Pending Fining Agent Regulations

1. Pending Fining Agent Regulations Labeling Implications

2. Required Allergen Labels • 1999 • Switzerland • 2002 • Australia • Japan • New Zealand • 2012 • Canada • EU • (required when present in the final food)

3. 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)

4. 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

5. 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

6. Exemptions • Australia, EU, New Zealand • Isinglass • Fish gelatin • Canada • Filtered wines

7. 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.

8. 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.

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

10. 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.

11. 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.

12. Comments Received • Objection to “contains” • May contain • Processed with • Produced using [allergen]. Traces may remain

13. OIV 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

14. FDA • 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

15. VEGAN • Vegan wine • Vegan friendly • Vegan symbol • “Certified vegan”: required documentation to be submitted with COLA application

16. List of wine treating materials approved pending rulemaking • http://www.ttb.gov/wine/wine_treating_materials.shtml

17. Contact 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)

18. Questions