South Korea Published Data Submission Guidance for Biocidal Products

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At the end of June 2023, the South Korean National Institute of Environmental Research (NIER) published three guidance documents to guide enterprises through biocidal product approval, namely:

Guidance for Environmental Data Submission;
Guidance on Product Name and Label; and
Guidance for Submission of Product Efficacy/Efficacy Test Data.

1. Guidance for Environmental Data Submission

Environmental data required for submission:

Category		Data Type	Mandatory/Optional	Items	Instructions for Mandatory/Optional Data Submission Requirements
Hazardous Information	Ecological effect	General Data	Mandatory	Ecotoxicological information of product used for ecotoxicity classification	Provide toxicological information, classification, and labeling information.
		General Data	Optional	Effect on other non-target organisms	-
		Test Data	Optional	More information on ecological effects	Meet one of the following conditions: 1) Hazard assessment was conducted based on the results of ecological effect testing, revealing the presence of hazards or potential, ongoing exposure possibilities in the evaluation outcome; or 2) According to regulations on the classification and labeling of chemicals, where there is insufficient valid data for the classification of individual components of a mixture, or when there is evidence of synergistic effects among the components.
	Fate and behavior in the environment	General Data	Mandatory	Provide estimated values of environmental emissions based on intended usage	Provide emissions of different environmental mediums based on the environmental emission of products in their production and usage stage
		Test Data	Optional	Fate and behavior in the environment	Meet the following conditions: 1) Hazard assessment was conducted based on fate and behavior in the environment test results, revealing the presence of hazards or potential, ongoing exposure possibilities in the evaluation outcome.
		Test Data	Optional	Environmental residue and monitoring data	Meet all of the following conditions: 1) If the substances, degradation products, or other hazardous substances in biocidal products may impose an impact on the distribution and decomposition characteristics of the environment, monitoring is required; and 2) Hazard assessments are conducted based on fate and behavior in the environment testing results. The hazard assessment result reveals the presence of hazards or potential, persistent exposure possibilities.
Hazard Information		General Data	Mandatory	Dose-effect analysis and derivation of PNEC	Provide the Predicted No Effect Concentration (PNEC) and the calculation method of various environmental compartments
				Exposure assessment	Provide the Predicted Environmental Concentration (PEC) of environmental compartments by using environmental behavioral models
				Risk assessment	Provide the risk assessment results of various environmental compartments
				Environmental hazard assessment results	Provide the risk assessment results of various environmental compartments

Data submission scope:

All biocidal products are required to submit environmental data regardless of whether they contain any of the following substances and their concentration:
- toxic substances;
- restricted substances;
- prohibited substances;
- substances under priority control;
- permitted substances; or
- substances under emergency response.
Generally speaking, components of mixtures affecting its classification are required to submit relevant data when its hazard concentration in the aquatic environment reaches or exceeds 0.1%. However, if there is evidence that proves it is an environmental hazard, relevant environmental data is required to be submitted even if its concentration is below 0.1%.
It is not necessary to submit environmental data for biocidal products deemed to have low hazards according to NIER or products exempted from registration or notification according to the Act on the Registration and Evaluation of Chemicals (K-REACH).
Enterprises must confirm whether their products may contain substances having synergism function based on the Consumer Chemical Products and Biocides Safety Act (K-BPR). If enterprises cannot find any relevant data on synergism, they may submit reports involving relevant databases and keywords.

Recognized data:

International data: data that has been assessed and published by international authorities (including the EU, IARC, and OECD) or governments (including members of the EU and OECD);
Domestic data: data assessed and published in accordance with the Act on the Registration and Evaluation of Chemicals (known as K-REACH).

Note: Material Safety Data Sheets (MSDS) and Product Safety Data Sheets (PSDS) are not accepted due to their unreliability.

2. Guidance on Product Name and Label

Generally speaking, product names must be described in Korean; if there are non-Korean names, the Korean name should be in a larger font size. (The content of biocidal products may be expressed in English units of measurement, such as mol, and M).
Product name may not exaggerate the efficacy or performance of a product, or potentially mislead consumers.
Product labels must indicate the product name, type of biocidal product, active substances (including active substance name and its percentage), expiration date, efficacy, and usage precautions.

The following circumstances are prohibited:

The product name cannot be identical to any existing product for sale. It must not contain titles such as celebrities or experts to improve the product’s image, and it must not use names that could lead to the product being mistaken for another;
Superlative characters including “the first” and “the best” are not allowed; and
Expressions that may lead people to believe the product is non-toxic or environmentally friendly are not allowed. Expressions implying multiple uses of the product are also prohibited.

3. Guidance for the Submission of Product Efficacy/Efficacy Test Data (concentration and co-formulants)

When applying for the approval of biocidal products, documents must be submitted based on their usage quantity (concentration), efficacy data, standard dosage, and usage method.
Data submission covers testing data and general data while testing data shall prevail. General data may be submitted such as similar ingredients or usage methods and targeted biological species.
Concentration settings without scientific proof will not be accepted, such as the usage concentration of other biocidal products or usage standards recommended in South Korea and foreign countries.
In the following circumstances, data submission may be exempted:
- For certain biocidal products that cannot conduct experiments under specific conditions due to their uniqueness, relevant information may be submitted; and
- In cases where a product involving several targets and test data is only required for certain species, reasonable supporting documents shall be provided.

The test data of co-formulants is not mandatory. However, additional data may be required to be submitted for biocidal components with disinfection functions.

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