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 09 April 2021. Database contains 122724 unique substances/entries.
Filter the list

 
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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.
Details
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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.
Details
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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.
Details
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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.
Details
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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
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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.
Details
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979
79987
yes
no
Only to be used in polyethylene terephthalate (PET) at a maximum level of 5 % w/w.
Details
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26
46700
yes
no
5 mg/kg
Details
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-
823
24889
no
no
5 mg/kg
Details
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-
27
48960
yes
no
5 mg/kg
Details
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7
30370
yes
no
Details
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-
8
30401
yes
no
Details
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11
30960
yes
no
Details
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-
9
30610
yes
no
Details
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801
30607
yes
no
Details
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-
10
30612
yes
no
Details
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879
31336
yes
no
Details
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878
31335
yes
no
Details
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880
31348
yes
no
Details
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12
31328
yes
no
Details
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-
3
12375
no
no
Details
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13
33120
yes
no
Details
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-
16
34230
yes
no
6 mg/kg
Details
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17
34281
yes
no
Details
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-
15
34130
yes
yes
30 mg/kg
Details
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-
752
39890
yes
no
Details
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-
662
25927
no
no
0.005 mg/kg
Only to be used in polycarbonates.
Details
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-
109
81840
23740
yes
no
Details
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-
343
23770
no
no
0.05 mg/kg
Details
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-
806
14876
no
no
5 mg/kg
Only to be used for manufacture of polyesters.
Details
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-
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
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361
18700
no
no
0.05 mg/kg
Details
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-
123
13840
no
no
Details
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-
267
15100
no
no
Details
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-
681
18310
no
no
Details
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331
22480
no
no
Details
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265
22600
no
no
Details
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124
22870
no
no
Details
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-
122
23800
no
no
Details
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443
12788
no
no
5 mg/kg
Details
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369
12761
no
no
0.05 mg/kg
Details
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214
61840
yes
no
Details
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285
66480
yes
yes
Details
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137
66580
yes
yes
Details
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472
66560
yes
yes
Details
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881
25187
no
no
5 mg/kg
Only for: (a) repeated use articles for long term storage at room temperature or below and hotfill; (b) single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.
Details
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484
13395
no
no
0.05 mg/kg
Details
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882
25872
no
no
0.05 mg/kg
Details
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758
38940
yes
yes
Details
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756
40020
yes
yes
Details
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765
49485
yes
yes
1 mg/kg
Details
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477
46720
yes
yes
4.8 mg/kg
Details
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-
315
46640
yes
no
3 mg/kg
Details
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352
16360
no
no
0.05 mg/kg
Details
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389
22360
no
no
5 mg/kg
Details
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770
51700
yes
no
0.05 mg/kg
Details
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617
10660
no
no
0.05 mg/kg
Details
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-
326
12763
35170
yes
no
0.05 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.
Details
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209
17050
no
no
30 mg/kg
Details
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118
23830
81882
yes
no
Details
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357
13932
no
no
0.01 mg/kg
Only to be used as a co-monomer for the preparation of polymeric additive.
Details
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178
92800
yes
yes
0.48 mg/kg
Details
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358
14841
no
no
0.05 mg/kg
Details
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186
14020
no
no
0.05 mg/kg
Details
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346
10030
no
no
Details
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115
10090
30000
yes
no
Details
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147
10690
no
no
Details
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-
303
31730
12130
yes
no
Details
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566
33350
yes
no
Details
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345
35840
yes
no
Details
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518
35845
yes
no
Details
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101
36000
yes
no
Details
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302
12820
no
no
Details
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272
37040
yes
no
Details
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-
116
13090
37600
yes
no
Details
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194
13150
no
no
Details
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766
38879
yes
no
Details
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743
38950
yes
no
Details
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-
808
38550
yes
no
5 mg/kg
SML including the sum of its hydrolysis products.
Details
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752
39890
yes
no
Details
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-
584
13620
40320
yes
no
Details
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229
14140
no
no
Details
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-
304
41960
14320
yes
no
Details
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-
139
14680
44160
yes
no
Details
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-
467
14800
45600
yes
no
Details
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-
752
39890
yes
no
Details
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263
15760
13326
yes
no
Details
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311
51200
16480
yes
no
Details
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-
257
51760
13550
16660
yes
no
Details
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-
658
52000
yes
no
30 mg/kg
Details
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273
52730
yes
no
Details
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-
113
16780
52800
yes
no
Details
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-
111
53600
yes
no
Details
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-
227
16990
53650
yes
no
Details
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-
114
55040
yes
no
Details
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-
249
17290
55120
yes
no
Details
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-
1031
no
no
5 mg/kg
Only to be used as a monomer in the production of polyethylene furanoate.
The migration of the oligomeric fraction of less than 1 000 Da shall not exceed 50 µg/kg food (expressed as furan-2,5-dicarboxylic acid).
Details
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-
667
55190
yes
no
Details
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-
256
55680
18010
yes
no
Details
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-
103
55920
18100
yes
no
Details
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-
794
18117
no
no
Only to be used for manufacture of polyglycolic acid (PGA) for (i) indirect food contact behind polyesters such as polyethylene terephthalate (PET) or polylactic acid (PLA); and (ii) direct food contact of a blend of PGA up to 3 % w/w in PET or PLA.
Details
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259
58720
yes
no
Details
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-
278
18250
no
no
0.01 mg/kg
Details
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329
59360
yes
no
Details
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-
507
59990
yes
no
Details
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-
494
62140
yes
no
Details
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291
19150
no
no
Details
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-
182
19270
no
no
Details
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-
161
92160
yes
no
Details
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-
99
19460
62960
yes
no
Details
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330
19470
63280
yes
no
Details
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-
299
63840
yes
no
Details
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350
63920
yes
no
Details
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-
540
63940
yes
no
0.24 mg/kg
Only to be used as dispersant for plastics dispersions.
Details
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-
112
64015
yes
no
Details
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-
663
64150
yes
no
Details
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-
235
14710
no
no
Details
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-
248
19540
64800
yes
no
Details
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499
65020
19965
yes
no
In case of use as a monomer only to be used as a co-monomer in aliphatic polyesters up to maximum level of 1 % on a molar basis.
Details
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328
65040
yes
no
Details
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162
65520
yes
no
Details
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-
150
20020
no
no
Details
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-
117
21550
no
no
Details
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348
22350
67891
yes
no
Details
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336
45940
15095
yes
no
Details
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-
367
16697
no
no
Details
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-
731
18220
no
no
0.05 mg/kg
Details
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-
483
68860
yes
no
0.05 mg/kg
Details
-
-
174
14740
no
no
Details
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-
270
22763
69040
yes
no
Details
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332
69760
yes
no
Details
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-
333
22775
69920
yes
no
6 mg/kg
Details
-
-
216
14770
no
no
Details
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-
190
18880
no
no
Details
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-
105
70400
22780
yes
no
Details
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-
338
71020
yes
no
Details
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-
279
22840
71600
yes
no
Details
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861
71990
yes
no
Only to be used in the polymerisation of fluoropolymers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles.
Details
-
-
241
22960
no
no
3 mg/kg
Details
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-
509
72640
23170
yes
no
Details
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-
192
23187
no
no
Details
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-
534
80720
yes
no
Details
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146
23890
82000
yes
no
Details
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-
445
83440
yes
no
Details
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-
609
83455
yes
no
Details
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-
324
83700
yes
yes
42 mg/kg
Details
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121
24270
84640
yes
no
Details
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-
260
24280
no
no
Details
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-
417
85680
yes
no
Details
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-
252
87200
yes
no
Details
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-
100
88320
24490
yes
no
Details
-
-
106
89040
24550
yes
no
Details
-
-
656
24760
no
no
0.05 mg/kg
Details
-
-
247
24820
90960
yes
no
Details
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-
511
91920
yes
no
Details
-
-
419
92150
yes
no
According to the JECFA specifications.
Details
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785
24910
no
no
Details
-
-
269
92350
25090
yes
no
Details
-
-
655
25450
no
no
0.05 mg/kg
Details
-
-
266
94320
25510
yes
no
Details
-
-
347
13050
25540
no
no
Details
-
-
110
93520
yes
no
Details
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-
501
34480
yes
no
Details
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21
42500
yes
no
Details
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-
22
43200
yes
no
Details
-
-
23
43515
yes
no
0.9 mg/kg
Details
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816
45704
yes
no
5 mg/kg
Details
-
-
817
38507
yes
no
5 mg/kg
Not to be used with polyethylene in contact with acidic foods.
Purity ≥ 96 %.
Details
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-
24
45280
yes
no
Details
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-
25
45440
yes
no
12 mg/kg
Details
-
-
28
50160
yes
no
Details
-
-
31
50800
yes
no
Details
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-
32
50880
yes
no
Details
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-
33
51120
yes
no
Details
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-
34
54270
yes
no
Details
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-
35
54280
yes
no
Details
-
-
36
54450
yes
no
Details
-
-
37
54480
yes
no
Details
-
-
1053
yes
no
Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.
Details
-
-
38
55520
yes
no
Details
-
-
39
55600
yes
no
Details
-
-
54
57040
yes
no
Details
-
-
55
57120
yes
no
Details
-
-
56
57200
yes
no
Details
-
-
57
57280
yes
no
Details
-
-
58
57600
yes
no
Details
-
-
59
57680
yes
no
Details
-
-
44
56495
yes
no
Details
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-
41
56486
yes
no
Details
-
-
42
56487
yes
no
Details
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-
43
56490
yes
no
Details
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-
45
56500
yes
no
Details
-
-
46
56510
yes
no
Details
-
-
48
56535
yes
no
Details
-
-
51
56570
yes
no
Details
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60
58300
yes
no
Details
-
-
1060
yes
no
Only to be used at room temperature or below in contact with foods for which Table 2 of Annex III assigns food simulant E.
The seed hulls shall be obtained from sunflower seeds that are fit for human consumption.
The processing temperature of the plastic containing the additive shall not exceed 240 °C.
Details
-
-
789
60027
yes
no
Average molecular weight not less than 440 Da.
Viscosity at 100 °C not less than 3,8 cSt (3,8 × 10-6 m2/s).
Details
-
-
62
64500
yes
no
Details
-
-
63
65440
yes
no
Details

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