On August 28, 2026, South Korea’s Ministry of Food and Drug Safety (MFDS) released the revised Guidelines on the Analysis Methods of Ingredients Prohibited in Cosmetics (Applicant Guide). The revision was completed by the Cosmetics Research Division of the Medical Products Research Department under its subordinate body, the National Institute of Food and Drug Safety Evaluation (NIFDS), covering improvements to the analytical methods for two ingredients, 1,4-dioxane and formaldehyde, as well as the removal of analytical methods for pesticide-related ingredients including molinate, and carbaryl.
Purpose and Legal Status of the Guidelines
The guidelines are intended, pursuant to Articles 8 and 15 of the Cosmetics Act, to provide analytical method references for the detection and confirmation of ingredients prohibited in cosmetics, for use in quality management by cosmetic manufacturers/responsible sellers and relevant testing institutions.
It should be noted that this document is an explanatory guide for applicants and has no externally binding legal effect; it is for reference only, and companies may also adopt other scientifically validated equivalent methods. The guidelines are prepared on the basis of the scientific and technical facts and the regulations in effect as of the date of preparation, and may be adjusted in their application as regulations are subsequently amended.
1,4-Dioxane Analytical Method: Calibration Curve Range Changed and Internal Standard Solution Added
- 1,4-Dioxane (CAS No. 123-91-1) is a prohibited ingredient in South Korea; when unintentionally present, the allowable limit is not more than 100 μg/g;
- This revision changes the calibration curve range to six concentration points-0.25, 0.5, 2, 4, 8 and 16 μg/mL-and adds an internal standard solution (1,4-dioxane-d8, 20 μg/mL), with quantification performed by the internal standard method.
Formaldehyde Analytical Method: Simplified Sample Preparation
- Formaldehyde (CAS No. 50-00-0) is a prohibited ingredient in South Korea; when unintentionally present, the allowable limit is not more than 2,000 μg/g, and not more than 20 μg/g for wet wipe products;
- This revision simplifies the sample preparation: the extraction step has been removed from the 2,4-dinitrophenylhydrazine (2,4-DNPH) derivatization method;
- The method applies to toner, lotion and cream products.
Deletion of Pesticide-Related Analytical Methods
According to the official explanation, the reason for the deletion is that the relevant ingredients are now managed as target residues under pesticide residue control, and the testing method system needs to be modernized.
Implications and Recommendations for Cosmetic Enterprises
- This revision does not involve any change to the list of prohibited ingredients itself, but only adjusts the testing methods, and has no direct impact on formulation compliance obligations;
- MFDS may apply the new analytical methods in subsequent market sampling and investigations of non-compliant cosmetics; enterprises exporting to Korea and responsible sellers in Korea are advised to update their internal testing procedures against the new guidelines in a timely manner;
- For higher-risk ingredients such as 1,4-dioxane (a by-product commonly found in products containing polyoxyethylene surfactants) and formaldehyde (a degradation product of slow-release preservatives), companies are advised to review their own testing capabilities against the new calibration curve range and the simplified sample preparation, and to entrust qualified laboratories with testing where necessary;
- The guidelines are a non-mandatory reference document; where companies adopt other scientifically sound and validated methods, they should ensure that the method validation data are complete and traceable.
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