First substance evaluation results - further information needed on 32 substances
The Member States have evaluated 36 substances listed in the community rolling action plan (CoRAP) for 2012. Four out of those 36 substances evaluated have been concluded without a need for additional information. For the rest of the substances the evaluating Member State has proposed to ask the registrants to provide further information. Next the registrants have the possibility to comment on the requests.
Helsinki, 06 March 2013 – The CoRAP lists substances subject to substance evaluation under REACH. In the first year, 2012, the Member States agreed to evaluate 36 substances. The deadline for submitting the results to ECHA was 28 February 2013. In 32 cases the evaluating Member State concluded to request further information from the registrants. These requests are presented in the form of a draft decision and they may concern any hazard and/or exposure information that is necessary for clarifying any identified concern during the evaluation.
As a coordinating body, ECHA will forward the draft decisions to the concerned registrants for comments in two batches. The target date for sending the draft decisions via REACH-IT is either 20 March 2013 or 4 April 2013. On 20 March, ECHA will send the draft decisions where there is only one registrant as a recipient and on 4 April the remaining decisions with multiple registrants as recipients will be sent. The registrants have 30 days to comment on the proposed requests included in the draft decisions. If there are multiple registrants per substance, the registrants should coordinate their views and submit the consolidated comments to ECHA within the 30 days.
Registrants can see the 32 substances subject to further decision making in the CoRAP list (year 2012) on the ECHA website. The evaluating Member States will examine any comments made by the registrants.
In four cases, the result was that the evaluating Member State concluded that there is no need to ask for further information as the suspected concern could already be clarified with the available information. These substances are:
- Ethylene oxide, EC 200-849-9, CAS 75-21-8 (MS Austria)
- Tributyl phosphate, EC 204-800-2, CAS 126-73-8 (MS Hungary)
- M-Tolylidene diisocyanate, EC 247-722-4, CAS 26471-62-5 (MS Poland)
- Toluene, EC 203-625-9, CAS 108-88-3 (MS Finland)
For these four substances, the Member States' conclusion documents will be published later on ECHA's website.
From the publication of the CoRAP, the 17 designated Member States had 12 months to evaluate substances listed for 2012 and, where justified, to prepare a draft decision requesting the registrant(s) to submit further information to clarify any possible risk. The final decision will be taken by ECHA after consultation of the Member State competent authorities and potentially of the Member State Committee (MSC). The decision will be taken by the European Commission if there is no unanimity at the MSC. As for other evaluation decisions, registrants of the substances listed on the CoRAP will have an opportunity to comment before any final decision is taken. Concerned registrants are defined as those entities that have a valid registration on the day that the draft decision is sent for the first time for comments (excluding registrants of onsite isolated intermediates).
Later in March, ECHA will publish the updated CoRAP list for 2013-2015. From that publication date, another round of evaluation starts for substances listed for 2013.