“This regulation outlines manufacturing and quality control standards for cosmetics under Article 5(2) of the Cosmetics Act and Article 12(2) of its Enforcement Regulations. Key points include:

  • Manufacturing & Storage:

Products must be stored appropriately for one year post-expiry or three years post-manufacture if no expiry date exists.
The quality assurance manager handles decisions on reworking or discarding recalled/returned products, with rework allowed under strict conditions.

  • Compliance & Documentation:

Companies must meet Good Manufacturing Practice (GMP) standards and maintain proper documentation, including agreements for consigned tasks and approval for raw material/process changes affecting quality.
Internal audits and clear document management are mandatory.

  • Product Recalls & Complaints:

A designated person oversees recalls, ensuring consumer safety. Complaints must be promptly investigated, with records maintained.

  • Updates (as of 22-Aug-2024):

The notice is effective immediately and applies to cosmetics manufacturers after enforcement.

The regulation ensures rigorous quality control, proper documentation, and compliance with safety standards in cosmetic manufacturing.”\

Source:https://www.law.go.kr/%ED%96%89%EC%A0%95%EA%B7%9C%EC%B9%99/%EC%9A%B0%EC%88%98%ED%99%94%EC%9E%A5%ED%92%88%20%EC%A0%9C%EC%A1%B0%20%EB%B0%8F%20%ED%92%88%EC%A7%88%EA%B4%80%EB%A6%AC%EA%B8%B0%EC%A4%80##~https://www.law.go.kr/LSW//admRulInfoP.do?admRulSeq=2100000246206&chrClsCd=010201#AJAX

Region: South Korea

pattern
pattern
Got questions? We’ve got answers!

Let's talk Regulatory!

Reach out to us and let’s unravel your Regulatory puzzle together. Unlock regulatory solutions with our global subject matter experts and tap into a wealth of regulatory intelligence.

Speak to an Expert