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MSC supports by majority inclusion of HDDA to the Candidate List

ECHA/NA/15/41

The majority of the Member State Committee's (MSC) members supported Sweden's proposal to identify the skin sensitiser HDDA as a substance of very high concern (SVHC) and include it in the Candidate List. The MSC opinion  and the minority position of those not agreeing on the identification will be sent to the European Commission for its final decision.

Helsinki, 14 December 2015 – Sweden proposed hexamethylene diacrylate (HDDA) to be identified as a substance of very high concern due to its skin sensitising properties. The substance has a harmonised classification and labelling as a Skin Sensitiser Category 1 under the CLP Regulation. This was the first time a substance was proposed to be included in the Candidate List due to skin sensitising properties.

At the committee's meeting last week, the MSC unanimously acknowledged that there is scientific evidence suggesting that HDDA is a strong skin sensitiser, that the induction phase of skin sensitisation is irreversible, and that cross-reactivity between HDDA and other acrylates could not be excluded.

The majority of members supported the conclusion that the information provided in Sweden's proposal is sufficient to constitute an equivalent level of concern to carcinogenic, mutagenic and toxic to reproduction substances (CMRs category 1A or 1B), based on the overall assessment of all the factors, including the severity and irreversibility of the skin sensitisation caused by HDDA.

However, a minority of members were of the view that, although a skin sensitiser might be identified as substances of very high concern, the case for HDDA did not qualify as being of equivalent level of concern since the symptoms following the skin sensitisation seem to be reversible in nature (at the elicitation stage) and not as severe as the CMR effects.

An MSC opinion with the majority's view was adopted during the meeting, and the minority position was also presented. In line with Article 59(9) of REACH, the ECHA Secretariat will submit the opinion and the minority position on Sweden's proposal to the European Commission without undue delay. Subsequently, the Commission has three months to prepare a draft proposal on the identification of this substance as an SVHC. The Commission will take the final decision in the committee procedure.