Europe Regulatory News

The European Union (EU) has decided not to renew the approval of the herbicide metribuzin due to concerns about its possible risks to human health and the environment. The decision comes after the Eur...

The European Union (EU) has decided not to renew the approval of the herbicide metribuzin due to concerns about its possible risks to human health and the environment. The decision comes after the European Food Safety Authority's (EFSA) study, which highlighted the substance's endocrine disruptive effects and possible hazards to bees.

As a result, Member States must withdraw authorisations for plant protection products containing metribuzin by 24 May 2025. Any grace period granted by Member States under Article 46 of Regulation (EC) No 1107/2009 shall expire by 24 November 2025

Reason for Non-Renewal

The European Union (EU) has chosen not to extend the approval for the active ingredient metribuzin. This decision is based on concerns made by the European Food Safety Authority (EFSA) about possible hazards to human health and the environment, particularly bees.

EFSA's Concerns:

• Endocrine Disruption: Metribuzin is identified to alter thyroid hormones.

• Human Exposure: Estimates of bystander and resident exposure levels exceed the Acceptable Operator Exposure Level (AOEL) value for all typical uses investigated. Consequently, potential risks to human health cannot be ruled out.

• Bee Risk: Exposure levels surpass defined safety limits, and studies do not rule out a significant risk to pollinators.

Alternative Control Methods

The European Food Safety Authority (EFSA) has determined that metribuzin is not essential to manage a substantial threat to plant health that cannot be addressed by other available means, including non-chemical approaches. While the herbicide has been used to manage both narrowleaf and broadleaf weeds, EFSA discovered that a variety of non-chemical approaches are available, though some may be less efficient or cost-effective than chemical ones.
 

Next Steps

Member States must ensure the withdrawal of metribuzin-based authorisations and enforce the grace period deadlines for existing stocks.

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New requirements for the storage of mixed and concentrated pesticide spray solutions in smaller containers have effect from January 2025. These revisions to the Pesticides Executive Order introduced s...

New requirements for the storage of mixed and concentrated pesticide spray solutions in smaller containers have effect from January 2025. These revisions to the Pesticides Executive Order introduced stricter labelling and storage rules that will affect a number of industries, including horticulture and agriculture.

The new standards concern the safe handling and storage of spray liquids that are transferred from their original packaging into smaller containers for use in a variety of applications. These include the use of dosing pumps in horticulture, direct injection sprayers in open fields, backpack sprayers, and pickling systems.

The Requirements

The fundamental premise remains unchanged: mixed or concentrated spray liquids must be stored in a manner that is safe for the environment and human health, out of the reach of children, and away from food, feed, medications, and other similar items. Unauthorised access to these liquids should also be avoided.

The most significant change is that all smaller spray tanks containing these chemicals must be clearly labelled, with the following information on each container:

1. The name and registration number of all plant protection products used in the spray liquid combination.

2. The concentration of the spray liquid.

3. The date the liquid was transferred to the spray tank.

Best Practices and Recommendations

Although not required, it is strongly advised that the original product packaging, including the label, be stored near the smaller container containing the mixed or concentrated spray liquid. Alternatively, a copy of the original label can be attached to the container, preferably laminated or in a protective plastic pocket. It is critical that any affixed label does not give the idea that the smaller container contains the original marketed product.

Limited Storage Time and Disposal

The regulations emphasise the importance of storing spray liquids for a limited time to ensure their efficacy. If the spray liquid is not used within this time frame, it should be disposed of in accordance with the instructions provided on the original product label. Proper disposal is crucial to reduce environmental impact and prevent potential hazards.

These updated regulations aim to enhance safety and promote the responsible handling of pesticides to protect both applicators and the environment. Applicators are encouraged to familiarize themselves with the full details of the amended Pesticides Executive Order to ensure compliance. To ensure compliance, applicators are recommended to review the amended Pesticides Executive Order with full details.

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On 3 February 2025, the European Chemicals Agency (ECHA) published its Single Programming Document for 2025–2027, outlining its strategic objectives and regulatory actions for the next three years. ...

On 3 February 2025, the European Chemicals Agency (ECHA) published its Single Programming Document for 2025–2027, outlining its strategic objectives and regulatory actions for the next three years. The plan reinforces ECHA’s role in ensuring chemical safety, supporting regulatory compliance, and advancing the EU’s Chemicals Strategy for Sustainability and Green Deal objectives.

Accelerating Regulatory Action on Chemicals of Concern

ECHA is strengthening its Integrated Regulatory Strategy (IRS) to accelerate the identification and management of hazardous substances. The Agency will focus on streamlining hazard assessments, prioritizing high risk chemicals and ensuring timely regulatory action to protect human health and the environment.

Enhancing the Biocidal Products Regulation Process

The Agency aims to reduce delays in the evaluation of active substances under the Biocidal Products Regulation (BPR) by improving the quality of dossiers, enhancing coordination with Member States, and optimizing assessment processes. This includes faster approvals of biocidal product families and better allocation of resources to support industry compliance.

Strengthening Non-Animal Testing Approaches

In line with EU policy objectives, ECHA will increase its efforts to promote alternative testing methods to reduce reliance on animal testing while ensuring regulatory robustness. This includes working with stakeholders to develop and integrate New Approach Methodologies (NAMs) into chemical safety assessments.

Driving Digital Transformation in Chemical Management

A strong focus on IT development will improve the efficiency and accessibility of regulatory processes. ECHA is working to modernize digital tools, improve data integration across different regulatory frameworks, and ensure that industry stakeholders have seamless access to compliance information.

Supporting Industry and Member States with Compliance

To help companies and authorities meet regulatory requirements, ECHA will expand its training, guidance, and technical support initiatives. This will include workshops, online resources, and tailor-made compliance tools for regulations such as REACH, CLP, and BPR.

Promoting Sustainability in Chemical Management

ECHA will continue to support the Safe and Sustainable by Design (SSbD) initiative, encouraging industry to move towards greener chemicals and circular economy principles. The Agency will work closely with stakeholders to ensure that sustainability considerations are embedded in chemical safety decisions.

Expected Results and Regulatory Impact

• More efficient regulatory action, leading to a higher number of restriction dossiers and harmonized classification proposals.

• Reduced delays in the assessment of biocidal products, ensuring timely market access while maintaining safety standards.

• Increased adoption of non-animal testing approaches, in line with ethical and scientific advances.

• Improved digital regulatory tools, making compliance processes more user-friendly and transparent.

ECHA’s Single Programming Document for 2025-2027 sets a clear roadmap for strengthening chemical safety while promoting innovation and sustainability across the EU. The full document is available here.

On 30 January 2025, the European Chemicals Agency (ECHA) and four other EU agencies published a report highlighting the risks associated with the use of azole fungicides, in particular their role in p...

On 30 January 2025, the European Chemicals Agency (ECHA) and four other EU agencies published a report highlighting the risks associated with the use of azole fungicides, in particular their role in promoting resistance in Aspergillus fungi. The findings underscore the need for a coordinated response under the One Health approach to mitigate the growing threat.

Azole Fungicides and Antifungal Resistance

Azole fungicides are widely used in agriculture and horticulture to prevent fungal infections in crops. However, overuse has been linked to increased resistance in Aspergillus fungi, which can cause aspergillosis in humans. This airborne fungal infection primarily affects people with weakened immune systems, lung conditions, or those undergoing medical treatment. Resistance reduces the effectiveness of critical antifungal treatments, making infections more difficult to treat in both humans and animals.

Findings of the EU Agencies’ Report

The report was prepared by five EU agencies - the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA), the European Centre for Disease Prevention and Control (ECDC), the European Environment Agency (EEA) and the European Medicines Agency (EMA) - with support from the European Commission’s Joint Research Centre (JRC). It highlights:

• The increasing occurrence of Aspergillus resistance due to prolonged exposure to azole fungicide.

• The impact on public health, as resistant Aspergillus strains can compromise antifungal treatments.

• The need for enhanced monitoring and control measures to limit the development of resistance.

The One Health Approach to Combating Resistance

The EU agencies emphasize a One Health strategy that integrates human, animal, and environmental health perspectives. Key recommendations include:

• Restricting unnecessary use of azole fungicides in agriculture.

• Improving surveillance and early detection of resistant Aspergillus strains.

• Promoting research into alternative treatments and resistance management strategies.

Next Steps for Policymakers and Stakeholders

The report calls for regulatory measures to balance the need of agriculture with public health priorities. EU agencies will continue to assess the risks and propose mitigation strategies to reduce resistance. Stakeholders, including policy makers, industry, and healthcare professionals, are urged to support sustainable agricultural practices.

The full report can be accessed here.

On 21 January 2025, the European Chemicals Agency (ECHA) published a new infographic to help companies manage their Unique Formula Identifiers (UFIs) effectively. The infographic provides guidance on ...

On 21 January 2025, the European Chemicals Agency (ECHA) published a new infographic to help companies manage their Unique Formula Identifiers (UFIs) effectively. The infographic provides guidance on how to ensure that UFIs included in Poison Centre Notifications (PCNs) are accurate and comply with the 'one UFI – one composition' principle.

Understanding the 'One UFI – One Composition' Principle

The 'one UFI – one composition' principle requires that each UFI corresponds to a single, specific mixture composition. Recent reports from Member States have identified cases where the same UFI was assigned to different mixture compositions, a practice that is prohibited. Such mismanagement can prevent poison centre operators from providing accurate information in emergencies and can lead to regulatory non-compliance and enforcement actions.

Guidelines for Proper UFI Management

To avoid problems related to UFI mismanagement, ECHA recommends that companies:

• Establish Clear Internal Processes: Implement structured procedures within the organisation to systematically manage UFIs.

• Maintain Good Practices with Third Parties: Ensure effective communication and collaboration with suppliers, distributors, and other stakeholders in the supply chain.

• Use Available Tools and Support: Use the resources provided by ECHA, such as the UFI Generator tool and guidance documents, to facilitate the correct assignment and management of UFIs.

Upcoming Enforcement Actions

Starting in January 2025, EU inspectors have launched a six-month pilot project to verify notifications for hazardous mixtures. The inspections will include checks of mixture labels and, where necessary, Safety Data Sheets, to ensure compliance with UFI regulations.

Access the UFI Management Infographic

For a visual guide and more detailed advice on proper UFI management, companies can access ECHA’s newly published infographic here.

By following these guidelines and using the resources available, companies can ensure compliance with UFI regulations, thereby facilitating accurate and efficient emergency responses by poison centres.

The European Council has formally adopted the Packaging and Packaging Waste Regulation (PPWR)  which focuses on reducing packaging waste and promoting sustainability. The rules introduce binding targ...

The European Council has formally adopted the Packaging and Packaging Waste Regulation (PPWR)  which focuses on reducing packaging waste and promoting sustainability. The rules introduce binding targets for re-use, restrict certain single-use packaging items, and require businesses to minimize packaging material. The regulation also encourages re-use by requiring take-away businesses to allow customers to use their own containers, marking a significant step towards a circular economy in the EU.  

Implementation 

The new regulations adopted by the EU will promote safe, sustainable, and recyclable packaging. These include setting ambitious targets for recycled content, such as 65% for single-use plastic bottles by 2040, and reducing packaging waste by minimizing its weight, volume, and harmful substances such as PFAS. The rules also introduce restrictions on single-use plastics for items such as pre-packed produce, food and drinks consumed in restaurants, small cosmetic products, and lightweight plastic bags. Furthermore, businesses will be required to allow customers to use their own containers for take-away food and drinks, with binding re-use targets set for 2030 and 2040. These changes aim to significantly reduce packaging waste and promote a circular economy across the EU. 

Key measures  

• Targets for recycled content in packaging for 2030 and 2040. 

• Limits on harmful substances such as PFAS.  

• New labelling requirements to help consumers with recycling and waste sorting. 

Entry into force 

The Regulation was published in the Official Journal of the EU on 22 January 2025 and will enter into force 20 days later. Its provisions will apply from 12 February 2026 (except for Article 67(5) which will apply from 12 February 2029. 

The full text of the Regulation can be accessed here. 

On January 13, 2025, the EU Scientific Committee on Consumer Safety (SCCS) released its preliminary opinion on the safety of salicylic acid as a cosmetic preservative concerning children's exposur...

On January 13, 2025, the EU Scientific Committee on Consumer Safety (SCCS) released its preliminary opinion on the safety of salicylic acid as a cosmetic preservative concerning children's exposure. The draft opinion is open for comments until March 10, 2025.

Background on Salicylic Acid

Salicylic acid (CAS No. 69-72-7), also known as benzoic acid, 2-hydroxy, is a chemical widely used in cosmetic products as a denaturant, hair and skin conditioning agent, exfoliant, anti-sebum agent, anti-dandruff/anti-seborrheic agent, and product preservative. It is currently regulated under Annex III and Annex V of the EU Cosmetics Regulation (EC) No 1223/2009, with specific concentration limits and conditions of use.

SCCS Scientific Opinion on Salicylic Acid

Based on its safety assessment, the SCCS concluded that:

• Salicylic acid is not safe when used as a preservative in cosmetic products at a concentration of 0.5%, despite the current restrictions. However, it is safe in single dermal and oral product categories, except body lotion. This opinion does not apply to sprayable products that may expose the lungs of the end-user by inhalation.

• The use of salicylic acid as a restricted ingredient for reasons other than to prevent the development of micro-organisms is not safe at the following doses when aggregate exposure is considered: Except for body lotion, it is safe when used in a single dermal and oral product category.

• The opinion does not consider the use of salicylic acid in products intended for children under 3 years of age due to the Cosmetic Regulation's prohibition. The conclusions only apply to salicylic acid as a cosmetic ingredient and do not cover other salicylates or salicylic acid salts. The SCCS mandates do not address environmental safety.

• The use of dermal products and toothpaste can be made safer by reducing the concentration of certain substances, such as 0.1%.

Comments Deadline

The preliminary opinion is open for comments till March 10, 2025.