Changing Requirements for Cosmetic Products

Decision 944: The new framework that will transform cosmetic sanitary notifications in the Andean region.

In a bid to modernize regional regulations and facilitate trade between countries, the Andean Community (CAN) approved on June 24 the Decision 944which redefines the requirements for the Mandatory Health Notification (MHN) of cosmetic products. This update will take effect on December 17, 2025, marking a milestone for manufacturers, importers, and distributors of cosmetics in Colombia, Peru, Ecuador, and Bolivia..

What Changes with the New Regulation?

The 944 amends Article 9 of Decision 833, introducing key improvements that address the current needs of the sector:

🔹 Unnecessary translations are eliminated: it will no longer be mandatory to submit all technical documentation in Spanish, unless specifically requested by an authority.

🔹 Greater clarity in requirements: the required information is organized into two blocks general and technical data making it easier to structure the procedures.

🔹 Labeling flexibility:it will be possible to submit a preliminary version of the label at the time of application, and provide the final version when commercialization begins.

🔹 Legal certainty:ongoing applications must be adapted to the new guidelines, improving the traceability and consistency of the system.

A Firm Step Toward Regional Harmonization

This change is a concrete response to the needs of a dynamic sector, which advances with constant innovation and demands clear and functional regulations. With this decision, the CAN strengthens the technical integration of its member countries and fosters a more efficient regulatory environment for businesses, without compromising consumer safety.

In addition, it provides companies with a more modern, coherent framework adapted to the current technological context, which is especially beneficial for those operating with private labels, contract manufacturing, or imports.

In Global Pharma, we support regulatory updates as a tool for development, competitiveness, and access. 

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Source: https://www.invima.gov.co/sala-de-prensa/el-invima-anuncia-cambios-en-la-regulacion-sanitaria-de-la-comunidad-andina-con-la

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