On March 31, 2023, the European Commission published a Delegated Regulation (EU) 2023/707 in the Official Journal of the European Union, which amends Regulation (EC) No 1272/2008. This is in response to the proposed revision of the CLP Regulation and the addition of new hazard classes for endocrine disruptors (EDs) and other hazardous chemicals.
The Annexes to Regulation (EC) No 1272/2008 have been adapted by Regulation 2023/707, which includes the addition of classification criteria for substances identified as endocrine disrupters for human health or the environment, PBT or vPvB, PMT or vPvM, as well as thresholds for the classification of mixtures and indicators related to hazard communication.
Background
Endocrine disruptors are chemicals that can interfere with the endocrine system, which is responsible for regulating hormones in the body. This disruption can lead to a wide range of adverse health effects, including developmental and reproductive issues, metabolic disorders, and even cancer. The regulation published by the EU establishes criteria for identifying endocrine disruptors and sets out a list of substances that meet those criteria.
The new list includes over 1,000 chemicals, such as bisphenol A, phthalates, and parabens, which are commonly used in consumer products. The regulation also outlines specific uses and exposure levels for each substance, as well as potential effects on human health and the environment.
In addition to the list of endocrine disruptors, the EU also published a list of chemicals that pose a risk to human health and the environment. This list includes substances that have been classified as carcinogenic, mutagenic, or toxic to reproduction. The regulation also establishes new criteria for identifying these substances and outlines the steps that companies must take to ensure their safe use.
New Classes
The Annexes to Regulation (EC) No 1272/2008 have been adapted by Regulation 2023/707.
Annex I has been amended to include four new hazard classes and criteria for classification of substances and mixtures, including classification criteria for endocrine disruptors for human health or the environment, PBT or vPvB, PMT or vPvM, and thresholds for the classification of mixtures. Additionally, two categories of endocrine disruptors have been created based on their scientific strength of evidence, known or presumed endocrine disruptors (category 1) and suspected endocrine disruptors (category 2), for both human health and the environment.
Annex II has been amended to include a new criterion triggering the hazard statement “Safety Data Sheet available on request” on the label for mixtures not classified as hazardous but containing a substance classified as a category 2 endocrine disruptor for human health or the environment, at a content equal to or higher than 0.1%.
Annex III has been amended to include new hazard statements for endocrine disruptors, such as “May cause endocrine disruption in humans” and “Suspected of causing endocrine disruption in humans” for human health, and “May cause endocrine disruption in the environment” and “Suspected of causing endocrine disruption in the environment” for the environment. It also includes hazard statements for accumulation in the environment and living organisms, and for long-lasting and diffuse contamination of water resources.
New hazard statements and codes have been added to the Annexes.
Timescales for changes
To give suppliers time to adapt to the new provisions, these changes will be applicable from:
- 1st May 2025, for Substances
- 1st May 2026, for Mixtures
Substances or mixtures placed on the market before these dates are not required to be classified and labelled according to the new criteria until:
- 1st November 2026, for Substances,
- 1st May 2028, for Mixtures
The Regulation comes into force from 20th April, 2023.
Other changes for labelling in CLP revision
In parallel to the introduction of the new hazard classes the EC has also revised the overall CLP law and published their Proposal in December 2022. These are currently being discussed by the Council and European Parliament and include major changes to label formatting, however these may well change before being entered into legislation. The consultation period for these proposals finished on 30th March 2023.
See also our previous article: EU Proposes Major Overhaul of Chemical Labelling
Important links: