REACH Authorisation
The REACH Regulation has introduced a new approach to chemicals management within the EU. An important novelty is the introduction of the Authorisation concept.
The aim of Authorisation is to ensure the good functioning of the internal market while ensuring that the risk from substances of very high concern are properly controlled and that these substances are eventually replaced by suitable alternative substances or technologies where these are economically and technically viable.
Substances of very high concern include substances which are:
-
Carcinogenic, Mutagenic or toxic to Reproduction (CMR) classified in category 1 or 2,
-
Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation, and/or
-
identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to humans or the environment of an equivalent level of concern as those above e.g. endocrine disrupter
Substances of very high concern will be gradually included in Annex XIV of the REACH Regulation. Once included in that Annex, they cannot be placed on the market or used after a date to be set (the so-called “sunset date”) unless the company is granted an Authorisation.
The Authorisation concerns the use(s) of a substance (on its own or in a preparation or the incorporation of the substance into an article) and not the substance itself.
Holders of authorisation shall include the authorisation number on the label before they place the substance or a preparation containing the substance on the market for an authorised use.
This shall be done without delay once the authorisation number has been made publicly available.
The Authorisation shall be subject to a time-limited review (whose duration shall be determined on a case-by-case basis) without prejudice to any decision on a future review period and shall normally be subject to conditions (such as monitoring).
DUs using an “authorised substance” shall notify the Agency within three months of the first supply of this substance. The Agency shall establish and keep up to date a register of DUs who have made a notification.
Given the high probability of key nickel compounds being listed on the “Candidate List”, the Nickel Institute has drawn up a response plan which is designed to ensure that there is an orderly and engaged response to any proposed listing of a nickel substance or group of nickel substances.
Several activities are also ongoing on Socio-Economic Analysis. A scoping study has been finalized end of 2010 and case studies on critical nickel compounds are currently underway.
The Nickel Institute via the Nickel REACH Consortia is working closely with key downstream user sectors since the REACH Authorisation process is a critical issue for the entire supply chain. Ongoing dialogue and activities are taking place in collaboration with important sectors such as surface treatment, aerospace and batteries sectors.
Click here to download the Communication on Authorisation with Downstream Users
