Europe Regulatory News

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 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.

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 30 May 2024, the Danish Parliament unanimously adopted the first National Action Plan to combat the pollution from per- and polyfluoroalkyl substances (PFAS). The plan, funded with 404 million Dani...

On 30 May 2024, the Danish Parliament unanimously adopted the first National Action Plan to combat the pollution from per- and polyfluoroalkyl substances (PFAS). The plan, funded with 404 million Danish kroner (DKK) ($58 million), aims to protect the environment and public health by preventing, containing and cleaning up PFAS contamination.

PFAS, known as "forever chemicals," persist in the environment and accumulate in living organisms, posing serious health risks. This comprehensive plan aims to tackle the widespread PFAS contamination through a series of targeted initiatives.

Key Measures in the Action Plan:

1. Banning PFAS in Consumer Products: Denmark will be the first EU country, possibly alongside France, to ban PFAS in clothing, shoes and consumer waterproofing agents. This initiative targets the 60% of PFAS emissions in the EU attributed to textiles. The ban will take effect on 1 July 2026, after a one-year transition period allowing industries to adapt.

2. Soil and Water Remediation: A budget of DKK 210 million has been allocated for soil and groundwater remediation, focusing on up to 15,000 sites suspected of PFAS contamination, such as former fire training areas and landfills. Additionally, water companies will receive funding to protect drinking water supplies from PFAS, including the installation of new supply pipes and purification systems where necessary.

3. Improved Monitoring and Regulation: The plan includes increased monitoring of PFAS in water, food and livestock. There will be stronger controls on products, including online and physical retail, and partnerships with industry to provide clear guidance to the public.

4. Public Health and Education: Efforts will be made to educate the public and provide municipalities and water companies with the knowledge and resources they need to deal with PFAS contamination.

5. EU-Wide Initiatives: Denmark will push for an EU-wide ban on PFAS and support stricter regulations on PFAS levels in food and the environment. Notably, a proposal for an EU ban on PFAS has been submitted by Denmark, Germany, the Netherlands, Norway, and Sweden.

Ministerial Statements:

Environment Minister Magnus Heunicke emphasised the importance of the plan in ensuring the safety of everyday activities, such as drinking tap water and wearing rain gear. He stressed the urgency of tackling PFAS in soil and drinking water to prevent long-term environmental and health impacts.

The Minister for Food, Agriculture and Fisheries Jacob Jensen stressed the need for robust monitoring of PFAS in the food supply chain to prevent contamination from animal feed to consumer products.

The Action Plan has received broad support from all parliamentary parties, who recognise the urgent need to tackle PFAS pollution comprehensively.

Facts about PFAS:

PFAS include more than 10,000 different per- and polyfluoroalkyl substances that have been used for more than 50 years in various industries for their water- and grease-resistant properties. They are notoriously difficult to break down and accumulate in the environment, animals, and humans, posing significant health risks.

The action plan will run until 2027 and is the first phase of Denmark's efforts to tackle PFAS pollution. Beyond this period, further measures will be considered based on the results of the plan and the evolving scientific understanding of the effects of PFAS.

IUCLID 6 has been upgraded version 8.0.2 by the European Chemicals Agency (ECHA). This update, which follows the larger version 8 release at the end of  April, focuses on minor corrections and impro...

IUCLID 6 has been upgraded version 8.0.2 by the European Chemicals Agency (ECHA). This update, which follows the larger version 8 release at the end of  April, focuses on minor corrections and improvements.

 
Update

Users who have not yet updated to IUCLID 6 version 8 are the main target group for this version. It is not necessary to install this new version for current users who have already finished the upgrade procedure, unless they encounter specific problems that are described in detail in the release notes.
 

The specific fixes included in this update are:

• IUCLID Migrator: This tool, used to migrate data from older versions of IUCLID, was failing in some cases due to a "Definition not found" error. This issue has been resolved.

• REACH Messages: The validation assistant, which helps to ensure that data submitted to ECHA complies with REACH regulations, has received updated messages.

• EU BPR Translations: New and updated translations have been added to the Summary of Product Characteristics (SPC) section for use in the context of the EU Biocidal Products Regulation (BPR).

• EU BPR Active Substances: The configuration of active substances under the EU BPR has been updated, including messages for the validation assistant.

• Chesar IUCLID Plug-in: The Chesar IUCLID plug-in, used for hazard assessment has been updated.

• User Synchronization: The process for synchronizing users for ECHA IUCLID instances has been updated.

Enhance Your IUCLID Experience with Powerful Add-on Tools

IUCLID provides a complete set of tools for organising chemical data. But did you know that its functionality can be further enhanced with other tools? With these downloadable tools, you can easily extend your current IUCLID installation and achieve new levels of productivity and data management:

Text Analytics: Perform a thorough search of all IUCLID data fields, including the textual content of any attached documents. Find the information you need quickly and easily.
Data Extractor: Need to extract specific information from your IUCLID dossiers? This user-friendly application makes it easy. Define your extraction criteria and easily extract the necessary data.
Knife Plug-In for Uploading Data: Simplify the procedure for adding external chemical data to your IUCLID database. By converting data from several sources into the IUCLID format, this plug-in helps you save a significant amount of time and work.

By using these add-on technologies you can optimise your chemical information workflows, make data more accessible and significantly improve your IUCLID experience.

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Attention seed suppliers! Proper labelling of seeds treated with plant protection products (PPP) is crucial. It ensures transparency and safety for both sellers and users. The government of the Republ...

Attention seed suppliers! Proper labelling of seeds treated with plant protection products (PPP) is crucial. It ensures transparency and safety for both sellers and users. The government of the Republic of Lithuania has released an important update for seed suppliers.

Here are some key points to consider:

• Only Registered PPP: Seeds must be treated with PPPs registered in the EU. It is absolutely forbidden to supply seed treated with unlicensed products.

• Labelling Responsibility: It is the responsibility of the seed to ensure that treated seeds comply with EU legislation, in particular Regulation (EC) No. 1107/2009.

• Labelling Requirements: The seed label or accompanying documents must clearly state:

  • Name of the plant protection product used for treatment.

  • Name(s) of the active ingredient(s) in the PPP.

  • Safety precautions for using the treated seeds.

  • Potential risks to human and animal health associated with the treatment.

• Reliable Sources: It is not permitted to sell seed treated with unregistered PPP or different from registered products.

Important points to remember:

• To obtain a list of PPPs that have been registered, always check the State Crop Production Service's VATIS information system.

• Adhere closely to the distribution, storage, and use policies specified for registered PPPs.

• Make sure you have read and understood all instructions before using treated seeds.

By following these instructions, ‘seed suppliers’ can ensure the safe and responsible use of treated seed, protecting both consumers and the environment.

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