On 17 May 2023, the Chemical Materials Research Division of the National Institute of Environmental Research uploaded its plans to conduct evaluations of biocidal substances submitted for approval under the "Act on the Safety Management of Household Chemical Products and Biocides."
In relation to this, the authority has provided guidance regarding the exemption of efficacy test data for biocidal substances (wood preservatives).
The Exemption Guidelines for Test Data on Efficacy and Effectiveness of Biocidal Substances (Wood Preservatives) are as follows:
For wood preservatives listed under the Korean standard on wood preservatives and similar substances, the submission of test data on efficacy and effectiveness may be exempted according to the Industrial Standardization Act. KSM 1701 is a standard number issued by the government agency, the Korea Agency for Technology and Standards (KATS), to designate wood preservatives.
Seven out of the 40 existing wood preservatives are subject to deferred approval in 2024. When applying for approval of these confirmed biocidal substances and their representative example products, the submission of test data on efficacy and effectiveness is exempted.
However, general data on the efficacy and effectiveness of the biocidal substances (such as their functions, control methods, mechanisms of action, limitations, etc.) should still be submitted.
The exemption for test data on efficacy and effectiveness only applies to wood preservatives and does not extend to other types of biocidal products. The exemption for test data on efficacy and effectiveness of wood preservatives is independent of the designation of existing biocidal substances and internationally approved evaluated substances. Changes in the inclusion or removal of substances under KSM 1701 may result in modifications to the eligibility for exemption from test data on efficacy and effectiveness.
For wood preservatives that are not included under KSM 1701, test data on efficacy and effectiveness should be submitted when applying for their approval. If the efficacy and effectiveness of the biocidal substance are not sufficiently proven or if individual testing is not feasible, evaluation of the representative example product can be used to demonstrate the efficacy and effectiveness of the biocidal substance. As wood preservatives fall under the category of preservatives used in biocidal treatment products, test data demonstrating the desired efficacy and effectiveness in treated biocidal products using the representative example product should be submitted. Both domestic and internationally recognized test methods can be used for evaluating the efficacy and effectiveness of wood preservatives. Refer to the information provided in the Chemical Products Management System.
Please note that the information provided is based on the referenced guidelines and regulations. It is advisable to consult the official regulatory authorities or seek legal guidance for precise and up-to-date information regarding the exemption of test data on efficacy and effectiveness for wood preservatives.
Read Less
