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East Asia · South Korea

What does it take to sell cosmetics in South Korea? Entry route, responsibility, labeling

No pre-market approval for general cosmetics (the registered responsible seller reports p…; Responsible person: A Korea-registered 화장품책임판매업자 (cosmetic responsible seller) …; Labeling: Korean-language label with full ingredient list (….

Latest change 2026-07-08 — MFDS issued draft amendments to the Cosmetics Act Enforcement Decree and Rule setting detailed safety-assessment standards (assessor qualifications, record retention) and custom-cosmetics rules, implementing Act No. 21302 whose mandatory safety assessment phases in from 2028. Fonte

Resumo do lado da fábrica; o texto oficial prevalece; não constitui aconselhamento jurídico.

Autoridade
Ministry of Food and Drug Safety (MFDS)
Regulamentação principal
Act No. 6025 (enacted 1999-09-07); latest amendment Act No. 21302 (2025-12-30) · Cosmetics Act
Vigente
2000-07-01
Entrada no mercado
No pre-market approval for general cosmetics (the registered responsible seller reports production/import), while 기능성화장품 (functional cosmetics: whitening, anti-wrinkle, UV, hair etc.) need MFDS review or report before sale.
Pessoa responsável
A Korea-registered 화장품책임판매업자 (cosmetic responsible seller) must register with MFDS, hold the product records and appear on the label.
Dossiê de segurança
Currently product safety/efficacy data are kept by the responsible seller; Act No. 21302 (promulgated 2025-12-30) requires a safety assessment prepared and reviewed by a qualified assessor before marketing, with MFDS guidelines issued 2026-06-10 and phased mandatory application from 2028 (full by about 2031).
Etiquetagem
Korean-language label with full ingredient list (전성분표시); 25 fragrance allergens must be named when above 0.01% in rinse-off or 0.001% in leave-on products (since 2020-01-01); the 2025-02-07 Enforcement Rule amendment revised how manufacturing number, expiry date, period-after-opening and precautions are shown.
Testes em animais
Sale of cosmetics tested on animals (finished products or ingredients) has been banned since 2017-02 under Art. 15-2, with limited exceptions such as tests required by foreign law.
Listas de ingredientes
화장품 안전기준 등에 관한 규정 (MFDS Notification: Annex 1 prohibited ingredients, Annex 2 restricted ingredients incl. preservatives, UV filters and colorants) plus the functional-cosmetics standards.
Notas
Exact effective dates of individual Act No. 21302 provisions were not verified from the statute text (ChemLinked gives a 2028 phase-in); a 2026-03-31 Enforcement Rule amendment also tightened supervision of directly-purchased overseas cosmetics.
Pesquisar este inventário aqui
韩国 · Regulation on Safety Standards for Cosmetics
Texto oficial
https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%ED%99%94%EC%9E%A5%ED%92%88%EB%B2%95

Alterações 2025–2026

  1. Korea enacts a mandatory cosmetic safety assessment system (Act No. 21302)

    Os vendedores responsáveis devem preparar e reter uma avaliação de segurança revista por um avaliador qualificado antes do marketing; a MFDS publicou diretrizes de preparação em 2026-06-10 e rascunhos de emendas ao Decreto/Regra em 2026-07-08, com aplicação faseada a partir de 2028 e aplicação total em torno de 2031. Fonte

  2. Korea amends cosmetic packaging labelling rules

    A MFDS alterou a Regra de Execução da Lei de Cosméticos (Anexo 4) com efeito imediato, revisando como o número de fabricação, data de validade, período após abertura e precauções devem constar em todos os cosméticos fabricados ou importados após essa data. Fonte

FAQ

Does South Korea require notification or registration before sale?

No pre-market approval for general cosmetics (the registered responsible seller reports production/import), while 기능성화장품 (functional cosmetics: whitening, anti-wrinkle, UV, hair etc.) need MFDS review or report before sale.

Is a local responsible person mandatory in South Korea?

A Korea-registered 화장품책임판매업자 (cosmetic responsible seller) must register with MFDS, hold the product records and appear on the label.

What are the labeling requirements in South Korea?

Korean-language label with full ingredient list (전성분표시); 25 fragrance allergens must be named when above 0.01% in rinse-off or 0.001% in leave-on products (since 2020-01-01); the 2025-02-07 Enforcement Rule amendment revised how manufacturing number, expiry date, period-after-opening and precautions are shown.

What changed recently in South Korea cosmetic regulation?

2026-07-08 MFDS issued draft amendments to the Cosmetics Act Enforcement Decree and Rule setting detailed safety-assessment standards (assessor qualifications, record retention) and custom-cosmetics rules, implementing Act No. 21302 whose mandatory safety assessment phases in from 2028.

Fonte: 12345

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