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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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Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
graphite	231-955-3	7782-42-5	521	58320	yes	no			Details
hydrochloric acid	231-595-7	7647-01-0	507	59990	yes	no			Details
isobutane	200-857-2	75-28-5	1069		yes	no		Only to be used as a blowing agent.	Details
isopentane	201-142-8	78-78-4	143	62450	yes	no			Details
manganese chloride	231-869-6	7773-01-5	520	65120	yes	no			Details
methacrylamide	201-202-3	79-39-0	149	19990	no	no	0.01 mg/kg		Details
methacrylic acid	201-204-4	79-41-4	150	20020	no	no			Details
methacrylic anhydride	212-084-8	760-93-0	370	21460	no	no			Details
phosphoric acid	231-633-2	7664-38-2	509	23170 72640	yes	no			Details
poly[6-[(1,1,3,3-tetramethylbutyl)amino]-1,3,5-triazine-2,4-diyl]-[(2,2,6,6-tetramethyl-4-piperidyl)-imino]hexamethylene[(2,2,6,6-tetramethyl-4-piperidyl) imino]	615-678-9	71878-19-8	740	81200	yes	yes	3 mg/kg		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
polyethyleneglycol-30 dipolyhydroxystearate	680-598-3	70142-34-6	737	77370	yes	no			Details
potassium bromide	231-830-3	7758-02-3	517	81520	yes	no			Details
potassium iodide	231-659-4	7681-11-0	512	81680	yes	no			Details
propionic acid	201-176-3	79-09-4	146	82000 23890	yes	no			Details
propylene oxide	200-879-2	75-56-9	135	24010	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
resin acids and rosin acids	277-299-1	73138-82-6	741	83610 24070	yes	no			Details
silicon dioxide	231-545-4	7631-86-9	504	86240	yes	no		For synthetic amorphous silicon dioxide: primary particles of 1 - 100 nm which are aggregated to a size of 0,1 - 1 µm which may form agglomerates within the size distribution of 0,3 µm to the mm size.	Details
sodium bisulphite	231-548-0	7631-90-5	505	86480	yes	no			Details
sodium bromide	231-599-9	7647-15-6	508	86560	yes	no			Details
sodium iodide	231-679-3	7681-82-5	513	86800	yes	no			Details
sodium nitrite	231-555-9	7632-00-0	506	86920	yes	no	0.6 mg/kg		Details
sodium sulphite	231-821-4	7757-83-7	516	86960	yes	no			Details
sodium thiosulphate	231-867-5	7772-98-7	519	87120	yes	no			Details
sulphur	231-722-6	7704-34-9	514	91840	yes	no			Details
sulphuric acid	231-639-5	7664-93-9	511	91920	yes	no			Details
tocopherol acetate	231-710-0	7695-91-2	1055		yes	no		Only to be used as antioxidant in polyolefins.	Details
tri-n-butyl acetyl citrate	201-067-0	77-90-7	138	93760	yes	no			Details
vinyl chloride	200-831-0	75-01-4	127	26050	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
vinylidene chloride	200-864-0	75-35-4	130	26110	no	no	0.01 mg/kg		Details
vinylidene fluoride	200-867-7	75-38-7	132	26140	no	no	5 mg/kg		Details
vinyltriethoxysilane	201-081-7	78-08-0	142	26305	no	no	0.05 mg/kg	Only to be used as a surface treatment agent.	Details
water	231-791-2	7732-18-5	515	95855 26360	yes	no		In compliance with Directive 98/83/EC [OJ L 330, 5.12.1998, p. 32.].	Details
β-dextrin	231-493-2	7585-39-9	503	46080	yes	no			Details
(1,3:2,4) diparamethyldibenylidene sorbitol	617-241-8	81541-12-0	752	39890	yes	no			Details
1,6-hexanediamine, N1,N6-bis(2,2,6,6-tetramethyl-4-piperidinyl)-, polymer with 2,4-dichloro-6-(4-morpholinyl)-1,3,5-triazine	617-335-9	82451-48-7	790	80480	yes	no	5 mg/kg	Average molecular weight not less than 2400 Da. Residual content of morpholine ≤ 30 mg/kg, of N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg.	Details
1-decene	212-819-2	872-05-9	375	15130	no	no	0.05 mg/kg		Details
2,2',2'-nitrilo(triethyl tris(3,3',5,5'-tetra-tert-butyl-1,1'-bi-phenyl-2,2'-diyl)phosphite)	279-459-6	80410-33-9	745	68145	yes	yes	5 mg/kg	SML expressed as sum of phosphite and phosphate.	Details
2,2'-methylene bis(4,6-di-tert-butylphenyl) sodium phosphate	286-344-4	85209-91-2	749	66360	yes	yes	5 mg/kg		Details
2,2'-methylene bis(4-ethyl-6-tert-butylphenol)	201-814-0	88-24-4	163	66400	yes	yes			Details
2,2'-methylenebis(4,6-di-tert-butylphenyl) lithium phosphate	617-688-9	85209-93-4	750	66350	yes	no	5 mg/kg		Details
2,2-bis(4-hydroxyphenyl)propane	201-245-8	80-05-7	151	13480 13607	no	no	0.05 mg/kg	Not to be used for the manufacture of polycarbonate infant [Infant as defined in Article 2(2)(a) of Regulation (EU) No 609/2013] feeding bottles [This restriction is applicable from 1 May 2011 as regards the manufacture and from 1 June 2011 as regards the placing on the market and importation into the Union]. Not to be used for the manufacture of polycarbonate drinking cups or bottles which, due to their spill proof characteristics, are intended for infants [Infant as defined in Article 2(2)(a) of Regulation (EU) No 609/2013] and young children [Young children as defined in Article 2(2)(b) of Regulation (EU) No 609/2013].	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
2,6-naphthalenedicarboxylic acid, dimethyl ester	212-661-4	840-65-3	373	22390	no	no	0.05 mg/kg		Details
2-aminobenzamide	201-851-2	88-68-6	164	34895	yes	no	0.05 mg/kg	Only for use in PET for water and beverages.	Details
3-hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer	616-996-0	80181-31-3	744	18888	no	no		The substance is used as product obtained by bacterial fermentation. In compliance with the specifications mentioned in the Table 4 of Annex I.	Details
4,4'-diaminodiphenyl sulphone	201-248-4	80-08-0	153	15267	no	no	5 mg/kg		Details
4,4'-dichlorodiphenyl sulphone	201-247-9	80-07-9	152	15610	no	no	0.05 mg/kg		Details
4,4'-dihydroxydiphenyl sulphone	201-250-5	80-09-1	154	13617 16090	no	no	0.05 mg/kg		Details

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