Regulators will expect from an RMOa that it helps them decide:
- whether there is a concern with a substance that requires regulatory intervention;
- what the most appropriate instrument is to address the identified concern. To enforce the management of risks, authorities rely on regulatory provisions.
That’s why the slightly more restrictive notion of Regulatory Management Options analysis appears more suited to describe their approach.
Identify & understand the nature of the risk
Consider all regulatory management options that are available to the regulators. List possible non-regulatory options that could lead to or help in achieving the same desired outcome.
Analyse the risk management options & find the most proportionate one
Most regulatory instruments include an evaluation process (adaptation to technical progress or scientific knowledge, in built regular review period)
We have prepared a fact sheet with more information on the definition and different types of RMOa which you can download here
Last page update: 12 May 2022