News

The Member State Committee identifies the first endocrine disruptor as a Substance of Very High Concern

ECHA/PR/11/25
Press release
Media enquiries: ECHA Press
 

Helsinki, 14 December 2011

The Member State Committee (MSC) unanimously agreed on the identification of twelve Substances of Very High Concern (SVHCs). These will be added to the Candidate List and may then become subject to authorisation. The Committee also indicated their agreement on ECHA's draft recommendation for adding new substances to the Authorisation List and reached an agreement on four draft dossier evaluation decisions.

Candidate List

The Member State Committee identified twelve new Substances of Very High Concern (SVHCs): nine through written procedure and three at its meeting from 7 to 9 December 2011. Amongst these substances, the substance 4-tert-octyl phenol was identified as a SVHC because of its endocrine disrupting properties causing probable serious effects to the environment. These are potentially so severe that they have been considered as giving rise to an equivalent level of concern to those of other SVHCs such as: Carcinogenic, Mutagenic or Toxic for Reproduction (CMRs), Persistent Bioaccumulative and Toxic (PBTs) or very Persistent and very Bioccumulative (vPvBs) properties.

All these twelve SVHCs are to be included in the update of the Candidate List  together with eight further substances, which did not require the MSC invovement. The Candidate List will be published next week on the ECHA website.

Authorisation List

The MSC also agreed in principle with ECHA's draft recommendation for the inclusion of substances in the Authorisation List - Annex XIV of REACH. Formal adoption of the opinion will take place in written procedure. The majority of the MSC members supports ECHA's draft recommendation to include seven chromium compounds, five cobalt compounds and trichloroethylene in the Authorisation List. However, some members considered that cobalt diacetate should not be prioritised for Annex XIV inclusion. whereas some members considered that none of the recommended cobalt compounds should now be included in Annex XIV.

ECHA will take the MSC opinion, once adopted,  into account when finalising its recommendation for Annex XIV which will then be transmitted to the Commission.

Dossier Evaluation

Furthermore, the MSC agreed unanimously on four draft dossier evaluation decisions (three testing proposal draft decisions and one compliance check draft decision).

No unanimous agreement was reached on one draft decision addressing a testing proposal for meeting the requirements of a two-generation reproductive toxicity study. In fact, though the majority of MSC members supported a draft decision giving the registrant the choice between a two-generation Study1 and an Extended One Generation Reproductive Toxicity Study2 (EOGRTS) with the second generation, a minority of MSC members considered that only an EOGRTS with extra cohorts on immunotoxicity and neurotoxicity and without the second generation should be requested.  

The disagreement is mainly due to legal uncertainty regarding the status of the EOGRTS under REACH.

Further information


 

 

1 EU B.35 - OECD Test Guideline 416: Reproduction/Developmental Toxicity Screening Study

2 OECD Test Guideline 443: Extended One-Generation Reproductive Toxicity Study.