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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:

博e乐娱乐网站 for Environmental 博e乐娱乐网站博e乐娱乐网站;
博e乐娱乐网站 on Product Name and Label; and
博e乐娱乐网站 for 博e乐娱乐网站 of Product Efficacy/Efficacy Test 博e乐娱乐网站.

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Environmental data required for submission:

Category		博e乐娱乐网站 Type	Mandatory/Optional	Items	Instructions for Mandatory/Optional 博e乐娱乐网站博e乐娱乐网站 Requirements
Hazardous Information	Ecological e ffect	General 博e乐娱乐网站	Mandatory	Ecotoxicological information of product used for ecotoxicity classification	Provide toxicological information, classification, and labeling information.
		General 博e乐娱乐网站	Optional	Effect on other non-target organisms	-
		Test 博e乐娱乐网站	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 博e乐娱乐网站	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 博e乐娱乐网站	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 博e乐娱乐网站	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 博e乐娱乐网站	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

博e乐娱乐网站 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 博e乐娱乐网站s (K-REACH).
Enterprises must confirm whether their products may contain substances having synergism function based on the Consumer 博e乐娱乐网站 Products and Biocides Safety Act (博e乐娱乐网站). 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 博e乐娱乐网站s (known as K-REACH).

Note: Material Safety 博e乐娱乐网站 Sheets (MSDS) and Product Safety 博e乐娱乐网站 Sheets (PSDS) are not accepted due to their unreliability.

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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.

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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.
博e乐娱乐网站 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.

If you need any assistance or have any questions, please contact us via [email protected].

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