plastic-material-food-contact

FCM and Articles Regulation, Annex I - Authorised Substances

EU. Union List of Authorised Substances: Annex I, Plastics Food Contact Regulation 10/2011/EU, as amended by Regulation 2020/1245/EU, 3 September 2020

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 September 2021. Database contains 1072 unique substances/entries.
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37953-21-2
857
66765
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % at room temperature or below.
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-
40471-03-2
867
40815
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 %.
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608-050-0
27136-15-8
869
66763
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 3 %.
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-
-
866
40620
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 7 %.
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200-254-4
56-06-4
864
46330
yes
no
5 mg/kg
Only to be used in rigid poly(vinyl chloride) (PVC) in contact with non-acidic and non-alcoholic aqueous food.
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229-934-9
6846-50-0
497
95020
yes
no
5 mg/kg
Only to be used in single-use gloves.
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288-287-0
85711-28-0
1065
yes
no
5 mg/kg
Only to be used in the manufacture of articles made of polyolefins, and which do not come into contact with foods for which food simulant D2 is assigned in Table 2 of Annex III.
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-
-
861
71990
yes
no
Only to be used in the polymerisation of fluoropolymers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles.
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236-236-8
13252-13-6
861
71990
yes
no
Only to be used in the polymerisation of fluoropolymers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles.
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680-272-0
51798-33-5
860
71980
yes
no
Only to be used in the polymerisation of fluoropolymers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles.
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700-323-3
908020-52-0
926
71955
yes
no
Only to be used in the polymerisation of fluoropolymers that are processed at temperatures higher than 300 °C for at least 10 minutes.
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958445-44-8
896
71958
yes
no
Only to be used in the polymerisation of fluoropolymers when: (1.) processed at temperatures higher than 280 °C for at least 10 minutes, (2.) processed at temperatures higher than 190 °C up to 30 % w/w for use in blends with polyoxymethylene polymers and intended for repeated use articles.
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215-222-5
1314-13-2
1050
yes
no
Only to be used in unplasticised polymers.
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215-222-5
1314-13-2
1046
yes
no
Only to be used in unplasticised polymers.
The restrictions and specifications specified for FCM substance No 788 shall be respected.
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607-698-1
25322-99-0
865
40619
yes
no
Only to be used in: (a) rigid poly(vinyl chloride) (PVC) at a maximum level of 1 % w/w. (b) polylactic acid (PLA) at a maximum level of 5 % w/w.
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618-459-6
9010-88-2
868
53245
yes
no
Only to be used in: (a) rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % w/w. (b) polylactic acid (PLA) at a maximum level of 5 % w/w. (c) polyethylene terephthalate (PET) at a maximum level of 5 % w/w.
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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.
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25101-28-4
856
40563
yes
no
Only to be used in: rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below; or at up to 40 % w/w in blends of styrene acrylonitrile copolymer (SAN)/poly(methyl methacrylate) (PMMA) repeatuse articles at room temperature or below, and when either in contact only with aqueous, acidic and/or low alcoholic (< 20 %) foodstuffs for less than 1 day, or when in contact only with dry foodstuffs for any duration of time.
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1547-26-8
1063
no
no
Only to be used together with tetrafluoroethylene and/or ethylene co-monomers to manufacture fluorocopolymers for application as polymer processing aid at up to 0,2 % w/w of the food contact material, and when the low-molecular mass fraction below 1 500 Da in the fluorocopolymer does not exceed 30 mg/kg.
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213-551-9
976-56-7
1007
no
no
Only to be used up to 0,2 % w/w based on the final polymer weight in the polymerisation process to manufacture poly(ethylene terephthalate) (PET).
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-
-
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.
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-
-
1016
yes
no
Only to be used up to: (a) 10 % w/w in non-plasticised PVC; (b) 15 % w/w in non-plasticised PLA.
The final material shall be used at room temperature or below.
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210-826-5
624-03-3
1048
yes
no
Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.
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-
-
1053
yes
no
Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.
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210-478-4
616-38-6
1067
no
no
Only to be used: a) with 1,6-hexanediol in the manufacture of polycarbonate pre-polymers that are used at up to 30 % to manufacture thermoplastic polyurethanes with 4,4'-methylenediphenyldiisocyanate and diols, such as polypropylene glycol and 1,4-butanediol. The resulting material shall only be applied in repeated use articles intended to come into short-term contact (≤ 30 min at room temperature) with food for which simulants A and/or B are assigned in Table 2 of Annex III; or b) for the production of other polycarbonates and/or under other conditions provided that the migration of dimethyl carbonate does not exceed 0,05 mg/kg food and that the migration of all polycarbonate oligomers with a molecular weight below 1 000 Da together does not exceed 0,05 mg/kg food.
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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.
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-
-
97
72081/10
yes
no
Petroleum hydrocarbon resins, hydrogenated are produced by the catalytic or thermalpolymerisation of dienes and olefins of the aliphatic, alicyclic and/or monobenzenoidarylalkene types from distillates of cracked petroleum stocks with a boiling range not greater than 220 °C, as well as the pure monomers found in these distillation streams, subsequently followed by distillation, hydrogenation and additional processing.
Properties: Viscosity at 120 °C: > 3 Pa.s,Softening point: > 95 °C as determined by ASTM Method E 28-67,Bromine number: < 40 (ASTM D1159),The colour of a 50 % solution in toluene < 11 on the Gardner scale,Residual aromatic monomer ≤ 50 ppm.
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215-609-9
1333-86-4
411
42080
yes
no
Primary particles of 10 - 300 nm which are aggregated to a size of 100 - 1200 nm which may form agglomerates within the size distribution of 300 nm - mm.
Toluene extractables: maximum 0,1 %, determined according to ISO method 6209.
UV absorption of cyclohexane extract at 386 nm: < 0,02 AU for a 1 cm cell or < 0,1 AU for a 5 cm cell, determined according to a generally recognised method of analysis.
Benzo(a)pyrene content: max 0,25 mg/kg carbon black.
Maximum use level of carbon black in the polymer: 2,5 % w/w.
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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).
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-
-
873
93460
yes
no
Reaction product of titanium dioxide with up to 2 % w/w surface treatment substance octyltriethoxysilane, processed at high temperatures.
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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.
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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.
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614-610-5
68554-70-1
730
66930
yes
no
Residual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane.
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224-594-8
4422-95-1
481
13060
no
no
0.05 mg/kg
SML expressed as 1,3,5-benzenetricarboxylic acid.
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204-179-8
117-21-5
786
14627
no
no
0.05 mg/kg
SML expressed as 3-chlorophthalic acid.
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204-251-9
118-45-6
787
14628
no
no
0.05 mg/kg
SML expressed as 4-chlorophthalic acid.
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681-637-7
25134-51-4
636
31500
yes
no
0.05 mg/kg
SML expressed as acrylic acid, 2-ethylhexyl ester.
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202-510-0
96-49-1
177
16955
no
no
30 mg/kg
SML expressed as ethyleneglycol.
Residual content of 5 mg ethylene carbonate per kg of hydrogel with max 10 g of hydrogel in contact with 1 kg of food.
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-
37296-97-2
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.
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279-459-6
80410-33-9
745
68145
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
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410-290-4
80693-00-1
746
38810
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
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416-140-4
145650-60-8
769
74010
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
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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.
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421-920-2
154862-43-8
773
38840
yes
yes
5 mg/kg
SML expressed as sum of the substance itself, its oxidised form bis(2,4-dicumylphenyl)pentaerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol).
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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).
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Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.
-
-
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
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-
203255-81-6
792
92475
yes
yes
5 mg/kg
SML expressed as the sum of phosphite and phosphate form of the substance and the hydrolysis products.
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700-485-5
939402-02-5
974
74050
yes
yes
10 mg/kg
SML expressed as the sum of the phosphite and phosphate forms of the substance, 4-tert-amylphenol and 2,4-di-tert-amylphenol.
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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.
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203-049-8
102-71-6
793
94000
yes
no
0.05 mg/kg
SML expressed as the sum of triethanolamine and the hydrochloride adduct expressed as triethanolamine.
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