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 22 June 2021. Database contains 1072 unique substances/entries.
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The wax from Euphorbia antisiphylitica or Pedilanthus pavonis, Euphorbiaceae.
232-347-0
8006-44-8
530
41760
yes
no
Details
The wax derived from Copernicia cerifera, Palmae.
232-399-4
8015-86-9
533
42720
yes
no
Details
Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acid ricinoleic. (Ricinus communis, Euphorbiaceae).
232-293-8
8001-79-4
527
14411
42880
yes
no
Details
A complex combination of hydrocarbons produced by the purification of ozocerite with sulfuric acid and filtration through bone black to form waxy cakes.
232-290-1
8001-75-0
526
43440
yes
no
Details
281-837-0
84030-61-5
747
47600
yes
yes
Details
212-485-8
822-06-0
372
18640
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
-
8001-39-6
525
62640
yes
no
Details
201-766-0
87-69-4
161
92160
yes
no
Details
The complex combination of diglycerides of fatty acids linked to the choline ester of phosphoric acid.
232-307-2
8002-43-5
528
63760
yes
no
Details
617-129-9
8062-15-5
540
63940
yes
no
0.24 mg/kg
Only to be used as dispersant for plastics dispersions.
Details
201-770-2
87-78-5
162
65520
yes
no
Details
201-297-1
80-62-6
156
21130
no
no
Details
212-782-2
868-77-9
374
21190
no
no
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
Wax obtained by extraction of lignite.
232-313-5
8002-53-7
529
67850
yes
no
Details
-
852282-89-4
809
49080
yes
yes
0.05 mg/kg
Only for use in PET.
Details
282-811-1
84434-12-8
748
12765
no
no
0.05 mg/kg
Details
212-828-1
872-50-4
376
66905
yes
no
60 mg/kg
Details
201-873-2
88-99-3
165
23200
74480
yes
no
Details
201-873-2
88-99-3
192
23187
no
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 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
201-622-7
85-68-7
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
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
0.3 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
201-607-5
85-44-9
158
23380
76320
yes
no
Details
700-107-9
87189-25-1
751
81515
yes
no
Details
232-417-0
8017-16-1
534
80720
yes
no
Details
201-898-9
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.
232-475-7
8050-09-7
535
24100
24190
83840
24130
yes
no
Details
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.
232-484-6
8052-10-6
539
24160
no
no
Details
232-482-5
8050-31-5
538
84000
yes
no
Details
232-479-9
8050-26-8
537
84080
yes
no
Details
232-476-2
8050-15-5
536
84320
yes
no
Details
201-728-3
87-18-3
160
84800
yes
yes
12 mg/kg
Details
Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic and stearic. (Soja hispida, Leguminosae).
232-274-4
8001-22-7
524
24520
no
no
Details
232-391-0
8013-07-8
532
88640
yes
no
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
232-391-0
8013-07-8
532
88640
yes
no
60 mg/kg
Details
212-757-6
867-13-0
800
94425
yes
no
Only for use in PET.
Details
201-291-9
80-56-8
155
23470
no
no
Details
618-459-6
9010-88-2
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
618-414-0
9005-37-2
567
82080
yes
no
Details
202-567-1
97-23-4
179
48800
yes
yes
12 mg/kg
Details
213-590-1
991-84-4
384
40000
yes
yes
30 mg/kg
Details
202-095-6
91-76-9
168
13075
15310
no
no
5 mg/kg
Details
202-039-0
91-08-7
167
25240
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
213-436-3
948-65-2
383
72160
yes
yes
15 mg/kg
Details
202-112-7
91-97-4
169
16240
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
410-730-5
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
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

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