Korea proposes “Criteria for Admitting Technical Equivalence of Active Substance and Similarity of Biocidal Product, and Preparation of Relevant Dossier”
Title of document
Proposed “Criteria for Admitting Technical Equivalence of Active Substance and Similarity of Biocidal Product, and Preparation of Relevant Dossier” (12 page(s), in Korean)
1) The Ministry of Environment announces the criteria for admitting technical equivalence of active substance and chemical similarity of biocidal product, and the way how to prepare dossier submitted for it in accordance with Article 16 and Article 25 of the Act on Consumer Chemical Products and Biocides Safety (Law No. 15511, which came into effect on January 1, 2019)
2) When a person wants to obtain approval of active substance or biocidal product that have technical equivalence or chemical similarity with already-approved substance or product, the person may apply for it with simplified data requirements. This ME Public Notice states the criteria to determinate the equivalence or similarity, and share relevant human health and environmental hazard, and the way how to prepare the dossier.
The criteria define technical equivalence of human health and environmental hazard, and chemical similarity including impurities by comparing with already-approved active substance or biocidal product.
Notifying member: Korea, Republic of
Protection of human health or safety
To secure chemical safety of active substance and biocidal product before they are placed on the market, with a view to prevent any incidents like the humidifier disinfectant case.
Ministry of Environment
- Submission: 02/05/2019
- Reception: 02/05/2019
- Distribution: 02/05/2019
- Final date for comments: 22/05/2019
- Proposed date of adoption: N/A