EU CLP regulation | New rules to classify endocrine disruptors and persistent chemicals enter into force

May 15, 2023

The EU's new Delegated Regulation on chemical classification, labelling and packaging came into force on 20 April 2023. Under Commission Delegated Regulation (EU) 2023/707, manufacturers, importers, downstream users, and distributors are required to apply the new hazard classes and update labels on packaging, safety data sheets, and/or REACH registration dossiers, as applicable. Four new hazard classes have been introduced, and companies must comply with these regulations by specific deadlines depending on whether the substance or mixture is new or already on the EU market.

New hazard classes

The Delegated Regulation adds four new hazard classes to Regulation (EC) No 1272/2008:

  • Endocrine disruption for human health (ED HH Category 1 and ED HH Category 2)
  • Endocrine disruption for the environment (ED ENV Category 1 or ED ENV Category 2)
  • Persistent, Bioaccumulative and Toxic or Very Persistent, Very Bioaccumulative properties (PBT and vPvB)
  • Persistent, Mobile and Toxic and Very Persistent, Very Mobile properties (PMT and vPvM)

Compliance deadlines

Manufacturers, importers, downstream users and distributors placing their products on the EU market must classify their substances or mixtures according to the new hazard classes by the relevant deadline (see the table below). Companies can of course voluntarily apply the new hazard classes before then.

Compliance deadlines for updating the classification and labelling for substances / mixtures:

1 May 20251 November 2026 1 May 2026 1 May 2028
New substances on the EU marketSubstances already on the EU marketNew mixtures on the EU marketMixtures already on the EU market

Evaluate the impact on product portfolios now

Organizations should not under-estimate the importance of a robust approach or the effort involved in evaluating the impact of the new hazard classes on their product portfolios. According to Sue Bullock, Head of Chemical Compliance, Stewardship & Sustainability at TSG Consulting. "These new hazard classes will certainly give rise to questions relating to data, approach and outcomes. An early approach will allow companies time to gauge, consider and respond thoughtfully to any issues thrown up by this new process. This should also give companies adequate time to identify substances that may be affected by the changes and make informed decisions about the use of these substances, providing opportunities for companies to enhance the sustainability and safety of their products, with benefits all round."

Need support?

Our team of scientific and regulatory experts is available to assist you in assessing the impact of the evolving regulations on your product portfolios. To learn more about our services, please contact us at [email protected], and we will schedule a call to discuss your requirements.

In a previous advisory - European Commission presents proposal for revised CLP regulation - our experts noted that while existing EU regulations already mandate evaluation of these chemical properties in certain circumstances, creating hazard classes under the CLP regulation will require their assessment for a much vaster set of chemicals. These assessments will often require expert judgements and assessment techniques to make sense of complex data sets, studies and related evidence. Better data may be needed to support conclusions and many more chemicals may be identified as of potential concern warranting more detailed assessment and/or risk management measures as a result. The forthcoming update to the REACH registration information requirements will clarify expectations on the data underpinning these hazard classes.

Frequently asked questions

The new EU Commission Delegated Regulation (EU) 2023/707, is a set of updated rules on the classification, labelling, and packaging of chemicals in the European Union. The regulation adds new hazard classes to Regulation (EC) No 1272/2008 and requires manufacturers, importers, downstream users, and distributors to apply the new hazard classes and update labels on packaging, safety data sheets, and/or REACH registration dossiers, as applicable. The new hazard classes include endocrine disruption for human health and the environment, as well as persistent, bioaccumulative, toxic, and very persistent, very bioaccumulative properties. The regulation has specific application dates for new substances and mixtures. Organizations should check their product portfolios comply with the new regulations.

The new EU CLP regulation introduced four new hazard classes. These are:

  1. Endocrine disruption for human health (ED HH Category 1 or ED HH Category 2) - This class is intended to identify substances that can interfere with the body's endocrine system, which regulates hormones and plays a crucial role in human health.
  2. Endocrine disruption for the environment (ED ENV Category 1 or ED ENV Category 2) - This class is intended to identify substances that can interfere with the endocrine systems of fish, invertebrates, birds, mammals and other animals.
  3. Persistent, Bioaccumulative and Toxic or Very Persistent, Very Bioaccumulative properties (PBT and vPvB) - This class is designed to identify substances that persist in the environment, accumulate in living organisms, and have toxic effects.
  4. Persistent, Mobile and Toxic and Very Persistent, Very Mobile properties (PMT and vPvM) - This class identifies substances that are persistent, mobile, and have toxic effects. These substances can be transported over long distances and can persist in the environment.

The new EU CLP delegated regulation applies to a wide range of products that contain hazardous chemicals, including chemicals and mixtures used in industrial processes, consumer products such as cleaning agents and paints, and products used in healthcare such as disinfectants and medical devices. The regulation also impacts the labelling and packaging of these products, as well as their safety data sheets and REACH registration dossiers of the substances present. Manufacturers, importers, downstream users, and distributors of these products are required to comply with the new regulation, update their labels and documentation, and ensure that their products are properly classified according to the new hazard classes. It is important for organizations to evaluate the impact of the new regulation on their product portfolios to ensure compliance and promote safety and sustainability.

Companies must comply with the new CLP rules for new substances on the EU market from 1 May 2025.

For substances already on the EU market, companies have until 1 November 2026 to comply.

The new hazard classes apply to new mixtures on the EU market from 1 May 2026.

Companies have until 1 May 2028 to update the classification and labelling for existing mixtures.

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