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 [CHEMP] Changes to the Format for the Approval Application of Biocidal Product Groups (24.MAY.2023)

[CHEMP Notice] Changes to the Format for the Approval Application of Biocidal Product Groups (Biocidal Product Group Overview Form)(24.MAY.2023)

1. According to Article 12 and Article 20 of the “Consumer Chemical Products And Biocides Safety Control Act”, those who manufacture or import biocides must obtain approval for the respective biocides.

2. In relation to the above, we would like to inform you that the submission format for the approval of biocidal product groups has been changed. For the previously submitted format (ver 1.0), no changes are required, and it can still be reviewed. However, for new submissions or revised documents, please use the updated format.

※ (Changes) Addition of a composition tab for each product in the biocidal product group overview form (ver 2.0)

Source: Chemical Product Management System>Announcements>Biocidal Product> LINK
Attached:
1. Guidebook for the approval of biocides (1 copy)
2. Biocidal products group overview form (1 copy)
3. Form of biocidal product characteristics summary (1 copy)
4. Matrix tool form (1 copy)
※ The attached matrix tool is publicly released information provided by the European Chemicals Agency (ECHA) and some parts are hidden as they do not apply to the Consumer Chemical Products And Biocides Safety Control Act. (Source: European Chemicals Agency, http://echa.europa.eu/)

May 24, 2023
[CHEMP] Guidelines for Exemption of Efficacy Testing Data for Biocidal Substances (Wood Preservatives)(16.MAY.2023)

[CHEMP Notice] Guidelines for Exemption of Efficacy Testing Data for Biocidal Substances (Wood Preservatives)]

The Chemical Substance Research Division of the National Institute of Environmental Research plans to conduct evaluations of biocide for which approval applications have been received, in accordance with the " Consumer Chemical Products and Biocides Safety Control Act."

In relation to this, we would like to provide guidance regarding the exemption of efficacy testing data for biocidal substances (wood preservatives). Please refer to this information .

Thank you.

Source: Chemical Product Management System>Announcements>LINK
Attached: Guidelines for Exemption of Efficacy Testing Data for Wood Preservatives

May 16, 2023
[CHEMNAVI] Major Questions and Answers regarding the registration of existing chemical substances.(15.MAY.2023)

[CHEMNAVI Announcement] Major Questions and Answers regarding the registration of existing chemical substances.

To assist you in the tasks related to the registration and compliance of existing chemical substances, please refer to the following frequently asked questions.

Source: Chemical Safety Industrial Support Group>Announcements>LINK
Attached: Major Questions and Answers regarding the registration of existing chemical substances

May 15, 2023
[CHEMP] Updated Materials for the Biocidal Product Safety Assessment System (BRAMS) (24.APR.2023)

[Chemical Product Management System Announcement] Updated Materials for the Biocidal Product Safety Assessment System (BRAMS) in the Chemicals Management System

This is the National Institute of Environmental Research.
Regarding the approval of biocide and biocidal products,
With the update of the Biocidal Product Safety Assessment System (BRAMS) to version 4.0,
we are distributing the program and user manual as attached.

Please refer attached.

Thank you.

Source: Chemical Product Management System>Announcements>Biocidal Product> LINK
Attached: User Manual for BRAMS(Biocide Risk AssessMent System).pdf
*please refer to the provided link

Apr 24, 2023
[CHEMP] Precautions for Acute Inhalation Toxicity Test of Biocidal products(24.APR.2023)

[Chemical Product Management System Announcement] Precautions for Acute Inhalation Toxicity Test of Biocidal products
The acute inhalation toxicity test of biocidal products is performed to obtain the concentration causing 50% mortality (LC50) or to obtain information on classification and labeling.

(Analytical concentration measurement method) For all biocidal product inhalation tests, the aerosol concentration in the chamber is measured by weight measurement method, and in addition, the concentration measurement value for the active ingredient (biocide) is provided through instrumental analysis (HPLC, GC, etc.).
※ If there are two or more active ingredients, the analysis values for all active ingredients should be provided. However, if analysis of active ingredients is not possible, relevant evidence (analysis results record below the quantification limit, etc.) should be provided.
※The analysis of substances should be referred to the "Data Collection of Analysis Methods for Biocidal Substances in Biocidal Products" (available in the Chemical Product Management System (chemp.me.go.kr), Notification Board - Notice (Biocidal Products)) or a certified domestic or foreign analysis method.

Please refer attachment for more details.

Source: Chemical Product Management System>Announcements>LINK
Attached: 20APR2023 Precautions for Inhalation Toxicity Test of Biocidal products

Apr 24, 2023
[CHEMP] Major Questions and Answers regarding the Approval of Biocidal Products (14.APR.2023)

[Chemical Product Management System Notice] Major Questions and Answers regarding the Approval of Biocidal Products

The Chemical Product Management Division of the Ministry of Environment has announced the major questions and answers related to the approval of biocidal products for your reference.

Source: Chemical Product Management System>Announcements>LINK
Attached: Major Questions and Answers regarding the Approval of Biocidal Products.pdf

Apr 14, 2023
[CHEMP] Changes to Test Data for Setting the Expiration Date of Biocidal Products (12.APR.2023)

[Chemical Product Management System Announcement] Announcement of Changes to Test Data for Setting the Expiration Date of Biocidal Products

The Chemicals Research Division at the National Institute of Environmental Research will be conducting evaluations of biocidal products for which approval applications have been submitted in accordance with the Act on the “Registration and Evaluation of Chemical Substances”.

In this regard, please refer the changes to the test data for setting the expiration date of biocidal products.

Thank you.

Source: Chemical Product Management System>Announcements>LINK
Attached: Changes to Test Data for Setting the Expiration Date of Biocidal Products_20230412.pdf

Apr 12, 2023
[CHEMNAVI] Results of Pre-Registration(Change of Registration)of Existing Chemical Substance Report (12.APR.2023)

[Chemical Safety Industrial Support Group Announcement] Announcement of Results of Pre-Registration(Change of Registration)of Existing Chemical Substance Report

In accordance with Article 42 (Disclosure of Chemical Substance Information) of “Act On Registration And Evaluation Of Chemical Substances” and Article 51(2) (Disclosure of Chemical Substance Information) of its enforcement regulations(Disclosure of Chemical Substance Information), the results of pre-registration of existing chemical substances are disclosed as attached.
The disclosed information is the results for each substance submitted by companies, and please make the best use of them for future joint registration discussion and operation.
Please note that we plan to update periodically and disclose the results of pre-registration (change of registration) reports in the future as well.

Source: Chemical Safety Industrial Support Group>Announcements>LINK
Attached: Results of Pre-Registration(Change of Registration)of Existing Chemical Substance data release(15th).xlsx

Apr 12, 2023
[CHEMP]Posting of User Guidelines for the Effectiveness/Efficacy Test for Wood Preservatives(29.MAR.2023)

[Chemical Product Management System Notice] Information on the Posting of User Guidelines for the Effectiveness/Efficacy Test for Wood Preservatives

Regarding the approval of biocide and biocidal products(hereinafter referred to as biocides), we are distributing the effectiveness/efficacy test user guidelines for wood preservatives as attached.

Please be interested and refer to it.

Thank you.

※ This guideline is based on the national standard 'KS M 1701:2018/Annex B/(Regulation) Test method for the preservative effect of wood preservatives' and was prepared to help the understanding of field users. and is not intended to recommend said test method as a priority.

Source: Chemical Product Management System>Announcements>LINK
Attached: User Guidelines for the Effectiveness/Efficacy Test for Wood Preservatives

Mar 29, 2023
[CHEMP]Posting of Biocidal Product Approval Application Manual(23.MAR.2023)

[Chemical Product Management System Notice] Posting of Biocidal Product Approval Application Manual

This is the biocidal product approval application system user manual.

You may check it in 'Biocides > Biocidal Product > Application for Approval of Biocidal Product'.

Thank you.

Source: Chemical Product Management System>Announcements>LINK
Attached: Posting of Biocidal Product Approval Application Manual(for applicant).pdf

Mar 23, 2023
[CHEMP]Presentation Materials for the Promotion of Biocide Approval and Implementation(15.MAR.2023)

[Chemical Product Management System Notice] Posting of Presentation Materials for Discussions with Consultancy Firms and Testing Institutions involved with the Promotion of Biocide Approval and Implementation

Date: March 14
Meeting with consultancy firms and testing institutes involved with the promotion of biocide approval and implementation.
This is material used in a presentation.

Source: Chemical Product Management System>Announcements>LINK
Attached: 230314 Presentation Materials for Discussions with Consultancy Firms and Testing Institutions involved with the Promotion of Biocide Approval and Implementation

Mar 15, 2023
[CHEMP]Disclosure of Information on Biocides Approved in 2022(02.MAR.2023)

[Chemical Product Management System Notice] Disclosure of Information on Biocides Approved in 2022

In accordance with Article 29 of the “Consumer Chemical Products And Biocides Safety Control Act” and Article 28 of the Enforcement Rules for the same Act, the information on biocide approved in 2022 is disclosed.

○ Substances subject to disclosure
   - The 48 existing biocidal substances subject to approval deferment in 2022 that received substance approval
     ※ 23 insecticides, 21 disinfectant, 5 algicides, 2 rodenticides, and 1 antifoulant (4 substances overlap as being both disinfectant and algicides)

○ Major points of disclosure
   - Name of biocidal substance and expiration date of substance approval
   - Physical, chemical, or biological characteristics of the biocide
   - Name or trade name, address and contact information of the person who has obtained substance approval
   - Hazard and risk level of the biocide
   - Classification and labeling of the biocide

○ How to check the information
- The information is disclosed through the Chemical Product Management System(chemp.me.go.kr)
   ※ Chemical Product Management System - Biocides - Biocide - Disclosure of approved biocide information

Thank you.

Source: Chemical Product Management System - Biocides - Biocide - Disclosure of approved biocide information>LINK

Mar 02, 2023
[CHEMP]Guidance on the Classification of 'Insecticides' among Biocidal Product Types(27.FEB.2023)

[Chemical Product Management System Notice] Guidance on the Classification of 'Insecticides' among Biocidal Product Types

The Chemical Substances Research Division of the National Institute of Environmental Research plans to assess biocides (biocide and biocidal products) for which approval applications have been received in accordance with the” Consumer Chemical Products And Biocides Safety Control Act”.

In relation to the above, we are providing guidance on the details of the 'insecticide' type classification of pest control products among the types of biocidal products; please refer.

Thank you.

Source: Chemical Product Management System>Announcements>LINK
Attached: Classification of 'Insecticides' among Biocidal Product Types_20230227

Feb 27, 2023
[CHEMP][Substances that have completed international approval assessment] Notice (correction) (Biocides)(21.FEB.2023)

[Chemical Product Management System Notice] [Substances that have completed international approval assessment] Notice (correction) for biocide that have completed international assessment (Approval Suspension untill 2024)

This mail is related to Biocide Notice No. 147.

Pursuant to the amendment of the notice “Designation of Existing Active Substance Eligible for Approval Deferment” (Public notice No. 2022-92), the disclosure of biocide that have been assessed internationally and items that can be exempted have been additionally reviewed, and the information for hazard data exemption of biocides which have completed international assessment for 2024 are re-announced.

○ Substances which have completed international assessment among the existing biocide subject to deferment of approval in 2024(hereinafter referred to as “substances subject to secondary national review”). Total 32 substances. (Attachment-1_1)
- Existing: Other vertebrate animal removal agents (1), other invertebrate animal removal agents (7), wood preservatives (25)
- Changed: Disinfectant (1)*, other vertebrate animal remover (1), other invertebrate remover (7), wood preservative (25)
* 32. Active chlorine released from hypochlorous acid (CAS No. 7790-92-3)
○ Substances under evaluation (3) and substances for which assessment information cannot be checked (14) were excluded (Attachment-1_2)

Please check the attached material for further details below.

Thank you.

Source: Chemical Product Management System>Announcements>LINK
Attached: (Attachments 1)_Internationally Approved Substances(2024) (Notice)_condition for hazard data submission-230220.pdf
(Attachments 2)_Internationally Approved Substances(2024) Categories of hazard data submission-230220.zip

Feb 21, 2023
[CHEMNAVI]Guidance on Utilizing the Government-owned Hazard Data List, e.g. Disclosure and Viewing(16.FEB.2023)

[Chemical Safety Industrial Support Group] Guidance on Utilizing the Government-owned Hazard Data List, e.g. Disclosure and Viewing

A list of chemical substance hazard test data owned by the government and how to use said data is provided as attached.

(Attachment 1) Government-owned hazard test data list as of Dec 31, 2022 (230215)
- Includes lists currently in production

(Attachment 2) Manual for application for approval of use for government-owned hazard test data
Chemical Substance Information Processing System (kreach.me.go.kr) > Approval of test data use > Application for use of test data, application through progress status
Also possible to check the results of the hazard test data (summary) and the cost of use for test data whose production has been completed.

※ This data is state-owned property, and thus can be used through the approval of its use rather than data purchase(transfer of data ownership).
Please note that this data can only be used under the applied conditions, such as domestic/overseas registration of chemical substances, and therefore sales, etc. of the data is not allowed.

※ For further inquiry:
(Governmen-produced data) Korea Environment Corporation Reliability Assurance Department
TEL. 032-590-4957 / 02-6050-1313
E-mail. glpdata@keco.or.kr

(Company-produced data) Korea Chemical Substances Management Association Registration Support Team
TEL. 02-3019-6787
E-mail. smes@kcma.or.kr

Source: Source: Chemical Safety Industrial Support Group>Resources>LINK
Attached:(Attachment 1) Government-owned hazard test data list(230215).xlsx
(Attachment 2) Manual for application for approval of use for government-owned hazard test data.pdf

Feb 16, 2023

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