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Review of MRLs under Regulation 396.2005 is on its final stage

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Belgium

EU Regulatory Bulletin contents

 

Following the adoption of decisions concerning the inclusion of plant protection product active substance in Annex I to Directive 91/414/EEC (now Regulation 1107/2009), the European Food Safety Authority ("EFSA") has been reviewing existing (or setting of new) maximum residue levels (''MRLs'') pursuant to Article 12 of Regulation 396/2005 (''MRLs Regulation'').

The revision process started in 2008, and after a significant period of time it has finally reached its final stage, with a series of EFSA's Reasoned Opinions being delivered to the Standing Committee on Phytopharmaceuticals. In turn, the latter recently gave green light to the proposed amendments of Annexes II to V of the MRLs Regulation for a series of compounds, such as tebuconazole, for which MRLs need to be adapted by 15 August 2014. For other substances, proposals are still being circulated among the World Trade Organization (''WTO'') Members, and a vote on the approval will take place during the next Standing Committee meeting scheduled for 12-13 June 2014.

Despite the efforts of EFSA, the review process does not seem immune from criticism. In addition to being delayed for five years, the revision has also posed problems in terms of coordination with the special procedure on import tolerance laid down in Article 6 of the MRLs Regulation. This provision allows business operators importing products into the EU market to apply for a further review of MRLs as to have them harmonized with the residue limits legally applied outside the EU (see also Recital 26 of the MRLs Regulation).

Moreover, and perhaps more importantly, Member States seem not to be coordinated as to how the new MRLs need to be implemented. In most countries this is done by reviewing the existing GAPs, whereas in some Member States such as Italy new data submissions are being requested from registration holders. This latter approach in some cases may be unlawful, inasmuch as such requests have no legal basis, and in any event, data submitted under the MRL Regulation do not benefit from data protection (see also EU guidance document on data protection, among others). The issue remains open and may trigger local legal actions.