CGMP vs ISO 22716: Korean Cosmetics GMP Compared
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In short: in CGMP vs ISO 22716, the difference is who stands behind each one. ISO 22716 is the International Organization for Standardization’s GMP guideline for cosmetics.
Korea’s CGMP is a standard set by the Ministry of Food and Drug Safety (MFDS), based on ISO 22716, under which MFDS inspects a facility on site and issues a certificate if it complies. The EU makes GMP a legal duty in its Cosmetics Regulation and presumes compliance when a manufacturer follows ISO 22716.
This comparison uses the ISO standard page, Article 8 of the EU Cosmetics Regulation, and MFDS press briefings from December 2024 and April 2025. It does not assess any particular factory.
CGMP vs ISO 22716 at a glance
Swipe sideways to see the whole table.
| Item | ISO 22716 | Korea CGMP | EU Cosmetics Regulation GMP |
|---|---|---|---|
| What it is | International standard (guidelines) | MFDS notice on cosmetic GMP plus a certificate for compliant facilities | Legal requirement in Article 8 of Regulation (EC) No 1223/20091 |
| Who sets it | ISO/TC 217; first edition November 2007, corrected May 2008 | MFDS | EU legislators |
| Scope | Production, control, storage and shipment; excludes R&D and distribution of finished products | Manufacturing and quality control of cosmetics | Manufacture of cosmetic products |
| Mandatory? | A standard is not law in itself | Run as a certification; 191 certified sites in 2024 | Manufacture must comply with GMP (Art. 8(1)) |
| How compliance is shown | Usually certified by a separate certification body | MFDS on-site inspection, then a certificate | Following EN ISO 22716 creates a presumption of compliance (Art. 8(2)) |
| Link to ISO 22716 | The original | Reflected in a 2011 full revision; further aligned in August 2024 | Listed as a harmonised standard in the Official Journal (2011/C 123/04) |
| Where a buyer checks | The certificate and its scope | MFDS list of cosmetic GMP-compliant companies | The responsible person’s product information file (PIF) |
ISO 22716: the international guideline
According to the ISO page, ISO 22716:2007 gives guidelines for the production, control, storage and shipment of cosmetic products. It covers product quality, not worker safety or environmental protection, and does not apply to research and development or to the distribution of finished products. It is written to follow the flow of products from receipt to shipment.
An ISO standard is not a law. Whether it becomes binding depends on how a country’s law uses it, and certificates of conformity are usually issued by separate certification bodies.
Korea’s CGMP: an MFDS standard and certificate built on ISO 22716
MFDS describes CGMP as the quality and manufacturing management standard for cosmetics, under which a certificate is issued to facilities found compliant after an on-site inspection (MFDS briefing, 21 April 20252, Korean). The same briefing gives the number of CGMP sites as 147 in 2018 and 191 in 2024, and describes MFDS consulting and training programmes to encourage certification.
The link to ISO 22716 has been tightened twice. MFDS’s 2011 full revision of the notice (No. 2011-14) reflected ISO 22716 to harmonise with the international standard (MFDS notice page3). The August 2024 revision went further. MFDS’s briefing of 30 December 20244 lists the main changes, each marked as harmonising with ISO:
- New definitions of “sample”, “sampling” and “waste”.
- “Quality assurance department” renamed “quality department”.
- More specific requirements for evaluating raw-material suppliers.
- Retained samples of finished products kept until the expiry date, instead of one year after expiry.
- Fixed rework conditions replaced by a rework procedure.
- A new duty to take action that prevents deviations from recurring.
The April 2025 briefing also notes that the US classifies sunscreens as OTC drugs and applies drug GMP to imported sunscreens. Neither CGMP nor ISO 22716 replaces US drug GMP.
EU: a legal duty, with ISO 22716 as the presumption
Article 8 of Regulation (EC) No 1223/20095 requires the manufacture of cosmetic products to comply with good manufacturing practice, and presumes compliance where manufacture follows the relevant harmonised standards published in the Official Journal. EN ISO 22716:2007 was listed for this purpose in Commission communication 2011/C 123/04.
So in the EU, ISO 22716 is the benchmark for showing the law has been met. Under Article 11, the responsible person’s product information file must include a description of the manufacturing method and a statement on GMP compliance, which means a Korean manufacturer’s GMP evidence ends up in the EU responsible person’s file.
What a buyer should actually check
- Korean factories: look up the manufacturing site in the MFDS list of cosmetic GMP-compliant companies, which MFDS says is on its drug safety portal (의약품안전나라).
- ISO 22716 certificates: check the issuing body, the scope (which site, which processes) and the validity dates.
- US-bound sunscreen: subject to drug GMP, not cosmetics GMP. For US cosmetics registration in general, see US MoCRA registration.
Related pages
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Notes
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Publications Office of the European Union, Regulation (EC) No 1223/2009, verified 2026-10-25. ↩
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Korea’s Ministry of Food and Drug Safety, 식약처, 화장품 GMP 인증 활성화 적극 지원, verified 2026-10-25. ↩
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Korea’s Ministry of Food and Drug Safety, 우수화장품 제조 및 품질관리기준, verified 2026-10-25. ↩
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Korea’s Ministry of Food and Drug Safety, 우수화장품 제조 및 품질관리기준 해설서 개정, verified 2026-10-25. ↩
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The National Archives (UK), Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance), verified 2026-10-25. ↩