Colombia Cosmetic Regulations & INVIMA Registration Requirements

Colombia is one of the fastest-growing cosmetic markets in Latin America, offering significant opportunities for global and regional cosmetic brands. However, market entry requires strict compliance with INVIMA cosmetic regulations, Andean Community rules, and Colombia’s progressive policies especially its animal testing ban.

This in-depth guide by Maven Regulatory Solutions explains the Colombia cosmetic registration process, mandatory health notification (NSO), labeling rules, fees, timelines, and post-market obligations structured to deliver maximum SEO reach and regulatory clarity.

Colombia Cosmetic Market Overview

Colombia has emerged as a strategic cosmetics hub in South America due to strong consumer demand, regulatory harmonization, and export-friendly policies.

Key Market Insights

• Colombia’s cosmetic market is projected to grow at a CAGR of ~4.1%
• Bogotá accounts for nearly 50% of national cosmetic sales
• Colombia is the first South American country to ban animal testing
• Ranked among the top skincare markets in Latin America

These factors make Colombia highly attractive but only for companies that fully comply with local regulatory frameworks.

Regulatory Authority for Cosmetics in Colombia

Cosmetic registration, import, manufacturing, and commercialization in Colombia are regulated by:

INVIMA

Instituto Nacional de Vigilancia de Medicamentos y Alimentos
(Under the Ministry of Health)

Regulations are based on Andean Community of Nations (CAN) legislation, ensuring harmonization across member countries.

Key Cosmetic Regulations in Colombia

Cosmetics in Colombia are regulated under:

Andean Community Decisions

• Decision 516 of 2002 – Core cosmetic regulation
• Decision 705
• Decision 833 of 2018 (amended and strengthened requirements)

Supporting Resolutions

• Resolutions 797, 1333, 1418, 1482
• For PHP & PAHP products: Decision 706, Decision 72, Resolution 1370

All cosmetic products must undergo Mandatory Health Notification (NSO) before market entry.

Definition of Cosmetics in Colombia

Any formulation or substance applied to external parts of the human body—such as skin, hair, nails, lips, external genitalia, teeth, or oral mucosa for cleaning, perfuming, protecting, maintaining, or modifying appearance.

Products making therapeutic, preventive, or diagnostic claims are not considered cosmetics and fall under pharmaceutical regulations.

Cosmetic Product Classification in Colombia

According to Annex I of Decision 516, cosmetic categories include:

• Baby and children cosmetics
• Eye and peri-ocular products
• Skin and epidermal cosmetics
• Hair and scalp products
• Lip products
• Nail cosmetics
• Antiperspirants and deodorants
• Oral and dental hygiene products
• Perfumery products
• Before/after shaving products
• Skin lightening products
• Sun protection and self-tanners
• Depilatory products
• Insect repellents applied to skin

All these categories require NSO notification prior to commercialization.

Mandatory Health Notification (NSO) – Colombia

What is NSO?

The Notification Sanitaria Obligatory (NSO) is an alphanumeric health notification code issued by INVIMA. It authorizes cosmetic commercialization and enables post-market surveillance.

Key Regulatory Updates under Decision 833 (2018)

• Products must be safe under normal conditions of use
• NSO holder is fully responsible for product quality
• Free Sale Certificate is no longer mandatory
• Therapeutic claims are prohibited
• Stronger post-market controls introduced

Cosmetic Registration Requirements in Colombia

General Documentation

• Application form (unstapled)
• Legal and technical information
• Proof of fee payment
• Product labeling draft

National (Locally Manufactured) Cosmetics

Legal Requirements

• Application signed by a licensed pharmaceutical chemist in Colombia
• Cosmetic group classification
• Dosage form (cream, gel, liquid, emulsion, etc.)
• Brand and product name
• Manufacturing or packaging contract (if applicable)

Technical Requirements

• Qualitative & quantitative formula (INCI nomenclature)
• Physicochemical and organoleptic specifications
• Microbiological testing (Resolution 1482)
• Product usage instructions
• Claims substantiation studies
• Packaging material details
• Batch numbering system

Imported Cosmetics – Additional Requirements

For imported cosmetics, the following are also required:

• Certificate of Free Sale (issued within last 5 years)
• Manufacturer authorization to the responsible party
• Importer details and commercialization authorization

INVIMA Cosmetic Registration Process

Once the NSO code is issued, the product can legally enter the Colombian market.

Registration Costs (Indicative)

INVIMA fees are calculated in UVT (Tax Value Units).

(1 UVT ≈ COP 35,607 – subject to annual updates)

Validity of Cosmetic Registration

• NSO validity: 7 years
• Valid from the date of NSO code issuance
• Renewable upon expiration

Labeling Requirements in Colombia

Labels must be in Spanish only and include:

• Responsible person or manufacturer
• Country of origin
• Net content (weight/volume)
• Precautions and warnings
• NSO number and country
• Batch/lot number
• Ingredient list (INCI)
• Expiry date or PAO
• Importer name and address (if applicable)

Labeling non-compliance is a leading cause of registration delays.

Animal Testing Ban in Colombia

Law 2047 of 2020

Colombia has enacted one of the strictest cosmetic animal testing bans globally.

• Bans animal testing for cosmetics, ingredients, and formulations
• Applies to manufacturing, import, export, and commercialization
• Fully enforceable from August 2024

Exceptions

• No alternative test method exists
• Testing serves non-cosmetic purposes

Penalties

• Fines up to 50,000 monthly minimum wages
• Enforcement by INVIMA

Post-Market Surveillance & Compliance

After approval, companies must:

• Maintain product safety documentation
• Respond to INVIMA inspections
• Report on adverse events
• Ensure continuous compliance with CAN regulations

Why Choose Maven Regulatory Solutions?

Maven Regulatory Solutions provides end-to-end support for:

• INVIMA cosmetic registration
• NSO dossier preparation
• Labeling & claims review
• Import & distribution compliance
• Animal testing compliance strategies
• Post-market regulatory support

Frequently Asked Questions (FAQs)

Q1. Is cosmetic registration mandatory in Colombia?
Yes. All cosmetics require NSO approval before sale.

Q2. Is a Free Sale Certificate required?
No. Decision 833 removed FSC as a mandatory requirement.

Q3. Can therapeutic claims be made?
No. Products with medical claims are not considered cosmetics.

Q4. Are imported cosmetics allowed?
Yes, with proper NSO notification and documentation.

Q5. Is animal testing completely banned?
Yes, with limited scientific exceptions from August 2024.