Assessment of regulatory needs
Assessment of regulatory needs
The purpose of the assessment of regulatory needs of a group of substances is to help authorities conclude on the most appropriate way to address the identified concerns for a group of substances or a single substance, i.e. the combination of the regulatory risk management instruments to be used and any intermediate steps, such as data generation, needed to initiate and introduce these regulatory measures.
An assessment of regulatory needs can conclude that regulatory risk management at EU level is required for a (group of) substance(s) (e.g. harmonised classification and labelling, Candidate List inclusion, restriction, other EU legislation) or that currently no (further) regulatory action is required at EU level. While the assessment is done for a group of substances, the (no) need for regulatory action can be identified for the whole group, a subgroup or for single substance(s).
The assessment of regulatory needs is an important step under ECHA’s Integrated Regulatory Strategy. However, it is voluntary, i.e., it is not part of the processes defined in the legislation but aims to support them. Assessing regulatory needs is an iterative process that can start from a low level of information and certainty on the best way forward to proposing more definitive regulatory management options for the (groups of) substance(s).
The assessment of regulatory needs can be applied to any group of substances or single substance, and can cover any type of hazards or uses, regardless of the previous regulatory history or lack of such. It can be done based on any level of information. A Member State or ECHA can carry out this case-by-case analysis. The starting point is available information on hazards and information on uses in the REACH registrations and any other REACH and CLP information. However, a more extensive set of information can be available, e.g. quantitative exposure and risk information from registration, assessments done under REACH/CLP or other EU legislation. Where needed further information can also be generated to progress with the group (e.g. under dossier evaluation). Uncertainties associated to the level of information used should be reflected in the documentation.
The assessment will be revisited when necessary. For example, after further information is generated and the hazard has been clarified or when new insights on uses and risks are available. It can be revisited by the same or another authority.
Before initiating a formal regulatory risk management process under REACH/CLP, authorities can optionally make a further, in-depth analysis of the most appropriate regulatory risk management option (RMOA).
The responsibility for the content of this assessment rests with the authority that developed it. It is possible that other authorities do not have the same view and may develop a further assessment of regulatory needs for the same (group of) substances.
Even if an assessment of regulatory needs concludes that regulatory action should be initiated, such an outcome does not have any direct legal implications.
To gain legal and regulatory relevance, the substances assessed need to successfully pass one or more of the formal regulatory management and decision-making processes under REACH, CLP such as harmonised classification and labelling (CLH), SVHC identification or authorisation, or restriction or other legislations. The intentions of authorities to submit a dossier to REACH/CLP formal processes are notified through the Registry of Intentions.
The outcome of the assessment of regulatory needs is shared in order to increase transparency and predictability of authorities’ work.