FCN 772 Legal and Regulatory Aspects

1. FCN 772Legal and Regulatory Aspects May 5, 2008 Martha Marrapese Partner Keller and Heckman LLP 1001 G St, NW Suite 500 Washington, DC 20001 202-434-4123 marrapese@khlaw.com www.khlaw.com Washington, D.C. ● Brussels ● San Francisco ● Shanghai

2. Legal Framework • A food additive is defined as a substance that is “reasonably expected to become a component of food under the intended conditions of use” • Considered “unsafe” unless it is used in accordance with an applicable food additive regulation or clearance • Uncleared food additives are automatically unsafe and adulterated

3. A UV/EB Coating, Adhesive, Or Ink Complies With The Act If : • Its use complies with an existing food additive regulation, e.g., 21 CFR § 176.170, 21 CFR § 178.3297 or FCN; • Its components are the subject of a prior FDA or United States Department of Agriculture (USDA) sanction or approval prior to 1958; • Its components are deemed GRAS; or • It is not reasonably expected to become a component of food, based on appropriate extraction studies or equivalent data

4. Subsets of “No Migration” • All depend on intended conditions of use and migration calculations or data - Functional Barrier - Basic Resin Doctrine - Housewares

5. Legal Framework, cont. • Food Contact Notification (FCN) • Pre-market notification to FDA • Information supporting the conclusion that the substance is safe for the intended use(s) • If no objection within 120 days, the submitter may market the product

6. FCNs, cont. • FCNs are proprietary to notifier identified in filing • Customers may rely on supplier’s notification • FDA issues a letter to the notifier stating that the notification is effective • Notifications will not appear in CFR or Federal Register; FDA lists effective FCNs on its web site

7. Food Packaging AllianceIn Plain Terms A formulator may combine the Alliance FCN materials with already FDA sanctioned components to offer inks, coatings, and adhesives suitable for food packaging, in many cases without having to obtain additional clearances.

8. Examples of Useful Clearances • Can coatings • 21 CFR § 175.300 (pertaining to metal substrates or repeated use applications) • Paper coatings • 21 CFR § 176.170 and/or 21 CFR §176.180 • Films • Polyolefins described in 21 CFR § 177.1520(c)2.2 or 3.2a may be used in cooking • Polyolefins in 21 CFR 177.1520(c)2.1 or (c)3.1a are only permitted for non-cooking applications • 21 CFR § 175.320 lists cleared resinous and polymeric coatings for polyolefin films • Inks • Many ink components can be found in 21 CFR § 178.3297 (Colorants for polymers) • Or, if used in paper applications, under 21 CFR § 76.170

9. What is the Food Contact Substance? • A mixture of one or more of • TPGDA • TMPTA • TMPEOTA • BADGEDA • optionally containing ESACURE ONE • Cleared effective March 7, 2008

10. What are the Cleared Conditions of Use? A - High temperature heat-sterilized (e.g.,over 212°F) B - Boiling water sterilized C - Hot filled or pasteurized above 150°F D - Hot filled or pasteurized below 150°F E - Room temperature filled and stored (no thermal treatment in the container) F - Refrigerated storage (no thermal treatment in the container) G - Frozen storage (no thermal treatment in the container) H - Frozen or refrigerated storage: Ready-prepared foods intended to be reheated in container at time of use

11. What types of packaging? • Food contact layers and non-food contact layers • To be used as coatings (including inks) or components of coatings (including inks) on • Polymeric substrates • Paper and paperboard • Metal substrates, or • as a component in Adhesives.

12. Who can use the Clearance? • Only companies listed in FCN 772 as the notifiers and their customers may rely on the clearance to manufacture food packaging materials • The acrylates and photoinitiator must be supplied by an FCN-listed company • Competitors must file their own FCNs

13. What Information is Public? • Identity of Food Contact Substances (FCS) • Identity of the Notifiers • Intended conditions of use • Maximum use level • Types of food that may contact the FCS

14. What to Tell Customers? • Some consumer product end users insist on seeing an FDA listing or regulation • Reference FCN 772: • “This product is cleared for broad use in food packaging by FCN 772, with a maximum extraction level of 10 μg/in2 for the substance and 10 μg/in2 for total extractables (TE). See http://www.cfsan.fda.gov/~dms/opa-fcn.html”

15. What is the Maximum Limit? • 10 μg/in2 per acrylate, for the photoinitiator, and for total extractables (TE) • Example: Assume making a UV-cured food-contact surface • TMPTA and TMPEOTA as monomers • ESACURE ONE as photoinitiator • Also use an antioxidant suitably cleared under 21 CFR • The resin is cured as a coating on a polyolefin film

16. Example, cont. • Run end-test using testing conditions required for intended use: • TMPTA 5 μg/in2 (0.5 ppm) • TMPEOTA 7 μg/in2 (0.7 ppm) • ESACURE ONE 4 μg/in2 (0.4 ppm) • Total Extractables (TE) 25 μg/in2 (2.5 ppm) • This meets end-test requirements because 25μg/in2-5μg/in2-7μg/in2-4μg/in2 = 9μg/in2 TE

17. What Verification is Needed? • Extraction test and analysis in FCN • Protocol is proprietary RadTech Alliance Members and customers • Can another method be used? • Yes, if equivalent • How often do you have to test? • As often as necessary. E.g., initially, six months, any process changes • Who tests? • The company that is using the product

18. When Is a New FCN Required? • If substance made by different manufacturer/notifier than identified in FCN • New conditions or levels of use (NEW FCN, not amendment of old) • When specifications of FCS substantively change • When changes made in manufacture that substantively change: - Product identity - Purity profile - Good Manufacturing Practices (GMP) changes

19. Can the FCN be Transferred/Assigned? • E.g., Notifier undergoes company name change (acquisition, corporate reorganization, etc.), or Notifier uses toll manufacturer or subsidiary for manufacture - no new FCN needed, providing process and chemical identity submitted stays the same • For transfer, submit letter to FDA requesting modification of FCN website list to reflect new company name

20. What to do When you Suspect a Non-FCN Supplied Material? • Uncleared food additives are automatically unsafe and adulterated • After food has been packaged, can lead to claims for direct damages (the value of the packaged food) far out of proportion to the value of the packaging materials themselves. • Also additional consequential or incidental damages such as loss of future sales from damage to a brand's reputation with consumers. • Bottom line: if there is a problem, the damages can add up fast

21. Enforcement, cont. • FDA’s actions can include issuing a warning letter, requesting a recall of affected products, requiring a recall if potential exposure is harmful enough, and issuing a fine. • What action FDA will take depends upon the safety implications raised by the uncleared additive. • The person may inform the company of its suspicion to seek clarification for the purpose of determining if additional action is warranted, such as informing FDA of the suspected activity.

22. How to Build on FCN 772? • Alliance members and their customers can reference the Alliance FCN in new FCN filings • Less additional effort to obtain clearance for an uncleared component in a new proprietary formulation

23. Thank you! Martha Marrapese Partner Keller and Heckman LLP 1001 G St, NW Suite 500 Washington, DC 20001 202-434-4123 marrapese@khlaw.com www.khlaw.com Washington, D.C. ● Brussels ● San Francisco ● Shanghai