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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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Showing 1,051 - 1,080 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
polyethyleneglycol monoricinoleate	618-404-6	9004-97-1	563	78320	yes	yes	42 mg/kg		Details
polyethyleneglycol sorbitan monopalmitate	618-421-9	9005-66-7	570	79200	yes	no			Details
polyethyleneglycol sorbitan trioleate	618-422-4	9005-70-3	572	79360	yes	no			Details
polyethyleneglycol sorbitan tristearate	618-424-5	9005-71-4	573	79440	yes	no			Details
polyethyleneglycol tridecyl ether phosphate	618-558-4	9046-01-9	578	79600	yes	no	5 mg/kg	For materials and articles intended for contact with aqueous foods only. Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether.	Details
polyethyleneglycol-30 dipolyhydroxystearate	680-598-3	70142-34-6	737	77370	yes	no			Details
polyglycerol	607-759-2	25618-55-7	1017		yes	no		To be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C.	Details
polyglycerol ricinoleate	608-428-5	29894-35-7	668	80240	yes	no			Details
polypropylene wax	618-352-4	9003-07-0	550	81060	yes	no			Details
polyvinylpyrrolidone	618-363-4	9003-39-8	552	81500	yes	no		The substance shall meet the purity criteria as laid down in Commission Directive 2008/84/EC [OJ L 253, 20.9.2008, p. 1.].	Details
pyrophyllite	602-803-7	12269-78-2	603	83460	yes	no			Details
starch, hydrolysed	686-629-7	68412-29-3	723	88880	yes	no			Details
α-alkenes(C20-C24) copolymer with maleic anhydride, reaction product with 4-amino-2,2,6,6-tetramethylpiperidine	604-838-3	152261-33-1	803	33535	yes	no		Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. Not to be used in contact with alcoholic foods.	Details
α-dimethyl-3-(4'-hydroxy-3'-methoxyphenyl)propylsilyloxy, ω-3-dimethyl-3-(4'-hydroxy-3'-methoxyphenyl) propylsilyl polydimethylsiloxane	641-029-4	156065-00-8	874	16265	no	no	0.05 mg/kg	Only to be used as comonomer in siloxane modified polycarbonate. The oligomeric mixture shall be characterised by the formula C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).	Details
α-dimethyl-3-(4'-hydroxy-3'-methoxyphenyl)propylsilyloxy, ω-3-dimethyl-3-(4'-hydroxy-3'-methoxyphenyl) propylsilyl polydimethylsiloxane	641-029-4	156065-00-8	874	16265	no	no		Only to be used as comonomer in siloxane modified polycarbonate. The oligomeric mixture shall be characterised by the formula C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).	Details
perfluoro[(2-ethyloxy-ethoxy)acetic acid], ammonium salt	700-323-3	908020-52-0	926	71955	yes	no		Only to be used in the polymerisation of fluoropolymers that are processed at temperatures higher than 300 °C for at least 10 minutes.	Details
phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters	700-485-5	939402-02-5	974	74050	yes	yes	10 mg/kg	SML expressed as the sum of the phosphite and phosphate forms of the substance, 4-tert-amylphenol and 2,4-di-tert-amylphenol.	Details
phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters	700-485-5	939402-02-5	974	74050	yes	yes	1 mg/kg	The migration of 2,4-di-tert-amylphenol shall not exceed 1 mg/kg food.	Details
poly(zinc glycerolate)	700-107-9	87189-25-1	751	81515	yes	no			Details
2,4,4'-trifluorobenzophenone	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.	Details
hydromagnesite	811-989-0	12072-90-1	600	60030	yes	no			Details
manganese hydroxide	882-488-2	12626-88-9	606	65200	yes	no			Details
Phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly [oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters	843-672-8	1227937-46-3	1076		yes	no	0.05 mg/kg	Only to be used (a)as an additive at up to 0.2 % w/w in high impact polystyrene materials and articles intended for 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; (b)as an additive at up to 0.025 % w/w in acrylonitrile-butadiene-styrene (ABS) materials for use at room temperature and below.	Details
polyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-hexanol	843-673-3	73018-26-5	797	76807	yes	yes			Details
polyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-hexanol	843-673-3	73018-26-5	797	76807	yes	yes			Details
STYRENE, POLYMER WITH 1,3-BUTADIENE, BUTYL ACRYLATE AND METHYL METHACRYLATE	843-371-1	25101-28-4	856	40563	yes	no		Only to be used in: rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below; or at up to 40 % w/w in blends of styrene acrylonitrile copolymer (SAN)/poly(methyl methacrylate) (PMMA) repeatuse articles at room temperature or below, and when either in contact only with aqueous, acidic and/or low alcoholic (< 20 %) foodstuffs for less than 1 day, or when in contact only with dry foodstuffs for any duration of time.	Details
glass microballs	919-828-7	308066-94-6	39	55600	yes	no			Details
mixture of (40 % w/w) 2,2,4-trimethylhexane-1,6-diisocyanate and (60 % w/w) 2,4,4-trimethylhexane-1,6-diisocyanate	915-277-1	32052-51-0	4	22332	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
poloxamer 407	923-642-1	106392-12-5	551	79920	yes	no			Details
trimethylolpropane trimethacrylate-methyl methacrylate copolymer	927-697-2	28931-67-1	664	95000	yes	no			Details

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