Korea MFDS explained, with its banned cosmetic ingredient lists
Korea MFDS, the former KFDA, regulates food, drugs, cosmetics and medical devices. Here is what it covers and how its banned and restricted lists work.
Korea MFDS and its cosmetics safety standards
Korea MFDS, the Ministry of Food and Drug Safety (식품의약품안전처), regulates food, drugs, biologics, cosmetics, quasi-drugs and medical devices. Its cosmetics safety standards ban ingredients in Annex 1 and restrict others in Annex 2. As of 14 October 2026, the current text is MFDS Notice No. 2026-19 of 18 March 2026.
From KFDA to MFDS
The Korea Food and Drug Administration (KFDA) was founded in February 1998. On 23 March 2013 it became MFDS and took food and drug safety policy from the Ministry of Health and Welfare (MFDS history). Article 26 of the Government Organization Act places MFDS under the Prime Minister. Older pages still say Article 25. That was the number until 1 October 2025.
People still say "Korean FDA" as an informal name for MFDS. MFDS is not the Ministry of Health and Welfare.
What MFDS regulates
The Korean site lists food (including health functional foods and additives), imported food, drugs, narcotics, biologics, herbal medicines, cosmetics, quasi-drugs, medical devices and hygiene products. Quasi-drugs are a Korean category for items such as masks, sanitary pads, toothpastes and disinfectants (MFDS). Foreign food facilities must register before they export to Korea (MFDS).
The main MFDS regulations sit under the Food Sanitation Act, the Pharmaceutical Affairs Act, the Cosmetics Act, the Medical Devices Act and the Special Act on Imported Food Safety Management, among others (MFDS list of laws).
For drug GMP and approvals, MFDS has been a PIC/S member since July 2014 and, by its own account, an ICH Regulatory Member since 2016 and an IMDRF member since December 2017.
Finding MFDS regulations in English
The English site at mfds.go.kr/eng has regulation pages for food, drugs, bio and cosmetics and medical devices. Official statute translations are on the Korean Law Information Center and KLRI.
The English cosmetics safety standards on mfds.go.kr are dated 22 April 2016, many amendments behind. The Korean text wins.
The cosmetics safety standards (화장품 안전기준)
Article 8 of the Cosmetics Act lets MFDS ban ingredients and set use limits. Manufacturers, responsible sellers, and universities or research institutes can ask MFDS to add, delist or change entries on the banned and restricted lists. MFDS must reply in writing. Products made only for export, and not sold in Korea, are exempt from Article 8, among other articles, under Article 30. They may follow the importing country's rules.
The rules themselves are in "화장품 안전기준 등에 관한 규정", now Notice No. 2026-19 (full PDF on mfds.go.kr). It applies to cosmetics manufactured, or imported by customs clearance date, after 18 March 2026.
Banned ingredients in Annex 1
Annex 1 includes lead, mercury and their compounds, glucocorticoids, oestrogens, antibiotics, hydroquinone, formaldehyde, methylene chloride, chloroform and asbestos. It also bans solid plastics of 5 mm or less in cleansing and exfoliating products, including shampoos, body cleansers and shaving foam. The last entry covers substances banned under Articles 2(9) and 27 of K-REACH, the Act on Registration and Evaluation of Chemicals.
Recent additions include seven hair dye ingredients (Notice No. 2023-73, 30 November 2023) and 1,2,4-trihydroxybenzene (Notice No. 2024-9, 7 February 2024).
Restricted ingredients in Annex 2
Annex 2 has four parts: preservatives, UV filters, hair dyes, and others. General ingredients use a negative list. If they are not in Annex 1 or Annex 2, they can be used. Preservatives and UV filters are closed lists. If they are not in Annex 2, they cannot be used. Colourants sit in a separate notice, not in Annex 2, and an unlisted colourant cannot be used.
Some current limits from the Annex 2 text:
| Ingredient | Limit |
|---|---|
| Phenoxyethanol (preservative) | 1.0% |
| Parabens (preservative) | 0.4% single, 0.8% mixed (as acid); phenyl ester excluded |
| Methylisothiazolinone (preservative) | 0.0015%, rinse-off only; not with the MCI/MI mixture |
| Zinc oxide, titanium dioxide (UV filters) | 25% each |
| Benzophenone-3 (oxybenzone, UV filter) | 2.4%, or 5% in face, hand and lip products |
| p-Phenylenediamine (hair dye) | 2.0% in oxidative hair dyes, banned elsewhere |
Article 5 keeps three groups out of customised cosmetics (맞춤형화장품): Annex 1 ingredients, Annex 2 ingredients, and functional-cosmetic actives. That active is allowed only if the supplying responsible seller has had it reviewed or reported.
Trace limits
Article 6 caps substances that show up without being added on purpose. Lead is 20 µg/g (50 in clay powders), mercury 1, cadmium 5 and dioxane 100 µg/g. Methanol is 0.2% by volume, and formaldehyde is 2,000 µg/g. Wet wipes are tighter: 0.002% methanol by volume and 20 µg/g formaldehyde (MFDS PDF).
Recent amendments
Notice No. 2025-63 of 2 September 2025 added tris-biphenyl triazine as a UV filter at 10% from that day. The other changes apply from 3 March 2026, including the benzophenone-3 cut from 5% to 2.4% outside face, hand and lip products and the 8.7% cap on cyclotetrasiloxane (D4). Cyclopentasiloxane (D5) is capped at 19.7% from 2 September 2028. Korea notified the draft to the WTO as G/TBT/N/KOR/1228 on 3 September 2024.
Notice No. 2026-19 added the UV filter phenylene bis-diphenyltriazine at 5%, but not in products that can be inhaled into the lungs.
Responsible sellers
The responsible seller (화장품책임판매업자) places cosmetics on the Korean market and controls their quality and safety. It must register with MFDS. That duty covers importers. Functional cosmetics, including whitening, wrinkle improvement and UV protection, need an MFDS review or a report for each product.
You can see these lists, with citations, in the RegAffairs AI answer on Korea's MFDS and its cosmetics ingredient lists.