ECHA Member State Committee Agrees on Eight Additional Substances of Very High Concern

At its meeting in Helsinki of 9 and 10 June 2010, the ECHA Member State Committee (MSC) agreed unanimously on one draft decision resulting from a testing proposal and two draft decisions resulting from compliance checks from ECHA. At the same meeting, the MSC also unanimously agreed on the identification of eight substances of very high concern (SVHC) that may become subject to authorization.

One draft decision concerned a testing proposal for a substance named hydrogenated oligomerisation products, including dimers and trimers, of tetradec-1-ene and alkene. The MSC agreed unanimously with the proposal of the registrant that the registrant will need to carry out tests for developmental toxicity and reproductive toxicity (two-generation).

The committee took into account the information provided through the public consultation on the registrant’s testing proposal and concluded, in agreement with ECHA, that the information received was not sufficient to provide the data needed for the endpoints and that the proposed tests needed to be carried out.

On one draft decision resulting from a compliance check for a substance the name of which is confidential the MSC agreed unanimously that the identity of the registered substance needs to be clarified. The registrant will be required to update the registration dossier with further information on substance identity including spectral and analytical data. ECHA may address the possible further data gaps in the registration dossier after the substance identity has been clarified.

On the other draft decision resulting from a compliance check for a substance the name of which is confidential the MSC agreed unanimously to require the registrant to update the registration dossier with study summaries of existing mutagenicity tests to make it possible to assess the relevance of these studies.

ECHA will take the final decisions in accordance with the Committee’s unanimous agreements and the decisions will be addressed to the registrants.

ECHA has already taken one decision resulting from a compliance check without the MSC on 3 May 2010 as no Member State felt necessary to provide proposals for amendments to the draft decision. In this decision the registrant was requested to carry out a test for growth inhibition of aquatic plants.

The Member State Committee also agreed unanimously on the identification of eight Substances of Very High Concern (SVHC) that may become subject to authorisation. These substances will be included in the ‘Candidate List’ after a decision on inclusion has been taken by ECHA. The Candidate List will then be updated on ECHA’s website in due course.

The agreement of the MSC concerns the following eight substances: Trichloroethylene, Boric acid, Disodium tetraborate anhydrous, Tetraboron disodium heptaoxide hydrate, Sodium chromate, Potassium chromate, Ammonium dichromate, Potassium dichromate, which are either carcinogenic, mutagenic or reprotoxic (CMR) substances.

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