Starting with the I-RMOa: setting the scene
Step 1: The substance or group of substances (hazard and risks)
This I-RMOa starts with the identification, in an objective way, of substances likely to be considered in need of regulatory management, in line with the current and anticipated regulatory environment.
The hazard-based screening is followed by an assessment of the risks.
Step 2: Lifecycle of the substance
The lifecycle perspective brings the flows and volumes perspectives into the discussion. This provides another perspective into the risk discussion (by i.a. refining the exposure dimension). The lifecycle overview may bring to light an important dimension for metals which is the possibly evolving speciation of the substances scrutinized.
Step 3: The regulatory and policy environment
At this stage, it is useful to understand whether there are already regulatory or voluntary instruments in place to manage the (potential) risk.
An overview of instruments allows assessing whether the existing tools can efficiently manage the identified risks. The conclusion may be that there is no need for additional instruments or that the existing measures should be modified or updated.
A checklist can be most useful to perform the three steps:
Part 1 of the Scene setting checklist: substance
- What does the Registration dossier tell us about the hazard profile vs. the REACH selection criteria or even upcoming concerns in society?
- Is the picture of hazards complete?
a. Do we have all relevant endpoints covered? Is the quality of the assessments satisfactory or are there still some endpoints under scrutiny?
b. What is the possible impact of remaining uncertainties?
- Do we have an unambiguous picture of how and to what degree the hazards translate into risks along the supply chain (for risk characterisation and discussion on point 7)? Do we have to go further in the analysis and consider a potential issue due to societal trends? There may be issues related to the acceptance of the substance as such or as part of a family of substances (heavy metals, solvents, fertilisers etc.).
- Is there a need or is it relevant to consider the presence of/exposure to/hazardousness of the substance in a broader context?
A more holistic view considering natural background, direct and indirect anthropogenic inputs may help put the risks into perspective and identify the most adequate risk management option.
Part 2 of the Scene setting checklist: the substance throughout its lifecycle
5.1. Is the Registration dossier clear and complete regarding the description of uses?
5.2. Is the description of the uses relevant to understand exposures?
5.3. Are these descriptions also providing information on the functionality of the substance?
6. Volumes and physical/chemical properties in life-cycle
6.1. Can a materials' flows table be made that covers each significant step in the substance/product lifetime?
6.2. Is important information on the nature and fate of the substance available such as presence as an impurity in industrial processes or presence in materials for recovery?
6.3. Is information available about the physical form of the substance throughout the lifecycle? This is relevant as exposure depends also on physical form.
6.4. What about changes of speciation in the course of the lifecycle?
7.1. Can (potential) exposures be identified?
7.2. What about the risk characterisation of the different exposure scenarios?
The possible areas of concern throughout the substance can be presented in many ways. The figure presented here shows an example of how the conclusions on risks can be summarized in one figure. In this example, potential concerns were identified and ranked per significance at occupational level (industrial and professional uses), in the environment (air and water emissions) as well as with articles that could lead to exposure.
Part 3 of the Scene setting checklist: the regulatory and policy environment and industry initiatives
8. Regulations and voluntary systems
8.1. What are the regulations covering the substance, throughout the lifecycle (including as part of articles)?
8.2. Are there non-regulatory schemes (such as voluntary systems for phasing-out or product stewardship) in place?
9. Policy environment
9.1. Which parts of the EU Green Deal should be considered when discussing the fate of the substance?
9.2. Are there other dimensions of EU/national/international policy to consider? Strategic resources, trade dimensions or others?
We have prepared a factsheet on how to perform an I-RMOa which you can download here.
Last page update: 12 May 2022