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South Korea to Revise Enforcement Rule of Cosmetics Act (MFDS Notice No. 2021-539)

On November 18, 2021, the Ministry of Food and Drug Safety (MFDS) issued the draft of Enforcement Rule of Cosmetics Act1 for public opinion. MFDS proposed requirements about food-simulating cosmetics recall, functional cosmetic's transfer and acquisition, and custom cosmetic business operation following the amendments in Cosmetics Act2

1. Designating food-simulating cosmetics as product subject to recall

The draft specifies food-simulating cosmetics as the "cosmetics subject to recall". The risk grade of food-stimulating cosmetics is Grade B.

According to the Cosmetic Act3 and the Enforcement Rule of the Cosmetics Act4, the business operator shall recall the product without delay when aware that the cosmetic poses or might pose a risk to public health. The recall period of cosmetics under Risk Grade B is 30 days.

2. Simplifying the Application of Functional Cosmetic's Transfer and Acquisition

The on-site inspection for functional cosmetic certificate's transfer and acquisition is proposed to be omitted. The authority also intended to shorten the review period from 60 days to 15 days.

3. Detailing Standards of Custom Cosmetic Business

The draft specified new custom cosmetics business operation standards.

(a) The facility for dealing with the custom cosmetic content is required to be stored separately from other facilities.

(b) When applying for the "custom cosmetic compounding manager qualification certificate", a doctor's medical certificate proving the applicant is not a mental patient or an addict to narcotics should be submitted.

(c) The procedure of reporting raw materials and side effects is drafted. The custom cosmetic sellers should report the raw materials used in making custom cosmetics to the Korea Cosmetic Association at the end of February of the following year. Side effects are required to be reported to MFDS immediately when it occurs.

4. Other amendments

The product name, business entity's name, manufacture number, and use-by date can be labeled either on the primary packaging or secondary packaging.

The precautions of using cosmetics shall be in accordance with the requirements in Regulation of Labelling Cosmetics Precautions for Use and Fragrance Allergens5.

The administrative requirements are proposed to be stricter.

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