Important News and Developments

Allergen Labeling Not As Simple As It Seems – Begin Changes Now

Del Mar, CA – September 22, 2004 – Food Consulting Company is advising food companies to prepare now to meet the January 1, 2006, mandatory compliance date for federally mandated allergen labeling. President Bush signed the Food Allergen and Consumer Protection Act of 2004, into law on August 2, 2004. This act amends the Federal Food Drug and Cosmetic Act and requires food manufacturers to identify, in plain, common language, the presence of any of the eight major food allergens (milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans) that are or might be present in any ingredient contained in a food product.

Many food labels already bear voluntary allergen declarations according to Karen Duester, president of Food Consulting Company, but the information may not satisfy the new law. “For example,” said Duester, “the ‘plain, common language’ requirement means that an ingredient such as sodium caseinate will have to be declared in the ingredient list as being derived from milk.” Right now manufacturers often use chemical names to declare certain ingredients like sodium caseinate without declaring in ‘plain, common language’ their associations with a major allergen.

The law also requires that labels must declare if flavorings, colorings, and other additives are derived from or have been in contact with a major allergen at any time during the manufacturing process. Duester explained that existing ingredient labeling regulations have not called for this and so manufacturers do not routinely declare the incidental additives found in these ingredients even if they have been associated with a major allergen. “Now manufacturers will need to research ingredients to determine or rule out exposure to allergens."

"The distant compliance date might imply plenty of time,” according to Duester, “but really it is just 15 months away.” Savvy manufacturers have to allow time for research and they will want to have revised label content ready to be incorporated into new label plates and print runs when current label inventories expire, or when labels are updated to reflect formulation changes or label design changes -- all in order to gain economic savings.

The bill has other requirements including facility inspections and the publication of a final rule to define and permit use of the term gluten-free on food labels. Manufacturers can read the bill by searching Bill Number “S.741.ENR” at Concerned parties can keep up-to-date on the allergen regulation progress and other government changes affecting food labels by subscribing to INTOUCH, a free email newsletter available at

Food Consulting Company, based in Del Mar, CA, and the largest out-source provider assisting food companies in meeting FDA label requirements, offers a full range of food labeling services including product analysis (both database and laboratory), nutrition facts panels, ingredient statements, allergen information, full label compliance packages, shelf life evaluations, and final label reviews. Duester can be reached through the company web site at, or by calling 800-793-2844.