Europe Regulatory News

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.

Update (24 June 2025): The European Commission has clarified that the upcoming Delegated Regulation will also partially implement GHS Revision 11, covering aerosols and skin sensitisers in mixtures, ...

Update (24 June 2025):
The European Commission has clarified that the upcoming Delegated Regulation will also partially implement GHS Revision 11, covering aerosols and skin sensitisers in mixtures, in addition to aligning CLP with GHS Revisions 8 to 10.

Original text: 

The European Commission is preparing a Delegated Regulation to update the Classification, Labelling and Packaging (CLP) Regulation in line with technical progress and the latest updates to the UN Globally Harmonised System (GHS), specifically revisions 8 to 10.

No Public Consultation Planned

As this will be a Delegated Regulation, no public consultation will be held. The regulation is expected to be published by the end of 2025 after which there will probably be a two-year implementation period.

Technical Updates Expected

The update is expected to include technical changes such as revised criteria for aerosols and desensitized explosives, updated precautionary statements, and clarificationon labelling small containers, aligning the CLP with GHS revisions 8 to 10. However, the actual draft of the Delegated Regulation has not yet been published.

On 16 April 2025, the European Commission adopted the 2025–2030 working plan under the Eco-design for Sustainable Products Regulation (ESPR) and the Energy Labelling Framework Regulation (ELFR). The...

On 16 April 2025, the European Commission adopted the 2025–2030 working plan under the Eco-design for Sustainable Products Regulation (ESPR) and the Energy Labelling Framework Regulation (ELFR). The plan prioritizes key product groups, such as steel, aluminium, textiles (especially apparel), furniture, tyres, and mattresses, for new eco-design and energy labelling requirements, with the aim of promoting sustainability and prioritising circularity, and energy efficiency. The plan also introduces cross-cutting measures, including the implementation of repairability scores and recyclability standards aimed at improving the sustainability of electronic devices and small household appliances. Developed through stakeholder consultation and technical analysis, the plan supports the EU’s climate and competitiveness goals while ensuring tailored support for SMEs. 

Background  

The Eco-design for Sustainable Products Regulation (ESPR), adopted in July 2024,  seeks to make products placed on the EU market more sustainable by enhancing their circularity, energy performance, recyclability, and durability. In addition to promoting environmental objectives, the regulation aims to strengthen the Single Market and improve the overall competitiveness and resilience of the European economy. 

In conjunction with the Energy Labelling Framework Regulation (ELFR), the ESPR empowers consumers to make more informed and sustainable purchasing decisions. The newly adopted working plan builds on the momentum of the 2022–2024 initiative, which targeted 16 energy-related products including dishwashers, electric motors, electric vehicle chargers, and electronic displays with updated sustainability and energy efficiency standards. 

Next steps  

The new ecodesign and energy labelling requirements will be developed through delegated acts, tailored to specific products or product groups and based on comprehensive studies and impact assessments. Stakeholder engagement will be a key part of the process, with active participation from the newly formed Ecodesign Forum. Meanwhile, ongoing efforts under the current Ecodesign Directive will continue for certain energy-related products, with final requirements expected to be adopted by 31 December 2026. 

On 20 May 2025, the European Chemicals Agency (ECHA) announced that it has officially launched its redesigned Classification and Labelling (C&L) Inventory, which is now integrated into the Agency’s ...

On 20 May 2025, the European Chemicals Agency (ECHA) announced that it has officially launched its redesigned Classification and Labelling (C&L) Inventory, which is now integrated into the Agency’s ECHA CHEM platform. This update provides clearer access to both harmonised EU-level classifications and company-notified entries under REACH.

Key Enhancements

• Comprehensive Data: The updated inventory includes over 4,400 EU-harmonised classifications and around 7 million classifications submitted through REACH registrations, covering approximately 350,000 substances.

• Visual Interface: Classification information for each substance is presented in a visual format, improving navigation and usability.

• Improved Transparency: Users can more easily identify the classification with the highest level of agreement and determine its source.

• Regulatory Updates Incorporated: The inventory reflects recent developments, including the introduction of new CLP hazard classes.

• Future Features: Additional functionalities such as application programming interfaces (APIs) are being explored to further enhance data accessibility.

ECHA CHEM

This update follows the initial launch of ECHA CHEM in January 2024, which gave th public access to over 100,000 REACH registrations. The revamped C&L Inventory is part of ECHA’s efforts to create a stable and scalable database that centralises EU chemical data.

Next Steps

Future releases of ECHA CHEM will include overviews of regulatory decisions and activities, such as REACH restrictions, thereby enhancing public access to EU chemicals regulation.

On 15 May 2025, the European Commission published Regulation (EU) 2025/877, which updates Annex II of the EU Cosmetics Regulation (Regulation (EC) No 1223/2009). This amendment adds 21 substances to t...

On 15 May 2025, the European Commission published Regulation (EU) 2025/877, which updates Annex II of the EU Cosmetics Regulation (Regulation (EC) No 1223/2009). This amendment adds 21 substances to the list of those prohibited in cosmetic products due to their classification as carcinogenic, mutagenic, or toxic to reproduction (CMR) under Delegated Regulation (EU) 2024/197. The new bans will apply from 1 September 2025 across all EU Member States.

Affected Substances

The new entries include substances used across industrial sectors, such as:

• Tetrabromobisphenol A and Bisphenol AF, which are often used for flame retardancy and plastic stabilisation.

• Transfluthrin and clothianidin, which are known for their pesticidal properties.

• Dibutyltin maleate and dibutyltin oxide, which are used as catalysts and stabilisers in polymers.

• Aromatic amines such as N,N-dimethyl-p-toluidine.

• Several reaction mass mixtures involving bisphenol and phosphonium compounds.

Also impacted is trimethylbenzoyl diphenylphosphine oxide (CAS 75980-60-8). Previously permitted for professional nail products, it has now been fully banned due to its classification as toxic for reproduction.

List of Newly Banned Substances in Cosmetics (Annex II)

Clarification of Cymoxanil Entry in Annex II

The regulation replaces entry 1580 for cymoxanil in Annex II to include a second chemical name and corresponding CAS number (166900-80-7). This change ensures coverage of the chemical identity for both forms of the substance and improves legal clarity. Additionally, entry 311 in Annex III has been deleted.

Compliance Reminder

From 1 September 2025, all cosmetic products containing these substances must be removed from the EU market. Manufacturers, importers, and distributors should carefully review their formulations and update their compliance documentation accordingly.

The full text of the Regulation can be accessed here.