Europe Regulatory News

Update 3 December 2025:The amendment introducing the “stop the clock” mechanism was published in the Official Journal of the European Union as Regulation (EU) 2025/2439 on 3 December 2025. The act...

Update 3 December 2025:

The amendment introducing the “stop the clock” mechanism was published in the Official Journal of the European Union as Regulation (EU) 2025/2439 on 3 December 2025. The act was signed on 26 November 2025 and enters into force on the twentieth day after publication, meaning it becomes legally binding on 23 December 2025.

With its publication, the postponement of the revised CLP Regulation’s application date to 1 January 2028 is formally confirmed. The delay covers obligations related to re-labelling, formatting rules for labels, advertising, distance sales, refill stations and fuel pump labelling. The harmonised 2028 date now applies across all affected provisions, ensuring a single starting point for compliance.

Update 23 October 2025:

The European Parliament has today approved the postponement of the revised CLP Regulation’s application date to 1 January 2028, confirming the text previously endorsed by the Council on 24 September 2025. The file was handled under the urgent procedure to speed up adoption, and the vote passed with 441 in favour, 108 against and 11 abstentions.

To enter into force, the draft law now requires formal approval by the Council, after which it will be published in the Official Journal of the European Union. The postponement covers obligations related to re-labelling, label formatting, advertising, distance sales, and fuel-pump labelling, easing the transition for companies.

Original News:

On 24 September 2025, the European Council approved the introduction of a “stop-the-clock” mechanism for the revised Classification, Labelling and Packaging (CLP) Regulation. The measure, part of the Commission’s Omnibus VI simplification package, delays the entry into application of the new rules to 1 January 2028.

Purpose: Legal Certainty and Simplification

The mechanism is designed to provide legal certainty for businesses and to avoid a fragmented regulatory framework. Without the postponement, different provisions of the revised CLP would have applied on different dates, creating additional compliance challenges for companies.

The alignment of deadlines covers obligations on:

• Relabelling of substances and mixtures
• Formatting requirements for labels
• Advertisements and distance sales
• Labelling at fuel pumps

By postponing these obligations, the European Council aims to give companies, particularly SMEs, more time to adapt to the new requirements while ensuring continued protection of health and the environment.

Background: Original Deadlines

The revised CLP Regulation entered into force on 10 December 2024, with the majority of obligations initially scheduled to apply from 1 July 2026, and some provisions from 2027 (see more details here). The “stop-the-clock” mechanism shifts all these dates to 1 January 2028, creating a single, harmonised starting point for compliance.

Next Steps in the Legislative Process

Following the European Council’s approval, negotiations will continue with the European Parliament to finalise the regulation. The measure forms part of the broader Omnibus VI package, which seeks to simplify EU chemicals legislation while maintaining high levels of health and environmental protection.

On 1 December 2025, the Council of the European Union agreed its position on the sixth update of the Carcinogens, Mutagens and Reprotoxic Substances Directive (CMRD). The revision introduces new bindi...

On 1 December 2025, the Council of the European Union agreed its position on the sixth update of the Carcinogens, Mutagens and Reprotoxic Substances Directive (CMRD). The revision introduces new binding occupational exposure limits, updates Annex I and reflects the latest scientific advice in order to strengthen the protection of workers exposed to hazardous substances.

New Substance Limits and Additions

The Council’s position confirms new or updated limits for several substances and processes. These include:

• Cobalt and inorganic cobalt compounds
• Polycyclic aromatic hydrocarbons (PAHs), measured as benzo[a]pyrene
• 1,4-dioxane, including a biological limit value
• Isoprene, with a new EU-level occupational exposure limit
• Welding fumes containing category 1A or 1B carcinogens, mutagens or reprotoxic substances

The revision also updates the definitions of carcinogens, mutagens and reprotoxic substances, reflecting scientific developments and accommodating the inclusion of welding fumes as a process covered by the directive.

Next Steps

The file will now move to the European Parliament, which will establish its position before the start of the trilogue negotiations. Transitional periods are planned for sectors where immediate compliance may be difficult. According to the Council, the revised limits and updated rules could prevent approximately 1,700 lung cancer cases and 19,000 other serious health conditions over the next 40 years.

On 26 November 2025, the European Chemicals Agency (ECHA) published the Reporting Guidelines for Synthetic Polymer Microparticles (SPMs) to support companies in preparing the annual emission reports r...

On 26 November 2025, the European Chemicals Agency (ECHA) published the Reporting Guidelines for Synthetic Polymer Microparticles (SPMs) to support companies in preparing the annual emission reports required under the EU microplastics restriction (Regulation (EU) 2023/2055). The guidance clarifies who must report, what information must be submitted, and how to prepare dossiers using the IUCLID reporting template prior to submission through REACH-IT.

Who Must Report and Key Deadlines

The reporting obligation applies to manufacturers, importers, industrial users, and suppliers who place SPMs on the market for uses that remain exempt from the restriction. The guidelines distinguish between two groups, each with a different start date for reporting.

• For manufacturers and industrial downstream users of SPMs in pellet, flake, or powder form, used as feedstock in plastic manufacturing at industrial sites, reporting begins in 2026. These companies must submit the required information to ECHA by 31 May each year, starting in 2026, and report on emissions from the previous calendar year.
• For other manufacturers of SPMs and other industrial downstream users using SPMs at industrial sites, reporting begins in 2027. These companies must also submit their information by 31 May each year, starting in 2027, based on emissions from the preceding year.

Although certain uses of SPMs remain exempt from the ban on placing on the market, are still subject to the annual reporting requirement.

Information Required in the Report

According to the guidelines, companies must provide comprehensive information on each relevant use of SPMs. This includes:

• Identification of the polymer, using generic names and available codes.
• Description of the use, including the sector, product category, technical function, and where applicable, site information.
• Quantities placed on the market and estimated emissions or potential releases to the environment.
• A description of containment or loss-prevention measures.
• Justification for any claimed derogations.

All reports must be completed using the dedicated IUCLID template. This template is designed to ensure traceability and consistency across sectors, particularly where the same SPM may be used in several applications. Submission takes place through REACH-IT, where the annual reporting window will open.

Preparing for Compliance

ECHA encourages companies to start preparing early by mapping their portfolios and determining whether SPMs are used in any exempted applications. Setting up internal systems to collect volume data, emissions estimates, and use descriptions will help ensure timely submission. The aggregated reporting data will support EU authorities in assessing environmental releases and monitoring the effectiveness of the microplastics restriction.

The guidelines can be accessed here.

On 25 November 2025, the European Parliament adopted an own-initiative report (2025/2086(INI)) calling for faster approval and authorisation procedures for biological control agents used in agricultur...

On 25 November 2025, the European Parliament adopted an own-initiative report (2025/2086(INI)) calling for faster approval and authorisation procedures for biological control agents used in agriculture.

The Parliament emphasises the important role of biocontrol products, which include living organisms, microorganisms and naturally derived substances in reducing reliance on chemical plant protection products. However, developers currently face lengthy and complex procedures that were originally designed for conventional pesticides. The Parliament therefore believes that more efficient processes are needed to help farmers access safer and more sustainable pest management solutions.

Current procedures for biological control substances and products fall under Regulation (EC) No 1107/2009 on plant protection products. In contrast invertebrate biological control agents are not covered by EU legislation, instead falling under diverse national rules.

Call for a Clear Definition and Adapted Data Requirements

The report calls on the European Commission to develop a clear and harmonised EU-wide definition of biological control agents. It stresses that the existing regulatory framework does not sufficiently reflect the specific characteristics and risk profiles of biocontrol products. The Parliament recommends adapting data requirements and risk assessment procedures, so that they are proportionate and better tailored to biological products. This would ensure that applicants, particularly small and medium sized enterprises (SMEs), face fewer administrative obstacles and greater predictability when submitting dossiers.

Measures to Speed Up Authorisation While Maintaining High Safety Standards

To accelerate market access, the report proposes fast-track approval routes for low-risk biological control agents, wider use of mutual recognition between Member States and the option of provisional authorisations under defined conditions. At the same time, the Parliament emphasises that these adapted procedures must continue to ensure a high level of protection for human health, non-target organisms, and the environment. Additional resources at the EU and national levels are recommended to prevent delays and to support the timely evaluation of applications.

The adopted text can be found here.

On 25 November 2025, the European Parliament adopted a new Toy Safety Regulation aimed at strengthening child health protection and updating safety requirements for all toys placed on the EU market.Ex...

On 25 November 2025, the European Parliament adopted a new Toy Safety Regulation aimed at strengthening child health protection and updating safety requirements for all toys placed on the EU market.

Expanded Restrictions on Hazardous Chemicals

The updated regulation broadens the existing bans on dangerous substances. In addition to carcinogenic, mutagenic and reproductive toxic chemicals, the rules now prohibit endocrine disruptors, substances that are harmful to the respiratory system, skin or other organs, per- and polyfluoroalkyl substance (PFAS) and the most hazardous bisphenols. Allergenic fragrances will no longer be permitted in toys intended for children under three years of age or in toys that children may put in their mouths.

Strengthened Safety Assessments and Digital Product Passports

Manufacturers will be required to carry out comprehensive safety assessments before placing toys on the market. These assessments must consider chemical, physical, mechanical and electrical risks, as well as flammability, hygiene and radioactivity. The rules also require manufacturers of connected or digital toys to assess potential risks to children’s mental health.

All toys will require a digital product passport (DPP), which is designed to support customs and market surveillance as well as giving consumers easy access to safety information via a QR code for example. Importers, distributors and online marketplaces will face stricter obligations, and toys that do not comply with the regulation will be treated as illegal.

Next Steps

The Toy Safety Regulation will apply 20 days after its publication in the Official Journal of the European Union. A transitional period of four and a half years will allow authorities and industry to adapt to the new requirements.

Update 13 November 2025:The Council of the European Union has today formally approved the One Substance, One Assessment (OSOA) legislative package, marking the final political step before publication ...

Update 13 November 2025:
The Council of the European Union has today formally approved the One Substance, One Assessment (OSOA) legislative package, marking the final political step before publication in the Official Journal. Once published, the three acts will enter into force 20 days later. The package introduces a harmonised assessment process across EU chemicals legislation and foresees the creation of a common data platform, which must become operational within three years of entry into force.

Original News:

On 21 October 2025, the European Parliament adopted three legislative resolutions forming the core of the One Substance, One Assessment (OSOA) initiative. The package aims to simplify and harmonise the evaluation of chemicals across the EU by improving data accessibility, strengthening coordination among EU agencies, and transferring certain scientific and technical tasks to the European Chemicals Agency (ECHA).

Common Data Platform on Chemicals

The first regulation (P10_TA(2025)0235) establishes a common data platform on chemicals to consolidate information on hazard properties, uses, emissions, presence in the environment, and human exposure. The platform will also include data on safer alternatives and will apply the FAIR principles (findable, accessible, interoperable, and reusable) to ensure consistency and transparency in chemical data. It also establishes a monitoring and outlook framework to support the early identification of emerging chemical risks.

Re-attribution of Tasks to ECHA

The second act (P10_TA(2025)0236) reallocates specific scientific and technical tasks from the European Commission and other bodies to ECHA. These include assessing exemption requests under the Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU, coordinating technical reviews, and publishing non-confidential application information. A twenty-month transition period is foreseen to enable the transfer of responsibilities and resources.

Strengthened Inter-Agency Cooperation

The third text (P10_TA(2025)0237) amends several existing EU regulations to strengthen cooperation among EU agencies involved in chemical safety, food safety, environmental protection, and product regulation. These include:

• Regulation (EC) No 178/2002 (General Food Law Regulation)
• Regulation (EC) No 401/2009 (European Environment Agency Regulation)
• Regulation (EU) 2017/745 (Medical Devices Regulation)
• Regulation (EU) 2019/1021 (Persistent Organic Pollutants Regulation)

The amendments introduce mechanisms for data exchange, coordinated scientific assessments, and the resolution of divergent scientific opinions.

Next Steps

These measures aim to eliminate the duplication of chemical assessments, improve regulatory efficiency, and enhance the scientific coherence of EU chemicals legislation. This is in line with the objectives of the Chemicals Strategy for Sustainability and the zero-pollution ambition of the European Green Deal.

Following Parliament’s approval, the package awaits formal adoption by the Council of the European Union before entering into force. Each act will enter into force following publication in the Official Journal of the European Union, typically twenty days after publication, unless otherwise specified.

On 18 November 2025, the European Chemicals Agency (ECHA) made its 12th recommendation to the European Commission, that four additional substances be added to the Authorisation List (Annex XIV of the ...

On 18 November 2025, the European Chemicals Agency (ECHA) made its 12th recommendation to the European Commission, that four additional substances be added to the Authorisation List (Annex XIV of the REACH Regulation (EC No 1907/2006)). If the Commission proceeds with this recommendation, manufacturers, importers and downstream users of these substances will need to apply for authorisation if they wish to continue using them beyond the set transition deadlines.

The authorisation process is intended to manage chemicals that have already been identified as Substances of Very High Concern (SVHCs), by imposing strict requirements on their use and promoting the use of safer alternatives. The four substances targeted in this recommendation are already listed on the Candidate List of SVHCs and their proposed inclusion in Annex XIV signals heightened regulatory scrutiny.

Substances Proposed for Authorisation

Below is a summary of the proposed entries and key use/volume data.

ECHA notes that the volumes and uses of barium diboron tetraoxide within the scope of authorisation are limited. Nevertheless, the substance is recommended based on grouping considerations, as it could otherwise be used to replace other boron compounds that are already recommended, which would risk regrettable substitution.

The document also notes that the draft entry for bis(2-ethylhexyl) tetrabromophthalate, covering all isomers and combinations, was not included in the final recommendation. This substance is being addressed in a parallel restriction initiative under the Restrictions Roadmap.

Implications and next steps

The recommendation will now be considered by the European Commission and EU Member States. If the substances are added to Annex XIV, the latest application dates and sunset dates will be set out in the authorisation list.

Companies that manufacture, import or use these substances in the European Economic Area will need to check whether their uses fall within the scope of the entries. Where relevant, they will also need to prepare for authorisation applications or consider alternatives in view of the future sunset dates.