plastic-material-food-contact

FCM and Articles Regulation, Annex I - Authorised Substances

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 13 October 2020. Database contains 1066 unique substances/entries.
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203-027-8
102-39-6
202
23070
no
no
0.05 mg/kg
Details
617-241-8
81541-12-0
752
39890
yes
no
Details
264-144-8
63438-80-2
711
42000
yes
yes
30 mg/kg
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
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
201-074-9
77-99-6
141
94960
25600
13380
yes
no
6 mg/kg
Details
221-950-4
3290-92-4
463
25840
no
no
0.05 mg/kg
Details
405-800-7
27955-94-8
662
25927
no
no
0.005 mg/kg
Only to be used in polycarbonates.
Details
217-420-7
1843-03-4
430
95600
yes
yes
5 mg/kg
Details
252-816-3
35958-30-6
679
39060
yes
yes
5 mg/kg
Details
200-866-1
75-37-6
131
48460
yes
no
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
-
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
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
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
500-311-6
136504-96-6
767
38510
yes
no
5 mg/kg
Details
431-890-2
166412-78-8
775
45705
yes
no
Details
204-427-5
120-80-9
289
24051
15880
no
no
6 mg/kg
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
224-594-8
4422-95-1
481
13060
no
no
0.05 mg/kg
SML expressed as 1,3,5-benzenetricarboxylic acid.
Details
216-971-0
1709-70-2
428
95200
yes
no
Details
616-108-1
745070-61-5
784
95420
yes
no
5 mg/kg
Details
248-597-9
27676-62-6
661
95360
yes
yes
5 mg/kg
Details
-
227099-60-7
781
95265
yes
no
0.05 mg/kg
Details
254-996-9
40601-76-1
689
95280
yes
yes
6 mg/kg
Details
216-032-5
1477-55-0
421
13000
no
no
Details
203-028-3
102-40-9
203
13323
no
no
0.05 mg/kg
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
203-585-2
108-46-3
237
15910
24072
no
no
2.4 mg/kg
Details
211-463-5
646-06-0
363
16450
no
no
5 mg/kg
Details
203-584-7
108-45-2
236
23050
no
no
0.01 mg/kg
Details
207-997-3
504-63-2
343
23770
no
no
0.05 mg/kg
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
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
208-015-6
505-65-7
344
13810
21821
no
no
0.05 mg/kg
Details
208-015-6
505-65-7
344
13810
21821
no
no
Details
208-015-6
505-65-7
344
13810
21821
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
203-782-3
110-60-1
253
15250
no
no
Details
203-400-5
106-46-7
217
15565
no
no
12 mg/kg
Details
204-617-8
123-31-9
295
48620
15940
18867
yes
no
0.6 mg/kg
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
221-641-4
3173-72-6
461
22420
no
no
1 mg/kg in final product expressed as isocyanate moiety.
Details
245-442-7
23128-74-7
631
59120
yes
yes
45 mg/kg
Details
252-346-9
35074-77-2
678
59200
yes
yes
6 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
211-074-0
629-11-8
361
18700
no
no
0.05 mg/kg
Details
223-054-9
3710-30-3
1034
no
no
0.05 mg/kg
Only to be used as a crosslinking co-monomer in the manufacture of polyolefins for contact with any type of foods for long term storage at room temperature, including when packaged under hot-fill conditions.
Details
216-711-6
1647-16-1
424
15070
no
no
0.05 mg/kg
Details
613-797-0
65447-77-0
716
60800
yes
no
30 mg/kg
Details
223-805-0
4080-31-3
474
43600
yes
no
0.3 mg/kg
Details
220-666-8
2855-13-2
454
12670
no
no
6 mg/kg
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
212-819-2
872-05-9
375
15130
no
no
0.05 mg/kg
Details
203-968-4
112-41-4
268
16704
no
no
0.05 mg/kg
Details
253-149-0
36653-82-4
681
18310
no
no
Details
209-753-1
592-41-6
356
18820
no
no
3 mg/kg
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
203-893-7
111-66-0
264
22660
no
no
15 mg/kg
Details
200-752-1
71-41-0
124
22870
no
no
Details
203-694-5
109-67-1
245
22900
no
no
5 mg/kg
Details
200-746-9
71-23-8
122
23800
no
no
Details
214-306-9
1120-36-1
388
25080
no
no
0.05 mg/kg
Details
214-012-0
1072-63-5
387
26155
no
no
0.05 mg/kg
Details
219-417-6
2432-99-7
443
12788
no
no
5 mg/kg
Details
211-754-7
693-57-2
369
12761
no
no
0.05 mg/kg
Details
203-366-1
106-14-9
214
61840
yes
no
Details
279-459-6
80410-33-9
745
68145
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
Details
418-280-1
18600-59-4
796
72141
yes
yes
0.05 mg/kg
SML including the sum of its hydrolysis products.
Details
202-567-1
97-23-4
179
48800
yes
yes
12 mg/kg
Details
205-026-8
131-53-3
317
48880
yes
yes
Details

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