AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA or we) is amending the food additive regulations to no longer provide for the use of 25 plasticizers in various food contact applications because these uses have been abandoned. We are taking this action in response to a food additive petition submitted by the Flexible Vinyl Alliance (FVA or petitioner).

DATES:

This rule is effective May 20, 2022. See section VIII for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing on the final rule by June 21, 2022.

ADDRESSES:

You may submit objections and requests for a hearing as follows. Please note that late, untimely filed objections will not be considered. Electronic objections must be submitted on or before June 21, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 21, 2022. Objections received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

25 plasticizers

1) Dimethyl phthalate (dimethyl orthophthalate)

2) Diphenyl phthalate

3) Methyl phthalyl ethyl glycolate (1,2-Benzenedicarboxylicacid, 1-(2-ethoxy-2-oxoethyl) 2-methyl ester)

4) Diethyl phthalate

5) Diphenylguanidine phthalate

6) Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl phthalate)

7) Diisobutyl phthalate

8) Butyl benzyl phthalate

9) Di-n-butyl phthalate

10) Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl phthalate)

11) Dihexyl phthalate (Di-n-hexyl phthalate)

12) Di(butoxyethyl) phthalate (Bis(2-n-butoxyethyl) phthalate)

13) Dimethylcyclohexyl phthalate

14) Diisooctyl phthalate

15) Dioctyl phthalate (Di-n-octyl phthalate)

16) Butyloctyl phthalate (n-butyl n-octyl phthalate)

17) Di(2-ethylhexyl) hexahydrophthalate

18) Amyl decyl phthalate (n-amyl n-decyl phthalate)

19) Butyl decyl phthalate (n-butyl n-decyl phthalate)

20) Decyl octyl phthalate (Octyldecyl phthalate/n-octyl n-decyl phthalate)

21) Didecyl phthalate (Di-n-decyl phthalate)

22) Dodecyl phthalate

23) Dihydroabietyl phthalate

24) Castor oil phthalate, hydrogenated

25) Castor oil phthalate with adipic acid and fumaric acid-diethylene glycol