1600 South Jackson Street Seattle, Washington 98144 Phone 206‐323‐3540 Fax 206‐323‐3543 SETTING THE STANDARD IN SEAFOOD SAFETY

ALLERGEN LABELING GUIDELINES

Technical Bulletin L-04

US On August 2, 2004, President Bush signed into the law the ‘Food Allergen Labeling and Consumer Protection Act of 2004’. Under the Senate bill (S.741), food manufacturers are required to clearly label food products with common names to describe the presence of the eight major food allergens, which include milk, eggs, fish (e.g., bass, flounder, or cod), crustacean shellfish (e.g. crab, lobster, or shrimp), tree nuts (e.g. almonds, pecans, or walnuts), peanuts, wheat, and soybeans. The eight major food allergens are associated with 90 percent of all reported allergic reactions to foods in the United States.

Under section 2003 of the Act, food manufacturing companies are required to identify all allergens in a ‘plain, common language’, which are commonly understood by consumers, such as ‘egg’, ‘fish’, ‘milk’, ‘shrimp’ etc. and removed ingredient labeling exemptions for food allergens in flavors, colors, and in incidental additives. In a product with multiple allergens such as tree nuts, crustacean shellfish or fin fish, each individual nut or species of seafood must be declared (e.g. contains: almonds, cashews, Halibut, Cod and Pollok.) Labeling of the food allergen is not required when the common or usual name already declares its food source. For example, if your list of ingredients is whole wheat flour, buttermilk, peanut butter, then it would not be necessary to write out the major allergens because they included in the name of the food. For example, if your list of ingredients is whole wheat flour, buttermilk, peanut butter, then it would not be necessary to write out the major allergens because they are included in the name of the food. In some cases, for products that contain species of fish or shellfish that are rare or unusual, a company may elect to insert 'fish' or ‘crustacean shellfish’ in parentheses following the species (e.g. hoki (fish). Currently, FDA has no guidance on this and identifying species by class is not required under the law." There are two options for presentation names of major food allergens, in association with the ingredient declaration of the food.

1. In a separate statement immediately following the ingredient declaration, the label states ‘Contains’ followed by the name of the food source from which the major food allergen is derived. Type size of the statement must be no smaller than the type size used in the list of ingredients. (e.g. Contains salmon, cod, shrimp) Or 2. Within the list of ingredients the common or usual name of the major food allergen is immediately followed parenthetically by the name of the food source which the major food allergen is derived. (e.g. whey (milk)

The regular ingredient declaration for canned salmon traded under the US standard of identity would comply with allergen labeling requirements (e.g. salmon, salt). No further labeling change would be required.

Revision Date: 6-10-08 Supersedes: Technical Bulletin L-04, 3-21-08

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cont. Allergen Labeling Guidelines

The law specifies that labeling provisions apply to ‘products labeled on or after January 1, 2006.’

For additional information, please see the links below. http://www.cfsan.fda.gov/~dms/wh-alrgy.html http://www.cfsan.fda.gov/~dms/alrgact.html http://www.silliker.com/html/allergens.php http://www.cfsan.fda.gov/~dms/alrguid4.html

Canada Health Canada is developing amendments to section B. 01.009, to require the declaration on the label of following foods, or any protein containing derivatives of these, in the list of ingredients by their common name if added directly as an ingredient in the prepackaged foods: peanuts; tree nuts; sesame seed; milk; eggs; fish; crustaceans & shellfish; soybean; wheat and sulfite (>10ppm). Health Canada's intention is to recommend that the proposed regulatory amendments be published in Canada Gazette, Part I, by early 2008 to allow for public comment.

For additional information, please see the links below. http://www.inspection.gc.ca/english/fssa/labeti/allerg/allerge.shtml http://www.hc-sc.gc.ca/fn-an/label-etiquet/allergen/index_e.html http://www.inspection.gc.ca/english/fssa/labeti/allerg/allergee.shtml

EU New Allergen Labeling rules were introduced by Directive 2003/89/EC, an amendment to the general food labeling directive 2003/13/EC. This directive requires food manufactures to indicate 12 groups of potential allergens by reference to the source of allergen if they are used as ingredient at any level in pre-packed foods, including alcoholic drinks. The rules were fully implemented and in affect on November 25, 2005. There are 13 potential ingredients to be labeled under the EU Allergen rules: wheat; crustacean & mollusk shellfish; egg; fish; peanuts; soybeans; Lupin; milk; tree nuts; celery; mustard; sesame seeds and sulfite (>10ppm).

For additional information, please see the links below. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:308:0015:0018:EN:PDF www.fas.usda.gov/gainfiles/200510/146131140.doc http://ec.europa.eu/food/food/labellingnutrition/foodlabelling/guidelines_6_10.pdf http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:368:0110:0111:EN:PDF

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Australia &New Zealand

The standard 1.2.3 of the Australia New Zealand Food Standards Code requires mandatory declaration of the following substances in food when they present as: an ingredient, an ingredient of a compound ingredient, a food additive or component of a food additive, and processing aid or component of a processing aid: crustacean; egg; fish; milk; peanuts; soybean; tree nuts; sesame seeds; cereals containing gluten (wheat, rye, barley, oat and spelt and their hybridized) and sulfite (>10ppm.)

There is no specific format to declare food allergen at this time. However, there are some recommendations of allergen declaration in the sections 5.4, 5.5 and 5.6 of the “Food Industry Guide to Allergen Management and Labeling”, which was published by Australian Food and Grocery Council in 2007.

For additional information, please see the links below. http://www.allergenbureau.net/downloads/allergen-guide/Allergen_Guide_2007.pdf http://www.foodauthority.nsw.gov.au/industry/fb-allergy-aware-legal.asp http://www.foodstandards.gov.au/thecode/foodstandardscode.cfm#_one http://www.allergenbureau.net/

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