The main amendments to CU TR 009/2011 adopted by EEC Council Decision No. 114 of 29 November 2024 took effect on 24 December 2025. Before manufacturing or importing cosmetics, review not only the formula but also registration documents, packaging and the product name.
Certificate validity
New cosmetic State Registration Certificates (SGRs) have a maximum validity of five years, which must be stated in the document. Older SGRs must be checked against transitional provisions: documents adopted before 24 December 2025 remain valid for 60 months from that date.
Packaging and product names
Oral hygiene products require packaging that provides first-opening control or protection against unauthorised opening. Cosmetic packaging must not mislead consumers by imitating food or medicines. Product names must also avoid confusion with registered medicines or medical devices.
Before submitting your dossier
- Check the current product category and whether an SGR is required: not all cosmetics require state registration.
- Review the formula, intended use and consumer age.
- Ensure the label, instructions and manufacturer dossier are consistent.
- Verify the issue date and validity of any existing document.
This checklist supports preparation for assessment. The final dossier depends on the specific product and the applicable version of the regulation.