CLP Regulation: New hazard classes

On 20 April 2023, an amendment to Regulation (EC) No. 1272/ 2008 and, with it, new hazard classes, came into force. The latter are being introduced for endocrine disruptors (EDs) and for substances that are persistent, bioaccumulative, toxic (PBT); very persistent, very bioaccumulative (vPvB); persistent, mobile, toxic (PMT); and very persistent, very mobile (vPvM).

The regulation is seeking to provide better protection for humans and the environment. This amendment of the CLP Regulation is a key pillar of the EU Chemicals Strategy for Sustainability (CSS) and thus also of the Green Deal.

The new hazard classes

The new hazard classes being introduced are:

• Category 1 and 2 endocrine disruption for human health
• Category 1 and 2 endocrine disruption for the environment 
• PBT (persistent, bioaccumulative, toxic) / vPvB (very persistent, very bioaccumulative)
• PMT (persistent, mobile, toxic) / vPvM (very persistent, very mobile)

Endocrine disruptors (EDs) have the potential to interfere with the natural hormone system of humans and animals, with adverse consequences for health and development. There are many different ways in which a substance exerts an adverse effect on the hormone system and these can be difficult to demonstrate.

Allocation into one of the two categories within the endocrine hazard classes is similar to the procedure for carcinogenic and mutagenic substances:

• Category 1: Known or presumed endocrine disruptors, with evidence demonstrated of endocrine activity, an adverse effect and a link between the activity and the adverse effect.
• Category 2: Suspected endocrine disruptors for human health. Where there is reasonable doubt about effects or evidence, the substance is classified in Category 2.

The Umwelt Bundesamt (Federal Environment Agency) defines PBT/vPvB substances as those which “degrade very poorly in the environment (i.e. are persistent), accumulate in organisms and thus in the food chain (i.e. are bioaccumulative) and are poisonous (i.e. toxic) to humans or organisms in the environment” (www.umweltbundesamt.de/service/uba-fragen/was-sind-pbtvpvb-stoffe).

PMT/vPvM substances are “poorly degraded by the environment, are mobile enough to enter the water cycle through natural or artificial barriers and are toxic.”

The new hazard classes are European classifications and so are not anchored within the Globally Harmonised System (GHS). Consequently, there will be no new pictograms, as they, like H and P phrases, are determined by the GHS. However, a working document for discussion of the new hazard classes at UN-GHS level has already been submitted. It remains to be seen whether the hazard classes will also be adopted into the UN-GHS system.

Data situation

Crucial to any classification and labelling of substances and mixtures is a knowledge of their intrinsic properties. REACH Regulation (EC) No. 1907/2006 has significantly improved the data situation for many substances in recent years. For all registered substances and to an extent depending on the registered tonnage band, information on the physicochemical and (eco)toxicological properties must be generated and submitted to the European Chemical Agency (ECHA).

There is already a good amount of data available for the new PBT and PMT hazard classes, in particular, as the determination of a substance’s PBT properties already forms part an element of a REACH assessment. And some of the criteria relating to classification into the hazard classes are standard under REACH as well. For example, registrants have to submit information on degradability (persistence), bioaccumulation and chronic (aquatic) toxicity. What is more, data may already be available on mobility. The classification criterion here is the partition coefficient between water and organic carbon (log-Koc) of the soil or sediment.

There is comparatively less data available for the categories of endocrine disruption for human health and the environment. Both of these categories are based on established scientific criteria (WHO/IPCS) for the identification of endocrine disruptors. There has been no standard requirement on this forthcoming from REACH as yet. This situation will very likely change under the upcoming amendment to the regulation and REACH will be extended to include specific (eco-) toxicological tests and alternative methods for these two endpoints. However, it will probably take some time for the resulting data to find its way into the supply chains. Even then, demonstrating the specific mechanism of the endocrine disruption will remain the greatest challenge.

Apart from the data specifically needed for classification, the REACH regulation also mandates the generation of additional data that can prove helpful with the weight-of-evidence determination. For example, registrants must submit information on the octanol-water partition coefficient, ready biodegradability and short-term aquatic toxicity for tonnages of 1 t/a and above.

Transition periods

Delegated Regulation (EU) 2023/707 has been in force since 20 April 2023. Substances placed on the market for the first time must therefore be classified and labelled accordingly by 1 May 2025. The transition period for mixtures lasts until 1 May 2026 while the corresponding deadlines for substances and mixtures already placed on the market are 1 November 2026 and 1 May 2028, respectively.

Problems

As already outlined, it can be difficult to make an unequivocal assesment of endocrine properties. The delegated regulation stipulates that the classification into these categories be based on an assessment of the total weight of evidence using expert judgment.

Another problem that must not be overlooked is the particular approach being adopted by the European Union in introducing the new hazard classes. This deviation from the United Nations system could create communications problems in the supply chain and it complicates the harmonized, comparative assessment of hazards. Companies will now have to carry out a vast amount of testing, as tests are mandatory for all products, irrespective of the tonnage band. Critics claim that this could disadvantage EU industry and that it is at odds with the objectives of the Chemicals Strategy for Sustainability. In the worst case, they say, it might even lead to a relocation of production to countries with a lower level of protection.

Conclusion

With the introduction of the new hazard classes, the EU is sending out a clear signal about the zero-pollution strategy of the CSS. The new hazard classes can help with the identification and labelling of substances that pose a potential risk to humans and the environment. A great deal of new data will have to be gathered in the years ahead, as the tonnage limit has been abolished and data must now be generated from levels of 1 t/a and above. That being said, however, until this data is available, a substance is deemed to be unclassified if there is no data available on it.