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On November 08, 2019, the European Commission published Regulation (EU) 2019/1881, amending Regulation (EU) No 37/2010, reducing the MRLs for diflubenzuron.

SAFEGUARDS | FoodNO. 176/19

 Salmon Cuts

On November 08, 2019, the European Commission published Regulation (EU) 2019/1881 [1], amending Regulation (EU) No 37/2010 [2] reducing the Maximum Residue Limits (MRLs) for diflubenzuron.

The EU commission requested the European Medicines Agency (EMA) consider diflubenzuron and the genotoxic potential of diflubenzuron’s metabolite 4-chloroaniline in accordance with Regulation (EU) No 470/2009[3], establishment of the maximum residue limit (MRL) for pharmacologically active substances in foodstuffs of animal origin, and Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin sets out that diflubenzuron is an allowed substance for muscle and skin of Salmonidae species.

On May 7, 2015 the EMA recommended to the Committee for Medicinal Products for Veterinary (CVMP) that the residue for diflubenzuron in Salmonidae species in Table 1 of the Annex to Commission Regulation (EU) No 37/2010 be amended and that a provisional MRL be established, pending provision of additional residue data.

On March 15, 2018 the CVMP agreed the opinion on the establishment of maximum residue limits for diflubenzuron for which there is a possibility that the genotoxic metabolite 4-chloroaniline is present in treated fish at levels that could be hazardous to human health and to follow Regulation (EC) No 470/2009 that allows the establishment of a provisional MRL in cases where the scientific data are incomplete and in cases where there are no grounds for supposing that residues of the substance at the level proposed poses a hazard to human health.

Regarding the CVMP opinion and the EMA recommendation, it is necessary to protect human health by reducing the MRL of diflubenzuron from 1,000 μg/kg to 10 μg/kg and amending the Annex of Commission Regulation (EU) No 37/2010.

Table 1 of the Annex to Regulation (EU) No 37/2010, the MRL of diflubenzuron is replaced, as follows:

 Pharmacologically active Substance  Marker residue  Animal Species  MRLs  Target Tissues
 Diflubenzuron   Diflubenzuron  Salmonidae 10 μg/kg Muscle and skin in natural proportions

This amendment entered into force on December 1, 2019.

What do the changes mean?

EU Member States, third countries and food business operators must ensure their products comply with the new requirements, modified MRLs for diflubenzuron in Salmonidae species. For more information, or to discuss your testing, analysis and certification requirements contact a food safety expert, such as SGS.

SGS is committed to keeping you informed of regulation news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions including analytical tests, audits, certifications, inspections, and technical support. We continually invest in our testing, capability, and state-of-the art technology to help you reduce risk, and to improve food safety and quality. For more information, please visit our website: www.foodsafety.sgs.com

For enquiries, please contact:

Naovarat Dachprasat
R&D Chemist, Food Technical Support Center
Tel: +66 2683 0541 ext. 2168, 2169

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