- Latest available (Revised)
- Point in Time (26/06/2018)
- Original (As adopted by EU)
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance)
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Point in time view as at 26/06/2018.
There are currently no known outstanding effects for the Commission Regulation (EU) No 10/2011, Division 1..
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Table 1 contains the following information:
Column 1 (FCM substance No): the unique identification number of the substance
Column 2 (Ref. No): the EEC packaging material reference number
Column 3 (CAS No): the Chemical Abstracts Service (CAS) registry number
Column 4 (Substance Name): the chemical name
Column 5 (Use as additive or polymer production aid (PPA) (yes/no)): an indication if the substance is authorised to be used as additive or polymer production aid (yes) or if the substance is not authorised to be used as additive or polymer production aid (no). If the substance is only authorised as PPA it is indicated (yes) and in the specifications the use is restricted to PPA.
Column 6 (Use as monomer or other starting substance or macromolecule obtained from microbial fermentation (yes/no)): an indication if the substance is authorised to be used as monomer or other starting substance or macromolecule obtained from microbial fermentation (yes) or if the substance is not authorised to be used as monomer or other starting substance or macromolecule obtained from microbial fermentation (no). If the substance is authorised as macromolecule obtained from microbial fermentation it is indicated (yes) and in the specifications it is indicated that the substance is a macromolecule obtained from microbial fermentation.
Column 7 (FRF applicable (yes/no)): an indication if for the substance the migration results can be corrected by the Fat Consumption Reduction Factor (FRF) (yes) or if they cannot be corrected by the FRF (no).
[F1Column 8 (SML [mg/kg]): the specific migration limit applicable for the substance. It is expressed in mg substance per kg food. It is marked as ND ( ‘ not-detectable ’ ) if the substance is one in respect of which no migration is permitted, to be determined in accordance with Article 11(4).]
Textual Amendments
Column 9 (SML(T) [mg/kg] (group restriction No)): contains the identification number of the group of substances for which the group restriction in Column 1 in Table 2 of this Annex applies.
Column 10 (Restrictions and specifications): contains other restrictions than the specific migration limit specifically mentioned and it contains specifications related to the substance. In case detailed specifications are set out a reference to Table 4 is included.
Column 11 (Notes on verification of compliance): contains the Notes number which refers to the detailed rules applicable for verification of compliance for this substance included in Column 1 in Table 3 of this Annex.
If a substance appearing on the list as an individual compound is also covered by a generic term, the restrictions applying to this substance shall be those indicated for the individual compound.
[ F2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]
Textual Amendments
d [F3Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications of food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council ( OJ L 83, 22.3.2012, p. 1 ).] | ||||||||||
f [F4Infant as defined in Article 2 of Directive 2006/141/EC. | ||||||||||
g This restriction is applicable from 1 May 2011 as regards the manufacture and from 1 June 2011 as regards the placing on the market and importation into the Union.] | ||||||||||
(1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | (10) | (11) |
FCM substance No | Ref. No | CAS No | Substance name | Use as additive or polymer production aid(yes/no) | Use as monomer or other starting substance or macromolecule obtained from microbial fermentation(yes/no) | FRF applicable(yes/no) | SML[mg/kg] | SML(T)[mg/kg](Group restriction No) | Restrictions and specifications | Notes on verification of compliance |
---|---|---|---|---|---|---|---|---|---|---|
1 | 12310 | 0266309-43-7 | albumin | no | yes | no | ||||
2 | 12340 | — | albumin, coagulated by formaldehyde | no | yes | no | ||||
3 | 12375 | — | alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22) | no | yes | no | ||||
4 | 22332 | — | mixture of (40 % w/w) 2,2,4-trimethylhexane-1,6-diisocyanate and (60 % w/w) 2,4,4-trimethylhexane-1,6-diisocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety. | (10) | |
5 | 25360 | — | trialkyl(C5-C15)acetic acid, 2,3-epoxypropyl ester | no | yes | no | ND | 1 mg/kg in final product expressed as epoxygroup. Molecular weight is 43 Da. | ||
6 | 25380 | — | trialkyl acetic acid (C7-C17), vinyl esters | no | yes | no | 0,05 | (1) | ||
7 | 30370 | — | acetylacetic acid, salts | yes | no | no | ||||
8 | 30401 | — | acetylated mono- and diglycerides of fatty acids | yes | no | no | (32) | |||
9 | 30610 | — | acids, C2-C24, aliphatic, linear, monocarboxylic from natural oils and fats, and their mono-, di- and triglycerol esters (branched fatty acids at naturally occuring levels are included) | yes | no | no | ||||
10 | 30612 | — | acids, C2-C24, aliphatic, linear, monocarboxylic, synthetic and their mono-, di- and triglycerol esters | yes | no | no | ||||
11 | 30960 | — | acids, aliphatic, monocarboxylic (C6-C22), esters with polyglycerol | yes | no | no | ||||
12 | 31328 | — | acids, fatty, from animal or vegetable food fats and oils | yes | no | no | ||||
13 | 33120 | — | alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C24) | yes | no | no | ||||
14 | 33801 | — | n-alkyl(C10-C13)benzenesulphonic acid | yes | no | no | 30 | |||
15 | 34130 | — | alkyl, linear with even number of carbon atoms (C12-C20) dimethylamines | yes | no | yes | 30 | |||
16 | 34230 | — | alkyl(C8-C22)sulphonic acids | yes | no | no | 6 | |||
17 | 34281 | — | alkyl(C8-C22)sulphuric acids, linear, primary with an even number of carbon atoms | yes | no | no | ||||
18 | 34475 | — | aluminium calcium hydroxide phosphite, hydrate | yes | no | no | ||||
19 | 39090 | — | N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine | yes | no | no | (7) | |||
20 | 39120 | — | N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine hydrochlorides | yes | no | no | (7) | SML(T) expressed excluding HCl | ||
21 | 42500 | — | carbonic acid, salts | yes | no | no | ||||
22 | 43200 | — | castor oil, mono- and diglycerides | yes | no | no | ||||
23 | 43515 | — | chlorides of choline esters of coconut oil fatty acids | yes | no | no | 0,9 | (1) | ||
24 | 45280 | — | cotton fibers | yes | no | no | ||||
25 | 45440 | — | cresols, butylated, styrenated | yes | no | no | 12 | |||
26 | 46700 | — | 5,7-di-tert-butyl-3-(3,4- and 2,3-dimethylphenyl)-3H-benzofuran-2-one containing: a) 5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-3H-benzofuran-2-one (80 to 100 % w/w) and b) 5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-3H-benzofuran-2-one (0 to 20 % w/w) | yes | no | no | 5 | |||
27 | 48960 | — | 9,10-dihydroxy stearic acid and its oligomers | yes | no | no | 5 | |||
28 | 50160 | — | di-n-octyltin bis(n-alkyl(C10-C16) mercaptoacetate) | yes | no | no | (10) | |||
29 | 50360 | — | di-n-octyltin bis(ethyl maleate) | yes | no | no | (10) | |||
30 | 50560 | — | di-n-octyltin 1,4-butanediol bis(mercaptoacetate) | yes | no | no | (10) | |||
31 | 50800 | — | di-n-octyltin dimaleate, esterified | yes | no | no | (10) | |||
32 | 50880 | — | di-n-octyltin dimaleate, polymers (n = 2-4) | yes | no | no | (10) | |||
33 | 51120 | — | di-n-octyltin thiobenzoate 2-ethylhexyl mercaptoacetate | yes | no | no | (10) | |||
34 | 54270 | — | ethylhydroxymethylcellulose | yes | no | no | ||||
35 | 54280 | — | ethylhydroxypropylcellulose | yes | no | no | ||||
36 | 54450 | — | fats and oils, from animal or vegetable food sources | yes | no | no | ||||
37 | 54480 | — | fats and oils, hydrogenated, from animal or vegetable food sources | yes | no | no | ||||
38 | 55520 | — | glass fibers | yes | no | no | ||||
39 | 55600 | — | glass microballs | yes | no | no | ||||
40 | 56360 | — | glycerol, esters with acetic acid | yes | no | no | ||||
41 | 56486 | — | glycerol, esters with acids, aliphatic, saturated, linear, with an even number of carbon atoms (C14-C18) and with acids, aliphatic, unsaturated, linear, with an even number of carbon atoms (C16-C18) | yes | no | no | ||||
42 | 56487 | — | glycerol, esters with butyric acid | yes | no | no | ||||
43 | 56490 | — | glycerol, esters with erucic acid | yes | no | no | ||||
44 | 56495 | — | glycerol, esters with 12-hydroxystearic acid | yes | no | no | ||||
45 | 56500 | — | glycerol, esters with lauric acid | yes | no | no | ||||
46 | 56510 | — | glycerol, esters with linoleic acid | yes | no | no | ||||
47 | 56520 | — | glycerol, esters with myristic acid | yes | no | no | ||||
48 | 56535 | — | glycerol, esters with nonanoic acid | yes | no | no | ||||
49 | 56540 | — | glycerol, esters with oleic acid | yes | no | no | ||||
50 | 56550 | — | glycerol, esters with palmitic acid | yes | no | no | ||||
51 | 56570 | — | glycerol, esters with propionic acid | yes | no | no | ||||
52 | 56580 | — | glycerol, esters with ricinoleic acid | yes | no | no | ||||
53 | 56585 | — | glycerol, esters with stearic acid | yes | no | no | ||||
54 | 57040 | — | glycerol monooleate, ester with ascorbic acid | yes | no | no | ||||
55 | 57120 | — | glycerol monooleate, ester with citric acid | yes | no | no | ||||
56 | 57200 | — | glycerol monopalmitate, ester with ascorbic acid | yes | no | no | ||||
57 | 57280 | — | glycerol monopalmitate, ester with citric acid | yes | no | no | ||||
58 | 57600 | — | glycerol monostearate, ester with ascorbic acid | yes | no | no | ||||
59 | 57680 | — | glycerol monostearate, ester with citric acid | yes | no | no | ||||
60 | 58300 | — | glycine, salts | yes | no | no | ||||
62 | 64500 | — | lysine, salts | yes | no | no | ||||
63 | 65440 | — | manganese pyrophosphite | yes | no | no | ||||
64 | 66695 | — | methylhydroxymethylcellulose | yes | no | no | ||||
65 | 67155 | — | mixture of 4-(2-benzoxazolyl)-4′-(5-methyl-2-benzoxazolyl)stilbene, 4,4′-bis(2-benzoxazolyl) stilbene and 4,4′-bis(5-methyl-2-benzoxazolyl)stilbene | yes | no | no | Not more than 0,05 % (w/w) (quantity of substance used/quantity of the formulation). Mixture obtained from the manufacturing process in the typical ratio of (58-62 %):(23-27 %):(13-17 %). | |||
66 | 67600 | — | mono-n-octyltin tris(alkyl(C10-C16) mercaptoacetate) | yes | no | no | (11) | |||
67 | 67840 | — | montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerol | yes | no | no | ||||
68 | 73160 | — | phosphoric acid, mono- and di-n-alkyl (C16 and C18) esters | yes | no | yes | 0,05 | |||
69 | 74400 | — | phosphorous acid, tris(nonyl-and/or dinonylphenyl) ester | yes | no | yes | 30 | |||
70 | 76463 | — | polyacrylic acid, salts | yes | no | no | (22) | |||
71 | 76730 | — | polydimethylsiloxane, γ-hydroxypropylated | yes | no | no | 6 | |||
72 | 76815 | — | polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched C12-C22 fatty acids | yes | no | no | (32) | The fraction with molecular weight below 1 000 Da [F1shall] not exceed 5 % (w/w) | ||
73 | 76866 | — | polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, which may be end-capped with acetic acid or fatty acids C12-C18 or n-octanol and/or n-decanol | yes | no | yes | (31) (32) | |||
74 | 77440 | — | polyethyleneglycol diricinoleate | yes | no | yes | 42 | |||
75 | 77702 | — | polyethyleneglycol esters of aliph. monocarb. acids (C6-C22) and their ammonium and sodium sulphates | yes | no | no | ||||
76 | 77732 | — | polyethylene glycol (EO = 1-30, typically 5) ether of butyl 2-cyano 3-(4-hydroxy-3-methoxyphenyl) acrylate | yes | no | no | 0,05 | Only for use in PET | ||
77 | 77733 | — | polyethyleneglycol (EO = 1-30, typically 5) ether of butyl-2-cyano-3-(4-hydroxyphenyl) acrylate | yes | no | no | 0,05 | Only for use in PET | ||
78 | 77897 | — | polyethyleneglycol (EO = 1-50) monoalkylether (linear and branched, C8-C20) sulphate, salts | yes | no | no | 5 | |||
79 | 80640 | — | polyoxyalkyl (C2-C4) dimethylpolysiloxane | yes | no | no | ||||
80 | 81760 | — | powders, flakes and fibres of brass, bronze, copper, stainless steel, tin, iron and alloys of copper, tin and iron | yes | no | no | ||||
81 | 83320 | — | propylhydroxyethylcellulose | yes | no | no | ||||
82 | 83325 | — | propylhydroxymethylcellulose | yes | no | no | ||||
83 | 83330 | — | propylhydroxypropylcellulose | yes | no | no | ||||
84 | 85601 | — | silicates, natural (with the exception of asbestos) | yes | no | no | ||||
85 | 85610 | — | silicates, natural, silanated (with the exception of asbestos) | yes | no | no | ||||
86 | 86000 | — | silicic acid, silylated | yes | no | no | ||||
[F187 | 86285 | Silicon dioxide, silanated | yes | no | no | For synthetic amorphous silicon dioxide, silanated: primary particles of 1–100 nm which are aggregated to a size of 0,1–1 μm and may form agglomerates within the size distribution of 0,3 μm to the mm size. | ] | |||
88 | 86880 | — | sodium monoalkyl dialkylphenoxybenzenedisulphonate | yes | no | no | 9 | |||
89 | 89440 | — | stearic acid, esters with ethyleneglycol | yes | no | no | (2) | |||
90 | 92195 | — | taurine, salts | yes | no | no | ||||
91 | 92320 | — | tetradecyl-polyethyleneglycol(EO = 3-8) ether of glycolic acid | yes | no | yes | 15 | |||
92 | 93970 | — | tricyclodecanedimethanol bis(hexahydrophthalate) | yes | no | no | 0,05 | |||
93 | 95858 | — | waxes, paraffinic, refined, derived from petroleum based or synthetic hydrocarbon feedstocks, low viscosity | yes | no | no | 0,05 | Not to be used for articles in contact with fatty foods for which [F1simulant D1 and/or D2] is laid down. Average molecular weight not less than 350 Da. Viscosity at 100 °C not less than 2,5 cSt (2,5 × 10-6 m2/s). Content of hydrocarbons with Carbon number less than 25, not more than 40 % (w/w). | ||
94 | 95859 | — | waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks, high viscosity | yes | no | no | Average molecular weight not less than 500 Da. Viscosity at 100 °C not less than 11 cSt (11 × 10-6 m2/s). Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w). | |||
95 | 95883 | — | white mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks | yes | no | no | Average molecular weight not less than 480 Da. Viscosity at 100 °C not less than 8,5 cSt (8,5 × 10-6 m2/s). Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w). | |||
96 | 95920 | — | wood flour and fibers, untreated | yes | no | no | ||||
97 | 72081/10 | — | petroleum hydrocarbon resins (hydrogenated) | yes | no | no | Petroleum hydrocarbon resins, hydrogenated are produced by the catalytic or thermalpolymerisation of dienes and olefins of the aliphatic, alicyclic and/or monobenzenoidarylalkene types from distillates of cracked petroleum stocks with a boiling range not greater than 220 °C, as well as the pure monomers found in these distillation streams, subsequently followed by distillation, hydrogenation and additional processing. Properties:
| |||
98 | 17260 | 0000050-00-0 | formaldehyde | yes | yes | no | (15) | |||
54880 | ||||||||||
99 | 19460 | 0000050-21-5 | lactic acid | yes | yes | no | ||||
62960 | ||||||||||
100 | 24490 | 0000050-70-4 | sorbitol | yes | yes | no | ||||
88320 | ||||||||||
101 | 36000 | 0000050-81-7 | ascorbic acid | yes | no | no | ||||
102 | 17530 | 0000050-99-7 | glucose | no | yes | no | ||||
103 | 18100 | 0000056-81-5 | glycerol | yes | yes | no | ||||
55920 | ||||||||||
104 | 58960 | 0000057-09-0 | hexadecyltrimethylammonium bromide | yes | no | no | 6 | |||
105 | 22780 | 0000057-10-3 | palmitic acid | yes | yes | no | ||||
70400 | ||||||||||
106 | 24550 | 0000057-11-4 | stearic acid | yes | yes | no | ||||
89040 | ||||||||||
107 | 25960 | 0000057-13-6 | urea | no | yes | no | ||||
108 | 24880 | 0000057-50-1 | sucrose | no | yes | no | ||||
109 | 23740 | 0000057-55-6 | 1,2-propanediol | yes | yes | no | ||||
81840 | ||||||||||
110 | 93520 | 0000059-02-9 0010191-41-0 | α-tocopherol | yes | no | no | ||||
111 | 53600 | 0000060-00-4 | ethylenediaminetetraacetic acid | yes | no | no | ||||
112 | 64015 | 0000060-33-3 | linoleic acid | yes | no | no | ||||
113 | 16780 | 0000064-17-5 | ethanol | yes | yes | no | ||||
52800 | ||||||||||
114 | 55040 | 0000064-18-6 | formic acid | yes | no | no | ||||
115 | 10090 | 0000064-19-7 | acetic acid | yes | yes | no | ||||
30000 | ||||||||||
116 | 13090 | 0000065-85-0 | benzoic acid | yes | yes | no | ||||
37600 | ||||||||||
117 | 21550 | 0000067-56-1 | methanol | no | yes | no | ||||
118 | 23830 | 0000067-63-0 | 2-propanol | yes | yes | no | ||||
81882 | ||||||||||
119 | 30295 | 0000067-64-1 | acetone | yes | no | no | ||||
120 | 49540 | 0000067-68-5 | dimethyl sulphoxide | yes | no | no | ||||
121 | 24270 | 0000069-72-7 | salicylic acid | yes | yes | no | ||||
84640 | ||||||||||
122 | 23800 | 0000071-23-8 | 1-propanol | no | yes | no | ||||
123 | 13840 | 0000071-36-3 | 1-butanol | no | yes | no | ||||
124 | 22870 | 0000071-41-0 | 1-pentanol | no | yes | no | ||||
125 | 16950 | 0000074-85-1 | ethylene | no | yes | no | ||||
126 | 10210 | 0000074-86-2 | acetylene | no | yes | no | ||||
127 | 26050 | 0000075-01-4 | vinyl chloride | no | yes | no | ND | 1 mg/kg in final product | ||
128 | 10060 | 0000075-07-0 | acetaldehyde | no | yes | no | (1) | |||
129 | 17020 | 0000075-21-8 | ethylene oxide | no | yes | no | ND | 1 mg/kg in final product | (10) | |
130 | 26110 | 0000075-35-4 | vinylidene chloride | no | yes | no | ND | (1) | ||
131 | 48460 | 0000075-37-6 | 1,1-difluoroethane | yes | no | no | ||||
132 | 26140 | 0000075-38-7 | vinylidene fluoride | no | yes | no | 5 | |||
133 | 14380 | 0000075-44-5 | carbonyl chloride | no | yes | no | ND | 1 mg/kg in final product | (10) | |
23155 | ||||||||||
134 | 43680 | 0000075-45-6 | chlorodifluoromethane | yes | no | no | 6 | Content of chlorofluoromethane less than 1 mg/kg of the substance | ||
135 | 24010 | 0000075-56-9 | propylene oxide | no | yes | no | ND | 1 mg/kg in final product | ||
136 | 41680 | 0000076-22-2 | camphor | yes | no | no | (3) | |||
137 | 66580 | 0000077-62-3 | 2,2′-methylenebis(4-methyl-6-(1-methylcyclohexyl)phenol) | yes | no | yes | (5) | |||
138 | 93760 | 0000077-90-7 | tri-n-butyl acetyl citrate | yes | no | no | (32) | |||
139 | 14680 | 0000077-92-9 | citric acid | yes | yes | no | ||||
44160 | ||||||||||
140 | 44640 | 0000077-93-0 | citric acid, triethyl ester | yes | no | no | (32) | |||
141 | 13380 | 0000077-99-6 | 1,1,1-trimethylolpropane | yes | yes | no | 6 | |||
25600 | ||||||||||
94960 | ||||||||||
142 | 26305 | 0000078-08-0 | vinyltriethoxysilane | no | yes | no | 0,05 | Only to be used as a surface treatment agent | [F6(1)] | |
143 | 62450 | 0000078-78-4 | isopentane | yes | no | no | ||||
144 | 19243 | 0000078-79-5 | 2-methyl-1,3-butadiene | no | yes | no | ND | 1 mg/kg in final product | ||
21640 | ||||||||||
145 | 10630 | 0000079-06-1 | acrylamide | no | yes | no | ND | |||
146 | 23890 | 0000079-09-4 | propionic acid | yes | yes | no | ||||
82000 | ||||||||||
147 | 10690 | 0000079-10-7 | acrylic acid | no | yes | no | (22) | |||
148 | 14650 | 0000079-38-9 | chlorotrifluoroethylene | no | yes | no | ND | (1) | ||
149 | 19990 | 0000079-39-0 | methacrylamide | no | yes | no | ND | |||
150 | 20020 | 0000079-41-4 | methacrylic acid | no | yes | no | (23) | |||
151 | 13480 | 0000080-05-7 | 2,2-bis(4-hydroxyphenyl)propane | no | yes | no | 0,6 | [F4Not to be used for the manufacture of polycarbonate infant f feeding bottles g .] | ||
13607 | ||||||||||
152 | 15610 | 0000080-07-9 | 4,4′-dichlorodiphenyl sulphone | no | yes | no | 0,05 | |||
153 | 15267 | 0000080-08-0 | 4,4′-diaminodiphenyl sulphone | no | yes | no | 5 | |||
154 | 13617 | 0000080-09-1 | 4,4′-dihydroxydiphenyl sulphone | no | yes | no | 0,05 | |||
16090 | ||||||||||
155 | 23470 | 0000080-56-8 | α-pinene | no | yes | no | ||||
156 | 21130 | 0000080-62-6 | methacrylic acid, methyl ester | no | yes | no | (23) | |||
157 | 74880 | 0000084-74-2 | phthalic acid, dibutyl ester | yes | no | no | 0,3 | (32) | Only to be used as: (a) plasticiser in repeated use materials and articles contacting non-fatty foods; (b) technical support agent in polyolefins in concentrations up to 0,05 % in the final product. | (7) |
158 | 23380 | 0000085-44-9 | phthalic anhydride | yes | yes | no | ||||
76320 | ||||||||||
159 | 74560 | 0000085-68-7 | phthalic acid, benzyl butyl ester | yes | no | no | 30 | (32) | 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. | (7) |
160 | 84800 | 0000087-18-3 | salicylic acid, 4-tert-butylphenyl ester | yes | no | yes | 12 | |||
[F7161 | 92160 | 000087-69-4 | L-(+)-tartaric acid | yes | no | no | ] | |||
162 | 65520 | 0000087-78-5 | mannitol | yes | no | no | ||||
163 | 66400 | 0000088-24-4 | 2,2′-methylene bis(4-ethyl-6-tert-butylphenol) | yes | no | yes | (13) | |||
164 | 34895 | 0000088-68-6 | 2-aminobenzamide | yes | no | no | 0,05 | Only for use in PET for water and beverages | ||
165 | 23200 | 0000088-99-3 | o-phthalic acid | yes | yes | no | ||||
74480 | ||||||||||
166 | 24057 | 0000089-32-7 | pyromellitic anhydride | no | yes | no | 0,05 | |||
167 | 25240 | 0000091-08-7 | 2,6-toluene diisocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
168 | 13075 | 0000091-76-9 | 2,4-diamino-6-phenyl-1,3,5-triazine | no | yes | no | 5 | [F6(1)] | ||
15310 | ||||||||||
169 | 16240 | 0000091-97-4 | 3,3′-dimethyl-4,4′-diisocyanatobiphenyl | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
170 | 16000 | 0000092-88-6 | 4,4′-dihydroxybiphenyl | no | yes | no | 6 | |||
171 | 38080 | 0000093-58-3 | benzoic acid, methyl ester | yes | no | no | ||||
172 | 37840 | 0000093-89-0 | benzoic acid, ethyl ester | yes | no | no | ||||
173 | 60240 | 0000094-13-3 | 4-hydroxybenzoic acid, propyl ester | yes | no | no | ||||
174 | 14740 | 0000095-48-7 | o-cresol | no | yes | no | ||||
175 | 20050 | 0000096-05-9 | methacrylic acid, allyl ester | no | yes | no | 0,05 | |||
176 | 11710 | 0000096-33-3 | acrylic acid, methyl ester | no | yes | no | (22) | |||
177 | 16955 | 0000096-49-1 | ethylene carbonate | no | yes | no | 30 | 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. | ||
178 | 92800 | 0000096-69-5 | 4,4′-thiobis(6-tert-butyl-3-methylphenol) | yes | no | yes | 0,48 | |||
179 | 48800 | 0000097-23-4 | 2,2′-dihydroxy-–5,5′-dichlorodiphenylmethane | yes | no | yes | 12 | |||
[F8180 | 17160 | 0000097-53-0 | eugenol | no | yes | no | (33) | ] | ||
181 | 20890 | 0000097-63-2 | methacrylic acid, ethyl ester | no | yes | no | (23) | |||
182 | 19270 | 0000097-65-4 | itaconic acid | no | yes | no | ||||
183 | 21010 | 0000097-86-9 | methacrylic acid, isobutyl ester | no | yes | no | (23) | |||
184 | 20110 | 0000097-88-1 | methacrylic acid, butyl ester | no | yes | no | (23) | |||
185 | 20440 | 0000097-90-5 | methacrylic acid, diester with ethyleneglycol | no | yes | no | 0,05 | |||
186 | 14020 | 0000098-54-4 | 4-tert-butylphenol | no | yes | no | 0,05 | |||
187 | 22210 | 0000098-83-9 | α-methylstyrene | no | yes | no | 0,05 | |||
188 | 19180 | 0000099-63-8 | isophthalic acid dichloride | no | yes | no | (27) | |||
189 | 60200 | 0000099-76-3 | 4-hydroxybenzoic acid, methyl ester | yes | no | no | ||||
190 | 18880 | 0000099-96-7 | p-hydroxybenzoic acid | no | yes | no | ||||
191 | 24940 | 0000100-20-9 | terephthalic acid dichloride | no | yes | no | (28) | |||
192 | 23187 | — | phthalic acid | no | yes | no | (28) | |||
193 | 24610 | 0000100-42-5 | styrene | no | yes | no | ||||
194 | 13150 | 0000100-51-6 | benzyl alcohol | no | yes | no | ||||
195 | 37360 | 0000100-52-7 | benzaldehyde | yes | no | no | (3) | |||
196 | 18670 | 0000100-97-0 | hexamethylenetetramine | yes | yes | no | (15) | |||
59280 | ||||||||||
197 | 20260 | 0000101-43-9 | methacrylic acid, cyclohexyl ester | no | yes | no | 0,05 | |||
198 | 16630 | 0000101-68-8 | diphenylmethane-4,4′-diisocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
199 | 24073 | 0000101-90-6 | resorcinol diglycidyl ether | no | yes | no | ND | Not to be used for articles in contact with fatty foods for which [F1simulant D1 and/or D2] is laid down. For indirect food contact only, behind a PET layer. | (8) | |
200 | 51680 | 0000102-08-9 | N,N′-diphenylthiourea | yes | no | yes | 3 | |||
201 | 16540 | 0000102-09-0 | diphenyl carbonate | no | yes | no | 0,05 | |||
202 | 23070 | 0000102-39-6 | (1,3-phenylenedioxy)diacetic acid | no | yes | no | 0,05 | [F6(1)] | ||
203 | 13323 | 0000102-40-9 | 1,3-bis(2-hydroxyethoxy)benzene | no | yes | no | 0,05 | |||
204 | 25180 | 0000102-60-3 | N,N,N′,N′-tetrakis(2-hydroxypropyl)ethylenediamine | yes | yes | no | ||||
92640 | ||||||||||
205 | 25385 | 0000102-70-5 | triallylamine | no | yes | no | 40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1,5 grams of hydrogel. Only to be used in hydrogels intended for non-direct food contact use. | |||
206 | 11500 | 0000103-11-7 | acrylic acid, 2-ethylhexyl ester | no | yes | no | 0,05 | |||
207 | 31920 | 0000103-23-1 | adipic acid, bis(2-ethylhexyl) ester | yes | no | yes | 18 | (32) | (2) | |
208 | 18898 | 0000103-90-2 | N-(4-hydroxyphenyl) acetamide | no | yes | no | 0,05 | |||
209 | 17050 | 0000104-76-7 | 2-ethyl-1-hexanol | no | yes | no | 30 | |||
210 | 13390 | 0000105-08-8 | 1,4-bis(hydroxymethyl)cyclohexane | no | yes | no | ||||
14880 | ||||||||||
211 | 23920 | 0000105-38-4 | propionic acid, vinyl ester | no | yes | no | (1) | |||
212 | 14200 | 0000105-60-2 | caprolactam | yes | yes | no | (4) | |||
41840 | ||||||||||
213 | 82400 | 0000105-62-4 | 1,2-propyleneglycol dioleate | yes | no | no | ||||
214 | 61840 | 0000106-14-9 | 12-hydroxystearic acid | yes | no | no | ||||
215 | 14170 | 0000106-31-0 | butyric anhydride | no | yes | no | ||||
216 | 14770 | 0000106-44-5 | p-cresol | no | yes | no | ||||
217 | 15565 | 0000106-46-7 | 1,4-dichlorobenzene | no | yes | no | 12 | |||
218 | 11590 | 0000106-63-8 | acrylic acid, isobutyl ester | no | yes | no | (22) | |||
219 | 14570 | 0000106-89-8 | epichlorohydrin | no | yes | no | ND | 1 mg/kg in final product | (10) | |
16750 | ||||||||||
220 | 20590 | 0000106-91-2 | methacrylic acid, 2,3-epoxypropyl ester | no | yes | no | 0,02 | (10) | ||
221 | 40570 | 0000106-97-8 | butane | yes | no | no | ||||
222 | 13870 | 0000106-98-9 | 1-butene | no | yes | no | ||||
223 | 13630 | 0000106-99-0 | butadiene | no | yes | no | ND | 1 mg/kg in final product | ||
224 | 13900 | 0000107-01-7 | 2-butene | no | yes | no | ||||
225 | 12100 | 0000107-13-1 | acrylonitrile | no | yes | no | ND | |||
226 | 15272 | 0000107-15-3 | ethylenediamine | no | yes | no | 12 | |||
16960 | ||||||||||
227 | 16990 | 0000107-21-1 | ethyleneglycol | yes | yes | no | (2) | |||
53650 | ||||||||||
228 | 13690 | 0000107-88-0 | 1,3-butanediol | no | yes | no | ||||
229 | 14140 | 0000107-92-6 | butyric acid | no | yes | no | ||||
230 | 16150 | 0000108-01-0 | dimethylaminoethanol | no | yes | no | 18 | |||
231 | 10120 | 0000108-05-4 | acetic acid, vinyl ester | no | yes | no | 12 | |||
232 | 10150 | 0000108-24-7 | acetic anhydride | yes | yes | no | ||||
30280 | ||||||||||
233 | 24850 | 0000108-30-5 | succinic anhydride | no | yes | no | ||||
234 | 19960 | 0000108-31-6 | maleic anhydride | no | yes | no | (3) | |||
235 | 14710 | 0000108-39-4 | m-cresol | no | yes | no | ||||
236 | 23050 | 0000108-45-2 | 1,3-phenylenediamine | no | yes | no | ND | |||
237 | 15910 | 0000108-46-3 | 1,3-dihydroxybenzene | no | yes | no | 2,4 | |||
24072 | ||||||||||
238 | 18070 | 0000108-55-4 | glutaric anhydride | no | yes | no | ||||
[F9239 | 19975 | 0000108-78-1 | 2,4,6-triamino-1,3,5-triazine | yes | yes | no | 2,5 | |||
25420 | ||||||||||
93720] | ||||||||||
240 | 45760 | 0000108-91-8 | cyclohexylamine | yes | no | no | ||||
[F7241 | 22960 | 0000108-95-2 | phenol | no | yes | no | 3 | ] | ||
242 | 85360 | 0000109-43-3 | sebacic acid, dibutyl ester | yes | no | no | (32) | |||
243 | 19060 | 0000109-53-5 | isobutyl vinyl ether | no | yes | no | 0,05 | (10) | ||
244 | 71720 | 0000109-66-0 | pentane | yes | no | no | ||||
245 | 22900 | 0000109-67-1 | 1-pentene | no | yes | no | 5 | |||
246 | 25150 | 0000109-99-9 | tetrahydrofuran | no | yes | no | 0,6 | |||
247 | 24820 | 0000110-15-6 | succinic acid | yes | yes | no | ||||
90960 | ||||||||||
248 | 19540 | 0000110-16-7 | maleic acid | yes | yes | no | (3) | |||
64800 | ||||||||||
249 | 17290 | 0000110-17-8 | fumaric acid | yes | yes | no | ||||
55120 | ||||||||||
250 | 53520 | 0000110-30-5 | N,N′-ethylenebisstearamide | yes | no | no | ||||
251 | 53360 | 0000110-31-6 | N,N′-ethylenebisoleamide | yes | no | no | ||||
252 | 87200 | 0000110-44-1 | sorbic acid | yes | no | no | ||||
253 | 15250 | 0000110-60-1 | 1,4-diaminobutane | no | yes | no | ||||
254 | 13720 | 0000110-63-4 | 1,4-butanediol | yes | yes | no | (30) | |||
40580 | ||||||||||
255 | 25900 | 0000110-88-3 | trioxane | no | yes | no | 5 | |||
256 | 18010 | 0000110-94-1 | glutaric acid | yes | yes | no | ||||
55680 | ||||||||||
[F8257 | 13550 | 0000110-98-5 | dipropyleneglycol | yes | yes | no | ||||
16660 | 0025265-71-8 | |||||||||
51760 | ] | |||||||||
258 | 70480 | 0000111-06-8 | palmitic acid, butyl ester | yes | no | no | ||||
259 | 58720 | 0000111-14-8 | heptanoic acid | yes | no | no | ||||
260 | 24280 | 0000111-20-6 | sebacic acid | no | yes | no | ||||
261 | 15790 | 0000111-40-0 | diethylenetriamine | no | yes | no | 5 | |||
262 | 35284 | 0000111-41-1 | N-(2-aminoethyl)ethanolamine | yes | no | no | 0,05 | Not to be used for articles in contact with fatty foods for which [F1simulant D1 and/or D2] is laid down. For indirect food contact only, behind a PET layer. | ||
263 | 13326 | 0000111-46-6 | diethyleneglycol | yes | yes | no | (2) | |||
15760 | ||||||||||
47680 | ||||||||||
264 | 22660 | 0000111-66-0 | 1-octene | no | yes | no | 15 | |||
265 | 22600 | 0000111-87-5 | 1-octanol | no | yes | no | ||||
266 | 25510 | 0000112-27-6 | triethyleneglycol | yes | yes | no | ||||
94320 | ||||||||||
267 | 15100 | 0000112-30-1 | 1-decanol | no | yes | no | ||||
268 | 16704 | 0000112-41-4 | 1-dodecene | no | yes | no | 0,05 | |||
269 | 25090 | 0000112-60-7 | tetraethyleneglycol | yes | yes | no | ||||
92350 | ||||||||||
270 | 22763 | 0000112-80-1 | oleic acid | yes | yes | no | ||||
69040 | ||||||||||
271 | 52720 | 0000112-84-5 | erucamide | yes | no | no | ||||
272 | 37040 | 0000112-85-6 | behenic acid | yes | no | no | ||||
273 | 52730 | 0000112-86-7 | erucic acid | yes | no | no | ||||
274 | 22570 | 0000112-96-9 | octadecyl isocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
275 | 23980 | 0000115-07-1 | propylene | no | yes | no | ||||
276 | 19000 | 0000115-11-7 | isobutene | no | yes | no | ||||
277 | 18280 | 0000115-27-5 | hexachloroendomethylenetetrahydrophthalic anhydride | no | yes | no | ND | |||
278 | 18250 | 0000115-28-6 | hexachloroendomethylenetetrahydrophthalic acid | no | yes | no | ND | |||
279 | 22840 | 0000115-77-5 | pentaerythritol | yes | yes | no | ||||
71600 | ||||||||||
280 | 73720 | 0000115-96-8 | phosphoric acid, trichloroethyl ester | yes | no | no | ND | |||
281 | 25120 | 0000116-14-3 | tetrafluoroethylene | no | yes | no | 0,05 | |||
282 | 18430 | 0000116-15-4 | hexafluoropropylene | no | yes | no | ND | |||
283 | 74640 | 0000117-81-7 | phthalic acid, bis(2-ethylhexyl) ester | yes | no | no | 1,5 | (32) | 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. | (7) |
284 | 84880 | 0000119-36-8 | salicylic acid, methyl ester | yes | no | no | 30 | |||
285 | 66480 | 0000119-47-1 | 2,2′-methylene bis(4-methyl-6-tert-butylphenol) | yes | no | yes | (13) | |||
286 | 38240 | 0000119-61-9 | benzophenone | yes | no | yes | 0,6 | |||
287 | 60160 | 0000120-47-8 | 4-hydroxybenzoic acid, ethyl ester | yes | no | no | ||||
288 | 24970 | 0000120-61-6 | terephthalic acid, dimethyl ester | no | yes | no | ||||
289 | 15880 | 0000120-80-9 | 1,2-dihydroxybenzene | no | yes | no | 6 | |||
24051 | ||||||||||
290 | 55360 | 0000121-79-9 | gallic acid, propyl ester | yes | no | no | (20) | |||
291 | 19150 | 0000121-91-5 | isophthalic acid | no | yes | no | (27) | |||
292 | 94560 | 0000122-20-3 | triisopropanolamine | yes | no | no | 5 | |||
293 | 23175 | 0000122-52-1 | phosphorous acid, triethyl ester | no | yes | no | ND | 1 mg/kg in final product | (1) | |
294 | 93120 | 0000123-28-4 | thiodipropionic acid, didodecyl ester | yes | no | yes | (14) | |||
295 | 15940 | 0000123-31-9 | 1,4-dihydroxybenzene | yes | yes | no | 0,6 | |||
18867 | ||||||||||
48620 | ||||||||||
296 | 23860 | 0000123-38-6 | propionaldehyde | no | yes | no | ||||
297 | 23950 | 0000123-62-6 | propionic anhydride | no | yes | no | ||||
298 | 14110 | 0000123-72-8 | butyraldehyde | no | yes | no | ||||
299 | 63840 | 0000123-76-2 | levulinic acid | yes | no | no | ||||
300 | 30045 | 0000123-86-4 | acetic acid, butyl ester | yes | no | no | ||||
301 | 89120 | 0000123-95-5 | stearic acid, butyl ester | yes | no | no | ||||
302 | 12820 | 0000123-99-9 | azelaic acid | no | yes | no | ||||
303 | 12130 | 0000124-04-9 | adipic acid | yes | yes | no | ||||
31730 | ||||||||||
304 | 14320 | 0000124-07-2 | caprylic acid | yes | yes | no | ||||
41960 | ||||||||||
305 | 15274 | 0000124-09-4 | hexamethylenediamine | no | yes | no | 2,4 | |||
18460 | ||||||||||
306 | 88960 | 0000124-26-5 | stearamide | yes | no | no | ||||
307 | 42160 | 0000124-38-9 | carbon dioxide | yes | no | no | ||||
308 | 91200 | 0000126-13-6 | sucrose acetate isobutyrate | yes | no | no | ||||
309 | 91360 | 0000126-14-7 | sucrose octaacetate | yes | no | no | ||||
310 | 16390 | 0000126-30-7 | 2,2-dimethyl-1,3-propanediol | no | yes | no | 0,05 | |||
22437 | ||||||||||
311 | 16480 | 0000126-58-9 | dipentaerythritol | yes | yes | no | ||||
51200 | ||||||||||
312 | 21490 | 0000126-98-7 | methacrylonitrile | no | yes | no | ND | |||
313 | 16650 | 0000127-63-9 | diphenyl sulphone | yes | yes | no | 3 | |||
51570 | ||||||||||
314 | 23500 | 0000127-91-3 | β-pinene | no | yes | no | ||||
315 | 46640 | 0000128-37-0 | 2,6-di-tert-butyl-p-cresol | yes | no | no | 3 | |||
316 | 23230 | 0000131-17-9 | phthalic acid, diallyl ester | no | yes | no | ND | |||
317 | 48880 | 0000131-53-3 | 2,2′-dihydroxy-4-methoxybenzophenone | yes | no | yes | (8) | |||
318 | 48640 | 0000131-56-6 | 2,4-dihydroxybenzophenone | yes | no | no | (8) | |||
319 | 61360 | 0000131-57-7 | 2-hydroxy-4-methoxybenzophenone | yes | no | yes | (8) | |||
320 | 37680 | 0000136-60-7 | benzoic acid, butyl ester | yes | no | no | ||||
321 | 36080 | 0000137-66-6 | ascorbyl palmitate | yes | no | no | ||||
322 | 63040 | 0000138-22-7 | lactic acid, butyl ester | yes | no | no | ||||
323 | 11470 | 0000140-88-5 | acrylic acid, ethyl ester | no | yes | no | (22) | |||
324 | 83700 | 0000141-22-0 | ricinoleic acid | yes | no | yes | 42 | |||
325 | 10780 | 0000141-32-2 | acrylic acid, n-butyl ester | no | yes | no | (22) | |||
326 | 12763 | 0000141-43-5 | 2-aminoethanol | yes | yes | no | 0,05 | Not to be used for articles in contact with fatty foods for which [F1simulant D1 and/or D2] is laid down. For indirect food contact only, behind a PET layer. | ||
35170 | ||||||||||
327 | 30140 | 0000141-78-6 | acetic acid, ethyl ester | yes | no | no | ||||
328 | 65040 | 0000141-82-2 | malonic acid | yes | no | no | ||||
329 | 59360 | 0000142-62-1 | hexanoic acid | yes | no | no | ||||
330 | 19470 | 0000143-07-7 | lauric acid | yes | yes | no | ||||
63280 | ||||||||||
331 | 22480 | 0000143-08-8 | 1-nonanol | no | yes | no | ||||
332 | 69760 | 0000143-28-2 | oleyl alcohol | yes | no | no | ||||
333 | 22775 | 0000144-62-7 | oxalic acid | yes | yes | no | 6 | |||
69920 | ||||||||||
334 | 17005 | 0000151-56-4 | ethyleneimine | no | yes | no | ND | |||
335 | 68960 | 0000301-02-0 | oleamide | yes | no | no | ||||
336 | 15095 | 0000334-48-5 | n-decanoic acid | yes | yes | no | ||||
45940 | ||||||||||
337 | 15820 | 0000345-92-6 | 4,4′-difluorobenzophenone | no | yes | no | 0,05 | |||
338 | 71020 | 0000373-49-9 | palmitoleic acid | yes | no | no | ||||
339 | 86160 | 0000409-21-2 | silicon carbide | yes | no | no | ||||
[F10340 | 47440 | 0000461-58-5 | dicyanodiamide | yes | no | no | 60 | ] | ||
341 | 13180 | 0000498-66-8 | bicyclo[2.2.1]hept-2-ene | no | yes | no | 0,05 | |||
22550 | ||||||||||
342 | 14260 | 0000502-44-3 | caprolactone | no | yes | no | (29) | |||
343 | 23770 | 0000504-63-2 | 1,3-propanediol | no | yes | no | 0,05 | |||
[F7344 | 13810 | 0000505-65-7 | 1,4-butanediol formal | no | yes | no | 0,05 | 15 30 | (21) | |
21821] | ||||||||||
345 | 35840 | 0000506-30-9 | arachidic acid | yes | no | no | ||||
346 | 10030 | 0000514-10-3 | abietic acid | no | yes | no | ||||
347 | 13050 | 0000528-44-9 | trimellitic acid | no | yes | no | (21) | |||
25540 | ||||||||||
348 | 22350 | 0000544-63-8 | myristic acid | yes | yes | no | ||||
67891 | ||||||||||
349 | 25550 | 0000552-30-7 | trimellitic anhydride | no | yes | no | (21) | |||
350 | 63920 | 0000557-59-5 | lignoceric acid | yes | no | no | ||||
351 | 21730 | 0000563-45-1 | 3-methyl-1-butene | no | yes | no | ND | Only to be used in polypropylene | (1) | |
352 | 16360 | 0000576-26-1 | 2,6-dimethylphenol | no | yes | no | 0,05 | |||
353 | 42480 | 0000584-09-8 | carbonic acid, rubidium salt | yes | no | no | 12 | |||
354 | 25210 | 0000584-84-9 | 2,4-toluene diisocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
355 | 20170 | 0000585-07-9 | methacrylic acid, tert-butyl ester | no | yes | no | (23) | |||
356 | 18820 | 0000592-41-6 | 1-hexene | no | yes | no | 3 | |||
357 | 13932 | 0000598-32-3 | 3-buten-2-ol | no | yes | no | ND | Only to be used as a co-monomer for the preparation of polymeric additive | (1) | |
358 | 14841 | 0000599-64-4 | 4-cumylphenol | no | yes | no | 0,05 | |||
359 | 15970 | 0000611-99-4 | 4,4′-dihydroxybenzophenone | yes | yes | no | (8) | |||
48720 | ||||||||||
360 | 57920 | 0000620-67-7 | glycerol triheptanoate | yes | no | no | ||||
361 | 18700 | 0000629-11-8 | 1,6-hexanediol | no | yes | no | 0,05 | |||
362 | 14350 | 0000630-08-0 | carbon monoxide | no | yes | no | ||||
363 | 16450 | 0000646-06-0 | 1,3-dioxolane | no | yes | no | 5 | |||
[F7364 | 15404 | 0000652-67-5 | 1,4:3,6-dianhydrosorbitol | no | yes | no | 5 | 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. | ] | |
365 | 11680 | 0000689-12-3 | acrylic acid, isopropyl ester | no | yes | no | (22) | |||
366 | 22150 | 0000691-37-2 | 4-methyl-1-pentene | no | yes | no | 0,05 | |||
367 | 16697 | 0000693-23-2 | n-dodecanedioic acid | no | yes | no | ||||
368 | 93280 | 0000693-36-7 | thiodipropionic acid, dioctadecyl ester | yes | no | yes | (14) | |||
369 | 12761 | 0000693-57-2 | 12-aminododecanoic acid | no | yes | no | 0,05 | |||
370 | 21460 | 0000760-93-0 | methacrylic anhydride | no | yes | no | (23) | |||
371 | 11510 | 0000818-61-1 | acrylic acid, monoester with ethyleneglycol | no | yes | no | (22) | |||
11830 | ||||||||||
372 | 18640 | 0000822-06-0 | hexamethylene diisocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
373 | 22390 | 0000840-65-3 | 2,6-naphthalenedicarboxylic acid, dimethyl ester | no | yes | no | 0,05 | |||
374 | 21190 | 0000868-77-9 | methacrylic acid, monoester with ethyleneglycol | no | yes | no | (23) | |||
375 | 15130 | 0000872-05-9 | 1-decene | no | yes | no | 0,05 | |||
[F9376 | 66905 | 0000872-50-4 | N-methylpyrrolidone | yes | no | no | 60 | ] | ||
377 | 12786 | 0000919-30-2 | 3-aminopropyltriethoxysilane | no | yes | no | 0,05 | Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler when used for the reactive surface treatment of inorganic fillers. SML = 0,05 mg/kg when used for the surface treatment of materials and articles. | ||
378 | 21970 | 0000923-02-4 | N-methylolmethacrylamide | no | yes | no | 0,05 | |||
379 | 21940 | 0000924-42-5 | N-methylolacrylamide | no | yes | no | ND | |||
380 | 11980 | 0000925-60-0 | acrylic acid, propyl ester | no | yes | no | (22) | |||
381 | 15030 | 0000931-88-4 | cyclooctene | no | yes | no | 0,05 | Only to be used in polymers contacting foods for which simulant A is laid down | ||
382 | 19490 | 0000947-04-6 | laurolactam | no | yes | no | 5 | |||
383 | 72160 | 0000948-65-2 | 2-phenylindole | yes | no | yes | 15 | |||
384 | 40000 | 0000991-84-4 | 2,4-bis(octylmercapto)-6-(4-hydroxy-3,5-di-tert-butylanilino)-1,3,5-triazine | yes | no | yes | 30 | |||
385 | 11530 | 0000999-61-1 | acrylic acid, 2-hydroxypropyl ester | no | yes | no | 0,05 | SML expressed as the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester. It may contain up to 25 % (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No 0002918-23-2). | (1) | |
386 | 55280 | 0001034-01-1 | gallic acid, octyl ester | yes | no | no | (20) | |||
387 | 26155 | 0001072-63-5 | 1-vinylimidazole | no | yes | no | 0,05 | [F6(1)] | ||
388 | 25080 | 0001120-36-1 | 1-tetradecene | no | yes | no | 0,05 | |||
389 | 22360 | 0001141-38-4 | 2,6-naphthalenedicarboxylic acid | no | yes | no | 5 | |||
390 | 55200 | 0001166-52-5 | gallic acid, dodecyl ester | yes | no | no | (20) | |||
[F1391 | 22932 | 0001187-93-5 | perfluoromethyl perfluorovinyl ether | no | yes | no | 0,05 | Only to be used in:
| ] | |
392 | 72800 | 0001241-94-7 | phosphoric acid, diphenyl 2-ethylhexyl ester | yes | no | yes | 2,4 | |||
393 | 37280 | 0001302-78-9 | bentonite | yes | no | no | ||||
394 | 41280 | 0001305-62-0 | calcium hydroxide | yes | no | no | ||||
395 | 41520 | 0001305-78-8 | calcium oxide | yes | no | no | ||||
396 | 64640 | 0001309-42-8 | magnesium hydroxide | yes | no | no | ||||
397 | 64720 | 0001309-48-4 | magnesium oxide | yes | no | no | ||||
398 | 35760 | 0001309-64-4 | antimony trioxide | yes | no | no | 0,04 | SML expressed as antimony | (6) | |
399 | 81600 | 0001310-58-3 | potassium hydroxide | yes | no | no | ||||
400 | 86720 | 0001310-73-2 | sodium hydroxide | yes | no | no | ||||
401 | 24475 | 0001313-82-2 | sodium sulphide | no | yes | no | ||||
402 | 96240 | 0001314-13-2 | zinc oxide | yes | no | no | ||||
403 | 96320 | 0001314-98-3 | zinc sulphide | yes | no | no | ||||
404 | 67200 | 0001317-33-5 | molybdenum disulphide | yes | no | no | ||||
405 | 16690 | 0001321-74-0 | divinylbenzene | no | yes | no | ND | SML expressed as the sum of divinylbenzene and ethylvinylbenzene. It may contain up to 45 % (m/m) of ethylvinylbenzene. | (1) | |
406 | 83300 | 0001323-39-3 | 1,2-propyleneglycol monostearate | yes | no | no | ||||
407 | 87040 | 0001330-43-4 | sodium tetraborate | yes | no | no | (16) | |||
408 | 82960 | 0001330-80-9 | 1,2-propyleneglycol monooleate | yes | no | no | ||||
409 | 62240 | 0001332-37-2 | iron oxide | yes | no | no | ||||
[F7410 | 62720 | 0001332-58-7 | kaolin | yes | no | no | Particles can be thinner than 100 nm only if incorporated at a quantity of less than 12 % w/w in an ethylene vinyl alcohol copolymer (EVOH) inner layer of a multi-layer structure, in which the layer in direct contact with the food provides a functional barrier preventing migration of particles into the food. | ] | ||
411 | 42080 | 0001333-86-4 | carbon black | yes | no | no | Primary particles of 10 – 300 nm which are aggregated to a size of 100 – 1 200 nm which may form agglomerates within the size distribution of 300 nm – mm. Toluene extractables: maximum 0,1 %, determined according to ISO method 6209. UV absorption of cyclohexane extract at 386 nm: < 0,02 AU for a 1 cm cell or < 0,1 AU for a 5 cm cell, determined according to a generally recognised method of analysis. Benzo(a)pyrene content: max 0,25 mg/kg carbon black. Maximum use level of carbon black in the polymer: 2,5 % w/w. | |||
412 | 45200 | 0001335-23-5 | copper iodide | yes | no | no | (6) | |||
413 | 35600 | 0001336-21-6 | ammonium hydroxide | yes | no | no | ||||
414 | 87600 | 0001338-39-2 | sorbitan monolaurate | yes | no | no | ||||
415 | 87840 | 0001338-41-6 | sorbitan monostearate | yes | no | no | ||||
416 | 87680 | 0001338-43-8 | sorbitan monooleate | yes | no | no | ||||
417 | 85680 | 0001343-98-2 | silicic acid | yes | no | no | ||||
418 | 34720 | 0001344-28-1 | aluminium oxide | yes | no | no | ||||
419 | 92150 | 0001401-55-4 | tannic acids | yes | no | no | According to the JECFA specifications | |||
420 | 19210 | 0001459-93-4 | isophthalic acid, dimethyl ester | no | yes | no | 0,05 | |||
[F10421 | 13000 | 0001477-55-0 | 1,3-benzenedimethanamine | no | yes | no | (34) | ] | ||
422 | 38515 | 0001533-45-5 | 4,4′-bis(2-benzoxazolyl)stilbene | yes | no | yes | 0,05 | (2) | ||
423 | 22937 | 0001623-05-8 | perfluoropropylperfluorovinyl ether | no | yes | no | 0,05 | |||
424 | 15070 | 0001647-16-1 | 1,9-decadiene | no | yes | no | 0,05 | |||
425 | 10840 | 0001663-39-4 | acrylic acid, tert-butyl ester | no | yes | no | (22) | |||
426 | 13510 | 0001675-54-3 | 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether | no | yes | no | In compliance with Commission Regulation (EC) No 1895/2005a | |||
13610 | ||||||||||
427 | 18896 | 0001679-51-2 | 4-(hydroxymethyl)-1-cyclohexene | no | yes | no | 0,05 | |||
428 | 95200 | 0001709-70-2 | 1,3,5-trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl)benzene | yes | no | no | ||||
429 | 13210 | 0001761-71-3 | bis(4-aminocyclohexyl)methane | no | yes | no | 0,05 | |||
430 | 95600 | 0001843-03-4 | 1,1,3-tris(2-methyl-4-hydroxy-5-tert-butylphenyl) butane | yes | no | yes | 5 | |||
431 | 61600 | 0001843-05-6 | 2-hydroxy-4-n-octyloxybenzophenone | yes | no | yes | (8) | |||
432 | 12280 | 0002035-75-8 | adipic anhydride | no | yes | no | ||||
433 | 68320 | 0002082-79-3 | octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate | yes | no | yes | 6 | |||
434 | 20410 | 0002082-81-7 | methacrylic acid, diester with 1,4-butanediol | no | yes | no | 0,05 | |||
435 | 14230 | 0002123-24-2 | caprolactam, sodium salt | no | yes | no | (4) | |||
436 | 19480 | 0002146-71-6 | lauric acid, vinyl ester | no | yes | no | ||||
437 | 11245 | 0002156-97-0 | acrylic acid, dodecyl ester | no | yes | no | 0,05 | (2) | ||
[F9438 | 13303 | 0002162-74-5 | bis(2,6-diisopropylphenyl) carbodiimide | no | yes | no | 0,05 | Expressed as the sum of bis(2,6-diisopropylphenyl)carbodiimide and its hydrolysis product 2,6-diisopropylaniline | ] | |
439 | 21280 | 0002177-70-0 | methacrylic acid, phenyl ester | no | yes | no | (23) | |||
440 | 21340 | 0002210-28-8 | methacrylic acid, propyl ester | no | yes | no | (23) | |||
441 | 38160 | 0002315-68-6 | benzoic acid, propyl ester | yes | no | no | ||||
442 | 13780 | 0002425-79-8 | 1,4-butanediol bis(2,3-epoxypropyl)ether | no | yes | no | ND | Residual content = 1 mg/kg in final product expressed as epoxygroup. Molecular weight is 43 Da. | (10) | |
443 | 12788 | 0002432-99-7 | 11-aminoundecanoic acid | no | yes | no | 5 | |||
444 | 61440 | 0002440-22-4 | 2-(2′-hydroxy-5′-methylphenyl)benzotriazole | yes | no | no | (12) | |||
445 | 83440 | 0002466-09-3 | pyrophosphoric acid | yes | no | no | ||||
446 | 10750 | 0002495-35-4 | acrylic acid, benzyl ester | no | yes | no | (22) | |||
447 | 20080 | 0002495-37-6 | methacrylic acid, benzyl ester | no | yes | no | (23) | |||
448 | 11890 | 0002499-59-4 | acrylic acid, n-octyl ester | no | yes | no | (22) | |||
[F8449 | 49840 | 0002500-88-1 | dioctadecyl disulphide | yes | no | yes | 0,05 | ] | ||
450 | 24430 | 0002561-88-8 | sebacic anhydride | no | yes | no | ||||
451 | 66755 | 0002682-20-4 | 2-methyl-4-isothiazolin-3-one | yes | no | no | 0,5 | Only to be used in aqueous polymer dispersions and emulsions | ||
[F9452 | 38885 | 0002725-22-6 | 2,4-bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazine | yes | no | no | 5 | ] | ||
453 | 26320 | 0002768-02-7 | vinyltrimethoxysilane | no | yes | no | 0,05 | (10) | ||
454 | 12670 | 0002855-13-2 | 1-amino-3-aminomethyl-3,5,5-trimethylcyclohexane | no | yes | no | 6 | |||
455 | 20530 | 0002867-47-2 | methacrylic acid, 2-(dimethylamino)-ethyl ester | no | yes | no | ND | |||
456 | 10810 | 0002998-08-5 | acrylic acid, sec-butyl ester | no | yes | no | (22) | |||
457 | 20140 | 0002998-18-7 | methacrylic acid, sec-butyl ester | no | yes | no | (23) | |||
458 | 36960 | 0003061-75-4 | behenamide | yes | no | no | ||||
459 | 46870 | 0003135-18-0 | 3,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester | yes | no | no | ||||
460 | 14950 | 0003173-53-3 | cyclohexyl isocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
461 | 22420 | 0003173-72-6 | 1,5-naphthalene diisocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
462 | 26170 | 0003195-78-6 | N-vinyl-N-methylacetamide | no | yes | no | 0,02 | [F6(1)] | ||
463 | 25840 | 0003290-92-4 | 1,1,1-trimethylolpropane trimethacrylate | no | yes | no | 0,05 | |||
464 | 61280 | 0003293-97-8 | 2-hydroxy-4-n-hexyloxybenzophenone | yes | no | yes | (8) | |||
465 | 68040 | 0003333-62-8 | 7-[2H-naphtho-(1,2-D)triazol-2-yl]-3-phenylcoumarin | yes | no | no | ||||
466 | 50640 | 0003648-18-8 | di-n-octyltin dilaurate | yes | no | no | (10) | |||
467 | 14800 | 0003724-65-0 | crotonic acid | yes | yes | no | 0,05 | [F6(1)] | ||
45600 | ||||||||||
468 | 71960 | 0003825-26-1 | perfluorooctanoic acid, ammonium salt | yes | no | no | Only to be used in repeated use articles, sintered at high temperatures | |||
469 | 60480 | 0003864-99-1 | 2-(2′-hydroxy-3,5′-di-tert-butylphenyl)-5-chlorobenzotriazole | yes | no | yes | (12) | |||
470 | 60400 | 0003896-11-5 | 2-(2′-hydroxy-3′-tert-butyl-5′-methylphenyl)-5-chlorobenzotriazole | yes | no | yes | (12) | |||
471 | 24888 | 0003965-55-7 | 5-sulphoisophthalic acid, monosodium salt, dimethyl ester | no | yes | no | 0,05 | |||
472 | 66560 | 0004066-02-8 | 2,2′-methylenebis(4-methyl-6-cyclohexylphenol) | yes | no | yes | (5) | |||
473 | 12265 | 0004074-90-2 | adipic acid, divinyl ester | no | yes | no | ND | 5 mg/kg in final product. Only to be used as co-monomer. | (1) | |
474 | 43600 | 0004080-31-3 | 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride | yes | no | no | 0,3 | |||
475 | 19110 | 0004098-71-9 | 1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
476 | 16570 | 0004128-73-8 | diphenylether-4,4′-diisocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
477 | 46720 | 0004130-42-1 | 2,6-di-tert-butyl-4-ethylphenol | yes | no | yes | 4,8 | (1) | ||
478 | 60180 | 0004191-73-5 | 4-hydroxybenzoic acid, isopropyl ester | yes | no | no | ||||
479 | 12970 | 0004196-95-6 | azelaic anhydride | no | yes | no | ||||
480 | 46790 | 0004221-80-1 | 3,5-di-tert-butyl-4-hydroxybenzoic acid, 2,4-di-tert-butylphenyl ester | yes | no | no | ||||
481 | 13060 | 0004422-95-1 | 1,3,5-benzenetricarboxylic acid trichloride | no | yes | no | 0,05 | SML expressed as 1,3,5-benzenetricarboxylic acid | [F6(1)] | |
482 | 21100 | 0004655-34-9 | methacrylic acid, isopropyl ester | no | yes | no | (23) | |||
483 | 68860 | 0004724-48-5 | n-octylphosphonic acid | yes | no | no | 0,05 | |||
484 | 13395 | 0004767-03-7 | 2,2-bis(hydroxymethyl)propionic acid | no | yes | no | 0,05 | (1) | ||
485 | 13560 | 0005124-30-1 | dicyclohexylmethane-4,4′-diisocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
15700 | ||||||||||
486 | 54005 | 0005136-44-7 | ethylene-N-palmitamide-N′-stearamide | yes | no | no | ||||
487 | 45640 | 0005232-99-5 | 2-cyano-3,3-diphenylacrylic acid, ethyl ester | yes | no | no | 0,05 | |||
488 | 53440 | 0005518-18-3 | N,N′-ethylenebispalmitamide | yes | no | no | ||||
489 | 41040 | 0005743-36-2 | calcium butyrate | yes | no | no | ||||
490 | 16600 | 0005873-54-1 | diphenylmethane-2,4′-diisocyanate | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
491 | 82720 | 0006182-11-2 | 1,2-propyleneglycol distearate | yes | no | no | ||||
492 | 45650 | 0006197-30-4 | 2-cyano-3,3-diphenylacrylic acid, 2-ethylhexyl ester | yes | no | no | 0,05 | |||
493 | 39200 | 0006200-40-4 | bis(2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy)methylammonium chloride | yes | no | no | 1,8 | |||
494 | 62140 | 0006303-21-5 | hypophosphorous acid | yes | no | no | ||||
495 | 35160 | 0006642-31-5 | 6-amino-1,3-dimethyluracil | yes | no | no | 5 | |||
496 | 71680 | 0006683-19-8 | pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate] | yes | no | no | ||||
497 | 95020 | 0006846-50-0 | 2,2,4-trimethyl-1,3-pentanediol diisobutyrate | yes | no | no | 5 | Only to be used in single-use gloves | ||
498 | 16210 | 0006864-37-5 | 3,3′-dimethyl-4,4′-diaminodicyclohexylmethane | no | yes | no | 0,05 | Only to be used in polyamides | (5) | |
499 | 19965 | 0006915-15-7 | malic acid | yes | 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 | |||
65020 | ||||||||||
500 | 38560 | 0007128-64-5 | 2,5-bis(5-tert-butyl-2-benzoxazolyl)thiophene | yes | no | yes | 0,6 | |||
501 | 34480 | — | aluminium fibers, flakes and powders | yes | no | no | ||||
502 | 22778 | 0007456-68-0 | 4,4′-oxybis(benzenesulphonyl azide) | no | yes | no | 0,05 | [F6(1)] | ||
503 | 46080 | 0007585-39-9 | β-dextrin | yes | no | no | ||||
504 | 86240 | 0007631-86-9 | silicon dioxide | yes | no | no | For synthetic amorphous silicon dioxide: primary particles of 1 – 100 nm which are aggregated to a size of 0,1 – 1 μm which may form agglomerates within the size distribution of 0,3 μm to the mm size. | |||
505 | 86480 | 0007631-90-5 | sodium bisulphite | yes | no | no | (19) | |||
506 | 86920 | 0007632-00-0 | sodium nitrite | yes | no | no | 0,6 | |||
507 | 59990 | 0007647-01-0 | hydrochloric acid | yes | no | no | ||||
508 | 86560 | 0007647-15-6 | sodium bromide | yes | no | no | ||||
509 | 23170 | 0007664-38-2 | phosphoric acid | yes | yes | no | ||||
72640 | ||||||||||
510 | 12789 | 0007664-41-7 | ammonia | yes | yes | no | ||||
35320 | ||||||||||
511 | 91920 | 0007664-93-9 | sulphuric acid | yes | no | no | ||||
512 | 81680 | 0007681-11-0 | potassium iodide | yes | no | no | (6) | |||
513 | 86800 | 0007681-82-5 | sodium iodide | yes | no | no | (6) | |||
514 | 91840 | 0007704-34-9 | sulphur | yes | no | no | ||||
515 | 26360 | 0007732-18-5 | water | yes | yes | no | In compliance with Directive 98/83/ECb | |||
95855 | ||||||||||
516 | 86960 | 0007757-83-7 | sodium sulphite | yes | no | no | (19) | |||
517 | 81520 | 0007758-02-3 | potassium bromide | yes | no | no | ||||
518 | 35845 | 0007771-44-0 | arachidonic acid | yes | no | no | ||||
519 | 87120 | 0007772-98-7 | sodium thiosulphate | yes | no | no | (19) | |||
520 | 65120 | 0007773-01-5 | manganese chloride | yes | no | no | ||||
521 | 58320 | 0007782-42-5 | graphite | yes | no | no | ||||
522 | 14530 | 0007782-50-5 | chlorine | no | yes | no | ||||
523 | 45195 | 0007787-70-4 | copper bromide | yes | no | no | ||||
524 | 24520 | 0008001-22-7 | soybean oil | no | yes | no | ||||
525 | 62640 | 0008001-39-6 | japan wax | yes | no | no | ||||
526 | 43440 | 0008001-75-0 | ceresin | yes | no | no | ||||
527 | 14411 | 0008001-79-4 | castor oil | yes | yes | no | ||||
42880 | ||||||||||
528 | 63760 | 0008002-43-5 | lecithin | yes | no | no | ||||
529 | 67850 | 0008002-53-7 | montan wax | yes | no | no | ||||
530 | 41760 | 0008006-44-8 | candelilla wax | yes | no | no | ||||
531 | 36880 | 0008012-89-3 | beeswax | yes | no | no | ||||
532 | 88640 | 0008013-07-8 | soybean oil, epoxidised | yes | no | no | 60 30(*) | (32) | (*)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. | |
533 | 42720 | 0008015-86-9 | carnauba wax | yes | no | no | ||||
534 | 80720 | 0008017-16-1 | polyphosphoric acids | yes | no | no | ||||
535 | 24100 | 0008050-09-7 | rosin | yes | yes | no | ||||
24130 | ||||||||||
24190 | ||||||||||
83840 | ||||||||||
536 | 84320 | 0008050-15-5 | rosin, hydrogenated, ester with methanol | yes | no | no | ||||
537 | 84080 | 0008050-26-8 | rosin, ester with pentaerythritol | yes | no | no | ||||
538 | 84000 | 0008050-31-5 | rosin, ester with glycerol | yes | no | no | ||||
539 | 24160 | 0008052-10-6 | rosin tall oil | no | yes | no | ||||
540 | 63940 | 0008062-15-5 | lignosulphonic acid | yes | no | no | 0,24 | Only to be used as dispersant for plastics dispersions | ||
541 | 58480 | 0009000-01-5 | gum arabic | yes | no | no | ||||
542 | 42640 | 0009000-11-7 | carboxymethylcellulose | yes | no | no | ||||
543 | 45920 | 0009000-16-2 | dammar | yes | no | no | ||||
544 | 58400 | 0009000-30-0 | guar gum | yes | no | no | ||||
545 | 93680 | 0009000-65-1 | tragacanth gum | yes | no | no | ||||
546 | 71440 | 0009000-69-5 | pectin | yes | no | no | ||||
547 | 55440 | 0009000-70-8 | gelatin | yes | no | no | ||||
548 | 42800 | 0009000-71-9 | casein | yes | no | no | ||||
549 | 80000 | 0009002-88-4 | polyethylene wax | yes | no | no | ||||
550 | 81060 | 0009003-07-0 | polypropylene wax | yes | no | no | ||||
551 | 79920 | 0009003-11-6 0106392-12-5 | poly(ethylene propylene) glycol | yes | no | no | ||||
552 | 81500 | 0009003-39-8 | polyvinylpyrrolidone | yes | no | no | The substance shall meet the purity criteria as laid down in Commission Directive 2008/84/ECc | |||
553 | 14500 | 0009004-34-6 | cellulose | yes | yes | no | ||||
43280 | ||||||||||
554 | 43300 | 0009004-36-8 | cellulose acetate butyrate | yes | no | no | ||||
555 | 53280 | 0009004-57-3 | ethylcellulose | yes | no | no | ||||
556 | 54260 | 0009004-58-4 | ethylhydroxyethylcellulose | yes | no | no | ||||
557 | 66640 | 0009004-59-5 | methylethylcellulose | yes | no | no | ||||
558 | 60560 | 0009004-62-0 | hydroxyethylcellulose | yes | no | no | ||||
559 | 61680 | 0009004-64-2 | hydroxypropylcellulose | yes | no | no | ||||
560 | 66700 | 0009004-65-3 | methylhydroxypropylcellulose | yes | no | no | ||||
561 | 66240 | 0009004-67-5 | methylcellulose | yes | no | no | ||||
562 | 22450 | 0009004-70-0 | nitrocellulose | no | yes | no | ||||
563 | 78320 | 0009004-97-1 | polyethyleneglycol monoricinoleate | yes | no | yes | 42 | |||
564 | 24540 | 0009005-25-8 | starch, edible | yes | yes | no | ||||
88800 | ||||||||||
565 | 61120 | 0009005-27-0 | hydroxyethyl starch | yes | no | no | ||||
566 | 33350 | 0009005-32-7 | alginic acid | yes | no | no | ||||
567 | 82080 | 0009005-37-2 | 1,2-propyleneglycol alginate | yes | no | no | ||||
568 | 79040 | 0009005-64-5 | polyethyleneglycol sorbitan monolaurate | yes | no | no | ||||
569 | 79120 | 0009005-65-6 | polyethyleneglycol sorbitan monooleate | yes | no | no | ||||
570 | 79200 | 0009005-66-7 | polyethyleneglycol sorbitan monopalmitate | yes | no | no | ||||
571 | 79280 | 0009005-67-8 | polyethyleneglycol sorbitan monostearate | yes | no | no | ||||
572 | 79360 | 0009005-70-3 | polyethyleneglycol sorbitan trioleate | yes | no | no | ||||
573 | 79440 | 0009005-71-4 | polyethyleneglycol sorbitan tristearate | yes | no | no | ||||
574 | 24250 | 0009006-04-6 | rubber, natural | yes | yes | no | ||||
84560 | ||||||||||
575 | 76721 | 0063148-62-9 | polydimethylsiloxane (Mw > 6 800 Da) | yes | no | no | Viscosity at 25 °C not less than 100 cSt (100 × 10-6 m2/s) | |||
576 | 60880 | 0009032-42-2 | hydroxyethylmethylcellulose | yes | no | no | ||||
577 | 62280 | 0009044-17-1 | isobutylene-butene copolymer | yes | no | no | ||||
578 | 79600 | 0009046-01-9 | polyethyleneglycol tridecyl ether phosphate | yes | no | no | 5 | For materials and articles intended for contact with aqueous foods only. Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether. | ||
579 | 61800 | 0009049-76-7 | hydroxypropyl starch | yes | no | no | ||||
580 | 46070 | 0010016-20-3 | α-dextrin | yes | no | no | ||||
581 | 36800 | 0010022-31-8 | barium nitrate | yes | no | no | ||||
582 | 50240 | 0010039-33-5 | di-n-octyltin bis(2-ethylhexyl maleate) | yes | no | no | (10) | |||
583 | 40400 | 0010043-11-5 | boron nitride | yes | no | no | (16) | |||
584 | 13620 | 0010043-35-3 | boric acid | yes | yes | no | (16) | |||
40320 | ||||||||||
585 | 41120 | 0010043-52-4 | calcium chloride | yes | no | no | ||||
586 | 65280 | 0010043-84-2 | manganese hypophosphite | yes | no | no | ||||
587 | 68400 | 0010094-45-8 | octadecylerucamide | yes | no | yes | 5 | |||
588 | 64320 | 0010377-51-2 | lithium iodide | yes | no | no | (6) | |||
589 | 52645 | 0010436-08-5 | cis-11-eicosenamide | yes | no | no | ||||
590 | 21370 | 0010595-80-9 | methacrylic acid, 2-sulphoethyl ester | no | yes | no | ND | (1) | ||
591 | 36160 | 0010605-09-1 | ascorbyl stearate | yes | no | no | ||||
592 | 34690 | 0011097-59-9 | aluminium magnesium carbonate hydroxide | yes | no | no | ||||
593 | 44960 | 0011104-61-3 | cobalt oxide | yes | no | no | ||||
594 | 65360 | 0011129-60-5 | manganese oxide | yes | no | no | ||||
595 | 19510 | 0011132-73-3 | lignocellulose | no | yes | no | ||||
596 | 95935 | 0011138-66-2 | xanthan gum | yes | no | no | ||||
597 | 67120 | 0012001-26-2 | mica | yes | no | no | ||||
598 | 41600 | 0012004-14-7 0037293-22-4 | calcium sulphoaluminate | yes | no | no | ||||
599 | 36840 | 0012007-55-5 | barium tetraborate | yes | no | no | (16) | |||
600 | 60030 | 0012072-90-1 | hydromagnesite | yes | no | no | ||||
601 | 35440 | 0012124-97-9 | ammonium bromide | yes | no | no | ||||
602 | 70240 | 0012198-93-5 | ozokerite | yes | no | no | ||||
603 | 83460 | 0012269-78-2 | pyrophyllite | yes | no | no | ||||
604 | 60080 | 0012304-65-3 | hydrotalcite | yes | no | no | ||||
605 | 11005 | 0012542-30-2 | acrylic acid, dicyclopentenyl ester | no | yes | no | 0,05 | (1) | ||
606 | 65200 | 0012626-88-9 | manganese hydroxide | yes | no | no | ||||
607 | 62245 | 0012751-22-3 | iron phosphide | yes | no | no | Only to be used in PET polymers and copolymers | |||
608 | 40800 | 0013003-12-8 | 4,4′-butylidene-bis(6-tert-butyl-3-methylphenyl-ditridecyl phosphite) | yes | no | yes | 6 | |||
609 | 83455 | 0013445-56-2 | pyrophosphorous acid | yes | no | no | ||||
610 | 93440 | 0013463-67-7 | titanium dioxide | yes | no | no | ||||
611 | 35120 | 0013560-49-1 | 3-aminocrotonic acid, diester with thiobis (2-hydroxyethyl) ether | yes | no | no | ||||
612 | 16694 | 0013811-50-2 | N,N′-divinyl-2-imidazolidinone | no | yes | no | 0,05 | (10) | ||
613 | 95905 | 0013983-17-0 | wollastonite | yes | no | no | ||||
614 | 45560 | 0014464-46-1 | cristobalite | yes | no | no | ||||
615 | 92080 | 0014807-96-6 | talc | yes | no | no | ||||
616 | 83470 | 0014808-60-7 | quartz | yes | no | no | ||||
617 | 10660 | 0015214-89-8 | 2-acrylamido-2-methylpropanesulphonic acid | no | yes | no | 0,05 | |||
618 | 51040 | 0015535-79-2 | di-n-octyltin mercaptoacetate | yes | no | no | (10) | |||
619 | 50320 | 0015571-58-1 | di-n-octyltin bis(2-ethylhexyl mercaptoacetate) | yes | no | no | (10) | |||
620 | 50720 | 0015571-60-5 | di-n-octyltin dimaleate | yes | no | no | (10) | |||
621 | 17110 | 0016219-75-3 | 5-ethylidenebicyclo[2,2,1]hept-2-ene | no | yes | no | 0,05 | (9) | ||
622 | 69840 | 0016260-09-6 | oleylpalmitamide | yes | no | yes | 5 | |||
623 | 52640 | 0016389-88-1 | dolomite | yes | no | no | ||||
624 | 18897 | 0016712-64-4 | 6-hydroxy-2-naphthalenecarboxylic acid | no | yes | no | 0,05 | |||
625 | 36720 | 0017194-00-2 | barium hydroxide | yes | no | no | ||||
626 | 57800 | 0018641-57-1 | glycerol tribehenate | yes | no | no | ||||
627 | 59760 | 0019569-21-2 | huntite | yes | no | no | ||||
628 | 96190 | 0020427-58-1 | zinc hydroxide | yes | no | no | ||||
629 | 34560 | 0021645-51-2 | aluminium hydroxide | yes | no | no | ||||
630 | 82240 | 0022788-19-8 | 1,2-propyleneglycol dilaurate | yes | no | no | ||||
631 | 59120 | 0023128-74-7 | 1,6-hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide) | yes | no | yes | 45 | |||
632 | 52880 | 0023676-09-7 | 4-ethoxybenzoic acid, ethyl ester | yes | no | no | 3,6 | |||
633 | 53200 | 0023949-66-8 | 2-ethoxy-2′-ethyloxanilide | yes | no | yes | 30 | |||
634 | 25910 | 0024800-44-0 | tripropyleneglycol | no | yes | no | ||||
635 | 40720 | 0025013-16-5 | tert-butyl-4-hydroxyanisole | yes | no | no | 30 | |||
636 | 31500 | 0025134-51-4 | acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymer | yes | no | no | 0,05 | (22) | SML expressed as acrylic acid, 2-ethylhexyl ester | |
637 | 71635 | 0025151-96-6 | pentaerythritol dioleate | yes | no | no | 0,05 | Not to be used for articles in contact with fatty foods for which [F1simulant D1 and/or D2] is laid down | ||
638 | 23590 | 0025322-68-3 | polyethyleneglycol | yes | yes | no | ||||
76960 | ||||||||||
639 | 23651 | 0025322-69-4 | polypropyleneglycol | yes | yes | no | ||||
80800 | ||||||||||
640 | 54930 | 0025359-91-5 | formaldehyde-1-naphthol, copolymer | yes | no | no | 0,05 | |||
[F1641 | 22331 | 0025513-64-8 | mixture of (35-45 % w/w) 1,6-diamino-2,2,4-trimethylhexane and (55-65 % w/w)1,6-diamino-2,4,4-trimethylhexane | no | yes | no | 0,05 | ] | ||
642 | 64990 | 0025736-61-2 | maleic anhydride-styrene, copolymer, sodium salt | yes | no | no | The fraction with molecular weight below 1 000 Da [F1shall] not exceed 0,05 % (w/w) | |||
643 | 87760 | 0026266-57-9 | sorbitan monopalmitate | yes | no | no | ||||
644 | 88080 | 0026266-58-0 | sorbitan trioleate | yes | no | no | ||||
645 | 67760 | 0026401-86-5 | mono-n-octyltin tris(isooctyl mercaptoacetate) | yes | no | no | (11) | |||
646 | 50480 | 0026401-97-8 | di-n-octyltin bis(isooctyl mercaptoacetate) | yes | no | no | (10) | |||
647 | 56720 | 0026402-23-3 | glycerol monohexanoate | yes | no | no | ||||
648 | 56880 | 0026402-26-6 | glycerol monooctanoate | yes | no | no | ||||
649 | 47210 | 0026427-07-6 | dibutylthiostannoic acid polymer | yes | no | no | Molecular unit = (C8H18S3Sn2)n (n = 1,5-2) | |||
650 | 49600 | 0026636-01-1 | dimethyltin bis(isooctyl mercaptoacetate) | yes | no | no | (9) | |||
651 | 88240 | 0026658-19-5 | sorbitan tristearate | yes | no | no | ||||
652 | 38820 | 0026741-53-7 | bis(2,4-di-tert-butylphenyl) pentaerythritol diphosphite | yes | no | yes | 0,6 | |||
653 | 25270 | 0026747-90-0 | 2,4-toluene diisocyanate dimer | no | yes | no | (17) | 1 mg/kg in final product expressed as isocyanate moiety | (10) | |
654 | 88600 | 0026836-47-5 | sorbitol monostearate | yes | no | no | ||||
655 | 25450 | 0026896-48-0 | tricyclodecanedimethanol | no | yes | no | 0,05 | |||
656 | 24760 | 0026914-43-2 | styrenesuphonic acid | no | yes | no | 0,05 | |||
657 | 67680 | 0027107-89-7 | mono-n-octyltin tris(2-ethylhexyl mercaptoacetate) | yes | no | no | (11) | |||
658 | 52000 | 0027176-87-0 | dodecylbenzenesulphonic acid | yes | no | no | 30 | |||
659 | 82800 | 0027194-74-7 | 1,2-propyleneglycol monolaurate | yes | no | no | ||||
660 | 47540 | 0027458-90-8 | di-tert-dodecyl disulphide | yes | no | yes | 0,05 | |||
661 | 95360 | 0027676-62-6 | 1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione | yes | no | yes | 5 | |||
662 | 25927 | 0027955-94-8 | 1,1,1-tris(4-hydroxyphenol)ethane | no | yes | no | 0,005 | Only to be used in polycarbonates | [F6(1)] | |
663 | 64150 | 0028290-79-1 | linolenic acid | yes | no | no | ||||
664 | 95000 | 0028931-67-1 | trimethylolpropane trimethacrylate-methyl methacrylate copolymer | yes | no | no | ||||
665 | 83120 | 0029013-28-3 | 1,2-propyleneglycol monopalmitate | yes | no | no | ||||
666 | 87280 | 0029116-98-1 | sorbitan dioleate | yes | no | no | ||||
667 | 55190 | 0029204-02-2 | gadoleic acid | yes | no | no | ||||
668 | 80240 | 0029894-35-7 | polyglycerol ricinoleate | yes | no | no | ||||
669 | 56610 | 0030233-64-8 | glycerol monobehenate | yes | no | no | ||||
670 | 56800 | 0030899-62-8 | glycerol monolaurate diacetate | yes | no | no | (32) | |||
671 | 74240 | 0031570-04-4 | phosphorous acid, tris(2,4-di-tert-butylphenyl)ester | yes | no | no | ||||
672 | 76845 | 0031831-53-5 | polyester of 1,4-butanediol with caprolactone | yes | no | no | (29) (30) | The fraction with molecular weight below 1 000 Da [F1shall] not exceed 0,5 % (w/w) | ||
673 | 53670 | 0032509-66-3 | ethylene glycol bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate] | yes | no | yes | 6 | |||
674 | 46480 | 0032647-67-9 | dibenzylidene sorbitol | yes | no | no | ||||
675 | 38800 | 0032687-78-8 | N,N′-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hydrazide | yes | no | yes | 15 | |||
676 | 50400 | 0033568-99-9 | di-n-octyltin bis(isooctyl maleate) | yes | no | no | (10) | |||
677 | 82560 | 0033587-20-1 | 1,2-propyleneglycol dipalmitate | yes | no | no | ||||
678 | 59200 | 0035074-77-2 | 1,6-hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) | yes | no | yes | 6 | |||
679 | 39060 | 0035958-30-6 | 1,1-bis(2-hydroxy-3,5-di-tert-butylphenyl)ethane | yes | no | yes | 5 | |||
680 | 94400 | 0036443-68-2 | triethyleneglycol bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionate] | yes | no | no | 9 | |||
681 | 18310 | 0036653-82-4 | 1-hexadecanol | no | yes | no | ||||
682 | 53270 | 0037205-99-5 | ethylcarboxymethylcellulose | yes | no | no | ||||
683 | 66200 | 0037206-01-2 | methylcarboxymethylcellulose | yes | no | no | ||||
684 | 68125 | 0037244-96-5 | nepheline syenite | yes | no | no | ||||
685 | 85950 | 0037296-97-2 | silicic acid, magnesium-sodium-fluoride salt | yes | no | no | 0,15 | SML expressed as fluoride. Only to be used in layers of multi-layer materials not coming into direct contact with food. | ||
686 | 61390 | 0037353-59-6 | hydroxymethylcellulose | yes | no | no | ||||
687 | 13530 | 0038103-06-9 | 2,2-bis(4-hydroxyphenyl)propane bis(phthalic anhydride) | no | yes | no | 0,05 | |||
13614 | ||||||||||
688 | 92560 | 0038613-77-3 | tetrakis(2,4-di-tert-butyl-phenyl)-4,4′-biphenylylene diphosphonite | yes | no | yes | 18 | |||
689 | 95280 | 0040601-76-1 | 1,3,5-tris(4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione | yes | no | yes | 6 | |||
690 | 92880 | 0041484-35-9 | thiodiethanol bis(3-(3,5-di-tert-butyl-4-hydroxy phenyl) propionate) | yes | no | yes | 2,4 | |||
691 | 13600 | 0047465-97-4 | 3,3-bis(3-methyl-4-hydroxyphenyl)2-indolinone | no | yes | no | 1,8 | |||
692 | 52320 | 0052047-59-3 | 2-(4-dodecylphenyl)indole | yes | no | yes | 0,06 | |||
693 | 88160 | 0054140-20-4 | sorbitan tripalmitate | yes | no | no | ||||
694 | 21400 | 0054276-35-6 | methacrylic acid, sulphopropyl ester | no | yes | no | 0,05 | (1) | ||
695 | 67520 | 0054849-38-6 | monomethyltin tris(isooctyl mercaptoacetate) | yes | no | no | (9) | |||
696 | 92205 | 0057569-40-1 | terephthalic acid, diester with 2,2′-methylenebis(4-methyl-6-tert-butylphenol) | yes | no | no | ||||
697 | 67515 | 0057583-34-3 | monomethyltin tris(ethylhexyl mercaptoacetate) | yes | no | no | (9) | |||
698 | 49595 | 0057583-35-4 | dimethyltin bis(ethylhexyl mercaptoacetate) | yes | no | no | (9) | |||
699 | 90720 | 0058446-52-9 | stearoylbenzoylmethane | yes | no | no | ||||
700 | 31520 | 0061167-58-6 | acrylic acid, 2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5-methylbenzyl)-4-methylphenyl ester | yes | no | yes | 6 | |||
701 | 40160 | 0061269-61-2 | N,N′-bis(2,2,6,6-tetramethyl-4-piperidyl)hexamethylenediamine-1,2-dibromoethane, copolymer | yes | no | no | 2,4 | |||
702 | 87920 | 0061752-68-9 | sorbitan tetrastearate | yes | no | no | ||||
703 | 17170 | 0061788-47-4 | fatty acids, coco | no | yes | no | ||||
704 | 77600 | 0061788-85-0 | polyethyleneglycol ester of hydrogenated castor oil | yes | no | no | ||||
705 | 10599/90A | 0061788-89-4 | acids, fatty, unsaturated (C18), dimers, non hydrogenated, distilled and non-distilled | no | yes | no | (18) | (1) | ||
10599/91 | ||||||||||
706 | 17230 | 0061790-12-3 | fatty acids, tall oil | no | yes | no | ||||
707 | 46375 | 0061790-53-2 | diatomaceous earth | yes | no | no | ||||
708 | 77520 | 0061791-12-6 | polyethyleneglycol ester of castor oil | yes | no | no | 42 | |||
709 | 87520 | 0062568-11-0 | sorbitan monobehenate | yes | no | no | ||||
710 | 38700 | 0063397-60-4 | bis(2-carbobutoxyethyl)tin-bis(isooctyl mercaptoacetate) | yes | no | yes | 18 | |||
711 | 42000 | 0063438-80-2 | (2-carbobutoxyethyl)tin-tris(isooctyl mercaptoacetate) | yes | no | yes | 30 | |||
712 | 42960 | 0064147-40-6 | castor oil, dehydrated | yes | no | no | ||||
[F7713 | 43480 | 0064365-11-3 | charcoal, activated | yes | no | no | Only for use in PET at maximum 10 mg/kg of polymer. Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Regulation (EU) No 231/2012 d with exception of ash content which can be up to 10 % (w/w). | |||
0007440-44-0] | ||||||||||
714 | 84400 | 0064365-17-9 | rosin, hydrogenated, ester with pentaerythritol | yes | no | no | ||||
715 | 46880 | 0065140-91-2 | 3,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, monoethyl ester, calcium salt | yes | no | no | 6 | |||
716 | 60800 | 0065447-77-0 | 1-(2-hydroxyethyl)-4-hydroxy-2,2,6,6-tetramethyl piperidine-succinic acid, dimethyl ester, copolymer | yes | no | no | 30 | |||
717 | 84210 | 0065997-06-0 | rosin, hydrogenated | yes | no | no | ||||
718 | 84240 | 0065997-13-9 | rosin, hydrogenated, ester with glycerol | yes | no | no | ||||
719 | 65920 | 0066822-60-4 | N-methacryloyloxyethyl-N,N-dimethyl-N-carboxymethylammonium chloride, sodium salt -octadecyl methacrylate-ethyl methacrylate-cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymers | yes | no | no | ||||
720 | 67360 | 0067649-65-4 | mono-n-dodecyltin tris(isooctyl mercaptoacetate) | yes | no | no | (25) | |||
721 | 46800 | 0067845-93-6 | 3,5-di-tert-butyl-4-hydroxybenzoic acid, hexadecyl ester | yes | no | no | ||||
722 | 17200 | 0068308-53-2 | fatty acids, soya | no | yes | no | ||||
723 | 88880 | 0068412-29-3 | starch, hydrolysed | yes | no | no | ||||
724 | 24903 | 0068425-17-2 | syrups, hydrolysed starch, hydrogenated | no | yes | no | In compliance with the purity criteria for maltitol syrup E 965(ii) as laid down in Commission Directive 2008/60/ECe | |||
[ F11 ] | ||||||||||
726 | 83599 | 0068442-12-6 | reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and trichloromethyltin | yes | no | yes | (9) | |||
727 | 43360 | 0068442-85-3 | cellulose, regenerated | yes | no | no | ||||
728 | 75100 | 0068515-48-0 0028553-12-0 | phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60 % C9 | yes | no | no | (26) (32) | 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. | (7) | |
729 | 75105 | 0068515-49-1 0026761-40-0 | phthalic acid, diesters with primary, saturated C9-C11 alcohols more than 90 % C10 | yes | no | no | (26) (32) | 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. | (7) | |
730 | 66930 | 0068554-70-1 | methylsilsesquioxane | yes | no | no | Residual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane | |||
731 | 18220 | 0068564-88-5 | N-heptylaminoundecanoic acid | no | yes | no | 0,05 | (2) | ||
732 | 45450 | 0068610-51-5 | p-cresol-dicyclopentadiene-isobutylene, copolymer | yes | no | yes | 5 | |||
733 | 10599/92A | 0068783-41-5 | acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled and non-distilled | no | yes | no | (18) | (1) | ||
10599/93 | ||||||||||
734 | 46380 | 0068855-54-9 | diatomaceous earth, soda ash flux-calcined | yes | no | no | ||||
735 | 40120 | 0068951-50-8 | bis(polyethyleneglycol)hydroxymethylphosphonate | yes | no | no | 0,6 | |||
736 | 50960 | 0069226-44-4 | di-n-octyltin ethyleneglycol bis(mercaptoacetate) | yes | no | no | (10) | |||
737 | 77370 | 0070142-34-6 | polyethyleneglycol-30 dipolyhydroxystearate | yes | no | no | ||||
738 | 60320 | 0070321-86-7 | 2-[2-hydroxy-3,5-bis(1,1-dimethylbenzyl)phenyl]benzotriazole | yes | no | yes | 1,5 | |||
739 | 70000 | 0070331-94-1 | 2,2′-oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate] | yes | no | no | ||||
740 | 81200 | 0071878-19-8 | poly[6-[(1,1,3,3-tetramethylbutyl)amino]-1,3,5-triazine-2,4-diyl]-[(2,2,6,6-tetramethyl-4-piperidyl)-imino]hexamethylene[(2,2,6,6-tetramethyl-4-piperidyl) imino] | yes | no | yes | 3 | |||
741 | 24070 | 0073138-82-6 | resin acids and rosin acids | yes | yes | no | ||||
83610 | ||||||||||
742 | 92700 | 0078301-43-6 | 2,2,4,4-tetramethyl-20-(2,3-epoxypropyl)-7-oxa-3,20-diazadispiro-[5.1.11.2]-heneicosan-21-one, polymer | yes | no | yes | 5 | |||
743 | 38950 | 0079072-96-1 | bis(4-ethylbenzylidene)sorbitol | yes | no | no | ||||
744 | 18888 | 0080181-31-3 | 3-hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer | no | yes | no | The substance is used as product obtained by bacterial fermentation. In compliance with the specifications mentioned in the Table 4 of Annex I | |||
745 | 68145 | 0080410-33-9 | 2,2′,2′-nitrilo(triethyl tris(3,3′,5,5′-tetra-tert-butyl-1,1′-bi-phenyl-2,2′-diyl)phosphite) | yes | no | yes | 5 | SML expressed as sum of phosphite and phosphate | ||
746 | 38810 | 0080693-00-1 | bis(2,6-di-tert-butyl-4-methylphenyl)pentaerythritol diphosphite | yes | no | yes | 5 | SML expressed as sum of phosphite and phosphate | ||
747 | 47600 | 0084030-61-5 | di-n-dodecyltin bis(isooctyl mercaptoacetate) | yes | no | yes | (25) | |||
748 | 12765 | 0084434-12-8 | N-(2-aminoethyl)-β-alanine, sodium salt | no | yes | no | 0,05 | |||
749 | 66360 | 0085209-91-2 | 2,2′-methylene bis(4,6-di-tert-butylphenyl) sodium phosphate | yes | no | yes | 5 | |||
750 | 66350 | 0085209-93-4 | 2,2′-methylenebis(4,6-di-tert-butylphenyl) lithium phosphate | yes | no | no | 5 | |||
751 | 81515 | 0087189-25-1 | poly(zinc glycerolate) | yes | no | no | ||||
[F1752 | 39890 | 0087826-41-3 0069158-41- 4 0054686-97-4 0081541-12-0 | bis(methylbenzylidene)sorbitol | yes | no | no | ] | |||
753 | 62800 | 0092704-41-1 | kaolin, calcined | yes | no | no | ||||
754 | 56020 | 0099880-64-5 | glycerol dibehenate | yes | no | no | ||||
755 | 21765 | 0106246-33-7 | 4,4′-methylenebis(3-chloro-2,6-diethylaniline) | no | yes | no | 0,05 | (1) | ||
756 | 40020 | 0110553-27-0 | 2,4-bis(octylthiomethyl)-6-methylphenol | yes | no | yes | (24) | |||
757 | 95725 | 0110638-71-6 | vermiculite, reaction product with citric acid, lithium salt | yes | no | no | ||||
758 | 38940 | 0110675-26-8 | 2,4-bis(dodecylthiomethyl)-6-methylphenol | yes | no | yes | (24) | |||
759 | 54300 | 0118337-09-0 | 2,2′-ethylidenebis(4,6-di-tert-butylphenyl) fluorophosphonite | yes | no | yes | 6 | |||
760 | 83595 | 0119345-01-6 | reaction product of di-tert-butylphosphonite with biphenyl, obtained by condensation of 2,4-di-tert-butylphenol with Friedel Craft reaction product of phosphorous trichloride and biphenyl | yes | no | no | 18 | Composition:
(*)Quantity of substance used/quantity of formulationOther specifications:
| ||
761 | 92930 | 0120218-34-0 | thiodiethanolbis(5-methoxycarbonyl-2,6-dimethyl-1,4-dihydropyridine-3-carboxylate) | yes | no | no | 6 | |||
762 | 31530 | 0123968-25-2 | acrylic acid, 2,4-di-tert-pentyl-6-(1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl)phenyl ester | yes | no | yes | 5 | |||
763 | 39925 | 0129228-21-3 | 3,3-bis(methoxymethyl)-2,5-dimethylhexane | yes | no | yes | 0,05 | |||
764 | 13317 | 0132459-54-2 | N,N′-bis[4-(ethoxycarbonyl)phenyl]-1,4,5,8-naphthalenetetracarboxydiimide | no | yes | no | 0,05 | Purity > 98,1 % (w/w). Only to be used as co-monomer (max 4 %) for polyesters (PET, PBT). | ||
765 | 49485 | 0134701-20-5 | 2,4-dimethyl-6-(1-methylpentadecyl)phenol | yes | no | yes | 1 | |||
766 | 38879 | 0135861-56-2 | bis(3,4-dimethylbenzylidene)sorbitol | yes | no | no | ||||
767 | 38510 | 0136504-96-6 | 1,2-bis(3-aminopropyl)ethylenediamine, polymer with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazine | yes | no | no | 5 | |||
768 | 34850 | 0143925-92-2 | amines, bis(hydrogenated tallow alkyl) oxidised | yes | no | no | Not to be used for articles in contact with fatty foods for which [F1simulant D1 and/or D2] is laid down. Only to be used in: (a) polyolefins at 0,1 % (w/w) concentration and in (b) PET at 0,25 % (w/w) concentration. | (1) | ||
769 | 74010 | 0145650-60-8 | phosphorous acid, bis(2,4-di-tert-butyl-6-methylphenyl) ethyl ester | yes | no | yes | 5 | SML expressed as sum of phosphite and phosphate | ||
770 | 51700 | 0147315-50-2 | 2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy)phenol | yes | no | no | 0,05 | |||
771 | 34650 | 0151841-65-5 | aluminium hydroxybis [2,2′-methylenebis (4,6-di-tert-butylphenyl) phosphate] | yes | no | no | 5 | |||
772 | 47500 | 0153250-52-3 | N,N′-dicyclohexyl-2,6-naphthalene dicarboxamide | yes | no | no | 5 | |||
773 | 38840 | 0154862-43-8 | bis(2,4-dicumylphenyl)pentaerythritol-diphosphite | yes | no | yes | 5 | SML expressed as sum of the substance itself, its oxidised form bis(2,4-dicumylphenyl)pentaerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol) | ||
774 | 95270 | 0161717-32-4 | 2,4,6-tris(tert-butyl)phenyl-2-butyl-2-ethyl-1,3-propanediol phosphite | yes | no | yes | 2 | SML expressed as sum of phosphite, phosphate and the hydrolysis product = TTBP | ||
775 | 45705 | 0166412-78-8 | 1,2-cyclohexanedicarboxylic acid, diisononyl ester | yes | no | no | (32) | |||
776 | 76723 | 0167883-16-1 | polydimethylsiloxane, 3-aminopropyl terminated, polymer with dicyclohexylmethane-4,4′-diisocyanate | yes | no | no | The fraction with molecular weight below 1 000 Da [F1shall] not exceed 1,5 % (w/w) | |||
777 | 31542 | 0174254-23-0 | acrylic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl esters | yes | no | no | 0,5 % in final product | (1) | ||
778 | 71670 | 0178671-58-4 | pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate) | yes | no | yes | 0,05 | |||
[F1779 | 39815 | 0182121-12-6 | 9,9-bis(methoxymethyl)fluorene | yes | no | yes | 0,05 | [F6(2)] ] | ||
780 | 81220 | 0192268-64-7 | poly-[[6-[N-(2,2,6,6-tetramethyl-4-piperidinyl)-n-butylamino]-1,3,5-triazine-2,4-diyl][(2,2,6,6-tetramethyl-4-piperidinyl)imino]-1,6-hexanediyl[(2,2,6,6-tetramethyl-4-piperidinyl)imino]]-α-[N,N,N′,N′-tetrabutyl-N"-(2,2,6,6-tetramethyl-4-piperidinyl)-N"-[6-(2,2,6,6-tetramethyl-4-piperidinylamino)-hexyl]-[1,3,5-triazine-2,4,6-triamine]-ω-N,N,N′,N′-tetrabutyl-1,3,5-triazine-2,4-diamine] | yes | no | no | 5 | |||
781 | 95265 | 0227099-60-7 | 1,3,5-tris(4-benzoylphenyl) benzene | yes | no | no | 0,05 | |||
782 | 76725 | 0661476-41-1 | polydimethylsiloxane, 3-aminopropyl terminated, polymer with 1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane | yes | no | no | The fraction with molecular weight below 1 000 Da [F1shall] not exceed 1 % (w/w) | |||
783 | 55910 | 0736150-63-3 | glycerides, castor-oil mono-, hydrogenated, acetates | yes | no | no | (32) | |||
[F7784 | 95420 | 0745070-61-5 | 1,3,5-tris (2,2-di-methylpropanamido) benzene | yes | no | no | 5 | ] | ||
785 | 24910 | 0000100-21-0 | terephthalic acid | no | yes | no | (28) | |||
786 | 14627 | 0000117-21-5 | 3-chlorophthalic anhydride | no | yes | no | 0,05 | SML expressed as 3-chlorophthalic acid | ||
787 | 14628 | 0000118-45-6 | 4-chlorophthalic anhydride | no | yes | no | 0,05 | SML expressed as 4-chlorophthalic acid | ||
788 | 21498 | 0002530-85-0 | [3-(methacryloxy)propyl]trimethoxysilane | no | yes | no | 0,05 | Only to be used as a surface treatment agent of inorganic fillers | (1) (11) | |
789 | 60027 | — | hydrogenated homopolymers and/or copolymers made of 1-hexene and/or 1-octene and/or 1-decene and/or 1-dodecene and/or 1-tetradecene (Mw: 440–12 000) | yes | no | 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). | (2) | ||
790 | 80480 | 0090751-07-8 0082451-48-7 | poly(6-morpholino-1,3,5-triazine-2,4-diyl)-[(2,2,6,6-tetramethyl-4-piperidyl)imino)] hexa-methylene-[(2,2,6,6-tetramethyl-4-piperidyl)imino)] | yes | no | no | 5 | Average molecular weight not less than 2 400 Da. Residual content of morpholine ≤ 30 mg/kg, of N,N′-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15 000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg. | (16) | |
791 | 92470 | 0106990-43-6 | N,N′,N″,N″-tetrakis(4,6-bis(N-butyl-(N-methyl-2,2,6,6-tetramethylpiperidin-4-yl)amino)triazin-2-yl)-4,7-diazadecane-1,10-diamine | yes | no | no | 0,05 | |||
792 | 92475 | 0203255-81-6 | 3,3′,5,5′-tetrakis(tert-butyl)-2,2′-dihydroxybiphenyl, cyclic ester with [3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propyl]oxyphosphonous acid | yes | no | yes | 5 | SML expressed as the sum of phosphite and phosphate form of the substance and the hydrolysis products | ||
793 | 94000 | 0000102-71-6 | triethanolamine | yes | no | no | 0,05 | SML expressed as the sum of triethanolamine and the hydrochloride adduct expressed as triethanolamine | ||
[F9794 | 18117 | 0000079-14-1 | glycolic acid | no | yes | 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. | ] | ||
795 | 40155 | 0124172-53-8 | N,N′-bis(2,2,6,6-tetramethyl-4-piperidyl)-N,N′-diformylhexamethylenediamine | yes | no | no | 0,05 | (2) (12) | ||
796 | 72141 | 0018600-59-4 | 2,2′-(1,4-phenylene)bis[4H-3,1-benzoxazin-4-one] | yes | no | yes | 0,05 | SML including the sum of its hydrolysis products | ||
[F9797 | 76807 | 0073018-26-5 | polyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-hexanol | yes | no | yes | (31) (32) | ] | ||
798 | 92200 | 0006422-86-2 | terephthalic acid, bis(2-ethylhexyl)ester | yes | no | no | 60 | (32) | ||
[F7799 | 77708 | polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C 8 -C 22 ) alcohols | yes | no | no | 1,8 | In compliance with the maximum ethylene oxide content as laid down in the purity criteria for food additives in Commission Regulation (EU) No 231/2012. | ] | ||
800 | 94425 | 0000867-13-0 | triethyl phosphonoacetate | yes | no | no | Only for use in PET | |||
801 | 30607 | — | acids, C2-C24, aliphatic, linear, monocarboxylic, from natural oils and fats, lithium salt | yes | no | no | ||||
802 | 33105 | 0146340-15-0 | alcohols, C12-C14 secondary, β-(2-hydroxyethoxy), ethoxylated | yes | no | no | 5 | (12) | ||
803 | 33535 | 0152261-33-1 | α-alkenes(C20-C24) copolymer with maleic anhydride, reaction product with 4-amino-2,2,6,6-tetramethylpiperidine | yes | no | no | Not to be used for articles in contact with fatty foods for which [F1simulant D1 and/or D2] is laid down. Not to be used in contact with alcoholic foods. | (13) | ||
804 | 80510 | 1010121-89-7 | poly(3-nonyl-1,1-dioxo-1-thiopropane-1,3-diyl)-block-poly(x-oleyl-7-hydroxy-1,5-diiminooctane-1,8-diyl), process mixture with x = 1 and/or 5, neutralised with dodecylbenzenesulfonic acid | yes | no | no | Only to be used as polymer production aid in polyethylene (PE), polypropylene (PP) and polystyrene (PS) | |||
805 | 93450 | — | titanium dioxide, coated with a copolymer of n-octyltrichlorosilane and [aminotris(methylenephosphonic acid), penta sodium salt] | yes | no | no | The content of the surface treatment copolymer of the coated titanium dioxide is less than 1 % w/w | |||
806 | 14876 | 0001076-97-7 | 1,4-cyclohexanedicarboxylic acid | no | yes | no | 5 | Only to be used for manufacture of polyesters | ||
[F8807 | 93485 | — | titanium nitride, nanoparticles | yes | no | no | No migration of titanium nitride nanoparticles. Only to be used in polyethylene terephthalate (PET) up to 20 mg/kg. In the PET, the agglomerates have a diameter of 100-500 nm consisting of primary titanium nitride nanoparticles; primary particles have a diameter of approximately 20 nm. | ] | ||
808 | 38550 | 0882073-43-0 | bis(4-propylbenzylidene)propylsorbitol | yes | no | no | 5 | SML including the sum of its hydrolysis products | ||
809 | 49080 | 0852282-89-4 | N-(2,6-diisopropylphenyl)-6-[4-(1,1,3,3-tetramethylbutyl)phenoxy]-1H-benzo[de]isoquinolin-1,3(2H)-dione | yes | no | yes | 0,05 | Only for use in PET | (6) (14) (15) | |
810 | 68119 | neopentyl glycol, diesters and monoesters with benzoic acid and 2-ethylhexanoic acid | yes | no | no | 5 | (32) | Not to be used for articles in contact with fatty foods for which [F1simulant D1 and/or D2] is laid down. | ||
811 | 80077 | 0068441-17-8 | polyethylene waxes, oxidised | yes | no | no | 60 | |||
[F9812 | 80350 | 0124578-12-7 | poly(12-hydroxystearic acid)-polyethyleneimine copolymer | yes | no | no | Only to be used in plastics up to 0,1 % w/w. Prepared by the reaction of poly(12-hydroxystearic acid) with polyethyleneimine. | ] | ||
813 | 91530 | — | sulphosuccinic acid alkyl (C4-C20) or cyclohexyl diesters, salts | yes | no | no | 5 | |||
814 | 91815 | — | sulphosuccinic acid monoalkyl (C10-C16) polyethyleneglycol esters, salts | yes | no | no | 2 | |||
815 | 94985 | — | trimethylolpropane, mixed triesters and diesters with benzoic acid and 2-ethylhexanoic acid | yes | no | no | 5 | (32) | Not to be used for articles in contact with fatty foods for which [F1simulant D1 and/or D2] is laid down | |
816 | 45704 | — | cis-1,2-cyclohexanedicarboxylic acid, salts | yes | no | no | 5 | |||
817 | 38507 | — | cis-endo-bicyclo[2.2.1]heptane-2,3-dicarboxylic acid, salts | yes | no | no | 5 | Not to be used with polyethylene in contact with acidic foods. Purity ≥ 96 %. | ||
818 | 21530 | — | methallylsulphonic acid, salts | no | yes | no | 5 | |||
819 | 68110 | — | neodecanoic acid, salts | yes | no | no | 0,05 | Not to be used in polymers contacting fatty foods. Not to be used for articles in contact with fatty foods for which [F1simulant D1 and/or D2] is laid down. SML expressed as neodecanoic acid. | ||
820 | 76420 | — | pimelic acid, salts | yes | no | no | ||||
821 | 90810 | — | stearoyl-2-lactylic acid, salts | yes | no | no | ||||
[F12822 | 71938 | Perchloric acid, salts | yes | no | no | 0,002 | (4)] | |||
823 | 24889 | — | 5-Sulphoisophthalic acid, salts | no | yes | no | 5 | |||
854 | 71943 | 0329238-24-6 | perfluoro acetic acid, α-substituted with the copolymer of perfluoro-1,2-propylene glycol and perfluoro-1,1-ethylene glycol, terminated with chlorohexafluoropropyloxy groups | yes | no | no | Only to be used in concentrations up to 0,5 % w/w in the polymerisation of fluoropolymers that are processed at temperatures at or above 340 °C and are intended for use in repeated use articles | |||
[F13855 | 40560 | (butadiene, styrene, methyl methacrylate) copolymer cross-linked with 1,3-butanediol dimethacrylate | yes | no | no | Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below. | ||||
[F14856 | 40563 | 25101-28-4 | (butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate | yes | no | no | Only to be used in:
| ] | ||
857 | 66765 | 0037953-21-2 | (methyl methacrylate, butyl acrylate, styrene, glycidyl methacrylate) copolymer | yes | no | no | Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % at room temperature or below. | ] | ||
[F5 [X1858 | 38565 | 0090498-90-1 | 3,9-bis[2-(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro[5,5]undecane | yes | no | yes | 0,05 | SML expressed as the sum of the substance and its oxidation product 3-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)prop-2-enoyloxy)-1,1-dimethylethyl]-9-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro[5,5]-undecane in equilibrium with its para quinone methid tautomer. | (2)] ] | |
[F3859 | (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with divinylbenzene, in nanoform | yes | no | 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. | ] | ||||
860 | 71980 | 0051798-33-5 | perfluoro[2-(poly(n-propoxy))propanoic acid] | yes | no | 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 | |||
861 | 71990 | 0013252-13-6 | perfluoro[2-(n-propoxy)propanoic acid] | yes | no | 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 | |||
[F9862 | 15180 | 0018085-02-4 | 3,4-diacetoxy-1-butene | no | yes | no | 0,05 | SML including the hydrolysis product 3,4-dihydroxy-1-butene Only to be used as a co-monomer for ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers. | (17) (19)] | |
[F13863 | 15260 | 0000646-25-3 | 1,10-decanediamine | no | yes | no | 0,05 | 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. | ] | |
864 | 46330 | 0000056-06-4 | 2,4-diamino-6-hydroxypyrimidine | yes | no | no | 5 | Only to be used in rigid poly(vinyl chloride) (PVC) in contact with non-acidic and non-alcoholic aqueous food | ||
[F8865 | 40619 | 0025322-99-0 | (butyl acrylate, methyl methacrylate, butyl methacrylate) copolymer | yes | no | 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. | ] | ||
866 | 40620 | — | (butyl acrylate, methyl methacrylate) copolymer, cross-linked with allyl methacrylate | yes | no | no | Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 7 % | |||
867 | 40815 | 0040471-03-2 | (butyl methacrylate, ethyl acrylate, methyl methacrylate) copolymer | yes | no | no | Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % | |||
[F8868 | 53245 | 0009010-88-2 | (ethyl acrylate, methyl methacrylate) copolymer | yes | no | 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. | ] | ||
869 | 66763 | 0027136-15-8 | (butyl acrylate, methyl methacrylate, styrene) copolymer | yes | no | no | Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 3 % | |||
870 | 95500 | 0160535-46-6 | N,N′,N″-tris(2-methylcyclohexyl)-1,2,3-propane-tricarboxamide | yes | no | no | 5 | |||
[F15871 | 0287916-86-3 | dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and 1-propene | yes | no | no | Only to be used in polyolefins at levels of up to 20 weight %. These polyolefins shall only be used in contact with foods for which Table 2 of Annex III assigns food simulant E, at ambient temperature or below, and when migration of the total oligomeric fraction of less than 1 000 Da does not exceed 50 μg/kg food. | (23)] | |||
[F16872 | 0006607-41-6 | 2-phenyl-3,3-bis(4-hydroxyphenyl)phthalimidine | no | yes | no | 0,05 | To be used only as a co-monomer in polycarbonate copolymers | (20)] | ||
[F13873 | 93460 | titanium dioxide reacted with octyltriethoxysilane | yes | no | no | Reaction product of titanium dioxide with up to 2 % w/w surface treatment substance octyltriethoxysilane, processed at high temperatures. | ] | |||
[F5874 | 16265 | 0156065-00-8 | α-dimethyl-3-(4’-hydroxy-3’-methoxyphenyl)propylsilyloxy, ω-3-dimethyl-3-(4’-hydroxy-3’-methoxyphenyl)propylsilyl polydimethylsiloxane | no | yes | no | 0,05 | (33) | Only to be used as comonomer in siloxane modified polycarbonate. The oligomeric mixture shall be characterised by the formula C 24 H 38 Si 2 O 5 (SiOC 2 H 6 )n (50 > n ≥ 26). | ] |
875 | 80345 | 0058128-22-6 | poly(12-hydroxystearic acid) stearate | yes | no | yes | 5 | |||
878 | 31335 | — | acids, fatty (C8-C22) from animal or vegetable fats and oils, esters with branched alcohols, aliphatic, monohydric, saturated, primary (C3-C22) | yes | no | no | ||||
879 | 31336 | — | acids, fatty (C8-C22) from animal or vegetable fats and oils, esters with alcohols, linear, aliphatic, monohydric, saturated, primary (C1-C22) | yes | no | no | ||||
[F7880 | 31348 | acids, fatty (C 8 -C 22 ), esters with pentaerythritol' | yes | no | no | |||||
881 | 25187 | 0003010-96-6 | 2,2,4,4-tetramethylcyclobutane-1,3-diol | no | yes | no | 5 | 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. | ] | |
882 | 25872 | 0002416-94-6 | 2,3,6-trimethylphenol | no | yes | no | 0,05 | |||
883 | 22074 | 0004457-71-0 | 3-methyl-1,5-pentanediol | no | yes | no | 0,05 | Only to be used in materials in contact with food at a surface to mass ratio up to 0,5 dm2/kg | ||
884 | 34240 | 0091082-17-6 | alkyl(C10-C21)sulphonic acid, esters with phenol | yes | no | no | 0,05 | Not to be used for articles in contact with fatty foods for which [F1simulant D1 and/or D2] is laid down. | ||
885 | 45676 | 0263244-54-8 | cyclic oligomers of (butylene terephthalate) | yes | no | no | Only to be used in poly(ethylene terephthalate) (PET), poly(butylene terephthalate) (PBT), polycarbonate (PC), polystyrene (PS) and rigid poly(vinyl chloride) (PVC) plastics in concentrations up to 1 % w/w, in contact with aqueous, acidic and alcoholic foods, for long term storage at room temperature. | |||
[F13894 | 93360 | 0016545-54-3 | thiodipropionic acid, ditetradecyl ester | yes | no | no | (14) | |||
895 | 47060 | 0171090-93-0 | 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoic acid, esters with C13-C15 branched and linear alcohols | yes | no | no | 0,05 | Only to be used in polyolefins in contact with foods other than fatty/high-alcoholic and dairy products. | ||
896 | 71958 | 0958445-44-8 | 3H-perfluoro-3-[(3-methoxy-propoxy)propanoic acid], ammonium salt | yes | no | no | Only to be used in the polymerisation of fluoropolymers when:
| |||
[F5902 | 0000128-44-9 | 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt | yes | no | no | The substance shall comply with the specific purity criteria as set out in Commission Regulation (EU) No 231/2012 h . | ] | |||
[F3903 | 37486-69-4 | 2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether] | yes | no | no | Only to be used as a polymer production aid in the polymerisation of fluoropolymers intended for: (a) repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360 °C for at least 10 minutes or at higher temperatures for equivalent shorter times; (b) repeated use materials and articles when processed (non-sintered) at temperatures from 300 °C and up to 360 °C for at least 10 minutes. | ] | |||
923 | 39150 | 0000120-40-1 | N,N-bis(2-hydroxyethyl)dodecanamide | yes | no | no | 5 | The residual amount of diethanolamine in plastics, as an impurity and decomposition product of the substance, [F1shall] not result in a migration of diethanolamine higher than 0,3 mg/kg food. | (18) | |
924 | 94987 | trimethylolpropane, mixed triesters and diesters with n-octanoic and n-decanoic acids | yes | no | no | 0,05 | Only for use in PET in contact with all types of foods other than fatty, high-alcoholic and dairy products. | |||
926 | 71955 | 0908020-52-0 | perfluoro[(2-ethyloxy-ethoxy)acetic acid], ammonium salt | yes | no | no | Only to be used in the polymerisation of fluoropolymers that are processed at temperatures higher than 300 °C for at least 10 minutes. | |||
[F3969 | 24937-78-8 | ethylene-vinyl acetate copolymer wax | yes | no | no | Only to be used as a polymeric additive up to 2 % w/w in polyolefins. The migration of low molecular weight oligomeric fraction below 1 000 Da shall not exceed 5 mg/kg food. | ] | |||
971 | 25885 | 0002459-10-1 | trimethyl trimellitate | no | yes | no | Only to be used as a co-monomer up to 0,35 % w/w to produce modified polyesters intended to be used in contact with aqueous and dry foodstuffs containing no free fat at the surface. | (17) | ||
972 | 45197 | 0012158-74-6 | copper hydroxide phosphate | yes | no | no | ||||
973 | 22931 | 0019430-93-4 | (perfluorobutyl)ethylene | no | yes | no | Only to be used as a co-monomer up to 0,1 % w/w in the polymerisation of fluoropolymers, sintered at high temperatures. | |||
[F12974 | 74050 | 939402-02-5 | phosphorous acid, mixed 2,4-bis(1,1- dimethylpropyl)phenyl and 4-(1,1- dimethylpropyl)phenyl triesters | yes | no | yes | 10 | SML expressed as the sum of the phosphite and phosphate forms of the substance, 4-tert-amylphenol and 2,4-di-tert-amylphenol. The migration of 2,4-di-tert- amylphenol shall not exceed 1 mg/kg food. | ] ] | |
[F5979 | 79987 | — | (polyethylene terephthalate, hydroxylated polybutadiene, pyromellitic anhydride) copolymer | yes | no | no | Only to be used in polyethylene terephthalate (PET) at a maximum level of 5 % w/w. | ] | ||
[F16988 | 3634-83-1 | 1,3-bis(isocyanatomethyl)benzene | no | yes | no | (34) | 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 | ] | ||
[F3998 | (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer not cross-linked, in nanoform | yes | no | 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. | |||||
[F171007 | 976-56-7 | diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate | no | yes | no | Only to be used up to 0,2 % w/w based on the final polymer weight in the polymerisation process to manufacture poly(ethylene terephthalate) (PET). | ||||
1016 | (methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer in nanoform | yes | no | 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. | ] | ||||
1017 | 25618-55-7 | polyglycerol | yes | no | no | To be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C. | ||||
[F171030 | montmorillonite clay modified by dimethyldialkyl(C16-C18)ammonium chloride | yes | no | no | Only to be used up to 12 % (w/w) in polyolefins in contact with dry foods to which simulant E is assigned in table 2 of Annex III at room temperature or below. The sum of the specific migration of 1-chlorohexadecane and 1-chlorooctadecane shall not exceed 0,05 mg/kg food. Can contain platelets in the nanoform that are only in one dimension thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer. | ] | ||||
[F151031 | 3238-40-2 | furan-2,5-dicarboxylic acid | no | yes | no | 5 | 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). | (22) (23) | ||
1034 | 3710-30-3 | 1,7-octadiene | no | yes | no | 0,05 | 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. | ] | ||
1043 | (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with 1,3-butanediol dimethacrylate, in nanoform | yes | no | 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. | ] | ||||
[F151045 | 1190931-27-1 | perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt | yes | no | no | Only to be used as a polymer production aid during the manufacture of fluoropolymers under high temperature conditions of at least 370 °C. | ||||
1046 | zinc oxide, nanoparticles, coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 788) | yes | no | no | Only to be used in unplasticised polymers. The restrictions and specifications specified for FCM substance No 788 shall be respected. | |||||
1048 | 624-03-3 | ethylene glycol dipalmitate | yes | no | no | (2) | Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils. | |||
1050 | zinc oxide, nanoparticles, uncoated | yes | no | no | Only to be used in unplasticised polymers. | |||||
1051 | 42774-15-2 | N,N′-bis(2,2,6,6-tetramethyl-4-piperidinyl) isophthalamide | yes | no | no | 5 | ||||
1052 | 1455-42-1 | 2,4,8,10-tetraoxaspiro[5,5]undecane-3,9-diethanol,β3,β3,β9,β9-tetramethyl- ( ‘ SPG ’ ) | no | yes | no | 5 | Only to be used as a monomer in the production of polyesters. The migration of oligomers of less than 1 000 Da shall not exceed 50 μg/kg food (expressed as SPG). | (22) (23) | ||
1053 | fatty acids, C16–18 saturated, esters with dipentaerythritol | yes | no | no | Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils | ] | ||||
[F171055 | 7695-91-2 58-95-7 | α-tocopherol acetate | yes | no | no | Only to be used as antioxidant in polyolefins. | (24) | |||
1060 | ground sunflower seed hulls | yes | no | 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. | |||||
[F181061 | 80512-44-3 | 2,4,4′-trifluorobenzophenone | no | yes | no | Only to be used as a co-monomer in the manufacture of polyether ether ketone plastics up to 0,3 % w/w of the final material. | ] | |||
1062 | mixture composed of 97 % tetraethyl orthosilicate (TEOS) with CAS No 78-10-4 and 3 % hexamethyldisilazane (HMDS) with CAS No 999-97-3 | no | yes | no | Only to be used for the production of recycled PET and at up to 0,12 % (w/w). | ] | ||||
[F181063 | 1547-26-8 | 2,3,3,4,4,5,5-heptafluoro-1-pentene | no | yes | no | Only to be used together with tetrafluoroethylene and/or ethylene co-monomers to manufacture fluorocopolymers for application as polymer processing aid at up to 0,2 % w/w of the food contact material, and when the low-molecular mass fraction below 1 500 Da in the fluorocopolymer does not exceed 30 mg/kg. | ||||
1064 | 39318-18-8 | tungsten oxide | yes | no | no | 0,05 | Stoichiometry: WO n , n = 2,72-2,90 | (25) | ||
1065 | 85711-28-0 | mixture of methyl-branched and linear C 14 -C 18 alkanamides, derived from fatty acids | yes | no | no | 5 | Only to be used in the manufacture of articles made of polyolefins, and which do not come into contact with foods for which food simulant D2 is assigned in Table 2 of Annex III. | (26)] | ||
[F191066 | 23985-75-3 | 1,2,3,4-tetrahydronaphtalene-2,6-dicarboxylic acid, dimethyl ester | no | yes | no | 0,05 | 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). | |||
1068 | 2530-83-8 | [3-(2,3-epoxypropoxy)propyl]trimethoxy silane | yes | no | no | Only to be used as a component of a sizing agent to treat glass fibres to be embedded in glass-fibre-reinforced low diffusivity plastics (polyethylene terephthalate (PET), polycarbonate (PC), polybutylene terephthalate (PBT), thermoset polyesters and epoxy bisphenol vinylester) in contact with all foodstuffs. In treated glass fibres, residues of the substance must not be detectable at 0,01 mg/kg for the substance and 0,06 mg/kg for each of the reaction products (hydrolysed monomers and epoxy-containing cyclic dimer, trimer and tetramer). | ] |
Editorial Information
X1 Substituted by Corrigendum to Commission Regulation (EU) No 1183/2012 of 30 November 2012 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Official Journal of the European Union L 338 of 12 December 2012).
Textual Amendments
F3 Inserted by Commission Regulation (EU) 2015/174 of 5 February 2015 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).
F4 Inserted by Commission Implementing Regulation (EU) No 321/2011 of 1 April 2011 amending Regulation (EU) No 10/2011 as regards the restriction of use of Bisphenol A in plastic infant feeding bottles (Text with EEA relevance).
F5 Inserted by Commission Regulation (EU) No 1183/2012 of 30 November 2012 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).
F6 Deleted by Commission Regulation (EU) 2017/752 of 28 April 2017 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).
F7 Substituted by Commission Regulation (EU) 2015/174 of 5 February 2015 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).
F8 Substituted by Commission Regulation (EU) No 1183/2012 of 30 November 2012 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).
F9 Substituted by Commission Regulation (EU) No 1282/2011 of 28 November 2011 amending and correcting Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).
F10 Substituted by Commission Regulation (EU) No 202/2014 of 3 March 2014 amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).
F11 Deleted by Commission Regulation (EU) 2015/174 of 5 February 2015 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).
F12 Substituted by Commission Regulation (EU) 2018/831 of 5 June 2018 amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).
F13 Inserted by Commission Regulation (EU) No 1282/2011 of 28 November 2011 amending and correcting Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).
F14 Substituted by Commission Regulation (EU) 2018/79 of 18 January 2018 amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).
F15 Inserted by Commission Regulation (EU) 2016/1416 of 24 August 2016 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).
F16 Inserted by Commission Regulation (EU) No 202/2014 of 3 March 2014 amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).
F17 Inserted by Commission Regulation (EU) 2017/752 of 28 April 2017 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).
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