June Regulatory Updates


Concerns Over Surge in Animal Testing Due to Endocrine Disruptors Deadline

Deadline Imposes Increased Testing: Industry representatives express concerns about a significant increase in animal testing due to a hard deadline for submitting data on the endocrine-disrupting properties of biocidal active substances by the end of 2026. This directive emerged during the Chemical Watch Events & Training Biocides Symposium on June 3. The European Commission’s plan aims to expedite the biocides review program, recently extended by six years, by mandating that missing data on endocrine effects be requested by June 30 and submitted by December 31, 2026.

Impact on Testing Protocols: The imposed deadline is expected to eliminate the tiered testing approach traditionally used for assessing endocrine disruptors, which begins with in vitro tests before resorting to animal testing. Ilona den Hartog from Nouryon Surface Chemistry highlighted that companies would be compelled to commence directly with extensive animal testing, such as the extended one-generation reproductive toxicity study (EOGRTS), potentially involving thousands of animals unnecessarily.

Financial and Regulatory Concerns: The necessity to generate endocrine effects data could double the costs associated with a biocidal products regulation (BPR) dossier. With the legal data protection period ending in 2025, the increased costs and time pressures could deter ongoing investment in biocidal substance dossiers, potentially leading to a loss of existing chemistries as feared by Carsten Baehr from Arxada.

Industry Skepticism and Testing Capacity: Many in the industry, including Ilse Tonk from Charles River, are skeptical about the feasibility of the deadline, citing capacity constraints at testing laboratories. Standard in vitro tests for endocrine effects take up to 14 weeks, while in vivo studies could take a year. This raises concerns about the realistic completion of necessary tests within the timeframe.

Challenges in Meeting 2030 Deadline: Doubts persist whether the biocides review program can be completed by the new deadline of December 31, 2030. Historical progress has seen only 48% completion over 26 years. Stakeholders, including ECHA regulatory officer Claudio Putzu, acknowledge that the agency alone cannot process the required 50 dossiers per year without additional resources and measures proposed by the Commission, which may also lead to increased fees for the industry.



EU Working Group Targets Safety Improvements in Dietary Supplements

Report on Hazardous Substances: Experts from European food safety agencies, organized under the Heads of Food Safety Agencies (HoA), have developed a report identifying substances that pose potential health risks in dietary supplements. The group, which includes leaders from food safety authorities of 26 European countries, convenes biannually under the EU Council presidency.

Substance Assessment and Recommendations: The working group has identified 117 substances with potentially hazardous properties in dietary supplements. Of these, thirteen substances were highlighted as priorities due to their possible health risks, including carcinogenic, mutagenic, or reprotoxic properties. The final list aims to inform EU legislators for potential regulatory actions.

Legislative and Safety Actions: The group recommends that the European Commission support the European Food Safety Authority (EFSA) in evaluating these substances. Pending EFSA’s agreement, the EU Commission may proceed with legislative measures. For substances not immediately prioritized, further regulatory steps are suggested.

Challenges and Methodological Adjustments: Initially, the working group intended to perform individual risk assessments for each substance but revised this approach due to unrealistic demands on time, resources, and data availability. Instead, they focused on substances exceeding typical intake levels through dietary supplements and those already causing alerts in the EU.

Substances of Concern and Novel Food Regulation: The identified substances include coumarin, piperine, and tryptophan among others, with some like Solanum dulcamara and Ginkgo biloba needing more exposure data for a complete risk assessment. The working group also referred to the EU’s Novel Food Regulation, which governs foods not significantly consumed in the EU before 1997, influencing the regulatory status of newer substances.

Alerts and Monitoring: An analysis of 1,500 Rapid Alert System for Food and Feed (RASFF) posts from 2017 to mid-2022 flagged eight substances including curcumin and melatonin for causing alerts due to their usage in food supplements, highlighting ongoing monitoring challenges and the need for continued vigilance in supplement safety.



NGO Report Highlights Overwhelming Presence of TFA in EU Waters

Dominant PFAS Compound Identified: An investigation conducted by Pesticide Action Network (PAN) Europe across 29 water sources in ten EU countries has revealed that trifluoroacetic acid (TFA) constitutes 99% of the total PFAS detected. This finding underscores the need to prioritize TFA in environmental regulation efforts.

Sources of TFA Contamination: TFA, an ultra-short-chain PFAS, arises from the degradation of longer-chain PFAS compounds and is notable for its high mobility and resistance to breakdown and removal by standard water purification methods. A 2023 report from the German Environment Agency highlighted pesticides and F-gases as significant contributors to TFA emissions, although the exact scale of industrial emissions remains unclear.

Measuring TFA Against EU Limits: In its detailed examination, PAN Europe tested TFA levels against the EU’s regulatory limit for total PFAS of 500ng/l (nanograms per liter). Alarmingly, TFA levels surpassed this limit in 23 of the samples, with the highest concentration reaching 3,300ng/l, more than six times the threshold. This widespread contamination emphasizes TFA’s significant contribution to the total PFAS load in EU waters.

Policy Implications and Recommendations: The report criticizes the current regulatory treatment of TFA as a ‘non-relevant’ metabolite under pesticides regulations, which offers lower protection levels for water sources. PAN Europe advocates for several regulatory changes:

  • Banning all PFAS in pesticide applications under the pesticides regulation.
  • Implementing a universal PFAS restriction under REACH.
  • Classifying TFA as a priority hazardous substance under the Water Framework Directive.
  • Establishing environmental quality standards and EU-wide monitoring obligations for TFA.

Toxicity and Regulatory Actions: Despite its widespread presence and persistence, the acute toxicity of TFA is considered low. However, PAN Europe points out that the toxicological profile of TFA remains largely unexplored, raising concerns about its long-term environmental impact. Germany has indicated plans to propose a reproductive toxicity classification for TFA under the CLP Regulation, highlighting the ongoing reassessment of its risks.



Italy’s 2024 National Control Plan for REACH Compliance Announced

Overview of the 2024 Control Plan: Italy has published its National Control Plan (PNC) for REACH-CLP for the year 2024. This plan outlines the strategy for inspection visits concerning compliance with the REACH and CLP regulations throughout the year.

Key Focus Areas: The 2024 PNC specifies that inspections will follow the guidelines set by the REACH Enforcement Project (REF-12), which focuses on the control of imported products, among other issues identified in pilot projects by ECHA’s Forum. Additionally, the plan supports integrated control of products that fall under other regulations such as POPs, RoHS, and the Toy Directive, advocating for cooperation among various regulatory authorities.

Inspection Topics for 2024:

  • Verification of registration obligations for substances as such or in mixtures.
  • Checks on authorization and restriction obligations, including related labeling and packaging for professional/industrial use.
  • Examination of notification requirements for substances in articles and communication within the supply chain.
  • Review of compliance with Safety Data Sheets (SDS) and extended SDS, chemical safety report obligations, and recommended risk management measures.
  • Verification of general classification, labeling, and packaging obligations, including exemptions and specific requirements for consumer-targeted products like soluble laundry detergent pods.
  • Assessment of advertisement and online sales regulations for chemical products.

Analytical Control Activities: The plan includes analytical control activities aimed at:

  • Verifying compliance with notification and communication obligations for SVHC substances in articles.
  • Ensuring adherence to authorization and restriction obligations.
  • Checking the accuracy of mixture compositions for classification, labeling, and SDS compliance.
  • Monitoring advertisement compliance for online-sold products.

Implementation and Reporting Timeline: Inspections will be conducted throughout 2024, with results expected to be reported by March 2025.

Further Analysis: A detailed analysis of the PNC 2024 will follow, highlighting the primary target categories identified as priorities. This analysis is crucial for businesses to understand and prepare for potential inspections by competent authorities, underscoring the significance of the PNC in Italy’s REACH-CLP regulatory inspections.