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 17 June 2024. Database contains 1080 unique substances/entries.
Filter the list

 
-
266309-43-7
1
12310
no
no
Details
-
-
10
30612
yes
no
Details
-
-
100
88320
24490
yes
no
Details
200-061-5
50-70-4
100
88320
24490
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
-
-
101
36000
yes
no
Details
200-066-2
50-81-7
101
36000
yes
no
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
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
200-075-1
50-99-7
102
17530
no
no
Details
-
-
103
18100
55920
yes
no
Details
200-289-5
56-81-5
103
18100
55920
yes
no
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
-
-
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
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
200-311-3
57-09-0
104
58960
yes
no
6 mg/kg
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
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
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
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
-
-
105
22780
70400
yes
no
Details
200-312-9
57-10-3
105
22780
70400
yes
no
Details
215-222-5
1314-13-2
1050
yes
no
Only to be used in unplasticised polymers.
Details
NYLOSTAB S-EED; NYSEED
419-710-0
42774-15-2
1051
yes
no
5 mg/kg
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
-
-
1053
yes
no
Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.
Details
200-405-4
58-95-7
1055
yes
no
Only to be used as antioxidant in polyolefins.
Details
231-710-0
7695-91-2
1055
yes
no
Only to be used as antioxidant in polyolefins.
Details
-
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
-
-
106
24550
89040
yes
no
Details
200-313-4
57-11-4
106
24550
89040
yes
no
Details
-
-
1060
yes
no
Only to be used at room temperature or below in contact with foods for which Table 2 of Annex III assigns food simulant E.
The seed hulls shall be obtained from sunflower seeds that are fit for human consumption.
The processing temperature of the plastic containing the additive shall not exceed 240 °C.
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
-
-
1062
no
no
Only to be used for the production of recycled PET and at up to 0,12 % (w/w).
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
254-413-8
39318-18-8
1064
yes
no
0.05 mg/kg
Stoichiometry: WOn, n = 2,72-2,90.
Details
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.
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
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
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
200-857-2
75-28-5
1069
yes
no
Only to be used as a blowing agent.
Details
200-315-5
57-13-6
107
25960
no
no
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 (a)as an additive at up to 0.2 % w/w in high impact polystyrene materials and articles intended for 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; (b)as an additive at up to 0.025 % w/w in acrylonitrile-butadiene-styrene (ABS) materials for use at room temperature and below.
Details
-
-
1077
yes
no
Only to be used at up to 25.0 % w/w, including in the nanoform.
Details
222-020-0
3319-31-1
1078
yes
no
1 mg/kg
Only to be used as plasticiser to manufacture soft poly(vinyl chloride).
Not to be used in contact with foods intended for infants.
Details
283-829-2
84731-70-4
1079
yes
no
0.05 mg/kg
Only to be used as an additive in poly(vinyl chloride) (PVC) at up to 25 % w/w in contact at room temperature or below with foods for which food simulants A or B are assigned in Table 2 of Annex III.
Details
200-334-9
57-50-1
108
24880
no
no
Details
480-340-8
156157-97-0
1080
yes
no
Only to be used in rigid poly (vinyl chloride) in contact with foods included in the food category with reference number 01.01.A in table 2 of Annex III.
Details
480-340-8
156157-97-0
1080
yes
no
Only to be used in rigid poly (vinyl chloride) in contact with foods included in the food category with reference number 01.01.A in table 2 of Annex III.
Details
-
-
1081
yes
no
Only to be used at up to 2 % (w/w) in plastic materials and articles intended for the packaging by food business operators of dry foods for which simulant E is assigned in table 2 of Annex III.
Details
258-053-2
52628-03-2
1082
no
no
0.05 mg/kg
Only to be used at up to 0,35 % (w/w) to manufacture polymethylmethacrylate.
Details
219-348-1
2421-28-5
1083
no
no
0.05 mg/kg
Only to be used at up to 43 % (w/w) as a co-monomer in the production of polyimides for use in contact with foods for which only simulants B and/or D2 are laid down in table 2 of Annex III at temperatures up to 250 °C.
Details
200-338-0
57-55-6
109
23740
81840
yes
no
Details
-
-
109
23740
81840
yes
no
Details
-
-
11
30960
yes
no
Details
-
-
110
93520
yes
no
Details
200-412-2
59-02-9
110
93520
yes
no
Details
233-466-0
10191-41-0
110
93520
yes
no
Details
-
-
111
53600
yes
no
Details
200-449-4
60-00-4
111
53600
yes
no
Details
-
-
112
64015
yes
no
Details
200-470-9
60-33-3
112
64015
yes
no
Details
-
-
113
52800
16780
yes
no
Details
200-578-6
64-17-5
113
52800
16780
yes
no
Details
-
-
114
55040
yes
no
Details
200-579-1
64-18-6
114
55040
yes
no
Details
200-580-7
64-19-7
115
30000
10090
yes
no
Details
-
-
115
30000
10090
yes
no
Details
-
-
116
37600
13090
yes
no
Details
200-618-2
65-85-0
116
37600
13090
yes
no
Details
-
-
117
21550
no
no
Details
200-659-6
67-56-1
117
21550
no
no
Details
200-661-7
67-63-0
118
81882
23830
yes
no
Details
-
-
118
81882
23830
yes
no
Details
200-662-2
67-64-1
119
30295
yes
no
Details
-
-
12
31328
yes
no
Details
200-664-3
67-68-5
120
49540
yes
no
Details
200-746-9
71-23-8
122
23800
no
no
Details
-
-
122
23800
no
no
Details
200-751-6
71-36-3
123
13840
no
no
Details
-
-
123
13840
no
no
Details
200-752-1
71-41-0
124
22870
no
no
Details
-
-
124
22870
no
no
Details
200-815-3
74-85-1
125
16950
no
no
Details
200-816-9
74-86-2
126
10210
no
no
Details
200-831-0
75-01-4
127
26050
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
200-836-8
75-07-0
128
10060
no
no
Details
200-849-9
75-21-8
129
17020
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
-
-
13
33120
yes
no
Details
200-864-0
75-35-4
130
26110
no
no
0.01 mg/kg
Details
200-866-1
75-37-6
131
48460
yes
no
Details
200-867-7
75-38-7
132
26140
no
no
5 mg/kg
Details
200-870-3
75-44-5
133
23155
14380
no
no
0.01 mg/kg
1 mg/kg in final product.
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
200-879-2
75-56-9
135
24010
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
200-945-0
76-22-2
136
41680
yes
no
Details
201-044-5
77-62-3
137
66580
yes
yes
Details
-
-
137
66580
yes
yes
Details
201-067-0
77-90-7
138
93760
yes
no
Details
-
-
139
44160
14680
yes
no
Details
201-069-1
77-92-9
139
44160
14680
yes
no
Details
-
-
14
33801
yes
no
30 mg/kg
Details
201-070-7
77-93-0
140
44640
yes
no
Details
201-074-9
77-99-6
141
94960
25600
13380
yes
no
6 mg/kg
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
201-142-8
78-78-4
143
62450
yes
no
Details
201-143-3
78-79-5
144
21640
19243
no
no
0.01 mg/kg
1 mg/kg in final product.
Details
201-173-7
79-06-1
145
10630
no
no
0.01 mg/kg
Details
-
-
146
82000
23890
yes
no
Details
201-176-3
79-09-4
146
82000
23890
yes
no
Details
201-177-9
79-10-7
147
10690
no
no
Details
-
-
147
10690
no
no
Details
201-201-8
79-38-9
148
14650
no
no
0.01 mg/kg
Details
201-202-3
79-39-0
149
19990
no
no
0.01 mg/kg
Details
-
-
15
34130
yes
yes
30 mg/kg
Details
-
-
150
20020
no
no
Details
201-204-4
79-41-4
150
20020
no
no
Details
201-245-8
80-05-7
151
13480
13607
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
201-247-9
80-07-9
152
15610
no
no
0.05 mg/kg
Details
201-248-4
80-08-0
153
15267
no
no
5 mg/kg
Details
201-250-5
80-09-1
154
13617
16090
no
no
0.05 mg/kg
Details
201-291-9
80-56-8
155
23470
no
no
Details
201-297-1
80-62-6
156
21130
no
no
Details
201-557-4
84-74-2
157
74880
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.
Details
201-557-4
84-74-2
157
74880
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.
Details
201-557-4
84-74-2
157
74880
yes
no
0.12 mg/kg
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in polyolefins in concentrations up to 0,05 % in the final product.
Details
201-607-5
85-44-9
158
23380
76320
yes
no
Details
201-622-7
85-68-7
159
74560
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product.
Details
201-622-7
85-68-7
159
74560
yes
no
6 mg/kg
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product.
Details
201-622-7
85-68-7
159
74560
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product.
Details
-
-
16
34230
yes
no
6 mg/kg
Details
201-728-3
87-18-3
160
84800
yes
yes
12 mg/kg
Details
-
-
161
92160
yes
no
Details
201-766-0
87-69-4
161
92160
yes
no
Details
-
-
162
65520
yes
no
Details
201-770-2
87-78-5
162
65520
yes
no
Details
201-814-0
88-24-4
163
66400
yes
yes
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
201-873-2
88-99-3
165
23200
74480
yes
no
Details
201-898-9
89-32-7
166
24057
no
no
0.05 mg/kg
Details
202-039-0
91-08-7
167
25240
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
202-095-6
91-76-9
168
13075
15310
no
no
5 mg/kg
Details
202-112-7
91-97-4
169
16240
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
-
-
17
34281
yes
no
Details
202-200-5
92-88-6
170
16000
no
no
6 mg/kg
Details
202-259-7
93-58-3
171
38080
yes
no
Details
202-284-3
93-89-0
172
37840
yes
no
Details
202-307-7
94-13-3
173
60240
yes
no
Details
-
-
174
14740
no
no
Details
202-423-8
95-48-7
174
14740
no
no
Details
202-473-0
96-05-9
175
20050
no
no
0.05 mg/kg
Details
202-500-6
96-33-3
176
11710
no
no
Details
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.
Details
202-525-2
96-69-5
178
92800
yes
yes
0.48 mg/kg
Details
-
-
178
92800
yes
yes
0.48 mg/kg
Details
202-567-1
97-23-4
179
48800
yes
yes
12 mg/kg
Details
-
191427-79-9
18
34475
yes
no
Details
202-589-1
97-53-0
180
17160
no
no
Details
202-597-5
97-63-2
181
20890
no
no
Details
-
-
182
19270
no
no
Details
202-599-6
97-65-4
182
19270
no
no
Details
202-613-0
97-86-9
183
21010
no
no
Details
202-615-1
97-88-1
184
20110
no
no
Details
202-617-2
97-90-5
185
20440
no
no
0.05 mg/kg
Details
202-679-0
98-54-4
186
14020
no
no
0.05 mg/kg
Details
-
-
186
14020
no
no
0.05 mg/kg
Details
202-705-0
98-83-9
187
22210
no
no
0.05 mg/kg
Details
202-774-7
99-63-8
188
19180
no
no
Details
202-785-7
99-76-3
189
60200
yes
no
Details
-
-
19
39090
yes
no
Details
-
-
190
18880
no
no
Details
202-804-9
99-96-7
190
18880
no
no
Details
202-829-5
100-20-9
191
24940
no
no
Details
-
-
192
23187
no
no
Details
201-873-2
88-99-3
192
23187
no
no
Details
202-851-5
100-42-5
193
24610
no
no
Details
-
-
194
13150
no
no
Details
202-859-9
100-51-6
194
13150
no
no
Details
202-860-4
100-52-7
195
37360
yes
no
Details
202-905-8
100-97-0
196
18670
59280
yes
no
Details
202-943-5
101-43-9
197
20260
no
no
0.05 mg/kg
Details
202-966-0
101-68-8
198
16630
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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
-
-
2
12340
no
no
Details
-
-
20
39120
yes
no
SML(T) expressed excluding HCl.
Details
203-004-2
102-08-9
200
51680
yes
yes
3 mg/kg
Details
203-005-8
102-09-0
201
16540
no
no
0.05 mg/kg
Details
203-027-8
102-39-6
202
23070
no
no
0.05 mg/kg
Details
203-028-3
102-40-9
203
13323
no
no
0.05 mg/kg
Details
203-041-4
102-60-3
204
92640
25180
yes
no
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
203-080-7
103-11-7
206
11500
no
no
0.05 mg/kg
Details
203-090-1
103-23-1
207
31920
yes
yes
18 mg/kg
Details
203-090-1
103-23-1
207
31920
yes
yes
Details
203-157-5
103-90-2
208
18898
no
no
0.05 mg/kg
Details
203-234-3
104-76-7
209
17050
no
no
30 mg/kg
Details
-
-
209
17050
no
no
30 mg/kg
Details
-
-
21
42500
yes
no
Details

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