Latin America · Colombia / Andean Community (Bolivia, Colombia, Ecuador, Peru)
What does it take to sell cosmetics in Colombia / Andean Community (Bolivia, Colombia, Ecuador, Peru)? Entry route, responsibility, labeling
Pre-market Notificación Sanitaria Obligatoria (NSO) — a code issued by the national autho…; Responsible person: A titular/holder domiciled in the member country (manufactu…; Labeling: Spanish labelling per Res.
Latest change 2025-06-24 — Decision 944 amended Art. 9 of Decision 833 to drop the blanket Spanish-translation requirement for technical documentation; the Andean Labelling Technical Regulation (Res. 2310) became mandatory 2025-12-17 and Colombia's MinSalud Resolution 0814/2026 (May 2026) now requires a no-animal-testing conformity declaration with new and renewed NSOs. Source
Factory-side digest; the official text prevails; not legal advice.
- Authority
- INVIMA (Colombia) and the other national competent authorities under Andean Community Decision 833
- Main regulation
- Decisión 833 (Gaceta Oficial 3450, 2018-11-26), amended by Decisions 857 and 944; Resolución 2108 (implementing regulation); Resolución 2310/2022 (labelling) · Andean Community Decision 833 'Harmonisation of Legislation on Cosmetic Products'
- In force
- 2021-03-01
- Market entry
- Pre-market Notificación Sanitaria Obligatoria (NSO) — a code issued by the national authority (INVIMA in Colombia) after filing the technical dossier, valid 7 years and recognised across CAN member states.
- Responsible person
- A titular/holder domiciled in the member country (manufacturer, importer or authorised company) files the NSO and is the legal responsible party named on the label.
- Safety file
- Technical information per Decision 833: qualitative/quantitative INCI formula, specifications, safety and efficacy substantiation, stability and label art, plus GMP evidence under Res. 2108.
- Labeling
- Spanish labelling per Res. 2310 (name, INCI ingredients, NSO holder/importer, country of origin, NSO number, lot, expiry, warnings); no fragrance-allergen threshold rule.
- Animal testing
- Colombia's Law 2047/2020 bans testing, import, manufacture and sale of animal-tested cosmetics from 2024-08-10 (regulated by Res. 0814/2026); Ecuador has a similar ban, Peru and Bolivia do not yet.
- Ingredient lists
- Decision 833 accepts the EU Annexes II–VI, US FDA and Mercosur lists as reference lists for prohibited, restricted and permitted ingredients.
- Notes
- The Decision 833 reference-list wording (Art. 5) was not re-fetched; Res. 0814/2026's date is as reported by Infobae (2026-05-06); the Ecuador ban is cited from secondary reports.
- Official text
- https://www.invima.gov.co/biblioteca/decision-833-armonizacion-legislaciones-cosmeticos-can
Changes 2025–2026
- Andean Decision 944, mandatory labelling regulation and Colombia's animal-testing rule
Decision 944 removes the blanket Spanish-translation requirement for NSO technical files; the Andean Labelling Technical Regulation (Res. 2310) became mandatory on 2025-12-17 for Colombia, Peru, Ecuador and Bolivia; Colombia's Res. 0814/2026 (May 2026) requires a first-party no-animal-testing declaration with new and renewed NSOs. Source
FAQ
Does Colombia / Andean Community (Bolivia, Colombia, Ecuador, Peru) require notification or registration before sale?
Pre-market Notificación Sanitaria Obligatoria (NSO) — a code issued by the national authority (INVIMA in Colombia) after filing the technical dossier, valid 7 years and recognised across CAN member states.
Is a local responsible person mandatory in Colombia / Andean Community (Bolivia, Colombia, Ecuador, Peru)?
A titular/holder domiciled in the member country (manufacturer, importer or authorised company) files the NSO and is the legal responsible party named on the label.
What are the labeling requirements in Colombia / Andean Community (Bolivia, Colombia, Ecuador, Peru)?
Spanish labelling per Res. 2310 (name, INCI ingredients, NSO holder/importer, country of origin, NSO number, lot, expiry, warnings); no fragrance-allergen threshold rule.
What changed recently in Colombia / Andean Community (Bolivia, Colombia, Ecuador, Peru) cosmetic regulation?
2025-06-24 Decision 944 amended Art. 9 of Decision 833 to drop the blanket Spanish-translation requirement for technical documentation; the Andean Labelling Technical Regulation (Res. 2310) became mandatory 2025-12-17 and Colombia's MinSalud Resolution 0814/2026 (May 2026) now requires a no-animal-testing conformity declaration with new and renewed NSOs.
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