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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 23 April 2024. Database contains 1080 unique substances/entries.

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Showing 651 - 700 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
sorbitol monostearate	248-027-9	26836-47-5	654	88600	yes	no			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
styrenesuphonic acid	248-104-7	26914-43-2	656	24760	no	no	0.05 mg/kg		Details
tert-butyl-4-hydroxyanisole	246-563-8	25013-16-5	635	40720	yes	no	30 mg/kg		Details
titanium nitride	247-117-5	25583-20-4	807	93485	yes	no		No migration of titanium nitride nanoparticles. Only to be used in polyethelyne terephthalate (PET) bottles up to 20 mg/kg. In the PET, the agglomerates have a diameter of 100 - 500 nm consisting of primary titanium nitride nanoparticles; primary particles have a diameter of approximately 20 nm.	Details
tricyclodecanedimethanol	248-096-5	26896-48-0	655	25450	no	no	0.05 mg/kg		Details
trimethyl trimellitate	219-547-3	2459-10-1	971	25885	no	no		Only to be used as a co-monomer up to 0,35 % w/w to produce modified polyesters intended to be used in contact with aqueous and dry foodstuffs containing no free fat at the surface.	Details
trimethylolpropane trimethacrylate-methyl methacrylate copolymer	927-697-2	28931-67-1	664	95000	yes	no			Details
tripropyleneglycol	246-466-0	24800-44-0	634	25910	no	no			Details
vinyltrimethoxysilane	220-449-8	2768-02-7	453	26320	no	no	0.05 mg/kg		Details
zinc hydroxide	243-814-3	20427-58-1	628	96190	yes	no			Details
(methyl methacrylate, butyl acrylate, styrene, glycidyl methacrylate) copolymer	-	37953-21-2	857	66765	yes	no		Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % at room temperature or below.	Details
1,1,1-trimethylolpropane trimethacrylate	221-950-4	3290-92-4	463	25840	no	no	0.05 mg/kg		Details
1,1-bis(2-hydroxy-3,5-di-tert-butylphenyl)ethane	252-816-3	35958-30-6	679	39060	yes	yes	5 mg/kg		Details
1,2-propyleneglycol dipalmitate	251-581-4	33587-20-1	677	82560	yes	no			Details
1,3-bis(isocyanatomethyl)benzene	222-852-4	3634-83-1	988		no	no		SML(T) applies to the migration of its hydrolysis product, 1,3- benzenedimethanamine. To be used only as co-monomer in the manufacture of a middle layer coating on a poly(ethylene terephthalate) polymer film in a multilayer film.	Details
1,5-naphthalene diisocyanate	221-641-4	3173-72-6	461	22420	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
1,6-hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)	252-346-9	35074-77-2	678	59200	yes	yes	6 mg/kg		Details
1,7-octadiene	223-054-9	3710-30-3	1034		no	no	0.05 mg/kg	Only to be used as a crosslinking co-monomer in the manufacture of polyolefins for contact with any type of foods for long term storage at room temperature, including when packaged under hot-fill conditions.	Details
1-hexadecanol	253-149-0	36653-82-4	681	18310	no	no			Details
2,2,4,4-tetramethylcyclobutane-1,3-diol	221-140-0	3010-96-6	881	25187	no	no	5 mg/kg	Only for: (a) repeated use articles for long term storage at room temperature or below and hotfill; (b) single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.	Details
2,2-bis(4-hydroxyphenyl)propane bis(phthalic anhydride)	253-781-7	38103-06-9	687	13614 13530	no	no	0.05 mg/kg		Details
2-(2'-hydroxy-3'-tert-butyl-5'-methylphenyl)-5-chlorobenzotriazole	223-445-4	3896-11-5	470	60400	yes	yes			Details
2-(2'-hydroxy-3,5'-di-tert-butylphenyl)-5-chlorobenzotriazole	223-383-8	3864-99-1	469	60480	yes	yes			Details
2-hydroxy-4-n-hexyloxybenzophenone	-	3293-97-8	464	61280	yes	yes			Details
2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether]	-	37486-69-4	903		yes	no		Only to be used as a polymer production aid in the polymerisation of fluoropolymers intended for: (a) repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360 °C for at least 10 minutes or at higher temperatures for equivalent shorter times; (b) repeated use materials and articles when processed (non-sintered) at temperatures from 300 °C and up to 360 °C for at least 10 minutes.	Details
3,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester	221-532-1	3135-18-0	459	46870	yes	no			Details
4,4'-difluorobenzophenone	206-466-3	345-92-6	337	15820	no	no	0.05 mg/kg		Details
5-sulphoisophthalic acid, monosodium salt, dimethyl ester	223-578-8	3965-55-7	471	24888	no	no	0.05 mg/kg		Details
7-[2H-naphtho-(1,2-D)triazol-2-yl]-3-phenylcoumarin	222-067-7	3333-62-8	465	68040	yes	no			Details
aluminum calcium oxide sulfate	609-389-7	37293-22-4	598	41600	yes	no			Details
behenamide	221-304-1	3061-75-4	458	36960	yes	no			Details
crotonic acid	223-077-4	3724-65-0	467	45600 14800	yes	no			Details
cyclohexyl isocyanate	221-639-3	3173-53-3	460	14950	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
di-n-octyltin bis(isooctyl maleate)	251-576-7	33568-99-9	676	50400	yes	no			Details
di-n-octyltin dilaurate	222-883-3	3648-18-8	466	50640	yes	no			Details
dibenzylidene sorbitol	251-136-4	32647-67-9	674	46480	yes	no			Details
ethylcarboxymethylcellulose	-	37205-99-5	682	53270	yes	no			Details
ethylene glycol bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate]	251-073-2	32509-66-3	673	53670	yes	yes	6 mg/kg		Details
furan-2,5-dicarboxylic acid	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).	Details
glass microballs	919-828-7	308066-94-6	39	55600	yes	no			Details
glycerol monobehenate	250-097-0	30233-64-8	669	56610	yes	no			Details
glycerol monolaurate diacetate	250-379-3	30899-62-8	670	56800	yes	no			Details
glycerol, esters with oleic acid	253-407-2	37220-82-9	49	56540	yes	no			Details
hydroxymethylcellulose	609-415-7	37353-59-6	686	61390	yes	no			Details
methylcarboxymethylcellulose	-	37206-01-2	683	66200	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
N,N'-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hydrazide	251-156-3	32687-78-8	675	38800	yes	yes	15 mg/kg		Details
n-decanoic acid	206-376-4	334-48-5	336	45940 15095	yes	no			Details
N-vinyl-N-methylacetamide	221-698-5	3195-78-6	462	26170	no	no	0.02 mg/kg		Details

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