Speciality Chemicals Magazine MAY / JUN 2025 | Page 55

REGULATION & COMPLIANCE substances have been classified regarding these properties yet.

Furthermore, according to the EUC criteria a substance can be only considered essential if there is no alternative available and if it is considered as necessary for health or safety, or if it is critical for the functioning of society. These two criteria are complemented with a longer list of more concrete examples in the communication. Some of those are relatively general and leave room for interpretation.

The objective of the EUC is straightforward. It should improve the protection of health and the environment. At the same time, it should make legislation faster and more predictable. In principle, the idea is simple: clearly essential uses and clearly non-essential uses would be identified based on the logic of the EUC criteria. Those left would be assessed in more detail. Nonessential uses would be banned.

This sounds promising and seems like a win-win-win-win-situation for consumers, authorities, industry and the environment. However, one important aspect is missing in the EUC communication: practical implementation and enforcement.

As with so many other rules, practical implementation and the availability of sufficient resources for enforcement are key for the success of a regulation. Looking at the EUC in

Figure 2 – Filter principle more detail this could soon turn into a Herculean task. To better understand the concerns, one can ask some simple questions:

• Who will assess essentiality in practice?

• How many essentiality assessments would be necessary?

• How can we enforce the‘ essentiality’ parameter?

• What are the risks related to the EUC?

Who will assess essentiality in practice?

For some of the elements in an essentiality assessment, it should be possible to develop objective criteria. For example, if a substance is used as medication that should be an essential use. Other elements are harder to cover with criteria and include a high level of subjectivity, for example to‘ manage societal risks’. Two people may have a very different understanding what such a risk could be.

Furthermore, one can expect cases, where two criteria run counter to each other, for example when an ecotoxicological substance is used in an application that helps protect the environment. Finally, even a process that we have for many years already, the assessment of alternatives, can be very complex and a significant bottleneck for assessments.

Considering all these elements and their diversity, it is obvious that many different experts will be needed to assess them. Someone who is qualified to assess societal risks will probably not be qualified to assess the safety nor economic impacts nor aspects related to R & D.

An essentiality assessment will definitely require more scientific qualification than we have today with ECHA’ s two scientific committees, the Risk Assessment Committee( RAC) and the Socio-Economic Assessment Committee( SEAC). These are already under pressure due to a chronic lack of qualified people.

There are other committees based on different EU legislation in place, but these would need to be integrated into the existing structure of ECHA, if it becomes responsible for essentiality assessments. However, not even these have the necessary expertise to cover all the criteria suggested in the EUC communication and they are even more underresourced than RAC and SEAC.

One possible way to solve this problem could be a kind of pooling system. There would be different expert pools, which would first receive a type of certification and could then be invited for individual tasks in their field.

This, however, needs to be looked at carefully from the perspective of potential conflicts of interest, especially if experts from academia, NGOs or industry are included. Finally, someone will have to take political decision, especially when two or more conflicting political objectives are involved.

MAY / JUN 2025 SPECCHEMONLINE. COM

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