Latin America · Colombia
What does it take to sell cosmetics in Colombia? Entry route, responsibility, labeling
Pre-market Notificación Sanitaria Obligatoria (NSO) filed with INVIMA under Decision 833 …; Responsible person: The NSO holder (titular) must be a Colombian legal entity; Labeling: Spanish labelling per Andean Resolution 2310 with….
Latest change 2025-12-17 — Andean Decision 944 (in force 2025-06-24) removed the blanket Spanish-translation requirement for NSO technical files (authorities may still request it); Resolution 2310 labelling technical regulation applies from 2025-12-17. Source
Factory-side digest; the official text prevails; not legal advice.
- Authority
- National Food and Drug Surveillance Institute (INVIMA)
- Main regulation
- Decisión 833 (in force 2019-03-01); Resolución 2108; Decisión 944 (2025-06-24); Resolución 2310 (2025-12-17) · Andean Community Decision 833 (harmonised cosmetics regulation) with Resolution 2108 (implementing rules); Decision 944 (2025) and Resolution 2310 (Andean labelling technical regulation)
- In force
- 2019-03-01
- Market entry
- Pre-market Notificación Sanitaria Obligatoria (NSO) filed with INVIMA under Decision 833 before import or sale; the product is declared under one of the "formas cosméticas" of Resolution 2108 (tablets have no own entry; the closest listed form is "sólido compacto").
- Responsible person
- The NSO holder (titular) must be a Colombian legal entity; per Decision 833 the holder "responderá por la seguridad y la calidad del producto cosmético"; foreign manufacturers need a local importer/holder named on the label.
- Safety file
- NSO dossier per Decision 833: INCI formula, organoleptic/physico-chemical/microbiological specifications, safety and efficacy substantiation, label art and GMP/free-sale evidence.
- Labeling
- Spanish labelling per Andean Resolution 2310 with NSO code, INCI ingredients, holder, origin, lot and expiry.
- Animal testing
- (pending verification) Colombia enacted Law 2047 of 2020 banning animal testing of cosmetics; confirm current application before claiming.
- Ingredient lists
- Andean Decision 833 reference lists (EU Annexes II–VI, US FDA, Mercosur) as applied by INVIMA.
- Notes
- 2026-09-22 主线按 claude 大哥 准入-Y3 的官方原文(INVIMA 官方库 + CAN 公报)整理;动物试验条目待核;费用与时限未写。
- Official text
- https://www.invima.gov.co/biblioteca/decision-833-armonizacion-legislaciones-cosmeticos-can
FAQ
Does Colombia require notification or registration before sale?
Pre-market Notificación Sanitaria Obligatoria (NSO) filed with INVIMA under Decision 833 before import or sale; the product is declared under one of the "formas cosméticas" of Resolution 2108 (tablets have no own entry; the closest listed form is "sólido compacto").
Is a local responsible person mandatory in Colombia?
The NSO holder (titular) must be a Colombian legal entity; per Decision 833 the holder "responderá por la seguridad y la calidad del producto cosmético"; foreign manufacturers need a local importer/holder named on the label.
What are the labeling requirements in Colombia?
Spanish labelling per Andean Resolution 2310 with NSO code, INCI ingredients, holder, origin, lot and expiry.
What changed recently in Colombia cosmetic regulation?
2025-12-17 Andean Decision 944 (in force 2025-06-24) removed the blanket Spanish-translation requirement for NSO technical files (authorities may still request it); Resolution 2310 labelling technical regulation applies from 2025-12-17.
Manufacturing for Colombia · by category
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