The purpose of regulatory management option analysis (RMOA) is to help authorities clarify whether regulatory action is necessary for a given substance and to identify the most appropriate measures to address a concern. This case-by-case analysis is carried out by Member States or by ECHA, if requested by the European Commission.
An RMOA can conclude that regulatory action – for example, harmonised classification and labelling, inclusion in the Candidate List, restriction, or another EU-wide measure – is required for a substance, or that no regulatory action is required.
Even if an RMOA concludes that regulatory action should be initiated, such an outcome does not have any direct legal implications. The outcomes presented in the RMOA are only the conclusions of the authority that developed it.
To gain legal and regulatory relevance, the substance assessed needs to successfully pass one or more of the formal regulatory management and decision-making processes under REACH or CLP, such as harmonised classification and labelling (CLH), SVHC identification or authorisation, or restriction. The intentions of authorities to submit a dossier to such a formal process are notified through the Registry of Intentions.
RMOA is an important step under ECHA’s Integrated Regulatory Strategy. However, it is important to note that an RMOA is voluntary, as it is not part of the processes defined in the EU chemicals legislation.
The RMOA process allows authorities to share information with other authorities and stakeholders, promotes early discussion, and helps create a common understanding of the appropriate action to be taken.
The responsibility for the content of an RMOA rests with the authority that developed it. It is possible that other authorities do not have the same view, and even develop a further RMOA. Any authority can consequently initiate a regulatory process but should indicate this by appropriate means, such as the Registry of Intentions.
RMOAs and their conclusions are compiled based on available information and may change in light of new information or further assessment.
NOTE: RMOA originally stood for risk management option analysis. The term now used is regulatory management option analysis, to better reflect the wide scope of the analysis undertaken. This change has been made following the European Commission’s general report on the operation of REACH and the review of certain elements, COM(2018) 116.