Introduction to Food Contact and the Food and Drug Administration

1. Introduction to Food Contact and the Food and Drug Administration Henry Su Monday, May 11, 2009 INTERNAL

2. Agenda • Introduction to FDA and Food Contact • Demonstrating Compliance • Registration Overview • Resources • Contact INTERNAL

3. Introduction to FDA and Food Contact • Any food additive should be deemed unsafe unless it is used in conformity with a regulation or notification issued by the FDA • Suppliers and manufacturers are ultimately held responsible for ensuring that the food contact substance and all of its components comply with the FDA’s requirements for safe use as indirect food additives INTERNAL

4. Introduction to FDA and Food Contact • FDA regulates “food additives”, substances which may become components of food by the intended use, either directly or indirectly • Direct food additive is added for a functional purpose, • colorant or antioxidant • Indirect food additive (called food contact substance) is introduced into food via food contact material and is not intended to have an effect on food • ink in a multi-layer lamination INTERNAL

5. Demonstrating Compliance • Listed on the 21 CFR (Code of Federal Regulations) • Listing for Food Contact Notification (FCN) • Listing for Threshold of Registration (TOR) • Generally Recognized as Safe (GRAS) • Prior Sanctions • Supplier’s Declaration of Compliance INTERNAL

6. Registration Overview – 21 CFR • Code of Federal Regulations • http://www.access.gpo.gov/nara/cfr/waisidx_03/21cfrv3_03.html • 21 CFR, Food and Drugs, Parts 174 – 182 • 21 CFR Part 175 – Adhesives and Components of Coatings • 21 CFR Part 176 – Paper and Paperboard • 21 CFR Part 177 – Polymers • 21 CFR Part 178 – Adjuvants, Production Aids and Sanitizers • Food Additive Petition (FAP) INTERNAL

7. Registration Overview – 21 CFR • § 176.180 Components of paper and paperboard in contact with dry food.The substances listed in this section may be safely used as components of the uncoated or coated food-contact surface of paper and paperboard intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding dry food of the type identified in § 176.170(c), table 1, under Type VIII, subject to the provisions of this section.(a) The substances are used in amounts not to exceed that required to accomplish their intended physical or technical effect, and are so used as to accomplish no effect in food other than that ordinarily accomplished by packaging.(b) The substances permitted to be used include the following: (1) Substances that by § 176.170 and other applicable regulations in parts 170 through 189 of this chapter may be safely used as components of the uncoated or coated food-contact surface of paper and paperboard, subject to the provisions of such regulation.(2) Substances identified in the following list: INTERNAL

8. Registration Overview – 21 CFR INTERNAL

9. Registration Overview – FCN • For a concentration in the daily diet from 0.5 ppb to 1 ppm • The Food Contact Notification process is the primary means for the FDA to authorize new uses of food additives that are Food Contact Substances (FCS). • A Food Contact Substance is defined as “any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have a technical effect in such food.” • Preparation of a “Notification for a New Use of a Food Contact Substance” or “FCN”– Form 3480 INTERNAL

10. Registration Overview – FCN • Effective after 120 days (if FDA does not object) • Withdrawal without prejudice • Proprietary for manufacturer / notifier and their customers • Not published in the 21 CFR, but on the FDA website • Limitations • for the notified production process only • “at use” concentration maximum in a substrate • food types • temperature conditions of use INTERNAL

11. Registration Overview – FCN • Information Requirements for FCN • Chemical Identity of the Food Contact Substance (FCS) • Manufacturing Information • Physical / Chemical Specifications • Intended Use • Stability Data (in the intended use) – decomposition products • Migration testing of the FCS • Dietary Concentration and Estimated Daily Intake (EDI calculations) • Toxicological and Environmental Information / Safety Assessment INTERNAL

12. Registration Overview – FCN TOR FCN FCN FAP Reproductive and Chronic toxicity in Rat and Dog Testing Requirements Subchronic Toxicity in Rat and Dog In vitro mutagenicity testing (2 studies) In vitro mutagenicity testing (2 studies) No tox studies required Valid Literature Data Acceptable Dietary Concentration < 50 ppb* < 0.5 ppb < 1 ppm >1 ppm * Total Dietary Concentration (DC) of all regulations INTERNAL

13. Registration Overview – FCN • Inventory of Effective Food Contact Substance (FCS) Notifications • http://www.foodsafety.gov/~dms/opa-fcn.html INTERNAL

14. Registration Overview – TOR 21 CFR §170.39 • For a concentration in the daily diet < 0.5 ppb • non-carcinogenic • no technical effect in food • no adverse impact on the environment • Requires submission to the FDA • Not proprietary • Not subject to the same 120-day review period as an FCN • Does not require toxicity testing beyond demonstration that the FCS is not carcinogenic – literature accepted INTERNAL

15. Registration Overview – TOR 21 CFR §170.39 • TOR confirmed by the FDA, and listed on the FDA website • http://www.cfsan.fda.gov/~dms/opa-torx.html INTERNAL

16. 21 CFR Part 182 – Substances Generally Recognized as Safe Pre- 1958 based on common use in food Common Knowledge of safety Some substances that are GRAS for use in food could be GRAS for use in packaging Self determination Registration Overview – GRAS 21 CFR §182 INTERNAL

17. Registration Overview – GRAS 21 CFR §182 • List of All GRAS Notices • http://www.cfsan.fda.gov/~rdb/opa-gras.html INTERNAL

18. Exist only for a specific use(s) of a substance in food, i.e., the level(s), condition(s), product(s), etc., for which there was explicit approval by the Food and Drug Administration or the United States Department of Agriculture prior to September 6, 1958. Tend to emerge in times of crisis, especially when the safety of GRAS or food additives is being challenged. Not “food additives” be definition Not subject to Delaney Clause Registration Overview – Prior Sanctions 21 CFR §181 INTERNAL

19. Food Contact in Canada • The Canadian legislation relating to the safety of food packaging materials, the Food and Drugs Act and Regulations, is administered by Canada's Health Products and Food Branch (HPFB). Division 23 of the regulations deals specifically with food packaging materials. • “No person shall sell any food in a package that may yield to its contents any substance that may be injurious to the health of a consumer for the food” • http://laws.justice.gc.ca/en/F-27/C.R.C.-c.870 INTERNAL

20. Food Contact in Canada • No statutory requirement for pre-market clearance of food packaging materials under Food and Drugs Act and Regulations. • No objection letter is an opinion by HPFB on acceptability of product in relation to B23.001. Does not constitute an approval and does not relieve food manufacturer of responsibilities under Division 23. • No list – positive or negative (versus Positive list in US) • 2 Submission categories: • Specific constituents/single additives • Formulated products and finished packaging materials or articles INTERNAL

21. Food Contact in Canada • Submission Requirements for Specific Constituent/Single Additive • Product Identity • Chemical name, formula, manufacturing process, purity specs, phys / chem properties • Proposed Usage • Technical effect or purpose, types of substrates, efficacy, types of foods, conditions of use • Migration/Extraction Data • Based on type of food – acidic, high/low alcoholic, fatty, aqueous • Toxicological Data • Data requirements based on exposure INTERNAL

22. Food Contact in Canada • Submission Requirements for Formulated Products/Finished Articles • Product Identity • Trade name and number • Structure (eg. laminate, etc) • Composition and Specifications • Phys / chem properties relative to proposed use • Proposed Usage • Form of finished package (eg. Bottle, film, casing, etc.) • Dimensions • Packaging ratio • Conditions to which article will be exposed • Estimate of projected market penetration INTERNAL

23. Food Contact in Canada • Unlike the FDA, there is no set review period • If a product meets US FDA clearances, industry can work with Health Products and Food Branch (HPFB) to obtain opinions for products and customer applications where required. • http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/index-eng.php • Strategy: • Utilize 120 day clock for Food Contact Notification with the FDA • Submit information to HPFB Canada and obtain no objection letter INTERNAL

24. Food Contact in BASF • Establish FDA Point of Contact • Regulatory Support for Food Contact in NAFTA • Establish Food Contact Program for BASF • NAFTA through PRCoE (Wyandotte) • Worldwide through Plastics Safety (Ludwigshaven) INTERNAL

25. Food Contact in BASF • Support through Product Regulatory Center of Expertise • Customer Inquiry • Compliance Check • Compliance Review • Feasibility Statement • Notifications • Resolving Noncompliance • Cross Contamination • Change Management • Change in Regulation INTERNAL

26. Food Contact in BASF • BASF Food Contact Process – DRAFT • Request Templates • Request for Notification – DRAFT • Request for Compliance Assessment – DRAFT • Project Rolling Document – DRAFT INTERNAL

27. Resources • 21 CFR • http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm • Inventory of Effective Food Contact Substance (FCS) Notifications • http://www.foodsafety.gov/~dms/opa-fcn.html • Numerical Listing of GRAS Notices • http://www.cfsan.fda.gov/~rdb/opa-gras.html • Cumulative Estimated Daily Intake / Acceptable Daily Intake Database • http://www.cfsan.fda.gov/~dms/opa-tedi.html • Threshold of Regulation Exemptions • http://www.cfsan.fda.gov/~dms/opa-torx.html • Definitions of Food Types and Conditions of Use for Food Contact Substances • http://www.cfsan.fda.gov/~rdb/opa-fcn3.html INTERNAL

28. Contacts INTERNAL

29. Questions? Thank You for Your Attention! INTERNAL