News Brief
Recently, the National Institute of Chemical Safety (NCIS) of South Korea issued the Guidance on Standards and Submitted Data for Changes to Biocidal Product Approvals (Notice 2.0).
This guidance specifies the reporting and approval standards for changing information on approved biocidal products, and outlines the required submission materials. Incorporating previous evaluation cases and feedback from industry briefings, this update aims to help enterprises manage product information more compliantly and efficiently.
Legal Basis: K-BPR Requirements for Change Applications
According to Article 23 of the Act on Safety Management of Consumer Chemical Products and Biocides (abbreviated as the Chemical Product Safety Act or K-BPR) and Article 20 of its Enforcement Decree, enterprises must apply for a change approval when altering important matters (such as hazard/risk information, efficacy/effectiveness, etc.) of an approved biocidal product. For changes to general information such as product name or address, a change notification (reporting) is required. With the increasing number of approved products, standardizing the change process and clarifying data requirements have become a primary focus for the industry.
Key Points of the Guidance
The issued “Guidance” clarifies 15 important matters requiring change approval, along with related general principles and required evidentiary materials. The core points are as follows:
Pre-approval Principle: In principle, changes must receive prior approval before the change occurs to ensure a pre-market safety evaluation is conducted. However, certain specific items (such as the submission of component analysis reports) can be applied for within 6 months after the change occurs.
Synchronized Update of Related Items: The guidance emphasizes the correlation of change items. For example, if a product’s “efficacy/effectiveness” is altered, related items such as “uses,” “target users and scope of use,” and “standard usage amount and method of use” must also be updated with corresponding data simultaneously.
Key Change Items:
Product Name: Includes changes to the product name and the addition/deletion of supplementary product names.
Product Type: Changing the product type (e.g., from an insecticide to a repellent) will result in a change to the approval number.
Composition and Mixing Ratio: Covers changes in biocidal substance content, suppliers, and the ratio of K-REACH regulated substances (e.g., hazardous or intensive control substances). If the content changes by 10% or more, efficacy and shelf life test data must be submitted.
Hazard/Risk Information and Manufacturing Facilities: Applications for change approval are required upon confirming new information or changing manufacturing facilities (including the addition or relocation of direct manufacturing or outsourced manufacturing facilities).
Efficacy/Effectiveness and Uses: Adding target organisms (e.g., adding efficacy against cockroaches) or expanding the scope of use (e.g., expanding from general consumers to professional users) falls under the scope of change approval.
Change Notification Items: For matters that do not affect product safety or efficacy/effectiveness (such as changes to administrative information like company name, representative name, or address), enterprises must submit a change notification within 1 month after the change occurs.
Conclusion
In summary, the new guidance document on application for changes to biocidal product approvals issued by South Korea’s NCIS provides a clear path for the lifecycle management of approved products.
Compliance is not just a momentary action of obtaining an approval certificate, but a continuous obligation throughout the product’s entire lifecycle. Industry practitioners and compliance managers are advised to study the details of the guidance thoroughly and plan compliance efforts in advance to ensure stable and compliant product operations in the South Korean market.
For companies seeking practical support or guidance on implementing these changes, REACH24H is here to help. Please feel free to contact us at customer@reach24h.com.
