Which rules apply to sun protection?

Preservative content on cosmetics marketed for infants/children

Label required

Content of preservatives that have a use criterion set under Art. 8(2)

• Intended for children under 12

Depends on: intended for children under 12

In force, start date unknown

In force no later than 2026-04-02 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.

Preservative content on cosmetics marketed for infants/children

Label required

Content of preservatives that have a use criterion set under Art. 8(2)

• Intended for children under 3

Depends on: intended for children under 3

In force, start date unknown

In force no later than 2026-04-02 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.

Annual list of ingredients of customised cosmetics (deadline)

Notification to MFDS through the 화장품업 단체

Prior-year ingredient list of customised cosmetics, by end of February each year

• Mixed or filled for the individual customer

Depends on: customised cosmetic

In force since 18 Feb 2022

Applies to products sold on or after 18 Feb 2022

Customised cosmetics seller safety management duties

Must meet the conditions of 시행규칙 제12조의2: facility checks, mixing/dispensing safety standards, sales records (lot, expiry, date, quantity), explanations to consumer, adverse-event reports

• Mixed or filled for the individual customer

Depends on: customised cosmetic

In force, start date unknown

In force no later than 2026-04-02 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.

Functional cosmetic reviewed efficacy and directions

Label required

Reviewed or reported efficacy and effect, directions and dosage (용법ㆍ용량)

• Makes a functional or quasi-drug claim (for example whitening or anti-wrinkle)

Depends on: quasi drug or functional claim

In force, start date unknown

In force no later than 2026-04-02 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.

Statement 'not a medicine for disease prevention or treatment' for functional cosmetics (hair loss, acne, skin barrier, stretch marks)

Label required

"질병의 예방 및 치료를 위한 의약품이 아님"

• Makes a functional or quasi-drug claim (for example whitening or anti-wrinkle)

Depends on: quasi drug or functional claim

In force, start date unknown

In force no later than 2026-04-02 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.

Non-emulsion liquid products (e.g. children's oils) with 10 % or more hydrocarbons and kinematic viscosity of 21 cSt or less at 40 C

Must meet the conditions of Child-resistant packaging that adults can open but children under 5 cannot (화장품법 제9조, 시행규칙 제18조제2항)

• Single-use product: no
• Not applied as a spray
• Sold in a pressurised aerosol can: no

Depends on: single use, sprayable, aerosol dispenser

In force, start date unknown

In force no later than 2026-04-02 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.

Must meet the conditions of Child-resistant packaging that adults can open but children under 5 cannot (화장품법 제9조, 시행규칙 제18조제2항)

• Single-use product: no
• Not applied as a spray
• Sold in a pressurised aerosol can: no

Depends on: single use, sprayable, aerosol dispenser

In force, start date unknown

In force no later than 2026-04-02 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.

Import management record of imported cosmetics

Declaration required

수입관리기록서: product name, ingredient specification and content, manufacturing country and company address, functional-cosmetic review notice copy, manufacture and sale certificate, Korean-language product description sample, import date and quantity per batch, batch quality inspection date and result, sales records

• Your role: Importer

Depends on: economic operator role

In force, start date unknown

In force no later than 2026-04-02 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.

Mandatory label element: Barcode set by the MFDS commissioner

Label required

Barcode set by the MFDS commissioner

• Mixed or filled for the individual customer: no

Depends on: customised cosmetic

In force, start date unknown

In force no later than 2026-04-02 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.

10 rules from 화장품법 시행규칙 (Enforcement Rule of the Cosmetics Act)

Label required

Every product in the category

2 Apr 2026

Each rule has its own date; open a target.

Example: Mandatory label element: Content of human cell or tissue culture fluid where contained

Mandatory label element: Imported cosmetic: country of manufacture, manufacturer name and address

Label required

Imported cosmetic: country of manufacture, manufacturer name and address

• Imported into the market of sale
• Your role: Importer

Depends on: imported, economic operator role

In force, start date unknown

In force no later than 2026-04-02 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.

Quality control standard of 별표 1 and post-market safety standard of 별표 2

Must meet the conditions of 화장품법 시행규칙 별표 1 (품질관리기준) and 별표 2 (책임판매 후 안전관리기준)

• Your role: Manufacturer or Importer

Depends on: economic operator role

In force, start date unknown

In force no later than 2026-04-02 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.

Stability test data for products with retinol, vitamin C, tocopherol, peroxides, enzymes

Declaration required

Retain stability-test data for 1 year after the expiry date of the last batch for products containing 0.5 % or more of retinol, ascorbic acid, tocopherol, peroxide compounds or enzymes

• Your role: Manufacturer or Importer

Depends on: economic operator role

In force, start date unknown

In force no later than 2026-04-02 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.

Precaution statement (별표 3)

Warning required when the substance is present

직사광선을 피해서 보관할 것

Every product in the category

In force, start date unknown

In force no later than 2026-04-02 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.

Precaution statement (별표 3)

Warning required when the substance is present

어린이의 손이 닿지 않는 곳에 보관할 것

Every product in the category

In force, start date unknown

In force no later than 2026-04-02 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.

Precaution statement (별표 3)

Warning required when the substance is present

화장품 사용 시 또는 사용 후 직사광선에 의하여 사용부위가 붉은 반점, 부어오름 또는 가려움증 등의 이상 증상이나 부작용이 있는 경우에는 전문의 등과 상담할 것

Every product in the category

In force, start date unknown

In force no later than 2026-04-02 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.

Precaution statement (별표 3)

Warning required when the substance is present

상처가 있는 부위 등에는 사용을 자제할 것

Every product in the category

In force, start date unknown

In force no later than 2026-04-02 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.

Per-product safety data for cosmetics marketed for infants/children: 어린이 4세 이상 13세 이하 (4 to 13 years)

Declaration required

제품별 안전성 자료 under 제4조의3제1항: (1) product and manufacturing description, (3) proof of efficacy; prepared and kept before marketing as for infants or children (item (2), safety assessment data, applies from 2029-01-01 under 부칙 제21302호 제1조 and is covered by the 제4조의2 rules)

• Intended for children under 12

Depends on: intended for children under 12

In force, start date unknown

In force no later than 2026-10-08 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text. Item (2) of 제4조의3제1항 is excluded here because 부칙 제21302호 제1조 starts it on 2029-01-01 (the duty duplicates the 제4조의2 safety-assessment rules); the age bands come from 시행규칙 제10조의2.

Per-product safety data for cosmetics marketed for infants/children: 영유아 3세 이하 (3 years or younger)

Declaration required

제품별 안전성 자료 under 제4조의3제1항: (1) product and manufacturing description, (3) proof of efficacy; prepared and kept before marketing as for infants or children (item (2), safety assessment data, applies from 2029-01-01 under 부칙 제21302호 제1조 and is covered by the 제4조의2 rules)

• Intended for children under 3

Depends on: intended for children under 3

In force, start date unknown

In force no later than 2026-10-08 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text. Item (2) of 제4조의3제1항 is excluded here because 부칙 제21302호 제1조 starts it on 2029-01-01 (the duty duplicates the 제4조의2 safety-assessment rules); the age bands come from 시행규칙 제10조의2.

Substantiation of factual labelling and advertising claims

Declaration required

Evidence substantiating factual claims in labelling and advertising, submitted to the MFDS within 15 days of request

Every product in the category

In force, start date unknown

In force no later than 2026-10-08 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.

Safety assessment data for each product reviewed by a 안전성 평가자 before distribution

Declaration required

화장품 안전성 평가 자료 (product safety data reviewed by a qualified assessor, kept on file)

Every product in the category

Takes effect 1 Jan 2028

Applies to products sold on or after 1 Jan 2028

Staged date by 부칙 제21302호 (2025-12-30) 제1조제1항제1호가목: sellers with annual production/import of KRW 1 billion or more (or registered after promulgation) selling products newly reviewed or reported as functional cosmetics.

Safety assessment data for each product reviewed by a 안전성 평가자 before distribution

Declaration required

화장품 안전성 평가 자료 (product safety data reviewed by a qualified assessor, kept on file)

Every product in the category

Takes effect 1 Jan 2030

Applies to products sold on or after 1 Jan 2030

Staged date by 부칙 제21302호 (2025-12-30) 제1조제1항제1호나목: sellers with annual production/import of KRW 1 billion or more (or registered after promulgation) launching products first made or imported after promulgation.

Safety assessment data for each product reviewed by a 안전성 평가자 before distribution

Declaration required

화장품 안전성 평가 자료 (product safety data reviewed by a qualified assessor, kept on file)

Every product in the category

Takes effect 1 Jan 2031

Applies to products sold on or after 1 Jan 2031

Staged date by 부칙 제21302호 (2025-12-30) 제1조제1항제1호다목 (other sellers of KRW 1 billion or more) and 제2호 (sellers under KRW 1 billion): 2031-01-01.

Annual list of all ingredients used in customised cosmetics

Notification to MFDS (through the cosmetics trade association)

List of all ingredients used in customised cosmetics, once a year

• Mixed or filled for the individual customer

Depends on: customised cosmetic

In force, start date unknown

In force no later than 2026-10-08 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.