The European Chemicals Agency (ECHA) has been keeping busy since the second REACH registration deadline passed on 31 May 2013, with 3,000 substances registered to date. As reported by ECHA, there are nearly 7,500 registered substances in total under REACH, reflecting around 38,000 registration dossiers submitted since the Regulations took effect.
Aside from registrations, there have been a number of other REACH developments in the closing months of 2013 that will be relevant throughout the supply chain. For instance, revised guidance has now been published for downstream users, which takes into account best practices developed by industry. The document also addresses the need to provide up-to-date guidance on two aspects of REACH compliance: i) the application of scaling when checking whether a downstream user’s use of substance is covered by the supplier’s exposure scenario and ii) the communication of information on the safe use of mixtures.
Wider scope of coverage
Overall, the scope of the REACH regime is extending. Following a consultation in June, the European Commission has announced plans to extend technical Annexes to cover nanomaterials. During the Second Regulatory Review on Nanomaterials conducted in February, ECHA found that nanomaterials, such as carbon black and synthetic amorphous silica, are commonly used on the market. With rapid development in nanotechnology, concerns have been raised that existing requirements are not sufficient to ensure that industry provides enough details on nanomaterials in registration dossiers. According to ECHA reports, it is reviewing both the EU nanomaterial definition and the revision of REACH annexes for nanomaterials. The outcome of these reviews should be available in 2014.
Of particular importance is the extension of Candidate List of substances of very high concern (SVHCs), which currently consists of 144 chemicals. To recap, the inclusion of a substance on the Candidate List has immediate implications under REACH, such as the potential requirement to notify the substance to ECHA and, in the case of articles containing Candidate List substances, the requirement to provide safe use information to recipients. As such, now more than ever it is important that businesses take steps to identify or verify whether there are any SVHCs in the chemicals or articles they manufacture, import or supply.
Use of Candidate List substances may also require authorisation from ECHA if they are further assessed and included on the REACH Authorisation List. Once substances are included on the Authorisation List, businesses must be granted an authorisation to place chemicals on the market after a certain date. Applications for authorisation are particularly onerous as they must be supported with a chemical safety report and analysis of substitute substances or technology.
On the subject of authorisation, we reported in our October newsletter that the first request for REACH authorisation had been submitted by Rolls Royce for its continued use of bis(2-ethylhexyl) phthalate (DEHP). ECHA has now adopted its final opinions on that application following a public consultation late last year. ECHA’s opinion was that the application had shown adequate control of the risks from Rolls Royce’s use of DHEP and that there were no suitable alternatives. The European Commission will now prepare its draft decision on the application within the next few months.
Preparing for 2018
One of the main strategic aims will focus on improving the quality of registration dossier between now and the final 2018 registration deadline. By way of reminder, the next registration phase applies to substances manufactured or imported at volumes of 1 tonne or more per year. Greater emphasis will be placed on completing safety data sheets and substance evaluation in order to improve the quality of data available on the database. ECHA has already announced plans to conduct database screening on the registered dossiers in order to examine quality, including further targeted screenings on intermediate use and substance identity.
Evaluation is the next stage of concern for registrants as this process determines if restrictions should be imposed on specific chemicals. The evaluation process is achieved over a three year period through a Community Rolling Action Plan (CoRAP) normally released annually in March, which allocates substances for evaluation to individual Member States. Of the first batch of 36 substances marked for evaluation in 2012, four have been concluded and related documents were published in November 2013. These are: Ethylene oxide, Tributyl phosphate, m-Tolylidene diisocyanate (TDI) and Toluene.
A draft CoRAP for 2014-16 was published in November 2013 and introduced 125 substances for Member States to review under the substance evaluation process. This figure adds 56 newly allocated substances to the list released on 20 March 2013.
Member State Competent Authorities (the HSE in the UK) received the plan in October 2013, and may require registrants to submit further information to clarify any possible risks associated with substances in the plan. REACH registrants would benefit from early engagement with the HSE to find out whether additional information may be required for substances on the plan. We expect the ECHA Member State Committee to prepare an opinion on the update in February. Companies should watch for the final CoRAP which should be available to industry in March 2014.