1 / 17

Recycled Plastics in Contact with Food: FDA’s Policy

Recycled Plastics in Contact with Food: FDA’s Policy. Kristina E. Paquette, Ph.D. U.S. FDA Center for Food Safety and Applied Nutrition Office of Premarket Approval California’s Rigid Plastic Packaging Container Law: How Does It Impact You? San Diego, CA May 16, 2000.

peter-mendez
Download Presentation

Recycled Plastics in Contact with Food: FDA’s Policy

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Recycled Plastics in Contact with Food: FDA’s Policy Kristina E. Paquette, Ph.D. U.S. FDA Center for Food Safety and Applied Nutrition Office of Premarket Approval California’s Rigid Plastic Packaging Container Law: How Does It Impact You? San Diego, CA May 16, 2000

  2. Legal Considerations • Food, Drug, and Cosmetic Act Section 409 • 21 CFR 177 Polymers • §174 Indirect Food Additives: General What is the purity suitable for the intended use? §174.5(a)(2)

  3. “Points to Consider” Guidance for Use of Recycled Plastics • Sourcing of post-consumer resin • Recycling process • Use of an effective barrier • Surrogate contaminant testing • “Points to Consider” available at: http://www.cfsan.fda.gov/~dms/opa-cg3b.html

  4. Sourcing of Post-Consumer Resin (PCR) PCR must comply with 21 CFR 177 Polymers • PCR from previous food-contact uses • bottle-bill collection • curbside recycling collection with appropriate sorting • PCR from previous non-food uses

  5. Recycling Process • Primary processing In-house plant trim • Secondary or physical processing • Grinding and washing • Melting and reforming • Tertiary or chemical processing • Depolymerization • Purification of regenerated chemicals • Cannot use unregulated substances

  6. Use of an Effective Barrier • Effective barrier between recycled material and food = Not a food-contact situation for recycled layer • Effective barriers: • Glass • Metal, metal foils •  1-mil thick PET at room temp and below • Any substance that limits migration of outer-layer components to 0.5 ppb dietary concentration

  7. Surrogate Contaminant Testing • Contaminate (“challenge”) virgin resin with surrogate cocktail • Run challenged resin through recycling process • Measure amount of surrogates remaining in resin after recycling • Dietary concentration of each surrogate must not exceed 0.5 ppb • Assume 100% migration • Migration tests or modeling

  8. Volatile polar Chloroform Non-volatile polar Benzophenone or Lindane Organometallic Copper(II) 2-ethylhexanoate Volatile non-polar Toluene Non-volatile non-polar Tetracosane or Methyl stearate Recommended Surrogates

  9. Maximum Surrogate Level Allowed in Finished Recycled Resin DC  10 g food/in2 CR = ------------------------- RMS CF CR = surrogate conc. in finished resin DC = allowed dietary concentration RMS = mass-to-surface area ratio of resin (g/in2) CF = consumption factor for polymer • Assumes 100% migration and 100% recycled content

  10. Example Calculation for PET • DC = 0.5 g/kg (ppb) • RMS = 0.46 g/in2 (density = 1.4 g/cm3, thickness = 20 mils) • CF = 0.05 for polyesters •  CR = 215 g/kg (ppb)

  11. Food vs. Non-Food Containers • PCR must comply with 21 CFR 177 Polymers • “Points to Consider” cover post-consumer contamination of food containers • Expose bottles or flake to surrogate cocktail for 2 weeks at 40o C • Do these conditions cover containers intended for non-food applications?

  12. Case Study: Non-Food PET • All rigid PET containers comply with 21 CFR 177.1630 or 177.1315 • Starting levels of surrogate contaminants in challenged PET flake can be no less than modeled sorption levels Assumptions used in modeling: • 1-L PET bottles • 10% w/w surrogate solutions in water • 365 days at 25o C

  13. Minimum Surrogate Levels in Challenged PET Flake to Allow Use of Non-Food PET Chloroform 4860 mg/kg Toluene 1000 mg/kg Lindane 750 mg/kg Tetracosane 154 mg/kg Benzophenone 49 mg/kg Copper(II) 49 mg/kg

  14. Administrative • Currently, FDA issues opinion letters to recyclers who submit surrogate testing data • For a list of all plastics recycling opinion letters issued by FDA, see http://www.cfsan.fda.gov/~dms/opa-recy.html • FDA is developing a regulation for recycled plastics that will codify the surrogate testing process

  15. Opinion Letter Statistics as of December 1, 1999 • PET 36 • Secondary 26 • Tertiary 10 • HDPE 7 • PS 12 • PE or PP 2 • PEN (tertiary) 1 • Other 1 Total 59

  16. Summary • Legal Considerations • “Points to Consider” Guidance • Sourcing of PCR • Recycling Process • Effective Barrier • Surrogate Testing • Use of Non-Food PCR • Administrative • Opinion letters • Regulation being developed

  17. Useful References • Kuznesof, P.M., and M.C. VanDerveer, “Recycled Plastics for Food-Contact Applications,” in Plastics, Rubber, and Paper Recycling, Ch. 32, ACS Symposium Series 609, Washington: American Chemical Society, 1995, pp. 389-403. • Begley, T.H., and H.C. Hollifield, “Food Packaging Made from Recycled Polymers,” in Plastics, Rubber, and Paper Recycling, Ch. 36, ACS Symposium Series 609, Washington: American Chemical Society, 1995, pp. 445-457. • Komolprasert, V. and A. Lawson, “Residual Contaminants in Recycled Poly(ethylene terephthalate),” in Plastics, Rubber, and PaperRecycling, Ch. 35, ACS Symposium Series 609, Washington: American Chemical Society, 1995, pp. 435-444.

More Related