The purpose of the risk management option analysis (RMOA) is to help decide whether further regulatory risk management activities are required for a substance and to identify the most appropriate instrument to address a concern. A Member State or ECHA (at the request of the Commission) can carry out this case-by-case analysis.
RMOA is an important step, agreed in the SVHC Roadmap, but it is voluntary (i.e. not part of the processes as defined in the legislation). For authorities, documenting the RMOA allows information to be shared. This promotes early discussion, which helps create a common understanding on the appropriate action to be taken.
An RMOA can conclude that regulatory risk management is required for a substance (for example, harmonised classification and labelling, inclusion on the Candidate List, restriction, other EU legislation) or that no regulatory action is required. Subsequent regulatory processes include consulting interested parties and appropriate decision making involving the MSCAs and Commission as defined in REACH.
Communicating information on substances undergoing RMOA through the Public Activities Coordination Tool (PACT), allows stakeholders and the general public to better predict which substances may be addressed by which formal risk management routes in the future. This gives registrants the opportunity to update their registration data, consider the best business strategy to address substances of potential concern, and to prepare for public consultation during any subsequent regulatory processes.
The responsibility for the content of an RMOA rests with the authority that developed it. RMOAs and their conclusions are compiled on the basis of available information and may change in the light of new information or further assessment.