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 21 January 2022. Database contains 1072 unique substances/entries.
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200-664-3
67-68-5
120
49540
yes
no
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-
-
12
31328
yes
no
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200-662-2
67-64-1
119
30295
yes
no
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-
-
118
81882
23830
yes
no
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200-661-7
67-63-0
118
23830
81882
yes
no
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200-659-6
67-56-1
117
21550
no
no
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-
-
117
21550
no
no
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200-618-2
65-85-0
116
37600
13090
yes
no
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-
-
116
37600
13090
yes
no
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-
-
115
30000
10090
yes
no
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200-580-7
64-19-7
115
10090
30000
yes
no
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200-579-1
64-18-6
114
55040
yes
no
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-
-
114
55040
yes
no
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200-578-6
64-17-5
113
16780
52800
yes
no
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-
-
113
52800
16780
yes
no
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200-470-9
60-33-3
112
64015
yes
no
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-
-
112
64015
yes
no
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200-449-4
60-00-4
111
53600
yes
no
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-
-
111
53600
yes
no
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233-466-0
10191-41-0
110
93520
yes
no
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200-412-2
59-02-9
110
93520
yes
no
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-
-
110
93520
yes
no
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-
-
11
30960
yes
no
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-
-
109
23740
81840
yes
no
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200-338-0
57-55-6
109
81840
23740
yes
no
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200-334-9
57-50-1
108
24880
no
no
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-
-
1077
yes
no
Only to be used at up to 25.0 % w/w, including in the nanoform.
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843-672-8
1227937-46-3
1076
yes
no
0.05 mg/kg
Only to be used as an additive at up to 0.2 % w/w in high impact polystyrene materials and articles intended contact with food at room temperature and below, including hot-fill and/or heating up to 100 ° C for up to 2 hours. It shall not be used in contact with foods for which simulant C and/or D1 is assigned in Annex III.
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-
-
1075
yes
no
Only to be used as additive at up to 4.0 % w/w in polylactic acid plastics intended for long-term storage of water at ambient temperature or below. Can form platelets in the nanoform that are in one or two dimensions thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.
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200-315-5
57-13-6
107
25960
no
no
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200-857-2
75-28-5
1069
yes
no
Only to be used as a blowing agent.
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219-784-2
2530-83-8
1068
no
no
Only to be used as a component of a sizing agent to treat glass fibres to be embedded in glass-fibre-reinforced low diffusivity plastics (polyethylene terephthalate (PET), polycarbonate (PC), polybutylene terephthalate (PBT), thermoset polyesters and epoxy bisphenol vinylester) in contact with all foodstuffs. In treated glass fibres, residues of the substance must not be detectable at 0,01 mg/kg for the substance and 0,06 mg/kg for each of the reaction products (hydrolysed monomers and epoxy-containing cyclic dimer, trimer and tetramer).
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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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-
23985-75-3
1066
no
no
0.05 mg/kg
Only to be used as a co-monomer in the manufacture of a polyester non-food contact layer in a plastic multilayer material, which is to be used only in contact with foods for which food simulants A, B, C and/or D1 are assigned in Table 2 of Annex III.
The specific migration limit in column 8 refers to the sum of the substance and of its dimers (cyclic and open chain).
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288-287-0
85711-28-0
1065
yes
no
5 mg/kg
Only to be used in the manufacture of articles made of polyolefins, and which do not come into contact with foods for which food simulant D2 is assigned in Table 2 of Annex III.
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254-413-8
39318-18-8
1064
yes
no
0.05 mg/kg
Stoichiometry: WOn, n = 2,72-2,90.
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-
1547-26-8
1063
no
no
Only to be used together with tetrafluoroethylene and/or ethylene co-monomers to manufacture fluorocopolymers for application as polymer processing aid at up to 0,2 % w/w of the food contact material, and when the low-molecular mass fraction below 1 500 Da in the fluorocopolymer does not exceed 30 mg/kg.
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-
-
1062
no
no
Only to be used for the production of recycled PET and at up to 0,12 % (w/w).
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813-638-7
80512-44-3
1061
no
no
Only to be used as a comonomer in the manufacture of polyether ether ketone plastics up to 0,3 % w/w of the final material.
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-
-
1060
yes
no
Only to be used at room temperature or below in contact with foods for which Table 2 of Annex III assigns food simulant E.
The seed hulls shall be obtained from sunflower seeds that are fit for human consumption.
The processing temperature of the plastic containing the additive shall not exceed 240 °C.
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200-313-4
57-11-4
106
89040
24550
yes
no
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-
-
106
24550
89040
yes
no
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-
147398-31-0
1059
no
no
Only to be used either alone or blended with other polymers in contact with all foods under contact conditions of up to 6 months and/or 6 months and more, at room temperature or below, including hot fill or a short heating up phase.
The migration of all oligomers with a molecular weight below 1 000 Da shall not exceed 5,0 mg/kg food.
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257-757-7
7695-91-2
1055
yes
no
Only to be used as antioxidant in polyolefins.
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200-405-4
58-95-7
1055
yes
no
Only to be used as antioxidant in polyolefins.
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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.
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485-230-3
1455-42-1
1052
no
no
5 mg/kg
Only to be used as a monomer in the production of polyesters.
The migration of oligomers of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as SPG).
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NYLOSTAB S-EED; NYSEED
419-710-0
42774-15-2
1051
yes
no
5 mg/kg
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215-222-5
1314-13-2
1050
yes
no
Only to be used in unplasticised polymers.
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200-312-9
57-10-3
105
22780
70400
yes
no
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