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 2020/1245/EU, 3 September 2020

Also referred to as the Plastics Implementation Measure (PIM), this Regulation provides the Union List of monomers and other substances authorized in the manufacture of food contact plastics.

Last updated 16 December 2020. Database contains 1072 unique substances/entries.
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203-400-5
106-46-7
217
15565
no
no
12 mg/kg
Details
202-567-1
97-23-4
179
48800
yes
yes
12 mg/kg
Details
203-545-4
108-05-4
231
10120
no
no
12 mg/kg
Details
209-530-9
584-09-8
353
42480
yes
no
12 mg/kg
Details
-
-
25
45440
yes
no
12 mg/kg
Details
EDA
203-468-6
107-15-3
226
15272
16960
no
no
12 mg/kg
Details
201-728-3
87-18-3
160
84800
yes
yes
12 mg/kg
Details
203-893-7
111-66-0
264
22660
no
no
15 mg/kg
Details
213-436-3
948-65-2
383
72160
yes
yes
15 mg/kg
Details
251-156-3
32687-78-8
675
38800
yes
yes
15 mg/kg
Details
-
-
91
92320
yes
yes
15 mg/kg
Details
203-090-1
103-23-1
207
31920
yes
yes
18 mg/kg
Details
264-122-8
63397-60-4
710
38700
yes
yes
18 mg/kg
Details
203-542-8
108-01-0
230
16150
no
no
18 mg/kg
Details
432-130-2
119345-01-6
760
83595
yes
no
18 mg/kg
Composition: 4,4'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0038613-77-3) (36-46 % w/w (*)),4,3'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-00-4) (17-23 % w/w (*)),3,3'-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-01-5) (1-5 % w/w (*)),4-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0091362-37-7) (11-19 % w/w (*)),tris(2,4-di-tert-butylphenyl)phosphite (CAS No 0031570-04-4) (9-18 % w/w (*)),4,4'-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonate-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0112949-97-0) (< 5 % w/w (*))(*)Quantity of substance used/quantity of formulationOther specifications: Phosphor content of min. 5,4 % to max. 5,9 %,Acid value of max. 10 mg KOH per gram,Melt range of 85- 110 °C.
Details
254-037-4
38613-77-3
688
92560
yes
yes
18 mg/kg
Details
264-144-8
63438-80-2
711
42000
yes
yes
30 mg/kg
Details
613-797-0
65447-77-0
716
60800
yes
no
30 mg/kg
Details
213-590-1
991-84-4
384
40000
yes
yes
30 mg/kg
Details
245-950-9
23949-66-8
633
53200
yes
yes
30 mg/kg
Details
203-234-3
104-76-7
209
17050
no
no
30 mg/kg
Details
-
-
15
34130
yes
yes
30 mg/kg
Details
-
-
209
17050
no
no
30 mg/kg
Details
-
-
658
52000
yes
no
30 mg/kg
Details
248-289-4
27176-87-0
658
52000
yes
no
30 mg/kg
Details
202-510-0
96-49-1
177
16955
no
no
30 mg/kg
SML expressed as ethyleneglycol.
Residual content of 5 mg ethylene carbonate per kg of hydrogel with max 10 g of hydrogel in contact with 1 kg of food.
Details
-
-
14
33801
yes
no
30 mg/kg
Details
-
-
69
74400
yes
yes
30 mg/kg
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
204-317-7
119-36-8
284
84880
yes
no
30 mg/kg
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
246-563-8
25013-16-5
635
40720
yes
no
30 mg/kg
Details
-
-
324
83700
yes
yes
42 mg/kg
Details
-
-
74
77440
yes
yes
42 mg/kg
Details
1 - 6.5 moles ethoxylated
500-151-7
61791-12-6
708
77520
yes
no
42 mg/kg
Details
618-404-6
9004-97-1
563
78320
yes
yes
42 mg/kg
Details
205-470-2
141-22-0
324
83700
yes
yes
42 mg/kg
Details
245-442-7
23128-74-7
631
59120
yes
yes
45 mg/kg
Details
207-312-8
461-58-5
340
47440
yes
no
60 mg/kg
Details
212-828-1
872-50-4
376
66905
yes
no
60 mg/kg
Details
614-498-8
68441-17-8
811
80077
yes
no
60 mg/kg
Details
232-391-0
8013-07-8
532
88640
yes
no
60 mg/kg
Details
229-176-9
6422-86-2
798
92200
yes
no
60 mg/kg
Details
617-241-8
81541-12-0
752
39890
yes
no
Details
-
-
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.
Details
-
-
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.
Details
-
-
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.
Details
-
-
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.
Details
-
-
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

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