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[Chemical Safety Industry Support Group Announcement] Final Selection Result of Demand Survey for English Translation of Government-Held Hazard Data
The Korea Environmental Corporation performs a project to provide low-cost hazard data to support compliance with “Act On Registration And Evaluation Of Chemical Substances” by the chemical related industry.
In addition, our corporation conducted a demand survey for English translations of "Corporation-held data" to support the smooth export of chemical substances, not just compliance with the “Act On Registration And Evaluation Of Chemical Substances” by the chemical industry, and the results are as follows:
Survey period: July 6, 2022, to July 20, 2022 (2 weeks)
Selected items: 39 items in 8 categories
English translations will be conducted until early December, and will be available within January 2023 after administrative procedures.
For more information, please refer to the attached file.
Contact: ☎ 02-6050-1311, 1313 (Korea Environmental Corporation, Reliability Assurance Department)
Source: Chemical Safety Industrial Support Group>Resources>LINK
Attached: Att_2022 Final Selection Result of Demand Survey for English Translation of Government-Held Hazard Data
Oct 14, 2022
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[Chemical Product Management System Announcement] Guidance on Implementation of Biocides Control System for Manufacturers and Importers of Consumer Chemical Products Subject To Safety Confirmation
1. We deeply appreciate your efforts for the safe management of your consumer chemical products.
2. To prevent incidents similar to the humidifier disinfectant case, the "Consumer Chemical Products and Biocides Safety Control Act" (hereinafter, the "Act") was enacted (in January 2019). In order to manufacture or import biocide or biocidal products for sale or distribution in Korea, approval from the Ministry of Environment (National Institute of Environmental Research) is required.
3. Accordingly, for the Consumer Chemical Products Subject To Safety Confirmation, which are applicable to biocidal products*, it is required to obtain approval for the biocidal products within the grace period of the approval of Consumer Chemical Products Subject To Safety Confirmation, as specified in the Act, in order to ensure smooth compliance with the system by the industry. Therefore, we would like to provide the following guidance.
(Please refer to Article 12, Article 20 of the Act, and Article 3 of the Supplementary Provisions of the Act for confirmation)
*10 types of products including disinfectants, algicides, antibacterial agents/ disinfectants for humidifiers, antifoulants, medical pesticide, medical repellents, insecticides for infectious disease prevention, rondenticides for infectious disease prevention, wood preservatives.
A. Biocidal products containing approved biocide: Must be Approved until 2024.
B. Biocidal products containing unapproved biocide: Must apply for substance and product approval simultaneously by January 2023 and approved within 2023.
C. Regardless of the validity period of the Consumer Chemical Products Subject To Safety Confirmation, approval for biocidal products, must be obtained within the aforementioned timeframes (+2 years for wood preservatives). Manufacturing, importing, selling, and distributing of biocidal products without approval after the deadline is prohibited (refer to attachment for details).
D. Inquiries: Biocidal product approval (National Institute of Environmental Research, 032-560-7913) / Notification of Consumer Chemical Products Subject To Safety Confirmation, (KEITI, 02-2284-1862) Approval of Consumer Chemical Products Subject To Safety Confirmation, (National Institute of Environmental Research, 032-560-7914) / Biocidal product approval support (Biocides Industry Support Team, 02-6050-1314~1316)
Note: Telephone and email inquiries other than the above contact points are not accepted. A briefing session for the industry will be held in the future (a notification will be sent when the schedule is confirmed).
Attachment: Guide on the Implementation of the Approval System for Biocidal Products of Consumer Chemical Products Subject To Safety Confirmation (1 copy). End of the notice.
Source: Chemical Product Management System>Announcements>LINK
Attached:[Official Paper] Implementation of Biocides Control System for Manufacturers and Importers of CCPS.pdf
[Attachment] Notice regarding the implementation of the system for the approval of biocidal products in CCPS (refer to Att. 7).pdf
[Attachment]Refernce_7.pdf
Aug 16, 2022
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[Chemical Product Management System Announcement] Guidance for Modification and Supplement of Existing Biocides Subject to Approval Suspension untill 2022 (10th)]
1. Wishs all the best to your company
2. Regarding Doucuments: MOE Chemical Products Management Division-371( '21.9.2. ) , 449( '21.9.17. ), 469( '21.9.24. ) , 542('21.10.13.), 579('21.10.22.), 760('21.12.3.), 837('21.12.20)
NIER Chemicals Research Division-2188( '22.3.31.) , 3167( '22.5.11. )
3. According to the "Consumer Chemical Products and Biocides Safety Control Act,"(Hereinafter, “Act”) if a member has not received a notification to start the evaluation by February 4, 2022 (Fri) regarding the approval of existing biocidal substances, we have repeatedly informed that it will be difficult to complete the evaluation within this year. However, we continue to identify deficiencies in the submitted approval application materials, so we are providing detailed guidance on the deadline for modifying and supplementing the materials. Please promptly make the necessary modifications and supplements.
A. Subject: The companies (representatives and members) that applied for approval of existing biocide that are subject to approval suspension until '22 under Article 18 of the Act and the companies that notifiy existing biocide.
B. Modification and supplementation deadline: Based on Article 14 and Article 10 of the Act, the deadline for modification and supplementation of the evaluation materials takes into account the minimum legal period required for the approval evaluation of biocide.
Deadline for completion of modification and supplementation in the completeness review stage
-July 31, 2022 (CHEMP block)
Deadline for completion of modification and supplementation for substances that have started evaluation
- August 31, 2022 (CHEMP block)
※ After the above date, the modification and supplementation function for the '22 approval deferred existing biocide approval applications in the Chemical Product Management System (CHEMP) will be blocked, and the relevant application will be rejected.
C. Measures for rejected or voluntarily withdrawn substance approvals: For substances where approval is difficult to obtain within this year due to the administrative process period under the law and maintaining the status of existing biocide under Article 18 of the Act is difficult, the designation of the existing biocide status will be revoked immediately (within this year of 2022), and manufacturing, import, sale, and distribution of the substance will be prohibited.
However, if a '2022 temporary production/import plan (Attachment 3)' is prepared within 10 days of the notification of rejection/voluntary withdrawal (by July 31 for cases that have already been voluntarily withdrawn [Reference 2 of Attachment 2]) and submitted to our institute (nierbiocide1@korea.kr), manufacturing and import of the substance will be allowed until December 31. (Inquiry: 1800-4840)
D. Obligation to provide information: Company that have notified existing biocide subject to approval and have been rejected · voluntarily withdrawn, or have not submitted the application documents must notify the lower-tier users (companies that manufacture or import biocidal products or treated products, etc.) of the discontinuation of the manufacture or import of the relevant substance.
4. Additionally, companies that manufacture or import biocidal products or biocidal treated products must comply with the grace period for product manufacturing and importation according to Articles 3 and 4 of the Supplementary Provisions of the Act, and take necessary measures in advance to avoid any violations of relevant laws and regulations.
Attached:
Existing guidance letter and notice of the deadline for reporting and approval of existing biocide subject to approval extension in 2022.
Notification of the deadline for modification and supplementation of existing biocide to approval extension in 2022.
2022 Temporary Manufacturing/Import Plan (Form) for rejected or voluntarily withdrawn biocide. End.
Source: Chemical Product Management System>Announcements>LINK
Attached:Attachment 1. Existing guidance document (9 copies) and 'guidance on notification and approval application deadlines for existing living organisms subject to approval deferral in 2022' (1 copy)..zip
Attachment 2. Modification and supplement deadlines of existing biocides subject to approval suspension untill 2022 .hwp
Attachment 3. 2022 temporary production/import plan for rejection/voluntary withdrawal biocide.hwp
Jul 18, 2022
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Jun 30, 2022
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Jun 27, 2022
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[Chemical Product Management System Announcement] List of Prohibited Substances Contained in Antifoulant of Consumer Chemical Products Subject to Safety Confirmation]
The Chemical Materials Research Division of the NIER manages medical insecticides* and other similar products as “Consumer Chemical Products Subject to Safety Confirmation”, in accordance with Article 10, Paragraph 6 of the” Consumer Chemical Products and Biocides Safety Control Act”.
* Pest control/prevention/attractcides for household hygiene that are used in homes and other everyday living spaces to prevent and control household pests (such as insects) that can transmit pathogens and cause diseases and hygiene hazards to humans.
In relation to the above, active ingredients of insecticides are designated as prohibited substances within Consumer Chemical Products Subject to Safety Confirmation subject to notification under Article 10, paragraph 1 of the “Consumer Chemical Products and Biocides Safety Control Act”. and are managed accordingly ('19.2.12~). Therefore, we provide the latest list of such materials below, use it for testing and inspection to confirm the safety standards of the relevant products.
a. Purpose of the List: To check whether prohibited substances contained in antifoulant* are present in Consumer Chemical Products Subject to Safety Confirmation.
*Chemical products used to prevent access by pests such as rice weevils in daily living spaces such as homes, offices, and public facilities, rather than for the purpose of sterilization and pest control.
b. Contents of the List: The main components of medical insecticides and insecticides for infectious disease prevention (as of June 17, 2022).
Attachment: List of active ingredients in medical insecticides and insecticides for infectious disease prevention. End.
Source: Chemical Product Management System>Announcements>LINK
Attached:(Official doucuments)List of Prohibited Substances Contained in Antifoulant(Insect repellent) of CCPS.pdf
(Attachment)『Names of active substance for medical/ disinfecting agents for infectious disease』List.pdf
Jun 17, 2022
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May 31, 2022
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May 31, 2022
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[Chemical Product Management System Notice] Changes to “Designation Of, And Safety And Labeling Standards For, Consumer Chemical Products Subject To Safety Confirmation” (Fabric Softeners, Disinfectants, Cleaning Agents, Laundry Detergents, Bleaching Agents)
Thank you for your interest and cooperation in the safe management of consumer chemical products.
Those who manufacture or import 39 types of Consumer Chemical Products Subject to Safety Verification, such as detergents, must comply with the safety standards confirmation and *notification (or **approval) procedures under Article 10 of the “Consumer Chemical Products and Biocides Safety Control Act” and related regulations.
*”Designation Of, And Safety and Labeling Standards For, Consumer Chemical Products Subject to Safety Confirmation" (MOE Notice No. 2022-19)
** “Approval of Daily Use Consumer Chemical Product Subject to Safety Confirmation” (NIER Notice No.2021-2)
Regarding the revised “Designation Of, And Safety and Labeling Standards For, Consumer Chemical Products Subject to Safety Verification”, which will be implemented from July 1, 2022, those who intend to manufacture or import the following products must comply with the following requirements as attached.
A. Fabric softeners: Must meet the biodegradability standards for surfactant management.
B. Disinfectants and Cleaning Agents: usage precautions must be added to prevent misuse.
C. Detergents, laundry detergents, and bleaching agents: all fluorescent whitening agents contained in the product must be labeled.
Please refer to the attached document or the above notification for specific standards.
Furthermore, please be aware that if you violate the revised standards after July 1, 2022, administrative measures such as recall orders and reports may be taken in accordance with the “Consumer Chemical Products and Biocides Safety Control Act”. Thank you for your full compliance with the regulations.
Source: Chemical Product Management System>Announcements>LINK
May 26, 2022
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Apr 18, 2022
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Apr 08, 2022
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[Chemical Safety Industry Support Group Notice] List of Existing Chemical Substances Confirmed for Exemption from Registration as Polymers
According to Article 10 of the "Act on the Registration and Evaluation of Chemical Substances" those who manufacture or import existing chemical substances over 1 ton annually must complete registration or confirmation of exemption within the grace period to manufacture or import them.
※(Grace Periods) 1,000 tons↑ ·CMR (~2021), 100~1,000 tons (~2024), 10~100 tons (~2027), 1~10 tons (~2030)
For polymer substances, if confirmation of exemption from registration under Article 11, Paragraph 1, Clause 3 of the "Act on the Registration and Evaluation of Chemical Substances", manufacturing or importation is possible without registration.
Therefore, we announce the list of existing chemical substances confirmed for exemption from registration as polymer substances (attached). If you plan to manufacture or import these substances, please first check whether exemption is possible and receive confirmation of exemption (contact the Korea Environmental Corporation at 032-590-4734~8) before registration. If cannot be exempted, please proceed with registration within the grace period.
If you have any questions regarding registration, please contact the Chemical Safety Industry Support Group at 02-6050-1304~08.
Source: Chemical Safety Industrial Support Group>Resources>LINK
Attached:(Attached) List of Existing Chemical Substances Confirmed for Exemption from Registration as Polymers
Mar 29, 2022
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[Chemical Safety Support Group Announcement] Simplification of Registration Application Materials for New Chemical Substance Below 1 Ton and Relaxation of Requirements for Confirmation of Exemption from Notification for Research and Development Chemicals]
The Ministry of Environment is currently preparing a revision of “the Enforcement Decree of the Chemicals Registration and Evaluation Act”, with the aim of facilitating the smooth implementation of the registration and evaluation of chemical substances for small and medium-sized enterprises. The revision includes differential evaluation of registration application data for substances with an annual manufacturing or import volume of less than 1 ton, according to their characteristics and uses, as well as relaxation of the notification exemption requirements for new chemical substances intended for research and development purposes, with an import volume of less than 0.1 ton. This revision is currently being announced for legislative review until March 30, 2022.
As it takes a certain amount of time for the revised enforcement decree to be promulgated and enforced, we would like to inform you that the following measures will be applied from March 16, 2022 through the active administrative system:
For new chemical substances with an annual manufacturing or importing volume between 0.1 and 1 ton, and with △a water solubility of less than 1 mg/L, or for substances △manufactured or imported solely for use as intermediates or process control agents, the registration application may be submitted without providing test data on environmental hazards (acute toxicity to fish or daphnia, and biodegradability).
Chemical substances for research and development with an annual import volume of less than 0.1 ton, if the foreign manufacturer or supplier does not provide the chemical substance name or identification number due to trade secrets, the applicant may omit the chemical substance name and identification number in the application for confirmation of reporting exemption, and attach MSDS on the substance instead. However, all substances that cannot be identified by name or identification number will be considered the same new chemical substances.
Source: Chemical Safety Industrial Support Group>Resources>LINK
Attached:(Attached) Reducing the burden of registration for low volume chemical and R&D chemicals(Press release: Chemical substances 3.15)
Mar 16, 2022
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[Chemical Safety Industry Support Group Notice] Revision of Example Manual for Exposure Scenario Preparation and Provision of Example Files for Exposure Scenarios and a Collection of Korean Use-Maps
“The Collection of Examples of Korean Use-maps" is a reference material that provides coefficients that can be used for exposure assessment for each scenario and exposure scenario necessary for chemical exposure assessment. It provides examples of exposure types for each industry in individual files.
For manufacturers and importers, this casebook provides exposure scenarios that can be used in their respective industries.
For users, they can easily create documentation by reviewing similar exposure scenarios when requested by manufacturers or importers to create an exposure scenario and modifying or supplementing it appropriately based on their specific workplace.
"The Collection of Examples of Korean Use-maps" contains an overview of exposure scenarios, instructions for preparing each item in the exposure scenarios, and methods for utilizing exposure scenario examples.
"The Example File for Exposure Scenarios" is a sample file that compiles examples of exposure scenarios in various industries and product groups. By referring to the exposure scenario example file when preparing exposure scenarios using K-Chesar or ESD&T, you can easily create exposure scenarios.
In the future, we plan to post exposure scenario examples continuously reflecting the Korean Use-map in the bulletin board, so please be interested and use them.
※ Use-map refers to information written in *technical terms that describe exposure times, frequencies, types, etc. required for exposure assessment by combining exposure types in the manufacturing and processing of workers, consumer exposure during product handling processes, and overall environmental exposure.
*The term refers to the classification of exposure types in the process of handling chemical substances for environmental discharge categories (ERC), process categories (PROC) for exposure types in workspaces, product categories (PC/AC) for exposure types during the use and consumption of products, and all items classified in [Appendix 2] of the "Act on the Registration and Evaluation of Chemicals."
Source: Chemical Safety Industrial Support Group
Attached:Examples of Exposure scenario (DB).xlsx
The Collection of Examples of Exposure scenario(2nd revised).pdf
List of The Collection of Examples of Korean Use-maps.pdf
The Collection of Examples of Korean Use-maps(Library).zip
Dec 30, 2021
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Dec 07, 2021
