plastic-material-food-contact
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 09 June 2023. Database contains 1067 unique substances/entries.
Filter the list
|
253-039-2
|
36443-68-2
|
680 |
94400 |
yes |
no |
9 mg/kg |
Details | ||
|
212-757-6
|
867-13-0
|
800 |
94425 |
yes |
no |
Only for use in PET. |
Details | ||
|
204-528-4
|
122-20-3
|
292 |
94560 |
yes |
no |
5 mg/kg |
Details | ||
|
201-074-9
|
77-99-6
|
141 |
94960 25600 13380 |
yes |
no |
6 mg/kg |
Details | ||
|
-
|
-
|
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. |
Details | |
|
-
|
-
|
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. |
Details | ||
|
-
|
-
|
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 | |
|
927-697-2
|
28931-67-1
|
664 |
95000 |
yes |
no |
Details | |||
|
229-934-9
|
6846-50-0
|
497 |
95020 |
yes |
no |
5 mg/kg |
Only to be used in single-use gloves. |
Details | |
|
216-971-0
|
1709-70-2
|
428 |
95200 |
yes |
no |
Details | |||
|
-
|
227099-60-7
|
781 |
95265 |
yes |
no |
0.05 mg/kg |
Details | ||
|
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 | |
|
254-996-9
|
40601-76-1
|
689 |
95280 |
yes |
yes |
6 mg/kg |
Details | ||
|
248-597-9
|
27676-62-6
|
661 |
95360 |
yes |
yes |
5 mg/kg |
Details | ||
|
456-830-2
|
745070-61-5
|
784 |
95420 |
yes |
no |
5 mg/kg |
Details | ||
|
481-840-9
|
160535-46-6
|
870 |
95500 |
yes |
no |
5 mg/kg |
Details | ||
|
217-420-7
|
1843-03-4
|
430 |
95600 |
yes |
yes |
5 mg/kg |
Details | ||
|
MICROLITE (R) POWDER; MICROLITE (R) VERMICULITE DISPERSIONS; MICROLITE POWDER; MICROLITE SPECIALITY VERMICULITE; MICROLITE VERMICULITE DISPERSIONS; MICROLITE-VERMICULITDISPERSIONEN
|
406-060-8
|
110638-71-6
|
757 |
95725 |
yes |
no |
Details | ||
|
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.]. |
Details | ||
|
-
|
-
|
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 | |
|
-
|
-
|
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) |
Details | ||
|
-
|
-
|
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) |
Details | ||
|
237-772-5
|
13983-17-0
|
613 |
95905 |
yes |
no |
Details | |||
|
-
|
-
|
96 |
95920 |
yes |
no |
Details | |||
|
234-394-2
|
11138-66-2
|
596 |
95935 |
yes |
no |
Details | |||
|
243-814-3
|
20427-58-1
|
628 |
96190 |
yes |
no |
Details | |||
|
215-222-5
|
1314-13-2
|
402 |
96240 |
yes |
no |
Details | |||
|
215-251-3
|
1314-98-3
|
403 |
96320 |
yes |
no |
Details | |||
|
-
|
-
|
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. |
Details | |||
|
-
|
-
|
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. |
Details | |||
|
-
|
-
|
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. |
Details | |||
|
-
|
-
|
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. |
Details | |||
|
-
|
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 | ||
|
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). |
Details | |||
|
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. |
Details | |||
|
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 | ||
|
-
|
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. |
Details | |||
|
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. |
Details | |||
|
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). |
Details | ||
|
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 | ||
|
-
|
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. |
Details | |||
|
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). |
Details | |||
|
-
|
-
|
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). |
Details | ||
|
200-405-4
|
58-95-7
|
1055 |
yes |
no |
Only to be used as antioxidant in polyolefins. |
Details | |||
|
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). |
Details | |||
|
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. |
Details | |||
|
-
|
287916-86-3
|
871 |
yes |
no |
Only to be used in polyolefins at levels of up to 20 weight %. These polyolefins shall only be used in contact with foods for which Table 2 of Annex III assigns food simulant E, at ambient temperature or below, and when migration of the total oligomeric fraction of less than 1 000 Da does not exceed 50 µg/kg food. |
Details | |||
|
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. |
Details | |||
|
429-840-1
|
24937-78-8
|
969 |
yes |
no |
Only to be used as a polymeric additive up to 2 % w/w in polyolefins. The migration of low molecular weight oligomeric fraction below 1 000 Da shall not exceed 5 mg/kg food. |
Details | |||
|
-
|
-
|
1053 |
yes |
no |
Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils. |
Details | |||
EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.