South Korea Reach Regulation for Various Sectors

The Consumer Chemical Products and Biocide Safety Management Law (known as K-BPR) concerns the placing on the market and use of hazardous consumer chemical and biocidal products, which aims to protect public health and environment from these chemicals and products. This is achieved by assessment or notification of consumer chemical products’ risk, authorization of biocidal chemical substances and products and determination of biocidal chemical used products. K-BPR was taken into force on January 1, 2019, and its recent amendment was promulgated on March 24, and May 26, 2020. Its enforcement will start on January 1, 2021.

1. Consumer chemical product

Ministry of Environment (MoE) designated consumer chemical products that have a potential to expose hazardous chemicals to human and environments while its use at the home, office, and public facilities (“consumer chemical product subject to safety confirmation”). The consumer chemical products are categorized into two, of which requires either approval or notification.

1) Notification of consumer chemical products subject to safety confirmation

Any person who intends to manufacture or import a consumer chemical product that is subject to notification needs a product safety confirmation from concerned research institutes and notifies the confirmation results to Korea Environmental Industry & Technology Institute (KEITI) no later than 30 days since its confirmation.

2) Approval of consumer chemical products subject to safety confirmation

Any person who intends to manufacture or import a consumer chemical product that is subject to approval shall gain approval from MoE. It includes sterilizing materials such as anti-bacterial disinfectant for humidifiers, for preventing infectious diseases and other disinfection purposes, as well as insecticides, rodenticides, and hygiene repellents.

2. Biocides (Biocidal substance, biocidal product, biocidal treated product)

Any person who intends to manufacture or import biocides shall gain approval from MoE. Biocides under K-BPR refer to biocidal substances, biocidal products, biocidal treated products.

1) Biocidal substance

Biocidal substance refers to the chemical, natural material and microorganism to remove or control harmful organisms like pests and bacteria and make them harmless.

* Existing Biocidal Substance

Existing Biocidal Substance refers to a biocidal active substance included in biocidal products, which has placed on the market before December 31, 2018. By December 31, 2019, the list of 741 existing biocidal substances has been confirmed and varying substances have different grace periods.

* Biocidal substance other than the Existing Biocidal Substance 

Any person who intends to manufacture and import biocidal substances requires approval from MoE. It applies to all biocidal substances except designated substances that have fewer risks, substances are used for research purposes and are subject to other laws.

2) Biocidal product

Biocidal product is defined as an article mainly used to remove harmful organisms, which is,

• comprised of more than one biocidal chemical substance, or a mixture of biocidal chemical substance and non-biocidal chemical substance, a natural substance, and microorganism
• made of a chemical substance or a mixture of a chemical substance, natural substance, and microorganism

Any person who intends to manufacture and import biocidal products requires approval from MoE. Once a product is approved to be manufactured or imported, safety labelling for products concerned shall be stated.

(1) ‘Consumer chemical product’ is defined as an article that has a potential of chemical exposure to human and environment while its use at the home, office, and public facilities etc.

(2) 'Biocidal substance’ refers to a chemical, natural material and microorganism to remove or control harmful organisms like pests and bacteria and make them harmless

(3)  ‘Biocidal product’ is an article mainly used to remove harmful organisms, which is 

• comprised of more than one biocidal chemical substance, or a mixture of biocidal chemical substance and non-biocidal chemical substance, a natural substance, and microorganism
• made of a chemical substance or a mixture of a chemical substance, natural substance, and microorganism

(4) ‘Biocidal treated product’ refers to a product that uses biocidal products during the production process, but its main purpose is not to remove harmful organisms

As per the recent amendment of K-BPR on March 24, 2020, the concept of Only Representative (OR) is included in the law, which will take into force on January 1, 2021.  OR is an intermediary appointed by a foreign manufacturer based outside of South Korea to get an approval of consumer chemical products, biocidal substances, and biocidal products so that such chemicals and products can be imported in South Korea.

During the grace periods, any person who intends to manufacture or import biocides can continue to manufacture and import the biocides without approval from MoE once he or she submits an Existing Biocidal Substance notification to MoE. By December 31, 2020, for those companies who had reported their Existing Biocidal Substances, an approval plan (simplified version of approval application) shall be submitted in National Institute of Environmental Research (NIER).

Biocides approval process begins with submitting approval application. Once the authority initiates the assessment, a notice informing approval assessment initiated will be sent to the applicant. In six months from the date of the notice, approval assessemnt result will come out and might require more information from the applicant. After going through committee deliberation, the approval application is finally approved and will be notified to the applicant. This process is described in the picture below. 

For biocides use approval, then necessary documents are as follows.

1. Biocidal substance

• An approval application form that includes applicant and biocides information (e.g. product name, material type etc.)

• Chemical substance identification and chemical processing procedure
• Chemical substance information (e.g. physicochemical properties, exposure, and safety information, labelling)
• MSDS and Risk assessment

2. Biocidal product

• An approval application form that includes applicant and biocides information (e.g. product name, material type etc.)

• Active substance information
• Biocidal product information (e.g. physicochemical properties, exposure, and safety information, labelling)
• MSDS and Risk assessment
• Product processing procedure and processing and storage methods/plans

Each biocides use approval has expiration period.

1. Biocidal substance

(1) Approval criteria for a biocidal substance are eased when 

• the biocidal substance has little potential to be exposed to human or environment due to its purpose and use is limited 
• the biocidal substance is needed due to lack of substitutable substance that has little risks

2. Biocidal product

(1) Approval criteria for a biocidal product are eased when

• the biocidal product used for an industrial purpose
• the biocidal product is needed due to lack of substitutable product that has little risks

In developing the cosmetics industry and improving public health, the Act regulate matters concerning the manufacture, sale, import, and export, etc of cosmetics. The Cosmetic Act has been enforced since July 1, 2000, and the recent amendment came into force on April 7, 2020.

Relevant documents are uploaded in the right-side bar ‘Downloadable Content’.

• Cosmetic Act (Korean and English)

According to the Cosmetic Act, cosmetics include two main categories: functional cosmetics and general cosmetics. Some articles in the Cosmetic Act particularly applies to functional cosmetics. For instance, a person or company who is involved in the sale of a functional cosmetic should process examinations of the safety and effectiveness of each product and report it to MFDS (Ministry of Food and Drug Safety).

1) Functional cosmetics: As determined by ordinance of the Prime Minister, these cosmetics include the following:

• Cosmetics that help whiten skin
• Cosmetics that help smoothen or improve skin wrinkles
• Cosmetics that help tan skin
• Cosmetics that help protect skin from ultraviolet rays
• Cosmetics that help change hair colour
• Cosmetics that help remove body hair
• Cosmetics that help alleviate alopecia
• Cosmetics that help alleviate acneiform skin
• Cosmetics that help alleviate urtication from atopic skin
• Cosmetics that help thin redlines from stretchmarks

2) General cosmetics: These include all cosmetics excluding functional cosmetics.

 1. Main requirement for manufacturers and manufacturer-seller

*** Anyone who violates these matters shall be fined up to 2 million KRW.

2. Contents to be stated on primary or secondary packages

• Name of the cosmetic
• Tradename and address of the business operator
• All ingredients used in manufacturing the relevant cosmetic
• Volume or weight of contents
• Manufacturing serial number
• Use-by date or best before date after opening
• Price
• The word “Functional cosmetic” or functional cosmetic logo (only for functional cosmetics)
• Cautions for use
• Other matters prescribed by ordinance of the Prime Minister

*** Anyone who violates these matters shall be fined up to 2 million KRW.

3. Prohibition of false labelling and advertising

• Labelling or advertising that might mislead consumers to think the cosmetics are medicines
• Labelling or advertising that might mislead consumers to think general cosmetic as functional cosmetic, or labelling or advertising that is different from the examination result of safety and efficacy of functional cosmetic
• Labelling or advertising that might mislead consumers to think any cosmetic other than a natural or organic cosmetic as a natural or organic cosmetic
• Other labelling or advertising that might mislead or deceive consumers

***Anyone who violates these matters shall either be sentenced up to one year imprisonment or fined up to 10 million KRW.

Source: MFDS (Ministry of Food and Drug Safety)

A person who intends to manufacture or import any chemical substance or a mixture, which falls under the classification standards for hazards and dangers of chemical substances, physical factors, etc. that cause health impairments to employees, shall prepare material safety data sheets and submit them to the Minister of Employment and Labor.

* Overseas manufactures can appoint an Only Representative (OR) to prepare and provide MSDS, as well as to apply Approval for Non-Disclosure.

* Process

Substances subject to prepare MSDS: a chemical substance or mixture that causes health disorders to employees

Exception:

1. a chemical substance or mixture that is specified in 15 other Acts.
2. a chemical substance or mixture provided mainly to general consumers for daily life
3. a chemical substance or mixture with low toxicity and explosiveness risk
4. a chemical substance or mixture for R&D

* 16 categories:

     1) Information about the chemical product and company

     2) Hazard and risk assessment

     3) Name and content of ingredients

     4) First Aid Measures

     5) How to deal with explosions and fires

     6) Measures for leakage accidents

     7) Handling and storage

     8) Exposure prevention and personal protection

     9) Physicochemical properties

     10) Stability and Reactivity

     11) Toxicological information

     12) Environmental Impact

     13) Disposal precautions

     14) Information required for transportation

     15) Legal Regulatory Status

     16) Other notes

* Deadline:

1) Existing MSDS (have been imported and provided MSDS before Jan 16th, 2021)

• A grace period based on tonnage band

2) New MSDS (newly imported after Jan 16th, 2021)

• No grace period
• Need to submit MSDS prior to manufacture or import

If a manufacturer or importer wants to write the alternative information (alternative name and alternative content) in MSDS instead of the name and content of the hazardous ingredients that are trade secrets, the person can apply Approval for Non-Disclosure.