How should we expect the new hazards under EU CLP to play out in practice?

As the European Chemicals Agency (ECHA) reminded us last week, the new hazard classes are now in force under the EU CLP regulation.

This means that all entities placing substances or mixtures on the European single market (barring a few exceptions) will soon be required to classify their products according to these new hazards.

As put by ECHA, these changes are expected to have a “far-reaching impact”, not least due to CLP’s links with many other EU laws.

As a reminder, the new hazard classes are:

• Endocrine disruptors (ED) for human health and the environment;

• Persistent, bioaccumulative and toxic (PBT); very persistent and very bioaccumulative (vPvB); and

• Persistent, mobile and toxic (PMT); very persistent and very mobile (vPvM).

But what do these developments mean in practice? How are they likely to play out in the years ahead? In this article I will offer a perspective and argue how, along with some other key changes, the new hazards will fundamentally transform the way the EU CLP regulation operates.

Limited changes to hazard labels based on self-classification

Although the eagerly awaited guidance on the new hazards is not expected to be available until the autumn, deadlines for classification start as early as 1st May 2025 for new substances. The far more critical deadline for existing substances comes 18 months later, on 1st November 2026.

By this date all substances in scope for classification under the CLP regulation will need to be evaluated, classified and labelled according to the new hazards before they can be placed on the market. But do we expect many substances to be brandishing these new classifications on their labels and SDS by this time? My suspicion is no.

I say this for three overarching reasons:

1. Lack of data

In many cases, these will be new assessments for the substances in question. The potential for these substances to exhibit endocrine disruption, or to pose a threat to drinking water, is unlikely to have been considered before. Even in the case of PBT/vPvB assessments, which – in principle – should be accessible from the publicly available registration dossiers of most REACH substances, these will not have been performed for substances in the < 10 tonnes per year band, or those exempt from registration (such as polymers).

This means that addressing the responsibilities of the new CLP hazards will be far from an information looking-up exercise in practice. In the case of PMT/vPvM assessments, many substances are likely to lack conclusive information on persistence (P/vP) or mobility (M/vM) for the very reason that it has, until now, not been a requirement to assemble this.

For persistence assessments, biodegradation simulation tests are the standard information used to reach conclusions for non-readily biodegradable substances. However, there are only a limited number of simulation tests in the REACH database (a search of the eChemPortal suggests 515 reliable experimental studies as of 22/05/2023). The scarcity of data from simulation tests is not really a surprise; given the cost, complexity and perceived risk (false positives, etc) of these tests, the preference for industry has generally been to avoid performing them.

It's a similar story for the mobility assessments. The M classification is brand new and, as mentioned, the guidance is not yet finalised. It seems pretty clear that the organic carbon-water partition coefficient, or Koc, will be the principal endpoint for classifying substances for this concern. However, adequate data, even for such a screening-level endpoint, is often missing from registration dossiers.

So, you might ask “will the new hazards under CLP trigger a wave of new testing?” The short answer is “probably not”. The CLP regulation has no mechanism to require assessors to carry out further data generation for health or environmental hazards. It is therefore more likely that assessors will try to ‘make do’ with whatever data is available. In most cases this information will be inadequate for classification and, as a result, substances will not be classified for these new hazards.

2. Lack of expertise

One thing that is common to assessments of endocrine disruption, persistence, bioaccumulation and mobility is that all of these assessments rely on a process known as ‘weight of evidence’. Weight of evidence is a somewhat opaque process that involves gathering and evaluating disparate pieces of evidence and combining these into a single conclusion. It necessarily relies on expert judgement – there’s a reason why ECHA expert groups dedicated to these assessments were established.

However, with the introduction of the new CLP hazards, these responsibilities will now fall to individual legal entities placing substances on the market. The requirements are the same whether the entity is a SME or a large multinational company. For many of the duty holders these assessments will be completely new and, with 100s of pages of guidance to pour over (the OECD guidance document on standard test guidelines for endocrine disruption alone stands at nearly 700 pages), it goes without saying that the new requirements are likely to be overwhelming.

It’s also not clear that the expertise or capacity to adequately carry out the required volume of assessments exists within the consultancy sector. It therefore remains to be seen how this expertise gap will be bridged to deliver all the required assessments in the short time available.

3. Lack of time

Speaking with people about the new CLP hazards has been something of a strange experience. There doesn’t seem to be anything like the urgency that has been expressed for other recent regulatory deadlines. This might be down to mission fatigue, with many companies and individual professionals being weary from all the legislative changes they’ve had to deal with lately. However, it could also be due simply to a lack of appreciation for the sheer amount of work standing before them.

It's common for regulatory deadlines to get quite close before the urgency triggers action on a massive scale. This has been the case for recent EU and UK REACH deadlines, as well as the CLP poison centre deadlines. However, in the present case this seems like a risky strategy. Each substance is required, in theory, to undergo several assessments: endocrine disruption for human health and environment, persistence, bioaccumulation, mobility and toxicity.

If following a weight of evidence approach, then all available relevant information should be gathered and evaluated, including literature data, and adaptations like read-across and QSAR methods. It takes a significant amount of effort to do these assessments justice, and to produce the documentary evidence that the necessary work has been done.

I suspect that those who have fully contemplated the requirements will be quite concerned about their ability to comply with them. Others likely do not yet appreciate what they are being required to do. A small minority may be adopting a “wait and see” approach, to see how the requirements ultimately play out and are enforced in practice.

Whatever the reasons, I suspect that industry will simply run out of time to complete these assessments by 1st November 2026 and, as a result, we will not see the anticipated ‘Great Re-classification’ of new CLP hazards. However, self-classification may not be the main means by which these new hazards get onto product labels.

A shift in regulatory strategy

It has been suggested that recent changes to the CLP regulation signal a shift in regulatory strategy for the risk management of chemicals in the EU. Specifically, that harmonised classification, with its subsequent impacts on other EU legislation, will become a more potent mechanism and important tool for chemicals management moving forward.

This is supported by the European Commission now having the right to develop classification and labelling proposals, and an increase in emphasis toward group-based harmonised classifications. We are also hearing rumours of Member States shifting their focus toward ECHA’s Risk Assessment Committee (RAC) – where harmonised classifications are implemented, and some are already in the process of developing CLH proposals.

It will be fascinating to see how all of this develops. At the very least, we will see many ‘firsts’ in the coming years, including harmonised classification of group(s) of substances. One thing is clear, the developments signal a fundamental shift in the way that the CLP regulation is likely to operate moving forward, with a greater emphasis on regulator-driven harmonised classification, and less emphasis on industry self-classification.

Is this symptomatic of an overall frustration at the rate of progress of action against harmful chemicals, or a growing lack of trust in industry to safeguard public health and the environment throughout the lifecycle of its products and operations? Or is it simply an admission that these new hazards were too complex to rely on industry actors to adequately implement them for their substances, and that the originally intended operational model of the CLP regulation had to be sacrificed in order to accommodate them?

The answer to this question will surely become clear in time…