South Korea Regulatory News

The Ministry of Food and Drug Safety (MFDS) in South Korea updated the regulation on cosmetic safety standards on April 1st, 2022. This is to strengthen the safety management of cosmetics and protect ...

The Ministry of Food and Drug Safety (MFDS) in South Korea updated the regulation on cosmetic safety standards on April 1^st, 2022. This is to strengthen the safety management of cosmetics and protect public health, as well as strengthening the competitiveness of the cosmetics industry.

The main updates are as follows:

1. Addition of prohibited raw materials for cosmetics and reinforcement in usage restriction standards (Annex 1 & 2)

• Adding some components of persistent pollutants and perfluorinated compounds to raw materials that cannot be used
• Prohibiting benzalkonium chloride (BKC) for spray products

2. Establishment of exceptions for raw materials that cannot be used in cosmetics (Annex 1)

• Establishing management standards for cannabis that can be unintentionally included from certain parts of cannabis (Tetrahydrocannabinol and Cannabidiol from hemp seed oil and hemp seed extract)
• Setting a permissible limit for radioactive materials that may exist in nature
• Setting a permissible standard of Fluorescent Brightener 367, which are raw materials prohibited for use in cosmetics, based on the risk assessment result

3. Addition of raw materials that can be used as hair dyes and setting an upper concentration limit (Annex 2)

• Adding 10 ingredients that can be used for hair dye and setting the upper concentration limit for using it based on functional cosmetics examination cases

4. Modification of terminology according to clarification of raw material names and revision of upper laws and regulations (Annex 2 & 3)

• Modifying phrases related to the upper concentration limit when using ‘p-methylaminophenol’
• Revising “cosmetics manufacturer and distributor” to “responsible cosmetic distributor” reflecting the amendments of the Cosmetics Act

Part of Annex 2, updates on Benzalkonium Chloride and Indigofera Leaf Powder, will come into effect from October 1^st, 2022.

All other amendment came into effect immediately.

The Ministry of Food and Drug Safety (MFDS) in South Korea updated the regulation on precautions when using cosmetics and labeling of allergens under Cosmetic Act on April 27th, 2022. This is due to ...

The Ministry of Food and Drug Safety (MFDS) in South Korea updated the regulation on precautions when using cosmetics and labeling of allergens under Cosmetic Act on April 27^th, 2022. This is due to the update of the enforcement rule of the Cosmetic Act.

The main updates are as follows:

1. Updates on classification of cosmetic types and precautions for using cosmetics (Annex 1)

• Classifying cosmetic types and removing some cosmetic types
• Integrating precautions by cosmetic type and precautions by ingredient

2. Addition on precautions for each cosmetic type (Annex 1)

• Adding precautions on the cosmetic type ‘Vulvar Cleanser’

Annex 1.2.1.6 (precautions on vulvar cleanser products) and Annex 1.2.1.9 (precautions on aerosol products with high-pressured gas) will come into effect from Dec 19^th, 2022.

All other amendment will come into effect from June 19^th, 2022.

On the 28th of April 2022, the Ministry of Environment, South Korea submits a draft on the labelling and advertising of chemical products. With comments expected to close 40 days from notification...

On the 28^th of April 2022, the Ministry of Environment, South Korea submits a draft on the labelling and advertising of chemical products.

With comments expected to close 40 days from notification, the proposal will be adopted after June 2022 and come into force in August 2023. The notification recommends tighter regulations on the labelling and advertising of chemical products by restricting the use of certain phrases. The phrases include phrases that can be misunderstood as non-toxic, as having no negative impact on the environment/nature, and as having no negative effects on humans/animals. It also restricts phrases that may mislead consumers to think there is no harm which can then lead to excessive use or incorrect use of the product.

The Ministry of Environment (MoE) in South Korea is consulting on a draft amendment of Designation of Toxic Substances under Enforcement Decree of the Act on Registration and Evaluation of Chemicals (...

The Ministry of Environment (MoE) in South Korea is consulting on a draft amendment of Designation of Toxic Substances under Enforcement Decree of the Act on Registration and Evaluation of Chemicals (K-REACH).

The draft amendment mainly proposes revisions including:

• New designation of toxic substances for which hazard reviews has been completed (from 2022-1-1099 to 2022-1-1109)
• Update details of toxic substances (35 substances)
• Regulate import declaration and business license for newly designated toxic substances, and transitional measures of labeling and handling standards for hazardous chemical substances

If you have any opinion on this amendment, please write your opinion and submit to the MoE.

The deadline of this consultation is May 9th, 2022.

The National Institute of Environmental Research (NIER) in South Korea updated the regulation on the scope and methods of biocidal substances and biocidal product approval application data under the C...

The National Institute of Environmental Research (NIER) in South Korea updated the regulation on the scope and methods of biocidal substances and biocidal product approval application data under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR) on April 8th, 2022.

The scope include:

The Ministry of Environment (MoE) in South Korea pre-announced the legislation to update K-REACH. This is aimed at simplifying K-REACH data submission for new substances under 1 TPA (Tonnes per Annu...

The Ministry of Environment (MoE) in South Korea pre-announced the legislation to update K-REACH. This is aimed at simplifying K-REACH data submission for new substances under 1 TPA (Tonnes per Annum) and easing exemption requirement on new substance reports for Research & Development purposes.

Environmental hazard data (acute toxicity to fish, acute toxicity to daphnia, biodegradability) can be omitted when registering new substances that are manufactured or imported under 1 TPA and when any of the following applies:

·       With water solubility less than 1㎎/ℓ

·       For intermediates use or process regulators use

Also, if an overseas manufacturer/producer does not provide the name and identification number of a substance to be imported due to trade secrets, Material Safety Data Sheet (MSDS) can be submitted instead.

In February 2022, the Ministry of Food and Drug Safety (MFDS) in South Korea proposed amendments to the ‘Regulation on Safety Standards, etc. of Cosmetics’. This is the cosmetics policy enacted...

In February 2022, the Ministry of Food and Drug Safety (MFDS) in South Korea proposed amendments to the ‘Regulation on Safety Standards, etc. of Cosmetics’. This is the cosmetics policy enacted in 2015 to guide the manufacture and import of cosmetics and their safety control, it provides a framework for determining the raw materials that can not be used in cosmetics.

The Ministry proposes that persistent pollutants, some components of perfluorinated compounds and 1, 2, 4-trihydroxybenzene should be added to the list of prohibited ingredients while benzalkonium chloride should be prohibited from use as a preservative in spray-type products. It also proposes the maximum limit concentration of ingredients used as hair dye.

Furthermore, some prohibited ingredients are to be established as new exceptions. There are proposed management standards for CBD and THC and radioactive materials and fluorescent brightener 367 have new permissible limits.

The final date to comment on this notification is April 28, 2022.