Europe Regulatory News

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.

On 14 May 2025, the European Chemicals Agency (ECHA) published a new guideline outlining standardized procedures for measuring formaldehyde emissions from consumer products and vehicle interiors. The ...

On 14 May 2025, the European Chemicals Agency (ECHA) published a new guideline outlining standardized procedures for measuring formaldehyde emissions from consumer products and vehicle interiors. The document supports the implementation of Regulation (EU) 2023/1464, which introduces strict limits on formaldehyde emissions in order to protect public health.

Emission Limits and Compliance Deadlines

Regulation (EU) 2023/1464 stipulates that, as of 6 August 2026, furniture and wood-based articles must not emit more than 0.062 mg/m³ of formaldehyde. For other articles, the limit is 0.080 mg/m³. The maximum concentration inside road vehicles is also set at 0.062 mg/m³, with compliance required by 6 August 2027.

Standardized Testing Methods

The new guideline outlines detailed procedures for testing formaldehyde emissions, to ensure consistent and reliable measurements across the EU. These procedures are crucial for manufacturers and importers to verify that their products meet the new limits.

Exemptions and Regulatory Scope

The regulation includes exemptions for second-hand articles, products intended solely for outdoor use, and products that are already covered by specific EU legislation. These exemptions are designed to ensure that the regulation is both protective and proportionate.

Public Health Impact

By standardizing measurement practices and enforcing emission limits, ECHA aims to significantly reduce exposure to formaldehyde in indoor environments, thereby lowering the associated health risks, such as respiratory conditions and cancer. Stakeholders are encouraged to familiarize themselves with the guidelines ahead of the upcoming deadlines.

The guidelines can be accessed here.

In May 2025, the European Commission adopted two Delegated Regulations introducing new restrictions under Regulation (EU) 2019/1021 on Persistent Organic Pollutants (POPs). These measures implement de...

In May 2025, the European Commission adopted two Delegated Regulations introducing new restrictions under Regulation (EU) 2019/1021 on Persistent Organic Pollutants (POPs). These measures implement decisions from the Stockholm Convention and target two hazardous substances: UV-328 and Dechlorane Plus.

UV-328 Added to POPs Regulation – Adopted 5 May 2025

On 5 May 2025, the Commission adopted a Delegated Regulation adding UV-328 (CAS No. 25973-55-1) to Annex I of the POPs Regulation. This follows the decision taken at the 11th Conference of the Parties to the Stockholm Convention to list UV-328 for global elimination due to its persistence, bioaccumulation, and toxicity.

Key Provisions:

• Manufacture, use, and placing on the market of UV-328 is prohibited.

• A maximum concentration limit of 1 mg/kg is set for UV-328 when present as an unintentional trace contaminant in substances, mixtures, or articles.

• Time-limited exemptions (5 years) apply for specific uses such as:

  • Triacetyl cellulose film in polarizers for LCDs.

  • Photographic paper and imaging products.

  • Mechanical separators in blood collection tubes.

  • Certain articles used in land-based motor vehicles.

• Articles containing UV-328 that were already in use in the Union before or on the date of expiry of the relevant exemption may continue to be used.

Dechlorane Plus Restricted Under POPs Regulation – Adopted 15 May 2025

On 15 May 2025, the Commission adopted a second Delegated Regulation to include Dechlorane Plus (CAS No.13560-89-9) in Annex I of the POPs Regulation. This amendment aligns with Decision SC-11/10 of the Stockholm Convention, which recognises Dechlorane Plus as a persistent organic pollutant with harmful environmental and health effects.

Key Provisions:

• Manufacture, use, and placing on the market of Dechlorane Plus is prohibited.

• A temporary higher limit of 1000 mg/kg is permitted for trace contamination, to, be reduced to 1 mg/kg after 30 months to allow laboratories to adapt.

• Exemptions (5 years with possible 5-year extension) apply to:

  • Spare parts for land-based motor vehicles and outdoor power equipment.

  • Medical devices and in-vitro diagnostic devices.

  • Analytical instruments used in testing, monitoring, and production.

• Articles containing dechlorane plus that were already in use in the Union before or on the date of expiry of the relevant exemption may continue to be used.

Next Steps

Both regulations will enter into force following their publication in the Official Journal of the European Union. Companies using these substances must review their supply chains and ensure compliance within the timelines set out in the respective regulations.

On 5 May 2025, the European Commission launched a public consultation on the evaluation of Regulation (EC) No 1223/2009 on cosmetic products. This regulation governs the safety, labelling and marketin...

On 5 May 2025, the European Commission launched a public consultation on the evaluation of Regulation (EC) No 1223/2009 on cosmetic products. This regulation governs the safety, labelling and marketing of cosmetics in the EU. The consultation is open until 28 July 2025 and invites feedback from consumers, industry representatives, NGOs, public authorities and other stakeholders.

What the Consultation Covers

The questionnaire seeks input on a broad range of topics to support the ongoing evaluation of the Cosmetics Regulation. These include:

• Whether the Regulation continues to ensure a high level of protection for human health.

• Views on labelling requirements, including clarity, usefulness, and digital solutions.

• Safety assessments, including the role of ingredients and traceability.

• Alignment with other EU chemicals legislation (e.g. REACH and CLP).

• The effectiveness of animal testing bans and their impact on innovation.

• Market surveillance and enforcement at Member State level.

• Whether the current framework supports technological and scientific developments.

Stakeholders can respond to targeted multiple-choice questions, submit written comments, and suggest areas where improvements or clarifications may be needed.

Background: Why the Regulation Is Being Evaluated

This consultation follows the call for evidence published earlier this year and forms part of the European Commission’s broader evaluation of the Cosmetics Regulation, which was launched in early 2025 under the Better Regulation framework. The evaluation aims to determine whether the Regulation remains effective, efficient, coherent, and relevant in light of emerging challenges, such as digital labelling, animal welfare, and its interface with chemicals legislation.

Access the Consultation

Stakeholders can participate here and more information on the evaluation can be found here.
 

The European Commission has published a draft amendment to Regulation (EC) No 340/2008, proposing a 19.5% increase in standard fees and charges payable to the European Chemicals Agency (ECHA) under th...

The European Commission has published a draft amendment to Regulation (EC) No 340/2008, proposing a 19.5% increase in standard fees and charges payable to the European Chemicals Agency (ECHA) under the REACH Regulation. The adjustment reflects cumulative inflation from 2021 to 2023.

To safeguard small and medium-sized enterprises (SMEs), the proposed inflation-linked increase will not apply to SMEs, in line with the EU’s SME Relief Package and the 2024–2029 Political Guidelines.

New Pre-Submission SME Verification Required

A major change concerns the SME status verification process. Under the draft regulation:

• Companies must apply for SME recognition at least two months before any fee-related submission.

• ECHA must decide on SME status within two months of receiving complete documentation.

• Recognised SME status will be valid for three years and apply to all relevant EU submissions during that period.

ECHA May Charge for SME Verification Workload

To improve efficiency, ECHA may introduce an administrative charge for SME verification, which will be waived if SME status is confirmed. The new SME provisions will take effect 15 months after the regulation enters into force. Submissions pending at the time of entry into force will not be affected.

This draft amendment forms part of the EU’s broader efforts to enhance the financial sustainability of ECHA, following a drop in fee revenue after the 2018 REACH registration deadline.

On 29 April 2025, the European Chemicals Agency (ECHA) announced a proposal for an EU-wide restriction on certain hexavalent chromium (Cr(VI)) substances. This initiative aims to mitigate the harmful ...

On 29 April 2025, the European Chemicals Agency (ECHA) announced a proposal for an EU-wide restriction on certain hexavalent chromium (Cr(VI)) substances. This initiative aims to mitigate the harmful effects of these carcinogenic chemicals on workers and the general public.

Background: Expansion of the Restriction Scope

In September 2023, the European Commission requested that ECHA prepare a REACH restriction proposal on certain chromium(VI) substances currently on the Authorisation List, specifically targeting chromium trioxide (entry 16) and chromic acids (entry 17). Recognizing the potential risks of substituting these substances with other hazardous chromium(VI) compounds, the Commission expanded the mandate in April 2024.

Scope of the Proposed Restriction

The restriction proposal targets Cr(VI) substances listed in entries 16 to 22 and 28 to 31 of the REACH Authorisation List. It also considers other Cr(VI) substances not currently on the Authorisation List, such as barium chromate, in order to prevent potential risks if these substances are used as substitutes.

The proposal suggests banning the use of these substances, except in specific applications where defined limits for worker exposure and environmental emissions are met. The exempted use categories include:

• Formulation of mixtures

• Electroplating on plastic substrates

• Electroplating on metal substrates

• Use of primers and other slurries

• Other surface treatments

• Functional additives/process aids

Risks Associated with Cr(VI) Exposure

Hexavalent chromium compounds are recognised as some of the most potent carcinogens in the workplace. Workers exposed to Cr(VI) are at an increased risk of developing serious health issues, particularly lung and intestinal cancers. Additionally, communities residing near industrial sites that emit these substances may also be at increased risk due to environmental contamination.

Health and Environmental Impact

The proposed EU-wide restriction on certain hexavalent chromium (Cr(VI)) substances aims to significantly reduce environmental emissions and protect public health. By limiting the use of these carcinogenic chemicals, the initiative could prevent up to 17 tonnes of Cr(VI) from being released into the environment each year. This reduction is projected to avert approximately 195 cancer cases each year. Over a 20-year period, the monetised benefits of the restriction are estimated to range between €331 million and €1.07 billion, depending on the specific measures implemented.

Next Steps

The European Chemicals Agency (ECHA) is set to initiate a six-month public consultation on the proposed restriction of certain chromium(VI) substances on 18 June 2025. This consultation period offers stakeholders an opportunity to submit detailed information and evidence pertinent to the proposal. To facilitate active participation and provide clarity on the restriction process, ECHA is planning to host an online information session. This session will provide guidance on how interested parties can contribute effectively to the consultation.

ECHA’s scientific Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) will evaluate the restriction proposal, based on the scientific evidence received during the consultation period. The European Commission, in collaboration with the 27 EU Member States, will make the final decision on the restriction and its conditions based on the proposal from ECHA and the committees’ opinions.

The full text of the Annex XV Restriction Report can be found here.