ECHA keeps the ball rolling on Authorisation under REACH

Alissa Sasso is a Chemicals Policy Fellow.

In our last update on the European Union’s Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), we noted a major milestone under the “A” of REACH, as the first application for an authorisation was passed to and is awaiting decision by the European Commission. The authorisation process is continuing to move along: as of May 19th, ECHA has received 13 applications for 35 uses of six different substances on the Authorisation list. Interest in ECHA’s authorisation work is also increasing, eliciting a greater variety of stakeholder input than in the first round. 

For a refresher on authorisation under REACH, click here.

Additional phthalate applications spark public interest

Our last blog post covered an application for authorisation of a very narrow use of Bis(2-ethylhexyl)phthalate (DEHP) by Rolls Royce: in the manufacture of fan blades for plane engines; a final decision from the European Commission on that application is pending.

ECHA received seven additional applications covering 16 uses for DEHP and another phthalate on the authorisation list: Dibutyl phthalate (DBP). You can see a summary of the uses applied for here.

The ECHA Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) have published a draft opinion on one use of DBP applied for by Sasol-Huntsman, determining the application “demonstrated adequate control of risks” (Chemical Watch, subscription required). In this application, DBP is used as an absorption solvent in the manufacture of another compound, maleic anhydride. The Committees have yet to publish opinions on the other applications for these phthalates; you can see the status of all applications here.

During the public consultation period for the seven additional phthalate applications, ECHA received 120 comments, way up from the five comments received on the first application by Rolls Royce. There are several reasons for the increase in stakeholder participation. First, the applications cover a greater variety of uses than that proposed by Rolls Royce. Applicants for these more recent authorizations, some of which are chemical manufacturers rather than downstream users, are only providing broad use descriptions and alternatives assessments. This has prompted many comments from both EU member state authorities and NGOs, calling on ECHA to reject these applications and require detailed descriptions and separate assessments for each specific use (Chemical Watch, subscription required).

Additionally, many NGO comments address the lack of detail and transparency in the broad information on these uses that is being shared with the public. This information is provided by the companies applying for authorisations, and NGOs have accused ECHA of broadly accepting all of their confidentiality claims. They argue that the lack of detail provided to the public makes it more difficult for third parties to assess or recommend alternatives. 

Finally, according to ECHA, many of the comments were prompted by the proposed large-volume use of DEHP as a plasticizer in a wide range of consumer plastic products; commenters noted that the potential for exposure to this chemical, should an authorisation be granted, is far greater than from the single narrow use proposed by Rolls Royce.

Interestingly, several NGOs and the Lowell Center for Sustainable Production at the University of Massachusetts submitted comments on alternatives to DEHP. Not only is there global interest in the EU’s authorisation process, but it is eliciting substantive comments aimed at promoting safer substitution even from groups outside the EU.

Other authorisation applications hit close to home

ECHA has also received four applications for uses of diarsenic trioxide and the lead chromate pigments, Yellow 34 and Red 104. You can view the status of the committee decisions as they are published and all public comments submitted for these substances here.

Applications for two uses of hexabromocyclododecane (HBCDD, abbreviated as HBCD in the U.S.), have also been received, both of them for use as a flame retardant in expanded polystyrene foam in building applications. HBCD is undergoing a risk assessment by the U.S. EPA as part of its 2013 TSCA Work Plan, and it was the subject of a U.S. EPA Action Plan issued in 2010. EPA’s Design for the Environment (DfE) program completed an alternatives assessment for certain uses of HBCD in 2013, including for the two uses for which authorisations are being sought under REACH.

Despite the flurry of activity on HBCD in both the EU and the U.S., this flame retardant is still in production and use here at home.  See EDF’s Toxics Across America map showing its sites of manufacture and import; two chemical names and CAS#s represent HBCD:

What’s coming next

ECHA has said that it expects to receive a total of 20 authorisation applications this year, for trichloroethylene (applications are due October 21st) and several chromium-containing substances (applications are not due until 2015).

We’ve previously blogged about the widespread exposure to TCE and evidence of its link to Parkinson’s Disease. TCE is also an EPA Work Plan chemical for which a draft risk assessment for particular uses was issued last year that indicated “a potential concern for human health under specific exposure scenarios…”. You can see sites of production and import of TCE (CAS # 79-01-6) in the U.S. on EDF’s Toxics Across America map.

ECHA’s balancing act

Though much of the EU’s progress on managing chemical risks under REACH is receiving little notice here in the U.S., many of these chemicals are in production and use here. The alternatives assessment process that is a key element of REACH authorisation will be particularly interesting to follow. For some of the uses alternatives may be difficult to find: Because the authorisation process is onerous and expensive, the sought-after uses are likely considered critical by the applicants, and they may already have looked into alternatives before pursuing authorisation. Where that turns out to be case, decisions on authorisation applications will highlight uses of hazardous chemicals for which no feasible alternative currently exists and could be a driver for research and development to identify alternatives.

On a broader level, states and organizations in the U.S. will be able to learn from ECHA’s progress on this front.  As discussed in a previous blog post, the California Department of Toxic Substances Control is beginning to implement its own alternatives analysis requirements for a few priority products; and various groups in the U.S. have also released their own principles and tools for alternatives assessment. As we’ve stressed before, transparency is key. A lack of transparency on the part of companies applying for authorisations is a frequent complaint voiced by observers of the REACH authorisation process. As ECHA currently relies on voluntary submissions during the public consultation to inform a robust alternatives assessment process, it will be interesting going forward to see how they balance the protection of business information with the need to gather useful and insightful public comments.

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