Europe Regulatory News

The European Commission has issued Commission Implementing Regulation (EU) 2025/182, correcting the chemical formula of riboflavin 5′-phosphate monosodium salt in Implementing Regulation (EU) 2019/9...

The European Commission has issued Commission Implementing Regulation (EU) 2025/182, correcting the chemical formula of riboflavin 5′-phosphate monosodium salt in Implementing Regulation (EU) 2019/901. This feed additive is authorized for all animal species except aquatic animals.

The original formula C₁₇H₂₂N₄O₉PNa was incorrect and has been changed to C₁₇H₂₀N₄O₉PNa. This correction ensures the accurate characterization of the additive in regulatory documents.

Ensuring Compliance with International Standards

The correction aligns the regulation with the Codex Alimentarius standards for Good Animal Feeding (CAC/RCP 54-2004). While the correction does not affect the authorization of the additive, it clarifies the chemical composition and helps maintain consistency and accuracy in regulatory compliance.

Key Dates and Entry into Force

• Adoption Date: 31 January 2025

• Publication Date: 3 February 2025

• Entry into Force: 23 February 2025 (twentieth day after publication)

The measure is considered trade facilitating, as it provides necessary clarity for industry stakeholders.

The full text of the Implementing Regulation can be accessed here.

On 28 February 2024, the European Chemicals Agency (ECHA) launched a public consultation on the classification of three substances as Substances of Very High Concern (SVHC) under the REACH Regulation....

On 28 February 2024, the European Chemicals Agency (ECHA) launched a public consultation on the classification of three substances as Substances of Very High Concern (SVHC) under the REACH Regulation. This step aims to enhance the protection of human health and the environment from potential risks associated with these chemicals.

Details of the Proposed Substances

1. 1,1,1,3,5,5,5-Heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane (EC 241-867-7, CAS 17928-28-8)

   • Uses: Widely used in cosmetics, personal care products, perfumes, fragrances, and as a binder in paints, coatings, and adhesives.

   • Reason for Inclusion: Identified as very Persistent and very Bioaccumulative (vPvB) under Article 57(e) of REACH.

2. Decamethyltetrasiloxane (EC 205-491-7, CAS 141-62-8)

   • Uses: Used in cosmetics, personal care items, detergents, car care products, lubricants, and greases.

   • Reason for Inclusion: Classified as vPvB under Article 57(e) of REACH

3. Reactive Brown 51 (Tetra(sodium/potassium) 7-[(E)-{2-acetamido-4-[(E)-(4-{[4-chloro-6-({2-[(4-fluoro-6-{[4-(vinylsulfonyl)phenyl]amino}-1,3,5-triazine-2-yl)amino]propyl}amino)-1,3,5-triazine-2-yl]amino}-5-sulfonato-1-naphthyl)diazenyl]-5-methoxyphenyl}diazenyl]-1,3,6-naphthalenetrisulfonate); (EC 466-490-7, CAS -)

   • Uses: Used in textile treatment products and dyes.

   • Reason for Inclusion: Identified as toxic for reproduction under Article 57(c) of REACH.

Public Consultation Process

Stakeholders and interested parties are invited to submit their comments and feedback on these proposals by 14 April 2025. Comments can be submitted here. This consultation will allow for the collection of scientific information and perspectives that will inform the regulatory process. The feedback will be reviewed by the Member State Committee (MSC) before a final decision the classification of the substances as SVHCs is made.

Potential Impact on Industry

If these substances are officially recognized as SVHCs, they will be added to the Candidate List, which currently contains 247 entries. This listing could lead to further regulatory actions, including possible restrictions or authorizations, affecting industries that use these chemicals.

Conclusion

ECHA's proposal to identify these three substances as SVHCs underlines the Agency's commitment to protecting health and the environment. Stakeholders are encouraged to actively participate in the consultation process to ensure comprehensive evaluation and informed decision-making.

On 25 February 2025, the European Chemicals Agency (ECHA) launched a public consultation on the possible designation of ethanol as a candidate for substitution under the Biocidal Products Regulation (...

On 25 February 2025, the European Chemicals Agency (ECHA) launched a public consultation on the possible designation of ethanol as a candidate for substitution under the Biocidal Products Regulation (BPR). The consultation is open until 28 April 2025 and invites stakeholders to provide input on alternative substances.

Ethanol Biocidal Products

Ethanol is widely used in biocidal products, including:

• Product type 1 – Human hygiene products.

• Product type 2 – Disinfectants and algaecides not for direct human or animal use.

• Product type 4 – Food and feed area disinfectants.

Ethanol has been identified as a substance of very high concern (SVHC) due to its hazardous properties. Under the BPR, substances that meet substitution criteria will be reviewed for potential phase-out if safer alternatives are available.

Rules for Candidates for Substitution under the BPR

Under the Biocidal Products Regulation (BPR) (Regulation (EU) 528/2012), substances are identified as Candidates for Substitution if they meet specific hazard criteria, such as being carcinogenic, mutagenic or toxic for reproduction (CMR), endocrine disrupting, or persistent, bioaccumulative, and toxic (PBT/vPvB). These substances are subject to stricter approval conditions, and their use is only permitted if no suitable alternatives exist. If an active substance is listed as a candidate for substitution, all biocidal products containing it must be evaluated against possible safer alternatives, with the aim of phasing out the substance where feasible.

Stakeholder Participation

ECHA encourages industry representatives, non-governmental organizations (NGOs), and other stakeholders to submit data on alternatives to ethanol, its safety, and efficacy in biocidal applications. The feedback will contribute to regulatory decisions on the approval of possible restrictions of ethanol.

How to Participate

Stakeholders can access details of the consultation and submit comments via ECHA’s website here. Participation in the consultation will ensure a comprehensive evaluation of the future use of ethanol in biocidal products and help shape EU regulatory decisions.

On 13 March 2025, the European Union notified the World Trade Organization (WTO) of a draft Commission Implementing Decision to update the glossary of common ingredient names for cosmetic products. Th...

On 13 March 2025, the European Union notified the World Trade Organization (WTO) of a draft Commission Implementing Decision to update the glossary of common ingredient names for cosmetic products. This update, proposed under the Cosmetics Regulation (Regulation (EC) No 1223/2009), aims to standardize labeling practices across the EU and improve ingredient transparency for consumers.

Key Updates in the Draft Decision

• Revised Ingredient Glossary: The draft proposes a comprehensive update of the glossary of common ingredient names used in cosmetic product labelling. The goal is to ensure consistent terminology and facilitate ingredient identification for consumers and regulatory authorities.

• Consistent Labelling Requirements: The revised glossary will support harmonized labeling across EU member states, reducing inconsistencies and improving regulatory clarity for manufacturers.

• Repeal of Existing Decision: The new regulation will replace Implementing Decision (EU) 2022/677, incorporating the latest ingredient classifications and nomenclature updates.

Regulatory and Industry Implications

• Compliance Obligations: Cosmetic manufacturers, importers, and distributors will need to align product labels with the updated glossary to ensure continued market compliance.

• Safety and Transparency: The update supports consumer protection by making ingredient names clearer and more accessible. It also assists regulatory authorities in monitoring cosmetic formulations.

• Potential Impact on Product Formulation: Some products may require reformulation to comply with the revised nomenclature and regulatory requirements.

Public Consultation and Next Steps

• Deadline for Comments: Stakeholders will have 60 days from the date of notification to submit comments.

• Proposed Adoption and Entry into Force: The Decision is expected to be adopted in the second quarter of 2025 and will enter into force 20 days after its publication in the Official Journal of the EU.

The full text of the draft decision is available here and the list of common ingredient names is available here.

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 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.

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