Europe Regulatory News

On 10 December 2024, the European Commission officially decided not to proceed with the inclusion of medium-chain chlorinated paraffins (MCCPs – CAS No 85535-85-9) and tetrabromobisphenol A (TBBP-A ...

On 10 December 2024, the European Commission officially decided not to proceed with the inclusion of medium-chain chlorinated paraffins (MCCPs – CAS No 85535-85-9) and tetrabromobisphenol A (TBBP-A – CAS No 79-94-7) under the Restriction of Hazardous Substances (RoHS) Directive. The substances, widely used as flame retardants and plasticizers in electrical and electronic equipment (EEE), had been under consideration due to concerns about their persistence in the environment and potential health risks.

Timeline of the Proposal

The decision marks the end of a multi-year process:

• 2019: MCCPs and TBBP-A were identified as candidates for restriction under RoHS due to their classification as Persistent Organic Pollutants (POPs) and bioaccumulative properties.

• 2021: The European Commission initiated a formal assessment to determine the need to restrict these substances under RoHS.

• 2022-2023: Public consultations and technical evaluations took place. Industry stakeholders raised concerns about regulatory overlap with existing measures under the REACH Regulation.

• 10 December 2024: Following these evaluations, the Commission concluded that the risks posed by MCCPs and TBBP-A are adequately addressed under REACH and that making additional restrictions under RoHS are not necessary.

Reason for the Decision

The Commission found that:

• The REACH Regulation already provides sufficient control of MCCPs and TBBP-A, including their risks and uses.

• Adding these substances to the RoHS Directive would lead to regulatory redundancy without significant additional environmental or health benefits.

Conclusion

While the proposal to restrict MCCPs and TBBP-A under the RoHS Directive has been abandoned, the substances remain regulated under REACH. The decision reflects the Commission’s efforts to balance regulatory efficiency with environmental and health protection.

The revised Classification, Labelling and Packaging (CLP) Regulation, which came into force on 10 December 2024, introduces important updates for poison centre notifications. Under the new rules, dist...

The revised Classification, Labelling and Packaging (CLP) Regulation, which came into force on 10 December 2024, introduces important updates for poison centre notifications. Under the new rules, distributors (i.e. companies that relabel, rebrand, or retail hazardous mixtures) are now classified as Duty Holders, which clarifies their responsibilities for ensuring compliance.

What Distributors Need to Know

Distributors must ensure that all hazardous mixtures placed on the market have accurate poison centre notifications. If no notification exists, or if product identifiers are updated, distributors must

• Provide the necessary information to the original notifier or supplier for inclusion, or

• Submit their own notification directly to the relevant poison centre.

Keeping Information Up to Date

In addition to initial notifications, Duty Holders must keep poison centres informed on changes in

• Packaging type

• Product category

• Contact information that could affect emergency response.

Guidance and Deadlines

To assist companies, the European Chemicals Agency (ECHA) is updating its guidance on poison centre notifications, expected by summer 2025. Companies should prepare now to meet the revised requirements.

For more details, visit ECHA’s poison centre notifications page here.

The updated EU Classification, Labelling, and Packaging (CLP) Regulation (Regulation (EU) 2024/2865) officially entered into force on 10 December 2024. The updated CLP Regulation was adopted by the Co...

The updated EU Classification, Labelling, and Packaging (CLP) Regulation (Regulation (EU) 2024/2865) officially entered into force on 10 December 2024. The updated CLP Regulation was adopted by the Council of the European Union on 14 October 2024 and published in the Official Journal of the European Union on 20 November 2024. This update aims to improve the identification and communication of chemical hazards, while ensuring greater protection for consumers and the environment.

Key Changes Under the Updated CLP Regulation

The updated CLP Regulation introduces several improvements to better protect public health and the environment. Notable updates include

• Improved Classification Rules: Clarification on how to classify mixtures and substances with multiple constituents.

• New Hazard Classes: Endocrine disruptors (ED), persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), and very persistent and very mobile (vPvM) substances are now considered to be hazards of very high concern.

• Focus on Grouping and Harmonization: Enhanced emphasis on grouping substances for harmonised classifications.

• Clearer Labelling Requirements: Introducing of rules for clearer labelling for hazardous chemicals.

• Online Hazard Communication: Mandatory inclusion of chemical hazard information in online sales and advertisements to effectively inform consumers.

• Flexible Labelling Options: Introduces fold-out and digital labelling options to improve legibility and accessibility for users.

• Distributor Responsibilities: Distributors now play an important role in poison centre notifications. They are required to submit information for certain chemicals to ensure appropriate emergency response.

• Regulations for Refill Stations: New rules regulate the sale of chemicals at refill stations to enhance consumer safety.

• ECHA and EFSA Proposals: The European Commission may request harmonized classification proposals from the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA).

• User-Friendly Substance Inventory: Development of an inventory system that improves access to information for SMEs and increases transparency for all stakeholders.

The Role of Distributors under the Updated CLP Regulation

One of the key changes introduced by the updated CLP Regulation is the clarification of the responsibility of distributors in poison centre notifications. Distributors are now required to notify poison centres of certain hazardous mixtures they place on the market, ensuring that emergency responders have accurate information in the event of an incident. This change underscores the growing importance of transparency and preparedness in chemical safety management.

Different Application Dates for Specific Measures

While the regulation entered into force on 10 December 2024, the applicability of certain provisions varies, giving industry time to adapt:

• General Obligations: Most of the new rules will apply from 1 July 2026, giving companies time to align their operations with the updated requirements.

• Label Formatting Rules: The new label formatting requirements, including fold-out and digital labels, will apply from 1 January 2027.

• Exemptions for Existing Products: Substances and mixtures already placed on the market before 1 January 2027 will not need to be re-labelled or re-packaged under the updated rules.

  • Substances: These can remain in the supply chain until 1 July 2028 without having to update to their labels or packaging.

  • Mixtures: These can remain in the supply chain until 1 January 2029 without having to comply with the new labelling and packaging rules.

These staggered deadlines provide industry with flexibility to ensure compliance while minimizing disruption to existing supply chains.

Compliance Guidance and Resources

To assist companies with these new requirements, ECHA has published resources, including

• Detailed guidance on the new hazard classes, such as ED and PBT substances.

• Guidance on the implementation of mixture classification using bridging principles.

Upcoming resources in 2025 will provide additional guidance on labelling, Annex VIII (poison centres), and practical methods for grouping and read-across approaches.

Industry Action Required

ECHA urges companies to review their chemical portfolios and update classifications to comply with the revised regulation. This includes revising REACH registration dossiers and CLP notifications.

The full text of the updated CLP Regulation is available here.

From 29 November 2024, the European Union enforces a strict ban on lead in polyvinyl chloride (PVC) products, targeting concentrations of 0.1% or more by weight. This measure aims to further reduce ex...

From 29 November 2024, the European Union enforces a strict ban on lead in polyvinyl chloride (PVC) products, targeting concentrations of 0.1% or more by weight. This measure aims to further reduce exposure to the toxic substance, thereby protecting both human health and the environment.

Key Provisions of the Restriction

• Scope: The regulation applies to all PVC products, including imported goods and recycled materials.

• Transition Periods for Recovered PVC Applications

Recognising the challenges in eliminating lead from recycled materials, the EU has introduced transition periods for certain applications:

• PVC Articles Containing Recovered PVC: A 15-year derogation is granted, allowing higher lead content limits - up to 2% by weight for rigid PVC and 1% for flexible PVC. This period allows for the gradual reduction of lead in recycled PVC and supports recycling initiatives.

• Review Timeline: The derogation will be reassessed within 7.5 years of the entry into force of the restriction to evaluate progress in reducing lead content in recycled PVC.

Health and Environmental Concerns

Lead is known to cause serious damage to the nervous system, particularly in children, and is associated with chronic kidney disease and high blood pressure. It is also highly toxic to aquatic life, underlining the importance of minimising its use.

EU's Industry Initiative and Regulatory Impact

The PVC industry in the European Union has already voluntarily phased out the use of lead stabilisers. This regulation goes further by addressing imported products and materials containing recycled PVC, ensuring comprehensive protection.

Detailed information can be found in the official EU regulation here.

On 10 December 2024, the European Chemicals Agency (ECHA) published the draft Community Rolling Action Plan (CoRAP) for 2025-2027. This annual update lists substances suspected of posing a risk to hum...

On 10 December 2024, the European Chemicals Agency (ECHA) published the draft Community Rolling Action Plan (CoRAP) for 2025-2027. This annual update lists substances suspected of posing a risk to human health or the environment and outlines the timetable for their evaluation. The plan is part of REACH (Regulation (EC) No. 1907/2006), which aims to generate information necessary to clarify such risks through substance evaluation.

The new draft includes 31 substances, 13 of which are new compared to the current CoRAP (2024-2026). Eight substances are scheduled for evaluation in 2025, including two groups of two substances, 15 in 2026 and five in 2027. The draft also proposes the withdrawal of three substances, citing sufficient data already available or low priority for further evaluation.

Addressing Health and Environmental Risks

The CoRAP focuses on substances with initial concerns such as potential carcinogenicity, endocrine disruption, persistent and bioaccumulative toxicity (PBT/vPvB) and high exposure levels. These substances are widely used in industrial or consumer products, leading to potential exposure of workers or the environment.

For each substance, the draft provides non-confidential details, including chemical names, CAS numbers, the reasons for concern, and the Member State responsible for the evaluation. For example, substances scheduled for evaluation in 2025 include tris(2-ethylhexyl) phosphate (a suspected endocrine disruptor) and potassium dicyanoargentate (with reproductive toxicity and endocrine disruption concerns).

Substances Scheduled for Evaluation in 2025

The draft CoRAP lists eight substances for evaluation in 2025, targeting concerns such as carcinogenicity, endocrine disruption and PBT/vPvB properties. Below is a detailed table summarizing the substances, their CAS numbers, and the evaluating Member States.

Stakeholder Engagement and Timeline

The draft CoRAP was submitted to the Member State Competent Authorities and the ECHA Member State Committee on 28 November 2024. The Committee will review the draft and give its opinion by February 2025, after which ECHA will adopt and publish the final CoRAP update by 25 March 2025.

ECHA emphasises the importance of early communication between substance registrants and the evaluating Member State authorities. This proactive approach will ensure smoother evaluations and address concerns effectively.

Stakeholders are encouraged to review the draft and prepare for any necessary engagement. The full list of substances is available here.

On 13 November 2024, the European Chemicals Agency (ECHA) announced that it has partnered with the Fraunhofer Institute to investigate a potential alternative to aquatic toxicity testing using fish. T...

On 13 November 2024, the European Chemicals Agency (ECHA) announced that it has partnered with the Fraunhofer Institute to investigate a potential alternative to aquatic toxicity testing using fish. The research will focus on whether the Fish Embryo Toxicity (FET) test, already recognized as an alternative for acute toxicity assessment, can be enhanced with transcriptomics to replace chronic toxicity testing.

The Role of Enhanced FET in Chemical Safety

Enhanced FET uses transcriptomics to detect molecular changes in fish embryos exposed to chemicals, providing insights into adverse effects and toxicological mechanisms, including endocrine disruption. Fish embryos are not classified as a protected life stage under EU animal welfare legislation, positioning this method as a promising New Approach Methodology (NAM) for regulatory hazard assessment.

Addressing Animal Testing Concerns

ECHA’s initiative responds to increasing societal and political pressure to phase out animal testing in the assessment of chemicals. The Agency is actively developing NAMs, working with stakeholders and organising events to promote non-animal testing methods.

On 26 November 2024, the European Commission notified the World Trade Organization (WTO) of its proposal to restrict the use of per- and polyfluoroalkyl substances (PFAS) in fire-fighting foams. The d...

On 26 November 2024, the European Commission notified the World Trade Organization (WTO) of its proposal to restrict the use of per- and polyfluoroalkyl substances (PFAS) in fire-fighting foams. The draft Regulation aims to amend Annex XVII of the REACH Regulation (Regulation (EC) No 1907/2006) to address the significant risks posed by PFAS to human health and the environment.

Details of the Proposed Regulation

The draft Regulation proposes a comprehensive ban on the placing on the market and use of PFAS in firefighting foams, accompanied by sector-specific transition periods to facilitate compliance. Key highlights include:

• Scope of the Restriction:

  • Applies to all firefighting foams and foam concentrates with a PFAS concentration equal to or greater than 1 mg/l.

  • Covers products used in industry, public services and portable fire extinguishers.

• Specific Measures:

  • Phasing out the use of PFAS-containing firefighting foams over five years for most sectors.

  • Introduces stricter labelling, disposal and management measures for PFAS-containing products during the transitional period.

Sector-Specific Transition Periods

The proposed Regulation provides for tailored timelines to allow industry and public services to transition to PFAS-free alternatives:

• Portable Fire Extinguishers:

  • Alcohol-resistant fire-fighting foams:

    • Placing on the market is permitted until 18 months after the entry into force of the Regulation.

  • Other fire-fighting foams for portable fire extinguishers:

    • Placing on the market is allowed until 12 months after entry into force.

    • Use permitted until 31 December 2030.

• Other Applications:

  • Offshore oil and gas installations, military and civilian ships, and establishments under the Seveso Directive: Use of foams containing PFAS will be allowed until 10 years after entry into force.

  • Public fire services: Use is permitted for 10 years when fighting industrial fires at Seveso sites.

• All Other Uses:

• For general uses not covered by the above categories, both placing on the market and use of PFAS-containing firefighting foams will be allowed until 5 years after entry into force.

Enhanced Labelling and Disposal Requirements

To reduce risks during the transition period, the Regulation requires:

• Labelling:

  • Clear warnings for foams and foam concentrates containing PFAS concentrations ≥1 mg/l.

  • Labels must indicate PFAS concentrations and comply with language requirements in Member States.

• Waste Management:

  • Prohibition of biological wastewater treatment for PFAS-containing waste.

  • Collected waste must be treated or incinerated at a minimum temperature of 1,100°C.

Objectives of the Restriction

This proposal is part of the EU’s wider strategy to minimize the risks posed by PFAS-related risks. Its main goals include:

• Protecting Water Sources: Reducing PFAS emissions to prevent contamination of groundwater and drinking water.

• Promoting Safer Alternatives: Encourage innovation and adoption of non-fluorinated firefighting foams.

• Ensuring Regulatory Uniformity: Establishing consistent rules across the EU to facilitate the free movement of goods.

Next Steps and Stakeholder Involvement

The proposal has been notified to the WTO under the Technical Barriers to Trade (TBT) framework, allowing stakeholders worldwide to review and provide feedback. Comments are invited until 26 January 2025 and the regulation is expected to be adopted in the second quarter of 2025. It will enter into force 20 days after publication in the Official Journal of the European Union.