Europe Regulatory News

On 1August 2025, the Court of Justice of the European Union (CJEU) delivered its final judgment on the classification of titanium dioxide (TiO2), upholding the 2022 General Court decision that an...

On 8 July 2025, the European Commission published a wide-ranging legislative proposal package aimed at simplifying the EU’s chemicals legislation. This includes significant proposed amendments to th...

On 8 July 2025, the European Commission published a wide-ranging legislative proposal package aimed at simplifying the EU’s chemicals legislation. This includes significant proposed amendments to the Classification, Labelling and Packaging (CLP) Regulation, the Cosmetics Regulation, and the Fertilising Products Regulation. The proposals also include a separate regulation that postpones key labelling obligations under the CLP Regulation until 1 January 2028.

Key Proposals: Greater Flexibility and Reduced Compliance Burden

The central legislative text (COM(2025) 531) proposes targeted amendments to three major regulations to address compliance challenges, reduce the administrative burden and enhance regulatory clarity across the chemicals sector. Accompanying the proposal is a detailed Annex outlining specific changes to the legal text, which is particularly relevant for compliance teams and legal counsel.

Highlights include:

• CLP Regulation (EC No 1272/2008):

  • Replaces rigid formatting rules (e.g. fixed font size and black-on-white labels) with readability standards, allowing for greater flexibility across product types.

  • Allows broader use of digital labelling to provide supplementary information online.

  • Revises Article 31 to simplify physical label requirements - label elements must be clear, indelible and contrasting with the background, but a fixed layout is no longer required.

• Cosmetics Regulation (EC No 1223/2009):

  • Removes the pre-notification requirement for nanomaterials.

  • Introduces clearer procedures for adding new UV filters, preservatives, and colourants to product annexes.

• Fertilising Products Regulation (EU 2019/1009):

  • Eliminates the need for extended REACH registration for certain component substances.

  • Simplifies the approval process for micro-organisms and introduces digital conformity documentation.

Postponement of CLP Amendments to 2028

In parallel, the Commission published a second legislative act (COM(2025) 526) which aims to postpone the implementation of certain controversial provisions introduced by Regulation (EU) 2024/2865. This includes changes to:

• Label layout and formatting

• Advertising rules

• Labelling for online and distance sales

The revised date for the entry into force of these provisions is now set for 1 January 2028, which gives industry more time to adapt.

Impact and Next Steps

According to the Commission’s impact assessment, the simplification measures are expected to save the chemicals sector up to €363 million annually without compromising health or environmental protection. These proposals form part of a broader effort under the EU’s Chemicals Industry Action Plan to promote competitiveness and innovation.

The simplification proposal (COM(2025) 531) and the postponement regulation (COM(2025) 526) will now proceed through the ordinary legislative procedure, involving review and potential amendment by the European Parliament and Council.

On 25 June 2025, the European Chemicals Agency (ECHA) formally requested that its Committee for Risk Assessment (RAC) reassess the hazard classification of glyphosate (CAS no 1071-83-6) under Article ...

On 25 June 2025, the European Chemicals Agency (ECHA) formally requested that its Committee for Risk Assessment (RAC) reassess the hazard classification of glyphosate (CAS no 1071-83-6) under Article 77(3)(c) of the REACH Regulation. This decision follows the submission of new scientific evidence during the renewal process for glyphosate’s approval as an active ingredient in plant protection products.

Trigger for the Reassessment: New Genotoxicity Study

The request is primarily driven by the availability of a new in vivo genotoxicity study that was not previously assessed by the RAC in its 2022 evaluation. Conducted as part of the pesticide renewal process, the study has raised questions regarding the potential mutagenic effects of glyphosate.

Focus of the Reassessment

ECHA has asked RAC to:

• Re-examine glyphosate’s classification for carcinogenicity, mutagenicity, and reproductive toxicity (CMR) under CLP Regulation (EC) No 1272/2008.

• Review additional scientific evidence and new information provided during the pesticide renewal process.

• Address public concerns and ensure alignment with the latest EU regulatory decisions.

Current Classification Status

Glyphosate is currently classified in the EU as follows:

• Eye damage 1 (H318): Causes serious eye damage.

• Aquatic chronic 2 (H411): Toxic to aquatic life with long-lasting effects.

Despite ongoing public and scientific debate about its potential health effects, glyphosate is not classified for carcinogenicity, mutagenicity, or reproductive toxicity.

The European Commission’s Implementing Regulation (EU) 2024/197, which renewed glyphosate’s approval, highlighted this data gap. This prompted the Commission to invite ECHA to re-examine the classification in an independent process.

15-Month Deadline for RAC Opinion

ECHA has set a 15-month deadline for RAC to deliver its opinion, ensuring that the process moves forward in a timely and transparent manner.

The reassessment reflects ECHA’s ongoing commitment to ensuring that chemical hazard classifications are based on the latest scientific evidence, while protecting human health and the environment.

On 2 July 2025, the European Commission released its evaluation of the Waste Electrical and Electronic Equipment (WEEE) Directive, reaffirming its importance in mitigating the environmental and health...

On 2 July 2025, the European Commission released its evaluation of the Waste Electrical and Electronic Equipment (WEEE) Directive, reaffirming its importance in mitigating the environmental and health risks posed by electronic waste. Despite improvements in collection and treatment, the report notes that nearly half of WEEE remains uncollected in the EU, with recycling rates still below target. Identified gaps include limited legislative scope, insufficient recovery of critical raw materials (CRMs), fragmented Extended Producer Responsibility (EPR) implementation, and inconsistent treatment standards. The Commission recommends revising the Directive to address digital and green technologies more effectively, enforce harmonised EPR schemes, and establish mandatory treatment standards to support the EU’s circular economy goals. 

Background  

Electrical and electronic waste is the fastest-growing waste stream in the EU, increasing by approximately 2% each year. In 2022, 14.4 million tonnes of equipment were placed on the market, yet only 5 million tonnes of e-waste were collected. The WEEE Directive addresses this challenge by requiring separate collection and proper treatment, setting targets for recovery and recycling, and applying the polluter-pays principle through EPR. It also seeks to streamline compliance by harmonising national registers and reporting formats across Member States. 

Key Findings 

• The WEEE Directive remains a relevant and well-aligned policy tool within the EU framework, contributing positively to e-waste management and stakeholder performance. 

• However, the Directive’s scope is outdated and fails to cover emerging waste streams from CRM-rich technologies such as renewable energy and digital equipment. 

• Collection rates across the EU remain low, with only a few Member States meeting the 65% target due to economic, infrastructural, and awareness-related barriers. 

• Recovery of critical raw materials (CRMs), such as copper and rare earth elements is limited as current recycling targets do not sufficiently incentivize their extraction. 

• Fragmented EPR implementation and inconsistent treatment standards hinder high-quality recycling efforts across the EU. 

Further Step 

As part of the upcoming Circular Economy Act, the European Commission will take the recent evaluation findings into account during the revision of the WEEE Directive, with the aim of enhancing e-waste management and aligning it with broader sustainability goals. 

On 25 June 2025, the European Chemicals Agency (ECHA) announced the addition of three hazardous chemicals to the Candidate List of Substances of Very High Concern (SVHCs) under the REACH Regulation. T...

On 25 June 2025, the European Chemicals Agency (ECHA) announced the addition of three hazardous chemicals to the Candidate List of Substances of Very High Concern (SVHCs) under the REACH Regulation. This latest update brings the total number of SVHC entries to 250.

Substances Added in June 2025

The newly listed substances include two siloxanes and one azo dye component:

• 1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane (CAS 17928-28-8): Classified as very persistent and very bioaccumulative (vPvB) under REACH Article 57(e), this substance is used in laboratory reagents, cosmetics, personal care products, and fragrances.

• Decamethyltetrasiloxane (CAS 141-62-8): Also meeting the vPvB criteria (Article 57(e)), this chemical is found in cosmetics, personal care products, lubricants, greases, and automotive care products.

• Tetra(sodium/potassium) 7-[(E)-{2-acetamido-4-[(E)-(4-{[4-chloro-6-({2-[(4-fluoro-6-{[4-(vinylsulfonyl)phenyl]amino}-1,3,5-triazine-2-yl)amino]propyl}amino)-1,3,5-triazine-2-yl]amino}-5-sulfonato-1-naphthyl)diazenyl]-5-methoxyphenyl}diazenyl]-1,3,6-naphthalenetrisulfonate (Reactive Brown 51) (EC 466-490-7): ​​​​​​​Listed due to its classification as toxic for reproduction (Article 57(c)). This substance is primarily used in textile treatment products and dyes.

Regulatory Implications for Industry

With the inclusion of these substances, companies supplying them, whether on their own, in mixtures, or in articles, now face specific legal obligations under REACH.

• Information Duty: Suppliers must provide customers and consumers with information on safe use if an article contains more than 0.1% w/w of any SVHC.

• Notification Requirement: Importers and producers of articles containing any of the new SVHCs must notify ECHA within six months (by 25 December 2025).

• Safety Data Sheet Updates: EU and EEA suppliers must update their Safety Data Sheets (SDS) to reflect the inclusion of these substances in the Candidate List.

• SCIP Database Notification: Under the Waste Framework Directive, producers are also required to notify ECHA if their articles contain SVHCs above the 0.1% threshold. This ensures that the substances are included in ECHA’s SCIP database of substances of concern in products.

• EU Ecolabel Impact: Products containing substances on the Candidate List cannot qualify for the EU Ecolabel.

Potential Future Authorisation

ECHA notes that inclusion on the Candidate List is often the first step towards further regulatory control. The newly listed substances may, in future, be placed on the Authorisation List (REACH Annex XIV). Once listed, their use would require formal authorisation from the European Commission.

The European Commission has adopted the 23rd Adaptation to Technical Progress (ATP) to the Classification, Labelling and Packaging (CLP9 Regulation (EC) No 1272/2008 through Delegated Regulation (EU) ...

The European Commission has adopted the 23rd Adaptation to Technical Progress (ATP) to the Classification, Labelling and Packaging (CLP9 Regulation (EC) No 1272/2008 through Delegated Regulation (EU) 2025/1222. This update concerns the harmonised classification and labelling of several chemical substances.

This amendment, based on opinions from the European Chemicals Agency’s Risk Assessment Committee (RAC), was adopted on 2 April 2025 and published in the Official Journal of the EU on 20 June 2025. It will enter into force on 10 July 2025, 20 days after publication, and become mandatory on 1 February 2027. Suppliers may apply the updated classifications voluntarily from the date of entry into force.

New Substance Entries

The following substances have been added to Table 3 of Annex VI with harmonised classifications.

Updated Substance Classifications

The following entries replace existing classifications in Annex VI and reflect updated hazard information for substances already listed under the CLP Regulation.

Next Steps

Stakeholders, particularly manufacturers, importers, and downstream users, should review the updated classifications and begin preparing to update safety data sheets, product labels, and internal documentation. The new rules can be applied early from 10 July 2025, but compliance will become mandatory from 1 February 2027.

The full text of Delegated Regulation (EU) 2025/1222 is available here.

On 3 June 2025, the European Commission published Commission Regulation (EU) 2025/1085 in the Official Journal of the European Union. The regulation introduces a new restriction under Annex XVII to RE...

On 3 June 2025, the European Commission published Commission Regulation (EU) 2025/1085 in the Official Journal of the European Union. The regulation introduces a new restriction under Annex XVII to REACH, targeting two aprotic solvents: N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP). These substances are classified as toxic to reproduction and are widely used in industrial applications, prompting regulatory action to mitigate risks to workers and unborn children.

Substances of Concern

DMAC (CAS No. 127-19-5) and NEP (CAS No. 2687-91-4) are classified as reproductive toxicants (Category 1B) under the CLP Regulation, indicating a high level of concern for human health. These substances are commonly used as solvents in the chemical and textile industries, and there is potential for harmful exposure through inhalation and dermal contact.

New Restriction under Annex XVII

From 23 December 2026, placing DMAC and NEP on the market, manufacturing them, and using them in concentrations ≥ 0.3% will only be permitted if strict conditions are met. Companies must:

• Demonstrate that worker exposure is kept below the Derived No-Effect Levels (DNELs) for inhalation and dermal routes.

• Implement and maintain appropriate risk management measures and operational controls.

Additional Ban on Use in Fibre Production

A further restriction applies specifically to DMAC used as a solvent in the manufacture of man-made fibres. This use will be fully prohibited after 23 June 2029, irrespective of any exposure controls.

Health and Regulatory Objectives

The restriction supports the EU’s objective of protecting workers and vulnerable populations from hazardous chemicals. It also aligns with the EU Chemicals Strategy for Sustainability, promoting safer chemical use and a toxic-free environment.

The full text of the regulation can be found here.