June regulatory roundup


New EU Template for Product Recall Notices

The European Commission has introduced a new standardized template for product recall notices under Implementing Regulation 2024/1435. This regulation, published on 27 May 2024, mandates a consistent format and content for recall notices, effective from 13 December 2024.

Key Points

  • Based on Regulation 2023/988: Aligns with general product safety standards.
  • Standardized Model: A single, detailed template for all recall notices.
  • Applicability: Valid for both in-store and online displays.
  • Effective Date: 13 December 2024.

Important Aspects

  1. Clear Communication: Recall notices must convey safety hazards.
  2. Consistency: Ensures uniform practices and easier compliance across the EU.
  3. Accessibility: Notices must be accessible, including adherence to web accessibility standards.

Action Required

Businesses must update their processes by 13 December 2024. The template will be available on the European Commission’s website for easy access and compliance.

Stay informed and compliant!

For more details, visit the European Commission’s official website.

French Senate Approves PFAS Ban in Consumer Products

The French Senate has unanimously approved a ban on PFAS in various consumer products, including cosmetics. This follows the National Assembly’s approval on 4 April. The ban will take effect on 1 January 2026.

Key Points

  • Ban Scope: Prohibits PFAS in manufacturing, import, export, and sale of products, including cosmetics.
  • Exemptions: Products with residual PFAS traces are excluded.
  • Effective Date: 1 January 2026.

Senate Enhancements

  • Improved Monitoring: Enhanced oversight and penalties for non-compliance.
  • Public Information: A public map of PFAS emissions and bottled water analysis program.

The text will undergo a second reading in the National Assembly for further amendments.

Stay updated on these regulatory changes for compliance and consumer safety.

For more details, visit the French Senate’s official website.

New Data on Children’s Exposure to Hexyl Salicylate

The European Commission has requested the SCCS to reassess the safety of Hexyl Salicylate for children under three years of age following new data submissions from the industry.

Key Points

  • Ingredient: Hexyl Salicylate is used in fragrances, cosmetics, and household products.
  • Previous Classification: Classified as “Toxic for Reproduction Category 2” and “Skin Sensitizer Category 1” in March 2022.
  • Current SCCS Opinion: Excluded children under three from safe use conditions in February 2024.

New Developments

  • Additional Data: Submitted in May 2024 to address concerns about children’s exposure.
  • Commission’s Request: The SCCS will reassess safety for children under three and determine the safe maximum concentration.

The SCCS approved the reassessment mandate on 31 May 2024.

Stay updated on regulatory changes to ensure compliance and product safety.

For more details, visit the European Commission’s official website.

French Conseil d’État Upholds Ban on “Biodegradable” Claims

On 31 May 2024, the French Conseil d’État upheld the ban on “Biodegradable” and “Environmentally friendly” claims, rejecting an appeal by the Federation of Hygiene and Responsible Care and FEBEA. This ban, part of the AGEC law, aims to protect the environment.

Key Points

  • AGEC Law: Prohibits terms like “biodegradable” and “environmentally friendly” on products and packaging.
  • Rationale: The ban strengthens environmental protection, not consumer economic interests.
  • Legal Justification: Aligns with European regulations and is necessary for ecological preservation.

Decision Highlights

  • Environmental Focus: The ban aims to improve waste management and prevent misleading claims.
  • Cost Impact: The Conseil d’État found no disproportionate burden on the industry.

This decision sets a precedent, allowing only verifiable environmental claims.

For more details, visit the French Conseil d’État’s official website.

HSE Proposes New Classifications for Benzotriazole and N, N’-Methylenebisacrylamide

On 20 June 2024, the UK’s Health and Safety Executive (HSE) proposed harmonized classifications for Benzotriazole and N,N’-Methylenebisacrylamide, aligning with European standards.

Key Points

  • Alignment: HSE’s proposals match ECHA’s Risk Assessment Committee (RAC) conclusions.
  • Substances: Benzotriazole and N,N’-Methylenebisacrylamide, used in cosmetics.
  • Status: UK proposals pending formalisation, European adoption in progress.

Proposed Classifications

  • Benzotriazole
  • Classification: Aquatic Chronic 2, H411 – Toxic to aquatic life with long-lasting effects.
  • Pictogram: GHS09 – Wng.
  • N,N’-Methylenebisacrylamide
  • Classification: Muta. 1B, H340 – May cause genetic defects.
  • Pictogram: GHS08 – Dgr.

Stay informed on regulatory updates for compliance and safety.

For more details, visit the HSE’s official website.

New CMR Substances Added by Omnibus Act VII

On June 25, 2024, the European Commission notified the World Trade Organization of a draft regulation amending the Cosmetic Regulation (EC) No 1223/2009. This amendment, known as Omnibus Act VII (Commission Regulation (EU) No 2024/197), will urgently ban certain CMR (Carcinogenic, Mutagenic, or Reproductive Toxicant) substances in cosmetics, effective from September 1, 2025.

Key Points

  • New Additions: CMR substances will be banned in cosmetics from September 1, 2025.
  • No Exceptions: The industry did not request exceptions, so all listed substances are forbidden.

Banned Substances Include:

  • Trimethylbenzoyl Diphenylphosphine Oxide
  • Tetrabromobisphenol-A
  • Transfluthrin
  • Clothianidin
  • Various others (complete list available on the EU Commission website).

Action Required

  • Reformulate Products: Check if your products contain any listed substances and reformulate as necessary to comply with the deadline.

Stay updated to ensure your products meet the new regulatory requirements. For more details, visit the European Commission’s official website.