ECHA Member State Committee Agrees on New SVHCs to Be Added to the Candidate List and First REACH Testing Decision
During the European Chemicals Agency (ECHA) Member State Committee’s December 2-4, 2009, meeting, the Committee unanimously agreed that 15 new substances of very high concern (SVHC) would be added to the Candidate List. The Committee also unanimously agreed on a testing proposal from ECHA that was submitted under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. More information on these actions is provided below.
15 SVHCs to Be Added to the Candidate List
ECHA will include the 15 SVHCs on the Candidate List in January 2010. Candidate List substances may eventually be included on the list of substances subject to authorization under REACH regulation. In this case, after a transition period, they can only be used if a specific authorization is granted. Information requirements for suppliers of substances, preparations, and articles containing these substances will also follow from the inclusion of the substances on the Candidate List. More information is available at http://echa.europa.eu/doc/press/pr_09_15_msc_svhc_20091207.pdf.
The new substances are listed below.
| SUBSTANCE NAME | EC NUMBER | CAS NUMBER | REASON FOR PROPOSAL |
| Anthracene oil | 292-602-7 | 90640-80-5 | PBT; vPvB; Carcinogen, category 21 |
| Anthracene oil, anthracene paste, distn. lights | 295-278-5 | 91995-17-4 | PBT; vPvB; Carcinogen, category 22; Mutagen, category 23 |
| Anthracene oil, anthracene paste, anthracene fraction | 295-275-9 | 91995-15-2 | PBT; vPvB; Carcinogen, category 22; Mutagen, category 23 |
| Anthracene oil, anthracene-low | 292-604-8 | 90640-82-7 | PBT; vPvB; Carcinogen, category 22; Mutagen, category 23 |
| Anthracene oil, anthracene paste | 292-603-2 | 90640-81-6 | PBT; vPvB; Carcinogen, category 22; Mutagen, category 23 |
| Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | PBT; vPvB; Carcinogen, category 2 |
| Acrylamide | 201-173-7 | 79-06-1 | Carcinogen, category 2; Mutagen, category 2 |
| Aluminosilicate Refractory Ceramic Fibres Aluminosilicate Refractory Ceramic Fibres are fibres covered by index number 650-017-00-8 in Annex VI, part 3, table 3.2 of Regulation (EC) No 1272/2008, and fulfil the two following conditions: a) Al2O3 and SiO2 are present within the following concentration ranges: • Al2O3: 43.5-47 % w/w, and SiO2: 49.5-53.5 % w/w, or • Al2O3: 45.5-50.5 % w/w, and SiO2: 48.5-54 % w/w, b) fibres have a length weighted geometric mean diameter less two standard geometric errors of six or less micrometers (μm) | – | – | Carcinogen, category 2 |
| Zirconia Aluminosilicate, Refractory Ceramic Fibres Zirconia Aluminosilicate Refractory Ceramic Fibres are fibres covered by index number 650-017-00-8 in Annex VI, part 3, table 3.2 of Regulation (EC) No 1272/2008, and fulfil the two following conditions: a) Al2O3, SiO2, and ZrO2 are present within the following concentration ranges: • Al2O3: 35-36 % w/w, and • SiO2: 47.5–50 % w/w, and • ZrO2: 15-17 % w/w, b) fibres have a length weighted geometric mean diameter less two standard geometric errors of six or less μm | – | – | Carcinogen, category 2 |
| 2,4-Dinitrotoluene | 204-450-0 | 121-14-2 | Carcinogen, category 2 |
| Diisobutyl phthalate | 201-553-2 | 84-69-5 | Toxic for reproduction, category 2 |
| Lead chromate | 231-846-0 | 7758-97-6 | Carcinogen, category 2; Toxic for reproduction, category 1 |
| Lead chromate molybdate sulphate red (C.I. Pigment Red 104) | 235-759-9 | 12656-85-8 | Carcinogen, category 2; Toxic for reproduction, category 1 |
| Lead sulfochromate yellow (C.I. Pigment Yellow 34) | 215-693-7 | 1344-37-2 | Carcinogen, category 2; Toxic for reproduction, category 1 |
| tris(2-chloroethyl) phosphate | 204-118-5 | 115-96-8 | Toxic for reproduction, category 2 |
PBT — Persistent, bioaccumulative, and toxic vPvB — Very persistent and very bioaccumulative
1 — The substance does not meet the criteria for identification as a carcinogen in situations where it contains less than 0.005% (w/w) benzo[a]pyrene (EINECS No 200-028-5).
2 — The substance does not meet the criteria for identification as a carcinogen in situations where it contains less than 0.005% (w/w) benzo[a]pyrene (EINECS No 200-028-5) and less than 0.1% w/w benzene (EINECS No 200-753-7).
3 — The substance does not meet the criteria for identification as a mutagen in situations where it contains less than 0.1% w/w benzene (EINECS No 200-753-7).
First REACH Testing Decision
This is the first time that the Member State Committee has discussed a testing proposal. The Committee agreed that the registrant should be required to carry out tests for:
- Viscosity;
- Aquatic toxicity (Daphnia magna long term toxicity);
- Repeated dose toxicity; and
- Reproductive toxicity.
The Committee discussed the registrant’s proposal to use read-across from another substance, instead of testing the repeated dose toxicity and reproductive toxicity. All Committee members agreed, after discussing the basis of scientific arguments and the REACH requirements, that the tests are necessary. The Committee concluded that the registrant had not provided enough justification for the read-across and that the hazards of the registered substance could therefore not be concluded on that basis. ECHA will make the final decision in accordance with the Committee’s unanimous agreement and the decision will be addressed to the registrant. More information is available on the Internet at http://echa.europa.eu/doc/press/na_09_33_msc_first_testing_decision_20091207.pdf.
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