Recycled Plastics in Contact with Food: FDAs Policy

1
Recycled Plastics in Contact with Food FDAs
Policy

• Kristina E. Paquette, Ph.D.
• U.S. FDA
• Center for Food Safety and Applied Nutrition
• Office of Premarket Approval
• Californias Rigid Plastic Packaging Container
  Law
• How Does It Impact You?
• San Diego, CA
• May 16, 2000

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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)

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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

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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

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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

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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

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Recommended Surrogates

• 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

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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

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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)

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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?

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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

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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

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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.go
  v/dms/opa-recy.html
• FDA is developing a regulation for recycled
  plastics that will codify the surrogate testing
  process

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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

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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

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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 Paper
  Recycling, Ch. 35, ACS Symposium Series 609,
  Washington American Chemical Society, 1995, pp.
  435-444.