A REACH milestone: First authorisation application passes the European Chemicals Agency

Alissa Sasso is a Chemicals Policy Fellow.

It’s been a while since we’ve posted an update on ongoing activities under the European Union’s Regulation on the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH).  The European Chemicals Agency (ECHA) has been quite busy in recent months.

The first application for authorisation (we’ll be using the English spelling of this term, as it is spelled in REACH) to use a Substance of Very High Concern (SVHC) cleared ECHA’s Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) on January 3rd. This is a significant step in the implementation of REACH in the EU. The authorisation process is intended both to manage the risks posed by SVHCs and to drive the replacement of these hazardous substances with safer alternatives.  And, as the final step in the process laid out under REACH for managing chemical substances, its execution is central to the success of REACH as a whole. This first application for authorisation was therefore a kind of test-run for ECHA, as well as the chemical industry, and sets the stage for the submission and review of future authorisation applications.

As we run through the details of this particular authorisation application, keep in mind that ECHA received seven other applications for authorisation last year, and will see even more activity in the coming year. 

A reminder on what is involved in applying for an authorisation

We’ve laid out the process of authorisation on this blog before (see here and here), but here’s a quick refresher course. The process begins when a chemical is added to the Candidate List of Substances of Very High Concern for Authorisation, which means that the chemical meets certain high levels of concern for potential risks to human health or the environment. Once a chemical is on the SVHC list, ECHA then prioritizes which SVHCs should actually be subject to authorisation, with greater consideration given for PBTs, vPvBs or chemicals with the potential for high exposure due to their use or volume.

The European Commission ultimately decides which chemicals are added to the authorisation list, and the published list provides two dates:  the date by which applications for authorisations must be filed, and the date by which any unauthorised or non-exempted use is to be phased out (the sunset date). (Currently, the only exempted uses for any substances on the authorisation list include their use in immediate packaging of medical devices.) You can view the Authorisation List here.  

Authorisations are use-specific and apply to the entire supply chain of a chemical; therefore, both manufacturers/importers and downstream users of a chemical must decide whether to apply for an authorisation. The Commission may grant an authorisation by either of two routes, which determines what kind of application needs to be prepared:

  • The risks associated with the specific use are shown by the applicant to be adequately controlled (the “adequately controlled route”) or
  • For certain chemicals that are deemed too risky to be adequately controlled, the applicant must show that the social and economic benefits of the continued use outweigh the risks involved (the so-called “socioeconomic route”)

The application must include a report on chemical safety, an analysis of alternatives, and a plan for substitution if alternatives are available.  In the case of the socioeconomic route to authorisation, a socioeconomic analysis must also be provided.

The current status of authorisation applications is available here. Within 10 months of receiving the application, the RAC and SEAC hold a public consultation on alternatives, and then draft opinions on the application that are presented to the European Commission. The European Commission then prepares a draft decision within three months and subsequently adopts a final decision granting or refusing the authorisation. A summary of the final decision is then made publicly available through ECHA and the Official Journal of the European Union. For more information, see this useful factsheet prepared by ECHA.

What was the chemical? And for what use was an authorisation applied for?

The chemical for which REACH’s first authorisation has been recommended by ECHA is Bis(2-ethylhexyl)phthalate or DEHP (CAS # 117-81-7). Applications for authorisations for this chemical were due by August, 2013, and only a single application was received:  It was prepared for Rolls-Royce, a UK company which uses DEHP to manufacture fan blades for plane engines. The sunset date for the unauthorised uses of DEHP is February 21, 2015.

The RAC and SEAC issued a positive opinion of the application, deciding that the risks associated with DEHP for this specific use were demonstrated to be “adequately controlled.”  The RAC opinion stated that the application demonstrated the safety of this use of DEHP because the use is limited, DEHP is used in very small quantities, consumer and indirect environmental exposure are negligible, and the health risk to workers is “adequately controlled.”

Interestingly, four possible alternatives to DEHP for this use were identified, and two of these suggestions were made during the public comment period (Chemical Watch, subscription required). While Rolls-Royce tested two of the alternatives (which were suggested by a research institute) and determined them to be ineffective, the other two alternatives still could be found to be feasible. Due to the time it will take to assess them and implement a substitution plan, the committees proposed that the application be reviewed again in seven years.

The opinions adopted by the RAC and SEAC will now be passed onto the European Commission to draft a decision on whether or not to grant the authorisation.  The final decision is expected to take about six months from the time the Commission received the Committee opinions (Chemical Watch, subscription required).

That seems simple… is there a catch?

It is unlikely that future authorisation applications will be this simple.  This use identified for an SVHC is a very specific one, only one company was involved, and at the time that the committees began assessing the application, they had yet to receive any other authorisation applications. In the future, applications will likely involve more complex supply chains and potentially broader uses, and the committees may well be looking at multiple applications for a variety of chemicals simultaneously.  So while the process ran relatively smoothly this time, ECHA is definitely still in the learning phase of dealing with authorisation.

The NGO community is not pleased about this one proceeding to completion.  In December, 2013, a group of European environmental NGOs sent a letter to Geert Dancet, the Executive Director of ECHA, accusing ECHA of making decisions that “are not in line with the aims of REACH” because the process does not sufficiently promote substitution with safer alternatives, one of the main goals of authorisation. The NGO community is also concerned with the degree of confidential information masked in the public application, which they argue compromises the utility of the public consultation period.

The upcoming year will likely be a busy time for REACH authorisation, and it will be important to see how ECHA addresses the current concerns with the process, particularly as the applications get more complicated.  

Stay tuned for an upcoming blog post looking at other authorisation applications that have been submitted, as well as chemicals for which application deadlines fall during this year.  It’s worth noting that some of these chemicals are among the U.S. EPA’s TSCA Work Plan Chemicals, which should be of interest to those of us here in the U.S.

 

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