On February 7, 2025, South Korea's Ministry of Food and Drug Safety (MFDS) issued amendments to the Enforcement Rule of the Cosmetics Act, which came into effect immediately upon publication.
One of the key changes includes an exemption from the submission of certain documents, provided they are issued in electronic format. These documents include cosmetic manufacturing registration licenses, functional cosmetics evaluation result notifications, cosmetic responsible sales business registration certificates, etc.
Additionally, the amendments introduce major updates to the labeling requirements for cosmetic packaging, with notable revisions to Annex 4 - Standards and Methods for Labeling on Cosmetic Packaging. These new labeling requirements cover the manufacturing number, expiration date, period of use after opening, and precautions for use, and will be applicable to all cosmetics manufactured or imported after February 7, 2025.
Manufacturing Information
The amendment specifies the required labeling method relating to the manufacturing information on cosmetics:
1. The expiration date or period of use after opening must be clearly marked and distinguishable on cosmetic external packaging. When the period of use after opening is displayed, the manufacturing date (or, for custom-made cosmetics, the mixing or filling date) must also be clearly indicated in a way that is easily distinguishable.
2. When multiple cosmetics are sold together as a set, the external packaging must display the manufacturing number in one of the following ways:
Each individual cosmetic in the set may display its own manufacturing number separately, or
A unified manufacturing number can be used for the entire set, replacing individual numbers.
Expiration Date and Period of Use After Opening for Cosmetics Sets
The amendment further clarifies the labeling requirements for the expiration date and period of use after opening for cosmetic sets.
1. For the expiration dates, only the earliest expiration date among the products in the set needs to be indicated, with guidance for other products stating: “Expiration date: Refer to individual product.”
2. For the period of use after opening, only the period of use after opening for the cosmetic product with the oldest manufacturing date in the set should be indicated. Guidance for other products can be added, such as: “Period of use after opening: Refer to individual product.”
Precautions for Use
The revised rules also introduce clearer guidelines for labeling warnings on cosmetics that alter hair color (except temporary hair color products) or remove body hair (except for physical hair removal products). These cosmetics must include the following warnings on the external packaging, with additional information allowed in accompanying documents:
1. Abnormal Symptoms or Side Effects: If users experience symptoms like red spots, swelling, or itchiness due to direct sunlight while using or after using the product, they should consult a specialist.
2. Avoid Use on Injured Areas: Users are advised not to apply the products to wounded or sensitive areas.
3. Storage and Handling:
Keep out of reach of children
Store the products away from direct sunlight to ensure their integrity
ChemLinked Comments
The MFDS has reaffirmed its dedication to enhancing the cosmetic labeling system, ensuring consumers can use cosmetics safely and responsibly. Under the new regulations, cosmetic outer packaging must now prominently display essential details—including the product name, manufacturer's name and address, ingredients, quantity or weight, expiration date, price, and usage precautions—without requiring consumers to open the packaging or container. Furthermore, to ease the labeling burden on the industry while allowing consumers to quickly identify product expiration dates, for cosmetic set packaging that includes multiple products, only the earliest expiration date needs to be displayed on the outer packaging.
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