1.Background

In 2011, the humidifier disinfectant incident in South Korea raised concerns among the Korean population about the safety of chemical products, leading to the desire to establish a management system for consumer chemicals and biocides.

On March 20, 2018, South Korea officially enacted the Consumer Chemical Products and Biocides Safety Act, known as K-BPR, which was formally implemented on January 1, 2019. After two revisions in March and May 2020, the revised version of K-BPR came into effect in January 2020.

K-BPR mainly involves the following aspects:

• Management of consumer chemicals;
• Pre-approval system for active substances and products of biocides;
• Distribution and post-market management of consumer chemicals and biocides.

2. Definition

3. Obligations

4. Product Types of Biocides

5. Consumer Chemical Products

5.1 Definition

Consumer chemical products: Chemical product that is used in our daily life (e.g. Home, office, multi-use facility) and may potentially expose people and/or the environment to chemical substance.

Consumer Chemical Product Subject to Safety Check: Consumer chemical product that is designated and announced by the Minister of Environment in recognition of its risks found from risk assessment.

5.2 Obligations

Consumer chemicals requiring safety confirmation can be classified into two categories based on the obligations they entail: Declaration type and Permitted type.

For declaration type consumer chemicals, compliance with relevant product safety and labeling standards is required. These chemicals need to undergo relevant testing every 3 years in officially designated laboratories to confirm compliance with safety standards. Subsequently, a declaration must be made to the Korea Environmental Industry and Technology Institute (KEITI).

For permitted type consumer chemicals, a permit application to the Ministry of Environment (MOE) in South Korea is required before production or importation. Relevant physicochemical and toxicological data must be submitted as part of the application process.

If an enterprise intends to sell consumer chemicals requiring safety confirmation and their safety has been verified, the enterprise must affix standardized labels that comply with the regulations.

Disinfection product shall affix label on the product or packaging:

• Product name
• Expiry date
• Weight and quantity
• Efficacy
• User category and scope of use
• Recommended usage
• Manufacturer/importer name, address, and contact information
• Child-resistant packaging identification symbol on the label
• Active substances
• If nanomaterials are used in the product, information about the nanomaterials should also be provided
• Any other chemical substances (toxic substances, priority-controlled chemicals)
• Hazard pictograms, signal words, etc.
• Instructions for use
• Precautions for use
• Approval number

6. Scope of Exemption

• Health functional foods specified by the Health Food Management Law;
• Military supplies specified by the Military Supplies Management Law;
• Pesticides, active ingredients, and pesticide control equipment specified by the Pesticide Management Law;
• Water treatment agents specified by the Drinking Water Management Law;
• Feeds and feed additives specified by the Feed Management Law;
• Treatment substances specified by the Ship Ballast Water Management Law;
• Foods, food additives, food utensils, and packaging specified by the Food Hygiene Law;
• Pharmaceuticals and veterinary drugs specified by the Pharmaceutical Administration Law;
• Sanitary products specified by the Sanitation Management Law;
• Medical devices specified by the Medical Device Management Law;
• Cosmetics specified by the Cosmetics Law;
• Organic foods, non-edible oil processed products, pesticide-free raw material processed foods, organic agricultural and fishery materials, and permitted substances specified by the Green Agriculture and Organic Food Law.

7. Active Substance 

7.1 Prior Notification of Existing Active Substances

Existing active substances need to be prior notified before production or importation to obtain a grace period. When conducting prior notification for the active substance, enterprises also need to confirm the product type of the substance. Depending on the product type, enterprises can obtain grace periods of different lengths (up to 10 years). During the grace period, enterprises can produce or import the active substances that have been prior notified without obtaining formal approval.

If an enterprise needs to produce or import existing active substances for use in biocidal products, and the product has already been on the market before December 31, 2018, the enterprise needs to submit a prior notification before production or importation to obtain a grace period for existing active substance authorization. When submitting the prior notification for the active substance, the enterprise also needs to declare the product type (4 major categories, as shown in the table on the second page). Depending on the product type, the enterprise can obtain a grace period of different lengths (up to 10 years). During the grace period, the enterprise can produce or import the existing active substance that has been pre-notified without obtaining authorization.

7.2 Authorization of Existing Active Substance

Enterprises planning to produce or import existing active substances are required to submit relevant substance data and obtain authorization from the Ministry of Environment. Depending on the nature of the substance, the authorization for active substances is valid for 5-10 years. Enterprises must reapply for authorization before the expiration of the validity period. The data requirements for active substance authorization are as follows:

7.3 Circulation and Post-Market Management

Report

Enterprises that manufacture or import consumer chemicals or biocides requiring safety confirmation need to report the following information to the Ministry of Environment annually (starting from March 31, 2020):

• Producers of consumer chemicals or biocides requiring safety confirmation: Names and quantities of products manufactured or imported; names and quantities of priority-controlled substances and active substances contained in the products.
• Manufacturers or importers of active substances: Names and quantities of active substances manufactured or imported.

Only representative (OR)

If overseas manufacturers or exporters wish to protect their commercial secrets and cannot provide substance information to importers, the importer cannot fulfill K-BPR obligations. To address this issue, overseas producers can appoint a qualified Only Representative (OR) to fulfill the importer's obligations stipulated by K-BPR. The role of the OR came into effect on January 1, 2021. 

Filing and reporting

Enterprises that produce or import consumer chemicals or biocides requiring safety confirmation must report the following information to the Ministry of Environment every two years (by March 31st):

• Producers of consumer chemicals or biocides requiring safety confirmation: Product name and quantity in tons, as well as the names and quantities of priority-controlled substances and active substances contained in the products.
• Active substances: Names and quantities of active substances manufactured or imported. 

The following information shall be filed for 10 years:

• Names and quantities of consumer chemicals requiring safety confirmation;
• Composition and mixture ratios of consumer chemicals requiring safety confirmation;
• Names, product names, and quantities of biocidal products requiring safety confirmation;
• Composition and mixture ratios of active substances in biocidal products;
• Names and contents of biocidal products used for treated articles.