In an important step forward for global chemicals management, the EU Chemicals Agency, ECHA, started to publish its analyses of the properties of groups of chemicals on 7th December 2021, and also put forward recommendations for regulatory action in the vast majority of the groups assessed so far. Using computer-based techniques, ECHA is grouping together similar chemicals and using this analysis as a way of determining likely hazards of those chemicals which are lacking in safety data.
Despite legal obligations to deliver safety data on all chemicals produced or imported at >1 tonne per annum in the EU, studies have shown a huge lack of data for a high proportion of these chemicals. Up until now, such chemicals have effectively escaped regulation as they didn’t have sufficient safety data to decide what regulation is needed – a vicious cycle of ‘no data no problem’. This new grouping approach allows the assessment of the likely properties of these chemicals. However, questions remain whether EU chemicals regulations are strong enough to act on these assessments.
Understanding the Chemical Universe
This work forms part of ECHA’s Integrated Regulatory Strategy, which aims to “efficiently select substances or groups of substances that raise potential concern“. It contributes to ECHA’s goal of understanding the ‘Universe’ of all the substances registered in REACH, enabling ECHA to conclude by the end of 2027 whether REACH-registered substances are either:
- a priority for regulatory risk management;
- currently a low priority for further regulatory action; or
- a priority for data generation.
It may seem surprising that ECHA is still trying to establish this information on chemicals registered in REACH in 2022, almost 15 years since it entered into force, but unfortunately this lack of safety data on widely used chemicals is the reality of chemicals regulation in the EU and around the world.
Explaining the grouping process
As ECHA states:
“The purpose of the assessment of regulatory needs of a group of substances is to help authorities conclude on the most appropriate way to address the identified concerns for a group of substances or a single substance, i.e. the combination of the regulatory risk management instruments to be used and any intermediate steps, such as data generation, needed to initiate and introduce these regulatory measures.”
ECHA also explains that the initial grouping is done primarily using IT-based algorithms, following two broad, complementary methods:
- structural similarity, which uses the substance identity information in registration dossiers and C&L notifications; and
- associations made by the registrants between substances through read-across and category approaches as well as category associations from external sources (e.g. OECD categories).
ECHA has published a podcast on this grouping process, in which they explain that one of the reasons for making the results public is that this will help industry avoid regrettable substitution, moving from one problem chemical to another. CHEM Trust highlighted this issue in our report on the bisphenol group in 2018.
If you want to access the group reports, go to the ‘Assessment of Regulatory Needs‘ list and click the eyeball symbol at the end of the line of a substance. Substances with group reports have a date of last update of 7th Dec 2021 or later, and ECHA in the ‘Authority’ column. Other entries on this list are from other REACH processes, for example substance evaluation.
ECHA has also produced a useful Q&A about this work on groups.
Phthalates as an example
One example of a group that ECHA has identified is a group of ortho-phthalates, covering 91 substances, 32 of which are registered in REACH:
“ECHA has grouped structurally similar phthalate and phthalate-like esters, acids and salts in 4 groups, based on the number and position of the alkyl/aryl substituents: (i) ortho-phthalates, (ii) isophthalates, (iii) terephthalates and (iv) trimellitates. Assessment of regulatory needs for substances belonging to the has been performed and documented in this report. Another report documents the assessment of regulatory needs for isophthalates, terephthalates and trimellitates.”
ECHA has then decided that it is most useful to sub-divide this ortho-phthalate group into a number of sub groups. For one of these sub-groups, “Subgroup 4:Medium-chain length (C4-C6 backbone) linear and branched ortho-phthalates incl. aromatic and cyclic” ECHA proposes that the entire group should be subject to risk management measures, including restrictions and authorisation, due to a range of concerning properties, for example:
“Based on ECHA’s assessment of currently available information (including registration dossiers), it is expected that all substances in subgroup 4 are reproductive toxicants at least for development, potentially also for fertility. All of them are also expected to have ED [endocrine disruption] properties for human health”
CHEM Trust has been highlighting concerns about phthalates for many years, for example evidence that some may disrupt brain development.
A confused response from the chemical industry?
In response to the launch of ECHA’s grouping work, the comments of EU chemical industry trade association CEFIC’s were reported by Chemical Watch:
“Cefic also calls for a feedback or input mechanism that would allow stakeholders to add new and more detailed information about each substance or a group of substances, for example, on how it is used. “We believe that this would further increase the value of Echa’s screening work,” it said.”
This is a slightly strange request, suggesting a misunderstanding of REACH obligations. REACH is very clear that if companies have additional or new information, they should update their registration dossier. ECHA emphasises this point in their Q&A on the grouping work:
“If you consider that the information in your registration is not up-to-date, or that you have additional data that may assist with the assessment of your substance, ECHA recommends updating your dossier as soon as feasible for you. The updated information will be taken into account during the ongoing or future group assessment or during any potential follow-up regulatory action. In any case, you as a registrant have the obligation to keep your dossiers up to date with the latest available information.”
Michael Warhurst, Executive Director of CHEM Trust, said
“CHEM Trust welcomes this important work from ECHA, using modern scientific tools to fill in the all too frequent gaps in safety data for chemicals that have been on the market for decades. ECHA has now demonstrated that grouping chemicals for regulatory action works, and this must now be extended to cover all chemicals in REACH.
Restricting groups of chemicals is a cornerstone of the Chemicals Strategy for Sustainability, and this requires both safety information and a faster and more effective approach to controlling use, banning the most hazardous chemicals in consumer products, including articles. The reform of EU chemicals laws that is now underway must deliver this, in order to achieve the pledge of a toxic-free environment made in the European Green Deal. By 2030 we should have all the most hazardous chemicals banned from consumer products and articles.
While we are waiting for revised legislation to be in place – which will be several years – the European Commission must move further and faster, including through group restrictions, as we can’t have a situation where we have good evidence of the hazards posed by a large number of chemicals but the EU postpones regulatory action on them.”