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 03 August 2021. Database contains 1072 unique substances/entries.
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613-797-0
65447-77-0
716
60800
yes
no
30 mg/kg
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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.
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252-346-9
35074-77-2
678
59200
yes
yes
6 mg/kg
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245-442-7
23128-74-7
631
59120
yes
yes
45 mg/kg
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204-617-8
123-31-9
295
48620
15940
18867
yes
no
0.6 mg/kg
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203-786-5
110-63-4
254
40580
13720
yes
no
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254-996-9
40601-76-1
689
95280
yes
yes
6 mg/kg
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-
227099-60-7
781
95265
yes
no
0.05 mg/kg
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248-597-9
27676-62-6
661
95360
yes
yes
5 mg/kg
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616-108-1
745070-61-5
784
95420
yes
no
5 mg/kg
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216-971-0
1709-70-2
428
95200
yes
no
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215-354-3
1323-39-3
406
83300
yes
no
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249-369-1
29013-28-3
665
83120
yes
no
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215-549-3
1330-80-9
408
82960
yes
no
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248-315-4
27194-74-7
659
82800
yes
no
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228-229-3
6182-11-2
491
82720
yes
no
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251-581-4
33587-20-1
677
82560
yes
no
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203-315-3
105-62-4
213
82400
yes
no
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245-217-3
22788-19-8
630
82240
yes
no
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618-414-0
9005-37-2
567
82080
yes
no
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200-338-0
57-55-6
109
23740
81840
yes
no
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431-890-2
166412-78-8
775
45705
yes
no
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500-311-6
136504-96-6
767
38510
yes
no
5 mg/kg
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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).
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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.
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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.
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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.
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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.
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200-866-1
75-37-6
131
48460
yes
no
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252-816-3
35958-30-6
679
39060
yes
yes
5 mg/kg
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217-420-7
1843-03-4
430
95600
yes
yes
5 mg/kg
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201-074-9
77-99-6
141
94960
25600
13380
yes
no
6 mg/kg
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-
-
979
79987
yes
no
Only to be used in polyethylene terephthalate (PET) at a maximum level of 5 % w/w.
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-
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.
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-
-
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.
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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.
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-
40471-03-2
867
40815
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 %.
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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 %.
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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.
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-
-
866
40620
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 7 %.
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-
25101-28-4
856
40563
yes
no
Only to be used in: rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below; or at up to 40 % w/w in blends of styrene acrylonitrile copolymer (SAN)/poly(methyl methacrylate) (PMMA) repeatuse articles at room temperature or below, and when either in contact only with aqueous, acidic and/or low alcoholic (< 20 %) foodstuffs for less than 1 day, or when in contact only with dry foodstuffs for any duration of time.
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-
-
855
40560
yes
no
Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below.
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-
-
998
yes
no
Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage.
When used together with the substance with FCM No 859 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.
The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
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-
-
859
yes
no
Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage.
When used together with the substance with FCM No 998 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.
The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
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-
-
1043
yes
no
Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long- term storage.
When used together with the substance with FCM No 859 and/or the substance with FCM No 998, the restriction of 10 % w/w applies to the sum of those substances.
The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
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264-144-8
63438-80-2
711
42000
yes
yes
30 mg/kg
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617-241-8
81541-12-0
752
39890
yes
no
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204-872-5
127-91-3
314
23500
no
no
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201-291-9
80-56-8
155
23470
no
no
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202-705-0
98-83-9
187
22210
no
no
0.05 mg/kg
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