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 18 May 2021. Database contains 1072 unique substances/entries.
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201-201-8
79-38-9
148
14650
no
no
0.01 mg/kg
Details
-
-
816
45704
yes
no
5 mg/kg
Details
-
10436-08-5
589
52645
yes
no
Details
-
-
817
38507
yes
no
5 mg/kg
Not to be used with polyethylene in contact with acidic foods.
Purity ≥ 96 %.
Details
201-069-1
77-92-9
139
14680
44160
yes
no
Details
201-070-7
77-93-0
140
44640
yes
no
Details
234-334-5
11104-61-3
593
44960
yes
no
Details
232-131-6
7787-70-4
523
45195
yes
no
Details
235-285-2
12158-74-6
972
45197
yes
no
Details
215-625-6
1335-23-5
412
45200
yes
no
Details
-
-
24
45280
yes
no
Details
-
-
25
45440
yes
no
12 mg/kg
Details
238-455-4
14464-46-1
614
45560
yes
no
Details
223-077-4
3724-65-0
467
14800
45600
yes
no
Details
-
263244-54-8
885
45676
yes
no
Only to be used in poly(ethylene terephthalate) (PET), poly(butylene terephthalate) (PBT), polycarbonate (PC), polystyrene (PS) and rigid poly(vinyl chloride) (PVC) plastics in concentrations up to 1 % w/w, in contact with aqueous, acidic and alcoholic foods, for long term storage at room temperature.
Details
221-639-3
3173-53-3
460
14950
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
203-629-0
108-91-8
240
45760
yes
no
Details
213-245-5
931-88-4
381
15030
no
no
0.05 mg/kg
Only to be used in polymers contacting foods for which simulant A is laid down.
Details
Extractives and their physically modified derivatives. It is a product which may contain resin acids and their esters, terpenes, and oxidation or polymerization products of these terpenes. (Shorea, Dipterocarpaceae).
232-528-4
9000-16-2
543
45920
yes
no
Details
611-185-8
54686-97-4
752
39890
yes
no
Details
281-837-0
84030-61-5
747
47600
yes
yes
Details
-
69226-46-6
30
50560
yes
no
Details
233-117-2
10039-33-5
582
50240
yes
no
Details
239-622-4
15571-58-1
619
50320
yes
no
Details
268-500-3
68109-88-6
29
50360
yes
no
Details
251-576-7
33568-99-9
676
50400
yes
no
Details
247-666-0
26401-97-8
646
50480
yes
no
Details
-
-
28
50160
yes
no
Details
222-883-3
3648-18-8
466
50640
yes
no
Details
239-625-0
15571-60-5
620
50720
yes
no
Details
-
-
31
50800
yes
no
Details
-
-
32
50880
yes
no
Details
260-414-4
69226-44-4
736
50960
yes
no
Details
239-581-2
15535-79-2
618
51040
yes
no
Details
-
-
33
51120
yes
no
Details
248-468-7
27458-90-8
660
47540
yes
yes
0.05 mg/kg
Details
612-383-7
61790-53-2
707
46375
yes
no
Details
272-489-0
68855-54-9
734
46380
yes
no
Details
251-136-4
32647-67-9
674
46480
yes
no
Details
-
26427-07-6
649
47210
yes
no
Molecular unit = (C8H18S3Sn2)n (n = 1,5-2).
Details
207-312-8
461-58-5
340
47440
yes
no
60 mg/kg
Details
225-863-2
5124-30-1
485
13560
15700
no
no
1 mg/kg in final product expressed as isocyanate moiety.
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).
Details
203-872-2
111-46-6
263
15760
13326
47680
yes
no
Details
203-865-4
111-40-0
261
15790
no
no
5 mg/kg
Details
247-977-1
26761-40-0
729
75105
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
247-977-1
26761-40-0
729
75105
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
249-079-5
28553-12-0
728
75100
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
249-079-5
28553-12-0
728
75100
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
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

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