As we discuss frequently on this blog, maintaining transparency and control of your company’s supply chain can help limit potential risks to your business. With some food additives, however, transparency is not enough and certain chemicals should be removed from your products, or risk having to reformulate quickly at significant cost or having to recall products with those ingredients.
A set of seven carcinogenic flavor chemicals under review by the Food and Drug Administration (FDA) offers a good example of these risks. On Jan. 4, 2016, the FDA announced that it is considering whether to rescind its 1964 approval of – effectively banning – seven flavoring chemicals as food additives.
The flavoring chemicals under review may be found in any food product but are not required to be named on the label. The most commonly used ones appear to be eugenyl methyl ether, myrcene and pulegone. They could be considered natural flavors, since they can be either extracted from plants or chemically synthesized.
|Carcinogenic Flavoring Chemical||Chemical Abstract Service Number||Sensory Properties per GoodScents Company|
|Benzophenone / diphenyl ketone||119–61–9||Balsam, rose, metallic, powdery, and geranium|
|Ethyl acrylate||140–88–5||Harsh, plastic, acrylate, and fruity|
|Eugenyl methyl ether / 4-allylveratrole / methyl eugenol||93–15–2||Sweet, fresh, warm, spicy, clove, carnation, and cinnamon|
|Myrcene / 7-methyl-3-methylene-1,6-octadiene||123–35–3||Peppery, terpene, spicy, balsam, and plastic|
|Pulegone / p-menth-4(8)-en-3-one)||89–82–7||Peppermint, camphor, fresh, herbal, buchu|
|Pyridine||110–86–1||Sickening, sour, putrid, fishy, and amine|
|Styrene||100–42–5||Sweet, balsam, floral, and plastic|
The agency filed the notice in response to a food additive petition from eight public interest organizations, including EDF, which asserted the chemicals were ‘found to induce cancer in man or animal.’ The law is clear that such chemicals must not be added to food. A food additive petition is FDA’s primary mechanism to add, remove or change its approval of food additives.
If FDA accepts the petition for one or more of the seven carcinogenic flavoring chemicals, food containing the affected flavor(s) would be considered adulterated on the same day the agency publishes its decision in the Federal Register. The petition process offers no exemption for existing food or a delayed effective date. The only way to suspend the decision is if someone objects to it and demands a hearing within 30 days of FDA’s announcement of acceptance.
FDA’s goal is to make a decision on food additive petitions within 360 days of filing, although the statute calls for action within 180 days. FDA filed the flavoring chemicals petition on August 17, 2015, so it’s possible they will make a decision by this summer.
Are these chemicals really unsafe?
The public interest groups’ petition asked FDA to determine whether the seven carcinogenic flavoring chemicals are unsafe because they violate the provision of 21 U.S.C. § 348, which states: “no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal…” If an additive is found to induce cancer, the law makes clear that it be banned without consideration to the amount people eat.
The National Toxicology Program (NTP) – a part of the U.S. Department of Health and Human Services – found each of the seven chemicals induces cancer in man or an animal. Two of the carcinogenic flavors, styrene and eugenyl methyl ether, have been officially designated by NTP to be ‘reasonably anticipated to be human carcinogens,’ and NTP studies concluded that the other five induced cancer in animal studies. The California Environmental Protection Agency and the International Agency for Research on Cancer have also designated many of them as carcinogens.
In contrast, the Flavor and Extract Manufacturers Association’s (FEMA) Expert Panel considers all of these same flavors except styrene, which it delisted in 2015, to be Generally Recognized as Safe (GRAS).
What do I do now?
Since there may be no notice of FDA’s action between the filing and the final decision, forward-thinking companies should identify which foods they make or sell that may contain any of the seven flavoring chemicals and reformulate the product to remove them. With more than 2,700 other flavoring chemicals allowed to be used, suppliers have options, but it can take time to find a different ingredient mix that provides a comparable taste.
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