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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 18 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)
diethylenetriamine	203-865-4	111-40-0	261	15790	no	no	5 mg/kg		Details
dimethylaminoethanol	203-542-8	108-01-0	230	16150	no	no	18 mg/kg		Details
dipentaerythritol	204-794-1	126-58-9	311	51200 16480	yes	no			Details
diphenyl carbonate	203-005-8	102-09-0	201	16540	no	no	0.05 mg/kg		Details
diphenyl sulphone	204-853-1	127-63-9	313	51570 16650	yes	no	3 mg/kg		Details
diphenylmethane-4,4'-diisocyanate	202-966-0	101-68-8	198	16630	no	no		1 mg/kg in final product expressed as isocyanate moiety.	Details
dipropyleneglycol	203-821-4	110-98-5	257	16660 13550 51760	yes	no			Details
divinylbenzene	215-325-5	1321-74-0	405	16690	no	no	0.01 mg/kg	SML expressed as the sum of divinylbenzene and ethylvinylbenzene. It may contain up to 45 % (m/m) of ethylvinylbenzene	Details
DL-alpha-tocopherol	233-466-0	10191-41-0	110	93520	yes	no			Details
dolomite	240-440-2	16389-88-1	623	52640	yes	no			Details
epichlorohydrin	203-439-8	106-89-8	219	14570 16750	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
erucamide	204-009-2	112-84-5	271	52720	yes	no			Details
erucic acid	204-011-3	112-86-7	273	52730	yes	no			Details
ethylenediamine	203-468-6	107-15-3	226	16960 15272	no	no	12 mg/kg		Details
ethyleneglycol	203-473-3	107-21-1	227	53650 16990	yes	no			Details
ethyleneimine	205-793-9	151-56-4	334	17005	no	no	0.01 mg/kg		Details
fumaric acid	203-743-0	110-17-8	249	55120 17290	yes	no			Details
gallic acid, dodecyl ester	214-620-6	1166-52-5	390	55200	yes	no			Details
gallic acid, octyl ester	213-853-0	1034-01-1	386	55280	yes	no			Details
gallic acid, propyl ester	204-498-2	121-79-9	290	55360	yes	no			Details
glutaric acid	203-817-2	110-94-1	256	18010 55680	yes	no			Details
glutaric anhydride	203-593-6	108-55-4	238	18070	no	no			Details
glycerol tribehenate	242-471-7	18641-57-1	626	57800	yes	no			Details
glycerol, esters with acetic acid	215-637-1	1335-58-6	40	56360	yes	no			Details
glycerol, esters with myristic acid	234-397-9	11140-02-6	47	56520	yes	no			Details
glycerol, esters with palmitic acid	234-400-3	11140-06-0	50	56550	yes	no			Details
glycerol, esters with stearic acid	234-325-6	11099-07-3	53	56585	yes	no			Details
heptanoic acid	203-838-7	111-14-8	259	58720	yes	no			Details
hexacalcium hexaoxotris[sulphato(2-)]dialuminate(12-)	234-448-5	12004-14-7	598	41600	yes	no			Details
hexachloroendomethylenetetrahydrophthalic acid	204-078-9	115-28-6	278	18250	no	no	0.01 mg/kg		Details
hexachloroendomethylenetetrahydrophthalic anhydride	204-077-3	115-27-5	277	18280	no	no	0.01 mg/kg		Details
hexafluoropropylene	204-127-4	116-15-4	282	18430	no	no	0.01 mg/kg		Details
hexamethylenediamine	204-679-6	124-09-4	305	18460 15274	no	no	2.4 mg/kg		Details
hexamethylenetetramine	202-905-8	100-97-0	196	18670 59280	yes	no			Details
hexanoic acid	205-550-7	142-62-1	329	59360	yes	no			Details
huntite	606-340-1	19569-21-2	627	59760	yes	no			Details
hydromagnesite	811-989-0	12072-90-1	600	60030	yes	no			Details
hydrotalcite	602-916-1	12304-65-3	604	60080	yes	no			Details
iron oxide	215-570-8	1332-37-2	409	62240	yes	no			Details
iron phosphide	235-798-1	12751-22-3	607	62245	yes	no		Only to be used in PET polymers and copolymers	Details
isobutene	204-066-3	115-11-7	276	19000	no	no			Details
isobutyl vinyl ether	203-678-8	109-53-5	243	19060	no	no	0.05 mg/kg		Details
isophthalic acid	204-506-4	121-91-5	291	19150	no	no			Details
isophthalic acid, dimethyl ester	215-951-9	1459-93-4	420	19210	no	no	0.05 mg/kg		Details
kaolin A clay that is essentially kaolinite, a hydrated aluminum silicate. It has a high fusion point and is the most refractory of all clays.	310-194-1	1332-58-7	410	62720	yes	no		Particles can be thinner than 100 nm only if incorporated at a quantity of less than 12 % w/w in an ethylene vinyl alcohol copolymer (EVOH) inner layer of a multi- layer structure, in which the layer in direct contact with the food provides a functional barrier preventing migration of particles into the food.	Details
lactic acid, butyl ester	205-316-4	138-22-7	322	63040	yes	no			Details
lauric acid	205-582-1	143-07-7	330	63280 19470	yes	no			Details
levulinic acid	204-649-2	123-76-2	299	63840	yes	no			Details
lignocellulose	234-384-8	11132-73-3	595	19510	no	no			Details
lithium iodide	233-822-5	10377-51-2	588	64320	yes	no			Details

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