plastic-material-food-contact

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 03 May 2024. Database contains 1080 unique substances/entries.
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147398-31-0
1059
no
no
The substance is a macromolecule obtained from microbial fermentation. Only to be used at temperature conditions not exceeding the conditions defined in point 2.1.4(d) of Annex V. The migration of all oligomers with a molecular weight below 1 000Da shall not exceed 5.0 mg/kg food.
Details
231-710-0
7695-91-2
1055
yes
no
Only to be used as antioxidant in polyolefins.
Details
200-405-4
58-95-7
1055
yes
no
Only to be used as antioxidant in polyolefins.
Details
-
-
1053
yes
no
Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.
Details
604-479-2
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
NYLOSTAB S-EED; NYSEED
419-710-0
42774-15-2
1051
yes
no
5 mg/kg
Details
215-222-5
1314-13-2
1050
yes
no
Only to be used in unplasticised polymers.
Details
200-312-9
57-10-3
105
22780
70400
yes
no
Details
-
-
105
22780
70400
yes
no
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
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.
Details
682-238-0
1190931-27-1
1045
yes
no
Only to be used as a polymer production aid during the manufacture of fluoropolymers under high temperature conditions of at least 370 °C.
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
200-311-3
57-09-0
104
58960
yes
no
6 mg/kg
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
221-800-8
3238-40-2
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
-
-
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
-
-
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
200-289-5
56-81-5
103
18100
55920
yes
no
Details
-
-
103
18100
55920
yes
no
Details
200-075-1
50-99-7
102
17530
no
no
Details
607-759-2
25618-55-7
1017
yes
no
To be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C.
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
200-066-2
50-81-7
101
36000
yes
no
Details
-
-
101
36000
yes
no
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) and poly(ethylene 2,5-furandicarboxylate) (PEF)
Details
200-061-5
50-70-4
100
88320
24490
yes
no
Details
-
-
100
88320
24490
yes
no
Details
-
-
10
30612
yes
no
Details
-
266309-43-7
1
12310
no
no
Details

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