Authorisation & Restriction
One of the main challenges related to REACH is the identification of Substances of Very High Concern (SVHC), and the additional regulatory processes that may follow
Authorisation and restriction are the tools established in the REACH Regulation to ensure adequate protection to human health and the environment against the potential negative effects derived from the use of substances identified as being of very high concern (SVHC). Substances that are classified under the CLP Regulation as CMR (Carcinogenic, Mutagenic, Reprotoxic in categories 1A/1B), PBT/vPvB (Persistent, Bioaccumulative, Toxic / very Persistent, very Bioaccumulative), will be candidates for inclusion in the SVHC list.
Companies that handle substances with potential SVHC properties should be aware that stringent regulatory procedures may be initiated on those chemicals. The development of proposals for harmonised classification (CLH) for those substances by regulators under CLP will typically be the first step for subsequent inclusion in the SVHC list.
Under REACH, the SVHC list is also called the Candidate List for Authorisation. In principle, all SVHCs would be expected to be included at some point in the Authorisation List of REACH (Annex XIV). However, as the implementation of REACH has progressed with time, it has become evident that in certain cases there may be more adequate regulatory options for a substance of concern. This is usually evaluated via a Regulatory Management Option Analysis (RMOA).
If a substance is placed on the Authorisation List, it may no longer be used in the EU, unless an authorisation has been granted by the European Commission for a specific use. The ultimate goal of authorisation is the replacement of an SVHC by alternatives of lower concern.
Authorisation is a complex and demanding process that requires the development of different reports in an Application for Authorisation (AfA):
- A Chemical Safety Report (CSR), demonstrating that exposure to the SVHC is adequately controlled
- Socio-Economic Analysis (SEA), in which the applicant should provide evidence that societal benefits derived from the continued use of the substance outweigh the remaining risk, which still needs to be minimised
- Analysis of Alternatives (AoA), aimed at proving that there are no viable alternatives for the substance; if there are alternatives, authorisation would in principle not be granted, or a substitution plan needs to be included
Even if granted, an authorisation is not forever, and re-submission is required after a given review period; when re-submitting AfAs, companies are expected to describe in detail all R&D initiatives that have been taken to find alternatives to the use of the SVHC during the review period.
The aim of the restriction process in REACH is to limit (or ban) the manufacture, placing on the market or use of certain substances that pose an unacceptable risk to human health and/or the environment, which requires action at a community-wide level. An EU Member State (or ECHA at request from the Commission) will develop a restriction proposal, for final approval by the Commission, in a comitology procedure that involves Member States and the European Parliament.
The final restriction dossier will describe the ban of the manufacture and use of a substance, or it will describe the conditions under which they can be continued. Timelines and derogations to the implementation of the restriction conditions will also be specified. Different consultation processes will be available for stakeholders to provide comments and information to the relevant Competent Authority in charge of the restriction.
If a substance is selected for restriction under REACH, companies need to ensure that they will be able to bring their processes within the boundaries defined in the restriction proposal.
We are ready to support you to grant compliance in the complex regulatory procedures established in REACH and offer the following services:
- We review whether your substance fulfils the SVHC criteria and develop regulatory strategies to guide you through the different procedures
- We develop RMOAs to identify the most efficient and proportionate regulatory option for your substance, which may include non-REACH procedures (e.g. workplace legislation)
- We ensure an adequate elaboration of all the components of AfAs – CSR, SEA, AoA
- We support you in evaluating restriction proposals and provide recommendations on how to adapt your process to a restriction