54 new SVHCs added to the REACH Candidates List
January 2013
Relevant for: Electrical & electronics, Food, health & beauty, Hardlines, Softlines, Toys & children's products
On 19 December 2012, the 8th update of the REACH Candidate List was officially published on the website of the European Chemicals Agency (ECHA). Fifty-four substances are included as Substances of Very High Concern (SVHC). The Candidate List now contains 138 SVHCs in total. The newly added SVHCs are the same as those proposed during the public consultation and meets the target set by the European Commission (EC) of having at least 136 SVHCs on the Candidate List by the end of 2012. However, the EC is aiming for a more ambitious goal for the inclusion of all SVHCs by 2020. Discussions are currently in progress among the EC, Member States and the ECHA.
For the current update, Member State Committee (MSC) has identified 23 chemicals. Substances which are respiratory sensitisers are added as substances of very high concern (SVHCs) for the first time. They are diazene-1,2-dicarboxamide (ADCA), hexahydro-2-benzofuran-1,3-dione (HHPA) and hexahydromethylphthalic anhydride (MHHPA). Besides, two endocrine disrupters 4-Nonylphenol, branched and linear and 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated are included. The property of the other newly added substances is carcinogenic, mutagenic or toxic for reproduction category 1A or 1B, persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB). Table A shows a list of newly added SVHCs.
Candidate List Obligation
Once the new SVHCs are added to the Candidate List, it immediately triggers the communication obligation along the supply chain if the articles contain one or more SVHCs in concentration over 0.1% weight by weight. In addition, companies which manufacture or import articles should submit notification to the ECHA starting from 19 June 2012 if the following conditions are met:
i. The substance is present in those articles in quantities totalling over one tonne per producer or importer per year.
ii. The substance is present in those articles above a concentration of 0.1% weight by weight.
The inclusion of the SVHCs into the Candidate List is the first step of Authorisation. The ECHA recommends SVHCs listed on the Candidate List to the European Commission (EC) regularly. The EC will determine whether it is necessary to include the substances into the Authorisation List (Annex XIV).
Table A: Newly added 54 SVHCs on the REACH Candidate List
No. | Substance name | EC number | CAS number | SVHC property |
1 | Bis(pentabromophenyl) ether (decabromodiphenyl ether; ecaBDE) | 214-604-9 | 1163-19-5 | PBT (Article 57 d); vPvB (Article 57 e) |
2 | Pentacosafluorotridecanoic acid | 276-745-2 | 72629-94-8 | vPvB (Article 57 e) |
3 | Tricosafluorododecanoic acid | 206-203-2 | 307-55-1 | vPvB (Article 57 e) |
4 | Henicosafluoroundecanoic acid | 218-165-4 | 2058-94-8 | vPvB (Article 57 e) |
5 | Heptacosafluorotetradecanoic acid | 206-803-4 | 376-06-7 | vPvB (Article 57 e) |
6 | Diazene-1,2-dicarboxamide (C,C'-azodi(formamide)) | 204-650-8 | 123-77-3 | Equivalent level of concern having robable serious effects to human health (Article 57 f) |
7 | Cyclohexane-1,2-dicarboxylic anhydride [1] | 201-604-9, 236-086-3, 238-009-9 | 85-42-7, 13149-00-3, 14166-21-3 | Equivalent level of concern having probable serious effects to human health (Article 57 f) |
8 | Hexahydromethylphthalic anhydride [1], | 247-094-1, 243-072-0, 256-356-4, 260-566-1 | 25550-51-0, 19438-60-9, 48122-14-1, 57110-29-9 | Equivalent level of concern having |
9 | 4-Nonylphenol, branched and linear | - | - | Equivalent level of concern having probable serious effects to the environment (Article 57 f) |
10 | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated [covering well-defined substances and UVCB substances, polymers and homologues] | - | - | Equivalent level of concern having |
11 | Methoxyacetic acid | 210-894-6 | 625-45-6 | Toxic for reproduction (Article 57 c) |
12 | N,N-dimethylformamide | 200-679-5 | 68-12-2 | Toxic for reproduction (Article 57 c) |
13 | Dibutyltin dichloride (DBTC) | 211-670-0 | 683-18-1 | Toxic for reproduction (Article 57 c) |
14 | Lead monoxide (Lead oxide) | 215-267-0 | 1317-36-8 | Toxic for reproduction (Article 57 c) |
15 | Orange lead (Lead tetroxide) | 215-235-6 | 1314-41-6 | Toxic for reproduction (Article 57 c) |
16 | Lead bis(tetrafluoroborate) | 237-486-0 | 13814-96-5 | Toxic for reproduction (Article 57 c) |
17 | Trilead bis(carbonate)dihydroxide | 215-290-6 | 1319-46-6 | Toxic for reproduction (Article 57 c) |
18 | Lead titanium trioxide | 235-038-9 | 12060-00-3 | Toxic for reproduction (Article 57 c) |
19 | Lead titanium zirconium oxide | 235-727-4 | 12626-81-2 | Toxic for reproduction (Article 57 c) |
20 | Silicic acid, lead salt | 234-363-3 | 11120-22-2 | Toxic for reproduction (Article 57 c) |
21 | Silicic acid (H2Si2O5), barium salt (1:1), lead-doped | 272-271-5 | 68784-75-8 | Toxic for reproduction (Article 57 c) |
22 | 1-bromopropane (n-propyl bromide) | 203-445-0 | 106-94-5 | Toxic for reproduction (Article 57 c) |
23 | Methyloxirane (Propylene oxide) | 200-879-2 | 75-56-9 | Carcinogenic (Article 57a); Mutagenic (Article 57b) |
24 | 1,2-Benzenedicarboxylic acid, dipentylester, branched and linear | 284-032-2 | 84777-06-0 | Toxic for reproduction (Article 57 c) |
25 | Diisopentylphthalate (DIPP) | 210-088-4 | 605-50-5 | Toxic for reproduction (Article 57 c) |
26 | N-pentyl-isopentylphthalate | - | 776297-69-9 | Toxic for reproduction (Article 57 c) |
27 | 1,2-diethoxyethane | 211-076-1 | 211-076-1 629-14-1 | Toxic for reproduction (Article 57 c) |
28 | Acetic acid, lead salt, basic | 257-175-3 | 51404-69-4 | Toxic for reproduction (Article 57 c) |
29 | Lead oxide sulfate | 234-853-7 | 12036-76-9 | Toxic for reproduction (Article 57 c) |
30 | [Phthalato(2-)]dioxotrilead | 273-688-5 | 69011-06-9 | Toxic for reproduction (Article 57 c) |
31 | Dioxobis(stearato)trilead | 235-702-8 | 12578-12-0 | Toxic for reproduction (Article 57 c) |
32 | Fatty acids, C16-18, lead salts | 292-966-7 | 91031-62-8 | Toxic for reproduction (Article 57 c) |
33 | Lead cynamidate | 244-073-9 | 20837-86-9 | Toxic for reproduction (Article 57 c) |
34 | Lead dinitrate | 233-245-9 | 10099-74-8 | Toxic for reproduction (Article 57 c) |
35 | Pentalead tetraoxide sulphate | 235-067-7 | 12065-90-6 | Toxic for reproduction (Article 57 c) |
36 | Pyrochlore, antimony lead yellow | 232-382-1 | 8012-00-8 | Toxic for reproduction (Article 57 c) |
37 | Sulfurous acid, lead salt, dibasic | 263-467-1 | 62229-08-7 | Toxic for reproduction (Article 57 c) |
38 | Tetraethyllead | 201-075-4 | 78-00-2 | Toxic for reproduction (Article 57 c) |
39 | Tetralead trioxide sulphate | 235-380-9 | 12202-17-4 | Toxic for reproduction (Article 57 c) |
40 | Trilead dioxide phosphonate | 235-252-2 | 12141-20-7 | Toxic for reproduction (Article 57 c) |
41 | Furan | 203-727-3 | 110-00-9 | Carcinogenic (Article 57a) |
42 | Diethyl sulphate | 200-589-6 | 64-67-5 | Carcinogenic (Article 57a); Mutagenic(Article 57b) |
43 | Dimethyl sulphate | 201-058-1 | 77-78-1 | Carcinogenic (Article 57a) |
44 | 3-ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine | 421-150-7 | 143860-04-2 | Toxic for reproduction (Article 57 c) |
45 | Dinoseb (6-sec-butyl-2,4-dinitrophenol) | 201-861-7 | 88-85-7 | Toxic for reproduction (Article 57 c) |
46 | 4,4'-methylenedi-o-toluidine | 212-658-8 | 838-88-0 | Carcinogenic (Article 57a) |
47 | 4,4'-oxydianiline and its salts | 202-977-0 | 101-80-4 | Carcinogenic (Article 57a); Mutagenic(Article 57b) |
48 | 4-aminoazobenzene | 200-453-6 | 60-09-3 | Carcinogenic (Article 57a) |
49 | 4-methyl-m-phenylenediamine (toluene-2,4-diamine) | 202-453-1 | 95-80-7 | Carcinogenic (Article 57a) |
50 | 6-methoxy-m-toluidine (p-cresidine) | 204-419-1 | 120-71-8 | Carcinogenic (Article 57a) |
51 | Biphenyl-4-ylamine | 202-177-1 | 92-67-1 | Carcinogenic (Article 57a) |
52 | o-aminoazotoluene [(4-o-tolylazo-o-toluidine]) | 202-591-2 | 97-56-3 | Carcinogenic (Article 57a) |
53 | o-toluidine | 202-429-0 | 95-53-4 | Carcinogenic (Article 57a) |
54 | N-methylacetamide | 201-182-6 | 79-16-3 | Toxic for reproduction (Article 57 c) |