EU court lawyer backs tougher pesticide rules

Member states should require new data when authorising generic products, says legal advisor

EU member states should not be permitted to rely on old safety data when approving new "generic" pesticides, a European Court of Justice (ECJ) advisor has argued. Firms could be forced to submit expensive new safety data before launching new products based on existing active ingredients if the legal opinion is upheld in a final ruling.

The opinion of advocate general Philippe Léger relates to a legal battle between the UK government and Monsanto, which was referred to the ECJ by the anglo-welsh high court. In the case, Monsanto objected to permission given by the UK authorities to another company to launch a new herbicide based on the active ingredient glyphosate, which Monsanto developed and first won marketing approval for in 1974.

The 1991 EU directive on marketing of pesticides specifies that safety assessments for such generic product applications should take account of current scientific and technical knowledge. But the UK authorities argued that it was legitimate to permit marketing of a new glyphosate-based product based on Monsanto's 1974 safety data because the pesticides directive was still in a 12-year transitional period.

Mr Léger has sided with Monsanto, arguing that the UK's interpretation could compromise environmental and safety standards. The directive's requirement for current data to be assessed is clear, he says, and the fact that not all elements of the law have been finalised should not mean that member states can ignore it.

If the legal opinion is confirmed by a panel of judges, then pressure will increase for older active pesticide compounds currently on the EU market to be reassessed. However, a spokesperson for British branch of Pesticide Action Network told ENDS Daily that such a ruling might well lead instead to companies abandoning plans to launch new generic pesticides to avoid the heavy costs of generating new safety data.

Follow Up:
European Court of Justice, tel: +352 43031; Philippe Léger's opinion; Pesticide Action Network UK, tel: +44 20 72 74 88 95.

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