Early Assessment of appropriate options for managing risks associated with potential Substances of Very High Concern (SVHC) is a prerequisite to effective & efficient REACH Decisions
The Member States and Commission are currently assessing the potential role timing of risk management option (RMO) analysis in preparation of a Road Map on restriction and authorisation announced by the Commission. Eurometaux asks them to undertake early RMO analysis for potential SVHCs as an effective and efficient basis for determining the most appropriate risk management tool for metal and chemical substances that may be of high concern.
“The metals sector is currently reviewing 5 years of experience with the authorisation and restriction system under REACH” states Hugo Waeterschoot (REACH Manager, Eurometaux). “The report and conclusions expected by the end of the year include an analysis of the effectiveness and relevance of the process leading to the restriction and authorisation of metal substances”. One of the preliminary conclusions arising from this review is “a clear deficit in respect of the efficiency and relevancy of the selection system to identify appropriate chemicals and the most relevant risk management options”.
Eurometaux believes that the way to address this deficiency is to conduct a full RMO analysis as early as possible in the process, and ideally before listing an SVHC on the Candidate List. While not explicitly foreseen in REACH, there is common understanding amongst the regulatory community that such an RMO assessment would indeed help in optimising the use of the authorisation process.
“Neither society nor the metals sector wants REACH to fail when it comes to the risk management of substances of very high concern” says Guy Thiran, Eurometaux’s Director-General. “There is a need now to ensure that the REACH Authorisation Process uses the registration information effectively to adequately manage the risks associated with using substances. We must ensure business confidence and certainty in value chains".
Confirming this concern, Eurometaux has detected clear signs from manufacturers and users that the lack of any authorisation applications so far is not driven by innovation towards non-SVHC substances, but rather from moving manufacturing, use and R&D outside the EU. Eurometaux's members also confirm that their users now regard the REACH authorisation process as a significant business threat.
Hugo Waeterschoot further explains that “an early RMO assessment, even before the substance is selected as a possible SVHC for the candidate list, clarifies the nature and scope of the potential risk and defines on that basis the best risk management option, whether this be Authorisation, Restriction or other options, such as already existing legislation or risk management measures already in place.”
In addition to increasing the efficiency of decision-making, major discussions could have been avoided if such RMO assessment had been made for substances on the first priority lists suggested by ECHA, the best example of this being the recent hesitation about Cobalt salts. After the Member States and ECHA had invested extensive resources, but in the absence of an early RMO, the Commission had to conclude that the suggested authorisation was not the most effective option, given the remaining challenge related to a very specific concern (workers' exposure in surface treatment shops), for which the authorisation tool is not sufficiently focused.
"The reason for REACH replacing the previous Existing Substances Regulation was to increase the effectiveness and efficiency of chemical management in Europe. We should carefully consider this when reviewing the 5-year experience with respect to REACH Authorisation" states Guy Thiran.
Eurometaux is the Brussels-based EU association of the non-ferrous metals industry, representing the main EU and international metals producers, EU and international metal commodity groups and national metal federations. The industry covers base metals (Al, Cu, Pb, Ni, Zn, Sn), precious metals (Au, Ag, PGM´s) and technical metals (e.g. Co, W, Cr, Mo, Mn), manufactured from both virgin and recycled raw materials.
For further information, please contact:
Director-General EUROMETAUX – European Association of Metals E-mail : firstname.lastname@example.org
REACH Manager EUROMETAUX – European Association of Metals E-mail : email@example.com