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. Источник
Краткая сводка со стороны производителя; приоритет имеет официальный текст; не является юридической консультацией.
- Орган
- Public Health Institute of Chile (ISP), Ministry of Health
- Основное регулирование
- 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
- Действует
- 2003-06-20
- Выход на рынок
- 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.
- Ответственное лицо
- A Chilean titular (manufacturer or importer with an ISP-authorised establishment and a technical director) holds the registration and is named on the label.
- Досье безопасности
- Registration dossier with formula, specifications, stability and safety/efficacy evidence; special-purpose cosmetics such as sunscreens need efficacy data.
- Маркировка
- Spanish labelling with ISP registration number, INCI ingredients, titular, lot, expiry and warnings; no fragrance-allergen declaration requirement.
- Тестирование на животных
- Banned since 2025-01-27 under Law 21.646 — safety must be demonstrated with validated alternative methods.
- Списки ингредиентов
- DS 239 relies on ISP-adopted lists of prohibited/restricted substances, preservatives, colorants and UV filters, largely aligned with EU/Mercosur references.
- Заметки
- Whether the DS 239 amendment implementing Law 21.646 has been published could not be confirmed; the ingredient-list instruments were not re-verified.
- Официальный текст
- 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.
Связанные вопросы покупателей
- Выход на шесть рынков АСЕАН: сколько времени занимает уведомление и где возникают задержки?
- Требуется ли переработка halal-косметики, и как работает мандат халяль в Индонезии в 2026 году?
- Как определить, является ли контрактный производитель косметики надёжным?
- Один продукт в шести странах: как оформляются этикетки и листовки без риска отказа?
Entering Chile? Send the product type and we reply with the factory-side document list and lead time. Отправить запрос