"Substance evaluation aims to clarify whether the manufacture or uses of a chemical pose a risk to human health or the environment. At the start of the process, the expectation is that new information may be needed to be able to decide whether there is a risk or not.
However, in the selection of candidate substances for the Community rolling action plan (CoRAP), no detailed assessment is done. Therefore, it is possible that the evaluating Member State is able to conclude on the potential risks on the basis of information that is already available," explains Pia Korjus from ECHA's Evaluation Directorate.
The request for further information in the 32 cases will be in the form of a draft decision. The registrants may be asked for additional information for example on any eco-toxicological or toxicological hazard and/or exposure.
"As persistent, bioaccumulative and toxic (PBT) and endocrine disrupting properties are among the selection criteria, there will in some cases be specific requests for tests to explore these properties," Ms Korjus adds as an example.
ECHA as the coordinating body, forwards the draft decisions to registrants. The decisions that affect only one registrant were sent on 20 March and those affecting multiple registrants on 4 April. After receiving the draft decision, registrants have 30 days to comment on the proposed request for further information. Registrants are advised to coordinate their views and to provide one set of comments per substance.
The evaluating Member State will examine the comments made by the registrants and may modify the contents of the draft decision. The draft decision is then sent to the other Member States and ECHA for possible amendments. In cases where Member States and ECHA do not propose any amendments, ECHA takes the decision as notified.
"If there are proposals for amendment to the draft decision, ECHA forwards the case to the Member State Committee and sends the proposals made to the registrants for comments. "We expect that the Member States are interested in each others' work and there may likely be comments coming from them. But we need to wait and see," says Ms Korjus.
If the Committee reaches a unanimous agreement, ECHA takes the decision accordingly. If a unanimous agreement cannot be reached, the European Commission will take the decision.
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