The purpose of assessing regulatory needs for a group of substances is to assist authorities in determining the best course of action for addressing identified concerns. This includes deciding on regulatory risk management instruments and any intermediate steps required for implementation.
An assessment of regulatory needs may determine that EU-level regulatory risk management is necessary for certain substances. This could involve various measures such as harmonized classification and labeling or inclusion in the Candidate List. Conversely, it may be concluded that no additional regulatory action is currently needed at the EU level..
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).
Assessment of regulatory needs – an interative process
The assessment of regulatory needs is applicable to any group of substances or individual substance, regardless of prior regulatory history. It encompasses all types of hazards or uses. 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 includes information on hazards and uses from REACH registrations, as well as other REACH and CLP data. 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, clarifying the hazard, or when new insights on uses and risks emerge. It can be revisited by the same or another authority.
Before initiating a formal regulatory risk management process under REACH/CLP. Аuthorities 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.