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 June 2021. Database contains 1072 unique substances/entries.
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174254-23-0
777
31542
yes
no
0,5 % in final product.
Details
-
-
5
25360
no
no
0.01 mg/kg
1 mg/kg in final product expressed as epoxygroup.
Molecular weight is 43 Da.
Details
221-641-4
3173-72-6
461
22420
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
223-861-6
4098-71-9
475
19110
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
209-544-5
584-84-9
354
25210
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
247-953-0
26747-90-0
653
25270
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
202-039-0
91-08-7
167
25240
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
202-112-7
91-97-4
169
16240
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
221-639-3
3173-53-3
460
14950
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
225-863-2
5124-30-1
485
13560
15700
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
626-593-1
4128-73-8
476
16570
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
227-534-9
5873-54-1
490
16600
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
202-966-0
101-68-8
198
16630
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
212-485-8
822-06-0
372
18640
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
915-277-1
32052-51-0
4
22332
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
204-019-7
112-96-9
274
22570
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
201-143-3
78-79-5
144
21640
19243
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
203-450-8
106-99-0
223
13630
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
200-870-3
75-44-5
133
23155
14380
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
203-439-8
106-89-8
219
16750
14570
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
200-849-9
75-21-8
129
17020
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
204-552-5
122-52-1
293
23175
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
200-879-2
75-56-9
135
24010
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
200-831-0
75-01-4
127
26050
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
203-048-2
102-70-5
205
25385
no
no
40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1,5 grams of hydrogel.
Only to be used in hydrogels intended for non-direct food contact use.
Details
223-792-1
4074-90-2
473
12265
no
no
0.01 mg/kg
5 mg/kg in final product.
Only to be used as co-monomer.
Details
-
-
419
92150
yes
no
According to the JECFA specifications.
Details
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
617-335-9
82451-48-7
790
80480
yes
no
5 mg/kg
Average molecular weight not less than 2400 Da.
Residual content of morpholine ≤ 30 mg/kg, of N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg.
Details
-
90751-07-8
790
80480
yes
no
5 mg/kg
Average molecular weight not less than 2400 Da.
Residual content of morpholine ≤ 30 mg/kg, of N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg.
Details
-
-
789
60027
yes
no
Average molecular weight not less than 440 Da.
Viscosity at 100 °C not less than 3,8 cSt (3,8 × 10-6 m2/s).
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
-
-
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
432-130-2
119345-01-6
760
83595
yes
no
18 mg/kg
Composition: 4,4'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0038613-77-3) (36-46 % w/w (*)),4,3'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-00-4) (17-23 % w/w (*)),3,3'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-01-5) (1-5 % w/w (*)),4-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0091362-37-7) (11-19 % w/w (*)),tris(2,4-di-tert-butylphenyl)phosphite (CAS No 0031570-04-4) (9-18 % w/w (*)),4,4'-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonate-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0112949-97-0) (< 5 % w/w (*))(*)Quantity of substance used/quantity of formulationOther specifications: Phosphor content of min. 5,4 % to max. 5,9 %,Acid value of max. 10 mg KOH per gram,Melt range of 85- 110 °C.
Details
200-871-9
75-45-6
134
43680
yes
no
6 mg/kg
Content of chlorofluoromethane less than 1 mg/kg of the substance.
Details
218-487-5
2162-74-5
438
13303
no
no
0.05 mg/kg
Expressed as the sum of bis(2,6-diisopropylphenyl)carbodiimide and its hydrolysis product 2,6-diisopropylaniline
Details
618-558-4
9046-01-9
578
79600
yes
no
5 mg/kg
For materials and articles intended for contact with aqueous foods only.
Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether.
Details
-
-
87
86285
yes
no
For synthetic amorphous silicon dioxide, silanated: primary particles of 1-100 nm which are aggregated to a size of 0,1-1 µm and may form agglomerates within the size distribution of 0,3 µm to the mm size.
Details
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
-
-
499
65020
19965
yes
no
In case of use as a monomer only to be used as a co-monomer in aliphatic polyesters up to maximum level of 1 % on a molar basis.
Details
230-022-8
6915-15-7
499
65020
19965
yes
no
In case of use as a monomer only to be used as a co-monomer in aliphatic polyesters up to maximum level of 1 % on a molar basis.
Details
216-823-5
1675-54-3
426
13510
13610
no
no
In compliance with Commission Regulation (EC) No 1895/2005 [OJ L 302, 19.11.2005, p. 28].
Details
231-791-2
7732-18-5
515
26360
95855
yes
no
In compliance with Directive 98/83/EC [OJ L 330, 5.12.1998, p. 32.].
Details
-
-
799
77708
yes
no
1.8 mg/kg
In compliance with the maximum ethylene oxide content as laid down in the purity criteria for food additives in Commission Regulation (EU) No 231/2012.
Details
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
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
-
26427-07-6
649
47210
yes
no
Molecular unit = (C8H18S3Sn2)n (n = 1,5-2).
Details
234-354-4
11116-16-8
807
93485
yes
no
No migration of titanium nitride nanoparticles.
Only to be used in polyethelyne terephthalate (PET) bottles up to 20 mg/kg.
In the PET, the agglomerates have a diameter of 100 - 500 nm consisting of primary titanium nitride nanoparticles; primary particles have a diameter of approximately 20 nm.
Details
247-117-5
25583-20-4
807
93485
yes
no
No migration of titanium nitride nanoparticles.
Only to be used in polyethelyne terephthalate (PET) bottles up to 20 mg/kg.
In the PET, the agglomerates have a diameter of 100 - 500 nm consisting of primary titanium nitride nanoparticles; primary particles have a diameter of approximately 20 nm.
Details
-
-
65
67155
yes
no
Not more than 0,05 % (w/w) (quantity of substance used/quantity of the formulation).
Mixture obtained from the manufacturing process in the typical ratio of (58-62 %):(23-27 %):(13-17 %)
Details
205-483-3
141-43-5
326
35170
12763
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.
For indirect food contact only, behind a PET layer.
Details
293-728-5
91082-17-6
884
34240
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.
Details
-
-
326
12763
35170
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.
For indirect food contact only, behind a PET layer.
Details
418-370-0
143925-92-2
768
34850
yes
no
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
Only to be used in: (a)polyolefins at 0,1 % (w/w) concentration and in(b)PET at 0,25 % (w/w) concentration.
Details
203-867-5
111-41-1
262
35284
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.
For indirect food contact only, behind a PET layer.
Details
-
-
810
68119
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
-
-
810
68119
yes
no
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
Details
246-665-2
25151-96-6
637
71635
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.
Details
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
-
-
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
-
-
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
604-838-3
152261-33-1
803
33535
yes
no
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
Not to be used in contact with alcoholic foods.
Details
201-245-8
80-05-7
151
13607
13480
no
no
0.05 mg/kg
Not to be used for the manufacture of polycarbonate infant [Infant as defined in Article 2(2)(a) of Regulation (EU) No 609/2013] feeding bottles [This restriction is applicable from 1 May 2011 as regards the manufacture and from 1 June 2011 as regards the placing on the market and importation into the Union].
Not to be used for the manufacture of polycarbonate drinking cups or bottles which, due to their spill proof characteristics, are intended for infants [Infant as defined in Article 2(2)(a) of Regulation (EU) No 609/2013] and young children [Young children as defined in Article 2(2)(b) of Regulation (EU) No 609/2013].
Details
248-093-9
26896-20-8
819
68110
yes
no
0.05 mg/kg
Not to be used in polymers contacting fatty foods.
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
SML expressed as neodecanoic acid.
Details
-
-
817
38507
yes
no
5 mg/kg
Not to be used with polyethylene in contact with acidic foods.
Purity ≥ 96 %.
Details
231-153-3
7440-44-0
713
43480
yes
no
Only for use in PET at maximum 10 mg/kg of polymer.
Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Regulation (EU) No 231/2012 with exception of ash content which can be up to 10 % (w/w).
Details
264-846-4
64365-11-3
713
43480
yes
no
Only for use in PET at maximum 10 mg/kg of polymer.
Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Regulation (EU) No 231/2012 with exception of ash content which can be up to 10 % (w/w).
Details
201-851-2
88-68-6
164
34895
yes
no
0.05 mg/kg
Only for use in PET for water and beverages.
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
-
852282-89-4
809
49080
yes
yes
0.05 mg/kg
Only for use in PET.
Details
-
-
76
77732
yes
no
0.05 mg/kg
Only for use in PET.
Details
-
-
77
77733
yes
no
0.05 mg/kg
Only for use in PET.
Details
212-757-6
867-13-0
800
94425
yes
no
Only for use in PET.
Details
221-140-0
3010-96-6
881
25187
no
no
5 mg/kg
Only for: (a) repeated use articles for long term storage at room temperature or below and hotfill; (b) single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.
Details
-
-
881
25187
no
no
5 mg/kg
Only for: (a) repeated use articles for long term storage at room temperature or below and hotfill; (b) single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.
Details
200-857-2
75-28-5
1069
yes
no
Only to be used as a blowing agent.
Details
211-471-9
646-25-3
863
15260
no
no
0.05 mg/kg
Only to be used as a co-monomer for manufacturing polyamide articles for repeated use in contact with aqueous, acidic and dairy foodstuffs at room temperature or for short term contact up to 150 °C.
Details
209-929-8
598-32-3
357
13932
no
no
0.01 mg/kg
Only to be used as a co-monomer for the preparation of polymeric additive.
Details
-
-
357
13932
no
no
0.01 mg/kg
Only to be used as a co-monomer for the preparation of polymeric additive.
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
243-053-7
19430-93-4
973
22931
no
no
Only to be used as a co-monomer up to 0,1 % w/w in the polymerisation of fluoropolymers, sintered at high temperatures.
Details
219-547-3
2459-10-1
971
25885
no
no
Only to be used as a co-monomer up to 0,35 % w/w to produce modified polyesters intended to be used in contact with aqueous and dry foodstuffs containing no free fat at the surface.
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
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
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
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
-
-
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
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
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
-
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
607-457-0
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
219-785-8
2530-85-0
788
21498
no
no
0.05 mg/kg
Only to be used as a surface treatment agent of inorganic fillers.
Details
201-081-7
78-08-0
142
26305
no
no
0.05 mg/kg
Only to be used as a surface treatment agent.
Details
-
-
1075
yes
no
Only to be used as additive at up to 4.0 % w/w in polylactic acid plastics intended for long-term storage of water at ambient temperature or below. Can form platelets in the nanoform that are in one or two dimensions thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.
Details
843-672-8
1227937-46-3
1076
yes
no
0.05 mg/kg
Only to be used as an additive at up to 0.2 % w/w in high impact polystyrene materials and articles intended contact with food at room temperature and below, including hot-fill and/or heating up to 100 ° C for up to 2 hours. It shall not be used in contact with foods for which simulant C and/or D1 is assigned in Annex III.
Details
200-405-4
58-95-7
1055
yes
no
Only to be used as antioxidant in polyolefins.
Details
257-757-7
7695-91-2
1055
yes
no
Only to be used as antioxidant in polyolefins.
Details
641-029-4
156065-00-8
874
16265
no
no
Only to be used as comonomer in siloxane modified polycarbonate.
The oligomeric mixture shall be characterised by the formula C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).
Details
641-029-4
156065-00-8
874
16265
no
no
0.05 mg/kg
Only to be used as comonomer in siloxane modified polycarbonate.
The oligomeric mixture shall be characterised by the formula C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).
Details

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