Europe Regulatory News

On 23 July 2024, the European Chemicals Agency (ECHA) announced that it has adopted a new policy on administrative charges for joint authorisation applications involving small and medium-sized enterpr...

On 23 July 2024, the European Chemicals Agency (ECHA) announced that it has adopted a new policy on administrative charges for joint authorisation applications involving small and medium-sized enterprises (SMEs). This update, which has been confirmed by the European Commission, simplifies the charging process for companies with an incorrectly declared size.

Single Charge for Joint SME Applications

Under the new policy, ECHA will now issue only one administrative charge for joint authorisation applications, even if several applicants have wrongly declared their company size. The charge will be based on the size of the largest applicant in the group. The invoice will be sent to the lead applicant. If all applicants have declared their company sizes correctly, no administrative charge will be applied.

Updated Definition of Financial Gain

The definition of ‘financial gain’ has been revised to include the benefit of incorrect size declarations made before the invoice is issued. This change will ensure that the lower charges SMEs might gain as a result of incorrect declarations are properly reflected in the administrative charges.

Charge Levels Remain Unchanged

The levels of administrative charges and other provisions remain the same as previously set. The updated decision, which applies from 22 July 2024, consolidates and simplifies past regulations into a single framework. The fee structure last revised in 2015 will continue to apply.

Background on SME Fees

The REACH Regulation and the REACH Fee Regulation authorise ECHA to levy charges for administrative and technical services. The updated policy integrates previous decisions from 2010, 2013 and 2015 into a single approach and streamlines the fee process for joint authorisation applications involving SMEs.

On 19 July 2024, the European Commission launched a consultation on a delegated regulation that will amend the EU’s Prior Informed Consent (PIC) Regulation (EU No 649/2012). The amendment primarily ...

On 19 July 2024, the European Commission launched a consultation on a delegated regulation that will amend the EU’s Prior Informed Consent (PIC) Regulation (EU No 649/2012). The amendment primarily updates the list of chemicals in Annex I, based on recent regulatory developments in the EU and decisions taken under international conventions such as the Rotterdam and Stockholm Conventions.

Understanding PIC

The Prior Informed Consent (PIC) Regulation regulates trade of certain hazardous chemicals that are banned or severely restricted in the EU. It imposes obligations on companies wishing to export these chemicals to non-EU countries or import them into the EU. PIC implements the Rotterdam Convention within the EU and promotes shared responsibility and cooperation in the international trade of hazardous chemicals. It also protects human health and the environment by providing importing countries with information on the safe storage, transport, use and disposal of hazardous chemicals. The PIC Regulation entered into force on 1 March 2014.

What does the PIC Regulation cover?

• Banned or severely restricted chemicals listed in Annex I to the PIC Regulation, including active substances in pesticides and industrial chemicals.

• Chemicals listed in Annex V to the PIC Regulation that are prohibited for export from the EU.

Main Changes in the Delegated Regulation

New Chemicals Added: A total of 42 new chemicals have been added to Part 1 of Annex I, including substances such as abamectin, acrolein, benfluralin and dihexyl phthalate. Part 2 sees the inclusion of 39 new chemicals such as benthiavalicarb, chloridazon, cyanamide and metiram.

Revised Entries: The entries for cyanamide, terbufos and warfarin in Part 1 have been updated with new details. In addition, the entry for polychlorinated biphenyls (PCBs) in Part 3 has been revised.

Deletions and Additions: Terbufos has been removed from Part 2 and added to Part 3 of Annex I with updated details.

New Export Ban: Perfluorohexanesulfonic acid (PFHxS), its salts and PFHxS-related compounds have been added to the list of chemicals subject to an export ban in Annex V. The entry for endosulfan has also been updated.

Consultation Deadline and Regulatory Goals

The consultation on this amendment closes on 16 August 2024 and stakeholders are encouraged to provide their feedback. The proposed amendments aim to improve the regulatory framework for the safe management of hazardous chemicals, ensuring better protection of human health and the environment.

The full text of the draft Delegated Regulation  and its annexes can be downloaded here.

On 18 July 2024, the European Union implemented its latest Eco-design for Sustainable Products Regulation, marking a significant step towards environmental sustainability. The regulation, referred to ...

On 18 July 2024, the European Union implemented its latest Eco-design for Sustainable Products Regulation, marking a significant step towards environmental sustainability. The regulation, referred to as ESPR, is a vital component of the Commission’s strategy to promote greener and more circular products. It is part of a comprehensive set of measures integral to realizing the goals set out in the 2020 Circular Economy Action Plan. These initiatives are designed to support the EU's efforts to meet its environmental and climate objectives, including doubling the rate of material circulation and achieving determined energy efficiency targets by 2030. 

Eco-design for Sustainable Products Regulation

The  Eco-design for Sustainable Products Regulation (ESPR) is an approach to sustainable design that operates under a framework, allowing specific product rules to be gradually established either individually or for groups of products with similar characteristics. To ensure transparency and public and stakeholders’ awareness of ESPR initiatives, the Commission will periodically adopt and update working plans. These plans will outline the products to be assessed and the measures to be implemented, over a period of at least three years. 

The Regulation (EU) No 2024/1781, effective from 18 July 2024, establishes this framework for eco-design requirements for sustainable products. It includes amendments to Directive (EU) No 2020/1828 and Regulation (EU) No 2023/1542, while repealing Directive 2009/125/EC, and applies to almost all categories of physical goods. This regulatory framework allows for the setting of performance and information criteria, referred to as ‘eco-design requirements’, which are crucial for advancing sustainability goals within the EU. 

Implementation 

The EU's Eco-design Forum is essential in shaping the ESPR, engaging stakeholders in the development of the post-implementation rules with inclusivity at its core. An open call for membership invites broad participation. The Commission will update working plans to ensure transparency, with the first plan set for mid-2025, covering textiles, steel and more. The ESPR aims to harmonize EU standards and align them with global trade rules to promote sustainability. Ongoing efforts support the transition from the Eco-design Directive, enhancing energy efficiency and labelling. Stakeholders are urged to follow updates on the European Product Registry for Energy Labelling (EPREL) for further details on the implementation of the ESPR. 

Essential Dates to Remember 

The key dates to remember for the ESPR are: 

1. Q3 2024: Establishment of the Eco-design Forum and call for membership applications. 

2. Q4 2024: First meeting of the Forum and consultation on draft first ESPR working plan. 

3. Q2 2025: Adoption and publication of the first ESPR working plan.  

On 22 July 2024, the European Council officially adopted a groundbreaking regulation requiring digital labelling of fertilising products across the EU. The regulation aims to modernise labelling pract...

On 22 July 2024, the European Council officially adopted a groundbreaking regulation requiring digital labelling of fertilising products across the EU. The regulation aims to modernise labelling practices, reduce costs and simplify obligations for suppliers, while maintaining essential physical labels for those who need them.

Background and Impact

Digital labels, already in use for some chemical products such as batteries, offer significant cost savings and ease of content updates. The new regulation is expected to reduce annual labelling costs by approximately €57,000 for large companies and by €4,500 for SMEs. The road to this regulation began with the Commission’s proposal on 27 February 2023 and culminated in a provisional agreement on 22 January 2024.

This regulation is part of the EU’s wider efforts to improve digital solutions, promote sustainability and protect consumer rights in the single market.

Embracing the Digital Age

The new regulation updates the existing guidelines on fertiliser labelling and promotes digital labelling to reduce bureaucracy and environmental impact. Digital labels, accessible via QR or barcodes, will provide comprehensive product information online for at least 10 years after the product is place on the market. This move is expected to improve the readability and updateability of labels, ensuring that consumers receive accurate and comprehensive information.

Protecting Vulnerable Consumers

Recognising the digital divide, the Regulation ensures that physical labels will continue to be available for vulnerable consumers and those with limited digital skills. Bulk products will also have physical labels at the point of sale to ensure accessible information.

Legislative Process and Implementation

Following the approval of the regulation by the Council, the regulation will nowbe signed by the Presidents of the European Parliament and the European Council. It will then be published in the Official Journal of the European Union and will enter into force three days after publication.

The European Chemicals Agency (ECHA) has released Chesar 3.9, the latest version of its chemical safety assessment and reporting tool. This update brings several enhancements to streamline chemical sa...

The European Chemicals Agency (ECHA) has released Chesar 3.9, the latest version of its chemical safety assessment and reporting tool. This update brings several enhancements to streamline chemical safety assessments for companies complying with REACH.

Improved Compatibility and Functionality

Chesar 3.9 is now fully compatible with IUCLID 6.8 (version 8.0.2 and up), ensuring seamless data integration and consistency across platforms. The main updates include changes to the picklists in Box 2 at the use level, such as the list of technical functions and options for "Physical form of the used product" and "Place of use." These changes are intended to align with the new IUCLID version and improve the user experience without affecting existing assessments.

Bug Fixes and Enhancements

The update addresses several issues from previous versions. In particular, it corrects the generation of the ESCom XML to ensure correct mapping to standard phrases for the unit h/day, and fixes the numbering of uses when exporting to IUCLID. In addition, a new functionality has been introduced to "Export all substances" from Chesar 3, which creates a .zip file with all substances in .chr3 format, together with a text document specifying the export status of each substance.

Known Issues

Despite these improvements, some issues remain in Chesar 3.9. Special characters may occasionally appear in free text fields due to increased security measures. Other known issues include incorrect LEV being values displayed under certain conditions for both simple and complex substances, and various SWED-related issues, such as formatting problems in exported reports and irrelevant warning messages.

Best Practices for Using Chesar 3.9

ECHA provides several suggestions to optimise the use of Chesar 3.9. Users are advised not to set their browsers to remember passwords to avoid connection problems. If the user interface is displayed incorrectly, clearing the browser history may solve the problem. ECHA recommends running Chesar 3.9 with IUCLID 6.8 for best results. For more details on compatibility and troubleshooting, users can refer to the FAQ section on the ECHA website here.

For more information on the new features and to download Chesar 3.9, please visit the official ECHA Chesar page.

On 2 July 2024, the European Food Safety Authority (EFSA) issued a call for data to support the re-evaluation of fumaric acid (E 297) and succinic acid (E 363) as food additives. This effort is part o...

On 2 July 2024, the European Food Safety Authority (EFSA) issued a call for data to support the re-evaluation of fumaric acid (E 297) and succinic acid (E 363) as food additives. This effort is part of EFSA's ongoing review process to ensure the safety and regulatory compliance of food additives that were approved before 20 January 2009, in accordance with Regulation (EU) No 257/2010. This program was supposed to be completed by the end of December 2020; however, the deadline was not met, and several food additives still need to be re-evaluated.

Objective and Participation

EFSA aims to confirm or revise the acceptable daily intakes and usage conditions of fumaric, and succinic acid based on new scientific evidence. Food business operators, national food authorities, research institutions and other stakeholders are invited to submit both published and un-published relevant data on toxicity, human exposure, and potential health effects. The deadline for submissions of interest via the EU Survey tool is 28 July 2024 and the deadline for submission of data is 31 December 2024.

Impact on Food Safety

The participation of stakeholders is essential for a comprehensive re-evaluation. The collected data will enable EFSA to make informed decisions on the regulation of these food additives, ultimately protecting consumer health.

The background document for the re-evaluation can be found here.

The latest version of the QSAR Toolbox, version 4.7, was released on 12 July 2024. The QSAR Toolbox is a freely available software developed by the European Chemicals Agency (ECHA) and OECD Environmen...

The latest version of the QSAR Toolbox, version 4.7, was released on 12 July 2024. The QSAR Toolbox is a freely available software developed by the European Chemicals Agency (ECHA) and OECD Environment and implemented by the Laboratory of Mathematical Chemistry. This major update introduces improvements in several aspects to provide users with a more powerful and efficient tool for predicting chemical toxicity and environmental fate.

Key Highlights and Improvements

Key highlights of QSAR Toolbox 4.7 include:

Database and Inventory Updates: The new version includes numerous updates and corrections to existing databases and inventories, as well as the addition of new chemicals and data points, improving the completeness and accuracy of the information available.

User Interface Enhancements: Improvements to the user interface allow for better presentation of observed metabolites and more intuitive navigation.

Enhanced Profiling and Simulation: Changes have been made to the Toxic Hazard Classification by the Cramer Profiling Scheme, along with updates to 21 profilers and several metabolic simulators, enhancing the predictive capabilities of the software.

Improved Reporting and Documentation: QSAR prediction and justification reports have been modified to comply with the OECD Quality Assurance Framework (QAF) guidelines, providing more detailed and customable reporting options.

Performance and Usability Improvements: Improved task management, better handling of larger datasets, and new features in the workflow editor contribute to improved performance and usability.

Enhanced Regulatory Support and Additional Features

In addition, the new version supports the mapping of seven additional OECD Harmonized Templates (OHTs) related to various physiochemical properties and endocrine disruptor tests. Updates to the TEDRA plug-in and enhancements to data gap filling workflows further extend the functionality of the tool.

QSAR Toolbox 4.7 is designed to meet the evolving needs of researchers, regulatory agencies, and industry professionals and provides a robust and reliable platform for chemical risk assessment and regulatory compliance.

The release notes for QSAR Toolbox 4.7 can be found here.