K-BPR – Consumer Chemical Products and Biocides Safety Act

Background of K-BPR

Why has the K-BPR been developed?

It is reported >100 people suffered lung injuries (many fatal) associated with the use of humidifier disinfectants (investigation concluded in 2011); the K-BPR has therefore been developed in response to these incidents to control biocidal and consumer chemical products.

Related Links

• China Pesticide Registration
• China Disinfectant Registration
• EU-BPR Compliance
  

Definition of K-BPR

1. Biocides

-Active substance: A chemical and natural substances or microorganisms that have the effect or property of eliminating, controlling, rendering harmless of deterring harmful organism

-Biocidal product: A product that has the primary purpose of eliminating harmful organisms or a product consists of one or more biocidal substances, a mixture with biocidal substance from contained mixture of chemical substances. The table below lists the detailed biocidal product types.

Biocidal product type
1	Disinfectants	a	Human hygiene
		b	Disinfectants and algaecides not intended for direct application to humans or animals
2	Pest control	a	Rodenticides
		b	Control of other vertebrates
		c	Insecticides, acaricides and products to control other arthropods
		d	Molluscicides, vermicides and products to control other invertebrates
		e	Repellents and attractants
3	Preservatives	a	Preservatives for products during storage
		b	Film preservatives
		c	Fibre, leather, rubber and polymerised materials preservatives
		d	Wood preservatives
		e	Construction material preservatives
		f	Working or cutting fluid preservatives
		g	Embalming and taxidermist fluids
4	Other biocidal products	a	Antifouling products

-Treated article: Any substance, mixture or article which has been treated with, or which works as biocidal products for the purpose of eliminating harmful organisms, but it is not main purpose of product.

2. Consumer chemical products:

Consumer chemical products (or household chemical products) are the chemical products daily used in the living spaces such as homes, offices and public facilities.

- Consumer chemical products subject to safety check: Consumer chemical products that are designated and announced by the Ministry of Environment in recognition of their risks found from the risk assessment. The table below lists the detailed types of Consumer chemical products that are subject to safety check.

Consumer chemical product subject to safety check
1	Cleaning products	a	Cleaning agent
		b	Removal
2	Detergent	a	Laundry detergent
		b	Bleach
		c	Fabric softener
3	Detergent	a	Glossy coating agent
		b	Coating agent with specific purpose
		c	Anti-rust agent
		d	Ironing aid
4	Adhesive	a	Adhesive
		b	Sealant
5	Air freshener	a	Air freshener
		b	Deodorant
6	Dyes	a	Material dyes
		b	Material ink
7	Car maintenance products	a	Car washer fluid
		b	Antifreeze
8	Printing products	a	Printing ink∙toner
		b	Red stamping ink
		c	Correction Tape or Correction fluid
9	Beauty products	a	Beauty adhesive
		b	Tattoo dye
10	Disinfectants	a	Disinfectants
		b	Algaecide
		c	Humidifier disinfectants
		d	Sterilizer and disinfectant for infectious diseases
		e	Other preventive disinfectants
11	Insecticide	a	Insect repellent
		b	Prevention, attracting insecticide for hygiene
		c	Repellent for hygiene
		d	Prevention insecticide for infectious diseases
		e	Rodenticide for infectious diseases
12	Preservatives	a	Wood preservatives
		b	Preservatives treated filter
13	Others	a	Candle
		b	Dehumidifier
		c	Artificial snow spray
		d	Fog fluid
		e	Consumer chemical products for humidifier

Regulatory Scope

K- BPR does no t apply to:

• Preservatives used in food and cosmetics.
• Pesticides, technical concentrates and pesticide control equipment in accordance with Pesticide Control Act
• Food additives in accordance with Food Sanitation Act
• Feeds in accordance with Control of Livestock and Fish Feed Act
• Drug and quasi-drugs
• Cosmetics and its raw materials in accordance with Cosmetic Act
• Water treatment chemicals in accordance with Drinking Water Management Act

Obligations

1. Notification of existing active substance

Any person who intends to manufacture or import an existing active substance which was contained in biocidal products distributed domestically until 31st December 2018 will be required to make a notification before manufacturing or importing to obtain a grace period of substance approval. When notifying the active substance, the product type of the substance must be declared together and a grace period of up to 10 years may be granted depending on the product type. During this period, it’s allowed to manufacture and import notified existing active substance without approval.

2. Approval of active substa nce

A person who has notified existing active substance must submit a plan for substance approval application (a proposal on the procedure and method of preparing the substance approval application document) within one year from the date the notified substance is designated as the active substance. Those who submit a substance approval application plan must prepare the appropriate materials accordingly.

Any person who intends to manufacture or import active substance for use in biocidal products must prepare and submit the appropriate data and obtain approval from the Minister of the Environment. The validity of active substance approval is set within 5~10 years depending on the properties of the substance and must be re-approved before expiration. Table below lists the data requirement for approval of active substance.

Data Requirement	Co-subm ission	Testin g
Applicant's general information (CEO, business number, etc.)
Substance identification information (name, CAS#, composition, formula, etc.)	●	● (3 batches)
Biocidal type likely to contain the active substance	●
Application number of existing active substance
Physicochemical or biological physical hazards	●	●
Information on exposures such as uses and routes of exposure	●
Hazards or risk information to humans, animals and the environment	●	●
Effectiveness · efficacy against target organisms	●	●
Classification and labelling	●
Data on raw materials & manufacturing process
Precautions for handling and disposal of active substance	●
Information on domestic and international use and regulation of lethal materials	●
Comprehensive data on the safety of the active substance	●
If applicable to the mitigation condition, evidence data	●

Note: ● means required.

3. Approval of biocidal product

Any person who intends to manufacture or import biocidal products for sale or distribution in the market shall obtain approval from the Minister of the Environment for biocidal products. The validity of biocidal product approval is set within the range of 10 years, and once it’s expired the person who intends to continue manufacturing and importing the product must get approval again. The person who obtained approval must have a manufacturing and storage facility that meets legal standards to maintain product quality as approved. Table below lists the data requirement of approval biocidal product.

Data Requirement	Testing
Applicant's general information (CEO, business number, etc.)
Product general information (name, type, formulation, composition, reason for R&D, etc.)	● (3 batches)
Physicochemical or biological physical hazards	●
Information on exposures such as uses and routes of exposure
Hazards or risk information to humans, animals and the environment (e.g. raw material excepting active substance)	●
Effectiveness · efficacy against target organisms	●
Classification and labelling
Data on raw materials & manufacturing process & Storage facility
Precautions for handling and disposal (Dose, expiry date, etc.)
Information on domestic and international use and regulation of lethal materials
Comprehensive data on the safety of the active substance
If applicable to the mitigation condition, evidence data

Note: ● means required.

4. Labeling for biocidal product

The following items shall be indicated on the surface of the product or package;

• Product name
• Product type
• Expiry date
• Weight, quantity
• Effectiveness and efficacy
• Category of users and range of use
• Standard usage
• Name of manufacturer or importer or company name, address and contact
• Indication of children protection packaging identification on the labelling
• Active substance
• If nanomaterials are used in the biocidal product intentionally, nanomaterial’s information
• Any other chemical substance (hazardous chemical, priority control substance)
• Hazards of biocidal product (pictogram, signal word, etc.)
• Direction for uses
• Precaution in use
• Approval number

5. Treated article

Approved biocidal products must be used in the treated article. Treated articles must comply with standards and labelling. If you wish to inform the effect and efficacy of the treated article, it should be indicated on the outside of the product according to the labelling criteria.

6. Consumer chemical products subject to safety check

Anyone who intends to manufacture or import products listed in the table of “Consumer chemical products subject to safety check” shall obtain safety confirmation from the designated test /inspection institutions at interval of every 3 years. After getting confirmation from institutes, they have to submit confirmation application to Korea Environmental Industry & Technology Institute.

Also, any person who intends to manufacture or import Consumer chemical products subject to safety check, of which the safety standards are not announced, shall submit the data materials on the chemical substance contained in the product to obtain the approval of the MoE such as below product types:

• Humidifier disinfectants
• Sterilizer and disinfectant for infectious diseases
• Other preventive disinfectants
• Insect repellent
• Prevention, attracting insecticide for hygiene
• Repellent for hygiene
• Prevention insecticide for infectious diseases

In addition, anyone who intends to sell or distribute Consumer chemical products subject to safety check, of which the safety is confirmed or approved on the market, shall comply with the labeling standards in labeling on the surface of the product.

7. Record keeping and reporting

Importers or manufactures of Consumer chemical products subject to safety check or biocides shall report the following information to the MoE every 2 years by 31st March

• Consumer chemical products subject to safety check or biocidal products: name and volume of priority controlled substances and active substances contained in the products
• Biocidal active substance: name and volume of biocidal active substance.

Records of following information should be kept for a period of 10 years

• Name and quantity of consumer chemical product subject to safety check
• Composition and mixing ratio contained in a consumer chemical product
• Biocides Name, product name, and quantity
• Composition and mixing ratio of active substances contained in a biocidal product
• Name and content of biocidal products treated to article

Grace Period

Grace period gr oup information for active substance approval
Category	Group 1	Group 2	Grou p 3	Group 4
Daily Exposure Level	High	Medium	Medium	Low
Biocidal product type	Disinfectant	Wood preservative	Product preservative	Construction material preservatives
	Algaecide	Control of other vertebrate	Product surface preservative	Working or cutting fluid preservatives
	Rodenticide	Control of other invertebrate	Fiber, leather, rubber and polymerized materials preservatives	Embalming and taxidermist fluids
	Insecticide			Antifouling products
	Repellent

Note: Grace period for Biocidal Product Approval: Two additional years, in case all of active substances of a biocidal product have been granted a grace period for approval.

Tim eline

The flowchart below shows the timeline of the total regulatory procedure.

Exemption

• Low hazardous substances notified by MoE
• R&D only
• Pilot/prototype (not market)
• Export only

O nly Re presentativ e

If a foreign manufacturer or exporter does not provide any information of a chemical substance to an importer due to confidential business information (CBI), the importer cannot comply with K-BPR. To solve this CBI issue, foreign manufacturers can appoint a qualified only representative (OR) to fulfill the obligations of the importer under K-BPR.

OR for K-BPR will start from Jan.1 ^st . 2021.

Downloadable Materials

• K-BPR service brochure (click to download)

CIRS K-BPR Service List

Category	CIRS Service
Active Substance	Notification of existing active substance Compilation and preparation for active approval Compilation and preparation of substance's equivalence data for approval CICO management Data gap analysis Communication with overseas data owners Preparation of chemical safety report Testing arrangement and scheduling Response to the inquiry Only Representative (~2021.1.1) Report (every 2yrs, by 3.31)
Biocidal Product	Compilation and preparation for the biocidal product approval Compilation and preparation of product’s similarity data for approval CICO management LoA intermediation for approved active substance Required test arrangement and scheduling Preparation of risk assessment of biocidal product Review labeling of biocidal product Only Representative (~’21.1.1) Report (every 2yrs, by 3.31)
Treated Article	Review the labelling of treated article
Consumer Chemical Product Subject to Safety Check	Confirmation of the type of product group and the Act applicable to your product Testing arrangement for safety check Application for approval of Consumer chemical products subject to safety check, of which the safety standards are not announced Review of the declaration of safety check of the Consumer chemical products subject to safety check Compliance check of safety standards (containers, packaging, and weights) Report (every 2yrs, by 3.31)

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