January Regulatory Updates

ECHA:

ECHA Unveils New Chemical Information Database: ECHA CHEM

The European Chemicals Agency (ECHA) has introduced a groundbreaking database, ECHA CHEM, marking a significant enhancement in the accessibility and transparency of chemical information in the European Union (EU). This initiative represents the latest effort by ECHA to provide comprehensive data on chemicals to the public, consolidating industry-submitted data with insights from EU regulatory processes.

ECHA, known for maintaining the EU’s largest chemicals database, has launched the first release of ECHA CHEM. This initial version offers details from all 100,000+ REACH registrations submitted by companies, with plans for future expansions. Upcoming updates will include a revamped Classification and Labelling Inventory and the introduction of regulatory lists.

Mercedes Viñas, ECHA’s Director of Submissions and Interaction, emphasized the importance of ECHA CHEM in improving the agency’s data-sharing capabilities. She highlighted its role in making vast amounts of chemical information readily accessible online in a stable and user-friendly format.

Kai Taka-aho, Director of Information Systems, noted the technical flexibility and future-proof design of ECHA CHEM. The platform is built to accommodate large datasets and adapt to varying needs, including potential new tasks for ECHA, leveraging the latest technological advancements.

ECHA’s journey in providing chemical information began in earnest with the launch of its Information on chemicals platform in 2016. As the platform expanded to include information on over 360,000 chemicals, the need for an advanced system became apparent. In response, ECHA announced its intention in 2022 to develop ECHA CHEM. This new system not only accommodates the increasing diversity and volume of chemical data but also capitalizes on technological progress to enhance data management and accessibility.

 

EU Sets New Standards to Reduce Harmful Substances in Drinking Water

The European Commission has recently established new minimum hygiene standards for materials and products in contact with drinking water. This initiative aims to mitigate the risk of harmful substances, such as PFAS (per- and polyfluoroalkyl substances) and microplastics, leaching into drinking water systems. These standards are part of a broader effort to ensure the safety and quality of drinking water across the EU.

Applicable from 31 December 2026, these standards will cover a wide range of materials and products used in water supply systems, including those for the abstraction, treatment, storage, or distribution of water, as well as for repair works. Items such as supply pipes, valves, pumps, water meters, fittings, and taps will need to comply. Products meeting these standards will be granted an EU declaration of conformity and a unique EU marking, facilitating their unrestricted sale within the single market.

This move is in line with the objectives of the revised Drinking Water Directive (DWD), effective since 2021, which focuses on improving water access and safeguarding both public health and the environment from contamination risks.

In support of the European Commission, the European Chemicals Agency (ECHA) has been instrumental in:

  • Developing European positive lists of substances approved for use in manufacturing materials in contact with drinking water.
  • Creating risk assessment methodologies and information requirements for the review and potential addition of substances to the positive lists.
  • Establishing administrative procedures for regularly updating these lists.

With the first European positive lists adopted on 12 January, the Commission plans to review the DWD’s implementation in January 2032. Meanwhile, the European Parliament and the Council of Ministers have a two-month period to raise objections to the adopted legislative acts.

Further efforts include refining methodologies and guidelines for detecting microplastics and PFAS in drinking water. Additionally, recent EU legislative negotiations have aimed to enhance the Urban Waste Water Treatment Directive (UWWTD), introducing stricter treatment requirements to eliminate micropollutants, showcasing the EU’s commitment to combating water contamination and protecting public health and the environment.

 

EU Parliament Committee Endorses Stricter Toy Safety Standards

The European Parliament’s Environment Committee (ENVI) has cast a significant vote to tighten restrictions on the use of nitrosamines and bisphenols in toys, a move that has sparked concerns among EU toy manufacturers. During a meeting held on 24 January 2024, ENVI voted overwhelmingly in favor of amending the European Commission’s proposed toy safety regulations, adopting stricter limits without exceptions and potentially impacting the availability of ‘safe’ toys in the market.

Key Amendments and Industry Reactions:

  • ENVI proposes stringent migration limits for nitrosamines (0.01mg/kg) and nitrosable substances (0.1mg/kg) in all toys, eliminating the prior exemptions for toys intended for children under 36 months and certain other toys.
  • The Toy Industries of Europe (TIE) warns that such restrictions could render the production of latex balloons, which naturally contain nitrosamines, unfeasible. TIE argues that existing standards already ensure safety and that the new restrictions may unjustly penalize conscientious manufacturers.
  • Additionally, ENVI seeks to lower the allowable trace levels for banned fragrance allergens in toys from 100mg/kg to 10mg/kg, challenging manufacturers to maintain undetectable levels in products like crayons and paints that rely on natural elements.
  • A notable amendment includes a comprehensive ban on all bisphenols in toys, expanding beyond the initial proposal that targeted only bisphenol A. This move has been praised by consumer rights groups as a vital step towards eliminating harmful chemicals from children’s environments.

The ENVI’s stance reflects growing concerns over children’s exposure to carcinogenic and harmful chemicals through toys, aiming for a safer, toxin-free future. However, the toy industry expresses apprehension over the feasibility of these new standards and calls for a more extended transition period to adapt.

With the toy safety regulation proposal now fast-tracked for a plenary vote on 11 March, the debate underscores the tension between advancing public health objectives and addressing industry challenges in ensuring product safety.

 

PCN:

New EU Poison Centre Notification Requirements Now Effective

As of 1 January 2024, companies involved in notifying EU poison centres about mixtures intended for industrial use are now required to follow a harmonized format, as outlined in Annex VIII of the Classification, Labelling and Packaging (CLP) regulation. This new rule mandates that the unique formula identifier (UFI) code must be included on the product’s label, aiming to streamline and enhance the efficiency of hazardous mixture notifications.

ECHA has provided a grace period for companies that had completed their notifications prior to the enforcement date, allowing them a 12-month transition period until 1 January 2025. This period is designed to facilitate the update of notifications and relabeling efforts for products whose composition, identifiers, hazard classification, or toxicological information change.

The implementation of these requirements comes amidst increased scrutiny by national enforcement authorities across the EU. An initiative led by the ECHA Enforcement Forum focused on verifying the compliance of poison centre notifications for hazardous mixtures such as paints, detergents, and adhesives. The operation, which concluded in mid-2023, highlighted the critical need for compliance, with a comprehensive report anticipated early this year.

Moreover, recent inspections in four member states have uncovered significant irregularities in the application of UFI codes, underscoring the importance of adherence to the new regulations.

These developments signify a concerted effort to ensure the safety of industrial mixtures and protect public health through better information management and compliance. Companies eligible for the transition period are encouraged to review their notification status and prepare for the necessary updates to align with the EU’s harmonized standards.