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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 801 - 900 of 1,080 results.

Substance Name	EC No.	CAS No.	FCM No	Ref No.	Additive or PPA	FRF applicable	SML (mg/kg)	Restriction(s)
phthalic acid	201-873-2	88-99-3	165	23200 74480	yes	no			Details
phthalic acid, benzyl butyl ester	201-622-7	85-68-7	159	74560	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product.	Details
phthalic acid, benzyl butyl ester	201-622-7	85-68-7	159	74560	yes	no	6 mg/kg	Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product.	Details
phthalic acid, benzyl butyl ester	201-622-7	85-68-7	159	74560	yes	no		Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product.	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
phthalic acid, bis(2-ethylhexyl) ester	204-211-0	117-81-7	283	74640	yes	no		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
phthalic acid, bis(2-ethylhexyl) ester	204-211-0	117-81-7	283	74640	yes	no		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
phthalic acid, diallyl ester	205-016-3	131-17-9	316	23230	no	no	0.01 mg/kg		Details
phthalic acid, dibutyl ester	201-557-4	84-74-2	157	74880	yes	no		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
phthalic acid, dibutyl ester	201-557-4	84-74-2	157	74880	yes	no		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
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
phthalic anhydride	201-607-5	85-44-9	158	23380 76320	yes	no			Details
polyphosphoric acids	232-417-0	8017-16-1	534	80720	yes	no			Details
potassium bromide	231-830-3	7758-02-3	517	81520	yes	no			Details
potassium hydroxide	215-181-3	1310-58-3	399	81600	yes	no			Details
potassium iodide	231-659-4	7681-11-0	512	81680	yes	no			Details
propionaldehyde	204-623-0	123-38-6	296	23860	no	no			Details
propionic acid	201-176-3	79-09-4	146	82000 23890	yes	no			Details
propionic acid, vinyl ester	203-293-5	105-38-4	211	23920	no	no			Details
propionic anhydride	204-638-2	123-62-6	297	23950	no	no			Details
propylene	204-062-1	115-07-1	275	23980	no	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
pyromellitic anhydride	201-898-9	89-32-7	166	24057	no	no	0.05 mg/kg		Details
pyrophosphoric acid	219-574-0	2466-09-3	445	83440	yes	no			Details
quartz	238-878-4	14808-60-7	616	83470	yes	no			Details
reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and trichloromethyltin	270-476-4	68442-12-6	726	83599	yes	yes			Details
resin acids and rosin acids	277-299-1	73138-82-6	741	83610 24070	yes	no			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
ricinoleic acid	205-470-2	141-22-0	324	83700	yes	yes	42 mg/kg		Details
rosin A complex combination derived from wood, especially pine wood. Composed primarily of resin acids and modified resin acids such as dimers and decarboxylated resin acids. Includes rosin stabilized by catalytic disproportionation.	232-475-7	8050-09-7	535	24100 24190 83840 24130	yes	no			Details
rosin tall oil A complex combination derived from tall oil. Composed primarily of tricyclic monocarboxylic acids, mainly abietic and dehydroabietic acids. Includes tall-oil rosin stabilized by catalytic disproportionation.	232-484-6	8052-10-6	539	24160	no	no			Details
rosin, ester with glycerol	232-482-5	8050-31-5	538	84000	yes	no			Details
rosin, ester with pentaerythritol	232-479-9	8050-26-8	537	84080	yes	no			Details
rosin, hydrogenated	266-041-3	65997-06-0	717	84210	yes	no			Details
rosin, hydrogenated, ester with glycerol	266-042-9	65997-13-9	718	84240	yes	no			Details
rosin, hydrogenated, ester with methanol	232-476-2	8050-15-5	536	84320	yes	no			Details
rosin, hydrogenated, ester with pentaerythritol	264-848-5	64365-17-9	714	84400	yes	no			Details
rubber, natural	232-689-0	9006-04-6	574	84560 24250	yes	no			Details
salicylic acid, 4-tert-butylphenyl ester	201-728-3	87-18-3	160	84800	yes	yes	12 mg/kg		Details
salicylic acid, methyl ester	204-317-7	119-36-8	284	84880	yes	no	30 mg/kg		Details
sebacic acid	203-845-5	111-20-6	260	24280	no	no			Details
sebacic acid, dibutyl ester	203-672-5	109-43-3	242	85360	yes	no			Details
sebacic anhydride	219-882-5	2561-88-8	450	24430	no	no			Details
silicic acid	215-683-2	1343-98-2	417	85680	yes	no			Details
silicon carbide	206-991-8	409-21-2	339	86160	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 hydroxide	215-185-5	1310-73-2	400	86720	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 sulphide	215-211-5	1313-82-2	401	24475	no	no			Details
sodium sulphite	231-821-4	7757-83-7	516	86960	yes	no			Details
sodium tetraborate	215-540-4	1330-43-4	407	87040	yes	no			Details
sodium thiosulphate	231-867-5	7772-98-7	519	87120	yes	no			Details
sorbic acid	203-768-7	110-44-1	252	87200	yes	no			Details
sorbitan dioleate	249-448-0	29116-98-1	666	87280	yes	no			Details
sorbitan monobehenate	263-600-3	62568-11-0	709	87520	yes	no			Details
sorbitan monolaurate	215-663-3	1338-39-2	414	87600	yes	no			Details
sorbitan monooleate	215-665-4	1338-43-8	416	87680	yes	no			Details
sorbitan monopalmitate	247-568-8	26266-57-9	643	87760	yes	no			Details
sorbitan monostearate	215-664-9	1338-41-6	415	87840	yes	no			Details
sorbitan tetrastearate	262-958-8	61752-68-9	702	87920	yes	no			Details
sorbitan trioleate	247-569-3	26266-58-0	644	88080	yes	no			Details
sorbitan tripalmitate	258-994-9	54140-20-4	693	88160	yes	no			Details
sorbitan tristearate	247-891-4	26658-19-5	651	88240	yes	no			Details
sorbitol	200-061-5	50-70-4	100	88320 24490	yes	no			Details
sorbitol monostearate	248-027-9	26836-47-5	654	88600	yes	no			Details
soybean oil Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic and stearic. (Soja hispida, Leguminosae).	232-274-4	8001-22-7	524	24520	no	no			Details
soybean oil, epoxidised	232-391-0	8013-07-8	532	88640	yes	no	60 mg/kg		Details
soybean oil, epoxidised	232-391-0	8013-07-8	532	88640	yes	no			Details
soybean oil, epoxidised	232-391-0	8013-07-8	532	88640	yes	no	30 mg/kg	In the case of PVC gaskets used to seal glass jars containing infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC, the SML is lowered to 30 mg/kg.Oxirane < 8 %, iodine number < 6.	Details
starch, edible High-polymeric carbohydrate material usually derived from cereal grains such as corn, wheat and sorghum, and from roots and tubers such as potatoes and tapioca. Includes starch which has been pregelatinized by heating in the presence of water.	232-679-6	9005-25-8	564	24540 88800	yes	no			Details
stearamide	204-693-2	124-26-5	306	88960	yes	no			Details
stearic acid	200-313-4	57-11-4	106	24550 89040	yes	no			Details
stearic acid, butyl ester	204-666-5	123-95-5	301	89120	yes	no			Details
stearoylbenzoylmethane	261-257-4	58446-52-9	699	90720	yes	no			Details
styrene	202-851-5	100-42-5	193	24610	no	no			Details
styrenesuphonic acid	248-104-7	26914-43-2	656	24760	no	no	0.05 mg/kg		Details
succinic acid	203-740-4	110-15-6	247	90960 24820	yes	no			Details
succinic anhydride	203-570-0	108-30-5	233	24850	no	no			Details
sucrose	200-334-9	57-50-1	108	24880	no	no			Details
sucrose acetate isobutyrate	204-771-6	126-13-6	308	91200	yes	no			Details
sucrose octaacetate	204-772-1	126-14-7	309	91360	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
syrups, hydrolysed starch, hydrogenated	270-337-8	68425-17-2	724	24903	no	no		In compliance with the purity criteria for maltitol syrup E 965(ii) as laid down in Commission Directive 2008/60/EC [OJ L 158, 18.6.2008, p. 17.].	Details
talc	238-877-9	14807-96-6	615	92080	yes	no			Details
tannic acids Gallic acid derivatives found in nutgalls, bark and other plant parts, especially oak bark.	215-753-2	1401-55-4	419	92150	yes	no		According to the JECFA specifications.	Details
terephthalic acid	202-830-0	100-21-0	785	24910	no	no			Details
terephthalic acid dichloride	202-829-5	100-20-9	191	24940	no	no			Details
terephthalic acid, bis(2-ethylhexyl)ester	229-176-9	6422-86-2	798	92200	yes	no	60 mg/kg		Details
terephthalic acid, bis(2-ethylhexyl)ester	229-176-9	6422-86-2	798	92200	yes	no			Details
terephthalic acid, diester with 2,2'-methylenebis(4-methyl-6-tert-butylphenol)	260-815-4	57569-40-1	696	92205	yes	no			Details
terephthalic acid, dimethyl ester	204-411-8	120-61-6	288	24970	no	no			Details
tert-butyl-4-hydroxyanisole	246-563-8	25013-16-5	635	40720	yes	no	30 mg/kg		Details
tetraethyleneglycol	203-989-9	112-60-7	269	92350 25090	yes	no			Details
tetrafluoroethylene	204-126-9	116-14-3	281	25120	no	no	0.05 mg/kg		Details
tetrahydrofuran	203-726-8	109-99-9	246	25150	no	no	0.6 mg/kg		Details
tetrakis(2,4-di-tert-butyl-phenyl)-4,4'-biphenylylene diphosphonite	254-037-4	38613-77-3	688	92560	yes	yes	18 mg/kg		Details

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