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ECHA launches a public consultation on 54 potential Substances of Very High Concern

ECHA/PR/12/24
Press Release
Media enquiries: ECHA Press

The public consultation will be open for 45 days and will end on 18 October 2012. Interested parties can post their comments on the ECHA website.

Helsinki, 3 September 2012 The European Commission has requested ECHA to prepare Annex XV dossiers for 37 substances on their behalf. Austria, Germany, the Netherlands, Poland, Slovakia, Sweden and the United Kingdom have also put forward proposals for the identification of 17 substances.

Amongst the substances, 44 are proposed to be identified as SVHCs on the basis of their classifications as carcinogenic, mutagenic and/or toxic for reproduction (REACH Article 57(a–c)). One of these substances is also suggested as being of equivalent concern in accordance with Article 57(f) based on its endocrine disrupting properties.

Five further substances are proposed to be of equivalent concern. In particular, three of those are respiratory sensitisers and proposed to be of equivalent level of concern for human health. Two further proposals comprise substances proposed to be of equivalent concern for the environment due to endocrine disrupting properties or because they are degrading to the already identified endocrine disruptor (1,1,3,3-tetramethylbutyl)phenol.

Finally, five substances are proposed to be identified as being persistent, bioaccumulative and toxic (PBT) and/or very persistent and very bioaccumulative (vPvB) in accordance with Article 57(d) and/or (e).

Comments should provide information concerning the identity of the substances or on their PBT/vPvB or "equivalent concern" properties. The Member State Committee will take these comments into account when seeking agreement on the identification of all proposed substances as SVHCs. No account will, however, be taken by the Committee of comments on CMR properties where harmonised classification is laid down in Annex VI of the regulation on classification, labelling and packaging of hazardous substances and mixtures (CLP Regulation).

Furthermore, ECHA invites the submission of information on the uses of the substances. This would include data on tonnages per use and exposures or releases resulting from these uses. Information on the availability of safer alternative substances and techniques as well as the structure of supply chains is also welcome. ECHA will consider this information when recommending SVHCs for inclusion in the Authorisation List (Annex XIV).

Information on the identity of the substances and the reasons for their proposal as SVHCs is available at ECHA's consultation web pages and on their uses in the registered substances database. Comments should be submitted using the dedicated webform available on the ECHA website.

Currently, 84 SVHCs have been included in the Candidate List. The current set of candidate SVHCs may take the total number above the policy target of 136 set for the end of 2012. Inclusion on this list imposes new information requirements on manufacturers and importers of listed substances and on suppliers of preparations and articles containing the substances.

Substances proposed for identification as SVHC and reasons for their proposal

Substance name

EC number

CAS number Proposed SVHC property

 

Bis(pentabromophenyl) ether (DecaBDE)

214-604-9

1163-19-5

PBT (Article 57 d);
vPvB (Article 57 e)

Pentacosafluorotridecanoic acid

276-745-2

72629-94-8

vPvB (Article 57 e)

Tricosafluorododecanoic acid

206-203-2

307-55-1

vPvB (Article 57 e)

Henicosafluoroundecanoic acid

218-165-4

2058-94-8

vPvB (Article 57 e)

Heptacosafluorotetradecanoic acid

206-803-4

376-06-7

vPvB (Article 57 e)

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated -
covering well-defined substances and UVCB substances, polymers and homologues

-

-

Equivalent level of concern - probable serious effects on the environment (Article 57 f)

4-Nonylphenol, branched and linear -
substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, covering also UVCB- and well-defined substances which include any of the individual isomers or a combination thereof

-

-

Equivalent level of concern - probable serious effects on the environment (Article 57 f)

Diazene-1,2-dicarboxamide (C,C'-azodi(formamide))

204-650-8

123-77-3

Equivalent level of concern - probable serious effects on human health (Article 57 f)

Cyclohexane-1,2-dicarboxylic anhydride (Hexahydrophthalic anhydride - HHPA)

201-604-9

85-42-7

Equivalent level of concern - probable serious effects on human health (Article 57 f)

Hexahydromethylphathalic anhydride, Hexahydro-4-methylphathalic anhydride, Hexahydro-1-methylphathalic anhydride, Hexahydro-3-methylphathalic anhydride

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 - probable serious effects on human health (Article 57 f)

Methoxy acetic acid

210-894-6

625-45-6

Toxic for reproduction (Article 57 c); equivalent level of concern -probable serious effects on human health and the environment (Article 57 f)

1,2-Benzenedicarboxylic acid, dipentylester, branched and linear

284-032-2

84777-06-0

Toxic for reproduction (Article 57 c)

Diisopentylphthalate (DIPP)

210-088-4

605-50-5

Toxic for reproduction (Article 57 c)

N-pentyl-isopentylphtalate

-

-

Toxic for reproduction (Article 57 c)

1,2-Diethoxyethane

211-076-1

629-14-1

Toxic for reproduction (Article 57 c)

N,N-dimethylformamide; dimethyl formamide 

200-679-5 

68-12-2

Toxic for reproduction (Article 57 c)

Dibutyltin dichloride (DBT)

211-670-0

683-18-1

Toxic for reproduction (Article 57 c)

Acetic acid, lead salt, basic

257-175-3

51404-69-4

Toxic for reproduction (Article 57 c)

Basic lead carbonate (trilead bis(carbonate)dihydroxide)

215-290-6

1319-46-6

Toxic for reproduction (Article 57 c)

Lead oxide sulfate (basic lead sulfate)

234-853-7

12036-76-9

Toxic for reproduction (Article 57 c)

[Phthalato(2-)]dioxotrilead (dibasic lead phthalate)

273-688-5

69011-06-9

Toxic for reproduction (Article 57 c)

Dioxobis(stearato)trilead

235-702-8

12578-12-0

Toxic for reproduction (Article 57 c)

Fatty acids, C16-18, lead salts

292-966-7

91031-62-8

Toxic for reproduction (Article 57 c)

Lead bis(tetrafluoroborate)

237-486-0

13814-96-5

Toxic for reproduction (Article 57 c)

Lead cynamidate

244-073-9

20837-86-9

Toxic for reproduction (Article 57 c)

Lead dinitrate

233-245-9

10099-74-8

Toxic for reproduction (Article 57 c)

Lead oxide (lead monoxide)

215-267-0

1317-36-8

Toxic for reproduction (Article 57 c)

Lead tetroxide (orange lead)

215-235-6

1314-41-6

Toxic for reproduction (Article 57 c)

Lead titanium trioxide

235-038-9

12060-00-3

Toxic for reproduction (Article 57 c)

Lead Titanium Zirconium Oxide

235-727-4

12626-81-2

Toxic for reproduction (Article 57 c)

Pentalead tetraoxide sulphate

235-067-7

12065-90-6

Toxic for reproduction (Article 57 c)

Pyrochlore, antimony lead yellow

232-382-1

8012-00-8

Toxic for reproduction (Article 57 c)

Silicic acid, barium salt, lead-doped

272-271-5

68784-75-8

Toxic for reproduction (Article 57 c)

Silicic acid, lead salt

234-363-3

11120-22-2

Toxic for reproduction (Article 57 c)

Sulfurous acid, lead salt, dibasic

263-467-1

62229-08-7

Toxic for reproduction (Article 57 c)

Tetraethyllead

201-075-4

78-00-2

Toxic for reproduction (Article 57 c)

Tetralead trioxide sulphate

235-380-9

12202-17-4

Toxic for reproduction (Article 57 c)

Trilead dioxide phosphonate

235-252-2

12141-20-7

Toxic for reproduction (Article 57 c)

Furan

203-727-3

110-00-9

Carcinogenic (Article 57a)

Propylene oxide; 1,2-epoxypropane; methyloxirane

200-879-2

75-56-9

Carcinogenic (Article 57 a); Mutagenic (Article 57 b)

Diethyl sulphate

200-589-6

64-67-5

Carcinogenic (Article 57 a); Mutagenic (Article 57 b)

Dimethyl sulphate

201-058-1

77-78-1

Carcinogenic (Article 57 a)

3-ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine

421-150-7

143860-04-2

Toxic for reproduction (Article 57 c)

Dinoseb

201-861-7

88-85-7

Toxic for reproduction (Article 57 c)

4,4'-methylenedi-o-toluidine

212-658-8

838-88-0

Carcinogenic (Article 57 a)

4,4'-oxydianiline and its salts

202-977-0

101-80-4

Carcinogenic (Article 57 a);
Mutagenic (Article 57 b)

4-Aminoazobenzene; 4-Phenylazoaniline

200-453-6

60-09-3

Carcinogenic (Article 57 a)

4-methyl-m-phenylenediamine (2,4-toluene-diamine)

202-453-1

95-80-7

Carcinogenic (Article 57 a)

6-methoxy-m-toluidine (p-cresidine)

204-419-1

120-71-8

Carcinogenic (Article 57 a)

Biphenyl-4-ylamine

202-177-1

92-67-1

Carcinogenic (Article 57 a)

o-aminoazotoluene

202-591-2

97-56-3

Carcinogenic (Article 57 a)

o-Toluidine; 2-Aminotoluene

202-429-0

95-53-4

Carcinogenic (Article 57 a)

N-methylacetamide

201-182-6

79-16-3

Toxic for reproduction (Article 57 c)

1-bromopropane; n-propyl bromide

203-445-0

106-94-5

Toxic for reproduction (Article 57 c)

 

Further information