plastic-material-food-contact

FCM and Articles Regulation, Annex I - Authorised Substances

EU. Union List of Authorised Substances: Annex I, Plastics Food Contact Regulation 10/2011/EU, as amended by Regulation 2020/1245/EU, 3 September 2020

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 23 September 2021. Database contains 1072 unique substances/entries.
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260-414-4
69226-44-4
736
50960
yes
no
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239-581-2
15535-79-2
618
51040
yes
no
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248-468-7
27458-90-8
660
47540
yes
yes
0.05 mg/kg
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272-489-0
68855-54-9
734
46380
yes
no
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251-136-4
32647-67-9
674
46480
yes
no
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207-312-8
461-58-5
340
47440
yes
no
60 mg/kg
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225-863-2
5124-30-1
485
15700
13560
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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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).
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203-872-2
111-46-6
263
47680
13326
15760
yes
no
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203-865-4
111-40-0
261
15790
no
no
5 mg/kg
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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.
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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.
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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 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.
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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 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.
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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.
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200-664-3
67-68-5
120
49540
yes
no
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203-542-8
108-01-0
230
16150
no
no
18 mg/kg
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260-829-0
57583-35-4
698
49595
yes
no
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247-862-6
26636-01-1
650
49600
yes
no
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219-702-5
2500-88-1
449
49840
yes
yes
0.05 mg/kg
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204-794-1
126-58-9
311
16480
51200
yes
no
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203-005-8
102-09-0
201
16540
no
no
0.05 mg/kg
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204-853-1
127-63-9
313
16650
51570
yes
no
3 mg/kg
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227-534-9
5873-54-1
490
16600
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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202-966-0
101-68-8
198
16630
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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246-770-3
25265-71-8
257
16660
13550
51760
yes
no
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203-821-4
110-98-5
257
16660
13550
51760
yes
no
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233-466-0
10191-41-0
110
93520
yes
no
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248-289-4
27176-87-0
658
52000
yes
no
30 mg/kg
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240-440-2
16389-88-1
623
52640
yes
no
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203-439-8
106-89-8
219
14570
16750
no
no
0.01 mg/kg
1 mg/kg in final product.
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204-009-2
112-84-5
271
52720
yes
no
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204-011-3
112-86-7
273
52730
yes
no
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200-578-6
64-17-5
113
52800
16780
yes
no
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200-815-3
74-85-1
125
16950
no
no
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202-510-0
96-49-1
177
16955
no
no
30 mg/kg
SML expressed as ethyleneglycol.
Residual content of 5 mg ethylene carbonate per kg of hydrogel with max 10 g of hydrogel in contact with 1 kg of food.
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251-073-2
32509-66-3
673
53670
yes
yes
6 mg/kg
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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.
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200-849-9
75-21-8
129
17020
no
no
0.01 mg/kg
1 mg/kg in final product.
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203-468-6
107-15-3
226
16960
15272
no
no
12 mg/kg
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200-449-4
60-00-4
111
53600
yes
no
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203-473-3
107-21-1
227
53650
16990
yes
no
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205-793-9
151-56-4
334
17005
no
no
0.01 mg/kg
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202-589-1
97-53-0
180
17160
no
no
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262-978-7
61788-47-4
703
17170
no
no
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269-657-0
68308-53-2
722
17200
no
no
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263-107-3
61790-12-3
706
17230
no
no
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200-579-1
64-18-6
114
55040
yes
no
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203-743-0
110-17-8
249
55120
17290
yes
no
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221-800-8
3238-40-2
1031
no
no
5 mg/kg
Only to be used as a monomer in the production of polyethylene furanoate.
The migration of the oligomeric fraction of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as furan-2,5-dicarboxylic acid).
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