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 29 May 2023. Database contains 1067 unique substances/entries.
Filter the list
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8001-39-6
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525 |
62640 |
yes |
no |
Details | |||
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201-766-0
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87-69-4
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161 |
92160 |
yes |
no |
Details | |||
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The complex combination of diglycerides of fatty acids linked to the choline ester of phosphoric acid.
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232-307-2
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8002-43-5
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528 |
63760 |
yes |
no |
Details | ||
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617-129-9
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8062-15-5
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540 |
63940 |
yes |
no |
0.24 mg/kg |
Only to be used as dispersant for plastics dispersions. |
Details | |
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201-770-2
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87-78-5
|
162 |
65520 |
yes |
no |
Details | |||
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201-297-1
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80-62-6
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156 |
21130 |
no |
no |
Details | |||
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212-782-2
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868-77-9
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374 |
21190 |
no |
no |
Details | |||
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288-287-0
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85711-28-0
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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 | ||
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Wax obtained by extraction of lignite.
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232-313-5
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8002-53-7
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529 |
67850 |
yes |
no |
Details | ||
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-
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852282-89-4
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809 |
49080 |
yes |
yes |
0.05 mg/kg |
Only for use in PET. |
Details | |
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282-811-1
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84434-12-8
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748 |
12765 |
no |
no |
0.05 mg/kg |
Details | ||
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212-828-1
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872-50-4
|
376 |
66905 |
yes |
no |
60 mg/kg |
Details | ||
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201-873-2
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88-99-3
|
165 |
23200 74480 |
yes |
no |
Details | |||
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201-873-2
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88-99-3
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192 |
23187 |
no |
no |
Details | |||
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201-622-7
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85-68-7
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159 |
74560 |
yes |
no |
30 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 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;(c)technical support agent in concentrations up to 0,1 % in the final product. |
Details | |
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201-622-7
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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 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;(c)technical support agent in concentrations up to 0,1 % in the final product. |
Details | ||
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201-557-4
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84-74-2
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157 |
74880 |
yes |
no |
0.3 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 | |
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201-557-4
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84-74-2
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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 | ||
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201-607-5
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85-44-9
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158 |
23380 76320 |
yes |
no |
Details | |||
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700-107-9
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87189-25-1
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751 |
81515 |
yes |
no |
Details | |||
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232-417-0
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8017-16-1
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534 |
80720 |
yes |
no |
Details | |||
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201-898-9
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89-32-7
|
166 |
24057 |
no |
no |
0.05 mg/kg |
Details | ||
|
A complex combination derived from wood, especially pine wood. Composed primarily of resin acids and modified resin acids such as dimers and decarboxylated resin acids. Includes rosin stabilized by catalytic disproportionation.
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232-475-7
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8050-09-7
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535 |
24100 24190 83840 24130 |
yes |
no |
Details | ||
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A complex combination derived from tall oil. Composed primarily of tricyclic monocarboxylic acids, mainly abietic and dehydroabietic acids. Includes tall-oil rosin stabilized by catalytic disproportionation.
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232-484-6
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8052-10-6
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539 |
24160 |
no |
no |
Details | ||
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232-482-5
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8050-31-5
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538 |
84000 |
yes |
no |
Details | |||
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232-476-2
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8050-15-5
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536 |
84320 |
yes |
no |
Details | |||
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201-728-3
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87-18-3
|
160 |
84800 |
yes |
yes |
12 mg/kg |
Details | ||
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Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic and stearic. (Soja hispida, Leguminosae).
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232-274-4
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8001-22-7
|
524 |
24520 |
no |
no |
Details | ||
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232-391-0
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8013-07-8
|
532 |
88640 |
yes |
no |
60 mg/kg |
Details | ||
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232-391-0
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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 | |
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232-391-0
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8013-07-8
|
532 |
88640 |
yes |
no |
Details | |||
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212-757-6
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867-13-0
|
800 |
94425 |
yes |
no |
Only for use in PET. |
Details | ||
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201-291-9
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80-56-8
|
155 |
23470 |
no |
no |
Details | |||
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618-459-6
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9010-88-2
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868 |
53245 |
yes |
no |
Only to be used in: (a) rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % w/w. (b) polylactic acid (PLA) at a maximum level of 5 % w/w. (c) polyethylene terephthalate (PET) at a maximum level of 5 % w/w. |
Details | ||
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618-414-0
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9005-37-2
|
567 |
82080 |
yes |
no |
Details | |||
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202-567-1
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97-23-4
|
179 |
48800 |
yes |
yes |
12 mg/kg |
Details | ||
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202-319-2
|
94-28-0
|
310 |
16390 22437 |
no |
no |
0.05 mg/kg |
Details | ||
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213-590-1
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991-84-4
|
384 |
40000 |
yes |
yes |
30 mg/kg |
Details | ||
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202-095-6
|
91-76-9
|
168 |
13075 15310 |
no |
no |
5 mg/kg |
Details | ||
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202-039-0
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91-08-7
|
167 |
25240 |
no |
no |
1 mg/kg in final product expressed as isocyanate moiety. |
Details | ||
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213-436-3
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948-65-2
|
383 |
72160 |
yes |
yes |
15 mg/kg |
Details | ||
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202-112-7
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91-97-4
|
169 |
16240 |
no |
no |
1 mg/kg in final product expressed as isocyanate moiety. |
Details | ||
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ADK STAB AO 80; SUMILIZER GA-80
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410-730-5
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90498-90-1
|
858 |
38565 |
yes |
yes |
0.05 mg/kg |
SML expressed as the sum of the substance and its oxidation product 3-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)prop-2-enoyloxy)-1,1-dimethylethyl]-9-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro [5,5]-undecane in equilibrium with its para quinone methid tautomer. |
Details |
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213-048-4
|
919-30-2
|
377 |
12786 |
no |
no |
0.05 mg/kg |
Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler when used for the reactive surface treatment of inorganic fillers. SML = 0,05 mg/kg when used for the surface treatment of materials and articles. |
Details | |
|
-
|
958445-44-8
|
896 |
71958 |
yes |
no |
Only to be used in the polymerisation of fluoropolymers when: (1.) processed at temperatures higher than 280 °C for at least 10 minutes, (2.) processed at temperatures higher than 190 °C up to 30 % w/w for use in blends with polyoxymethylene polymers and intended for repeated use articles. |
Details | ||
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202-200-5
|
92-88-6
|
170 |
16000 |
no |
no |
6 mg/kg |
Details | ||
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202-525-2
|
96-69-5
|
178 |
92800 |
yes |
yes |
0.48 mg/kg |
Details | ||
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202-785-7
|
99-76-3
|
189 |
60200 |
yes |
no |
Details | |||
|
202-307-7
|
94-13-3
|
173 |
60240 |
yes |
no |
Details | |||
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202-679-0
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98-54-4
|
186 |
14020 |
no |
no |
0.05 mg/kg |
Details | ||
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