ECHA Identifies 1,900 Chemicals as Regulatory Risks: Integrated Regulatory Strategy (IRS) Report

ECHA’s Milestones in Chemical Hazard Identification

ECHA’s Integrated Regulatory Strategy, implemented between 2019 and 2023, has screened over 6,000 chemical substances, identifying about 30% as candidates for further regulatory risk management (RRM). The agency prioritised high-volume chemicals, particularly those exceeding 100 tonnes per year, and also screened around 20% of lower-volume substances due to their potential risk profiles.

“Almost all high-tonnage chemicals have been assessed or categorised for regulatory action,” said Ofelia Bercaru, ECHA’s Director of Prioritisation and Integration. By the end of 2024, nearly all substances registered by 2018 are expected to be screened, marking a critical step toward ensuring chemical safety across industries.

Industries and Uses of the High-Risk Substances

The flagged chemicals are used across a range of industries, including automotive, construction, electronics, textiles, and consumer products. Many of these substances play essential roles in the formulation of plastics, paints, adhesives, and cleaning products. For instance:

• Bisphenols: Widely used in the production of polycarbonate plastics and epoxy resins, these chemicals are common in products like water bottles, food containers, and coatings.
• Ortho-Phthalates: Primarily found as plasticisers in flexible plastics, they are used in flooring, wall coverings, and personal care products.
• Flame Retardants: Added to various materials in electronics, textiles, and building insulation, flame retardants enhance fire resistance but have raised concerns over toxicity and persistence in the environment.
• Hydrocarbyl Siloxanes and Phenols: These are used in a range of personal care products, cleaning agents, and coatings but are under scrutiny for their potential endocrine-disrupting effects.

Why These Substances Require Regulatory Oversight

The chemicals highlighted by ECHA’s report present risks that span both environmental and human health concerns. Many of these substances are flagged for potential carcinogenic, mutagenic, or toxic (CMR) properties, meaning they may be harmful if inhaled, ingested, or if they come into contact with skin. Others are classified as persistent, bioaccumulative, and toxic (PBT) substances, which resist degradation and accumulate in the ecosystem, causing long-term ecological impacts. ECHA’s assessment process helps prioritise substances for action, focusing on both human health and environmental safeguards.

Next Steps in Regulatory Risk Management

Following ECHA’s report, the flagged chemicals will undergo further regulatory processes, including potential classification under REACH as Substances of Very High Concern (SVHC), harmonised labelling, and possible restrictions or authorisation requirements. ECHA’s Risk Management and Evaluation Platform (RIME+) will guide EU Member States and industry stakeholders through each stage, ensuring coordinated actions across the EU to manage the identified risks effectively.

Strengthening Cooperation and Transparency

ECHA has placed significant emphasis on transparency and cooperation with EU Member States, utilising tools like the Public Activities Coordination Tool (PACT) and the Risk Management and Evaluation Platform (RiME+). These initiatives have bolstered information-sharing on regulatory actions and streamlined decision-making for potential RRM processes. ECHA also collaborates with industry groups under initiatives like the Joint Evaluation Action Plan (JEAP) to identify data needs and improve dossier quality for registered substances.

Key Regulatory Challenges and Future Objectives

Despite these achievements, ECHA reports ongoing challenges, including limited regulatory capacity and insufficient data on chemical hazards and exposures. ECHA notes that addressing data gaps for certain groups of substances may take years, impacting the timeliness of RRM actions. Additionally, ECHA has begun exploring alternative data-generation methods, like new approach methodologies (NAMs), to accelerate risk assessments.

For 2024-2028, ECHA has outlined an updated regulatory framework that will focus on coordinated prioritisation, enhanced database management, and expanded collaboration. Notably, the agency aims to leverage its new regulatory tasks under the Drinking Water Directive, Industrial Emissions Directive, and Batteries Regulation to ensure a unified regulatory approach.

The report underscores ECHA’s commitment to strengthening regulatory actions and enhancing EU-wide chemical safety standards. As the agency enters a new strategic phase, it aims to deepen collaboration with the European Commission and Member States to advance RRM and continue its mission towards sustainable chemical safety.