Case study: importing cosmetics – ensuring labeling compliance in the EU

Import: understanding regulatory differences in cosmetics

Cosmetic regulations are harmonized within the European Union but not in other parts of the world. Each country or economic region enforces its own requirements regarding labeling, composition, and notification, which can complicate the market placement of these cosmetic products in Europe.

Labeling audit: a case of non-compliance for the U.S. market

Findings: regulatory gaps to address

An American client requested a labeling review for their product before drafting their Cosmetic Product Safety Report (CPSR).

🔍 Issues identified:

Missing address of the responsible person, mandatory in Europe.

Differences between American and European INCI names (e.g., WATER/AQUA, PARFUM/AROMA).

Missing “Made in USA” statement, which is required to indicate the origin of imported products from a third country.

Regulatory analysis: why are these errors problematic?

The labeling of a cosmetic product must comply with European standards to avoid regulatory non-compliance, which may result in delays in market entry or even an import refusal.

🚨 Key non-compliance points identified:
📌 Article 19 of Regulation (EC) No 1223/2009 requires that every cosmetic product sold in Europe includes the address of the Responsible Person.
📌 For products originating from a third country (in this example, the United States), the imported product in the European Union must include the mention “Made In …” to indicate its origin.

Correction and labeling compliance

✅ Solutions implemented:
✔️ Adjusted INCI mentions to ensure compliance with European standards.
✔️ Added the address of the Responsible Person to meet European requirements.
✔️ Included the mention “Made in …” for all products imported from a third country.
✔️ Submitted a compliant labeling draft for regulatory approval before final validation.

Conclusion

Anticipating regulatory differences for successful expo

Cosmetic standards vary across countries, requiring greater vigilance before export. Non-compliant labeling can result in customs blocks, fines, or a ban on sales.

✅ Best practices to follow:
🔹 Always verify the INCI names to ensure compliance with the target country’s requirements.
🔹 Clearly display the address of the Responsible Person on European labels.
🔹 Add mandatory mentions such as “Made in …” for a product imported from a third country.
🔹 Conduct a labeling audit before drafting the CPSR to ensure full compliance.

A preliminary regulatory audit helps facilitate importation and prevent any market entry refusals.