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Allergens: A Need for Transparency

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Millions of people suffer from food allergies. For most people, the allergenic reaction is mild, but uncomfortable. Some people, however, may have severe or even life-threatening reactions. Concern for consumer protection has increased scrutiny on allergens. Undeclared allergens are now the most common reason for food recalls in the United States resulting in over ten million pounds of recalled food in 2015.1

The occurrence of people with food allergens and foods to which they are allergic may vary regionally, often based on traditional food products for different regions. Local allergen labeling requirements may therefore vary by region. Japan, for example, requires buckwheat labelling, whereas in the United States, buckwheat is not commonly used and buckwheat allergies are very rare. In general, most countries have strict requirements for the food ingredients that account for the majority of allergens in that region. The US for example, has strict labelling requirements for 8 ingredients including fish, eggs, and peanuts that account for 90% of the food allergens in the USA.2

Due to increasing globalization of both food ingredients and local populations it is important for all suppliers in the food chain to have strong controls of not only major allergens but all potential allergens. A good allergen program involves strict separation of known allergens and rigorous cleaning of shared equipment. A robust allergen program and transparency is the key to providing food manufacturers and consumers the information they need to keep themselves safe.

Greater allergen safety was one of the factors driving the US Food Safety Modernization Act (FSMA). Over 25 food allergen requirements were added to the US Good Manufacturing Practices (GMP) for the food manufacturing requirements implemented in 2016. The FDA and food safety professionals now have a much greater focus on allergen control.

Major food allergens are of particular concern since they not only account for the majority of food allergies, but for those affected cause a true allergic reaction. An allergic reaction is an immune response that can have a wide variety of symptoms including anaphylactic shock that could result in death. Consumers could also suffer from food intolerances, a condition where the body lacks enzymes to digest certain foods (lactose intolerance is a well known food intolerance) or sensitivities to certain ingredients. Although intolerances and sensitivities are very seldom life-threatening, they still make for an unpleasant food experience.

Although there is a medical distinction between allergies, intolerances, and sensitivities, many consumers consider all potentially recurring adverse reaction to food ingredients an allergy. Similarly people may suffer from sensitivities in cosmetic and fragrance ingredients which can result in an immune response, irritation, or swelling. With the ubiquity of fragrances in common household products like laundry detergent or dish soaps, cosmetic and fragrance ingredients are under increased scrutiny. The EU requires any cosmetic product to list on its ingredient label 26 known allergens.3 The EU Scientific Committee on Consumer Safety (SCCS) also reviewed many fragrance ingredients for possible adverse reactions. As a result of the SCCS study several changes and additions were submitted and implemented as part of the EU regulation on cosmetic products (EU 1223/2009).

Current EU regulations identify almost 1400 aroma compounds they prohibit in cosmetics. This regulation also lists almost 300 materials that are restricted in different cosmetic products including the 26 known skin allergens. Cosmetic manufacturers and other firms that blend or use fragrance ingredients need transparency in the supply chain to confirm the ingredients they use are safe and meet the regulatory requirements.

Supplier allergen statements and technical support are important tools for food and cosmetic manufacturers to help them meet regulatory requirements and provide consumers with the information they need to be safe and stay healthy. Undeclared allergens can result in recalls, damage brand reputation, and harm consumers. A secure, transparent supply chain with a reliable supplier who has a robust allergen control program will help food and cosmetic manufactures maintain the high quality the public and regulatory authorities demand.


USDA, . [Internet]. Available from:
FDA, . [Internet]. Available from:
2009, . Regulation (EC) No 1223/2009 of the European Parliament and of the council, Official Journal of the European Union.