Latin America · Chile
What does it take to sell cosmetics in Chile? Entry route, responsibility, labeling
Pre-market ISP sanitary registration for cosmetics, while low-risk products (DS 239 Art; Responsible person: A Chilean titular (manufacturer or importer with an ISP-aut…; Labeling: Spanish labelling with ISP registration number, I….
Latest change 2025-01-27 — Law 21.646 banning animal testing of cosmetics and their ingredients (and marketing of such products) entered into force; a March-2025 public consultation proposed amending DS 239 to implement it. Source
Factory-side digest; the official text prevails; not legal advice.
- Authority
- Public Health Institute of Chile (ISP), Ministry of Health
- Main regulation
- DS 239/2002 (Diario Oficial 2003-06-20), as amended; Código Sanitario; Ley 21.646 · Supreme Decree No. 239/2002 — Regulation of the National Cosmetics Control System, under the Sanitary Code
- In force
- 2003-06-20
- Market entry
- Pre-market ISP sanitary registration for cosmetics, while low-risk products (DS 239 Art. 5 b–c, e.g., solid soaps and ISP-listed categories) only require notification to ISP before sale.
- Responsible person
- A Chilean titular (manufacturer or importer with an ISP-authorised establishment and a technical director) holds the registration and is named on the label.
- Safety file
- Registration dossier with formula, specifications, stability and safety/efficacy evidence; special-purpose cosmetics such as sunscreens need efficacy data.
- Labeling
- Spanish labelling with ISP registration number, INCI ingredients, titular, lot, expiry and warnings; no fragrance-allergen declaration requirement.
- Animal testing
- Banned since 2025-01-27 under Law 21.646 — safety must be demonstrated with validated alternative methods.
- Ingredient lists
- DS 239 relies on ISP-adopted lists of prohibited/restricted substances, preservatives, colorants and UV filters, largely aligned with EU/Mercosur references.
- Notes
- Whether the DS 239 amendment implementing Law 21.646 has been published could not be confirmed; the ingredient-list instruments were not re-verified.
- Official text
- https://www.bcn.cl/leychile/navegar?idNorma=211455
FAQ
Does Chile require notification or registration before sale?
Pre-market ISP sanitary registration for cosmetics, while low-risk products (DS 239 Art. 5 b–c, e.g., solid soaps and ISP-listed categories) only require notification to ISP before sale.
Is a local responsible person mandatory in Chile?
A Chilean titular (manufacturer or importer with an ISP-authorised establishment and a technical director) holds the registration and is named on the label.
What are the labeling requirements in Chile?
Spanish labelling with ISP registration number, INCI ingredients, titular, lot, expiry and warnings; no fragrance-allergen declaration requirement.
What changed recently in Chile cosmetic regulation?
2025-01-27 Law 21.646 banning animal testing of cosmetics and their ingredients (and marketing of such products) entered into force; a March-2025 public consultation proposed amending DS 239 to implement it.
Related buyer questions
- Venda nos seis mercados do ASEAN: quanto tempo leva a notificação e onde ela trava?
- Cosméticos halais precisam de reformulação e como funciona a obrigatoriedade halal de 2026 na Indonésia?
- Como saber se um fabricante de cosméticos sob contrato é credível?
- Um produto em seis países: como são organizados os rótulos e folhetos para evitar rejeições?
Entering Chile? Send the product type and we reply with the factory-side document list and lead time. Send an inquiry