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Preparatory steps

These four steps should be performed before starting with the I-RMOa properly:

1. Define the purpose

The Industry-Risk Management Options Analysis (I-RMOA) can be performed to address:

  • an imminent or ongoing assessment by regulators (the analysis described as a ‘simple I-RMOa’).  The purpose of the exercise is clear as it needs to contribute information to the regulatory community as well as present the industry’s own assessment of options.
  • an array of anticipated external challenges and/or objectives that may be proper to an industry branch or a company. Such exercises can vary from anticipative assessments of substances in a company's portfolio to the identification by a value chain of data gaps requiring data collection or studies. This type of I-RMOa, designated ‘integrated I-RMOa’, goes beyond the mere reaction to an imminent or ongoing regulatory exercise, and may include different levels of in-depth analysis.

2. Scope the RMOa

When the purpose is not to react to a regulatory initiative, an I-RMOa may adopt a forward-looking approach, focusing on substances likely to be scrutinised by regulators at some point in time.
The Roadmap on Substances of Very High Concern for 2020 has been the main source of inspiration when selecting the substances for a regulatory review as well as for an I-RMOa. The selection criteria were then set by the REACH regulation and focused basically on CMR 1A and AB as well as PBT and vPvB substances.

Selection of Substances of Very High Concern according to REACH Regulation criteria vs. type of I-RMOa

However, the criteria for selection have been expanding to those substances that could be of “equivalent concern” with a focus on sensitising substances and endocrine disruptors.  These criteria and the resulting lists of substances under scrutiny are evolving in sync with new policies aimed at protecting better the citizens and the environment against hazardous chemicals (most recently Europe’s Chemical strategy for sustainability and Zero pollution action plan water, air and soil)

When considering substances that are not directly in the regulators’ focus (i.e. not directly qualifying for identification as Substances of Very High Concern), an integrated I-RMOa may be advisable.  For example, a CMR 2 substance or one with chronic toxicity (especially with high workplace exposure) or ecotoxicity (high regional values), an integrated I-RMOa allows for an in-depth discussion of the risks and their management, and the exploration of combinations of measures, not all of them necessitating a regulatory intervention.

Broader range for selection of substances vs. type of I-RMOa

3. Consider timing when deciding on the approach

The time available to perform the analysis and to conclude will heavily determine the approach. Who sets the deadlines? Is it a regulator who informally consults or is the timing set by a public consultation procedure? Those timelines will be decisive on the priorities of the exercise. An I-RMOa may be geared toward those elements that are the most useful as industry input for a regulator.

When time constraints are looser, a broader analysis is possible and an integrated I-RMOa can help identify relevant data gaps, or medium- to long-term strategies (such as the development of cross-sector initiatives, for example).

4. Decide who should perform the I-RMOa

One can initiate an I-RMOA independently of a particular regulatory challenge under REACH, though the REACH processes will usually determine who will take the lead or perform the analysis.

Who?

  • Companies will be involved as drivers in consortia (lead registrants e.g.) or as privileged stakeholders (downstream users)
  • Companies will perform their own I-RMOa when planning their future raw material choices, investments and product portfolio.
  • Commodity organisations will play a key role when a regulatory challenge requires the involvement of value chains, with industry-wide data collection and processing.
  • Consortia have a critical role in the provision/collection/processing of the data that are necessary for the I-RMOa. They are responsible for the production and upkeep of the REACH Registration dossier, the data source by excellence for regulators in the REACH risk management phase.

We have prepared a fact sheet with more information and recommendations for those preparatory steps, which you can download here.

Last page update: 28 November 2023