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FDA Limits the Use of Certain Phthalates in Food Packaging and Issues Request for Information About Current Food Contact Uses and Safety Data

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)

Check here for more information.


Xuechen Wang

Regulatory Manager at Chemycal

Antwerp, Belgium

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