plastic-material-food-contact

FCM and Articles Regulation, Annex I - Authorised Substances

EU. Union List of Authorized Substances: Annex I, Plastics Food Contact Regulation 10/2011/EU, as amended by Regulation (EU) 2023/1627, OJ L 201, 11 August 2023

This list contains the Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids. It is taken from Annex I of the Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.

Last updated 19 April 2024. Database contains 1080 unique substances/entries.
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29204-02-2
667
55190
yes
no
Details
203-743-0
110-17-8
249
55120
17290
yes
no
Details
200-579-1
64-18-6
114
55040
yes
no
Details
200-001-8
50-00-0
98
17260
54880
yes
no
Details
263-107-3
61790-12-3
706
17230
no
no
Details
269-657-0
68308-53-2
722
17200
no
no
Details
262-978-7
61788-47-4
703
17170
no
no
Details
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-
1053
yes
no
Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.
Details
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-
37
54480
yes
no
Details
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-
36
54450
yes
no
Details
202-589-1
97-53-0
180
17160
no
no
Details
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-
35
54280
yes
no
Details
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-
34
54270
yes
no
Details
618-385-4
9004-58-4
556
54260
yes
no
Details
203-473-3
107-21-1
227
53650
16990
yes
no
Details
200-449-4
60-00-4
111
53600
yes
no
Details
429-840-1
24937-78-8
969
yes
no
Only to be used as a polymeric additive up to 2 % w/w in polyolefins.
The migration of low molecular weight oligomeric fraction below 1 000 Da shall not exceed 5 mg/kg food.
Details
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5136-44-7
486
54005
yes
no
Details
210-826-5
624-03-3
1048
yes
no
Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.
Details
200-815-3
74-85-1
125
16950
no
no
Details
618-384-9
9004-57-3
555
53280
yes
no
Details
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37205-99-5
682
53270
yes
no
Details
200-578-6
64-17-5
113
52800
16780
yes
no
Details
204-011-3
112-86-7
273
52730
yes
no
Details
204-009-2
112-84-5
271
52720
yes
no
Details
240-440-2
16389-88-1
623
52640
yes
no
Details
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287916-86-3
871
yes
no
Only to be used in polyolefins at levels of up to 20 weight %. These polyolefins shall only be used in contact with foods for which Table 2 of Annex III assigns food simulant E, at ambient temperature or below, and when migration of the total oligomeric fraction of less than 1 000 Da does not exceed 50 µg/kg food.
Details
233-466-0
10191-41-0
110
93520
yes
no
Details
246-770-3
25265-71-8
257
16660
13550
51760
yes
no
Details
203-821-4
110-98-5
257
16660
13550
51760
yes
no
Details
202-966-0
101-68-8
198
16630
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
227-534-9
5873-54-1
490
16600
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
626-593-1
4128-73-8
476
16570
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
204-794-1
126-58-9
311
51200
16480
yes
no
Details
247-862-6
26636-01-1
650
49600
yes
no
Details
260-829-0
57583-35-4
698
49595
yes
no
Details
200-664-3
67-68-5
120
49540
yes
no
Details
210-478-4
616-38-6
1067
no
no
Only to be used: a) with 1,6-hexanediol in the manufacture of polycarbonate pre-polymers that are used at up to 30 % to manufacture thermoplastic polyurethanes with 4,4'-methylenediphenyldiisocyanate and diols, such as polypropylene glycol and 1,4-butanediol. The resulting material shall only be applied in repeated use articles intended to come into short-term contact (≤ 30 min at room temperature) with food for which simulants A and/or B are assigned in Table 2 of Annex III; or b) for the production of other polycarbonates and/or under other conditions provided that the migration of dimethyl carbonate does not exceed 0,05 mg/kg food and that the migration of all polycarbonate oligomers with a molecular weight below 1 000 Da together does not exceed 0,05 mg/kg food.
Details
249-079-5
28553-12-0
728
75100
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product.
Not to be used in combination with FCM substances 157, 159, 283, or 1085.
Details
249-079-5
28553-12-0
728
75100
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product.
Not to be used in combination with FCM substances 157, 159, 283, or 1085.
Details
247-977-1
26761-40-0
729
75105
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product.
Details
247-977-1
26761-40-0
729
75105
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product.
Details
203-872-2
111-46-6
263
47680
13326
15760
yes
no
Details
213-551-9
976-56-7
1007
no
no
Only to be used up to 0,2 % w/w based on the final polymer weight in the polymerisation process to manufacture poly(ethylene terephthalate) (PET) and poly(ethylene 2,5-furandicarboxylate) (PEF)
Details
225-863-2
5124-30-1
485
15700
13560
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
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26427-07-6
649
47210
yes
no
Molecular unit = (C8H18S3Sn2)n (n = 1,5-2).
Details
251-136-4
32647-67-9
674
46480
yes
no
Details
272-489-0
68855-54-9
734
46380
yes
no
Details
612-383-7
61790-53-2
707
46375
yes
no
Details
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-
33
51120
yes
no
Details

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