Europe Regulatory News

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.

On April 16, 2025, the European Chemicals Agency (ECHA) published detailed requirements for the reporting of synthetic polymer microparticles, commonly referred to as microplastics, under the REACH Re...

On April 16, 2025, the European Chemicals Agency (ECHA) published detailed requirements for the reporting of synthetic polymer microparticles, commonly referred to as microplastics, under the REACH Regulation. This initiative aims to enhance transparency and facilitate regulatory oversight of intentionally added microplastics in products.

Background: EU Restriction on Intentionally Added Microplastics

In October 2023, the European Union adopted a restriction on intentionally added microplastics by amending Annex XVII of the REACH Regulation (Entry 78). This restriction is intended to prevent the release of synthetic polymer microparticles that are resistant to environmental degradation. It applies to a wide range of products, including cosmetics, detergents, fertilizers, plant protection products, and medical devices. Depending on the product category, the restriction will be phased in over several years, but a key requirement for manufacturers and importers is to report the presence of synthetic polymer microparticles in their products from 2026 onwards.

Key Elements of the Reporting System

• Who must report: Manufacturers and importers placing mixtures or articles on the market containing synthetic polymer microparticles that meet the definition set under the restriction.

• What must be reported: Information including the polymer identity, particle size and shape, functional use, quantities placed on the market, and the manner in which the microparticles are used or released.

• When to report: Reporting must occur annually. The first reports, covering the 2026 calendar year, must be submitted by 31 May 2027.

• Reporting platform: Companies must submit their reports through a dedicated web-based portal being developed by ECHA. Submissions must be made in IUCLID format, and templates and technical guidance will be provided to assist companies in compiling their data.

• Format and data requirements: The reporting system will be structured around specific mandatory fields to ensure the consistency and usability of the reported information. Data must be complete and accurate, and submitted electronically.

Practical Considerations for Companies

Companies subject to the reporting requirement should start preparing early by:

• Identifying and characterizing any synthetic polymer microparticles present in their products.

• Collecting data on polymer composition, particle dimensions, intended uses, and quantities placed on the market.

• Familiarizing themselves with the IUCLID system and ECHA’s reporting instructions to avoid delays in data submission.

While ECHA is working to ensure the online portal will be available before the first reporting deadline, companies are encouraged to monitor ECHA updates and prepare their data in advance.

Next Steps

The reporting obligation is part of a broader set of measures introduced by the EU to minimize the release of persistent microplastics into the environment. By collecting standardized information on the presence and use of synthetic polymer microparticles, the EU aims to better understand sources of emissions and monitor the restriction’s effectiveness over time.

For full technical details, stakeholders are encouraged to consult the official document here.  

On 14 April 2025, the European Commission adopted a Delegated Regulation amending the Persistent Organic Pollutants (POPs) Regulation (Regulation (EU) 2019/1021). The amendment introduces stricter con...

On 14 April 2025, the European Commission adopted a Delegated Regulation amending the Persistent Organic Pollutants (POPs) Regulation (Regulation (EU) 2019/1021). The amendment introduces stricter control measures for perfluorooctane sulfonic acid (PFOS) and its derivatives, with the aim of better protecting human health and the environment.

Updated PFOS Terminology

To align with the terminology already used for perfluorooctanoic acid (PFOA), the PFOS entry in Annex I of the POPs Regulation has been updated. PFOS will now be referred to as "perfluorooctane sulfonic acid (PFOS), its salts and PFOS-related compounds," ensuring consistency across the POPs Regulation.

New UTC Limit Values for PFOS

The Commission has significantly tightened the unintentional trace contaminant (UTC) limits for PFOS:

• The limit for PFOS and its salts is reduced to 0.025 mg/kg.

• The limit for PFOS-related compounds is set at 1 mg/kg.

These new thresholds align with those already established for PFOA, reflecting the technical feasibility of achieving lower contamination levels today than to when PFOS was first regulated.

Removal of Specific Exemption for Hard-Chromium Plating

The specific exemption allowing the use of PFOS as a mist suppressant for non-decorative hard chromium (VI) plating has been deleted. Investigations at Member State level confirmed that PFOS is no longer necessary for this purpose as the industry has transitioned to alternative substances.

Transitional Period for Compliance

To allow sufficient time for adjustment the new UTC limits for PFOS will apply from 3 December 2025. Other changes, including the revised terminology and the removal of the exemption, will apply 20 days after the publication of the Regulation in the Official Journal of the European Union.

Background and Alignment with International Obligations

The amendment is part of the EU’s continued effort to meet its obligations under the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution. It also contributes to the EU’s broader strategy of phasing out persistent organic pollutants and minimizing environmental and health risks.

On 11 April 2025, the European Commission welcomed the provisional political agreement reached between the European Parliament and the Council on the new Regulation on the Safety of Toys. The new Regu...

On 11 April 2025, the European Commission welcomed the provisional political agreement reached between the European Parliament and the Council on the new Regulation on the Safety of Toys. The new Regulation aims to strengthen protections for children's health while ensuring the proper functioning of the Single Market. It will replace the current Toy Safety Directive 2009/48/EC.

Key Features of the Agreed Toy Safety Regulation

• Stricter Limits on Hazardous Chemicals:

The new rules will extend existing bans to include additional harmful substances in toys, such as endocrine disruptors and reprotoxic chemicals. This goes beyond the current protections against carcinogenic and mutagenic substances. The Regulation also enables the Commission to impose future restrictions on groups of substances, such as per- and polyfluoroalkyl substances (PFAS), through implementing acts based on scientific assessments.

• Introduction of a Digital Product Passport:

All toys sold in the EU will be required to carry a Digital Product Passport (DPP), accessible via a QR code, containing detailed safety and compliance information for authorities and consumers.

• Enhanced Control of Online Sales:

Online marketplaces will be required to verify that toys offered on their platforms meet EU safety requirements, thereby addressing safety risks associated with e-commerce.

• Clearer Duties for Economic Operators:

Manufacturers, importers, and distributors will have strengthened obligations to ensure that only compliant toys are placed on the market, thereby improving traceability and enforcement.

Transition Periods

Once the Regulation is formally adopted by the European Parliament and the Council, it will enter into force 20 days after its publication in the Official Journal of the European Union. Most of its obligations will begin to apply 30 months after the entry into force. However, the requirements related to the Digital Product Passport will apply 48 months after entry into force.

Next Steps

The provisional agreement must now be formally approved by both the European Parliament and the Council. Once adopted, the new Regulation will replace Directive 2009/48/EC on the Safety of Toys, updating EU toy safety rules to address emerging risks, including chemical hazards such as PFAS, and ensuring higher standards across the Single Market.

The European Commission has published a comprehensive explanatory guide to support the implementation of Regulation (EU) 2023/2055, which restricts the placing on the market of products containing int...

The European Commission has published a comprehensive explanatory guide to support the implementation of Regulation (EU) 2023/2055, which restricts the placing on the market of products containing intentionally added microplastics. The restriction entered into force on 17 October 2023 under the REACH Regulation.

The measure targets synthetic polymer microparticles intentionally added to products such as cosmetics, detergents, fertilizers, and medical devices. The aim is to reduce microplastic pollution and limit the unintentional release of persistent, non-biodegradable particles into the environment.

While the core provisions are already in force, the regulation includes transition periods for certain products to allow time for reformulation or innovation. These transition periods vary by product category and use.

Guide Aims to Support Compliance Across the EU

To help companies and authorities apply the new rules, the Commission’s guide provides practical explanations and tools to ensure consistent interpretation and enforcement across Member States.

What’s Inside the Guide

The guide is divided into three main parts:

• Part I – Narrative Explanation

Provides a structured overview of the legal text, including definitions, the scope of the restriction, exemptions, and how the provisions apply over time.

• Part II – Questions and Answers

Provides clarification on common points of uncertainty, based on questions raised by stakeholders and national authorities.

• Annexes
  Provide decision trees and practical examples to help users determine whether a product falls within the scope of the restriction.

Translations Coming in Q3 2025

Currently available in English, the guide will be translated into all 22 official EU languages by the third quarter of 2025. Stakeholders are encouraged to consult the English version in the meantime to prepare for compliance.

The guide is available here.

At the CARACAL-54 meeting on 3 April 2025, the European Commission outlined its latest proposals to revise the REACH Regulation. These updates, forming part of the broader Chemicals Industry Package, ...

At the CARACAL-54 meeting on 3 April 2025, the European Commission outlined its latest proposals to revise the REACH Regulation. These updates, forming part of the broader Chemicals Industry Package, are now open for public consultation until 25 April 2025. Adoption of the final legislative package is targeted for the fourth quarter of 2025.

The revision aims to simplify registration requirements, improve enforcement through new auditing tools, accelerate digitalisation of supply chain communication and modernise risk management procedures. Together, the proposals represent the most significant update to REACH since its inception

Key changes under the REACH revision package include:

1. Overhaul of the Registration System

• Registration validity will be limited to 10 years. ECHA may revoke registration numbers in several cases, including expiry of the validity period, failure to submit a required update after an evaluation decision, lack of a complete dataset for previously notified substances (NONS), or incompleteness identified during an ad-hoc completeness check.

• New dossier update requirements if a substance is identified as substance of very high concern (SVHCs).

• Removal of reduced requirements for substances notified under previous legislation (NONS).

• New obligations for polymers, including:

  • Notification for all polymers above 1 tonne per year.

  • Registration for polymers requiring registration (PRRs), based on hazard-related criteria.

• Stronger provisions to encourage data sharing between registrants and reduce duplication of studies. Data access mechanisms will apply to studies on structurally similar substances, especially after the expiry of data protection periods.

• Reinforced commitment to reduce animal testing, in line with Directive 2010/63/EU. Testing on vertebrate animals must be avoided whenever possible, and testing proposals will be required even for some lower-tier endpoints (Annex VII and VIII).

2. Reinforced Evaluation and Compliance Checks

The REACH revision introduces several changes aimed at improving the effectiveness, transparency, and impact of both dossier and substance evaluation.

• ECHA will be empowered to revoke registration numbers following persistent non-compliance with evaluation decisions. This applies to both dossier and substance evaluations when registrants fail to act on required updates or decisions issued by ECHA.

• The compliance check process will be clarified, particularly regarding the use of available information that is not currently part of the dossier. This aims to make ECHA’s decisions more predictable and legally sound.

• ECHA will gain stronger powers to require specific adaptations, such as read-across or derivation of Derived No-Effect Levels (DNELs) or Predicted No-Effect Concentrations (PNECs), rather than defaulting to animal testing.

• The substance evaluation procedure will explicitly allow selection based on hazard concerns, in addition to potential risks. Substances may also be selected based on similarity to other chemicals, including degradation products or constituents.

3. Streamlined Authorisation Process

The REACH revision introduces greater flexibility and clearer prioritisation in the authorisation system.

• The Candidate List will become a general tool for risk management prioritisation, not just a step toward authorisation.

• New substance prioritisation criteria will focus on high-volume chemicals, those with limited uses, or potential substitutes for existing Annex XIV substances.

• The revised approach allows uses to be included or excluded from Annex XIV, enabling tailored combinations of authorisation and restriction where appropriate.

• Greater use of Regulatory Management Option Analyses (RMOAs) will help identify the best regulatory path earlier in the process.

• The essential use concept and Derived Minimal Effect Levels (DMELs) are being considered to simplify decision-making.

4. More Targeted and Efficient Restriction Procedure

Changes to the restriction process aim to reduce delays and improve enforceability.

• Restriction proposals will be better prioritised and scoped upfront, avoiding overload and unnecessary complexity.

• The generic risk management approach will be expanded to more hazard classes, particularly for consumer uses.

• Early information on use, exposure, and alternatives will support more targeted proposals.

• Forum advice will be integrated directly into the restriction process to improve enforceability.

• The essential use concept will also play a role in simplifying restriction decisions.

5. Enhanced Enforcement and Market Surveillance

To level the playing field across the EU, the Commission proposes stronger enforcement mechanisms:

• A new European Audit Capacity will allow the Commission to assess Member States' enforcement systems.

• Customs controls will be improved via:

  • Mandatory provision of safety data sheets (SDS) at import.

  • Automated verification of registration and authorisation numbers.

  • Potential integration with the EU Single Window Environment for Customs.

• The European Anti-Fraud Office (OLAF) will be empowered to investigate serious cross-border REACH violations.

5. Tackling Distance Sales and Enabling Public Participation

• Distance sales into the EU will require a designated EU-based economic operator to ensure REACH compliance.

• Individuals and organisations will be allowed to submit substantiated concerns about non-compliance.

• Member States will be required to implement whistle-blower protections and follow Aarhus Convention principles on access to justice.

6. Digitalisation of Supply Chain Communication

 Digital transformation is central to the proposals, especially for Safety Data Sheets and product traceability:

• Introduction of harmonised electronic formats for SDS to support digital exchange across the supply chain.

• Gradual integration of Digital Product Passports (DPPs) for articles, initially covering batteries and later expanding to toys, detergents, textiles, and furniture.

• The aim is to reduce the administrative burden while increasing transparency on the presence of substances of concern.

7. Clarification of Nanomaterials Requirements

• The REACH revision will align with the EU’s 2022 definition of nanomaterials.

• Clarified registration and reporting rules will improve predictability and transparency, particularly for downstream users and nanoform characterisation.

REACH Revision Set to Modernise EU Chemicals Law by End of 2025

These proposed updates represent the most comprehensive revision of REACH in nearly two decades. They respond to long-standing challenges related to complexity, inefficiency, and uneven enforcement while also positioning the EU chemicals legislation to support the goals of the Green Deal and the circular economy.

The Commission is expected to finalise the legislative proposal following public feedback, CARACAL consultation, and internal legal drafting. Adoption is targeted for late 2025.

Stakeholders are encouraged to engage with the Commission’s consultation process, which remains open until 25 April 2025. Feedback will help shape the final legislative proposal, expected for adoption by the end of the year as part of the EU Chemicals Industry Package.