Performing the I-RMOa

The Chemicals management pillar of the I-RMOa

Once a clear view has been reached of the risks, the risk management options identification and analysis can start.

Identification of Risk Management Options

An Industry-Risk management options analysis may result in different conclusions. It may suggest that there is no need for measures when the scene-setting led to a conclusion of no risk or indicated that the existing regulatory instruments were adequate. Alternatively, it may come up with one or more actions and measures.

As discussed more in detail in the downloadable factsheets:

All potential options should be listed, irrespective of the perception one may have of their pertinence. Assumptions on workability or acceptability may be discussed later in the exercise, but the purpose of the listing is to force those performing the I-RMOa to consider the likely views of other stakeholders. One should also not exclude that options that initially seem counter-intuitive may prove to have unexpected merits.
All potential options should be described with sufficient precision, i.e. their content (scope, basic definitions) should be clear in the minds of the assessors.

This will provide the long list of RMOs which can then be gradually reduced to a couple of measures that pass the fitness tests.

Additional suggestions:

When identifying and listing the potential risk management options, I-RMOA performers will devote particular attention to:

Alternatives

Regulators in the EU generally favour substitution of the problematic substance (a means of risk removal) to risk reduction (such as exposure reduction). The fact that substitution tends to be on top of the regulators’ preferences will play a role when discussing the most adequate RMO. At the I-RMOa level, the assessment of alternatives will generally not be as developed in comparative cost calculations as would be the case in a full-blown Analysis of Alternatives in an application for authorisation.

Industry measures

Industry cannot introduce measures that have a force of law, yet industry can depending on the nature of the risks, do a lot to eliminate or mitigate risks. Industry-developed and promoted risk management range from the education of workers, downstream users and consumers, product stewardship, investments in new technologies up to voluntary substitution. It is noteworthy that regulators have recently become less reluctant to integrate industry-managed measures in their regulatory packages.

Regulatory measures

Although Industry has no regulatory authority, it can formulate an opinion on regulatory management measures considered by authorities and suggest alternative regulatory approaches. Typically, I-RMOa performers will tend to discuss the relative merits of restriction vs authorisation or consider whether an Occupational Exposure Limit (OEL) could address adequately workplace exposure challenges…

Three RMO approaches may be considered when considering the RMO strategy for a substance:

Simple approach: Risk management can be limited to the substance and its use(s) and will be limited to one measure. Usually: Restriction, Authorisation, Occupational Exposure Level. This is the simplest approach, which will be the favoured one when there are no cross-substance issues such as the use of other Substances of Very High Concern (SVHCs) in the same processes or complex issues requiring other ad-hoc measures such as a specific restriction. Regulators may want to focus on substitution or non-use of the substance, i.e. through Authorisation or Restriction. A Restriction may address some conditions of use or some uses whilst Authorisation would allow sorting out the uses between those for which there is a case for continued use and those for which there is no solid reason to avoid an organized phasing-out. However other substance-specific regulatory or technological solutions (OEL, EQS, BATNEEC) may also be considered.

Combined approach: Risk management may consist of a combination of measures to achieve an optimal way of addressing the challenges identified. It may also consist of mixes of measures in the function of uses. Typically, one may, for example, consider combining Authorisation with a Restriction on imports of the substance through articles.

Integrated Approach: Risk Management recognises that the potential risk is related to a process that may be common to other substances (of potential concern) and other value chains. For example, the use of a substance in surface treatment would lend itself to such an integrated approach as these processes are using many substances of potential concern. An integrated approach might then look at the process rather than at the individual substance, in the knowledge that the other substances involved in the process may be scrutinised sooner or later. An authorisation process per substance, would be a long and complex process and highly disturbing for the companies concerned (uncertainty - what guarantees of equality of treatment? - consistency?) and a repetitive one if several substances involved in the same processes go through authorisation. However, a creative approach may focus on acid mist, for example, as the carrier of the various substances under particulate form and look for the introduction of a technological solution for the entire sector (BATNEEC) able to solve the problems common to the different substances in the surface treatment process.

Discussion of Risk Management Options

Proportionality criteria

When the I-RMOa is not performed as a contribution to a regulatory initiative that has its own proportionality assessment, the I-RMOa will test the different potential RMOs against four key criteria. The level of expertise needed for this part of the I-RMOa is less technical but requires some familiarity with policy, legal and economic considerations.

The 4 key criteria are:

Effectiveness: Can the measure produce the desired effect? It is a way of measuring the efficacy of the measure considered. Questions to answer will be:

- Is it able to reduce or eliminate the risk?

- Are the means ( e.g., proven technology) available to achieve the goal?

- Can the effects be measured?

- Can the measure be monitored?

Practicability: How easily can the measure be implemented? Is the measure efficient when considering the efforts required?
Consistency: There can be a lot of challenges in terms of regulatory consistency (between Member States e.g.), assessment consistency (What about the conclusions of previous risk assessments?), policy consistency (various dimensions of the Green Deal) etc.
Broader impacts

- Socio-economic

- Human health, Environmental

- Societal and broader policy dimension

When looking at potential broader impacts, one may assess whether there are:

- Value chain impacts at sector-level/ company-level (SMEs and non-SMEs),

- Possible unexpected collateral impacts way down the supply chain such as loss of functionality in articles?

- Market impacts (impacts on market shares, trade balance, resource supply challenges),

- Monitoring costs and administrative consequences, etc.

The synthesis of the chemicals’ management pillar of the I-RMOa

All the criteria and their dimensions can be brought together in one table to

Present an industry view on possible proportional risk management approaches

Decide on a strategy at the company or sector level.

Here below is an illustration of such a synthetic presentation of a proportionality assessment. These are the RMOs that have passed the fitness tests and went through a final discussion with an optional scoring of the different proportionality criteria. The advantage of scoring is that it may provide a ranking between the final selection of options.

How the scoring is done is left to the assessors but needs to be transparent. In cases where bias is difficult to avoid (known aversion vs. specific regulatory instruments e.g.), scoring can even be counter-productive if not discussed and explained thoroughly. The I-RMOa guidance document has a section devoted to the setting up and use of a scoring system.

A theoretical example (not based on any real case) is given of what a scoring may look like, here with a range between - - and + +.

The Circular Economy pillar of the I-RMOa

The purpose of including the Circular Economy dimension of the substance in the risk management discussion is to:

Assess whether the Circularily dimension will be relevant to discussing the suggested risk management measures.
Establish, if that dimension is considered relevant, the relative performance of the risk management measures in terms of Circular Economy objectives (durability, reusability, recyclability etc.)
To include the Circular Economy dimension in the I-RMOa proportionality assessment.

The I-RMOa considers the fate of the substance throughout its life-cycle, and hence also its Circular Economy dimension. Mass balance and recycling data inform the discussion on current performances and may help identify areas of potential improvement. In doing so, the Circular Economy information can help broaden the discussion on the type of measures or combination of measures able to address the risks and to respond to Circular Economy challenges.

In practice:

The suggested RMO for the chemicals management of a metal element, compound or material may prove to be relevant to achieve the goals of the New Circular Economy Strategy. The practical approach is discussed in the downloadable factsheet.

The RMOs identified in the Pillar I analysis are discussed from a circular economy perspective and a proportionality scoring is given. An example is shown here where the different parameters are scored within a range between - - and + +.

The Climate pillar of the I-RMOa

The objectives of discussing the Climate dimension of the substance are to:

Establish whether the Climate dimension – linking to the various Climate policy aspects – will be relevant to discussing the RMOs.
Discuss, when that dimension is relevant, the relative performance in terms of Climate policy of the RMOs considered.
Include Climate aspects in the overall RMOa proportionality assessment.

Even if the I-RMOa contains a scanning of the fate of the substance throughout its life-cycle, it does not equate to a Life-Cycle Assessment (LCA) per se that will be looking at overall resource and energy performances. An I-RMOa, looks at these aspects relative to alternative substances and technologies. The discussion of the climate dimension will be qualitative at this stage.

Another critical aspect is to consider the climate impacts (energy consumption and/or CO2 emission) over the substance's life-cycle. Indeed, a substance may be energy-intensive in its extraction/production but simultaneously contribute to sustainability when it provides durability to articles, is recyclable or allows energy recovery at the end-of-life stage. The details of such a discussion go beyond the scope of an RMOa and will be addressed in an LCA. Alternatively, in an RMOa assessment different options can be qualitatively compared for their positive or negative climate aspects during manufacturing/use/EOL and recycling.

Depending on whether the climate dimension of the substance (in its life cycle) is relevant, the type of regulatory/risk management measures will vary. Details of this approach are discussed in the downloadable factsheet.

This may ultimately lead to a proportionality scoring of the RMOs identified in the Pillar I analysis from the point of view of the climate. The illustration here uses a scoring range between - - and + +.

Explanation of the scoring:

RMO 1: The scoring group considered that a forced substitution with a less energy-efficient substance would lead to an overall negative climate impact.
RMO 2: The scoring group considered that the restriction would not perform better than Authorisation.
RMO 3: The scoring group considered that the OEL would impact the climate performance at the manufacturing stage due to the need for the installation of additional equipment to collect and treat gases.

The Synthesis of the 3-pillar approach to Integrated I-RMOa

This section shows how to reach conclusions in a two or three pillar analysis

How to proceed in practice is explained in the downloadable factsheets but the final synthesis table of scoring of an Integrated I-RMOa of a full three-pillar analysis may look like this*:

*: This is an overly simplified representation, and one must be very careful with the comparison and weighing of the scoring between the pillars. A section in the I-RMOa guidance is devoted to this aspect.

The example illustrates how the proportionality scoring of the three pillars can affect the discussion leading to the most suited RMO:

The chemicals management analysis (Pillar I) would not have led to an easy choice, as the three options score the same.
The conclusion of the circular economy dimension (Pillar II) clearly favours RMO2.
In terms of climate (Pillar III), RMO 3 scores the best.

Overall RMO 3 scores the best, but only after an analysis of the three pillars!

The Integrated I-RMOa is a powerful tool whose main purpose is to inform political or strategic decisions.

Last page update: 28 November 2023