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Candidate List for authorisation updated with fifty-four new substances of very high concern (SVHCs)

ECHA/PR/12/39
Press Release
Media enquiries: ECHA Press

Helsinki, 19 December 2012 – With the addition of 54 new SVHCs to the Candidate List, it now contains a total of 138 substances and the target set by Vice-President Tajani and Commissioner Potočnik to have 136 SVHCs on the Candidate List by the end of 2012 has been reached.

"The Agency is very pleased that this ambitious intermediate target has been reached which could not have happened without the consolidated efforts of the Member States, the Commission and the ECHA secretariat", said Geert Dancet, Executive Director of ECHA. "We can now focus our energy on the longer term goal of ensuring that all relevant substances of concern are identified and addressed via the most appropriate risk management route. I believe that through the recent work on respiratory sensitisers, PBTs and endocrine disruptors we have created a solid foundation for the inclusion of all types of substances of concern in the 2020 roadmap that the Commission is currently debating with the Member States and ECHA."

23 substances (#1-23) have been included in the Candidate List following scrutiny by the Member State Committee (MSC) of the comments received and the MSC's unanimous agreement on the identification of these substances as SVHCs. During the public consultation, no comments challenging the identification as SVHC were received for a further 31 substances (#24-54). Therefore, these substances have been added to the Candidate List without the involvement of the MSC.

Five substances (#1-5) are identified as PBT substances (persistent, bioaccumulative and toxic) and/or vPvB substances (very persistent and very bioaccumulative). The identification of the vPvB substances (#2-5) is based on the revised criteria introduced to Annex XIII of REACH in 2011.

Five further substances are identified as giving rise to an equivalent level of concern. Three of these substances (#6, 7 and 8) are identified because there is scientific evidence of probable serious effects to human health due to their strong respiratory sensitising properties. The other two substances are identified because there is scientific evidence of probable serious effects to the environment. One of these substances (#9) has endocrine disrupting properties and the other one (#10) degrades to an endocrine disruptor already identified as an SVHC (i.e. (1,1,3,3-tetramethylbutyl)phenol).

The remaining 44 SVHCs added to the Candidate List are identified as having carcinogenic, mutagenic and/or toxic for reproduction properties (#11-54), thereby fulfilling the criteria outlined in Art. 57 (a, b and/or c) of REACH.

The legal obligations that companies may have resulting from the inclusion of substances in the Candidate List apply to the listed substances on their own, in mixtures or in articles. Producers and importers of articles containing any of the 54 substances included in the Candidate List by 19 December 2012 have six months from today to notify ECHA if both of the following conditions apply: (i) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year and (ii) the substance is present in those articles above a concentration of 0.1% weight by weight.

There are exemptions from the notification obligation if the substance is already registered for the use or when exposure can be excluded. Information on the notification of substances in articles and related submission tools, as well as a manual with instructions on how to create and submit a notification dossier are available on ECHA´s website. A webform to facilitate the submission of substances in articles notifications is available on ECHA's website. Nevertheless, datasets are also provided for submission of the notifications via REACH-IT.

The Candidate List now contains 138 substances. As foreseen by REACH, a specific procedure will be followed to decide whether the substances should also be included in the List of substances subject to authorisation (Annex XIV of the REACH Regulation).

 

# Substance name EC number CAS Number SVHC property

1

Bis(pentabromophenyl) ether (decabromodiphenyl ether; DecaBDE)

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 probable serious effects to human health (Article 57 f)

7

Cyclohexane-1,2-dicarboxylic anhydride [1]

cis-cyclohexane-1,2-dicarboxylic anhydride [2]

trans-cyclohexane-1,2-dicarboxylic anhydride [3]

[The individual cis- [2] and trans- [3] isomer substances and all possible combinations of the cis- and trans-isomers [1] are covered

by this entry].

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],

Hexahydro-4-methylphthalic anhydride [2],

Hexahydro-1-methylphthalic anhydride [3],

 Hexahydro-3-methylphthalic anhydride  [4]

[The individual isomers [2], [3] and [4] (including their cis- and trans- stereo isomeric forms) and all possible combinations of the isomers [1] are covered by this entry]

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 probable serious effects to human health (Article 57 f)

9

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 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 probable serious effects to the environment (Article 57 f)

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

[with lead (Pb) content above the applicable generic concentration limit for 'toxicity for reproduction' Repr. 1A (CLP) or category 1 (DSD); the substance is a member of the group entry of lead compounds, with index number 082-001-00-6 in Regulation (EC) No 1272/2008]

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

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)

 

Further information