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Article related to: News from ECHA
Applications for authorisation on the increase
ECHA has now made a positive recommendation to the European Commission on the first authorisation application from Rolls-Royce plc. on the use of the phthalate DEHP to manufacture aircraft engine fan blades. The Agency has already started work on the next seven applications for 16 uses of the phthalates DEHP and DBP. The public consultation for alternatives to those uses ended on 8 January 2014 with more than 120 comments from third parties.
"The first application by Rolls-Royce was quite straight-forward. The company demonstrated that adequate control has been achieved for the specific use, had analysed alternatives and described how they are planning to substitute the substance," says Thierry Nicot from ECHA's Risk Management Implementation Unit, and continues, "the Committees for Risk Assessment and Socio-economic Analysis therefore adopted positive opinions on the application."
As for the next seven applications in the pipeline, the opinion making may be more complex. "Some of the uses applied for are less specific, which has resulted in a larger number and variety of comments received from the public consultation. We got comments not only from NGOs, but also from Member State competent authorities and industry. The applications also raised interest worldwide, for example, in the United States and Japan," Mr Nicot mentions.
The comments concerned mainly the use of DEHP as a plasticiser in soft PVC. This is a large-volume use resulting in a broad range of consumer plastic articles. "The amount of information coming in from third parties puts pressure on the applicants to thoroughly assess the potential alternatives. This will help to meet one of the aims of authorisation: hazardous substances being progressively substituted with safer ones."
Trialogue discusses the information submitted
To start the committees' opinion forming on the applications, trialogue meetings may be held between the RAC and SEAC rapporteurs and the applicants. The trialogues for the seven DBP and DEHP applicants will be held in mid-February. "In these meetings, the outcome of the public consultation is discussed and rapporteurs can ask questions from the applicants. In some cases, the third party submitting the information on potential alternatives may be invited to the meeting," says Denis Mottet of ECHA.
These trialogue discussions can help rapporteurs to better understand the applicability of the suggested alternatives, and support RAC and SEAC in swiftly adopting their opinions.
Keeping it transparent
The Agency has put a lot of effort into keeping the application process open and transparent. The public version of the application as well as the comments made during the public consultation and the applicants' responses are all published on ECHA's website. "We encourage applicants to include as much information as possible in the public version of the application. This follows the general transparency principle and enables others to openly see the arguments and reasoning behind the application," Mr Mottet says.
ECHA has so far received one access to document request for information that was not included in the public version of four authorisation applications. Dealing with the request is a heavy process for applicants, and another reminder of why it pays to make the maximum of their information public.
Applications for chromate uses expected
In 2014, ECHA expects to receive the first applications for different uses of chromium-containing substances. It is working closely with industry to make sure that the chromate applications that involve different kinds of large-volume uses are submitted early to enable downstream users to see which applications are coming. "The latest application date for these chromates is 21 March 2016 but we hope to get many of them in well before that," says ECHA's Markus Berges.
The European Chemical Industry Council (Cefic) and the European Association of Metals (Eurometaux) will organise a workshop with ECHA in March to support potential chromate applicants in submitting their applications. More about the workshop on ECHA's website.
ECHA will organise a seminar/workshop for future applicants from 28 to 30 April. More information is available on ECHA's website.
- Authorisation to use a substance of very high concern - first opinions adopted, Press release: 3 January 2014
- Authorisation process
- Public consultations on alternatives
Did you know?
Companies wishing to continue to use substances of very high concern which are subject to authorisation after the sunset date have to apply for authorisation and assess potential alternatives. To make sure that applicants have done this properly, third parties are encouraged to submit additional information on alternatives during an eight-week public consultation period.
All the information submitted will then be considered by the ECHA Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC). The final opinions of the two committees will be sent to the European Commission, who will decide whether to grant the applicant an authorisation for the use.
The first REACH authorisation application passed from ECHA to the European Commission with the adoption of positive opinions by RAC and SEAC in December 2013. The committees have proposed to review the authorisation in seven years' time.
This application, from Rolls-Royce plc., covers the use of bis(2-ethylhexyl)phthalate) (DEHP) to manufacture aircraft engine fan blades.
The next opinions of the committees on seven applications for 16 uses of the phthalates DEHP and DBP are expected to be adopted by September 2014. The public consultation for alternatives ended on 8 January 2014.
In 2014, ECHA expects to receive approximately 20 authorisation applications, in particular for chromium substances and trichloroethylene.
Text by Hanna-Kaisa Torkkeli
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Committee for Socio-Economic
1-4 and 8-11 June (tentative);
7-11 and 14-18 September (tentative)
Committee for Risk Assessment:
1-5 and 8-12 June;
7-11 and 14-18 September (tentative)
Member State Committee:
Biocidal Products Committee:
Management Board meeting: