Thursday, October 30, 2014
With the two first Registration deadlines behind us, it was true to think that the REACh workload would be less heavy. In fact, 2010 was dedicated to the registrations of the substances with tonnages greater than 1000 tpa (ton per year) , as well as to the registration of substances of Very High Concern. 2013 focused on substances with medium tonnages, that is to say 100-1000 tpa. Only the substances with lower tonnages, as well as new substances on the market, will need to be registered in the near future.
However REACh is not limited to the R – Registration of Chemicals.
Behind the R of REACh, there are E for Evaluation and A for Authorization.
WHAT IS EVALUATION UNDER REACh?
Title VI of the REACh Regulation describes 2 different types of Evaluation processes: Substance Evaluation and Dossier Evaluation.
The Substance Evaluation is to check if the substance poses a risk for human health or for the environment during either manufacture or uses cycles. Substance Evaluation is driven by EU Member States by which the substances to be evaluated are listed on the CoRAP list, which is a 3 year rolling list. The Substance Evaluation is expected to last one year, but experience shows that this is usually a 3-year project for all registrants.
The Dossier Evaluation process includes 2 sub-types: the examination of testing proposals and the compliance check of registrations. Dossier Evaluations are driven by The European Chemical Agency (ECHA). Whereas the examination of the testing proposals is a systematic process – all testing proposals are examined by ECHA. Any registration file can be selected for compliance check. The conclusion of ECHA examination is mainly to request further information because the registration file does not yet comply with REACh requirements.
WHAT IS AUTHORIZATION UNDER REACh?
Authorization is defined under Title VII of the REACh Regulation. If a substance is listed on the Annex XIV, a manufacturer, importer or downstream user shall not place a substance on the market for a use or use it himself anymore. This use should be ‘authorized’ by ECHA. Substances subject to Authorization are either:
* Substances classified as either Carcinogen, Mutagen or Reprotoxic categories 1A and 1B as per CLP:
* Persistent, Bioaccumulable and Toxic (PBT) or very Persistent and very Bioaccumulable (vPvB) substances; or
* Substances with equivalent level of concern.
Before being listed on the Annex XIV, eligible substances undergo the Substances of Very High Concern listing which is a pre-requisite. Public consultations enable all the players involved (manufacturers, importers, downstream users, non-governmental organizations) to provide comments on volumes, uses and information related to exposure and risk for human health and/or the environment.
Once a substance is listed on the Annex XIV, either the manufacturer/importer or the downstream user shall submit an Authorization file so that the substance can continue to be used for a specific use. Authorization file should include among others analyses of available alternatives and socio-economic impact.
Even if the Authorization is a long-term procedure – it can last many years between the inclusion in the SVHC list and the sunset date, there is a need of involvement both in time and money all along the process for the Industry in question to sustain the application sector.
With those 2 heavy processes - Evaluation and Authorization - it is now easier to understand why REACh world is still very active and concerned with the on-going activities and decisions at ECHA level.
If you have questions or need more information concerning REACh registration, please contact us at email@example.com