Korea MFDS Regulatory Scope
What does Korea's MFDS regulate?
MFDS (식품의약품안전처, the Ministry of Food and Drug Safety) is South Korea's main regulator for food, drugs, biologics and cosmetics (including quasi-drugs), and medical devices. Its English site groups this work into four areas: Food, Drugs, Bio & Cosmetics and Medical Devices. Its stated standard is "Your safety is our standard" (MFDS home; MFDS card news).
Approach: I read MFDS's English-language pages on its remit, food safety and quasi-drugs. I also confirmed that the datasets I can search hold MFDS registers on food, cosmetics and medicines.
What falls under MFDS, by area
| Area | What MFDS covers |
|---|---|
| Food |
|
| Drugs | Drug approvals, regulations, product certification and guidelines (MFDS card news). |
| Bio & Cosmetics |
|
| Medical Devices | Device approvals, designation of innovative devices, and product certification (MFDS card news). |
Quasi-drugs
Quasi-drugs are a Korean category with no exact EU or US equivalent. They are items the Minister designates, other than medicines. Examples include sanitary pads, masks, bandages, disinfectants, toothpastes and insecticides.
They come in through one of two routes:
- Approval: needed when safety and efficacy have to be evaluated, or the product contains new excipients. It takes about 55-70 days.
- Notification: for products that meet established standards or are listed in recognised pharmacopoeias. It takes about 10-90 days (MFDS Quasi-Drugs).
Structure
MFDS has three parts: the Ministry itself, the National Institute of Food and Drug Safety Evaluation, and the Regional Offices of Food and Drug Safety. It is based in Cheongju. Separate related organisations support its drug, bio and cosmetics, and device work (MFDS home).
If useful, I can look up a specific MFDS register next. The datasets include, for example, Korean pesticide maximum residue limits (MRLs) in food, the Cosmetics Act safety standards (banned and restricted ingredients), health functional food ingredients, reviewed functional cosmetics, rare-disease drug designations, and drug administrative sanctions.
Which cosmetic ingredients are banned in Korea?
Korea bans 1,077 ingredients from cosmetics. They are listed in Annex 1 (별표 1) of MFDS's Regulation on Safety Standards of Cosmetics (화장품 안전기준 등에 관한 규정). Article 3 of that notice says that the raw materials that may not be used in cosmetics are those in Annex 1 [1]. The full list, with Korean names, CAS numbers and chemical names, is in the panel document.
Approach: I searched the MFDS cosmetics safety-standard ingredient tables (Annex 1 prohibited and Annex 2 restricted) and the Cosmetics Act and its implementing rules. The ingredient names appear in Korean, as MFDS publishes them.
Examples from Annex 1
- Metals: lead and its compounds [2]; mercury and its compounds [3].
- Medicine-type substances:
- Skin lighteners: hydroquinone [9] and its monomethyl ether (4-methoxyphenol) [10].
- Solvents and other chemicals:
- Asbestos: asbestos itself [15], plus talc that fails the asbestos limit in the Korean Pharmacopoeia talc monograph [16].
Bans with conditions or carve-outs
- Microplastics (solid plastics of 5 mm or less) are banned only in the listed product types. These are mainly wash-off products: baby shampoos and washes, bath and body cleansers, rinse-off hair, shaving and skin products, and make-up removers [17].
- Human cells, tissues and their culture media are banned. The exception is culture media that meet the Annex 3 safety standard for human cell and tissue culture media [18].
- Radioactive substances are banned unless the radioactivity meets Article 15 of the Act on Safety Control of Radiation in Living Environments [19].
- Peroxide-value limits: α- and γ-terpinene are banned only when their peroxide value exceeds 10 mmol/L [20].
- K-REACH link: the last Annex 1 entry bans every substance designated as prohibited under Articles 2(9) and 27 of the Act on Registration and Evaluation of Chemicals (K-REACH) [21].
Related rules
- Unintended traces: Article 6(2) allows detection limits for some substances that are not added on purpose but cannot technically be removed, such as substances migrating from packaging. Examples are lead (20 µg/g, or 50 µg/g in clay-based powders), mercury (1 µg/g), dioxane (100 µg/g), formaldehyde (2,000 µg/g) and the three phthalates (100 µg/g in total). If a banned Annex 1 ingredient turns up as a trace with no set limit, a risk assessment decides whether it is harmful (Article 6(3)) [22].
- Customised cosmetics may not use Annex 1 ingredients either (Article 5) [23].
- Getting a ban lifted: a company can apply to have a ban lifted or changed under Cosmetics Act Article 8(6). The application form gives a 180-day processing period [24].
Annex 2 is a separate list of 248 ingredients that are restricted rather than banned: preservatives, UV filters, hair dyes and others. I can pull it, or check particular ingredients or CAS numbers against both annexes, if that would help.
What about restricted ones like preservatives and UV filters?
Korea restricts 248 ingredients in Annex 2 (별표 2) of MFDS's Regulation on Safety Standards of Cosmetics: 59 preservatives, 32 UV filters, 75 hair-dye ingredients and 82 other restricted ingredients. Article 4 makes the first two classes closed positive lists. It sets the Annex 2 limits and says that preservatives and UV filters not listed in Annex 2 may not be used [25]. All 248 entries, with limits, conditions and citations, are in the panel document.
Approach: I read the MFDS Annex 2 table and the regulation's articles. Ingredient names are my English renderings of MFDS's Korean names. A few condition cells are cut off in the source text, and I note where that matters.
Preservatives (59): main limits
| Ingredient | Max. level | Conditions |
|---|---|---|
| Phenoxyethanol | 1.0% | none [26] |
| Parabens (p-hydroxybenzoic acid, its salts and esters, except the phenyl ester) | 0.4% for a single paraben, 0.8% for mixtures (as acid) | none [27] |
| Methylisothiazolinone | 0.0015%, rinse-off only | May not be used together with the MCI/MI mixture; banned in other products [28] |
| MCI/MI (3:1) | 0.0015%, rinse-off only | Banned in other products [29] |
| IPBC | 0.02% rinse-off; 0.01% leave-on; 0.0075% in deodorants | Banned in lip products, aerosol sprays, body lotions and creams. Also banned in baby products and products labelled for children aged 13 or under, except bath products, shower gels and shampoos [30] |
| Salicylic acid and its salts | 0.5% (as acid) | Banned in baby and children's products, except shampoo (the source cell is partly garbled) [31] |
| Benzoic acid, its salts and esters | 0.5% (as acid); benzoic acid and sodium benzoate up to 2.5% in rinse-off | none [32] |
| Benzyl alcohol | 1.0%; 10% when used as a solvent in hair dyes | none [33] |
| Formaldehyde releasers: DMDM hydantoin, imidazolidinyl urea, diazolidinyl urea, quaternium-15 | 0.6%, 0.6%, 0.5%, 0.2% | none [34][35][36][37] |
| Bronopol | 0.1% | Banned in products containing amines or amides [38] |
| Triclosan | 0.3% | Allowed only in rinse-off body cleansers, non-spray deodorants, face powders and blemish concealers [39] |
| Zinc pyrithione | 0.5%, rinse-off only | none [40] |
| Polyaminopropyl biguanide (PHMB) | 0.05% | Banned in aerosol sprays [41] |
| Chlorhexidine and its salts | 0.1% in rinse-off products not used on mucosa; 0.05% in other products | none [42] |
UV filters (32): main limits
| Ingredient | Max. level | Conditions |
|---|---|---|
| Zinc oxide; titanium dioxide | 25% each | none [43][44] |
| Benzophenone-3 (oxybenzone) | 2.4%; 5% in face, hand and lip products | none [45] |
| Ethylhexyl methoxycinnamate | 7.5% | none [46] |
| Octocrylene; homosalate | 10% each | none [47][48] |
| Butyl methoxydibenzoylmethane (avobenzone) | 5% | none [49] |
| Bis-ethylhexyloxyphenol methoxyphenyl triazine; methylene bis-benzotriazolyl tetramethylbutylphenol | 10% each | none [50][51] |
| Drometrizole trisiloxane | 15% | none (the highest organic-filter limit in the table) [52] |
| 4-Methylbenzylidene camphor | 4% | none [53] |
| Tris-biphenyl triazine | 10% | Banned in aerosols, including pump sprays. Nano form must be uncoated, with a median particle size above 80 nm and purity of at least 98% [54] |
| Methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate (marked as newly added) | 3% | Not for products that could expose the lungs by inhalation; banned with nitrosating agents [55] |
| Phenylene bis-diphenyltriazine | 5% | Not for products that could expose the lungs by inhalation [56] |
Practical points
- Some limits depend on purpose. Several preservatives also appear in the "other restricted" group with a separate limit when used as the active ingredient of a functional cosmetic:
- Hair dyes are mostly limited to oxidative or non-oxidative dyes, and "banned in other products" is the standard condition. Examples: p-phenylenediamine at 2.0% [60] and hydrogen peroxide at 12.0% in hair dyes and bleaches [61].
- The other restricted group includes:
- Customised cosmetics (맞춤형화장품) may not contain any Annex 2 ingredient (Article 5) [23].
- Export-only products are exempt from Cosmetics Act Article 8 and may follow the importing country's rules instead (Article 30) [67].
I can check specific ingredients or CAS numbers against both Korean annexes next, or compare these limits with EU Annex V (preservatives) and Annex VI (UV filters) under Regulation (EC) No 1223/2009.