Europe Regulatory News

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.

On 24 June 2024, the European Commission issued a draft amendment to Regulation (EC) No 1223/2009, which regulates the use of substances in cosmetic products. The draft was notified to the World Trade...

On 24 June 2024, the European Commission issued a draft amendment to Regulation (EC) No 1223/2009, which regulates the use of substances in cosmetic products. The draft was notified to the World Trade Organization (WTO) on the same day.

The proposed amendments aim to ban the use of certain chemicals classified as carcinogenic, mutagenic or toxic for reproduction (CMR). This regulatory update is in line with the classifications under the Classification, Labelling and Packaging (CLP) Regulation (EC) No 1272/2008.

The draft introduces stricter controls on a number of CMR substances and ensures that they are included in the list of banned substances in Annex II of the Cosmetics Regulation. This will ensure a uniform implementation of these bans throughout the internal market, increase legal certainty for economic operators and national authorities and, most importantly, ensure a high level of protection of human health.

Key Points of the Draft Amendment

1. Prohibition of CMR Substances:

   - Substances classified by the Risk Assessment Committee of the European Chemicals Agency (ECHA) as Categories 1A, 1B, or 2 will be banned.

   - The Regulation applies to substances classified as CMRs by Delegated Regulation (EU) 2024/197 with effect from 1 September 2025.

2. Specific Substances Targeted:

   - Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (CAS No 75980-60-8) will be banned due to its classification as a Category 1B reproductive toxicant. Previously listed in Annex III and authorised for use in artificial nail systems, this substance will now be transferred to the list of prohibited substances (Annex II).

   - Cymoxanil (CAS No 57966-95-7), already listed in Annex II, will have its entry updated to include its additional chemical names and CAS number for clarity and legal certainty.

- The 21 substances listed in the table below will be added to Annex II to Regulation (EC) No 1223/2009.

3. Implementation and Compliance:

   - The Regulation will apply from 1 September 2025, in line with the classification dates of the substances concerned.

   - No requests for exceptions for the use of these substances in cosmetic products have been submitted, reinforcing the commitment to high safety standards.

Objectives and Expected Impact

The amendment is driven by the need to protect human health from the risks posed by hazardous substances in cosmetic products. By harmonising the classification and prohibition of CMR substances, the European Commission aims to ensure safer products for consumers across the EU. This update also supports the smooth functioning of the internal market by providing clear guidance and certainty for manufacturers and regulatory bodies.

Timetable for Public Consultation and Regulation Enforcement

Stakeholders have until 23 August 2024, to submit comments on the draft regulation. The final version will be adopted following these consultations and will enter into force 20 days after its publication in the Official Journal of the European Union.

On 1 July 2024, CARACAL (Competent Authorities for REACH and CLP) approved the review of the rolling list, leading to the publication of updates to Annex I of the Restrictions Roadmap under the Chemic...

On 1 July 2024, CARACAL (Competent Authorities for REACH and CLP) approved the review of the rolling list, leading to the publication of updates to Annex I of the Restrictions Roadmap under the Chemicals Strategy for Sustainability. This roadmap, which is part of the European Green Deal's commitment to sustainability, aims to reduce hazardous chemicals in the environment. It outlines planned restrictions on harmful substances, offering transparency to stakeholders and allowing companies to prepare for potential changes.

REACH Restriction Roadmap

On 14 October 2020, the European Commission released its chemicals strategy for sustainability under the European Green Deal. This strategy emphasizes the crucial role of chemicals in society and the need for stronger, more cohesive Union legislation. It outlines a range of measures aimed at achieving a toxic-free environment and protect people and ecosystems from dangerous chemicals. It proposes to extend the 'generic approach to risk management' to potentially restrict certain substances in products for specific users, with limited exemptions under clearly defined legal conditions.

Pending assessment and integration into Regulation (EC) No 1907/2006 (REACH Regulation), the strategy prioritizes substances such as carcinogens, mutagens, reprotoxicants (CMRs), endocrine disruptors, persistent, bio accumulative, and toxic substances (PBTs), as well as substances toxic to specific organs and respiratory sensitizers for group restrictions. In order to simplify these initiatives, the Commission has developed a roadmap aimed at prioritizing these substances for regulation under REACH.

Recent Decisions on Restrictions

Following the release of the initial Restrictions Roadmap in April 2022, the European Commission has taken decisions to either revise the list of restrictions in Annex XVII of REACH or to officially end certain restrictions.

Substances under Review for Regulatory Restrictions

Annex II of REACH lists substances that are currently being evaluated for possible regulatory restrictions. At this stage, no decision has been taken regarding the preparation of a restriction dossier or whether it will be submitted by a Member State or by the European Chemicals Agency (ECHA) acting on behalf of the Commission. Annex II also guides authorities in prioritizing future restriction dossiers. Similarly, substances in Annex II may be subject to classification under the Classification, Labelling and Packaging (CLP) Regulation or identification as Substances of Very High Concern (SVHCs) under REACH, potentially leading to subsequent restriction measures.

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.