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 26 November 2021. Database contains 1072 unique substances/entries.
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203-632-7
108-95-2
241
22960
no
no
3 mg/kg
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214-987-2
1241-94-7
392
72800
yes
yes
2.4 mg/kg
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204-118-5
115-96-8
280
73720
yes
no
0.01 mg/kg
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416-140-4
145650-60-8
769
74010
yes
yes
5 mg/kg
SML expressed as sum of phosphite and phosphate.
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204-552-5
122-52-1
293
23175
no
no
0.01 mg/kg
1 mg/kg in final product.
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843-672-8
1227937-46-3
1076
yes
no
0.05 mg/kg
Only to be used as an additive at up to 0.2 % w/w in high impact polystyrene materials and articles intended contact with food at room temperature and below, including hot-fill and/or heating up to 100 ° C for up to 2 hours. It shall not be used in contact with foods for which simulant C and/or D1 is assigned in Annex III.
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204-211-0
117-81-7
283
74640
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in concentrations up to 0,1 % in the final product.
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204-211-0
117-81-7
283
74640
yes
no
1.5 mg/kg
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in concentrations up to 0,1 % in the final product.
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205-016-3
131-17-9
316
23230
no
no
0.01 mg/kg
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923-642-1
106392-12-5
551
79920
yes
no
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-
147398-31-0
1059
no
no
Only to be used either alone or blended with other polymers in contact with all foods under contact conditions of up to 6 months and/or 6 months and more, at room temperature or below, including hot fill or a short heating up phase.
The migration of all oligomers with a molecular weight below 1 000 Da shall not exceed 5,0 mg/kg food.
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630-556-5
124578-12-7
812
80350
yes
no
Only to be used in plastics up to 0,1 % w/w.
Prepared by the reaction of poly(12-hydroxystearic acid) with polyethyleneimine.
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-
1010121-89-7
804
80510
yes
no
Only to be used as polymer production aid in polyethylene (PE), polypropylene (PP) and polystyrene (PS).
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606-265-4
192268-64-7
780
81220
yes
no
5 mg/kg
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-
167883-16-1
776
76723
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 1,5 % (w/w).
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215-181-3
1310-58-3
399
81600
yes
no
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204-623-0
123-38-6
296
23860
no
no
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203-293-5
105-38-4
211
23920
no
no
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204-638-2
123-62-6
297
23950
no
no
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204-062-1
115-07-1
275
23980
no
no
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-
13445-56-2
609
83455
yes
no
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602-803-7
12269-78-2
603
83460
yes
no
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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.
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202-987-5
101-90-6
199
24073
no
no
0.01 mg/kg
Not to be used for articles in contact with fatty foods for which simulant D1 and/or D2 is laid down.
For indirect food contact only, behind a PET layer.
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205-470-2
141-22-0
324
83700
yes
yes
42 mg/kg
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204-317-7
119-36-8
284
84880
yes
no
30 mg/kg
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203-845-5
111-20-6
260
24280
no
no
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203-672-5
109-43-3
242
85360
yes
no
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215-683-2
1343-98-2
417
85680
yes
no
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215-185-5
1310-73-2
400
86720
yes
no
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215-211-5
1313-82-2
401
24475
no
no
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215-540-4
1330-43-4
407
87040
yes
no
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203-768-7
110-44-1
252
87200
yes
no
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215-663-3
1338-39-2
414
87600
yes
no
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215-665-4
1338-43-8
416
87680
yes
no
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215-664-9
1338-41-6
415
87840
yes
no
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204-693-2
124-26-5
306
88960
yes
no
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204-666-5
123-95-5
301
89120
yes
no
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202-851-5
100-42-5
193
24610
no
no
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203-740-4
110-15-6
247
90960
24820
yes
no
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203-570-0
108-30-5
233
24850
no
no
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204-771-6
126-13-6
308
91200
yes
no
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204-772-1
126-14-7
309
91360
yes
no
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238-877-9
14807-96-6
615
92080
yes
no
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Gallic acid derivatives found in nutgalls, bark and other plant parts, especially oak bark.
215-753-2
1401-55-4
419
92150
yes
no
According to the JECFA specifications.
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202-830-0
100-21-0
785
24910
no
no
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202-829-5
100-20-9
191
24940
no
no
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204-411-8
120-61-6
288
24970
no
no
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203-989-9
112-60-7
269
25090
92350
yes
no
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204-126-9
116-14-3
281
25120
no
no
0.05 mg/kg
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