ECHA members conclude first stage of substance evaluation

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."

ECHA