Authorisation
REACH aims to ensure that the risks resulting from the use of substances of very high concern (SVHCs) are properly controlled while ensuring a good functioning of the internal market and that these substances are progressively replaced when/where technically and economically feasible.
The authorization process consists of 3 distinctive phases:
- Step 1: selection of substances for the candidate list, i.e. Substances of Very High Concern
- Step 2: prioritisation of substances for the authorisation list (Annex XIV of REACH)
- Step 3: Authorisation applications
SVHC: Candidate substances for authorisation
SVHCs are substances that meet some of the criteria discussed below.
The ECHA Member States Committee (MSC) adopts the proposal for selecting an SVHC. A Member State or ECHA at the request of the European Commission may propose a substance to be identified as an SVHC.
With the Roadmap on Substances of Very High Concern (February 2013), the European Commission intends to define a process to identify and assess the following categories of potential SVHCs:
- CMRs (substances that are carcinogenic, mutagenic or toxic for reproduction category 1A or 1B in accordance with Commission Regulation (EC) N° 1272/2008 (CMR substances) (CLP regulation),
- PBTs (substances that are Persistent, Bioaccumulative or Toxic for the Environment), according to REACH (Annex XIII)
- vPvBs (substances that are very Persistent and very Bioaccumulative) according to REACH (Annex XIII),
- substances of equivalent concern (such as endocrine disruptors or sensitisers).
The ambition is to have all currently known SVHCs included in the candidate list by 2020.
The Roadmap can be found here: http://register.consilium.europa.eu/doc/srv?l=EN&f=ST%205867%202013%20INIT
The SVHC identification process includes a Public Consultation (45 days). Once a substance is identified as SVHC, it is included in the Candidate List.
The inclusion in the Candidate List requires suppliers of the substance to:
- supply a safety data sheet
- communicate on safe uses
- respond to consumers in 45 days
- notify ECHA if the article they produce contains a SVHC in quantities > 1 ton per producer / importer per year and if the substance is present in those articles at a concentration > 0.1% (w/w)
Prioritisation for inclusion in the authorisation list (Annex XIV)
After a two-step regulatory process, SVHCs may be included in the Authorisation List (Annex XIV of REACH) and become subject to authorisation. This means that these substances cannot be placed on the market or used after a given date, called the sunset date (SD), unless authorisation is granted for their specific use, or the use is exempted from authorisation.
For both industry and EU/ national authorities, authorisation has now become a ‘hot issue’, requiring capacity building and further information gathering.
Authorisation is of key relevance for some substances within the metals industry, not only as a manufacturing output but also as a use (e.g. As203 reagent or Refractory Ceramic Fibres…), and will be a determining factor in the future manufacturing, marketing and availability of these substances in the European Union.
More information can be found here: https://echa.europa.eu/regulations/reach/authorisation/recommendation-for-inclusion-in-the-authorisation-list
Authorisation applications
The manufacturers, importers or downstream users of a substance on the Authorisation List can apply for authorisation for given uses. Before the latest application date (LAD), they have to apply for an authorisation for each of their uses, provided none of them is exempted.
Authorisation will be granted only to applicants that are able to demonstrate that:
- in case of a threshold substance, the risks to human health and the environment for their uses are adequately controlled or
- in case of a non-threshold substance, the socio-economic benefits of continued use outweigh the risks and no suitable alternative substances or technologies are available.
Depending on the application route, the application for an authorisation requires a Socio-Economic Analysis or an extended proof of adequate control and in both cases an assessment of alternatives. A substitution plan is further required in some cases.
Further information on the authorisation process and application, and more specifically on metals in this context, can be found on the Members’ webpages.
Generic information on the authorisation process can be found on the ECHA webpages https://echa.europa.eu/regulations/reach/authorisation/applications-for-authorisation and https://echa.europa.eu/applying-for-authorisation
Last page update: 1 October 2018