Candidate List

The five new SVHCs identified by the MSC are:

Diborontrioxide 1303-86-2

C.I. Basic Violet 3 548-62-9

C.I. Basic Blue 26 2580-56-5

C.I. Solvent Blue 4 6786-83-0

4,4’-bis(dimethylamino)-4’’-(methylamino)trityl alcohol 561-41-1

As a result of the MSC discussion, the adopted four dyes shall be identified as SVHCs only if the concentration of the impurities Michler’s ketone or Michler’s base is equal to or higher than 0.1%.

These five SVHCs will be included in the Candidate List in its next update together with eight further substances that did not require the MSC’s involvement. The updated Candidate List will be published in due course on ECHA’s website.

Dossier Evaluation

The MSC also unanimously agreed on 9 draft dossier evaluation decisions (8 testing proposal draft decisions and 1 compliance check draft decision).

Yet no unanimous agreement was reached on whether one testing proposal is competent to meet the information requirements for a two-generation reproductive toxicity. Though the majority of MSC members supported a draft decision giving the registrant the choice between a two-generation study² and an extended one generation reproductive toxicity study³ (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.

In addition to the above 10 evaluation decisions, the committee agreed in written procedure on 23 draft dossier evaluation decisions. Also, another 8 testing proposals hang in the balance, which all address issues of two-generation reproductive toxicity where the EOGRTS was involved. The disagreement is mainly due to legal uncertainty regarding the status of the EOGRTS under REACH.

The cases where no unanimous agreement of the MSC was reached willl be referred by ECHA to the Commission for decision making.

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1, The Member State Committee (MSC) participates in several REACH processes such as evaluation and authorisation. The MSC is responsible for resolving divergences of opinions among Member States and on proposals for the identification of SVHC. The Committee provides opinions on ECHA’s draft recommendation for the authorisation list (Annex XIV) and draft Community Rolling Action Plan (CoRAP) for the substance evaluation process. If an agreement is not reached within the MSC, the matter is referred to the European Commission for decision-making.

2, EU B.35 – OECD Test Guideline 416: Reproduction/Developmental Toxicity Screening Study

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

This news was sourced from ECHA’s Press Release.