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U.S. Consumer Groups Hail FDA Decision to Ban Use of Seven Food Additives

The Center for Food Safety and the Natural Resources Defense Council are hailing a recent decision by the Food and Drug Administration to remove seven synthetic food flavouring substances and flavour enhancers (adjuvants) from its approved food additives list. This action was taken in response to a petition filed in 2016 by these two groups and seven other non-profit advocacy organisations that cited test results from the National Toxicology Program that these flavourings cause cancer.

The FDA determined that six of these synthetic substances caused cancer in laboratory animals under the conditions of the studies, while the seventh synthetic flavour is being de-listed because it is no longer used by industry. The six flavouring substances include synthetically-derived benzophenone, ethyl acrylate, eugenyl methyl ether (methyl eugenol), myrcene, pulegone and pyridine. These substances are being removed from the food additive regulations under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. Enacted in 1958, this clause provides that the FDA cannot find as safe (i.e., cannot approve) the use of any food additive that has been found to induce cancer in humans or animals at any dose.

The FDA notes, however, that rigorous scientific analysis has determined that these substances do not pose a risk to public health under the conditions of their intended use. The synthetic flavouring substances in question are typically used in foods available in the U.S. marketplace (including in such products as ice cream, baked goods, chewing gum and beer) in very small amounts and their use results in very low exposure levels and low risk. While the FDA’s recent exposure assessment of these substances does not indicate that they pose a risk to public health under the conditions of their intended use, the petitioners provided evidence that these substances caused cancer in animals who were exposed to much higher doses. As such, the FDA is only revoking the listing of these six synthetic flavourings as a matter of law.

The FDA adds that each of these synthetic substances has a natural counterpart in food or in natural substances used to flavour foods. The revocation of the listings providing for the use of these synthetic flavouring substances and adjuvants does not affect the legal status of foods containing their natural counterparts or of flavouring substances extracted from such food, often labelled as “natural flavors.” Based on evidence presented by the petitioners that benzophenone causes cancer in animals, the FDA also is amending the food additive regulations to no longer provide for its use as a plasticiser in rubber articles intended for repeated use in contact with food.

Finally, the FDA has granted a separate petition from the Styrene Information and Research Center by amending its food additive regulations to no longer allow for the use of styrene as a synthetic flavouring substance and adjuvant because industry has abandoned this use. For the other six synthetic flavouring substances, the FDA will provide 24 months from the publication of the rule in the Federal Register for companies to identify suitable replacement ingredients and reformulate their food products.

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