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 01 July 2022. Database contains 1072 unique substances/entries.
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211-074-0
629-11-8
361
18700
no
no
0.05 mg/kg
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
252-346-9
35074-77-2
678
59200
yes
yes
6 mg/kg
Details
245-442-7
23128-74-7
631
59120
yes
yes
45 mg/kg
Details
221-641-4
3173-72-6
461
22420
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
211-492-3
652-67-5
364
15404
no
no
5 mg/kg
Only to be used as: (a) a co-monomer in poly (ethylene-co-isosorbide terephthalate); (b) a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters. Polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol.
Details
204-617-8
123-31-9
295
48620
15940
18867
yes
no
0.6 mg/kg
Details
203-400-5
106-46-7
217
15565
no
no
12 mg/kg
Details
203-782-3
110-60-1
253
15250
no
no
Details
214-068-6
1076-97-7
806
14876
no
no
5 mg/kg
Only to be used for manufacture of polyesters.
Details
208-015-6
505-65-7
344
21821
13810
no
no
Details
208-015-6
505-65-7
344
21821
13810
no
no
Details
208-015-6
505-65-7
344
21821
13810
no
no
0.05 mg/kg
Details
219-371-7
2425-79-8
442
13780
no
no
0.01 mg/kg
Residual content = 1 mg/kg in final product expressed as epoxygroup.
Molecular weight is 43 Da.
Details
203-786-5
110-63-4
254
40580
13720
yes
no
Details
203-268-9
105-08-8
210
13390
14880
no
no
Details
207-997-3
504-63-2
343
23770
no
no
0.05 mg/kg
Details
203-584-7
108-45-2
236
23050
no
no
0.01 mg/kg
Details
211-463-5
646-06-0
363
16450
no
no
5 mg/kg
Details
203-585-2
108-46-3
237
24072
15910
no
no
2.4 mg/kg
Details
203-529-7
107-88-0
228
13690
no
no
Details
222-852-4
3634-83-1
988
no
no
SML(T) applies to the migration of its hydrolysis product, 1,3- benzenedimethanamine.
To be used only as co-monomer in the manufacture of a middle layer coating on a poly(ethylene terephthalate) polymer film in a multilayer film.
Details
203-028-3
102-40-9
203
13323
no
no
0.05 mg/kg
Details
216-032-5
1477-55-0
421
13000
no
no
Details
254-996-9
40601-76-1
689
95280
yes
yes
6 mg/kg
Details
-
227099-60-7
781
95265
yes
no
0.05 mg/kg
Details
248-597-9
27676-62-6
661
95360
yes
yes
5 mg/kg
Details
216-971-0
1709-70-2
428
95200
yes
no
Details
224-594-8
4422-95-1
481
13060
no
no
0.05 mg/kg
SML expressed as 1,3,5-benzenetricarboxylic acid.
Details
215-354-3
1323-39-3
406
83300
yes
no
Details
249-369-1
29013-28-3
665
83120
yes
no
Details
215-549-3
1330-80-9
408
82960
yes
no
Details
248-315-4
27194-74-7
659
82800
yes
no
Details
228-229-3
6182-11-2
491
82720
yes
no
Details
251-581-4
33587-20-1
677
82560
yes
no
Details
203-315-3
105-62-4
213
82400
yes
no
Details
245-217-3
22788-19-8
630
82240
yes
no
Details
618-414-0
9005-37-2
567
82080
yes
no
Details
200-338-0
57-55-6
109
23740
81840
yes
no
Details
204-427-5
120-80-9
289
24051
15880
no
no
6 mg/kg
Details
431-890-2
166412-78-8
775
45705
yes
no
Details
500-311-6
136504-96-6
767
38510
yes
no
5 mg/kg
Details
204-886-1
128-44-9
902
yes
no
The substance shall comply with the specific purity criteria as set out in Commission Regulation (EU) No 231/2012 (OJ L 83, 22.3.2012, p. 1).
Details
271-091-4
68515-49-1
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
271-091-4
68515-49-1
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
271-090-9
68515-48-0
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
271-090-9
68515-48-0
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
-
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
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
200-866-1
75-37-6
131
48460
yes
no
Details

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