The first results of substance evaluation done by the Member States were concluded at the end of February. 17 Member States evaluated all together 36 substances in 2012 and in 32 cases they propose to ask the registrants to provide more information to clarify a potential concern. For four substances the evaluation was concluded without a need for additional information.
"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.
Evaluation finalised for four substances
For four substances, namely ethylene oxide, tributyl phosphate, M-tolylidene diisocyanate and toluene, the substance evaluation has been finalised. The four evaluating Member States - Austria, Hungary, Poland and Finland - concluded in their assessment that no further information is needed to clarify a potential concern.
The next step for the four countries concerned is to consider whether any further regulatory risk management is needed and to prepare a concluding document.
"There is a possibility that the Member States conclude that the concern on certain hazard properties is removed or that appropriate risk management measures are already in place, and therefore no further actions are needed.
On the other hand, they might also indicate a need for further risk management actions, e.g. inclusion in the Candidate List of substances of very high concern (SVHC) for authorisation. All this information will be available in the conclusion documents, which will be published on ECHA's website as soon as they have been processed," says Claudio Carlon, ECHA's Head of Unit for Evaluation.
Mr Carlon highlights that there is no automatic transfer of any substance to the Candidate List of SVHC. "Such inclusion requires the preparation of an Annex XV dossier and completion of all the usual steps of the specific decision making process."
In the case of substances, where no further information is requested, the other Member States have no specific role under substance evaluation.
"However, they will have a say, if the substance is taken forward by the evaluating Member State to one of the regulatory risk management processes: harmonised classification and labelling, authorisation or restriction," Ms Korjus explains.
Some Member States have proposed to have an unofficial peer review during the process to learn more about the findings and plans of the evaluating Member State. "Time available for the assessment is a limiting factor, but this issue will be discussed in workshops with the Member States," she says.
Community Rolling Action Plan updated
After publishing the results of the first round of substance evaluation, ECHA updated the draft Community rolling action plan (CoRAP) for years 2013, 2014 and 2015 with 62 new substances. It now contains 115 substances that the Member States will evaluate between 2013 and 2015.
"One substance, 1-ethylpyrrolidin-2-one, was taken out of the 2012-2014 CoRAP, because the evaluating Member State came to the conclusion that there is enough information already available on the substance," explains Ms Korjus.
In 2013, 21 countries will evaluate 46 substances. "To find candidate substances for CoRAP, we do IT screening of our databases and the Member States send in their notifications on substances they would like to evaluate. In doing the IT screening, we need to analyse whether the substances identified would be more suitable to be handled under substance evaluation or under other REACH processes," Ms Korjus explains.
Currently ECHA plans to include around 50 substances to be evaluated annually. "This seems realistic with a view of the capacity of the Member States for the evaluation work and responds to the current regulatory needs for triggering the substance evaluation process."
