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 24 April 2024. Database contains 1080 unique substances/entries.
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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
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
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
-
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
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
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
283-829-2
84731-70-4
1079
yes
no
0.05 mg/kg
Only to be used as an additive in poly(vinyl chloride) (PVC) at up to 25 % w/w in contact at room temperature or below with foods for which food simulants A or B are assigned in Table 2 of Annex III.
Details
219-348-1
2421-28-5
1083
no
no
0.05 mg/kg
Only to be used at up to 43 % (w/w) as a co-monomer in the production of polyimides for use in contact with foods for which only simulants B and/or D2 are laid down in table 2 of Annex III at temperatures up to 250 °C.
Details
200-405-4
58-95-7
1055
yes
no
Only to be used as antioxidant in polyolefins.
Details
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-
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).
Details

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