Decision 944 and Its Impact on the Regulatory Harmonization of Cosmetic Products in the Andean Community
On June 24, 2025, the Commission of the Andean Community (CAN) approved Decision No. 944, a key amendment to Decision 833, aimed at updating and optimizing the regional regulatory framework for cosmetic products. This decision strengthens legislative harmonization among CAN member countries (Bolivia, Colombia, Ecuador, and Peru) by incorporating technological advances, modern regulatory practices, and efforts to reduce unnecessary administrative burdens.
Key Regulatory Changes
General Approach and Regulatory Objective
Decision 944 reaffirms the principles of harmonization established under Decision 833—regarding the production, storage, importation, marketing, quality control, and health surveillance of cosmetic products—while introducing a more modern and flexible framework. This is evident in the simplification of requirements and greater technical clarity in the submission of applications for the Obligatory Sanitary Notification (NSO).
Replacement of Article 9: Obligatory Sanitary Notification
One of the most significant changes is the comprehensive revision of Article 9, which governs the NSO application process. Decision 944 introduces new technical requirements to ensure proper substantiation of cosmetic product information. Key elements now required include:
- The generic name of the cosmetic product.
- Details on the commercial presentation.
- Identification of the technical officer.
- Submission of the quantitative formula, especially when restricted substances or nanomaterials are involved.
- Clear instructions for use.
- Description of the primary and secondary packaging.
- Permission to submit documentation in the original language, unless the national authority specifically requires a translation.
This updated approach standardizes the quality of information submitted by product holders, enhancing the technical evaluation process.
Elimination of the Mandatory Spanish Translation
Decision 944 explicitly eliminates the mandatory translation of technical and general product information into Spanish, unless required by the national regulatory authority. This change reduces operational costs and processing times, facilitating intra-community trade without compromising safety or regulatory oversight.
Immediate Effect
The regulation entered into force on the date of its publication, June 24, 2025. From that date forward, all NSO submissions and related procedures for cosmetic products within the Andean Community must comply with the provisions of Decision 944.
Final Considerations
The publication of Decision 944 marks a significant evolution in the regional regulation of cosmetic products. By modernizing and simplifying the requirements, this amendment promotes a more efficient, predictable, and internationally aligned regulatory environment. For cosmetic product holders and their local representatives, it is essential to review and adapt their sanitary registration strategies in accordance with this updated legal framework.
Prepared by:
Carolina Núñez – Associate Consultant in Quality Assurance and Regulatory Intelligence