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 28 March 2024. Database contains 1080 unique substances/entries.
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866
40620
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 7 %.
Details
607-698-1
25322-99-0
865
40619
yes
no
Only to be used in: (a) rigid poly(vinyl chloride) (PVC) at a maximum level of 1 % w/w. (b) polylactic acid (PLA) at a maximum level of 5 % w/w.
Details
608-050-0
27136-15-8
869
66763
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 3 %.
Details
-
40471-03-2
867
40815
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 %.
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
-
-
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
-
37953-21-2
857
66765
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % at room temperature or below.
Details
243-053-7
19430-93-4
973
22931
no
no
Only to be used as a co-monomer up to 0,1 % w/w in the polymerisation of fluoropolymers, sintered at high temperatures.
Details
-
-
979
79987
yes
no
Only to be used in polyethylene terephthalate (PET) at a maximum level of 5 % w/w.
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
200-866-1
75-37-6
131
48460
yes
no
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;(c)technical support agent in concentrations up to 0,1 % in the final product.
Not to be used in combination with FCM substances 157, 159, 283, or 1085.
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;(c)technical support agent in concentrations up to 0,1 % in the final product.
Not to be used in combination with FCM substances 157, 159, 283, or 1085.
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
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
431-890-2
166412-78-8
775
45705
yes
no
Details
200-338-0
57-55-6
109
23740
81840
yes
no
Details
618-414-0
9005-37-2
567
82080
yes
no
Details
245-217-3
22788-19-8
630
82240
yes
no
Details
203-315-3
105-62-4
213
82400
yes
no
Details
251-581-4
33587-20-1
677
82560
yes
no
Details
228-229-3
6182-11-2
491
82720
yes
no
Details
248-315-4
27194-74-7
659
82800
yes
no
Details
215-549-3
1330-80-9
408
82960
yes
no
Details
249-369-1
29013-28-3
665
83120
yes
no
Details
215-354-3
1323-39-3
406
83300
yes
no
Details
216-971-0
1709-70-2
428
95200
yes
no
Details
216-032-5
1477-55-0
421
13000
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
203-529-7
107-88-0
228
13690
no
no
Details
203-268-9
105-08-8
210
13390
14880
no
no
Details
203-786-5
110-63-4
254
40580
13720
yes
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
Details
203-782-3
110-60-1
253
15250
no
no
Details
221-641-4
3173-72-6
461
22420
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
200-751-6
71-36-3
123
13840
no
no
Details
203-449-2
106-98-9
222
13870
no
no
Details
203-956-9
112-30-1
267
15100
no
no
Details
253-149-0
36653-82-4
681
18310
no
no
Details
223-861-6
4098-71-9
475
19110
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
205-583-7
143-08-8
331
22480
no
no
Details
203-917-6
111-87-5
265
22600
no
no
Details
200-752-1
71-41-0
124
22870
no
no
Details
200-746-9
71-23-8
122
23800
no
no
Details
203-366-1
106-14-9
214
61840
yes
no
Details
205-026-8
131-53-3
317
48880
yes
yes
Details
201-814-0
88-24-4
163
66400
yes
yes
Details

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