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Regulation Changes

Your need-to-know

Food Allergens 101

The FDA Label Rules

CFR Guide (PDF)

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Regulation Changes
New Trans Fat Labeling feature.

As of January 1st 2006 the Food and Drug Administration's (FDA) final rule on trans fatty acids (also called "trans fat") requires that the amount of trans fat in a serving be listed on a separate line under Saturated Fat on the Nutrition Facts panel. This action responds, in part, to a citizen petition from the Center for Science in the Public Interest (CSPI). The trans fat final rule will affect most, but not all, packaged, labeled food products sold in the United States.

Declaration of "0g" of trans fat is not required for products that contain less than 0.5g of Total Fat in a serving and if no claims are made about Fat, fatty acid (includes Saturated Fat) or Cholesterol. In the absence of these claims, the statement "Not a significant source of trans fat" may be placed at the bottom of the Facts Panel in lieu of declaring "0g" of trans fat. If however you Facts Panel lists Total Fat and Saturated fat or includes "not a significant source of" statement, then your product's Facts Panel must meet the January 1st, 2006 labeling requirements.

On December 30th 2005 the FDA has issued a revised guidance for requesting an extension to use existing label stock after January 1st 2006. This revised guidance is available here.

FoodCalc is here to help! Manufacturers who are required to meet the Trans Fat labeling requirements no longer need to look further. Our Nutritional Panels and nutrient values are up-to-date on the latest USDA/FDA regulations.

New Allergen Labeling feature

Another change the New Year brought was the January 1, 2006 labeling of the "Big 8" Allergens. The Food and Drug Administration (FDA) is requiring food labels to clearly state if food products contain any ingredients that contain protein derived from the eight major allergenic foods:

  1. milk
  2. eggs
  3. fish
  4. crustacean shellfish
  5. tree nuts
  6. peanuts
  7. wheat
  8. soybeans

As a result of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), manufacturers are required to identify in plain English the presence of ingredients that contain protein derived from the above 8 in the list of ingredients or to say "contains" followed by name of the source of the food allergen after or adjacent to the list of ingredients.

FALCPA requires that in the case of tree nuts, the specific type of nut must be declared (e.g., almonds, pecans, or walnuts). The species must be declared for fish (e.g., bass, flounder, or cod) and Crustacean shellfish (crab, lobster, or shrimp).

FALCPA does not address the use of advisory labeling such as "May Contain" statements describing the potential presence of unintentional ingredients in food products resulting from the food manufacturing process ("processed in a facility that also processes [allergen]"). The FDA advised that advisory labeling such as "may contain [allergen]" should not be used as a substitute for adherence to current Good Manufacturing Practices (cGMPs). In addition, any advisory statement such as "may contain [allergen]" must be truthful and not misleading.

Labeling of food products that contain flavoring, coloring, or have been in contact with a allergen that are, or contain, a major food allergen must also be identified on the label.

FoodCalc once again provides support tools and compliance assistance in order to help manufacturers meet the new Allergen labeling requirements. Ingredients that contain or may contain a FALCPA allergen are flagged and transferred into the editing section or your review.

To learn more about LabelCalc, review our Demo/Tutorial and use the Free Trial

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