TTB M 1334.01 (04/2010)

Pending Fining Pending Fining Agent RegulationsAgent Regulations

Labeling ImplicationsLabeling Implications

Required Allergen Required Allergen LabelsLabels

• 1999– Switzerland

• 2002– Australia– Japan– New Zealand

• 2012– Canada– EU

» (required when present in the final food)

Which Allergens?Which Allergens?

• Switzerland– Sulfites (10 ppm)– Cereals (gluten)– Celery– Crustacean

shellfish– Eggs– Fish– Lupine– Milk

– Mollusks– Mustard– Peanuts– Sesame– Soybeans– Tree nuts– Wheat

– (1000 ppm mandatory labeling)

• Australia/New Zealand– Sulfites (10 ppm)– Egg– Fish– Milk– Lupine– Peanut– Sesame– Shellfish– Soy– Tree nut– Wheat

• Japan (10ppm)– Buckwheat– Crustaceans– Egg– Milk– Peanut– Wheat

• Canada– Sulfites (10 ppm)– Eggs– Milk– Mustard– Peanuts– Seafood

• (Fish, Crustaceans, shellfish)

– Sesame– Soy– Tree nuts– Wheat

• EU– Sulfur dioxide,

sulfites (10 ppm)– Cereals containing

gluten– Crustaceans– Eggs– Fish– Milk– Mustard– Nuts– Peanuts– Sesame seeds– Soybeans

ExemptionsExemptions

• Australia, EU, New Zealand– Isinglass– Fish gelatin

• Canada– Filtered wines

Food Allergen Labeling and Consumer Protection Act of

2004

• Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) to require the declaration in labeling of eight major food allergens in plain, common language on the food and beverage products regulated under the Federal Food, Drug and Cosmetic Act.

• the Committee on Energy and Commerce issued a Report that accompanied FALCPA (H.R. Rep. No. 608, 108th Cong. At (2004)), which provides:

• The Committee expects, consistent with the November 30, 1987 Memorandum of Understanding, that the Alcohol and Tobacco Tax and Trade Bureau (TTB) of the Department of the Treasury will pursuant to the Federal Alcohol Administration Act determine how, as appropriate, to apply allergen labeling of beverage alcohol products and the labeling requirements for those products. The Committee expects that the TTB and the FDA will work together in promulgation of allergens regulations, with respect to those products.

United StatesUnited States

• Sulfites (10 ppm)• Crustacean shellfish• Egg• Fish• Milk• Peanuts• Soybeans• Tree nuts• Wheat

• On July 26, 2006, TTB published two rulemaking documents: an interim rule for voluntary allergen labeling (T.D. TTB-53, 71 FR 42260), and a notice of proposed rulemaking (Notice No. 62, 71 FR 42329) proposing to make allergen labeling mandatory for all alcohol beverage products.

• Since the interim voluntary rule went into effect in 2006, TTB received only a small number of label submissions (109) with voluntary allergen declarations. The most typical allergens listed are egg whites and fish (isinglass) on wine labels, milk and eggs on distilled spirits labels, and wheat on malt beverage labels.

Comments ReceivedComments Received

• Objection to “contains”– May contain– Processed with– Produced using [allergen]. Traces

may remain

OIV ResolutionOIV Resolution

• LOD 0.25 ppm• LOQ 0.50 ppm

– Availability of kits (cost)– Availability of standards– Shelf life of reagents

– FIVS “Good Fining Practice Guidelines for Wine” 2007

FDAFDA

• December 2012– Notice seeking comments on

establishing action levels/regulatory thresholds for allergens

• Allergen statement only required if the final food contains the allergen protein

VEGANVEGAN

• Vegan wine• Vegan friendly• Vegan symbol

• “Certified vegan”: required documentation to be submitted with COLA application

• List of wine treating materials approved pending rulemaking

• http://www.ttb.gov/wine/wine_treating_materials.shtml

Contact InfoContact Info

• Mari Kirrane• TTB – International Trade

Division• 490 N. Wiget Lane• Walnut Creek, CA 94598• 513-684-3289 (office)• 202-329-6564 (cell)• 2002-453-2678 (fax)

QuestionsQuestions