ECHA:
New EU-Wide Project to Ensure Correct Classification and Labelling of Hazardous Mixtures
Objective of REF-14 Project: The European Chemicals Agency’s (ECHA) Enforcement Forum has launched a new project, REF-14, aimed at ensuring that hazardous mixtures within consumer products are accurately classified, labelled, and packaged. This initiative targets products such as air fresheners and electronic cigarettes, which may contain dangerous substances like acutely toxic nicotine or irritants.
Focus on Consumer Safety: The checks will focus on ensuring that products containing hazardous mixtures are not only correctly classified and labelled to inform consumers about potential dangers but also packaged securely to prevent children’s access. The project is set to begin preparations in 2025 with inspections planned for 2026. Key areas of inspection will include compliance with the CLP regulation, the efficacy of child-resistant fastenings, and the accuracy of safety data sheets and poison centre notifications.
Enforcement on Import Registration: Alongside REF-14, the Enforcement Forum will conduct a pilot project focusing on only representatives responsible for registering imported substances. This project aims to detect non-compliant operators and ensure that substance tonnages are accurately registered, which is crucial for managing chemical risks effectively.
Public Stakeholder Engagement: To increase transparency, the Forum plans to publicly broadcast workshops that present findings and recommendations from its enforcement projects. This move is designed to enhance public understanding of compliance challenges and the work of enforcement authorities.
Ongoing Enforcement Efforts: The Forum, along with its biocides subgroup BPRS, continues to steer and review various national-level enforcement campaigns. These groups plan to convene again in November 2024.
Background and Broader Goals: The Enforcement Forum and its subgroups, including BPRS, form a crucial network of enforcement authorities across the EU and EEA. They coordinate the enforcement of multiple chemical regulations, including REACH, CLP, PIC, POPs, and Biocidal Product regulations, aiming to safeguard health and the environment while ensuring fair market practices
CLP:
EU Debates Classification of Micro-Encapsulated Substances Under CLP Regulation
Seeking Consensus on Microcapsules: The European Commission is actively seeking input on the appropriate classification and labeling of micro-encapsulated substances. These substances are encapsulated within microscale polymer shells and are released at certain stages of a product’s lifecycle, post-manufacture. This query has been directed to the Competent Authorities for REACH and CLP (CARACAL) to determine if specific interpretations are required for these formulations.
Origin of Inquiry: The discussion was initially prompted by the Austrian competent authority during a CARACAL meeting in March 2022. Micro-encapsulation is a technology predominantly utilized in pesticides, biocides, detergents (for fragrances), and the food industry (for flavorings). The polymer casing of these microcapsules allows hydrophobic substances to be incorporated into water-based systems, managing their release effectively.
Differing Opinions Among Member States: In preparation for the CARACAL meeting held on July 1-2, the Commission described encapsulated systems as mixtures. However, opinions among member states vary. Germany, Sweden, and Austria support this classification, viewing the encapsulated substances as mixtures. Conversely, the Dutch authority contends that these should not be classified as mixtures since the capsule and its contents are not homogeneously mixed. They argue that the capsule should be viewed as a separate entity, akin to packaging, with classification based solely on the capsule’s contents.
Continuing Discussions: This ongoing debate underscores the complexities of classifying advanced chemical formulations within the existing regulatory frameworks. The resolution of this issue will be crucial for ensuring consistent and accurate labeling and handling of micro-encapsulated substances across the EU.
REACH
EU Commission to Publish Roadmap on Phasing Out Animal Testing in 2025
Development of the Roadmap: The European Commission is set to publish a comprehensive roadmap by the end of 2025 aimed at phasing out animal testing for chemical safety assessment. This announcement was made during a presentation to the Committee for REACH and CLP (CARACAL) in early July.
Focus Areas of the Roadmap: The roadmap will detail strategies to enhance and expedite the development, validation, and implementation of alternative, non-animal test methods. It aims to encourage the adoption of these methods across various regulatory frameworks to ensure the protection of human health and the environment without the need for new animal testing.
Collaborative Efforts and Stakeholder Engagement: An interservice group comprising experts from the Commission, its Joint Research Centre, the European Chemicals Agency (ECHA), and the European Food Safety Authority (EFSA) convened in May to discuss the validation and standardization of alternative testing methods. The group highlighted the need for better funding and prioritization of OECD test guideline development to meet EU regulatory demands. In preparation for the roadmap, the Commission is organizing a stakeholder consultation and will soon issue a call for evidence.
Impetus and Future Directions: The initiative for this roadmap originated from a European Citizens’ Initiative (ECI), which called for actions including reinforcing the ban on cosmetic animal testing, transforming EU chemicals regulation to manage chemicals safely without new animal tests, and proposing legislation to eliminate all animal testing in the EU. This roadmap reflects the EU’s ongoing commitment to these goals.
Challenges in Compliance Checks: In related news, ECHA has reported difficulties in completing compliance checks for REACH registration dossiers due to the unavailability of validated test methods for nanomaterials, underscoring the urgent need for advancements in testing methodologies.
PFAS
Study Reveals PFAS Migration Through Skin into Bloodstream
Research Findings on PFAS Permeation: New research from the University of Birmingham demonstrates that per- and polyfluoroalkyl substances (PFAS) can migrate through human skin into the bloodstream, suggesting that skin contact is a significant route of exposure to these persistent chemicals. Traditionally, PFAS exposure was thought to occur primarily through ingestion of contaminated food or water. However, this study highlights the potential risks from everyday products like cosmetics, hand sanitizers, and water-repellent clothing that come into contact with the skin.
Details of the Study: The study involved testing 17 different PFAS, revealing that all tested substances could permeate the skin to varying degrees. Particularly, substances with shorter carbon chains, such as perfluoropentanoic acid (PFPeA) and perfluorobutane sulfonate (PFBS), showed higher migration rates of 59% and 49%, respectively. This trend indicates that shorter-chain PFAS, which are often used as they are believed to be less toxic, might actually pose higher risks due to their greater skin absorption.
Implications and Industry Trends: Oddný Ragnarsdóttir, who conducted the research, emphasized that skin contact might be a significant source of PFAS exposure. Her supervisor, Stuart Harrad, a professor of environmental chemistry, noted the implications of industry shifts towards using shorter-chain PFAS. Although these are considered less toxic, the trade-off might be increased absorption into the body.
Methodology and Previous Research: The research team used the Episkin 3D human skin model for their tests, applying a methanol-based solution of each PFAS at concentrations of 500 nanograms per cubic centimeter for 24-36 hours. This study builds on previous findings from April, where similar methods showed comparable results for brominated flame retardants in microplastics, reinforcing concerns about various substances’ ability to breach the skin barrier.
Regulatory Context: The tested PFAS are among those highly studied for their toxic effects and are regulated under the EU’s Drinking Water Directive, emphasizing the need for comprehensive regulatory strategies that consider multiple exposure routes, including dermal absorption.
