Europe Regulatory News

On 20 February 2025, the French National Assembly adopted a new law aimed at reducing public exposure to per- and polyfluoroalkyl substances (PFAS), often referred to as "forever chemicals" due to the...

On 20 February 2025, the French National Assembly adopted a new law aimed at reducing public exposure to per- and polyfluoroalkyl substances (PFAS), often referred to as "forever chemicals" due to their persistence in the environment and the human body.

Ban on PFAS in Key Consumer Products

Beginning in 2026, the legislation will prohibit the manufacture, import, and sale of PFAS-containing products as follows:

• 1 January 2026: Prohibition on the manufacture, import, export, and sale of products containing PFAS in the following categories:

  • Cosmetics: All beauty and personal care products.

  • Textiles: Clothing items, except protective gear for military personnel and firefighters.

  • Ski Waxes: Products used to maintain and enhance the performance of skis.

• 1 January 2030: Expansion of the ban to include all textiles containing PFAS, including a broader range of fabric-based products.

These measures aim to reduce public exposure to PFAS, which are used for their waterproofing and non-stick properties, but have raised health and environmental concerns due to their persistence.

Exemptions and Industry Implications

Notably, the legislation exempts certain items from the ban:

• Protective Clothing: Gear designed for security forces and emergency responders is exempt to ensure their safety and operational effectiveness.

• Cookware: Kitchen utensils, such as nonstick pans, are exempt from the law, giving manufacturers additional time to develop suitable PFAS-free alternatives.

The phased implementation provides industries with a clear timeline to transition to safer alternatives, reflecting a balance between public health priorities and economic considerations.

This legislative move positions France at the forefront of global efforts to regulate and reduce the use of PFAS and sets a precedent for comprehensive chemical safety standards.

France’s PFAS Ban and the EU-Wide Restriction Proposal

France’s national restrictions on PFAS are being introduced alongside the EU-wide restriction proposal currently under review by the European Chemicals Agency (ECHA). The proposal, which was submitted in January 2023, seeks to ban the production, use, and sale of around 10,000 PFAS across the EU. Public consultations ended in September 2023, and a final decision is expected following a review by the European Commission and EU member states.

France is not the first EU country to take independent action on PFAS ahead of the EU-wide restriction. Denmark has already banned PFAS in paper and board food packaging from 2020 and recently announced plans to extend this ban to consumer clothing, footwear, and waterproofing agents from July 2026 (read more here). Denmark, along with Germany, the Netherlands, Norway, and Sweden, has also been a key proponent of the EU’s broader restriction proposal.

By moving forward with national legislation, France is taking a leading role in addressing PFAS pollution while supporting the broader European regulatory framework. If adopted, the EU-wide restriction could further strengthen measures to phase out PFAS in industrial and consumer applications in all member states.

The Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation, Regulation (EC) No 1907/2006, is the legal framework for the regulation of chemicals in the European Union...

The Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation, Regulation (EC) No 1907/2006, is the legal framework for the regulation of chemicals in the European Union (EU). It was adopted to enhance the protection of human health and the environment from potential risks posed by chemicals, while promoting the competitiveness of the EU chemicals industry. REACH entered into force on June 1, 2007, and applies to all chemical substances, including those used in industrial processes, consumer products, and articles such as paints, cleaning products, furniture, and electronics. It requires manufacturers and importers to register substances produced or imported in quantities of one tonne per year or more, unless specifically exempted. Registered substances can then circulate freely within the EU market. The regulation also encourages alternative testing methods to reduce reliance on animal testing.

Under REACH, companies have the burden of proof to identify and manage the risks associated with their substances. They must demonstrate safe use to the European Chemicals Agency (ECHA) and communicate risk management measures to downstream users. If risks cannot be controlled, authorities can restrict or ban substances, with the long-term goal of substituting hazardous chemicals with safer alternatives. The registration process follows a “one substance, one registration” principle, requiring companies producing the same substance to share data through a joint registration dossier submitted to ECHA. The dossier consists of a Technical Dossier (covering identity, classification, test data, and use) and a Chemical Safety Report (CSR) (for substances exceeding 10 tonnes per year, detailing hazard assessments and exposure scenarios). Since the registration deadline of May 31, 2018, unregistered chemicals cannot be manufactured or marketed in the EU, ensuring strict compliance with REACH regulations.

Key News from 2024

ECHA Expands SVHC Candidate List in 2024

In 2024, the European Chemicals Agency (ECHA) added seven substances to its Candidate List of Substances of Very High Concern (SVHC) on three occasions, bringing the total to 242 entries. Notable additions include bis(α,α-dimethylbenzyl) peroxide in June for its reproductive toxicity, and triphenyl phosphate in November for its endocrine disrupting properties. These updates aim to better protect human health and the environment by identifying and regulating hazardous chemicals. Companies are now required to manage the risks associated with these substances and provide safety information to customers and consumers. Read more here, here and here.

European Union Updates CLP Regulation and ECHA Issues Revised Guidance

The European Union has adopted Regulation (EU) 2024/2865, amending the Classification, Labelling, and Packaging (CLP) Regulation. It was published in the Official Journal on November 20, 2024, and entered into force on December 10, 2024. In conjunction, the European Chemicals Agency (ECHA) published updated guidance on November 13, 2024, detailing the application of new hazard classes, including criteria for endocrine disruptors and persistent, bioaccumulative, and toxic substances. Read more here, here and here.

EU Adopts New Regulation to Combat Ozone Depletion

The European Union has adopted Regulation (EU) 2024/590 to limit emissions of ozone-depleting substances. The Regulation was published on February 20, 2024, and entered into force on March 11, 2024, repealing Regulation (EC) No 1005/2009. The Regulation prohibits the production, import, export, and sale of listed substances, with exemptions for specific uses such as feedstock, process agents, essential laboratory applications, critical halon uses, and emergency methyl bromide applications. This initiative is in line with the European Green Deal, which aims to protect the ozone layer and reduce greenhouse gas emissions. Read more here.

ECHA Launches ECHA CHEM Database

On January 30, 2024, the European Chemicals Agency (ECHA) launched ECHA CHEM, a user-friendly platform providing information on more than 100,000 chemicals registered under REACH. This initial release aims to enhance public access to chemical data, with future expansions planned to include the Classification and Labelling Inventory and Regulatory Lists. ECHA CHEM reflects ECHA’s commitment to efficiently manage the growing volume of chemical data and to take advantage of technological advances. Read more here.

New Distributor Responsibilities and UFI Compliance in Poison Centre Notifications

The recent amendments to the Classification, Labelling, and Packaging (CLP) Regulation introduce significant responsibilities for distributors. Distributors are now required to ensure that hazardous mixtures are correctly classified, labelled, and packaged before they are placed on the market. They must also verify that suppliers have fulfilled their Poison Centre Notification (PCN) obligations, including the assignment and proper labeling of Unique Formula Identifiers (UFIs). To help companies manage UFIs effectively, the European Chemicals Agency (ECHA) published an infographic on January 21, 2025, emphasizing the 'one UFI – one composition' principle. Adherence to this principle is critical for compliance and to facilitate accurate emergency response by poison centres. Read more here and here.

Progress on the EU PFAS Restriction Proposal in 2024

The European Chemicals Agency (ECHA) has made significant progress on the restriction proposal for per- and polyfluoroalkyl substances (PFAS) in 2024. In March, ECHA's Scientific Committees began evaluating the proposal, focusing on the potential health and environmental impacts of PFAS. In June, ECHA provided updates showing significant progress in assessing the risks associated with these substances. In July, the EU introduced restrictions on a specific PFAS sub-group, perfluorohexanoic acid (PFHxA), to reduce associated health and environmental risks. These developments underscore the EU's commitment to regulating PFAS and protecting public health and the environment. Read more here, here and here.

Key Dates for 2025

From January 1, 2025, all hazardous mixtures must be notified to poison centers using the harmonized format under Annex VIII of the CLP Regulation. From May 1, 2025, new hazard classifications under the CLP Regulation, including endocrine disruptors and persistent, bioaccumulative, and toxic substances, will apply for substances placed on the market.

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.

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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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 Union has taken an important step to improve the safety and transparency of plant protection products by updating Regulation (EU) No 547/2011. The proposed updates aim to harmonise labell...

The European Union has taken an important step to improve the safety and transparency of plant protection products by updating Regulation (EU) No 547/2011. The proposed updates aim to harmonise labelling standards, improve risk communication to end-users, and strengthen safety measures while supporting sustainability goals. This updated legislation seeks to make information clearer and more accessible to farmers and other users, while also aligning with the EU's Farm to Fork strategy. It is important that all users of plant protection products understand these significant improvements.

Key Changes in the Updated Regulation

• Standardised Risk Mitigation Phrases: Clear and concise language will be provided. These phrases will be grouped according to evaluations of the risks to the environment and human health.

• Enhanced Bee Safety: Agrochemicals, that may endanger bees will be prominently marked with a particular phrase and symbol.

• Micro-organism Sensitization Warnings: Precautionary statements will be included to warn and alert consumers to the possible sensitisation effects of micro-organisms used in plant protection products.

• Combating Illegal Trade: Plant protection products covered by ‘a parallel trade permit’ will be required to carry a special label that includes the batch number, date of manufacture date, permit number, and details about the permission holder.

• Improved Research Labelling: Plant protection products used in research and development must have clearer labelling instructions that highlight their experimental nature and the need for utmost caution.

• Improved Disposal Guidance: To reduce packaging waste, standardised language will be used to instruct consumers on how to properly dispose of plant protection product containers.

• Colour-coded Labelling: To quicky communicate the hazard status of active ingredients, the presence of micro-organisms, and whether the product is approved as low-risk, a colour-coded scheme shall be used on labels.

• Accessibility of Digital Labelling: Digital labels will be made available to users through links or machine-readable forms, including features such as voice assistance, auto-search, larger fonts, and multilingual support.

Feedback Period

Public consultation: Open from January 6, 2025, to February 3, 2025.

Expected Entry into Force:  January 1, 2026.’

The revised regulation supports the Farm to Fork strategy, which seeks to reduce dependency on chemical plant protection products. By improving labelling clarity and risk communication, the EU seeks to help consumers make informed choices while minimising risks to the environment, animal health, and human health.

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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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