Reform of the CAN Cosmetics Regulation: What Changes for Your Company in 2025–2026
The Andean Community is advancing adjustments to Decision 516, which governs cosmetic NSOs. Learn what is changing, what deadlines matter, and what to review in your portfolio before the next update takes effect.
Cosmetics regulation in Colombia operates under a supranational framework: Decision 516 of the Andean Community of Nations (CAN), adopted in 2002 and complemented by INVIMA resolutions. This framework has worked for more than two decades, but its original structure did not anticipate how quickly modern cosmetic portfolios would evolve — especially formulations with biotechnological actives, naturally derived ingredients, and products at the boundary between cosmetics and medicines.
Over the past two years, the CAN member countries have driven a process of regulatory review that is generating concrete changes. For companies operating in Colombia with cosmetics portfolios, this means revisiting assumptions that have worked for years.
The Current Framework and Its Present Tensions
Decision 516 established the Mandatory Health Notification (NSO) system for cosmetics across the Andean subregion. Its main advantage was simplifying the process compared with the old registration regime: instead of a case-by-case evaluation by the regulator, the company assumes technical responsibility through the notification.
However, that same freedom has created areas of interpretation where INVIMA has had to clarify criteria that the original decision left open:
What is a cosmetic and what is a medicine? The boundary remains the greatest point of conflict. Products with actives such as minoxidil, azelaic acid at high concentrations, or retinoids have been subject to reclassification by INVIMA in the last 18 months. The trend is clear: therapeutic concentrations or claims of physiological action move the product into the medicines regime.
Holder responsibility across the supply chain. In recent years, INVIMA has deepened its requirements regarding what the NSO holder must guarantee about its manufacturers: current GCP (Good Cosmetic Practices) certificates, quality control of critical ingredients, and traceability of the production chain. A validly obtained NSO can be subject to observations during a visit if the manufacturer's supporting documentation is outdated.
Restricted and prohibited ingredients. The CAN ingredient list has been expanded several times with updates that incorporate European Union prohibitions. Companies without an active system to track these updates run the risk of marketing products with ingredients that are no longer permitted.
Recent Changes That Impact Operations
GCP certification for national manufacturers. INVIMA has been increasing the rigor of its verification of Good Cosmetic Practices (GCP) for national manufacturers. By 2026, GCP accreditation is expected to be verified more frequently during inspection visits, with emphasis on production records, raw-material control, and nonconformity management.
Spanish labeling and CAN requirements. Labeling regulation for imported cosmetics requires that essential information be in Spanish before the product is marketed in Colombia. Recent updates have clarified what information is "essential" and what may remain in the manufacturer's original language. This is a point where multinational companies frequently accumulate observations during inspections.
NSO validity and early renewal. NSO validity in Colombia is indefinite as long as the conditions of the original notification are maintained. However, changes in the manufacturer, the formula, the packaging, or the product's function trigger an obligation to modify or file a new notification. Poor change management — especially in large portfolios — is one of the most common findings in inspections.
How to Prepare Your Portfolio
Regulatory risk in cosmetics comes not so much from the absence of an NSO as from the deterioration of the conditions that support it. A portfolio that was in order in 2020 may present vulnerabilities today if it has not been actively managed.
The areas of greatest exposure in 2026:
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Formulas not updated after manufacturer changes: The manufacturer changed a functional ingredient or its raw-material supplier, and that variation was not notified to INVIMA.
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Expired GCP certificates: The manufacturer's certificate has expired and the holder has no automatic renewal protocol.
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Benefit claims that exceed the cosmetic scope: Marketing materials or labels contain statements that border on the medicinal without the product holding the correct classification.
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Now-restricted ingredients: Formulations approved years ago that include actives whose maximum concentration was revised downward in CAN updates.
At Vexpro we conduct cosmetics portfolio diagnostics that identify these exposure points before they appear during an inspection visit or in an INVIMA request. If your company manages cosmetics in Colombia, the time to review is before the notice arrives.