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.

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Last updated 24 April 2024. Database contains 1080 unique substances/entries.
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Substance Name
EC No.
CAS No.
FCM No
Ref No.
Additive or PPA
FRF applicable
SML (mg/kg)
Restriction(s)
 
diatomaceous earth
612-383-7
61790-53-2
707
46375
yes
no
Details
fatty acids, tall oil
263-107-3
61790-12-3
706
17230
no
no
Details
acids, fatty, unsaturated (C18), dimers, non hydrogenated, distilled and non-distilled
500-148-0
61788-89-4
705
10599/91
10599/90A
no
no
Details
polyethyleneglycol ester of hydrogenated castor oil
1 - 6.5 moles ethoxylated
500-147-5
61788-85-0
704
77600
yes
no
Details
fatty acids, coco
262-978-7
61788-47-4
703
17170
no
no
Details
sorbitan tetrastearate
262-958-8
61752-68-9
702
87920
yes
no
Details
dimethyl carbonate
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
N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)hexamethylenediamine-1,2-dibromoethane, copolymer
-
61269-61-2
701
40160
yes
no
2.4 mg/kg
Details
acrylic acid, 2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5-methylbenzyl)-4-methylphenyl ester
262-634-6
61167-58-6
700
31520
yes
yes
6 mg/kg
Details
4,4'-dihydroxybenzophenone
210-288-1
611-99-4
359
15970
48720
yes
no
Details
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