Azelaic acid is banned in Korean cosmetics — export only
Requests to have an azelaic acid product made in Korea keep arriving. The ingredient is closed off in Korean cosmetics, and the ban covers its salts and derivatives in the same entry. One route stays open, and it is export-only production.
Korea lists azelaic acid as an ingredient that may not be used in cosmetics, and the same entry covers its salts and derivatives. Using it in a product sold domestically carries up to three years in prison or a KRW 30 million fine. Products made solely for export fall under Article 30 of the Cosmetics Act and may follow the importing country's rules instead, so Korean production works inside caps such as Canada's 14% and Saudi Arabia's 15%.
The ingredient itself is closed off in Korea
When a buyer asks a Korean manufacturer for an azelaic acid serum, the first thing checked is not the concentration but whether the ingredient is usable at all. Appendix 1 of the Regulation on Safety Standards for Cosmetics — the list of ingredients that may not be used — carries the entry "1,7-heptanedicarboxylic acid (azelaic acid), its salts and derivatives". The CAS number is 123-99-9, and the entry sits among prohibited substances rather than among restricted ones with a concentration limit attached.
The weight behind it is real. Article 15 item 5 of the Cosmetics Act bars manufacturing, importing, selling, storing or displaying a cosmetic that uses a prohibited ingredient, and a breach carries up to three years in prison or a fine of up to KRW 30 million. Article 39 extends the fine to the company, and a recall and disposal order can follow. This is not a line you add to an INCI list and tidy up later.
The derivative route is closed too
Overseas formulas often reach for potassium azeloyl diglycinate, the water-soluble derivative, instead of azelaic acid itself. In Korea that is not an alternative. The prohibited entry already names salts and derivatives, and the ingredient database built from the MFDS country-by-country regulatory information marks the derivative as prohibited domestically.
What makes this awkward is that the same derivative runs free elsewhere. China, Taiwan, Japan, the EU and ASEAN carry no restriction on it. Azelaic acid itself is prohibited in ASEAN while its derivative is not, and Korea ties the two together in one entry. Take the same ingredient list to two countries and the answers come out reversed.
One route stays open, and it is export-only
A domestic ban does not close Korean production. Article 30 of the Cosmetics Act exempts products not sold in Korea and intended solely for export from items 1 and 5 of the business prohibition, letting them follow the importing country's standards instead. That is the legal basis for making an azelaic acid product in a Korean plant and shipping it to Canada or Saudi Arabia.
| Sales route | Azelaic acid | Basis |
|---|---|---|
| Cosmetic sold in Korea | Not permitted | Cosmetics Act Art. 15(5), Appendix 1 |
| Export-only product | Up to the importing country's cap | Cosmetics Act Art. 30 |
| One SKU for both | Not permitted | Article 30 exemption does not apply |
The third row is where projects come apart. A plan to list the same SKU on a Korean marketplace and ship it abroad loses the exemption. The SKU and the label have to be split for export, with no domestic distribution history attached to them. Costing across those two builds is quicker to compare in the product planner first.
The caps are different in every market
Once the export route is settled, the next question is the ceiling. The numbers differ by country, and prohibitions sit alongside limits.
| Market | Azelaic acid in cosmetics | Basis |
|---|---|---|
| Korea | Prohibited, incl. salts and derivatives | Appendix 1, record 1-1269 |
| ASEAN | Prohibited | Annex II, A1141 |
| Canada | 14% maximum | Hotlist restricted entry 12 |
| Saudi Arabia | 15% maximum | SFDA Circular 26119 |
| EU | Not in Annex II or III | CosIng (buffering, fragrance) |
| US | 15% and 20% are prescription drugs | FDA-approved products |
The EU row deserves a second look. Nothing prohibits or restricts it, yet the functions recorded in CosIng are buffering and fragrance, and 15% and 20% products are authorised as medicines in several markets. Push the concentration up and the product drifts towards the medicinal border rather than the cosmetic one. Canada's 14% and Saudi Arabia's 15% are ceilings of the same kind, so a single formula covering four markets has to be designed to the lowest of them.
Demand grew at the pharmacy counter
A domestic ban has not made the demand disappear. Imports of Azelia Cream — azelaic acid 200 mg/g, an over-the-counter drug approved on 24 November 2006 — rose from about USD 130,000 in 2023 to roughly USD 734,000 in 2024 and about USD 1.86 million in 2025. Through 2026, five Korean pharmaceutical companies won approval at the same strength, from GC Green Cross on 29 July to Kwangdong Pharmaceutical on 21 September.
For a buyer the reading is straightforward. Korean consumers reach this ingredient through pharmacies rather than beauty retail, and there is no competing cosmetic on the domestic shelf. Testing demand in Korea before committing to an export SKU therefore does not work for this one. For ingredients that are moving on the shelf, the daily ingredient signal is the place to check.
«Takeaways»
- Korea places azelaic acid on the prohibited list, and salts and derivatives sit in the same entry.
- Using it in a domestic product carries up to three years in prison or a KRW 30 million fine, with the company fined alongside.
- Products made solely for export may follow the importing country's rules under Article 30. A dual domestic-and-export SKU loses that exemption.
- Caps run to 14% in Canada and 15% in Saudi Arabia, ASEAN prohibits it and the EU lists it nowhere. Design to the lowest number.
*Sources: Regulation on Safety Standards for Cosmetics (Korea), Appendix 1 record 1-1269; Cosmetics Act Articles 15, 30 and 39, via the Korea Ministry of Government Legislation plain-language service, cosmetics section (accessed 3 November 2026) · Health Canada Cosmetic Ingredient Hotlist, restricted entry 12 (2025-08-13) · SFDA Circular 26119 (14 May 2023) · ASEAN Cosmetic Directive Annex II A1141 · CosIng entry for AZELAIC ACID · Korea Pharmaceutical Information Center listing for Azelia Cream · Newsmp, "Azelaic acid acne treatment market expands as five Korean firms enter" (2026)*
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Questions people ask
No. Appendix 1 of the Regulation on Safety Standards for Cosmetics, the list of ingredients that may not be used, carries "1,7-heptanedicarboxylic acid (azelaic acid), its salts and derivatives" at CAS 123-99-9. It sits on the prohibited list, not among restricted ingredients with a concentration condition.
Not in Korea. The prohibited entry names salts and derivatives itself, and the MFDS country-by-country ingredient database also flags that derivative as prohibited domestically. The EU, Japan, China and ASEAN carry no restriction on it.
It can, for export only. Article 30 of the Cosmetics Act exempts products not sold domestically and intended solely for export from items 1 and 5 of the business prohibition, letting them follow the importing country's standards. Running one SKU through both domestic retail and export falls outside that exemption.
Canada allows up to 14% as a restricted Hotlist entry, and Saudi Arabia up to 15% under an SFDA circular. The EU lists it in neither Annex II nor Annex III, while ASEAN prohibits it under Annex II reference A1141. In the US, 15% and 20% products are approved prescription drugs, so cosmetic use turns on the claims made.
At the pharmacy, not on the shelf. Imports of Azelia Cream, the 20% product, rose from about USD 130,000 in 2023 to about USD 1.86 million in 2025, and between July and September 2026 five Korean pharmaceutical companies won approval for creams at the same strength.