EU - Key Regulatory Insights 2024

The Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation, Regulation (EC) No 1907/2006, is the legal framework for the regulation of chemicals in the European Union (EU). It was adopted to enhance the protection of human health and the environment from potential risks posed by chemicals, while promoting the competitiveness of the EU chemicals industry. REACH entered into force on June 1, 2007, and applies to all chemical substances, including those used in industrial processes, consumer products, and articles such as paints, cleaning products, furniture, and electronics. It requires manufacturers and importers to register substances produced or imported in quantities of one tonne per year or more, unless specifically exempted. Registered substances can then circulate freely within the EU market. The regulation also encourages alternative testing methods to reduce reliance on animal testing.

Under REACH, companies have the burden of proof to identify and manage the risks associated with their substances. They must demonstrate safe use to the European Chemicals Agency (ECHA) and communicate risk management measures to downstream users. If risks cannot be controlled, authorities can restrict or ban substances, with the long-term goal of substituting hazardous chemicals with safer alternatives. The registration process follows a “one substance, one registration” principle, requiring companies producing the same substance to share data through a joint registration dossier submitted to ECHA. The dossier consists of a Technical Dossier (covering identity, classification, test data, and use) and a Chemical Safety Report (CSR) (for substances exceeding 10 tonnes per year, detailing hazard assessments and exposure scenarios). Since the registration deadline of May 31, 2018, unregistered chemicals cannot be manufactured or marketed in the EU, ensuring strict compliance with REACH regulations.

Key News from 2024

ECHA Expands SVHC Candidate List in 2024

In 2024, the European Chemicals Agency (ECHA) added seven substances to its Candidate List of Substances of Very High Concern (SVHC) on three occasions, bringing the total to 242 entries. Notable additions include bis(α,α-dimethylbenzyl) peroxide in June for its reproductive toxicity, and triphenyl phosphate in November for its endocrine disrupting properties. These updates aim to better protect human health and the environment by identifying and regulating hazardous chemicals. Companies are now required to manage the risks associated with these substances and provide safety information to customers and consumers. Read more here, here and here.

European Union Updates CLP Regulation and ECHA Issues Revised Guidance

The European Union has adopted Regulation (EU) 2024/2865, amending the Classification, Labelling, and Packaging (CLP) Regulation. It was published in the Official Journal on November 20, 2024, and entered into force on December 10, 2024. In conjunction, the European Chemicals Agency (ECHA) published updated guidance on November 13, 2024, detailing the application of new hazard classes, including criteria for endocrine disruptors and persistent, bioaccumulative, and toxic substances. Read more here, here and here.

EU Adopts New Regulation to Combat Ozone Depletion

The European Union has adopted Regulation (EU) 2024/590 to limit emissions of ozone-depleting substances. The Regulation was published on February 20, 2024, and entered into force on March 11, 2024, repealing Regulation (EC) No 1005/2009. The Regulation prohibits the production, import, export, and sale of listed substances, with exemptions for specific uses such as feedstock, process agents, essential laboratory applications, critical halon uses, and emergency methyl bromide applications. This initiative is in line with the European Green Deal, which aims to protect the ozone layer and reduce greenhouse gas emissions. Read more here.

ECHA Launches ECHA CHEM Database

On January 30, 2024, the European Chemicals Agency (ECHA) launched ECHA CHEM, a user-friendly platform providing information on more than 100,000 chemicals registered under REACH. This initial release aims to enhance public access to chemical data, with future expansions planned to include the Classification and Labelling Inventory and Regulatory Lists. ECHA CHEM reflects ECHA’s commitment to efficiently manage the growing volume of chemical data and to take advantage of technological advances. Read more here.

New Distributor Responsibilities and UFI Compliance in Poison Centre Notifications

The recent amendments to the Classification, Labelling, and Packaging (CLP) Regulation introduce significant responsibilities for distributors. Distributors are now required to ensure that hazardous mixtures are correctly classified, labelled, and packaged before they are placed on the market. They must also verify that suppliers have fulfilled their Poison Centre Notification (PCN) obligations, including the assignment and proper labeling of Unique Formula Identifiers (UFIs). To help companies manage UFIs effectively, the European Chemicals Agency (ECHA) published an infographic on January 21, 2025, emphasizing the 'one UFI – one composition' principle. Adherence to this principle is critical for compliance and to facilitate accurate emergency response by poison centres. Read more here and here.

Progress on the EU PFAS Restriction Proposal in 2024

The European Chemicals Agency (ECHA) has made significant progress on the restriction proposal for per- and polyfluoroalkyl substances (PFAS) in 2024. In March, ECHA's Scientific Committees began evaluating the proposal, focusing on the potential health and environmental impacts of PFAS. In June, ECHA provided updates showing significant progress in assessing the risks associated with these substances. In July, the EU introduced restrictions on a specific PFAS sub-group, perfluorohexanoic acid (PFHxA), to reduce associated health and environmental risks. These developments underscore the EU's commitment to regulating PFAS and protecting public health and the environment. Read more here, here and here.

Key Dates for 2025

From January 1, 2025, all hazardous mixtures must be notified to poison centers using the harmonized format under Annex VIII of the CLP Regulation. From May 1, 2025, new hazard classifications under the CLP Regulation, including endocrine disruptors and persistent, bioaccumulative, and toxic substances, will apply for substances placed on the market.