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