Europe Regulatory News

The European Commission has announced plans to approve three active substances - 2,2-Dibromo-2-cyanoacetamide (DBNPA), 1,2-Benzisothiazol-3(2H)-one (BIT) and formic acid - for specific uses in biocida...

The European Commission has announced plans to approve three active substances - 2,2-Dibromo-2-cyanoacetamide (DBNPA), 1,2-Benzisothiazol-3(2H)-one (BIT) and formic acid - for specific uses in biocidal products. These proposals, detailed in WTO notifications G/TBT/N/EU/1099, G/TBT/N/EU/1100 and G/TBT/N/EU/1101 of 2 December 2024, aim to harmonise the EU market for biocidal products while ensuring the protection of human health and the environment.

DBNPA Approval for Product Type 6

The EU intends to approve DBNPA (CAS No 10222-01-2) as an active substance for use in product type 6 biocidal products, which are in-can preservatives. DBNPA is recognised for its rapid antimicrobial action, making it effective in preserving products susceptible to microbial contamination. However, due to its endocrine disrupting properties, it meets the exclusion criteria set out in Article 5(1) of the Biocidal Products Regulation (BPR; Regulation (EU) No 528/2012). Nevertheless, a derogation under Article 5(2)(c) of the BPR allows for its approval for specific uses where there are no suitable alternatives and the benefits outweigh the risks.

BIT Approval for Product Types 6 and 13

Similarly, the EU is proposing the approval of BIT (CAS No 2634-33-5) for use in product types 6 and 13. Product type 13 refers to metalworking fluid preservatives. BIT is widely used for its efficacy against bacteria and fungi, making it valuable in the preservation of various products. Its approval is intended to provide manufacturers with an effective means of ensuring product longevity and safety.

Formic Acid Approval for Product Type 6

The EU is also planning to approve formic acid (CAS No 64-18-6) for use in product-type 6 biocidal products. Formic acid is known for its effectiveness in controlling microbial growth and is widely used in industrial applications.

Stakeholder Involvement and Implementation Date

These approvals are part of the EU's ongoing efforts to regulate biocidal products under the Biocidal Products Regulation, which aims to improve the functioning of the biocidal products market while ensuring a high level of protection for human health and the environment. Stakeholders are invited to comment on these proposals within 60 days from the date of notification. The proposed date of adoption for the approvals is February 2025, with entry into force 20 days after publication in the Official Journal of the EU.

These developments underline the EU's commitment to maintaining high standards for biocidal products, balancing the need for effective preservation solutions with the need to protect public health and the environment.

On 27 November 2024, Denmark notified the European Commission of a draft Order to ban per- and polyfluoroalkyl substances (PFAS) in consumer products. The proposed measure targets clothing, footwear, ...

On 27 November 2024, Denmark notified the European Commission of a draft Order to ban per- and polyfluoroalkyl substances (PFAS) in consumer products. The proposed measure targets clothing, footwear, and waterproofing agents containing PFAS in order to reduce their environmental and health impacts. The notification, submitted under Directive 2015/1535, outlines a framework for national restrictions to complement the anticipated EU-wide PFAS legislation.

Scope and Application of the Draft Order

The draft Order introduces a ban on the import and sale of clothing, footwear and waterproofing agents containing PFAS at concentrations above 50 mg F/kg. The restriction applies only to consumer products for private use, including online purchases by individuals. Key dates outlined in the Order include:

• 1 July 2025: The Order is set to enter into force.

• 1 July 2026: The ban on import and sale begins.

• 1 January 2027: Sale of pre-imported stock is permitted until this date.

Production and export activities are exempted, ensuring the measure is focused solely on domestic consumer markets.

Key Exemptions and Considerations

Certain products and scenarios are excluded from the scope of the draft Order:

• Personal Protective Equipment (PPE): Items that re critical to user safety, as defined in Regulation (EU) 2016/425, are exempt due to the lack of suitable alternatives.

• Medical Devices: Products covered by the EU Medical Devices Regulation are excluded.

• Existing EU Regulated Products: Products already covered by EU-REACH and the Persistent Organic Pollutants (POPs) Regulation are not subject to the national ban.

Textiles such as curtains and home furnishings, which contribute less to PFAS emissions, are also excluded, as are reused and recycled materials due to compliance challenges.

Environmental Justification

The draft Order is in line with Denmark’s broader environmental objectives. A mass flow analysis published in February 2024 showed that textiles account for a significant portion of PFAS emissions, with clothing and footwear alone contributing 2.3 tonnes per year. Waste treatment of these articles results in additional discharges of approximately 380 tonnes per year. By implementing this restriction, Denmark expects to reduce PFAS emissions by 200-300 tonnes per year, which represents 35-50% of the country's total emissions from these sources.

The Order's threshold of 50 mg F/kg is designed to capture the intentional use of PFAS while excluding trace contaminants from manufacturing processes. This level reflects the thresholds proposed in the draft EU restrictions.

Implementation and Enforcement

To facilitate compliance by industry, the Order includes transitional measures such as a one-year grace period and permission to sell pre-imported stock until the beginning of 2027. Enforcement will be overseen by the Danish Environmental Protection Agency, with penalties for non-compliance ranging from fines to imprisonment.

Importers and downstream users will be able to provide documentary evidence to prove that fluorine content above the threshold originates from non-PFAS substances. This approach reduces the regulatory burden while ensuring effective control.

Denmark’s Commitment to PFAS Regulation

Denmark’s draft Order reflects its proactive stance on PFAS pollution. The measure is in line with the Organization for Economic Cooperation and Development (OECD) definition of PFAS and supports ongoing efforts to establish EU-wide regulations. The notification also stems from national concerns, including contamination incidents and the results of a 2024 PFAS action plan supported by all Danish parliamentary parties.

Next Steps

The European Commission’s standstill period for feedback ends on 28 February 2025. Pending approval, the Order will enter into force in mid-2025, setting a precedent for other Member States to address PFAS through national measures. By acting decisively, Denmark underlines its commitment to protecting public health and the environment, while contributing to broader EU initiatives.

The full text of the notification is accessible here.

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).