- Getting ready for the Biocidal Products Regulation
- World of biocides brought up to date
- Steering the work to make the new biocides regulation a success
- From our stakeholders: "Support for small enterprises is crucial"
- Setting up national biocides helpdesks
- New online tools for biocides applications
- Raising awareness on the new Biocidal Products Regulation
- Working together for better communication on the safe use of chemicals
- What to do when receiving an extended safety data sheet?
- Working towards the REACH dossier evaluation goal
- Setting the scene for applications for authorisation
- Board of Appeal members' term in office prolonged
- Guest column: Reflections on the review of REACH
- Making use of derived no-effect levels generated under REACH
- Call for creative ideas to overcome REACH challenges
- Croatia joins the EU chemicals management framework
- Debating chemicals policy
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Article related to: news from echa
Setting the scene for applications for authorisation
ECHA received its first application to use a substance on the REACH Authorisation List in May. The application has been submitted for the use of DEHP in the manufacture of aircraft engines. The eightweek public consultation to find safer alternatives was launched on 14 August. This last process of REACH – application for authorisation – has now officially started.
ECHA is now inviting interested parties to provide information on safer alternative substances or technologies that could be used instead of DEHP for the use defined in the application. "In the application, the company applying for authorisation has to assess potential alternatives. The public consultation aims to ensure that the assessment has been done properly and that all relevant information on alternatives is gathered," says Richard Dubourg from ECHA's Risk Management Implementation Unit.
Getting the most from the consultation
When preparing their applications, applicants need to find the right balance between the information they claim confidential and the information they agree to be published.
The information which is made publicly available should be clear and detailed enough to allow a meaningful consultation. By doing so, applicants can avoid having to respond to comments which are not relevant to their application.
How does the consultation work?
During the consultation, anyone can provide information on alternative substances or technologies for the uses of the substance included in the application. "Those most interested will be other companies or organisations representing industry or civil society since they are most likely to have information relevant to an application," Mr Dubourg says, and adds, "But in principle anyone can contribute."
The information on alternatives should include the identity of the alternative substance and/or the description of the technology. For a substance, its properties and classification should be included. Information related to the technical and economic feasibility, availability and risks to human health and the environment is also very valuable. "Most important is that the information is relevant to the applicant's situation. It should relate to an alternative, which the applicant could actually use instead of the Annex XIV substance for which they are applying for authorisation."
All non-confidential information provided by interested third parties will be published on ECHA's website on a regular basis. If the applicant wishes to provide responses, they will also be published on ECHA's website.
All the information submitted will then be considered by the ECHA Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC). "The Committees will evaluate the information submitted in terms of its relevance, quality, clarity and completeness. It is really important that the information is detailed and complete enough to allow proper evaluation by the Committees," says Richard Dubourg.
The final opinions of the two committees will be sent to the European Commission. Based on these opinions, the European Commission will decide whether to grant the applicant an authorisation for the use requested or not.
Authorisation for a limited time
The decision to authorise the use of a substance of very high concern (SVHC) will be based on solid risk assessment and socio-economic analysis. If a company using a substance listed on the Authorisation List has a good case for continuing to use it after the sunset date and the circumstances of its use meet the requirements laid down in REACH, there is in principle, no reason why an application should not be granted. "Companies should not be afraid of applying for an authorisation if they believe they have a case. However, they have to take the process seriously. The decision to apply for authorisation rather than to replace the Annex XIV substances should be a core business decision," says Mr Dubourg.
The large investment that companies have to make in preparing an application; the involvement of third parties; the scrutiny provided by ECHA's Committees; and the time-limited nature of the granted authorisations, all make it more likely that the use of Annex XIV substances occurs only where risks are properly controlled.
- Authorisation process
- Public consultations on alternatives
- Public consultation on the first Application for Authorisation for Bis(2-ethylhexyl) phthalate (DEHP), News alert 14 August 2013
Did you know?
The aim of authorisation is to ensure that risks arising from the use of substances of very high concern are properly controlled and that such substances are progressively substituted, while ensuring the functioning of the EU internal market.
Companies wishing to continue to use substances subject to authorisation after the sunset date have to apply for an authorisation and assess potential alternatives. To ensure that applicants have done this properly, third parties are encouraged to scrutinise it and to submit additional information on alternatives during an eight week public consultation.
Text by Hanna-Kaisa Torkkeli
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Biocidal Products Committee:
26 February-1 March
Committee for Risk Assessment:
6-8 March and
Committee for Socio-Economic
Management Board meeting:
23-27 March (tentative)
Member State Committee:
20-24 April (tentative)