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 17 September 2021. Database contains 1072 unique substances/entries.
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232-552-5
9000-65-1
545
93680
yes
no
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201-067-0
77-90-7
138
93760
yes
no
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-
-
92
93970
yes
no
0.05 mg/kg
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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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-
-
266
94320
25510
yes
no
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253-039-2
36443-68-2
680
94400
yes
no
9 mg/kg
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212-757-6
867-13-0
800
94425
yes
no
Only for use in PET.
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204-528-4
122-20-3
292
94560
yes
no
5 mg/kg
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201-074-9
77-99-6
141
94960
25600
13380
yes
no
6 mg/kg
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-
-
815
94985
yes
no
5 mg/kg
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
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-
-
815
94985
yes
no
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
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-
-
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.
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927-697-2
28931-67-1
664
95000
yes
no
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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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216-971-0
1709-70-2
428
95200
yes
no
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-
227099-60-7
781
95265
yes
no
0.05 mg/kg
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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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254-996-9
40601-76-1
689
95280
yes
yes
6 mg/kg
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248-597-9
27676-62-6
661
95360
yes
yes
5 mg/kg
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616-108-1
745070-61-5
784
95420
yes
no
5 mg/kg
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481-840-9
160535-46-6
870
95500
yes
no
5 mg/kg
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217-420-7
1843-03-4
430
95600
yes
yes
5 mg/kg
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406-060-8
110638-71-6
757
95725
yes
no
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231-791-2
7732-18-5
515
95855
26360
yes
no
In compliance with Directive 98/83/EC [OJ L 330, 5.12.1998, p. 32.].
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-
-
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).
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-
-
94
95859
yes
no
Average molecular weight not less than 500 Da.
Viscosity at 100 °C not less than 11 cSt (11 × 10-6 m2/s).
Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w)
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-
-
95
95883
yes
no
Average molecular weight not less than 480 Da.
Viscosity at 100 °C not less than 8,5 cSt (8,5 × 10-6 m2/s).
Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w)
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237-772-5
13983-17-0
613
95905
yes
no
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-
-
96
95920
yes
no
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234-394-2
11138-66-2
596
95935
yes
no
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243-814-3
20427-58-1
628
96190
yes
no
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215-222-5
1314-13-2
402
96240
yes
no
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215-251-3
1314-98-3
403
96320
yes
no
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-
-
1043
yes
no
Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage.
When used together with the substance with FCM No 859 and/or the substance with FCM No 998, the restriction of 10 % w/w applies to the sum of those substances.
The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
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-
-
859
yes
no
Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage.
When used together with the substance with FCM No 998 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.
The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
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-
-
998
yes
no
Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage.
When used together with the substance with FCM No 859 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.
The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
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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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-
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).
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204-886-1
128-44-9
902
yes
no
The substance shall comply with the specific purity criteria as set out in Commission Regulation (EU) No 231/2012 (OJ L 83, 22.3.2012, p. 1).
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222-852-4
3634-83-1
988
no
no
SML(T) applies to the migration of its hydrolysis product, 1,3- benzenedimethanamine.
To be used only as co-monomer in the manufacture of a middle layer coating on a poly(ethylene terephthalate) polymer film in a multilayer film.
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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.
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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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813-638-7
80512-44-3
1061
no
no
Only to be used as a comonomer in the manufacture of polyether ether ketone plastics up to 0,3 % w/w of the final material.
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485-230-3
1455-42-1
1052
no
no
5 mg/kg
Only to be used as a monomer in the production of polyesters.
The migration of oligomers of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as SPG).
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455-890-7
6607-41-6
872
no
no
0.05 mg/kg
To be used only as a co-monomer in polycarbonate copolymers.
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-
37486-69-4
903
yes
no
Only to be used as a polymer production aid in the polymerisation of fluoropolymers intended for: (a) repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360 °C for at least 10 minutes or at higher temperatures for equivalent shorter times; (b) repeated use materials and articles when processed (non-sintered) at temperatures from 300 °C and up to 360 °C for at least 10 minutes.
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219-784-2
2530-83-8
1068
no
no
Only to be used as a component of a sizing agent to treat glass fibres to be embedded in glass-fibre-reinforced low diffusivity plastics (polyethylene terephthalate (PET), polycarbonate (PC), polybutylene terephthalate (PBT), thermoset polyesters and epoxy bisphenol vinylester) in contact with all foodstuffs. In treated glass fibres, residues of the substance must not be detectable at 0,01 mg/kg for the substance and 0,06 mg/kg for each of the reaction products (hydrolysed monomers and epoxy-containing cyclic dimer, trimer and tetramer).
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-
-
1031
no
no
5 mg/kg
Only to be used as a monomer in the production of polyethylene furanoate.
The migration of the oligomeric fraction of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as furan-2,5-dicarboxylic acid).
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200-405-4
58-95-7
1055
yes
no
Only to be used as antioxidant in polyolefins.
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Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.
-
-
1017
yes
no
To be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C.
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