The ECPA repeats its call for a full impact assessment to be carried out on the proposals. Other EU groups are also pressing the Commission to study the practical implications of its plans, including the impact on food quality and prices, and to establish evidence of benefits to human health and the environment (see this issue).
Elsewhere, the text agreed by Ministers sides with the Commission's plans to stop the routine granting of three-year provisional approvals to new ais before they have completed the EU registration process and been listed in Annex I of Directive 91/414. However, provisional approvals will be permitted if the EU-level assessment lasts longer than two and a half years, the Slovenian presidency says.
The latest compromise also adopts the proposed division of the EU into three geographical zones for product approvals. Registration of a product in one country will allow marketing in other EU member states within the same zone under the mutual recognition system. However, "member states will be able to reject the mutual recognition of registration of certain products or restrict their application in the event of specific national environmental protection or agro-technological circumstances", points out the Slovenian presidency.
Elsewhere, a compromise has been reached on data protection, where the industry had expressed concern over the Commission's original bid to remove protection for data submitted for the renewal or review of an authorisation. The latest proposals maintain the Commission's aim to simplify the rules and reduce the duplication of tests on vertebrates, but have restored data protection to two and a half years, reports AgraFacts.
Finally, the agreed text requires professional users and producers of pesticides to keep records of product use and handling. Such record-keeping has not previously been uniformly regulated at EU level, the presidency says.
EU officials hope to formalise the agreed text into a Ministers' "common position" by the autumn, so that it can be passed to the Parliament for its second reading. The outcome is uncertain. At the Parliament's first reading, MEPs voted for an even wider range of hazard-based criteria, but the Commission and Ministers refused to incorporate such amendments into the latest proposals. The parliamentary debate and vote will be followed by a second reading by Ministers.
Source: ECPA

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