News

Six new substances of very high concern (SVHCs) added to the Candidate List and one entry updated

ECHA/PR/14/18

Today, ECHA has added six new SVHCs to the Candidate List, based on the agreement of the Member State Committee and updated an existing entry to address an additional reason for inclusion.

Helsinki, 17 December 2014 - Cadmium fluoride and cadmium sulphate are added to the Candidate List as being ‘Carcinogenic', ‘Mutagenic', ‘Toxic for reproduction' and are also identified as being of ‘Equivalent level of concern based on probable serious effects to human health' (specifically due to the effects on kidney and bone). Two benzotriazole substances (UV-320 and UV-328) are identified as being ‘persistent bioaccumulative and toxic and very persistent and very bioaccumulative (PBT/vPvB)' and two further substances, DOTE and the reaction mass of DOTE:MOTE are identified as being ‘Toxic for reproduction'.

The Member State Committee also unanimously agreed that bis(2-ethylhexyl) phthalate (DEHP) meets the criteria for identification as an SVHC under Article 57(f) due to its endocrine disrupting properties causing probable serious effects to the environment. As DEHP is already included in the Candidate List based on its toxic for reproduction properties, this entry will be updated to address the additional reason for inclusion.

As DEHP is already listed in the Authorisation List (Annex XIV), companies that were initially exempt from the authorisation requirement may, in the future, be subject to authorisation. However, before this could happen, the European Commission would need to amend the corresponding entry for DEHP in the Authorisation List. 

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 six substances newly added to the Candidate List by 17 December 2014 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, unless exemptions apply.

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. The notifications can be submitted to ECHA through a webform or REACH-IT.

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).

Substances included in the Candidate List for authorisation on 17 December 2014 and their SVHC properties:

#

Substance name

EC number

CAS number

Reason for inclusion

1

Cadmium fluoride

232-222-0

7790-79-6

Carcinogenic (Article 57 a);

Mutagenic (Article 57 b);

Toxic for reproduction (Article 57 c);

Equivalent level of concern having probable serious effects to human health (Article 57 f)

2

Cadmium sulphate

233-331-6

10124-36-4; 31119-53-6

Carcinogenic (Article 57 a);

Mutagenic (Article 57 b);

Toxic for reproduction (Article 57 c);

Equivalent level of concern having probable serious effects to human health (Article 57 f)

3

2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320)

223-346-6

3846-71-7

PBT (Article 57 d);

vPvB (Article 57 e)

4

2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)

247-384-8

25973-55-1

PBT (Article 57 d);

vPvB (Article 57 e)
5 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) 239-622-4

15571-58-1

Toxic for reproduction (Article 57 c)

6

reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE)

- -

Toxic for reproduction (Article 57 c)

 

Entry updated in the Candidate List for authorisation on 17 December 2014 and the SVHC property:

#

Substance name

EC number

CAS number

Reason for inclusion

1

Bis(2-ethylhexyl) phthalate (DEHP)

204-211-0

117-81-7

Equivalent level of concern having probable serious effects to the environment (Article 57 f)