First MSC agreements on substance evaluation
The Member State Committee (MSC) agreed that ECHA should request further information on six substances. This is the first batch of substance evaluations agreed by the MSC.
Helsinki, 14 November 2013 – In their meeting last week, the MSC agreed that ECHA should request more information on six substances because the currently available information is insufficient to enable an assessment on the risks that they pose to human health and/or the environment. These particular six substances listed in the Community Rolling Action Plan (CoRAP) were evaluated by Germany, France, Denmark, the United Kingdom, Belgium and Spain.
Further information on Bisphenol-A (BPA) will be requested to clarify a number of concerns. Firstly, the MSC agreed to request a new in vitro skin absorption study to assess the risk to consumers from, for example, toys and PVC articles. Secondly, information on the emissions and environmental exposure of BPA will be requested in order to assess the impact on the environment. The information will help to finalise the risk assessment and to decide whether further risk management measures are needed. There are on-going studies on BPA in the USA which the German authority will also take into account in the next step of the assessment on endocrine disrupting properties for humans.
The MSC also agreed to request further information on the reproductive toxicity of carbon tetrachloride in an extended one generation reproductive toxicity study (EOGRTS, OECD 443). More information on the exposure of workers to carbon tetrachloride will also be requested.
The MSC agreed to request further information on oligomerisation and alkylation reaction products of 2-phenylpropane and phenol (previously registered as Phenol, methylstyrenated). The information requested is a bioaccumulation study in fish to clarify the concern for potential persistent, bioaccumulative and toxic properties. A combined repeated dose toxicity (90 day) and reproductive toxicity study is also requested (EOGRTS, OECD 443) to investigate endocrine disrupting effects.
The MSC agreed to ask for further information on workers' exposure to imidazole and on its reproductive toxicity effects. Information will also be requested on short-term toxicity in the environment and on mutagenicity through an in vitro study.
The MSC agreed to request further information on N,N'-bis(1,4-dimethylpentyl)-p-phenylenediamine to clarify the concerns relating to persistent, bioaccumulative and toxic properties of the substance. A soil simulation test will be requested to look at aerobic and anaerobic transformation in soil.
Finally, information will be requested on a mixture of cis- and trans- tetrahydro-2-isobutyl-4-methylpyran-4-ol to clarify concerns relating to the environment. The requested study will be a short-term growth inhibition study, followed if necessary, by a long-term toxicity study in the aquatic environment.
Under the REACH Regulation, the substances subject to evaluation are listed in the Community rolling action plan (CoRAP) indicating the initial grounds for concern and the Member State responsible for the substance evaluation. If the Member State believes that there is insufficient information on the substance, it produces a draft decision recommending requests for further information. All other Member States are able to propose amendments to the draft decision. When amendments are proposed, the Member State Committee (MSC) has the task of seeking unanimous agreement. The draft decisions are discussed and agreed upon by the MSC in its meetings, or alternatively, agreement may be sought through written procedure. Once agreed by the Member State Committee, ECHA finalises the decision and provides it to the registrants concerned. If unanimous agreement cannot be reached, the matter is referred to the European Commission for decision. ECHA will publish all the decisions taken under substance evaluation on ECHA's website after removing any confidential business information.