South Korea Regulatory News

A re-assessment of use ahead of approval deadlines was carried out in late May in South Korea, where more than 20% of existing pre-registered biocidal substances under their domestic Consumer Chemical...

A re-assessment of use ahead of approval deadlines was carried out in late May in South Korea, where more than 20% of existing pre-registered biocidal substances under their domestic Consumer Chemical Products and Biocides Safety Act (K-BPR) were withdrawn.

According to the updated National Institute of Environmental Research (NIER) list published on May 24, the still-standing 452 biocidal substances, compared to that of 582 in the previous year, indicates there has been a reflection among companies to re-evaluate what substances to use ahead of deadlines for the completion of approvals, which led to a reduction in substances on the list.

Once removed from the list, the pre-registered substances have lost their pre-approved status, no longer owning the legality to be imported or manufactured for use as a biocide. Nevertheless, if the companies wish to extend the permit for activity until December 31, 2022, concerned parties can decide to submit a “Temporary manufacture/import plans in 2022” within 10 days from the notification date of a withdrawal/the rejection of an application.

Following the vast removal of the pre-registered substances, 116 product types have been removed from the listing regarding the allowed biocide product types covered under the aforementioned approval. However, despite the reduction in the approved number of chemicals, there is an additional product type for substance naphthalene for insecticides.

The deadlines for completion of approvals range from December 31, 2022, to December 31, 2029, depending on the product type where the substance is used. Companies are responsible for informing the downstream users of any changes in listing status for those substances in products or treated articles.

For the authority to process applications in time, NIER on March 31 also urged companies to submit dossiers by mid-April, where if the deadline was reckoned unlikely to be met, the substance would be withdrawn. Once again on May 11, NIER issued a notice in pursuit of completed dossiers that needed corrections or supplementary data, for that many applicants had failed to supply them.

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘the results of hazard review of chemical substances’ under the Act on Registration and Eva...

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘the results of hazard review of chemical substances’ under the Act on Registration and Evaluation of Chemicals (K-REACH).

The draft amendment mainly proposes revisions including:

• Notification of the results of hazard review of registered chemical substances
• Revision of 15 notified chemical substances by adding additional information and correcting wrong information
• Notification of information on classified substances: the name of chemical substances, CAS no., toxic substance designation, main hazard, classification and labeling, etc

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

The deadline for this consultation is June 20th, 2022.

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘Designation of existing biocidal substances subject to approval deferment’ under the Consum...

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘Designation of existing biocidal substances subject to approval deferment’ under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR).

The draft amendment mainly proposes revisions including:

• Additional designation of biocidal product types of existing designated substances
• Cancellation of designation of existing biocidal substances subject to approval deferment
• Cancellation of designation of biocidal product type of existing biocidal substances subject to approval deferment

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

The deadline for this consultation is June 2^nd, 2022

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.