Regulating groups of substances to speed up action and ensure a coherent approach (Signal)

The Chemical Strategy for Sustainability (CSS) highlights the need to strengthen the legal framework in particular to better protect consumers, vulnerable groups and workers from the most harmful chemicals. Regulating substances as groups rather than single substances is one way to strengthen the current approach.

Addressing groups of substances enhances consistency and coherence in regulatory action proposed for similar substances; enables the use of all available data to cover a bigger share of substances; and has the potential to accelerate both the assessment and regulatory measures taken on chemicals. It also avoids unnecessary animal testing and ensures that risk management actions are taken in a timely manner and whenever possible at group level, supporting informed substitution by industry.

Several regulatory actions are already ongoing for groups of substances

Per and polyfluoroalkyl substances (PFAS) are a large class of thousands of synthetic chemicals that are widely used for their unique desirable properties. For example, they remain stable under intense heat. Many of them are also surfactants and are used as water and grease repellents. However, PFAS are very persistent and many are increasingly detected as environmental pollutants. Hazard data are only available for a limited number of PFAS but often show links to negative effects on human health.

PFAS have been frequently observed to contaminate groundwater, surface water and soil. Cleaning up polluted sites is technically difficult and costly. PFAS are persistent in the environment: some are known to persist in the environment longer than any other synthetic substance. As long as PFAS continue to be released to the environment, humans and other species will be exposed to ever greater concentrations. Over the past few decades, global manufacturers have started to replace certain PFAS with others or with fluorine-free substances. This trend has been driven by recognition of the harmful effects of some PFAS (particularly long-chain PFAS) on human health and the environment. As the focus shifted to other PFAS, these have also been found to have properties of concern.

Certain PFAS are regulated but by far not all of them. The national authorities of Germany, Denmark, the Netherlands, Norway and Sweden are proposing a restriction covering a wide range of PFAS uses. They submitted their proposal to ECHA in January 2023, and ECHA’s scientific committees are now evaluating it.

In the bisphenols group, Bisphenol A (BPA) is classified as reprotoxic. Since March 2018, it has been restricted in the EU as a substance on its own as well as in mixtures intended for consumer use. Its use in thermal paper has been restricted since January 2020. However, companies have commonly used Bisphenol S (BPS) to replace BPA in thermal paper. This is a concern as BPS is also suspected of damaging human reproductive and hormonal systems. Three bisphenols (BPA, Bisphenol B and 2,2-bis(4'-hydroxyphenyl)-4-methylpentane) have already been identified as substances of very high concern (SVHCs) for human health and the environment due to their endocrine-disrupting properties. However, not all structurally-related bisphenols have been assessed.

German authorities have proposed restricting the use of BPA and other bisphenols with endocrine-disrupting properties for the environment, including those identified in the future. A proposal was submitted to the European Chemicals Agency (ECHA) in October 2022. Following a six-month third-party consultation on the dossier, Germany concluded that a revision of the proposal was necessary to achieve the intended goals of the restriction. Therefore, the dossier has been withdrawn temporarily and a resubmission will be announced via ECHA's Registry of Intentions once the schedule is clearer.

In addition, the regulatory needs of 148 bisphenols have also been assessed by ECHA and several Member States. A group restriction was identified as the best way to manage the risks from 34 bisphenols. This number may change as more information is generated for these and other bisphenols that lacked sufficient data. 

ECHA continues to identify and prioritise groups for future regulatory risk management actions under REACH

Through grouping and the assessment of regulatory needs (ARN), ECHA aims to systematically screen REACH-registered substances and identify where there is a need for regulatory action or where no further action is needed for groups of substances. For instance, ECHA’s strategy for flame retardants covers the assessment of regulatory needs for halogenated (including brominated) and organophosphorus flame retardants, which make up around 70% of the organic flame retardants market. The strategy identifies flame retardants, their potential hazards and information gaps. It aims to avoid regrettable substitution through grouping and gives companies more predictability through increased transparency of potential regulatory actions. Flame retardants, other than halogen or organophosphorus-based products, will continue to be assessed in future ARNs. The strategy was announced in the Restrictions Roadmap.

ECHA assessed the regulatory needs of four groups of phthalates and phthalate-like substances covering 134 substances due to their potential reprotoxic, endocrine-disrupting or persistent, bioaccumulative and toxic (PBT) properties. The groups include a group of ortho-phthalates, which have already been under regulatory scrutiny. For example, several ortho-phthalates have been identified as substances of very high concern (SVHCs) and have been included in the Authorisation List. Some are restricted for use under certain articles. However, many structurally-similar substances of the group are not yet regulated. The same applies to substances potentially containing hazardous ortho-phthalates as constituents in significant concentrations. Together with several EU Member States, ECHA is preparing to address these two groups of structurally related substances. As the first step towards restriction, preparatory activities are ongoing to develop an harmonised classification (CLH) proposal for ortho-phthalates. Ortho-phthalates are also included in the Restrictions Roadmap as planned restrictions that are not yet on the REACH Registry of Intentions (RoI) for restriction.

The Restrictions Roadmap sets out a rolling list of planned, prepared and progressed restrictions. The roadmap aims to ensure transparent and timely commitments by authorities and allow companies to anticipate any potential upcoming restrictions.

The roadmap was published in 2022 and will be subject to regular review, which may lead to changes in the anticipated regulatory risk management action. Therefore, substances covered by the Restrictions Roadmap may come off the list while others may be added. Groups of substances listed on the restriction roadmap include PFAS, bisphenols and ortho-phthalates, among others.

More information can be found at the ECHA website on the Working with Groups webpage, the assessment of regulatory needs list and the assessment of regulatory needs.

Relevant objectives under the Chemicals Strategy for Sustainability

• Minimise exposure of humans and environment to substances hazardous to health and the environment, through risk management measures and full information to users of chemicals

• Restore human health and environment to a good quality status

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Minimise and control

Eliminate and remediate

EU indicator framework for chemicals

Other relevant indicators and signals

Progress in regulating substances under REACH and CLP (Indicator)

Human exposure to bisphenols (Signal)

Risks of PFAS for human health in Europe (Signal)

Market volume changes of chemicals subject to REACH authorisation (Signal)