Navigating EU Regulatory Updates: What you need to know in 2024

In July 2023, the European Union introduced?EU Regulation 2023/1545, a crucial step towards ensuring consumer safety and transparency in cosmetics. This regulation, which requires stricter fragrance allergen labeling, expands the list of allergens that must be declared on product labels and introduces new compliance deadlines, impacting all cosmetics brands selling products within the EU market.

This regulation mandates that cosmetic companies urgently adjust their labeling practices by disclosing allergens if they exceed certain thresholds in both leave-on and rinse-off products. This article provides a full breakdown of the regulation, its annexes, updates, and what brands must do to stay compliant.

Fundamental Changes Introduced by EU Regulation 2023/1545

Regulation 2023/1545?updates?Annex III?of the EU Cosmetic Products Regulation (EC) No. 1223/2009 by introducing?56 new fragrance allergens. These allergens must be declared on the product labels if their concentrations exceed the following thresholds:

• 0.001% in leave-on products?(e.g., creams, lotions, serums)
• 0.01% in rinse-off products?(e.g., shampoos, soaps, conditioners)

This is a significant expansion from the original list of 26 allergens, making it critical for brands to review their formulations and labeling to ensure compliance with these new requirements. Some newly added allergens include?Amyl Salicylate, Camphor, Eugenol, and various essential oils?like?Lavandula Oil?and?Peppermint Oil.

List of Newly Added Allergens in Annex III:

• 3-Propylidenephthalide
• Acetyl Cedrene
• Alpha-Terpinene
• Amyl Salicylate
• Anethole
• Beta-Caryophyllene
• Camphor
• Cedrus Atlantica Oil
• Eucalyptus Globulus Oil
• Eugenia Caryophyllus Oil
• Mentha Piperita Oil
• and many more...

Brands must diligently evaluate whether these allergens are present in their formulations and update their product labels accordingly.

Key Compliance Deadlines

The European Commission has set two critical deadlines for personal care and beauty companies:

• July 31, 2026: Deadline for selling products already on the market. Brands must update labels to reflect the new allergen disclosure rules or withdraw products from the market by this date.
• July 31, 2028: New products introduced into the market after this date must comply with the updated provisions of Regulation 2023/1545.

Preparing for Compliance: Steps for Cosmetic Brands

1. Ingredient Review and Testing: Conduct a?comprehensive ingredient audit?across your product lines. Identify all fragrance ingredients in use and test them against the updated allergen list. Analytical testing may be required to determine the concentration of these allergens. Standard clinical tests include?Human Repeat Insult Patch Test (HRIPT),?Photoallergy, and?Phototoxicity?tests to confirm ingredient safety and compliance.
2. Label Updates: Once you’ve identified allergens that exceed the thresholds, update your product labels to include them. Labels must display the allergens in a legible and accessible manner. Ensure that all affected products comply with this requirement by the specified deadlines.
3. Supplier Coordination: Work closely with your fragrance suppliers to get the most up-to-date safety data sheets (SDS) that reflect the new allergen requirements. Suppliers should provide full transparency on the composition of their fragrance ingredients.
4. Staff Training: Ensure that everyone in your team – from R&D to production to marketing – knows the new regulations and understands their role in ensuring compliance. Conduct training sessions focused on the importance of allergen labeling and regulatory compliance.
5. Clinical Safety Testing: Cosmetic brands should invest in?clinical safety tests, such as HRIPT and?Risk Assessment?procedures, to ensure their products are compliant and safe for consumers. These tests should be conducted in collaboration with?dermatologists, pediatricians, and other medical specialists?to assess product safety comprehensively.
6. Risk Assessment: Conduct a risk assessment that evaluates the cumulative exposure of consumers to allergens from various products they might use. This helps ensure that the overall exposure to these allergens remains within safe limits.

Additional Regulatory Updates: New EU Annexes for Cosmetic Ingredients

In addition to allergen labeling changes,?EU Regulation 2023/1545?introduces updates to other critical cosmetic ingredient guidelines:

1. Vitamin A and Arbutin Updates: The EU has revised safety standards regarding ?Vitamin A (Retinol)and?Alpha-Arbutin?in cosmetic formulations. These ingredients are popular in skincare due to their anti-aging and brightening properties, but the updated regulation sets safe usage limits to prevent adverse effects like irritation and photosensitivity.
2. Nanomaterials Regulation (EU) 2024/858: The use of nanomaterials in cosmetics has also been further restricted. Specific nanomaterials, including?Colloidal Silver, Gold, Platinum, and?Styrene/Acrylates Copolymer, have been banned from cosmetic products. Brands using nanomaterials in their formulations must ensure that their products comply with the new standards by?February 1, 2025,?for market placement and by?November 1, 2025,?for off-shelf availability.

Conclusion

The introduction of?EU Regulation 2023/1545?represents a significant step toward ensuring consumer safety in the cosmetics industry by increasing transparency around potential allergens. Brands must act now to conduct a full ingredient review, update labels, and complete the necessary clinical tests to meet the upcoming compliance deadlines. By proactively adopting these changes, brands can maintain consumer trust, avoid market penalties, and ensure continued success in the EU market.