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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 19 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)
1,1,1-tris(4-hydroxyphenol)ethane THPE; TRIS(P-HYDROXYPHENYL)ETHANE; TRIS(PARA-HYDROXYPHENYL)ETHANE	405-800-7	27955-94-8	662	25927	no	no	0.005 mg/kg	Only to be used in polycarbonates.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1,1,1-Tris(4-hydroxyphenol)ethane	-	-	662	25927	no	no	0.005 mg/kg	Only to be used in polycarbonates.	Details
1,3-phenylenediamine	203-584-7	108-45-2	236	23050	no	no	0.01 mg/kg		Details
1,4-butanediol bis(2,3-epoxypropyl)ether	219-371-7	2425-79-8	442	13780	no	no	0.01 mg/kg	Residual content = 1 mg/kg in final product expressed as epoxygroup. Molecular weight is 43 Da.	Details
2-methyl-1,3-butadiene	201-143-3	78-79-5	144	21640 19243	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
3-buten-2-ol	209-929-8	598-32-3	357	13932	no	no	0.01 mg/kg	Only to be used as a co-monomer for the preparation of polymeric additive.	Details
3-methyl-1-butene	209-249-1	563-45-1	351	21730	no	no	0.01 mg/kg	Only to be used in polypropylene.	Details
acrylamide	201-173-7	79-06-1	145	10630	no	no	0.01 mg/kg		Details
acrylonitrile	203-466-5	107-13-1	225	12100	no	no	0.01 mg/kg		Details
adipic acid, divinyl ester	223-792-1	4074-90-2	473	12265	no	no	0.01 mg/kg	5 mg/kg in final product. Only to be used as co-monomer.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 3-Buten-2-ol	-	-	357	13932	no	no	0.01 mg/kg	Only to be used as a co-monomer for the preparation of polymeric additive.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Hexachloroendomethylenetetrahydrophthalic acid	-	-	278	18250	no	no	0.01 mg/kg		Details
butadiene	203-450-8	106-99-0	223	13630	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
carbonyl chloride	200-870-3	75-44-5	133	23155 14380	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
chlorotrifluoroethylene	201-201-8	79-38-9	148	14650	no	no	0.01 mg/kg		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
epichlorohydrin	203-439-8	106-89-8	219	14570 16750	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
ethylene oxide	200-849-9	75-21-8	129	17020	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
ethyleneimine	205-793-9	151-56-4	334	17005	no	no	0.01 mg/kg		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
methacrylamide	201-202-3	79-39-0	149	19990	no	no	0.01 mg/kg		Details
methacrylic acid, 2-(dimethylamino)-ethyl ester	220-688-8	2867-47-2	455	20530	no	no	0.01 mg/kg		Details
methacrylic acid, 2-sulphoethyl ester	234-207-4	10595-80-9	590	21370	no	no	0.01 mg/kg		Details
methacrylonitrile	204-817-5	126-98-7	312	21490	no	no	0.01 mg/kg		Details
N-methylolacrylamide	213-103-2	924-42-5	379	21940	no	no	0.01 mg/kg		Details
phosphoric acid, trichloroethyl ester	204-118-5	115-96-8	280	73720	yes	no	0.01 mg/kg		Details
phosphorous acid, triethyl ester	204-552-5	122-52-1	293	23175	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
phthalic acid, diallyl ester	205-016-3	131-17-9	316	23230	no	no	0.01 mg/kg		Details
propylene oxide	200-879-2	75-56-9	135	24010	no	no	0.01 mg/kg	1 mg/kg in final product.	Details
resorcinol diglycidyl ether	202-987-5	101-90-6	199	24073	no	no	0.01 mg/kg	Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. For indirect food contact only, behind a PET layer.	Details
trialkyl(C5-C15)acetic acid, 2,3-epoxypropyl ester	-	-	5	25360	no	no	0.01 mg/kg	1 mg/kg in final product expressed as epoxygroup. Molecular weight is 43 Da.	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
methacrylic acid, 2,3-epoxypropyl ester	203-441-9	106-91-2	220	20590	no	no	0.02 mg/kg		Details
N-vinyl-N-methylacetamide	221-698-5	3195-78-6	462	26170	no	no	0.02 mg/kg		Details
(1,3-phenylenedioxy)diacetic acid	203-027-8	102-39-6	202	23070	no	no	0.05 mg/kg		Details
1,1,1-trimethylolpropane trimethacrylate	221-950-4	3290-92-4	463	25840	no	no	0.05 mg/kg		Details
1,10-decanediamine	211-471-9	646-25-3	863	15260	no	no	0.05 mg/kg	Only to be used as a co-monomer for manufacturing polyamide articles for repeated use in contact with aqueous, acidic and dairy foodstuffs at room temperature or for short term contact up to 150 °C.	Details
1,2,3,4-tetrahydronaphthalene-2,6-dicarboxylic acid, dimethyl ester	-	23985-75-3	1066		no	no	0.05 mg/kg	Only to be used as a co-monomer in the manufacture of a polyester non-food contact layer in a plastic multilayer material, which is to be used only in contact with foods for which food simulants A, B, C and/or D1 are assigned in Table 2 of Annex III. The specific migration limit in column 8 refers to the sum of the substance and of its dimers (cyclic and open chain).	Details
1,3,5-benzenetricarboxylic acid trichloride	224-594-8	4422-95-1	481	13060	no	no	0.05 mg/kg	SML expressed as 1,3,5-benzenetricarboxylic acid.	Details
1,3,5-tris(4-benzoylphenyl) benzene	-	227099-60-7	781	95265	yes	no	0.05 mg/kg		Details
1,3-bis(2-hydroxyethoxy)benzene	203-028-3	102-40-9	203	13323	no	no	0.05 mg/kg		Details
1,3-propanediol	207-997-3	504-63-2	343	23770	no	no	0.05 mg/kg		Details
1,4-butanediol formal	208-015-6	505-65-7	344	21821 13810	no	no	0.05 mg/kg		Details
1,6-hexanediol	211-074-0	629-11-8	361	18700	no	no	0.05 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
1,9-decadiene	216-711-6	1647-16-1	424	15070	no	no	0.05 mg/kg		Details
1-decene	212-819-2	872-05-9	375	15130	no	no	0.05 mg/kg		Details
1-dodecene	203-968-4	112-41-4	268	16704	no	no	0.05 mg/kg		Details
1-tetradecene	214-306-9	1120-36-1	388	25080	no	no	0.05 mg/kg		Details
1-vinylimidazole	214-012-0	1072-63-5	387	26155	no	no	0.05 mg/kg		Details
12-aminododecanoic acid	211-754-7	693-57-2	369	12761	no	no	0.05 mg/kg		Details
2,2'-(1,4-phenylene)bis[4H-3,1-benzoxazin-4-one] CYASORB(R) UV-3638 LIGHT STABILISER	418-280-1	18600-59-4	796	72141	yes	yes	0.05 mg/kg	SML including the sum of its hydrolysis products.	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
2,2-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-bis(hydroxymethyl)propionic acid	225-306-3	4767-03-7	484	13395	no	no	0.05 mg/kg		Details
2,2-dimethyl-1,3-propanediol	204-781-0	126-30-7	310	16390 22437	no	no	0.05 mg/kg		Details
2,3,6-trimethylphenol	219-330-3	2416-94-6	882	25872	no	no	0.05 mg/kg		Details
2,6-dimethylphenol	209-400-1	576-26-1	352	16360	no	no	0.05 mg/kg		Details
2,6-naphthalenedicarboxylic acid, dimethyl ester	212-661-4	840-65-3	373	22390	no	no	0.05 mg/kg		Details
2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy)phenol CG 30-1577	411-380-6	147315-50-2	770	51700	yes	no	0.05 mg/kg		Details
2-acrylamido-2-methylpropanesulphonic acid	239-268-0	15214-89-8	617	10660	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
2-aminoethanol	205-483-3	141-43-5	326	35170 12763	yes	no	0.05 mg/kg	Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. For indirect food contact only, behind a PET layer.	Details
2-cyano-3,3-diphenylacrylic acid, 2-ethylhexyl ester	228-250-8	6197-30-4	492	45650	yes	no	0.05 mg/kg		Details
2-cyano-3,3-diphenylacrylic acid, ethyl ester	226-029-0	5232-99-5	487	45640	yes	no	0.05 mg/kg		Details
2-phenyl-3,3-bis(4-hydroxyphenyl)phthalimidine	455-890-7	6607-41-6	872		no	no	0.05 mg/kg	To be used only as a co-monomer in polycarbonate copolymers.	Details
3,3'-dimethyl-4,4'-diaminodicyclohexylmethane	229-962-1	6864-37-5	498	16210	no	no	0.05 mg/kg	Only to be used in polyamides.	Details
3,3-bis(methoxymethyl)-2,5-dimethylhexane	430-800-9	129228-21-3	763	39925	yes	yes	0.05 mg/kg		Details
3,4-diacetoxy-1-butene 3,4-DIACETOXY-1-BUTENE	421-720-5	18085-02-4	862	15180	no	no	0.05 mg/kg	SML including the hydrolysis product 3,4- dihydroxy-1-butene. Only to be used as a co-monomer for ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers.	Details
3,9-bis[2-(3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro[5,5] undecane ADK STAB AO 80; SUMILIZER GA-80	410-730-5	90498-90-1	858	38565	yes	yes	0.05 mg/kg	SML expressed as the sum of the substance and its oxidation product 3-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)prop-2-enoyloxy)-1,1-dimethylethyl]-9-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro [5,5]-undecane in equilibrium with its para quinone methid tautomer.	Details
3-(3,5-di-tert-butyl-4-hydroxyphenyl) propanoic acid, esters with C13-C15 branched and linear alcohols ANOX 1315; ANOX BF; DURAD AX 38	413-750-2	171090-93-0	895	47060	yes	no	0.05 mg/kg	Only to be used in polyolefins in contact with foods other than fatty/ high-alcoholic and dairy products.	Details
3-aminopropyltriethoxysilane	213-048-4	919-30-2	377	12786	no	no	0.05 mg/kg	Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler when used for the reactive surface treatment of inorganic fillers. SML = 0,05 mg/kg when used for the surface treatment of materials and articles.	Details
3-chlorophthalic anhydride	204-179-8	117-21-5	786	14627	no	no	0.05 mg/kg	SML expressed as 3-chlorophthalic acid.	Details
3-methyl-1,5-pentanediol	224-709-1	4457-71-0	883	22074	no	no	0.05 mg/kg	Only to be used in materials in contact with food at a surface to mass ratio up to 0,5 dm2/kg.	Details
4,4'-bis(2-benzoxazolyl)stilbene	216-245-3	1533-45-5	422	38515	yes	yes	0.05 mg/kg		Details
4,4'-dichlorodiphenyl sulphone	201-247-9	80-07-9	152	15610	no	no	0.05 mg/kg		Details
4,4'-difluorobenzophenone	206-466-3	345-92-6	337	15820	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
4,4'-methylenebis(3-chloro-2,6-diethylaniline)	402-130-7	106246-33-7	755	21765	no	no	0.05 mg/kg		Details
4,4'-oxybis(benzenesulphonyl azide)	431-850-4	7456-68-0	502	22778	no	no	0.05 mg/kg		Details
4-(hydroxymethyl)-1-cyclohexene	216-847-6	1679-51-2	427	18896	no	no	0.05 mg/kg		Details
4-chlorophthalic anhydride	204-251-9	118-45-6	787	14628	no	no	0.05 mg/kg	SML expressed as 4-chlorophthalic acid.	Details
4-cumylphenol	209-968-0	599-64-4	358	14841	no	no	0.05 mg/kg		Details
4-methyl-1-pentene	211-720-1	691-37-2	366	22150	no	no	0.05 mg/kg		Details
4-tert-butylphenol	202-679-0	98-54-4	186	14020	no	no	0.05 mg/kg		Details
5-ethylidenebicyclo[2,2,1]hept-2-ene	240-347-7	16219-75-3	621	17110	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
6-hydroxy-2-naphthalenecarboxylic acid	240-759-7	16712-64-4	624	18897	no	no	0.05 mg/kg		Details
9,9-bis(methoxymethyl)fluorene	682-678-3	182121-12-6	779	39815	yes	yes	0.05 mg/kg		Details
[3-(methacryloxy)propyl]trimethoxysilane	219-785-8	2530-85-0	788	21498	no	no	0.05 mg/kg	Only to be used as a surface treatment agent of inorganic fillers.	Details
acrylic acid, 2-ethylhexyl ester	203-080-7	103-11-7	206	11500	no	no	0.05 mg/kg		Details
acrylic acid, 2-hydroxypropyl ester	213-663-8	999-61-1	385	11530	no	no	0.05 mg/kg	SML expressed as the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester. It may contain up to 25 % (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No 0002918-23-2).	Details
acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymer	681-637-7	25134-51-4	636	31500	yes	no	0.05 mg/kg	SML expressed as acrylic acid, 2-ethylhexyl ester.	Details
acrylic acid, dicyclopentenyl ester	235-697-2	12542-30-2	605	11005	no	no	0.05 mg/kg		Details
acrylic acid, dodecyl ester	218-463-4	2156-97-0	437	11245	no	no	0.05 mg/kg		Details
alkyl(C10-C21)sulphonic acid, esters with phenol	293-728-5	91082-17-6	884	34240	yes	no	0.05 mg/kg	Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1,3-Propanediol	-	-	343	23770	no	no	0.05 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 1,6-Hexanediol	-	-	361	18700	no	no	0.05 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 12-Aminododecanoic acid	-	-	369	12761	no	no	0.05 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2,2-Bis(hydroxymethyl)propionic acid	-	-	484	13395	no	no	0.05 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2,3,6-Trimethylphenol	-	-	882	25872	no	no	0.05 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2,6-Dimethylphenol	-	-	352	16360	no	no	0.05 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy)phenol	-	-	770	51700	yes	no	0.05 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2-Acrylamido-2-methylpropanesulphonic acid	-	-	617	10660	no	no	0.05 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2-Aminoethanol	-	-	326	35170 12763	yes	no	0.05 mg/kg	Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. For indirect food contact only, behind a PET layer.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 4-Cumylphenol	-	-	358	14841	no	no	0.05 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 4-tert-Butylphenol	-	-	186	14020	no	no	0.05 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of N-Heptylaminoundecanoic acid	-	-	731	18220	no	no	0.05 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of n-Octylphosphonic acid	-	-	483	68860	yes	no	0.05 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Styrenesuphonic acid	-	-	656	24760	no	no	0.05 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Tricyclodecanedimethanol	-	-	655	25450	no	no	0.05 mg/kg		Details
Benzophenone-3,3',4,4'-tetracarboxylic dianhydride (BTDA)	219-348-1	2421-28-5	1083		no	no	0.05 mg/kg	Only to be used at up to 43 % (w/w) as a co-monomer in the production of polyimides for use in contact with foods for which only simulants B and/or D2 are laid down in table 2 of Annex III at temperatures up to 250 °C.	Details
bicyclo[2.2.1]hept-2-ene	207-866-0	498-66-8	341	22550 13180	no	no	0.05 mg/kg		Details
bis(2,6-diisopropylphenyl) carbodiimide	218-487-5	2162-74-5	438	13303	no	no	0.05 mg/kg	Expressed as the sum of bis(2,6-diisopropylphenyl)carbodiimide and its hydrolysis product 2,6-diisopropylaniline	Details
bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (DEHCH)	283-829-2	84731-70-4	1079		yes	no	0.05 mg/kg	Only to be used as an additive in poly(vinyl chloride) (PVC) at up to 25 % w/w in contact at room temperature or below with foods for which food simulants A or B are assigned in Table 2 of Annex III.	Details
bis(4-aminocyclohexyl)methane	217-168-8	1761-71-3	429	13210	no	no	0.05 mg/kg		Details
cyclooctene	213-245-5	931-88-4	381	15030	no	no	0.05 mg/kg	Only to be used in polymers contacting foods for which simulant A is laid down.	Details
di-tert-dodecyl disulphide	248-468-7	27458-90-8	660	47540	yes	yes	0.05 mg/kg		Details
dioctadecyl disulphide	219-702-5	2500-88-1	449	49840	yes	yes	0.05 mg/kg		Details
diphenyl carbonate	203-005-8	102-09-0	201	16540	no	no	0.05 mg/kg		Details
formaldehyde-1-naphthol, copolymer	607-708-4	25359-91-5	640	54930	yes	no	0.05 mg/kg		Details
isobutyl vinyl ether	203-678-8	109-53-5	243	19060	no	no	0.05 mg/kg		Details
isophthalic acid, dimethyl ester	215-951-9	1459-93-4	420	19210	no	no	0.05 mg/kg		Details
methacrylic acid, allyl ester	202-473-0	96-05-9	175	20050	no	no	0.05 mg/kg		Details
methacrylic acid, cyclohexyl ester	202-943-5	101-43-9	197	20260	no	no	0.05 mg/kg		Details
methacrylic acid, diester with 1,4-butanediol	218-218-1	2082-81-7	434	20410	no	no	0.05 mg/kg		Details
methacrylic acid, diester with ethyleneglycol	202-617-2	97-90-5	185	20440	no	no	0.05 mg/kg		Details
methacrylic acid, sulphopropyl ester	-	54276-35-6	694	21400	no	no	0.05 mg/kg		Details
mixture of (35-45 % w/w) 1,6-diamino-2,2,4-trimethylhexane and (55-65 % w/w)1,6-diamino-2,4,4-trimethylhexane	247-063-2	25513-64-8	641	22331	no	no	0.05 mg/kg		Details
montmorillonite clay modified by dimethyldialkyl (C16-C18)ammonium chloride	-	-	1030		yes	no	0.05 mg/kg	Only to be used up to 12 % (w/w) in polyolefins in contact with dry foods to which simulant E is assigned in table 2 of Annex III at room temperature or below. The sum of the specific migration of 1-chlorohexadecane and 1-chlorooctadecane shall not exceed 0,05 mg/kg food. Can contain platelets in the nanoform that are only in one dimension thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.	Details
N,N',N'',N''-tetrakis(4,6-bis(N-butyl-(N-methyl-2,2,6,6-tetramethylpiperidin-4-yl)amino)triazin-2-yl)-4,7-diazadecane-1,10-diamine CHIMASSORB 119; LOWILITE 19	401-990-0	106990-43-6	791	92470	yes	no	0.05 mg/kg		Details
N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)-N,N'-diformylhexamethylenediamine LICHTSCHUTZMITTEL 1736	413-610-0	124172-53-8	795	40155	yes	no	0.05 mg/kg		Details
N,N'-bis[4-(ethoxycarbonyl)phenyl]-1,4,5,8-naphthalenetetracarboxydiimide	-	132459-54-2	764	13317	no	no	0.05 mg/kg	Purity > 98,1 % (w/w). Only to be used as co-monomer (max 4 %) for polyesters (PET, PBT).	Details
N,N'-divinyl-2-imidazolidinone	237-457-2	13811-50-2	612	16694	no	no	0.05 mg/kg		Details
N-(2,6-diisopropylphenyl)-6-[4-(1,1,3,3-tetramethylbutyl)phenoxy]-1H-benzo[de]isoquinolin-1,3(2H)-dione	-	852282-89-4	809	49080	yes	yes	0.05 mg/kg	Only for use in PET.	Details
N-(2-aminoethyl)-β-alanine, sodium salt	282-811-1	84434-12-8	748	12765	no	no	0.05 mg/kg		Details
N-(2-aminoethyl)ethanolamine	203-867-5	111-41-1	262	35284	yes	no	0.05 mg/kg	Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. For indirect food contact only, behind a PET layer.	Details
N-(4-hydroxyphenyl) acetamide	203-157-5	103-90-2	208	18898	no	no	0.05 mg/kg		Details
N-heptylaminoundecanoic acid	271-487-7	68564-88-5	731	18220	no	no	0.05 mg/kg		Details
N-methylolmethacrylamide	213-086-1	923-02-4	378	21970	no	no	0.05 mg/kg		Details
n-octylphosphonic acid	225-218-5	4724-48-5	483	68860	yes	no	0.05 mg/kg		Details
neodecanoic acid, salts	248-093-9	26896-20-8	819	68110	yes	no	0.05 mg/kg	Not to be used in polymers contacting fatty foods. Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. SML expressed as neodecanoic acid.	Details
pentaerythritol dioleate	246-665-2	25151-96-6	637	71635	yes	no	0.05 mg/kg	Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.	Details
pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate)	429-160-3	178671-58-4	778	71670	yes	yes	0.05 mg/kg		Details
perfluoromethyl perfluorovinyl ether	214-703-7	1187-93-5	391	22932	no	no	0.05 mg/kg	Only to be used in: anti-stick coatings; fluoro- and perfluoropolymers intended for repeated use applications where the contact ratio is 1 dm2 surface in contact with at least 150 kg food.	Details
perfluoropropylperfluorovinyl ether	216-600-2	1623-05-8	423	22937	no	no	0.05 mg/kg		Details
Phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate	258-053-2	52628-03-2	1082		no	no	0.05 mg/kg	Only to be used at up to 0,35 % (w/w) to manufacture polymethylmethacrylate.	Details
phosphoric acid, mono- and di-n-alkyl (C16 and C18) esters	-	-	68	73160	yes	yes	0.05 mg/kg		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
polyethylene glycol (EO = 1-30, typically 5) ether of butyl 2-cyano 3-(4-hydroxy-3-methoxyphenyl) acrylate	-	-	76	77732	yes	no	0.05 mg/kg	Only for use in PET.	Details
polyethyleneglycol (EO = 1-30, typically 5) ether of butyl-2-cyano-3-(4-hydroxyphenyl) acrylate	-	-	77	77733	yes	no	0.05 mg/kg	Only for use in PET.	Details
pyromellitic anhydride	201-898-9	89-32-7	166	24057	no	no	0.05 mg/kg		Details
styrenesuphonic acid	248-104-7	26914-43-2	656	24760	no	no	0.05 mg/kg		Details
tetrafluoroethylene	204-126-9	116-14-3	281	25120	no	no	0.05 mg/kg		Details
trialkyl acetic acid (C7-C17), vinyl esters	-	-	6	25380	no	no	0.05 mg/kg		Details
tricyclodecanedimethanol	248-096-5	26896-48-0	655	25450	no	no	0.05 mg/kg		Details
tricyclodecanedimethanol bis(hexahydrophthalate)	-	-	92	93970	yes	no	0.05 mg/kg		Details
trimethylolpropane, mixed triesters and diesters with n-octanoic and n-decanoic acids	-	-	924	94987	yes	no	0.05 mg/kg	Only for use in PET in contact with all types of foods other than fatty, high- alcoholic and dairy products.	Details
tungsten oxide	254-413-8	39318-18-8	1064		yes	no	0.05 mg/kg	Stoichiometry: WOn, n = 2,72-2,90.	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
vinyltrimethoxysilane	220-449-8	2768-02-7	453	26320	no	no	0.05 mg/kg		Details
waxes, paraffinic, refined, derived from petroleum based or synthetic hydrocarbon feedstocks, low viscosity	-	-	93	95858	yes	no	0.05 mg/kg	Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down. Average molecular weight not less than 350 Da. Viscosity at 100 °C not less than 2,5 cSt (2,5 × 10-6 m2/s). Content of hydrocarbons with Carbon number less than 25, not more than 40 % (w/w).	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-methylstyrene	202-705-0	98-83-9	187	22210	no	no	0.05 mg/kg		Details
2-(4-dodecylphenyl)indole	257-624-3	52047-59-3	692	52320	yes	yes	0.06 mg/kg		Details
phthalic acid, dibutyl ester	201-557-4	84-74-2	157	74880	yes	no	0.12 mg/kg	Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.	Details
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	685	85950	yes	no	0.15 mg/kg	SML expressed as fluoride. Only to be used in layers of multi-layer materials not coming into direct contact with food.	Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of Lignosulphonic acid	-	-	540	63940	yes	no	0.24 mg/kg	Only to be used as dispersant for plastics dispersions.	Details
lignosulphonic acid	617-129-9	8062-15-5	540	63940	yes	no	0.24 mg/kg	Only to be used as dispersant for plastics dispersions.	Details
1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride	223-805-0	4080-31-3	474	43600	yes	no	0.3 mg/kg		Details
4,4'-thiobis(6-tert-butyl-3-methylphenol)	202-525-2	96-69-5	178	92800	yes	yes	0.48 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 4,4'-Thiobis(6-tert-butyl-3-methylphenol)	-	-	178	92800	yes	yes	0.48 mg/kg		Details
2-methyl-4-isothiazolin-3-one	220-239-6	2682-20-4	451	66755	yes	no	0.5 mg/kg	Only to be used in aqueous polymer dispersions and emulsions.	Details
1,4-dihydroxybenzene	204-617-8	123-31-9	295	48620 15940 18867	yes	no	0.6 mg/kg		Details
2,5-bis(5-tert-butyl-2-benzoxazolyl)thiophene	230-426-4	7128-64-5	500	38560	yes	yes	0.6 mg/kg		Details
benzophenone	204-337-6	119-61-9	286	38240	yes	yes	0.6 mg/kg		Details
bis(2,4-di-tert-butylphenyl) pentaerythritol diphosphite	247-952-5	26741-53-7	652	38820	yes	yes	0.6 mg/kg		Details
bis(polyethyleneglycol)hydroxymethylphosphonate	614-830-1	68951-50-8	735	40120	yes	no	0.6 mg/kg		Details
phthalic acid, bis(2-ethylhexyl) ester	204-211-0	117-81-7	283	74640	yes	no	0.6 mg/kg	Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in concentrations up to 0,1 % in the final product.	Details
sodium nitrite	231-555-9	7632-00-0	506	86920	yes	no	0.6 mg/kg		Details
tetrahydrofuran	203-726-8	109-99-9	246	25150	no	no	0.6 mg/kg		Details
chlorides of choline esters of coconut oil fatty acids	-	-	23	43515	yes	no	0.9 mg/kg		Details
2,4-dimethyl-6-(1-methylpentadecyl)phenol CG 27-145	411-220-5	134701-20-5	765	49485	yes	yes	1 mg/kg		Details
All salts of Al, NH4, Ba, Ca, Co, Cu, Fe, Li, Mg, Mn, K, Na, Zn, Eu, Gd, La and Tb of 2,4-Dimethyl-6-(1-methylpentadecyl)phenol	-	-	765	49485	yes	yes	1 mg/kg		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
tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate	222-020-0	3319-31-1	1078		yes	no	1 mg/kg	Only to be used as plasticiser to manufacture soft poly(vinyl chloride). Not to be used in contact with foods intended for infants.	Details
2-[2-hydroxy-3,5-bis(1,1-dimethylbenzyl)phenyl]benzotriazole	274-570-6	70321-86-7	738	60320	yes	yes	1.5 mg/kg		Details
3,3-bis(3-methyl-4-hydroxyphenyl)2-indolinone	256-318-7	47465-97-4	691	13600	no	no	1.8 mg/kg		Details
bis(2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy)methylammonium chloride	228-253-4	6200-40-4	493	39200	yes	no	1.8 mg/kg		Details
polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C8-C22) alcohols	-	-	799	77708	yes	no	1.8 mg/kg	In compliance with the maximum ethylene oxide content as laid down in the purity criteria for food additives in Commission Regulation (EU) No 231/2012.	Details
2,4,6-tris(tert-butyl)phenyl-2-butyl-2-ethyl-1,3-propanediol phosphite	423-560-1	161717-32-4	774	95270	yes	yes	2 mg/kg	SML expressed as sum of phosphite, phosphate and the hydrolysis product = TTBP.	Details
sulphosuccinic acid monoalkyl (C10-C16) polyethyleneglycol esters, salts	-	-	814	91815	yes	no	2 mg/kg		Details
1,3-dihydroxybenzene	203-585-2	108-46-3	237	24072 15910	no	no	2.4 mg/kg		Details
hexamethylenediamine	204-679-6	124-09-4	305	18460 15274	no	no	2.4 mg/kg		Details
N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)hexamethylenediamine-1,2-dibromoethane, copolymer	-	61269-61-2	701	40160	yes	no	2.4 mg/kg		Details
phosphoric acid, diphenyl 2-ethylhexyl ester	214-987-2	1241-94-7	392	72800	yes	yes	2.4 mg/kg		Details
thiodiethanol bis(3-(3,5-di-tert-butyl-4-hydroxy phenyl) propionate)	255-392-8	41484-35-9	690	92880	yes	yes	2.4 mg/kg		Details

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