4 July 2012 Mr. Michael Flüh Head of Unit Chemicals, contaminants, pesticides – E3 EU Commission DG SANCO B-1049 Brussels Request EU temporary MRL for Quaternary Ammonium Compounds Dear Mr. Flüh, In recent weeks an issue regarding the presence of quaternary ammonium compounds (QAC) on fruit and vegetables has emerged and led to considerable disruptions in the trade. Labs have detected Didecyl Dimethyl Ammonium Chloride (DDAC) and Alkyl Dimethyl Benzalkonium Chloride (ADBAC) in various fruit and vegetables both from third countries and Europe, as well as on organic products. These compounds are mainly used as biocides (disinfectant/cleaning agent) but in some countries also as pesticides (foliar spray, dip application), in certain cases they are also used as co-formulants. Whereas the strict regulatory status regarding residues is clear, Regulation (EC) No 396/2005 EU provides the default MRLs of 0,01 ppm for both DDAC and the QAC-family in general, the extensive presence of unintentional residues on a variety of foodstuffs requires an urgent temporary solution pending the investigation of the exact causes for the contamination sources. Monitoring data from our members, which are enclosed, suggest residues up to 0,5 ppm both for DDAC and ADBAC which cannot be linked to the direct use of QACs as pesticides. Crosscontamination from the use of biocides in food areas and washing water as well as from the use of co-formulants in biostimulants have thus far been identified as major causes for the unintentional QAC residues. Based on the toxicological information available in the registration reports from the US Environmental Protection Agency (ADBAC, DDAC) and a preliminary risk assessment by the German institute for risk assessment BfR, the observed residue levels are not likely to represent any danger to consumer health. Our members have been extensively informed on the issue and were asked to investigate the use of QACs in their supply chain and where possible immediately discontinue any further use of products containing QACs. The results from these actions will however take time and meanwhile produce will continue to be harvested or delivered. Furthermore cost-effective and efficient alternatives need to be available to ensure continued good hygiene practices. In this light, we request an action limit of 0,5 ppm to replace the present default MRL of 0,01 ppm for both DDAC and QAC pending the setting of a temporary MRL. Such a level would only cover unintentional QAC residues and would exclude post-harvest treatments which result in higher residue levels. This solution would provide the industry enough time to further investigate the exact causes of cross-contamination and discontinue any non-essential uses throughout the supply chain. Monitoring data would be assembled to assess the required level of a temporary MRL. Given cross-contamination was identified as a major cause, the temporary MRL would need to apply for all fresh fruit and vegetables. Rue de Trèves 49-51, bte 8 - 1040 Brussels - Belgium Tel: +32 (0)2 777 15 80 Fax: +32 (0)2 777 15 81 e-mail: [email protected] - www.freshfel.org - www.freshquality.org - www.freshcongress.com - www.enjoyfresh.eu Considering the ongoing trade disruptions accompanied with the destruction of perfectly safe food, we request the Standing Committee on the Food Chain and Animal Health to take action at the earliest. With best regards, Frédéric Rosseneu Director Food Quality & Sustainability Rue de Trèves 49-51, bte 8 - 1040 Brussels - Belgium Tel: +32 (0)2 777 15 80 Fax: +32 (0)2 777 15 81 e-mail: [email protected] - www.freshfel.org - www.freshquality.org - www.freshcongress.com - www.enjoyfresh.eu Page 2
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