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USA: FDA issues decisions on Phthalates in food contact materials

JUNE 2022 - ELECTRICAL AND ELECTRONICS, HARDLINES, TOYS AND CHILDREN'S PRODUCTS

On 19 May 2022, the U.S. Food and Drug Administration (FDA) issued a final rule1 to update its food additive regulations related to the use of certain phthalates in food contact applications. 

Considering the most previously-authorised phthalates are no longer used as food additives due to abandonment by industry, the FDA revoked authorisations for the food contact use of twenty-three (23) phthalates and two (2) other substances used as plasticizers, adhesives, defoaming agents, lubricants, resins, and slimicides, and determined diallyl phthalate (CAS no. 131-17-9) is only authorised for use in these regulations as a monomer in the manufacture of polymers and not as a plasticiser.

The FDA also denied petitions which requested

  • the removal of all clearance for phthalates used in food contact applications,
  • a ban on the use of eight (8) phthalates that remain on the food additive list, and revocation of the prior sanctioned authorisations.

The twenty-five (25) phthalates subject to the final rule are:

  1. Dimethyl phthalate (dimethyl orthophthalate) (CAS no. 131-11-3)
  2. Diphenyl phthalate (CAS no. 84-62-8)
  3. Methyl phthalyl ethyl glycolate (1,2-Benzenedicarboxylicacid, 1-(2-ethoxy-2-oxoethyl) 2-methyl ester) (CAS no.  85-71-2)
  4. Diethyl phthalate (CAS no. 84-66-2)
  5. Diphenylguanidine phthalate (CAS no. 17573-13-6)
  6. Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl phthalate) (CAS no. 84-72-0)
  7. Diisobutyl phthalate (CAS no. 84-69-5)
  8. Butyl benzyl phthalate (CAS no. 85-68-7)
  9. Di-n-butyl phthalate (CAS no. 84-74-2)
  10. Butyl phthalyl butyl glycolate 4 (Butyl carbobutoxymethyl phthalate) (CAS no. 85-70-1)
  11. Dihexyl phthalate (Di-n-hexyl phthalate) (CAS no. 84-75-3)
  12. Di(butoxyethyl) phthalate (Bis(2-n-butoxyethyl) phthalate) (CAS no. 117-83-9)
  13. Dimethylcyclohexyl phthalate (CAS no. 1322-94-7)
  14. Diisooctyl phthalate (CAS no. 27554-26-3)
  15. Dioctyl phthalate (Di-n-octyl phthalate) (CAS no. 117-84-0)
  16. Butyloctyl phthalate (n-butyl n-octyl phthalate) (CAS no. 84-78-6)
  17. Di(2-ethylhexyl) hexahydrophthalate (CAS no. 84-71-9)
  18. Amyl decyl phthalate (n-amyl n-decyl phthalate) (CAS no. 7493-81-4)
  19. Butyl decyl phthalate (n-butyl n-decyl phthalate) (CAS no. 89-19-0)
  20. Decyl octyl phthalate (Octyldecyl phthalate/n-octyl n-decyl phthalate) (CAS no. 119-07-3)
  21. Didecyl phthalate (Di-n-decyl phthalate) (CAS no. 84-77-5)
  22. Dodecyl phthalate (CAS no. 21577-80-0)
  23. Dihydroabietyl phthalate (CAS no. 26760-71-4)
  24. Castor oil phthalate with adipic acid and fumaric acid-diethylene glycol (CAS no. 68650-73-7)
  25. Castor oil phthalate, hydrogenated (CAS no. not available)

This action removed these phthalates from the list of substances authorised in the following FDA regulations:

  • 21 CFR 175.105 Adhesive
  • 21 CFR 176.300 Resinous and polymeric coating
  • 21 CFR 176.320 Resinous and polymeric coatings for polyolefin films
  • 21 CFR 175.380 Xylene-formaldehyde resins condensed with 4,4’-isopropylidenediphenol-epichlorohydrin epoxy resins
  • 21 CFR 175.390 Zinc-silicon dioxide matrix coatings
  • 21 CFR 176.170 Components of paper and paperboard in contact with aqueous and fatty foods
  • 21 CFR 176.180 Components of paper and paperboard in contact with dry food
  • 21 CFR 176.300 Slimicides
  • 21 CFR 177.1010 Acrylic and modified acrylic plastics, semirigid and rigid
  • 21 CFR 177.1200 Cellophane
  • 21 CFR 177.1210 Closures with sealing gaskets for food containers
  • 21 CFR 177.1440 Hydroxyethyl cellulose film, water-insoluble
  • 21 CFR 177.1460 Melamine-formaldehyde resins in molded articles
  • 21 CFR 177.1590 Polyester elastomers
  • 21 CFR 177.2420 Polyester resins, cross-linked
  • 21 CFR 177.2600 Rubber articles intended for repeated use
  • 21 CFR 178.3740 Plasticizers in Polymeric Substances
  • 21 CFR 178.3910 Surface lubricants used in the manufacture of metallic articles

This action results in limiting the use of phthalates in food contact applications to nine (9) phthalates – eight (8) authorised for use as plasticisers and one (1) authorised for use as a monomer.

On 20 May 2022, the Agency published a request for information2 on the current specific uses, usage levels, dietary exposures, and safety data for the remaining eight (8) phthalates that are still authorised as plasticisers for use in food contact applications through either as food additive regulation or a prior-sanctioned use. The request for information does not include the phthalate authorised for use as a monomer since any exposure resulting from this use is expected to be negligible. Comments must be submitted by 19 July 2022.

The eight (8) phthalates are:

  1. Diisononyl phthalate (DINP, CAS no. 28553-12-0)
  2. Diisodecyl phthalate (DIDP, CAS no.  26761-40-0)
  3. Di(2-ethylhexyl) phthalate (DEHP, CAS no. 117-81-7)
  4. Dicyclohexyl phthalate (DCHP, CAS no. 84-61-7)
  5. Butylphthalyl butyl glycolate (BPBG, CAS no. 85-70-1)
  6. Diethyl phthalate (DEP, CAS no. 84-66-2)
  7. Ethylphthalyl ethyl glycolate (EPEG, CAS no. 84-72-0)
  8. Diisooctyl phthalate (DIOP, CAS no. 27554-26-3)

 

[1]  Final rule on the petitions, Federal Register

[2]  Phthalates for Food Contact Use; Request for Information

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