United States

Of particular interest is the Food and Drug Administration (FDA) position in this respect. In June 1996, the Center for Food Safety and Applied Nutrition issued a Notice to Manufacturers concerning the Label Declaration of Allergenic Substances in Foods.

The Food, Drug and Cosmetic Act requires, in virtually all cases, a complete ingredients listing on foods. Two exemptions to this are that spices, flavourings and colourings may be declared collectively under the Act, without each individual one having to be specifically named; also, incidental additives, such as processing aids, that are present in foods at an insignificant level and do not have a technical or functional effect in the final food, need not be declared, under Title 21 of the Code of Federal Regulations. The FDA, in this Notice, stressed to manufacturers that the exemption applied only when the incidental additive is present at an insignificant level and it must not have any technological effect in the final product. An example is quoted of egg white as a binder in breading on a breaded fish product; the egg white is not incidental as it is acting in the final food, so should be declared. Owing to the low levels of ingredients concerned with allergens, the FDA is considering whether it is necessary to clarify the regulations to ensure that manufacturers fully understand the circumstances in which allergenic food ingredients must be declared and to ensure that sensitive individuals are protected by appropriate labelling. The FDA is also open to comment on how the problem of potential allergens in additives should be handled. It may consider it necessary to introduce rule-making for the labelling of allergenic ingredients.

While assessing the situation, the FDA, in the Notice, requests manufacturers to examine their product formulations for ingredients and processing aids containing known allergens that are currently exempted from declaration as incidental additives and to declare these in the ingredients statement. Where appropriate, the name of the ingredient may be accompanied by a parenthetical statement for clarity, for example '(processing aid)'. It is felt that allergenic ingredients in an additive could be declared in the correct position in the list (owing to their low levels, usually at the end) and other non-allergenic ingredients would continue to be exempt.

Examples of foods that are among the most commonly known to cause serious allergenic responses are, according to the FDA, milk, eggs, fish, crustacea, molluscs, tree nuts, wheat and legumes (in particular soyabeans and peanuts). The FDA advises that the issue of declaring allergenic ingredients in food is being discussed on an international level - a move it welcomes.

Another area of concern to the FDA is cross-contamination so as to cause inadvertent addition to or introduction of an allergenic ingredient into a product where it would not normally be found. For example, a product without peanuts could end up containing peanut traces. The FDA feels that labelling such as 'may contain peanuts' should not be used as a substitute for Good Manufacturing Practice (GMP); manufacturers are urged to take all steps to eliminate such contamination and ensure the absence of the allergenic food or ingredient. The FDA is considering options for providing consumers with further information in this respect and how this issue should be addressed.

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