Allergens and Contaminants in Food and Fragrance Regulations
Luke Grocholl, Head of Food Regulatory Experts
The Big Eight Is Now Nine
In late January 2020 Talia Day, the mother of 2 young children with severe food allergies testified before congress on the dangers of undeclared allergens. Her children, like an estimated 1.6 million other Americans, are allergic to sesame. With support from her testimony and the work of groups like FARE1 (Food Allergy Research & Education), the FASTER Act2 was signed into law requiring that sesame be declared on food labels as a major food allergen.
Sesame was already considered major food allergen in Europe, Canada, Australia, New Zealand, much of the Middle East, and parts of Asia. Now in the US all GMP and manufacturing controls for allergens must include sesame. Furthermore, if present in any quantity, sesame must be called out on product labels. The addition of sesame as a major food allergen requires flavors and fragrance companies to review their processes and supply chains to ensure that any potential source of sesame is identified and controlled. Recent changes to food allergen requirements were not exclusive to the US. Japan is also expanding its list of major food allergens with walnuts being shifted from a voluntary disclosure status to mandatory labeling.
Smells Great, but How Does it Feel?
Although the recategorization of sesame and walnuts as major food allergens may heavily impact much of the food industry, it will be a minor challenge compared to proposed EU cosmetic regulation changes for the flavors and fragrances industry. Regulation (EC) No 1223/2009 currently identifies two dozen chemical substances and two botanical extracts as fragrance allergens. A proposed update to the regulations expands the list of fragrance allergens to 82 substances and extracts. The scope of this change is significant as it will likely triple the number of fragrance allergens that require reporting in the EU. Once implemented, a thorough review of all raw materials for fragrance applications will likely be required to maintain compliance with any changes to the EU cosmetic regulations. The European Commission is currently reviewing comments made on the proposed draft, and an adoption transition period will be included for new mandates.
A Tiny Molecule and a Major Food Recall
Europe also had a major requirement change stemming from the largest food recall in EU history. While this issue again originated with sesame, it was not due to allergenic concerns.
In September 2020 sesame seeds imported from India were found to be contaminated with ethylene oxide, also called ETO. Ethylene oxide is a powerful fumigant and is commonly used to sanitize medical equipment. It is also used as a sanitizing agent for foods (most commonly spices) and food equipment in some parts of the world. It is a small, volatile molecule which disperses into very small or porous spaces and quickly dissipates, thus its utility for treating medical equipment. It is a known carcinogen, however, and exhibits reproductive toxicity when ingested. So, how did it contaminate Indian sesame resulting in some 3000 product recalls?
Ethylene oxide fumigation of sesame seeds in India is not uncommon. Treatment with ETO will kill salmonella, a significant risk in warm, humid Indian granaries. Since it is volatile, ethylene oxide should quickly dissipate bringing any residual ETO to below 0.1 ppm (<0.1 mg/kg) as recommended by safety limits. In the presence of moisture and chloride sources, such as salt, ETO can readily convert to 2-chloroethanl (2-CE), a much less volatile compound that may not evaporate from treated seeds, thereby making it an excellent proxy in testing for ethylene oxide. 2-Chloroethanyl has its own toxicological concerns, however, so the presence of 2-CE is still a major issue.
But it was not just sesame seeds. The initial report from the autumn of 2020 raised the concern about ETO which was subsequently found in bean gum, guar gum, and xantham gum from Turkey and other regions. Many of these ingredients are commonly used as thickening agents, emulsifiers, and stabilizers in food products ranging from ice cream to chewing gum. But where was the ETO coming from?
Ethylene oxide is a raw material used in the production of some common food additives such as polysorbate and polyethylene glycol. For this reason, the EU set a limit of not more than 0.2 mg/kg (ppm) ethylene oxide for these food additives. But now ETO and 2-CE were being found in many other food ingredients. Treatment with ethylene oxide as a sanitizing agent, the suspected source in sesame seeds, was thought to be the cause, but investigations found ETO fumigation unlikely for many of the contaminated products. Finally, a likely source was identified. Food ingredients must be stored in sanitary conditions but packing and shipping them introduce potential hazards. Sea freight in particular may find ingredients contained in a warm, wet environment ideal for microbiological growth. Some shipping firms thought they had found a solution; they were treating shipping containers with ethylene oxide.
Sea freight containers create a major challenge for sanitary shipping. They are often large and difficult to clean. Decontaminating the containers with sanitizing detergent or bleach can leave residual odors that would impact the quality of the food shipped. Ethylene oxide presented a seemingly ideal solution. Shipping containers could be treated with the ETO and then aired out to let the volatile material evaporate before loading with food. However, since 2-chloroethanol readily forms in the presence of chloride and water, as found in seaside conditions, residual 2-CE remained to contaminate food and ingredients.
As a result, the EU implemented screening of imported foods, particularly from Asia where ETO treatment is more common. Additionally, the requirements for food additives were updated. Previously only those food additives manufactured using ethylene oxide as a raw material had specified limits on the amount of ETO. Now the regulation3 stipulates that ethylene oxide cannot be used for sterilization of food additives and further sets a specification of no more than 0.1 mg/kg (ppm) ETO in any food additive used in the EU.
Although EU regulations distinguish flavors from food additives and the regulation does not directly impact flavor ingredients themselves, many flavor formulations require food additives as stabilizers, surfactants, antioxidants, and other technical functions. Flavors and fragrances companies must ensure that any ingredient classified as a food additive meets this strict ethylene oxide limit.
A New Vision for Food Safety
To help prevent significant food safety issues like the national baby formula shortage, the FDA commissioned an independent expert panel in July 2022 to review their food programs. This report,4 published in December by the Reagan-Udall Foundation, outlines several recommendations and highlights areas for improvement. Acting on this report, the FDA plans a “new vision” to quickly resolve potential and known food safety hazards. This report demonstrates the FDA’s continued commitment to food safety and will result in many new regulations that impact the flavors and fragrances industry. Although an overhaul of the FDA’s approach to food safety may take many years, it will likely result in many new regulations impacting the flavors & fragrances industry.
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