Europe Regulatory News

The European Union has notified the World Trade Organization (WTO) of a draft Commission Regulation proposing amendments to the REACH Regulation (Regulation (EC) No 1907/2006). The amendment aims to i...

The European Union has notified the World Trade Organization (WTO) of a draft Commission Regulation proposing amendments to the REACH Regulation (Regulation (EC) No 1907/2006). The amendment aims to include recently classified carcinogens, germ cell mutagens, and reproductive toxicants (CMRs) in category 1A and 1B of the EU’s Classification, Labelling, and Packaging (CLP) Regulation (Regulation (EC) No 1272/2008). The amendments will extend the scope of Annex XVII of REACH and impose new restrictions on the placing on the market or use of these substances, in particular for supply to the general public. The amendments are in line with the recent harmonised classification of these substances under the CLP Regulation, ensuring stricter control of their use in consumer products.

Key Provisions of the Proposed Regulation

• Extended Restrictions for CMR Substances: The draft Regulation introduces new amendments to Entries 28, 29 and 30 of Annex XVII to REACH, which will impose restrictions on substances classified as CMR category 1A or 1B. These restrictions will apply to substances when sold as such, in mixtures or as constituents of other substances.

• Labelling Requirements: To further ensure safety, packaging containing these newly classified substances will have to be labelled with the warning "restricted to professional users", effectively restricting consumer access to products containing these substances.

• Derogation for Cumene in Aviation Fuels: An important derogation is introduced for cumene, allowing its presence in certain aviation fuels (kerosene and aviation gasoline) used in small aircraft flown by non-professional pilots. This derogation takes into account the limited use of aviation fuels by non-professional pilots compared to motor fuels used by non-professional car drivers.

Objectives and Rationale for the Regulation

The regulation is motivated by the recent harmonised classification of certain substances as CMR category 1A or 1B under the CLP Regulation. In response, the European Commission is using its powers under Article 68(2) of REACH to propose these restrictions which aim to protect human health and safety by reducing exposure to these dangerous substances.

Timeline and Next Steps

• Adoption Date: The Regulation is expected to be adopted in the second quarter of 2025.

• Effective Date: The restrictions on CMR substances classified as category 1B will apply from 1 September 2025. Operators will be able to apply the restrictions earlier if they wish.

• Entry into Force: The Regulation will enter into force 20 days after its publication in the Official Journal of the EU, with the derogation for cumene in aviation fuels applying immediately.

• Final Date for Comments: Stakeholders have 60 days from the date of notification to submit comments on the draft Regulation. The notification was sent to the WTO on 22 November 2024, so the final date for comments is 21 January 2025.

Conclusion

The EU’s proposed amendments to REACH aim to strengthen protection against hazardous CMR substances, particularly those newly classified as category 1A and 1B. The regulation introduces important restrictions, including enhanced labelling and an exemption for cumene in aviation fuels. Industry stakeholders are encouraged to review the draft regulation and participate in the public comment period to help shape the final text of the regulation.

The full text of the draft regulation can be accessed here.

On 20 November 2024, the European Union (EU) notified the World Trade Organization (WTO) of a draft Commission Implementing Decision proposing the non-approval of ethylene oxide as an active substance...

On 20 November 2024, the European Union (EU) notified the World Trade Organization (WTO) of a draft Commission Implementing Decision proposing the non-approval of ethylene oxide as an active substance in product-type 2 biocidal products. This measure, notified under document G/TBT/N/EU/1096, reflects the EU's commitment to improving public health and environmental protection.

Understanding Ethylene Oxide and Its Uses

Ethylene oxide (CAS No 75-21-8) is a versatile chemical compound widely used in industrial processes, including the production of textiles, detergents and adhesives. In the context of biocidal products, its main use is as a sterilizing agent, particularly in the healthcare sector for the sterilisation of medical equipment.

Health and Environmental Concerns

Although highly effective as a sterilizing agent, ethylene oxide poses significant health risks. Classified as a carcinogen, exposure to ethylene oxide has been linked to cancers such as leukaemia and lymphoma, as well as reproductive toxicity and respiratory irritation. Environmental concerns include its contribution to air pollution and its persistence in the environment.

EU Regulatory Framework for Biocidal Products

Under the Biocidal Products Regulation (BPR; Regulation (EU) No 528/2012), the EU rigorously evaluates and approves active substances in biocidal products to ensure that they do not pose unacceptable risks. The draft decision to disapprove ethylene oxide for product-type 2 biocidal products is in line with this framework and underlines the EU's commitment to public health and environmental safety.

Impact on Industry and Stakeholders

If adopted, this decision will require manufacturers and users of biocidal products containing ethylene oxide to switch to alternative substances or sterilization methods. This transition may require research and development to identify effective and safer alternatives.

Public Consultation and International Trade Considerations

The EU's notification to the WTO allows member countries and stakeholders to review and provide feedback on the proposed measure. This ensures transparency and promotes international dialogue on safety standards and potential trade implications.

Next Steps

Stakeholders are invited to participate in the consultation process by submitting comments and feedback on the draft decision within 60 days of the notification date. This engagement will help evaluate the impact of the proposal on public health, environmental safety and international trade.

The full text of the draft Commission Implementing Decision is available here.

On 11 November 2024, the European Union Chemicals Agency (ECHA) announced the release of a new service version for the International Uniform Chemical Information Database (IUCLID). This most recent ve...

On 11 November 2024, the European Union Chemicals Agency (ECHA) announced the release of a new service version for the International Uniform Chemical Information Database (IUCLID). This most recent version, IUCLID v8.13.2, focuses on resolving important issues and making substantial improvements to the user experience and functionality.

Key Improvements in IUCLID v8.13.2

• The document comparison feature has been restored for easier document inspection and analysis. Text wrapping for large strings has been optimised, which improves readability and user experience.

• Enhanced date-picker control and full-screen mode for rich text fields simplify data entry.

• The process of creating a dossier is simplified by the automatic selection of legal entities in dossier headers.

• More flexibility in data management is offered by the option to rearrange records in multi-reference fields.

Technical Upgrades in IUCLID v8.13.2

• Java upgrade

• Unified authentication mechanism

Enhanced User Group Features

• Improved report formats and validation rules.

• Extended labelling calculator for non-GHS hazard statements (EU CLP). A revised PCN report and an extended labelling calculator.

• A new report on analytical methodologies (EU PPP) has been released. Improved quality criteria, a new report on analytical techniques and better component filtering.

• Improved quality standards for applications involving active substances (EU BPR). New set of quality standards for applications involving active substances.

Impact of IUCLID v8.13.2 on Users

IUCLID v8.13.2 seeks to improve chemical information management and regulatory compliance for users across sectors by addressing major issues and delivering valuable innovations.

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On 20 November 2024, the European Chemicals Agency (ECHA), in collaboration with authorities from Denmark, Germany, the Netherlands, Norway and Sweden, provided a progress update on the restriction pr...

On 20 November 2024, the European Chemicals Agency (ECHA), in collaboration with authorities from Denmark, Germany, the Netherlands, Norway and Sweden, provided a progress update on the restriction proposal for per- and polyfluoroalkyl substances (PFAS).  The update outlines the current status and future plans of ECHA's Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) as they assess the potential impact of the proposed restriction on different sectors using PFAS.

Submitted in January 2023, the PFAS restriction proposal under REACH aims to reduce the environmental and health risks associated with these persistent chemicals. PFAS are a group of thousands of man-made chemicals known for their persistence, bioaccumulation and potential toxic effects. The proposed restriction aims to ban the manufacture, use and sale of these substances in the EU in order to reduce their environmental and health impacts.

Extensive Consultation and Sector-Specific Insights

More than 5,600 scientific and technical comments were received during the six-month consultation in 2023, providing valuable insights into PFAS uses and alternatives across Europe. Newly identified uses include:

• Sealing applications: Fluoropolymer uses in seals, gaskets, and pipe linings.

• Technical textiles: High performance membranes and technical fabrics for outdoor use.

• Medical applications: Pharmaceutical packaging and excipients.

• Printing: Permanent parts and consumables.

Fluoropolymers, a subgroup of PFAS, have emerged as a key area of interest during the consultation process. Stakeholder input has provided critical insights into the availability of alternatives for certain fluoropolymer applications and the measures needed to minimise their environmental emissions. The socio-economic implications of restricting their manufacture, market placement, and use are being carefully evaluated. Due to their significance, fluoropolymers are receiving focused attention from all actors involved in the opinion development process.

Exploring Alternative Restriction Options

In addition to the initial proposals for a total ban or a ban with time-limited derogations, alternative options are being assessed to balance risk reduction with socio-economic impacts. These may include conditional authorisations for specific uses, such as:

• Batteries, fuel cells, and electrolysers

• Medical devices and semiconductors

The European Commission, with input from ECHA’s Risk Assessment and Socio-Economic Analysis Committees (RAC and SEAC), will evaluate these options and take final decisions.

Next Steps

ECHA and the dossier submitters will continue to refine their evaluation throughout 2025, leading to a consolidated opinion. Stakeholders will have further opportunities to provide input on socio-economic aspects before final decisions are taken.

The European Commission has released a detailed Frequently Asked Questions (FAQ) document to provide initial clarification on the newly implemented Eco-design for Sustainable Products Regulation (ESPR...

The European Commission has released a detailed Frequently Asked Questions (FAQ) document to provide initial clarification on the newly implemented Eco-design for Sustainable Products Regulation (ESPR), which officially took effect on July 18, 2024. The ESPR seeks to establish a new benchmark for product sustainability, requiring all products introduced to the EU market to be designed with a strong focus on environmental impact. 

Key Insights from the FAQ Document 

The FAQ document addresses frequently asked questions from stakeholders regarding the ESPR (Regulation (EU) 2024/1781), which was adopted by the European Parliament and the Council on June 13, 2024. This Regulation establishes a framework for the setting of ecodesign requirements for sustainable products (ESPR). The document offers preliminary clarifications from the European Commission's services, but should not be considered as an official stance of the Commission. It aims to provide clarity on the Regulation, with the Court of Justice of the European Union being the only body authorized to give an authoritative interpretation of EU law. 

The FAQ document covers a broad spectrum of topics including: 

• The scope of the regulation 

• Specific product categories 

• Digital Product Passport 

• Eco-design Forum 

• Implementation timeline 

Support for Stakeholders 

The European Commission is dedicated to supporting stakeholders during the transition to the new regulations, offering guidance, training and financial support, with a particular focus on small and medium-sized enterprises (SMEs). The Commission’s efforts are aimed at helping stakeholders such as manufacturers, importers, and consumers to manage the impact of the Eco-design for Sustainable Products Regulation (ESPR). 

The European Chemicals Agency (ECHA) has published the updated Guidance on the Application of the CLP Criteria to reflect the latest regulatory developments and scientific advances. The revised guidan...

The European Chemicals Agency (ECHA) has published the updated Guidance on the Application of the CLP Criteria to reflect the latest regulatory developments and scientific advances. The revised guidance is now presented as a series of five separate documents to enhance usability and support compliance with Regulation (EC) No 1272/2008 (CLP Regulation).

Key Features of the Updated Guidance

Comprehensive Scope

The guidance provides detailed technical and scientific advice on the application of the classification, labelling, and packaging (CLP) criteria for physical, health and environmental hazards. It supports manufacturers, importers and downstream users in meeting their obligations under the CLP Regulation.

New Structure for Improved Usability

To improve accessibility, the guidance has been reorganised into five distinct parts:

1. Overview Document: An introduction to the guidance series.

2. Part 1: General Principles for Classification and Labelling: This basic part contains practical examples and must be consulted before using other parts.

3. Part 2: Physical Hazards: Updated to reflect recent advances, including criteria for desensitised explosives.

4. Part 3: Health Hazards: Includes new guidance on endocrine disruptors affecting human health.

5. Part 4/5: Environmental Hazards and Additional Hazards: Includes new sections on environmental endocrine disruptors, Persistent, Bioaccumulative, and Toxic (PBT), very Persistent and very Bioaccumulative (vPvB), Persistent, Mobile, and Toxic (PMT) and very Persistent and very Mobile (vPvM) criteria.

Guidance on the New Hazard Classes

The updated guidance introduces key sections addressing emerging safety concerns, with detailed information available in specific parts of the guidance series:

• Endocrine Disruption (Human Health): This section, found in Part 3: Health Hazards, Section 3.11, provides criteria for identifying substances with endocrine disrupting properties that affect human health.

• Endocrine Disruption (Environmental): Addressed in Part 4/5: Environmental Hazards and Additional Hazards, Section 4.2, this section provides guidance on the identification and classification of environmental endocrine disruptors.

• PBT, vPvB, PMT and vPvM: Covered in Part 4/5, Section 4.3, where criteria for the assessment of substances with PBT, vPvB, PMT or vPvM properties are detailed.

Each part provides comprehensive guidance on these hazard classes to ensure that stakeholders have the necessary tools for accurate classification and labelling under the CLP Regulation.

Background and Legal Notice

The guidance is based on the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) and builds on the EU’s long-standing expertise in chemical safety. ECHA emphasises that the CLP Regulation itself remains the only legally binding reference, and this guidance is intended to support its application.

The updated guidance incorporates input from experts from Member States, industry stakeholders and organisations such as the European Food Safety Authority (EFSA) to ensure a robust and science-based framework.

Recent Adoption of the New CLP Regulation

On 14 October 2024, the Council of the European Union adopted the new Regulation on the Classification, Labelling and Packaging of Chemical Substances (CLP), marking a significant step forward in chemical safety. This update modernises the 2008 CLP Regulation to better reflect evolving hazards, consumer protection trends, and sustainable practices.

The new regulation introduces voluntary digital labelling, rules for chemical refill stations and a five-year grace period for non-modified substances of botanical origin with multiple constituents (MOCS). Key changes include faster identification and classification of hazards, including endocrine disruptors, updated labelling requirements for both traditional and digital formats, and adaptations to modern trading practices such as online sales and bulk purchasing. These updates aim to enhance consumer and environmental protection while supporting the circular economy.

The Regulation was published in the Official Journal of the European Union on 20 November 2024 and will enter into force 20 days later.

Access the Updated Guidance

Stakeholders are invited to consult the new guidance documents, which are available on ECHA’s website here. The updated structure and content reflect the EU’s commitment to chemical safety and effective hazard communication.

The European Union is set to revise its REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation in 2025, with the aim of streamlining chemical safety protocols and stre...

The European Union is set to revise its REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation in 2025, with the aim of streamlining chemical safety protocols and strengthening environmental protection. Insights into the forthcoming changes were highlighted in recent responses by Commissioner-designate Stéphane Séjourné (candidate for the Prosperity and Industrial Strategy portfolio) and Jessika Roswall (candidate for the Environment, Water Resilience and a Competitive Circular Economy portfolio) to questionnaires for their confirmation hearings in the European Parliament. These questionnaires, designed to detail each Commissioner’s priorities and strategies, outlined key features of the expected REACH revision, such as stricter regulations on hazardous chemicals, a greater emphasis on sustainability and simplified compliance processes for industry.

Emphasis on Broader Chemical Restrictions

A key aspect of the upcoming REACH revision is the move from individual chemical authorisations to broader category-wide restrictions. This strategy is designed to speed-up the removal of high-risk substances from the market and make compliance easier for companies, particularly small and medium-sized enterprises (SMEs). Commissioner-designate Séjourné underlined the need for a more efficient regulatory framework that will rapidly eliminate harmful substances while providing long-term investment certainty for Europe's chemical industry.

Tighter PFAS Regulations with Essential Use Criteria

The revision will also target per- and polyfluoroalkyl substances (PFAS), which are known for their persistence in the environment. The EU plans a complete ban on PFAS in consumer products such as cosmetics, food packaging and outdoor equipment. However, essential use criteria will allow PFAS applications in critical industrial sectors where no viable alternatives exist. Commissioner-designate Roswall emphasised the importance of balancing environmental protection with industrial needs and supported the continued use of PFAS in essential applications under strictly controlled conditions until suitable substitutes are developed.

Tackling Information Gaps in Chemical Safety

The forthcoming revision of REACH aims to address existing information gaps on chemical safety. Enhanced data requirements in particular for substances identified as endocrine disruptors or those with high environmental persistence, will allow for more informed regulatory decisions. This approach aims to improve risk control and ensure that both human health and the environment are adequately protected.

Advancing Circular Economy Goals through Sustainable Chemical Practices

In line with the EU's Clean Industrial Deal and Circular Economy goals, the 2025 REACH revision promotes the sustainable use of chemicals and resource efficiency. By encouraging the adoption of safer alternatives and reducing dependence on virgin materials, the EU aims to foster a more sustainable and competitive chemical industry. Commissioner-designate Séjourné underlined the need to create an enabling framework for investments that drive the transition to green and digital solutions, including clean energy sources and sustainable chemicals.

As the 2025 revision of REACH approaches, the EU is ready to implement a streamlined regulatory framework that enhances chemical safety, supports sustainable industrial practices and protects public health and the environment.

The full text of the questionnaires can be found here and here.