Food and Health E-ssentials

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EU Commission issues draft regulations on pharmacologically-active substances in food

The Commission of the European Union (EU) has issued a draft regulation that would set what it calls “reference points” for actions related to certain pharmacologically-active substances in food of animal origin.

Released in early January, the draft regulation represents an effort to regulate pharmacologically-active substances for which no maximum residue limits have been set. The regulation identifies methodological principles and scientific methods for assessing risk levels associated with these substances, as well as rules for setting reference points for these substances that provides assurances of safety. The draft regulation also specifies actions to be taken in cases where residues of pharmacologically-active substances are found at levels above the established reference points.

The Commission’s action was prompted in part by concerns raised by the EFSA’s Panel on Contaminants in the Food Chain (EFSA CONTAM Panel) regarding the safety of chloramphenicol, malachite green and nitrofuran metabolites, and the need for what it calls a “substance-specific risk assessment” that addresses the unique analytic considerations and toxic potential of these substances.

The EU’s draft regulation is available here.

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