Europe Regulatory News

The European Commission adopted Regulation (EU) 2025/351 on 19 February 2025, which introduces significant amendments to Regulation (EU) No 10/2011 on plastic materials and articles intended as food c...

The European Commission adopted Regulation (EU) 2025/351 on 19 February 2025, which introduces significant amendments to Regulation (EU) No 10/2011 on plastic materials and articles intended as food contact materials (FCMs). The updated rules were published on 24 February 2025 and will enter into force on 16 March 2025. Companies need to ensure compliance within the transition period, which ends on 16 September 2026, to avoid potential market restrictions.

Key Amendments in Regulation (EU) 2025/351

The newly adopted Regulation now explicitly extends compositional requirements to all plastic materials and articles, removing previous ambiguities. It also refines definitions to improve the clarity of the legislation.

• Extended Scope: The compositional requirements now apply to all plastic materials and articles, not just 'plastic layers'. This change removes ambiguity, particularly for single homogeneous materials with complex shapes and ensures consistent safety standards for all plastic products. ​

• Clearer Definition of Additives: The definition of 'additives' has been clarified to distinguish them from starting substances. In particular, solid materials that are chemically bonded to polymers are now categorized as additives, even if their surfaces react with the polymers. This clarification will ensure proper classification and regulatory oversight of substances used in the manufacture of plastics.

Alignment with Biocidal Product Regulations

To ensure that food contact materials do not introduce harmful substances, the amended Regulation strengthens alignment with existing biocidal product legislation. The amendments include a reference to the Biocidal Products Regulation (Regulation (EU) No 528/2012), ensuring that only approved biocidal active substances are used in food contact materials. This alignment strengthens consumer protection by preventing the use of unauthorised biocidal substances in FCMs. ​

Stricter Migration Limits for Plastic Food Contact Materials

The Regulation introduces updated specific migration limits (SMLs) to ensure that hazardous substances are not transferred from plastic materials into food at levels that could pose a health risk. These stricter limits apply to a wider range of substances, strengthening the safety standards for food packaging.

• Compliance for multi-layer plastic materials:

Manufacturers using adhesives, coatings, or printing inks in food packaging must ensure compliance with migration testing requirements. The updated regulations emphasise the need for reliable testing methods to verify that no harmful chemicals exceed the new SML thresholds.

• Requirement for migration test data at each production stage:

Companies involved in food contact plastics, including polymer resin producers, additive suppliers, and coating manufacturers, must now provide migration test data at each stage of the production process. This will ensure that materials comply with SMLs before reaching the final product, strengthening accountability throughout the supply chain.

These measures enhance consumer protection and regulatory oversight, ensuring that plastic food contact materials meet the highest safety standards.

High Purity Standards and Sustainability Measures

The revised regulation strengthens purity requirements and introduces stricter risk assessments to ensure safer food contact materials. Key updates include:

• Stricter purity criteria:

  • Additives and UVCB substances (substances of unknown or variable composition) must meet higher purity standards.

  • Only substances with well-defined chemical identities and minimal impurities will be allowed.

  • This is particularly important for manufacturers using recycled or naturally derived materials that may contain residual contaminants.

• More comprehensive risk assessment for NIAS:

  • Non-intentionally added substances (NIAS) will have to undergo detailed risk assessments if migration exceeds 0.00015 mg/kg of food.

  • This measure aligns food contact legislation with EU-REACH (Regulation (EC) No 1907/2006) and the latest risk evaluation framework of the European Food Safety Authority (EFSA).

  • The approach will strengthen safety assessments and ensure better control of potential contaminants in food packaging and materials.

These updates reflect the EU’s commitment to higher safety standards and greater regulatory consistency in the management of FCMs.

Recycling and Reprocessing Provisions

Regulation 2025/351 introduces measures to promote sustainability and ensure the safety of recycled materials:

• Definition of 'reprocessing of plastic': A clear definition for ‘reprocessing of plastic’ has been introduced to distinguish it from recycling. This clarification ensures that by-products from plastic manufacturing, such as off-cuts and scraps, are properly managed and reused, supporting sustainability goals.

• Alignment with the Recycled Plastics Regulation (EU) 2022/1616: The amendments ensure that recycled plastics used in food contact applications meet stringent safety criteria. This alignment requires recycled plastic materials to undergo rigorous decontamination processes and reinforces the requirement that plastic materials derived from waste maintain high purity standards to prevent contamination. ​

Transitional Measures for Compliance

To facilitate a smooth transition, the Regulation provides a grace period for products already on the market and sets clear labelling requirements for non-compliant substances.

• Plastic materials and articles that comply with previous regulations and are placed on the market before 16 September 2025 may remain available until stocks are exhausted.

• Intermediates and substances that do not comply with the new regulation may still be used until 16 September 2026 but must be clearly labelled to indicate their restricted use after the transition date.

The full text of the regulation can be accessed here.

On 21 February 2025, the European Commission launched a comprehensive evaluation of the Cosmetic Products Regulation (Regulation (EC) No 1223/2009) to assess its effectiveness in protecting human heal...

On 21 February 2025, the European Commission launched a comprehensive evaluation of the Cosmetic Products Regulation (Regulation (EC) No 1223/2009) to assess its effectiveness in protecting human health, ensuring a harmonized EU market, and supporting innovation in the cosmetics industry. This is the first full review of the Regulation since its full implementation in 2013, covering all 50 amendments to its annexes, as well as broader regulatory developments.

One-Month Call for Evidence Open Until 21 March 2025

As a first step in the evaluation process, the Commission has opened a one-month Call for Evidence from 21 February to 21 March 2025. This will allow stakeholders to submit their views on the functioning, strengths, and potential gaps of the Regulation. Feedback can be provided here.

Scope of the Evaluation

The Cosmetic Products Regulation (CPR) sets strict safety and compliance requirements for cosmetic products in the European Union (EU) and European Economic Area (EEA) markets, ensuring consumer protection and fair competition. However, evolving challenges such as the growth of e-commerce, digital labelling, sustainability trends, and international regulatory alignment have prompted the Commission to assess whether the Regulation remains fit for purpose.

Key Areas under Review

The evaluation will examine the impact, effectiveness, and potential gaps of the Regulation in a number of areas, including:

• Consumer Safety and Ingredient Risk Assessment – Reviewing the generic risk approach to ensure that high-risk ingredients are properly regulated.

• Labelling and Digitalization – Examining digital labelling and whether current information requirements remain relevant.

• Market Surveillance and Online Sales – Addressing the challenges posed by e-commerce, bulk sales, and cross-border trade.

• Environmental Considerations – Assessing whether the Regulation should be extended to cover the environmental impacts of chemicals in cosmetics.

• International Competitiveness and Trade – Analyzing how the EU regulation is aligned with global cosmetics regulations to facilitate trade.

• Administrative Burden & Regulatory Simplification – Identifying opportunities to reduce compliance costs, in particular for small and medium-sized enterprises (SMEs).

The review will also evaluate consistency with other EU legislation, including the REACH Regulation, CLP Regulation, Biocidal Products Regulation (BPR), and Medical Devices Regulation.

Timeline for Stakeholder Engagement and Consultation

Following the call for evidence, the Commission will launch a 12-week public consultation to allow stakeholders to provide further feedback through surveys and interviews. The whole evaluation process will run from Q2 2025 to Q2 2026.

The Commission will be seeking feedback from:

• Industry representatives (manufacturers, suppliers, SMEs)

• Regulators and customs authorities

• Consumer and environmental organizations

• Scientific researchers and academia

• General public and end-users

On 18 February 2025, the European Chemicals Agency (ECHA) announced that it will update REACH-IT list numbers from the current numeric format (e.g. 100-000-1) to an alphanumeric format (e.g. A00-001-5...

On 18 February 2025, the European Chemicals Agency (ECHA) announced that it will update REACH-IT list numbers from the current numeric format (e.g. 100-000-1) to an alphanumeric format (e.g. A00-001-5) due to limited availability.

New format applies from early summer 2025

Every substance registered or notified under REACH or CLP requires an identifier. If a substance does not have an EC number and has not been previously notified or registered, REACH-IT will assign a new list number.

The new format will retain the original length and will be implemented in early summer 2025. Companies should check the potential impact on their record keeping systems outside REACH-IT. List numbers assigned before the change will not be affected.

The European Union has introduced restrictions on per- and polyfluoroalkyl substances (PFAS) in food contact materials (FCMs) under the Packaging and Packaging Waste Regulation (PPWR).  These measure...

The European Union has introduced restrictions on per- and polyfluoroalkyl substances (PFAS) in food contact materials (FCMs) under the Packaging and Packaging Waste Regulation (PPWR).  These measures aim to limit PFAS in packaging, due to their persistence in the environment and potential health risks such as carcinogenicity, mutagenicity, and reproductive toxicity. From August 2026, PFAS concentrations in food packaging will be limited to specific levels. The European Commission will evaluate by 2030 whether these restrictions need to be further amended to bring them in line with other Eu PFAS regulations. 

PFAS in Food-Contact Materials 

The European Union is addressing concerns about PFAS, a group of thousands of synthetic chemicals commonly used worldwide in various applications, including food contact materials and packaging. These chemicals are known to be extremely persistent in the environment, with many degrading into harmful, long-lasting PFAS variants. 

Exposure to PFAS, especially through food packaging, poses significant human health risks. Long-term exposure has been linked to serious health issues, including carcinogenicity, mutagenicity, reproductive toxicity, and specific organ damage. Due to their persistent nature and harmful effects, PFAS are classified as a major environmental and health hazard. 

To protect public health, the EU has introduced stricter regulations on PFAS in food contact materials. Given the unacceptable health risks posed by these chemicals, the Commission will evaluate the existing legislation and assess whether amendments or repeals are necessary to enhance protection. 

Levels of PFAS  

Starting 12 August 2026, food contact packaging in the European Union will be prohibited if it contains PFAS above specific concentration limits. The new rules set the thresholds at: 

• 25 ppb for individual PFAS  

• 250 ppb for the sum of PFAS  

• 50 ppm for total fluorine content (measured as total fluorine), including polymeric PFAS.  

Manufacturers will need to provide proof of fluorine content if the concentration exceeds certain levels and to ensure compliance with technical documentation requirements. 

Implementation Timeline 

• 11 February 2025: PPWR entered into force. 

• 12 August 2026: General application date of PPWR provisions. 

• 2030: The European Commission will assess whether further restrictions are needed. 

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.

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.

*Source