First Authorisation Application gets an “A”
The first Authorisation Application submitted under the REACH program for the use of a substance of very high concern (SVHC), took a big step forward when ECHA‘s scientific committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) adopted acceptable opinions on this application. Rolls-Royce is the first company to go through the review process by both ECHA’s committees, after submitting an authorisation for the continued use of the plasticizer DEHP (Bis(2-ethylhexyl)phthalate) within the manufacture of aero engines.
Background: Authorisation will be granted if the applicant can demonstrate that the risk from the use of the substance on REACH’s Annex XIV (Authorisation list) is adequately controlled. If not, then an authorisation can still be granted when the socio-economic benefit of using the substance outweighs the risks and there are no suitable alternative substances or technologies. Key parts of the application include a chemical safety report, an analysis of the possible alternatives, a substitution plan (if suitable alternatives are available) and as needed a socio-economic analysis. The Risk Assessment committee (RAC) is tasked with evaluating the risks to human health and the environment of the substance use plus the adequacy of the risk management measures and any possible alternatives. The Socio-economic Analysis committee is tasked with assessing the socio-economic factors and the feasibility of the alternatives to the use of the substance.
So why is the RAC and SEAC opinion a noteworthy event? With the Rolls-Royce’s application for authorisation being the first submission to ECHA, it became the unofficial authorisation beacon in yet unchartered territory; REACH authorisation approval. This authorisation application has been and will continue to be closely monitored by all interested parties and if successful, it may be heralded as the unofficial “model” for subsequent applications.
Jukka Malm, ECHA’s director of regulatory affairs, stated that this application was able to processed efficiently and quickly based on the quality of the submission and its specialized use. In addition, the two committees took just four of the allocated ten months to issue their opinions.
So what are the milestones for an authorisation application? To better understand what the SEAC and RAC opinion means, one should have an overview of the application procedure and where the RAC and SEAC opinions rest within the overall process. ECHA defines the following as the procedural steps for an application for authorisation:
· Notification of intention to submit an application for authorisation by the applicant
· Submission of the application and fee payment
- Checking of application’s conformity by ECHA
- Public consultation on the uses applied for
- Draft opinions by RAC and SEAC
- Comments on the draft opinions
- Adoption of final opinions by RAC and SEAC
- EU Decision
- Downstream users notifications
The draft RAC and SEAC opinion for the DEHP authorisation application was issued in early December 2013, which Rolls-Royce quickly accepted, confirming a favorable outcome for their application.
So what was the final opinion of RAC and SEAC?
Both committees indicated that the application included the required information, that it is possible to determine a DNEL for the reprotoxic properties of the substance, and that adequate control of risks from the use can be achieved using the risk management measures and operational conditions as described in the application. Additionally SEAC concluded that based on the technical and economic feasibility there appears to be no suitable alternatives at this time. However, suitable alternatives appear to exist and were included in the application. It is possible that an alternative could be available in the near future but further technical validation and qualification is needed and not likely before mid-2016. Therefore the standard authorisation review period of seven years was granted for this application.
So what is next?
The European Commission will review the two opinions and has six months make a decision to grant the authorisation and under what conditions. Once that happens the applicant can continue to use the substance as authorized in adherence with the risk management and operation conditions listed in the application.
It is important to consider that this application was for a specialized downstream use with relatively low volumes; in a manufacturing setting under controlled conditions, and that consumer exposure and indirect exposure via the environment were considered to be negligible. Additionally it appears that alternatives exist but not at this time. Therefore, the first authorisation application represents an important milestone in the REACH authorisation process but what happens with the next eight applications for authorisation with 17 different specific uses will also be significant. Future cases will be more complicated, but “if there is a straightforward case and the application is of good quality, the committees have shown they can work quickly,” says Mr Malm.
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