On 5 December 2024, ECHA's Risk Assessment Committee (RAC) published its meeting highlights and adopted changes to the list of chemicals. The discussion decided that two groups of essential oil fragrances should be classified as category 1B reproductive toxicants under the EU’s Classification, Labelling, and Packaging (CLP) Regulation.

Burgeonal and Cyclamal Groups Classified as Reprotoxic 1B Under CLP Regulation

The RAC opinions are based on two proposals for fragrance substances: one for Burgeonal compounds and the other for Cyclamal compounds. Both are widely used as fragrances in personal care, cleaning, and consumer products. The classification reflects concerns about their potential to impair fertility or harm the unborn child.

Industry Concerns over RAC’s Classification of Essential Oil Compounds

The European Federation of Essential Oils warned that the classification could potentially lead to some essential oils being classified as Reprotoxic 1B, potentially stopping their use in cosmetics and consumer products. The industry also argued that reproductive toxicity observed in laboratory animals does not apply to humans, as seen in a similar classification proposed for tea tree oil.

Details of RAC's Decisions on Burgeonal and Cyclamal Groups

ECHA’s Risk Assessment Committee has accepted the proposed changes to the essential oil classification that specify the potential reproductive toxicity under the CLP Regulation. The list of accepted changes is listed below:

For further details, refer to the RAC Meeting highlights in the Annex

The General Product Safety Regulation (EU) 2023/988 (GPSR) applies from 13 December 2024, replacing the General Product Safety Directive (2001/95/EC) and Council Directive 87/357/EEC. This modernized regulation ensures consumer protection in the EU by addressing new challenges posed by digitalization, global supply chains and technological advances. It acts as the default safety framework for non-food consumer products not covered by harmonized product-specific legislation, such as cosmetics and food.

Key Updates under the General Product Safety Regulation

The GPSR introduces significant updates to the safety of consumer products:

• Extended Scope to Cover Online Sales:

  • Online marketplaces must take greater responsibility for removing unsafe products and protecting consumers in digital transactions.

• Accident Reporting Through the Product Safety Gateway:

  • Economic operators are now required to report all individual accidents involving products to the authorities, not just those that pose a "risk."

• Improved Product Recall Mechanisms:

  • Mandatory templates for recall notices and direct communication with consumers improve the efficiency of recalls. Consumers are also entitled to a remedy (e.g., repair, replacement, or refund) for recalled products.

• New Rules on the Responsible Person in the Supply Chain:

  • A designated "Responsible Person" must be based in the EU and ensure compliance with technical documentation, labelling, and safety requirements.

  • The Responsible Person must liaise with market surveillance authorities and verify ongoing product compliance.

• Labelling and Contact Information Requirements:

  • Products must now include an "electronic address" in addition to the name and postal address of the manufacturer or importer.

• Importer Responsibilities:

  • If no other relevant EU-based party can be identified, the importer is considered the Responsible Person and must ensure that all regulatory obligations are met. Importers must work with non-EU suppliers to obtain the necessary documentation.

Harmonized Market Surveillance for Safer Products

The GPSR strengthens the enforcement powers of national authorities to ensure compliance across the EU. Improved cooperation between Member States will enable rapid responses to safety issues, including the recall of unsafe products.

With 31% of product safety alerts stemming from online sales, the GPSR addresses risks in the digital marketplace and ensures that all products sold in the EU meet stringent safety standards.

A Major Step in EU Consumer Protection

Adopted on 10 May 2023, the GPSR is part of the EU's New Consumer Agenda and replaces outdated rules to adapt to a rapidly changing market. By strengthening oversight, enhancing safety measures, and addressing the complexities of digital and globalized supply chains, the GPSR reaffirms the EU’s position as a global leader in consumer product safety.

The official text of the GPSR can be found here.