Europe Regulatory News

The European Union is set to revise its REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation in 2025, with the aim of streamlining chemical safety protocols and stre...

The European Union is set to revise its REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation in 2025, with the aim of streamlining chemical safety protocols and strengthening environmental protection. Insights into the forthcoming changes were highlighted in recent responses by Commissioner-designate Stéphane Séjourné (candidate for the Prosperity and Industrial Strategy portfolio) and Jessika Roswall (candidate for the Environment, Water Resilience and a Competitive Circular Economy portfolio) to questionnaires for their confirmation hearings in the European Parliament. These questionnaires, designed to detail each Commissioner’s priorities and strategies, outlined key features of the expected REACH revision, such as stricter regulations on hazardous chemicals, a greater emphasis on sustainability and simplified compliance processes for industry.

Emphasis on Broader Chemical Restrictions

A key aspect of the upcoming REACH revision is the move from individual chemical authorisations to broader category-wide restrictions. This strategy is designed to speed-up the removal of high-risk substances from the market and make compliance easier for companies, particularly small and medium-sized enterprises (SMEs). Commissioner-designate Séjourné underlined the need for a more efficient regulatory framework that will rapidly eliminate harmful substances while providing long-term investment certainty for Europe's chemical industry.

Tighter PFAS Regulations with Essential Use Criteria

The revision will also target per- and polyfluoroalkyl substances (PFAS), which are known for their persistence in the environment. The EU plans a complete ban on PFAS in consumer products such as cosmetics, food packaging and outdoor equipment. However, essential use criteria will allow PFAS applications in critical industrial sectors where no viable alternatives exist. Commissioner-designate Roswall emphasised the importance of balancing environmental protection with industrial needs and supported the continued use of PFAS in essential applications under strictly controlled conditions until suitable substitutes are developed.

Tackling Information Gaps in Chemical Safety

The forthcoming revision of REACH aims to address existing information gaps on chemical safety. Enhanced data requirements in particular for substances identified as endocrine disruptors or those with high environmental persistence, will allow for more informed regulatory decisions. This approach aims to improve risk control and ensure that both human health and the environment are adequately protected.

Advancing Circular Economy Goals through Sustainable Chemical Practices

In line with the EU's Clean Industrial Deal and Circular Economy goals, the 2025 REACH revision promotes the sustainable use of chemicals and resource efficiency. By encouraging the adoption of safer alternatives and reducing dependence on virgin materials, the EU aims to foster a more sustainable and competitive chemical industry. Commissioner-designate Séjourné underlined the need to create an enabling framework for investments that drive the transition to green and digital solutions, including clean energy sources and sustainable chemicals.

As the 2025 revision of REACH approaches, the EU is ready to implement a streamlined regulatory framework that enhances chemical safety, supports sustainable industrial practices and protects public health and the environment.

The full text of the questionnaires can be found here and here.

On 7 November 2024, the European Chemicals Agency (ECHA) added triphenyl phosphate (CAS No 115-86-69) to its Candidate List of substances of very high concern (SVHC). Triphenyl phosphate is known to b...

On 7 November 2024, the European Chemicals Agency (ECHA) added triphenyl phosphate (CAS No 115-86-69) to its Candidate List of substances of very high concern (SVHC). Triphenyl phosphate is known to be an endocrine disruptor and is widely used as a flame retardant and plasticiser in a variety of products, including polymers, adhesives and sealants. This latest update brings the Candidate List to 242 entries, underlining ECHA’s commitment to chemical safety.

Impact of the Inclusion of Triphenyl Phosphate in the Candidate List

With triphenyl phosphate now on the SVHC list, companies across the EU and the European Economic Area (EEA) face new obligations under REACH. Companies must assess and communicate the risks associated with this chemical to ensure its safe use. Suppliers are required to inform consumers if articles contain more than 0.1% triphenyl phosphate and provide information on safe use. They must also update the safety data sheet they provide to their customers. Importers and manufacturers must notify ECHA of all articles containing the substance within six months of inclusion in the Candidate list.

New Regulatory Requirements and Industry Compliance

The inclusion of triphenyl phosphate on the SVHC list brings additional compliance requirements. Under the Waste Framework Directive, companies must notify ECHA if the articles they produce contain SVHCs above a concentration of 0.1%.  The notifications will be published ECHA’s database of substances of concern in products (SCIP), helping to increase transparency on hazardous chemicals in products. In addition, items containing SVHCs cannot be awarded the EU Ecolabel, in line with ECHA’s mission for safer consumer products.

At the end of October 2024, the European Chemicals Agency (ECHA) published a report on hazardous chemicals found in cosmetic products, identifying non-compliance with the REACH and Persistent Organic ...

At the end of October 2024, the European Chemicals Agency (ECHA) published a report on hazardous chemicals found in cosmetic products, identifying non-compliance with the REACH and Persistent Organic Pollutants (POPs) Regulations. The report covers a pilot project on the enforcement of restrictions on perfluoroalkyl carboxylic acids (PFCAs) and related substances in cosmetics. It shows that around 6% of the inspected cosmetic products contained banned hazardous substances. The project, which ran from November 2023 to April 2024, involved inspections by national enforcement authorities in 13 European Economic Area (EEA) countries including Denmark, Germany, Italy, Norway and Sweden. Of nearly 4,500 products inspected, 285 were found to contain banned chemicals, including perfluorononyl dimethicone, perfluorooctylethyl triethoxysilane, cyclopentasiloxane (D5) and other cyclic siloxanes.

Health and Environmental Risks of Hazardous Chemicals in Cosmetics

The substances identified pose serious health and environmental risks due to their persistence and bioaccumulation. Two main restricted substances were frequently found in non-compliant products:

• Perfluorononyl dimethicone: Detected in 151 non-compliant products (e.g. eyeliners and lip liners), this per- and polyfluoroalkyl substance (PFAS) is restricted under both the POPs and REACH regulations. It is highly persistent in the environment and breaks down into perfluorooctanoic acid (PFOA), a chemical known for its reproductive toxicity and suspected carcinogenicity.

• Cyclopentasiloxane (D5): Found in 111 non-compliant products (e.g. hair conditioners and hair masks), this compound is restricted under REACH due to its persistence in the environment and tendency to accumulate in organisms. D5 raises concerns about reproductive toxicity effects and long-term ecological impact.

The wider set of substances identified, including various siloxanes and fluorinated compounds, are associated with serious risks to human health and the environment. These compounds are slow to degrade and accumulate in humans and other species, with potential adverse effects including reproductive toxicity and cancer risk.

Consumer Awareness and Regulatory Actions by ECHA

The national authorities carried out the inspections mainly by checking product ingredient lists, an approach that can also be used by consumers to check for banned substances. Non-compliant products were found across different types, brands, and price ranges. As a corrective measure, enforcement authorities issued written advice to suppliers to ensure compliance and initiated the removal of affected products from the market. Further investigations are ongoing in about half of the cases identified.

Project Background and Objectives

This enforcement project is part of ECHA’s wider efforts to ensure consistent enforcement of the POPs and REACH Regulations across the EEA. By focusing on chemicals commonly used in cosmetics, the project aims to strengthen the integrated control of hazardous substances in consumer products, protecting both public health and the environment.

The full report is available here.

On 17 October 2024, the European Ombudsman published a recommendation calling on the European Commission to address delays in the authorisation of dangerous chemical substances under the REACH Regulat...

On 17 October 2024, the European Ombudsman published a recommendation calling on the European Commission to address delays in the authorisation of dangerous chemical substances under the REACH Regulation. These delays, which average 14.5 months instead of the statutory three months, allow companies to continue using harmful chemicals, including carcinogens and endocrine disruptors, while decisions are pending. The Ombudsman’s inquiry found that the Commission’s internal procedures and incomplete applications by companies significantly slow down the process, sometimes extending decisions by years.

The REACH Regulation and its Objectives

The REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation aims to protect public health and the environment by regulating substances of very high concern (SVHCs). Companies applying for authorisation must demonstrate that the risks posed by the chemical are adequately controlled or that there are no suitable alternatives, often requiring extensive technical reviews. However, the Commission has struggled to meet deadlines, undermining the effectiveness of the Regulation in controlling hazardous chemicals in the EU.

Concerns about Transparency in Decision-Making

In addition to delays, the Ombudsman identified transparency issues, criticising the Commission for insufficient public access to the details of its decision-making. The Ombudsman recommended that the Commission publish more comprehensive reports of REACH Committee meetings and ensure that they are available before the next meeting. Greater transparency, the report suggests, will help the public to hold relevant stakeholders accountable for the prolonged decision-making process.

Recommendations for Improvement

To address these systemic issues, the Ombudsman recommends that the Commission streamline its internal procedures, enforce stricter data submission requirements on companies, and ensure greater transparency in the decision-making process. This would uphold the REACH Regulation's objectives of protecting human health and the environment from hazardous chemicals while ensuring timely action.

The European Commission has launched a public consultation to gather feedback on a new draft delegated decision to revise the European List of Waste. This update focuses on incorporating changes relat...

The European Commission has launched a public consultation to gather feedback on a new draft delegated decision to revise the European List of Waste. This update focuses on incorporating changes related to new battery chemistries and rapidly evolving manufacturing and recycling processes. The feedback period runs from 11 October 2024 until 8 November 2024.

Aim of the Revision

The European List of Waste serves as a common terminology for waste classification across EU Member States and provides an essential framework for the management and tracking of waste, including hazardous materials. The proposed revision aims to enhance the identification, monitoring and traceability of different waste streams, in particular in the light of recent technological advances in battery production. The aim is to ensure better alignment between environmental legislation and waste management processes, such as the handling of lithium-based batteries, which are increasingly considered hazardous under the ADR agreement.

CLP Classification and Reclassification of Battery Waste

The proposed delegated decision introduces important updates to waste classification under the Classification, Labelling, and Packaging (CLP) Regulation (EC No 1272/2008). New hazardous waste codes have been introduced for battery-related waste streams, in particular for "black masses", which are intermediate fractions from battery treatment. These codes are supported by updated hazard classifications to ensure better alignment with waste shipment requirements under the Waste Shipment Regulation.

Another significant change is the reclassification of alkaline batteries. Previously classified as non-hazardous, alkaline batteries are now considered hazardous due to updated scientific evidence on the concentration of hazardous substances in these batteries. In addition, a new waste code has been introduced for lithium-based batteries, which pose specific hazards such as fire and explosion risks. This aims to improve the safe management and recycling of lithium-based batteries.

Key Considerations for Stakeholders

The Commission is seeking input on how best to adapt the waste classification system to reflect modern battery chemistries and improve waste management practices. Stakeholders are invited to provide feedback on whether the proposed changes will sufficiently address the challenges posed by the rapid development of new battery technologies and whether the classification of certain waste streams should be redefined as hazardous or non-hazardous.

Next Steps

Following the consultation period, the European Commission will review the feedback and refine the draft delegated decision before adopting it. All feedback will be published on the European Commission’s website and where appropriate, incorporated into the final text of the legislation.

This consultation is an important opportunity for industry stakeholders, environmental groups and EU citizens to shape the future of waste management in Europe, particularly in the context of the growing use of advanced battery technologies.

On September 6, 2024, the European Chemicals Agency (ECHA) launched a consultation for medetomidine in accordance with Articles 10 and 5 of Regulation (EU) No 528/2012 (the Biocidal Products Regulatio...

On September 6, 2024, the European Chemicals Agency (ECHA) launched a consultation for medetomidine in accordance with Articles 10 and 5 of Regulation (EU) No 528/2012 (the Biocidal Products Regulation, BPR). The Biocidal Products Committee (BPC) has determined that medetomidine does not meet the renewal criteria for product type 21 set out in Article 5(1)(d) of the BPR. As a result, the approval for medetomidine will not be renewed unless it meets one of the exceptions specified in Article 5(2). 

Overview of Medetomidine 

Medetomidine is a synthetic compound used as an anaesthetic and analgesic in veterinary medicine and as a sedative in human medicine. It consists of two stereoisomers, of which dexmedetomidine exhibits significant biocidal activity as an antifouling agent. Dexmedetomidine selectively activates α2 adrenoceptors, reducing norepinephrine release and decreasing central nervous system excitation, which contributes to its sedative effects and potential toxicity. In antifouling applications, medetomidine binds to octopamine receptors on marine larvae, increasing their motility and preventing settling.  

Safety Assessment 

The BPC has concluded that medetomidine is not mutagenic, carcinogenic, or a reproductive toxicant. However, it does exhibit endocrine-disrupting properties that  affect and related biological pathways. Although there are no standardized methods for assessing these effects, medetomidine is categorized as an endocrine disruptor under EU regulations. Traditional exposure assessment revealed no significant risks, except for young children who may come into contact with freshly treated surfaces. However, a definitive conclusion regarding the overall risk to human health remains elusive. 

Substitution 

Medetomidine has been determined to meet the exclusion criteria specified in Article 5(1)(d) of the BPR, making it eligible for substitution under Article 10. This classification is due to its identification as a persistent, bio-accumulative, and toxic (PBT) substance containing a significant amount of non-active isomers. The assessment was carried out in accordance with guidelines established during recent meetings of Member State Competent Authorities, focusing on the relevant exclusion and substitution criteria in the BPR. 

Consultation Deadline 

The consultation for medetomidine will close on November 6, 2024. 

On 30 September 2024, the European Commission published the 22nd Adaptation to Technical Progress (ATP) under Regulation (EC) No 1272/2008 (CLP). The 22nd ATP was adopted on 19 June 2024 and published...

On 30 September 2024, the European Commission published the 22nd Adaptation to Technical Progress (ATP) under Regulation (EC) No 1272/2008 (CLP). The 22nd ATP was adopted on 19 June 2024 and published in the Official Journal of the European Union and amend Table 3 of Part 3 of Annex VI to the Classification, Labelling and Packaging (CLP) Regulation by introducing 27 new harmonised classifications, modifying 16 preexisting entries and deleting 7 harmonised classifications. The amendments will come into effect on 1 May 2026.

Compliance Deadlines for 22nd ATP

The new classifications enter into force on 20 October 2024 and will apply from 1 May 2026, giving suppliers sufficient time to adjust their labelling and packaging in line with the new rules. However, suppliers may voluntarily adopt the updated classifications before this date to ensure compliance and to better protect public health and the environment.

New Harmonised Classifications in 22nd ATP

The table below lists the 27 new harmonised classifications added to Part 3, Table 3 of Annex VI to the CLP Regulation. The 16 modified entries can be found here.

For full access to the regulation, visit https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202402564

Deadline for 21^st Adaptation to Technical Progress

The previous ATP (21st ATP) was published in the Official Journal of the European Union on 5 January 2024 and will apply from 1 September 2025. It, however, entered into force on 25 January 2024 and therefore suppliers may already now classify label and package substances and mixtures in accordance with the CLP regulation as amended by the 21st ATP.