12 new Annex XIV substances: how to succeed in your application for Authorisation under REACH
With a dozen dossiers submitted to ECHA, covering about 20 uses and 20 legal entities, EcoMundo is a key actor of REACH Authorisation applications in Europe. This expertise is recognized by the European Chemicals Agency (ECHA): all the dossiers submitted since 2015 have been granted the requested review periods, including those with 12-year durations.
We are pleased to announce a new webinar during which EcoMundo’s experts will share their experience of Authorisation, present the keys of a successful application and give an insight of the challenges associated with the new substances of Annex XIV.
Twelve new substances: specificities, challenges and impacts
The new substances of Annex XIV will impact several sectors in Europe, and notably pharmaceutical and aero/space industries since they are involved in many uses.
These substances have specific toxicological and ecotoxicological properties compared to the previous substances already in Annex XIV: carcinogenic, PBT and vPvB for anthracene oil and pitch, coal tar; endocrine disrupting properties for the environment for nonylphenol and 4-tert-OPnEO. Dedicated methodologies will have to be developed in order to support applications, notably regarding:
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Exposure assessment
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Risk characterisation
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Monetisation of impacts
In addition, choices will have to be made regarding route of Authorisation that will be followed: adequate control or socio-economic assessment.
EcoMundo’s experts will develop these issues, and highlight the implications for applications for Authorisation.
Application for Authorisation: keys of success
A significant refinement was observed over the last years in terms of level of requirements for applications for Authorisation, regarding all sections of the dossiers:
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Chemical Safety Report
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Analysis of Alternatives
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Socio-Economic Analysis
EcoMundo’s experts will identify the key challenges and the main elements of success, based on their direct experience of such dossiers for several high-level industrial sectors (aeronautics, aerospace, defence, …)
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