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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The European Chemicals Agency (ECHA) released the revised Emission Scenario Document (ESD) for Product Type 18 (PT18) in December 2024. This substantial update to the 2008 OECD ESD PT18 offers critica...

The European Chemicals Agency (ECHA) released the revised Emission Scenario Document (ESD) for Product Type 18 (PT18) in December 2024. This substantial update to the 2008 OECD ESD PT18 offers critical enhancements for the environmental risk assessment of pesticides, in line with the Biocidal Products Regulation (BPR).

Background

Directive 98/8/EC was superseded by the Biocidal Products Regulation (BPR), which requires biocidal products and their active ingredients to undergo thorough risk evaluations. The updated draft Emission Scenario Document (ESD) for Product Type 18 (PT 18) was distributed to industry associations, Member States (MS) and Working Group/Expert Group (WG/EG) members on May 2, 2024, for additional evaluation and final feedback. The remaining concerns were resolved at the WG ENV II 2024 meeting after all outstanding topics were handled and discussed following this distribution.

In September 2024, the ECHA received the final draft of the updated ESD PT 18 for publication. The goal of this updated document is to provide in-depth information on emission scenarios for product type 18 to ensure improved environmental protection and regulatory compliance.

Significant Improvements

1. With a new scale idea and improved parameters, the updated ESD offers enlarged and updated scenarios for both residential and non-residential structures. New indoor and outdoor situations are also included in line with recent accords at the EU level.

2. The upgrade includes improved methods for determining simultaneity factors (the chance of several applications running concurrently) and assessing wet cleaning efficiency. Notably, it incorporates a new quantitative primary poisoning evaluation and improved secondary poisoning frameworks for spray and non-spray applications.

3. The revised ESD includes additional chapters on Risk Mitigation Measures (RMMs) and seasonal control. It also includes updated information on target organisms, active compounds, formulations, and user classifications.

Implications for Environmental Risk Assessment

These advancements in the ESD PT18 will enhance the scientific accuracy and robustness of environmental risk assessments for insecticides. This will ensure greater compliance with the BPR and contribute to better protection of human health and the environment. The revised ESD is a valuable resource for environmental risk assessors, regulators, and industry professionals involved in the development, authorization, and use of insecticide products.

Resource for Professionals

The updated ESD is an invaluable resource for environmental risk assessors, regulators, and industry professionals involved in the development, approval, and use of insecticides.

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On 11 February 2025, the European Union’s Packaging and Packaging Waste Regulation (PPWR) officially entered into force, introducing stricter requirements to reduce packaging waste, improve recyclab...

On 11 February 2025, the European Union’s Packaging and Packaging Waste Regulation (PPWR) officially entered into force, introducing stricter requirements to reduce packaging waste, improve recyclability, and eliminate hazardous substances. The regulation is a cornerstone of the EU’s circular economy strategy, which aims to make all packaging reusable or recyclable by 2030.

Under the PPWR, the European Chemicals Agency (ECHA) has been given a key role including identifying harmful chemicals in packaging materials and proposing restrictions on their use if requested. This initiative aims to protect both human health and the environment from potential risks associated with packaging substances.

ECHA’s New Responsibilities

ECHA’s mandate includes:

• Assessing chemicals used in packaging to determine their safety.

• Identifying substances of concern and supporting regulatory action.

• Providing scientific expertise to support future policy decisions on packaging safety.

In addition, ECHA has been tasked to conduct a study on substances in packaging materials, to be completed by September 2026. The study will help guide future restrictions on hazardous chemicals and ensure that safer materials are used in packaging.

PPWR Sustainability Goals and Next Steps

The PPWR aims to achieve a 15% reduction in packaging waste per person by 2040 (compared to 2018 levels) by reducing unnecessary packaging, increasing recyclability, and improving safety standards. The Regulation also includes measures in order to phase out harmful substances to protect consumers and the environment.

ECHA’s work under the PPWR will play a crucial role in ensuring that packaging used in the EU meets strict safety and sustainability standards. The results of the Agency’s study will help shape future regulatory action and support the transition to safer and more sustainable packaging solutions.

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.