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.