The Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021 officially added sesame as the ninth major allergen. Since January 1, 2023, all food regulated by the FDA containing sesame needs to be clearly identified per the Food Allergen Labeling and Consumer Protection Act (FALCPA), including in the "contains" list of allergens.
All food containing sesame as an ingredient that's produced after January 1, 2023, and covered by FDA regulation will need to comply with major allergen labeling rules.
Food produced before January 1, 2023, will not need to be relabeled and can continue to be sold until it runs out of stock.
No, foods with allergen cross-contact risk do not need to be labeled. Companies can choose to add a "may contain" advisory label to disclose this risk and reduce liability.
The advisory label can only be added if the facility has made its best efforts to avoid cross-contact with sesame through Good Manufacturing Practices and its allergen control plans based on an updated Hazard Analysis and Risk-Based Preventive Controls (HARPC) that considers sesame.
Some food producers have controversially added sesame as an officially listed ingredient to avoid having to take measures to control cross-contact, but this step often leads to backlash from consumers and regulators and can result in higher long-term costs than compliance.
Preventing sesame cross-contact in food facilities can be a major burden, especially for small enterprises. Often-cited reasons are the costs associated with updating equipment, processes, and training.
The reality is that companies that treat food safety and allergen control with proactive, systemic approaches shouldn't feel overburdened at all — all of the pieces to control sesame cross-contact are already in place. Dealing with sesame as a major allergen may not be easy for all, but it shouldn't be overly cumbersome, either.
The following steps will help food manufacturers ensure the risk of sesame cross-contact is minimized:
Besides updating HARPC to reflect sesame as a potential allergen hazard, food safety plans will need some updating to:
Sesame is a common ingredient that can sneak in with other raw materials if suppliers aren't instituting effective controls. Food manufacturers should audit suppliers for allergen control compliance and avoid working with suppliers that can't or won't disclose the presence of sesame in their facilities, or ones that don't comply with allergen regulations.
As with any major change to food safety plans or food safety regulations, companies need to ensure that employees are aware of the change, understand the new procedures, and know why the new procedures are important. This includes employees not working directly in production.
The FDA has put a lot of emphasis on better traceability for more effective public health responses. Make sure you clearly document where sesame is (or could be) present in your supply chain and production process. Verify that your suppliers are doing the same for their suppliers.
Testing, with ELISA kits, for example, will be a critical piece of the validation process to ensure cleaning and sanitation procedures are effective at eliminating sesame residue on your tools and equipment. But testing should go beyond just validation: a scheduled and consistent testing plan will ensure you're staying compliant with FASTER regulations and will spot problems early enough so they can be prevented or mitigated.
Facilities required to be GMP-compliant should take this opportunity to audit their practices and processes to ensure they're still fully compliant. While this shouldn't be an issue for companies that have invested in a culture of food safety, it's never a bad idea to reverify.
This is especially important for minimizing risk from sesame cross-contact since the FDA requires GMP compliance for companies that wish to use advisory labels.
The addition of sesame to the list of major allergens in the U.S. has been seen as disruptive and monumental, but it's unlikely to be the last such change. While the U.S. recognizes nine major allergens, large parts of the world already recognize significantly more, including 10 in Australia, 11 in Canada, and 14 in the E.U. It's fair to assume that some or all of these will be added to the list in the U.S. as well in the foreseeable future.
Using the addition of sesame as a learning experience and blueprint for successful allergen cross-contact control will not only allow manufacturers to produce safer food but also prepare them to be more adaptable if and when future allergens are added to the list.
If you need help building a cross-contact prevention blueprint for your facilities, contact AIB International about our Food Safety Program Development consulting today.