Authored by Chris Robertson, ERA Technology, Data Partner to Compliance & Risks
The first request for authorization for continued use of a substance on REACH Annex XIV after the sunset date has received a favorable hearing from ECHA's scientific committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC)[1]. The application for the plasticiser Bis (2-ethylhexyl) phthalate (DEHP) by Rolls-Royce was for a very specialized, low volume use in the brazing of turbine blades. To the observer, the technical case submitted was well founded and took proper account of risks and how to mitigate these. Even so this first request for continued authorization to use an SVHC, through an as yet untried REACH mechanism, was a step into the unknown and has been unclear how submissions would be evaluated.
Rolls-Royce’s submission and payment of a fee on August 13, 2013 was followed by a public consultation which concluded in October. SEAC/RAC’s draft opinion was sent to Rolls-Royce on 13 December who indicated within a week that they had no comments to make which suggests that the opinion supported their submission in its essential aspects.
The proposed “review period” for this authorized use is 7 years- the so called “normal” review period. SEAC rejected setting a shorter period of 4 years as being unnecessary as risks were well controlled but also saw that setting a “long” review period of 12 years as inappropriate since alternatives showed good promise of success within a shorter time frame. It is unclear if this is 7 years from when the authorized use is finally approved or 7 years from the sunset date of Feb 21, 2015. Rolls-Royce’s submission states that 5-10 years beyond the sunset date will be required for technical validation and qualification of alternatives.
Eleven further requests for authorization to use DEHP and five uses for DBP are in the pipeline. Some of these applications are for quite specialized uses so if the case is well founded then their prospects for approval appear good. However the applications for use in PVC formulation could be more difficult as they may represent significant volume uses. How these cases fare will highlight what is the trade-off between socio-economic factors and hazards/risks.
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