Services
K-BPR
Biocidal Products
Biocidal products are mainly used to remove harmful organisms and falling under any of the following:
- Products consisting of one or more active substances, or consisting of a mixture of active substances and chemical/natural substances and/or microorganisms that are not active substances.
- Products that produce active substances from chemical substances or mixtures of chemical substances, natural substances and/or microorganisms
Approval for Biocidal Products is required by each company and by each product.
Approval for Biocidal Products
Preparation for Approval of Biocidal Products
- Preparation of hazard information on active substances and other ingredients in the biocidal product
- Preparation of documents on safety of biocidal products, including exposure assessment
- Approval dossier including documents on safety of biocidal products
Submission of Approval for Biocidal Products
- Correspondence with NIER
| Review by NIER | Timescale |
|---|---|
| Completeness Check | 30 days |
| Product Assessment | 6 months |
| Peruse and feedback comments on Draft Assessment Report | 30 days |
| Committee Review | 30 days |
Completion notice for Biocidal Product Approval
Application for Product Similarity Check
Product Similarity
- Similarity in different biocidal products that contain identical active substances (including those approved through active substance similarity check) and other ingredients, or have similar content ratio, use, risks, effects/efficacy of removal of harmful organisms, etc.
A biocidal product within the same product family of an already-approved biocidal product may receive approval through Product Similarity Check.
※ Same Approval Expiry Date as the already-approved biocidal product will be applied.
※ For Changes in Approval of the already-approved biocidal product, Product Similarity Check may have to be re-approved also.
Confirmation of Availability for Product Similarity Check
- Existing Biocidal Products
Review of Approval Criteria- Biocidal products with similarity check approved
Preparation of Data Use Agreement for Main Biocidal Product Data
Application for Product Similarity Check
- Correspondence with NIER
| NIER Review | 90 days |
|---|
Notification of Product Similarity
Special Approval for Biocidal Products
- If a biocidal product meets all the Special Approval conditions, it may be approved through the Special Approval.
Review of Special Condition Eligibility
- Confirmation on use of announced low-risk active substances
- Confirmation on use of hazardous chemical substance/nanomaterial/substances with hazard classification
- Confirmation of Effect and Efficacy
- Confirmation on use of personal protection equipment
Application for Special Approval
- Correspondence with NIER
| NIER Review | 90days |
|---|
Completion Notice for Approval Issued
Review of Labels on Biocidal Products
To sell/distribute approved biocidal products, information required under K-BPR must be indicated on the surface of the products, so that it is easily identified by the consumers
Review of Labels on Biocidal Products According to Labelling Requirement
Result and Comments from Review of Labels
