June 26, 2012
Beverage Alcohol Brief
The European Union (EU) notified the World Trade Organization (WTO) on May 25, 2012, that the EU Commission intends to announce compulsory allergen labeling requirements for wine on June 30, 2012. The regulation, effective three (3) days after official publication, will require allergen labeling if milk or eggs or derived products are used during the production of the wine and are still present in the final product at a detection of 0.25 mg/L or greater.
Under the new requirements, all wines from the 2012 or after harvests, labeled after June 30, 2012, and intended to be sold within a country of the EU, will be required to comply. The labeling standards require the statement “Contains” followed by the specific allergen detected (e.g., “Contains sulphites, egg, milk”). The labeling must be made in specific languages in different EU countries, which also may require that the allergen statement appear in multiple languages. To accommodate the concerns over the natural size limitations of a label, the EU Commission proposed optional icons that can be combined with the English statement and then exported to any or all EU countries:*
Due to the expense associated with the enzyme-linked immunosorbent assay (ELISA) test kits used to detect the allergen in the finished product, the Wine and Spirit Board reports that the “consensus seems, even on the remotest of possibility that some residues might be present, to be that the lesser of the two evils will be to declare said allergens.” As the EU regulations become enforceable only three days after official publication, and apply to the 2012 harvest if labeled after June 30, 2012, winemakers need to implement their compliance efforts as soon as possible.
In the U.S., the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) amended the Federal Food, Drug and Cosmetic Act (FD&C Act) to require the FDA to issue requirements for allergen labeling regarding the presence of all major food allergens in finished food products. (Major food allergens are defined as milk, egg, fish, shellfish, tree nuts, wheat, peanuts, and soybeans.)
Beverage Alcohol products are not within the jurisdiction of the FDA, therefore beverage alcohol labeling was not directly affected. Instead, the House of Representatives committee noted an expectation that the U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB), in cooperation with the FDA, issue its own allergen labeling requirements using the TTB’s existing authority under the Federal Alcohol Administration Act’s (FAA) Section 205(e) to “provide the consumer with adequate information as to the identity and quality of the products.” Separately in 2004, Dr. Christine Rogers, senior research scientist at the Harvard School of Public Health, petitioned the TTB for allergen labeling after she had an allergic reaction to egg in wine.
These two events led to the TTB’s proposal of a mandatory allergen labeling rule and the issuance of a voluntary interim rule. Unlike FALCPA, TTB’s proposed mandatory allergen labeling rule contains no exception for major food allergens unintentionally added by cross-contact and applies regardless of whether the allergen remains present in the finished product. Many comments received on the proposed rule requested that a “presence” limitation be added, similar to Australia, New Zealand, and the EU’s regulations.
The voluntary interim rules require specific information and wording to be included if a producer, bottler, or importer voluntarily discloses allergen information. Similar to the pending EU regulations, any allergen declaration must state “Contains” followed by the common name for the major food allergen. For example, if the word “albumen” is used, it must be followed by the common name “eggs,” and if one allergen is listed, all major food allergens must be listed. Unlike the pending EU regulation, however, the interim rule contains no threshold levels for allergen presence.
In June 2011, Susan Evans, executive liaison for the TTB, reported that “ultimately” the TTB will have a mandatory allergen disclosure requirement, but explained that, the “science is not there yet.” Specifically, the TTB has stated publicly that it is difficult to find accurate and reliable testing methods for compliance purposes. Now that the EU Commission has made known its implied approval of testing down to a 0.25 mg/L detection limit, it is possible the TTB will follow suit.
The foregoing has been prepared for the general information of clients and friends of the firm. It is not meant to provide legal advice with respect to any specific matter and should not be acted upon without professional counsel. If you have any questions or require any further information regarding these or other related matters, please contact your regular Nixon Peabody LLP representative. This material may be considered advertising under certain rules of professional conduct.