1. Regulatory Authority & Framework

Cosmetics in Colombia are regulated by:

• Decreto 677 de 1995
• Decreto 219 de 2022
• Resolución 1482 de 2021
• Andean Community (CAN) Decisions 516 & 833
• INVIMA – National Institute for Food and Drug Surveillance

Colombia follows the Andean Community harmonized cosmetic regulations (Bolivia, Ecuador, Peru, Colombia).

Legally, cosmetics require a Notificación Sanitaria Obligatoria (NSO) before commercialization.

2. Definition of Cosmetic (CAN Decision 516)

Product intended to contact external body parts for:

• Cleansing
• Perfuming
• Modifying appearance
• Protecting
• Maintaining condition

If the product has therapeutic or physiological modification claims, it becomes:

• Health Product,
• Drug, or
• Medical Device,
  not a cosmetic.

3. Type of Registration Required

Cosmetics → Notificación Sanitaria Obligatoria (NSO)

This is a mandatory pre-market notification, similar to Brazil Class I or EU CPNP.

Output:

• NSO number
• Validity: 7 years
• Must be updated if changes occur in:
  • Formula
  • Manufacturer
  • Name/branding
  • RP/importer details

NSO is required before importation or sale.

4. Who Can Apply? – Colombian Legal Representative (RP) Required

Foreign manufacturers cannot apply directly.

An importer or distributor based in Colombia must serve as:

• Titular (Owner) of NSO, and
• Responsible Person under Colombian law

Responsibilities:

• Submit NSO
• Maintain technical documentation
• Handle adverse event reports
• Manage recalls and communication with INVIMA

Changing the RP requires modifying the NSO.

5. NSO Dossier Requirements

A. Administrative Requirements

• Completed NSO form
• Proof of payment of renewal/applicant fees
• Power of Attorney (if RP submits on behalf of manufacturer)

B. Technical Requirements

Similar to an internal PIF under EU rules:

1. Product description
2. Full qualitative & quantitative formula (%)
3. Ingredient safety data (toxicology)
4. Manufacturing process
5. ISO 22716 GMP certificate (mandatory for manufacturer)
6. Stability studies
7. Microbiological limits testing
8. Packaging material compatibility
9. Label artwork
   • Spanish compliance
10. Claims substantiation

Note: Documents are submitted directly to INVIMA (not kept internally like Canada/Mexico).

6. Ingredient Restrictions (CAN Harmonized List)

Colombia follows Andean Community Ingredient Lists, harmonized with the EU:

• Prohibited ingredients (similar to EU Annex II)
• Restricted ingredients (Annex III-type)
• Approved preservatives
• Approved UV filters
• Approved colorants

Common prohibitions:

• Hydroquinone (cosmetic)
• Mercury compounds
• Corticosteroids
• Prescription retinoids
• Strong bleaching agents

Warnings required for:

• Hair dyes
• AHA
• Salicylic acid
• Peroxide-based products

7. Labeling Requirements (Spanish Mandatory)

Under INVIMA + CAN Resolution 833, labels must include:

• Product name & cosmetic category
• Function & usage instructions
• Ingredient list (INCI)
• Lot/batch number
• Manufacturing & expiry date
• Country of origin
• Name & address of NSO Holder (RP)
• Net content
• Warnings (for restricted ingredients)

Spanish is mandatory on the label.
Stickers for imported products are accepted.

8. Fees & Timelines

Government Fees (approximate)

• NSO application: ~USD 300–350
• Modification: ~USD 100
• Renewal (every 7 years): ~USD 250–300

Fees may vary depending on product subtype.

Timelines

• Preparation of dossier: 1–2 weeks
• INVIMA review: 2–6 weeks
• Validity: 7 years

Colombia has one of the longest-validity cosmetic authorizations in LATAM.

9. Importation Requirements

Before importation, you must have:

• Valid NSO number (mandatory)
• Label aligned with Colombian standards
• Import license (from importer)
• Commercial invoice & packing list
• Product samples (for customs inspection if requested)

INVIMA may perform:

• Border inspections
• Sampling for microbiology or heavy metals
• Label compliance review

10. Post-Market Surveillance (PMS)

INVIMA enforces strict PMS:

• Market inspections
• Laboratory testing
• Claims evaluation
• Recall orders and sanctions
• Online advertising monitoring
• Manufacturer/importer audits

RP (Titular) must:

• Maintain tech documentation
• Report adverse events
• Conduct recalls when required

11. Borderline Product Classification

12. Consulting Notes for Your Portfolio

13. Advantages of the Colombian Cosmetic Market

• Harmonized with Andean Community (Peru, Ecuador, Bolivia) → easy expansion
• Long validity (7 years)
• Predictable INVIMA procedures
• Strong beauty and personal-care market
• High consumer trust for Korean/Japanese/European/Chinese skincare