Cosmetic Products in Colombia – Overview
Freyr provides comprehensive regulatory support for cosmetic products in Colombia, assisting companies in defining their regulatory strategy, ensuring compliance with applicable sanitary requirements, and managing regulatory activities throughout the product lifecycle.
The Colombian regulatory framework for cosmetics is harmonized at the Andean level and is designed to ensure product safety, quality, and appropriate consumer information. Effective regulatory management is essential to secure market access, minimize compliance risks, and maintain product continuity in the Colombian market.
Regulatory Authority and Framework
In Colombia, the competent health authority responsible for the inspection, surveillance, and control of cosmetic products is the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA).
The regulatory framework applicable to cosmetic products is primarily established under Andean Decision 833 of 2018, which sets out harmonized requirements for the commercialization of cosmetics within the Andean Community, and is complemented by the applicable national regulations, including Decree 219 of 1998.
This regulatory scheme emphasizes post-market control, without prejudice to prior compliance with the sanitary requirements applicable to notification and commercialization.
Cosmetic Product Classification in Colombia
In Colombia, cosmetic products are classified primarily based on their intended use and area of application, in accordance with the Andean regulatory framework.
In general terms, cosmetic products are grouped into categories such as products for children, eyes, skin, lips, body hygiene, hair, nails, perfumery, oral hygiene, sun tanning and sun protection, depilatory products, skin lightening products, repellents, among others.
In addition, various cosmetic forms are recognized, including creams, gels, sticks, powders, sprays, and other presentations, which may impact labeling requirements, consumer information, and sanitary control considerations.
Sanitary Notification and Regulatory Controls
Under the Andean regulatory framework, cosmetic products require a Mandatory Sanitary Notification (NSO) for commercialization.
In Colombia, this process is managed before INVIMA and constitutes the starting point for sanitary control of the product, including compliance with requirements related to composition, labeling, and permitted communication.
Proper management of the NSO and its modifications is essential to ensure regulatory compliance and product continuity in the Colombian market, considering that health authority oversight is primarily exercised during the post-market phase.
Labeling and Communication Requirements
Cosmetic product labeling must comply with the requirements established under Andean and national regulations, ensuring clear, truthful, and sufficient information for consumers.
Product composition, denomination, claims, and other communication elements must not be misleading or attribute therapeutic, preventive, or curative properties, which are not permitted for cosmetic products.
Freyr Expertise
Freyr provides specialized regulatory support for companies seeking to commercialize and maintain cosmetic products in the Colombian market, combining global regulatory experience with in-depth knowledge of the Andean regulatory framework and INVIMA requirements.
Our expertise includes:
- Regulatory strategy definition for cosmetic products in Colombia
- Support for Mandatory Sanitary Notification (NSO) and management of modifications
- Ingredient and formulation review against applicable restrictions and lists
- Labeling review and regulatory compliance assessment
- Claims review to ensure non-therapeutic communication
- Regulatory gap analysis against applicable requirements
- Regulatory support throughout the product lifecycle
- Support during post-market surveillance and control activities