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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)
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	200-289-5	56-81-5	103	18100 55920	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 monooctanoate	247-668-1	26402-26-6	648	56880	yes	no			Details
glycerol tribehenate	242-471-7	18641-57-1	626	57800	yes	no			Details
glycerol triheptanoate	210-647-2	620-67-7	360	57920	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 oleic acid	253-407-2	37220-82-9	49	56540	yes	no			Details
glycerol, esters with palmitic acid	234-400-3	11140-06-0	50	56550	yes	no			Details
glycerol, esters with ricinoleic acid	261-327-4	58561-47-0	52	56580	yes	no			Details
glycerol, esters with stearic acid	234-325-6	11099-07-3	53	56585	yes	no			Details
glycolic acid	201-180-5	79-14-1	794	18117	no	no		Only to be used for manufacture of polyglycolic acid (PGA) for (i) indirect food contact behind polyesters such as polyethylene terephthalate (PET) or polylactic acid (PLA); and (ii) direct food contact of a blend of PGA up to 3 % w/w in PET or PLA.	Details
graphite	231-955-3	7782-42-5	521	58320	yes	no			Details
guar gum	232-536-8	9000-30-0	544	58400	yes	no			Details
gum arabic	232-519-5	9000-01-5	541	58480	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
hexadecyltrimethylammonium bromide	200-311-3	57-09-0	104	58960	yes	no	6 mg/kg		Details
hexafluoropropylene	204-127-4	116-15-4	282	18430	no	no	0.01 mg/kg		Details
hexamethylene diisocyanate	212-485-8	822-06-0	372	18640	no	no		1 mg/kg in final product expressed as isocyanate moiety.	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
hydrochloric acid	231-595-7	7647-01-0	507	59990	yes	no			Details
hypophosphorous acid	228-601-5	6303-21-5	494	62140	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
isobutane	200-857-2	75-28-5	1069		yes	no		Only to be used as a blowing agent.	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
isopentane	201-142-8	78-78-4	143	62450	yes	no			Details
isophthalic acid	204-506-4	121-91-5	291	19150	no	no			Details
isophthalic acid dichloride	202-774-7	99-63-8	188	19180	no	no			Details
isophthalic acid, dimethyl ester	215-951-9	1459-93-4	420	19210	no	no	0.05 mg/kg		Details
itaconic acid	202-599-6	97-65-4	182	19270	no	no			Details
kaolin, calcined The product of high temperature calcination (above 450°C (842°F)) of naturally occurring kaolin, a hydrated aluminum silicate, resulting in the evolution of water and the formation of new substances depending upon the calcination temperatures employed.	296-473-8	92704-41-1	753	62800	yes	no			Details
L-(+)-tartaric acid	201-766-0	87-69-4	161	92160	yes	no			Details
lactic acid	200-018-0	50-21-5	99	19460 62960	yes	no			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
lauric acid, vinyl ester	218-414-7	2146-71-6	436	19480	no	no			Details
laurolactam	213-424-8	947-04-6	382	19490	no	no	5 mg/kg		Details
lecithin The complex combination of diglycerides of fatty acids linked to the choline ester of phosphoric acid.	232-307-2	8002-43-5	528	63760	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

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