Europe Regulatory News

On 27 June 2024, the European Chemicals Agency (ECHA) announced that bis(α,α-dimethylbenzyl)peroxide has been added to the Candidate List of Substances of Very High Concern (SVHC) by the ECHA Member...

On 27 June 2024, the European Chemicals Agency (ECHA) announced that bis(α,α-dimethylbenzyl)peroxide has been added to the Candidate List of Substances of Very High Concern (SVHC) by the ECHA Member State Committee (MSC) due to its hazardous properties. The Candidate List now contains 241 entries.

About bis(α,α-dimethylbenzyl)peroxide

Bis(α,α-dimethylbenzyl)peroxide (EC No. 201-279-3) is known to be toxic for reproduction and is commonly used as a processing aid, including. as a flame retardant. More detailed information on the substance can be found in the Member State Support document here.

Suspension of Triphenyl Phosphate Classification

In addition to the update, ECHA has suspended the SVHC classification of triphenyl phosphate (TPhP; EC no. 2024-112-2), which was scheduled for the June MSC meeting. This suspension follows the emergence of significant new information shortly before the meeting that required further evaluation.

Understanding Substances of Very High Concern

Substances of Very High Concern (SVHCs) are substances that may cause serious and often irreversible effects on human health and the environment. A substance identified as an SVHC is placed on the Candidate List for possible inclusion in the Authorisation List. Some of the entries in the Candidate List are groups of chemicals, so the total number of chemicals concerned is higher. The Authorisation List contains 59 entries. If a substance is on the Authorisation List, its use is prohibited unless the European Commission grants an authorisation for continued use.

Legal obligations for Candidate List Substances under REACH

Under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation there are legal obligations for substances included in the Candidate List.

• Suppliers must inform their customers and consumers if their products contain more than 0.1 % (weight by weight) of a Candidate List substance.

• Consumers have the right to ask suppliers whether their products contain SVHCs.

• Suppliers of Candidate List substances, either on their own or in mixtures, must provide a safety data sheet (SDS)to their customers.

• Importers and manufacturers of articles containing a Candidate List substance must notify ECHA within six months of the substance being added to the list.

In addition, under the Waste Framework Directive, companies must notify ECHA if the articles they produce contain SVHCs in concentrations above 0.1 % (weight by weight). This notification is then made publicly available in ECHA's Substances of Concern in Products (SCIP) database.

New Intentions to Identify Substances for the Candidate List

ECHA also announced on 27 June 2024, that 2 new intentions to identify SVHCs have been received. The two substances are tris(4-nonylphenyl, branched) phosphite (EC 701-028-2) and 6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid (EC 701-118-1). The registry of SVHC intentions until outcome can be found here.

At their June meetings, the European Chemicals Agency's (ECHA) Committee for Risk Assessment (RAC) and Committee for Socio-Economic Analysis (SEAC) have evaluated four key sectors and made provisi...

At their June meetings, the European Chemicals Agency's (ECHA) Committee for Risk Assessment (RAC) and Committee for Socio-Economic Analysis (SEAC) have evaluated four key sectors and made provisional conclusions on the impact of the EU-wide proposal to restrict per- and polyfluoroalkyl substances (PFAS) for these sectors. The committees also announced the program for the next sectors to be evaluated and concluded provisionally on the scope of the restriction proposal and the hazards of PFAS.

Sectors evaluated at the June Meeting

At the June meetings, RAC and SEAC reached provisional conclusions on the following sectors:

• Consumer mixtures, cosmetics, and ski wax (initially discussed in the March plenary).

• Metal plating and the manufacture of metal products (discussed in June).

These conclusions remain provisional until the committees complete the evaluation of the entire restriction proposal, encompassing all sectors of use, and formally adopt their opinions. Once finalized, these opinions will be communicated to the public.

Planned Sector Evaluations

Looking ahead, RAC and SEAC have announced the next sectors to be evaluated in upcoming meetings. In September, the focus will be on:

• Textiles, upholstery, leather, apparel, and carpets (TULAC)

• Food contact materials and packaging

• Petroleum and mining

Following the September evaluations, the committees will consider:

• Applications of fluorinated gases

• Transport

• Construction products

PFAS Hazards and Scope               

The RAC also provisionally concluded on the overall scope of the restriction proposal and the hazards posed by PFAS. A primary concern highlighted by the committee is the persistence of PFAS in the environment, which means these substances can remain for a very long time. Additionally, certain PFAS may pose further risks to both the environment and human health. RAC expressed concerns that excluding specific PFAS from the restriction based on their potential environmental degradation is not sufficiently justified.

ECHA’s Commitment to Progress

ECHA is committed to advancing the opinion-making process, in line with updates made to the proposal by five national authorities. The finalized opinions will be submitted to the European Commission as soon as possible.

On 17 June 2024, the European Chemicals Agency (ECHA) announced a new EU-wide project, REF-14, to ensure that products containing hazardous mixtures are correctly classified, labelled and packaged. Th...

On 17 June 2024, the European Chemicals Agency (ECHA) announced a new EU-wide project, REF-14, to ensure that products containing hazardous mixtures are correctly classified, labelled and packaged. This initiative aims to protect consumers, especially children, from chemical hazards in everyday products such as air fresheners and electronic cigarettes. The inspections will check compliance with the Classification, Labelling and Packaging (CLP) Regulation, including requirements for child-resistant packaging and accurate hazard reporting to poison centres.

Addressing Mislabelling Issues

The project was initiated after it was found that many consumer products are not properly classified and labelled, which fails to inform consumers about potential hazards and safe use. The checks will focus on widely available products known to contain hazardous mixtures, such as nicotine products containing acutely toxic substances and air fresheners containing sensitising or irritating substances. Preparations for REF-14 will occur in 2025, with inspections expected to start in 2026.

Background on the Enforcement Forum

The Enforcement Forum and its Biocides Subgroup is a network of enforcement authorities from the EU and the European Economic Area (EEA). They coordinate the enforcement of regulations such as REACH, CLP, PIC, POPs and the Biocidal Product Regulation (BPR) to protect health and the environment while ensuring a level playing field for companies in the EU market.

Pilot Project on Only Representatives

The ECHA Enforcement Forum has also agreed on an enforcement pilot project focusing on Only Representatives (ORs) registering imported substances. This project will target free riders and potentially fraudulent operators to ensure fair competition between companies in different EU countries. Inspectors will verify the correct registration of substance tonnage, as under-registration can result in insufficient information for proper risk management. The project will also check that Only Representatives keep accurate records of importers and comply with safety data sheet (SDS) obligations.

Increased Transparency and Ongoing Efforts

In order to increase transparency, the Enforcement Forum has decided to publicly broadcast future stakeholder workshops where the results and recommendations of enforcement projects will be presented. This initiative aims to raise awareness of compliance issues and the work of enforcement authorities. Both the Forum and its Biocides Subgroup (BPRS) provided guidance on ongoing projects and reviewed the results of national enforcement campaigns during their recent meeting held on 10-14 June 2024. The next meeting is scheduled for November 2024.

The European Chemicals Agency (ECHA) launched a call for evidence on the uses and alternatives for certain hexavalent chromium (CrVI) substances on 5 June 2024. The information will support ECHA’s p...

The European Chemicals Agency (ECHA) launched a call for evidence on the uses and alternatives for certain hexavalent chromium (CrVI) substances on 5 June 2024. The information will support ECHA’s preparation of an Annex XV Restriction Dossier on Cr(VI) substances, including those listed in REACH Annex XIV (excluding lead chromates) and barium chromate. The call for evidence will be open until 15 August 2024.

First Call for Evidence

To support the preparation of the restriction proposal, ECHA launched a first call for evidence from December 2023 to February 2024. While this first phase aimed to gather comprehensive data, some gaps remained, necessitating a second call for evidence. In addition, on 29 April 2024, the scope of the restriction proposal for chromium (VI) substances was extended by the European Commission to cover a wider range of Cr(VI) substances, further highlighting the need for additional data collection.

Second Call for Evidence

The second call for evidence consists of two separate surveys to collect detailed information for the Restriction Dossier.

Survey 2a focuses on the different uses of Cr(VI) substances, targeting companies in sectors such as transport, aerospace, defence and specialty surface treatment. This survey seeks input from companies that did not respond to the first call and from users of specific Cr(VI) substances, including barium chromate.

Survey 2b targets manufacturers, suppliers, importers, distributors and users of alternatives to Cr(VI) substances, as well as companies that have recently completed or are in the process of replacing Cr(VI) substances.

ECHA encourages participation from a wide range of stakeholders, including private companies, sector associations, scientific organizations, NGOs, and authorities from both EU/EEA and non-EU countries. Information can be submitted on a confidential basis.

For more details and to participate, visit the surveys here and here.

On May 21, 2024, the European Union published Commission Delegated Decision (EU) 2024/1441, Enhancing Water Quality and Safety, which establishes a methodology for measuring microplastics in water int...

On May 21, 2024, the European Union published Commission Delegated Decision (EU) 2024/1441, Enhancing Water Quality and Safety, which establishes a methodology for measuring microplastics in water intended for human consumption. This complements Directive (EU) 2020/2184, which focuses on the quality of water intended for human consumption. 

Importance of the New Methodology 

Microplastics, which are widespread in the environment, food, and water, pose significant health and environmental risks. Monitoring their presence in drinking water is essential to protect public health. 

Definition of Water for Human Consumption 

Directive (EU) 2020/2184 defines water for human consumption as: 

• All water used for drinking, cooking, and domestic purposes. 

• Water used in food businesses for production and processing. 

Methodology Highlights 

The methodology focuses on: 

• Collecting particles and fibres using a filtration cascade. 

• Use of optical microscopy or chemical mapping for size and shape analysis. 

• Using vibrational micro spectroscopy for compositional identification. 

• Targeting particles from 20 μm to 5 mm and fibres from 20 μm to 15 mm. 

• Concentrations are expressed as microplastics per cubic meter and categorizing based on size, shape, and composition. 

This comprehensive approach ensures accurate detection and categorization of microplastics and reflects the EU’s commitment to understanding and mitigating the impact of microplastics in drinking water. 

For more details, refer to the complete text of Commission Delegated Decision (EU) 2024/1441 here. 

On May 23, 2024, the European Union’s Regulation (EU) 2024/12521, known as the Critical Raw Materials Act (CRMA), officially took effect. This landmark regulation establishes a framework to ensure a...

On May 23, 2024, the European Union’s Regulation (EU) 2024/12521, known as the Critical Raw Materials Act (CRMA), officially took effect. This landmark regulation establishes a framework to ensure a secure and sustainable supply of critical raw materials which are essential for strategic sectors such as clean technologies, digital industries, defence, and aerospace. 

Importance of the CRMA 

The European Commission highlights the importance of secure access to critical raw materials. The EU is currently heavily dependent on imports, with 97% of its magnesium coming from China, 98% of its borate from Türkiye and 71 % of platinum group metals from South Africa. The CRMA aims to diversify and secure the EU's supply chain, reducing dependency on individual suppliers and enhancing domestic production capacity. 

The CRMA distinguishes between two categories of raw materials that are essential for the economic and strategic stability of the EU: 

• Critical Raw Materials: Vital for the European economy with a high risk of supply disruption. A list of the 34 raw materials considered to be critical can be found in Annex II of the Regulation. 

• Strategic Raw Materials: Used in strategic sectors such as renewable energy and defence, with projected demand growth likely to outstrip current supply, creating supply risks. A list of the 17 raw materials identified as strategic can be found in Annex I of the Regulation. 

Key Highlights and Policy Measures 

1. Establishing Priorities and Objectives 

The CRMA sets benchmarks for the strategic raw materials value chain, including: 

• Extraction: At least 10% of the EU’s annual consumption. 

• Processing: At least 40% of the EU’s annual consumption. 

• Recycling: At least 25% of the EU’s annual consumption. 

• Diversity of Supply: No more than 65% of the EU’s annual consumption should come from a single country. 

2. Streamlining Permitting Procedures 

Projects that increase capacity for strategic raw materials can apply for "Strategic Project" status and benefit from expedited permitting processes, which should not exceed 27 months for extraction projects within the EU. 

3. Monitoring and Resilience 

To ensure the stability and reliability of the supply chain for critical raw materials, the EU will implement a series of measures focusing on monitoring and resilience. In particular, the EU will: 

• Monitor supply risks. 

• Conduct stress tests for each strategic raw material supply chain. 

• Provide updates via a monitoring dashboard. 

• Coordinate strategic stocks. 

• Require large companies to conduct supply chain risk assessments every three years. 

4. Promoting Sustainability and Circularity 

National measures will encourage: 

• The collection, sorting, and processing of waste containing critical raw materials. 

• Technological advances in recycling. 

• Circular design and materials efficiency. 

By December 31, 2031, companies will need to comply with labelling requirements for various products and ensure a specified minimum share of certain raw materials. Additionally, the EU will establish rules for calculating and verifying the environmental footprint of critical raw materials and require companies to provide declarations based on these rules. 

5. Establishing EU-Level Supervision 

The European Critical Raw Materials Board, composed of representatives from all Member States and the Commission, will oversee the implementation and progress of the CRMA. 

For more detailed information, visit the European Commission’s Legal Content at Regulation - EU - 2024/1252 - EN - EUR-Lex (europa.eu). 

On 12 June 2024, the European Chemicals Agency (ECHA) published an updated report identifying key areas where further scientific research is needed to improve the regulation of hazardous chemicals in ...

On 12 June 2024, the European Chemicals Agency (ECHA) published an updated report identifying key areas where further scientific research is needed to improve the regulation of hazardous chemicals in the EU. This update provides a more detailed insight into the areas of research needed to better protect human health and the environment.

Key Research Areas Highlighted

In 2023, ECHA presented its key research needs in line with the EU's Chemicals Strategy for Sustainability (CSS). Key areas where more scientific research is needed include:

• Protection Against Harmful Chemicals: Focus on neurotoxicity, immunotoxicity and endocrine disruption.

• Managing Chemical Pollution: Research on bioaccumulation, sensitivity of non-bee pollinators to biocides, and new methods for monitoring environmental chemicals.

• Moving Away from Animal Testing: Development of alternative methods such as read-across, new approach methodologies (NAMs), in vitro/in silico absorption, distribution, metabolism and excretion (ADME), and new models for fish toxicity and carcinogenicity.

• Improving the Availability of Chemical Data: Improving knowledge of polymers, micro- and nano-sized materials, and developing new analytical methods for regulatory enforcement.

Focus on Sustainability and New Research Approaches

In line with the EU's Chemicals Strategy for Sustainability (CSS), ECHA's updated report highlights significant regulatory challenges that require innovative solutions. Dr. Sharon McGuinness, ECHA’s Executive Director, expressed the hope that the research community will actively engage with these outlined needs, which also support the Agency's Strategy Statement 2024-2028. This initiative is part of ECHA’s broader role within the Partnership for the Assessment of Risk from Chemicals (PARC), which aims to advance research and improving chemical safety assessments across Europe.

The full text of the report can be found here.