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[(K-BPR) Newsletter No. 43] Preparation for pre-notification of Existing active substance and announ

Date :2019.03.28

NEWS LETTER 2019.(VOL.43)

Chemtopia thinks ahead of clients

Chemtopia gives honest consultation to clients

[(K-BPR) Newsletter No. 43] Preparation for pre-notification of Existing active substance and announ

Existing active substances shall be notified by June 30th, 2019 and the Regional seminar chaired by MoE is still ongoing since this January. we would like to send the summary of the Public Q&A from the seminar and share the summary of the public notice related to Biocide.

ISSUE & FOCUS

I. Summary of Q&A from Regional seminar regarding K-BPR.
II. Published list of the notice related to Biocide

I. Summary of Q&A from Regional seminar regarding K-BPR.

Q: Could the notification of existing active substance which shall be performed by June 30th, 2019 be made by the OR who is appointed by a foreign manufacturer?
A: Currently, there is no concept of OR in the K-BPR. Although we are considering the possibility of adopting the concept of OR in the step of active substance approval later. Thus, there is no way for the OR to notify the existing active substance on behalf of Korean local importer before the deadline, June 30th, 2019. Korean local importer should notify the existing active substance under current legislation.

Q. If the active substance approval is completed earlier than the grace period of approval, does the grace period for the biocidal product approval apply from the date of the active substance approval? For example, the grace period of approval for an active substance contained in a disinfectant is legally by Dec. 31st, 2022. If the active substance approval is completed on July 25th, 2022, before the legal end date of the grace period, then is the grace period of active substance approval on July 25th, 2024 or Dec. 31st, 2024?
A: Only applies from the legal end date of the grace period of active substance approval (additional clause Art 3). Even though the approval is completed earlier than the given grace period, the biocidal product approval is enacted within 2 years from the end date of grace period. So, from the above example, it is Dec. 31st, 2024.

Q: How does a company deal with the case that a biocidal product used in an imported treated article has not been approved?
A: In spite of the importer of a treated article, they shall complete the active substance approval and biocidal product approval to comply with K-BPR.

Q: What is the coverage of the treated article?
A: The treated article is defined as the final product. Raw materials or subsidiary materials are not considered as the treated article. According to this, the relevant guidelines are expected to be provided.

Q: Will the products that only used in a designated place (Laundry room in a hotel, Kitchen for school meals) also be considered as Household chemical products subject to Safety confirmation?
A: Considering that “workplace” where it is not occupied by unspecified people other than workers is not a daily living space, so the product is not a subject of Household chemical products subject to Safety confirmation. (Article 2, paragraph 4 of the designation of Household chemical products subject to safety confirmation and safety ∙ labelling standard)

Q: Toothbrush disinfectant that was previously not controlled by any other authorities such as MoE, KFDA, MOTIE. Is this also subject to Household chemical products subject to Safety confirmation now?
A: They will be announced as “Disinfectants for disinfection of toothbrush or tongue cleaner” and they are going to be controlled by Household chemical products subject to Safety confirmation with the enforcement of K-BPR sub-notice.

Q: It is quite burdensome to submit a labelling sample that is required at the time of notification for conformity of safety standard. Is there any alternative option to relieve the burden of a company for preparing the data submission?
A: It is essential to submit the sample of labelling indication to some extent of information at least that consumer should know. A program that can create labeling information through a system will be supported in the future.

II. Published list of the notice related to Biocide

Notice	Notice number	Notice date	Key points
Regulation on the labeling of biocidal products	Ministry of Environment Notice No. 2018-242	2018-12-28	Regulation on the data requirement for the labelling of biocidal products - Labelling statement (product name, type of biocidal product, expiration date, weight/capacity, effect/ efficacy, target user and use category, standard usage, manufacturer, address, contact information (Domestic manufactured product only), Country of origin and manufacturer’s information (Imported product only), importer, address, contact information (Imported product only), labelling of child protection packaging (The product subject to child protection packaging only), active substance, nanomaterials, other chemicals, product’s hazard∙risk information, methods of use, use precaution, approval number, and indication of serial numbers according to the indication method - Providing indication method and design
Detailed standard for calculation of penalties	Ministry of Environment Notice No. 2018-243	2018-12-28	Regulation on the detailed standard for calculation of penalties under violation of K-BPR. - If the sales amount is possible to be calculated, Sales quantity x Sales price - If the sales amount is impossible to be calculated, the level of penalties will be classified according to each violation, and the penalty will be calculated considering the scale of actual amount of profit.
Regulation on subject and method of risk assessment for household chemical products and Biocidal products	National Institute of Environmental Research Notice No. 2018-70	2018-12-31	Determination of the subject and the method on risk assessment for the household chemical products and biocidal products
Regulations on Standards, Methods, etc. for Testing, Inspection, etc. of Household chemical products subject to Safety confirmation	National Institute of Environmental Research Notice No. 2018-71	2018-12-31	Regulations on standards and methods for testing, inspection to confirm a safety standard of household chemical products subject to the safety confirmation - General provisions on the overall application of the standard test procedures - Quality management (QA / QC) - Standard test procedure for the identification of restricted use substances in the household chemical products subject to the safety confirmation - Standard test procedures for the identification of content limiting substance and emission limiting substance contained in the household chemical products subject to the safety confirmation - Standard test procedures for the identification of used substance and usable major component contained in household chemical products subject to the safety confirmation - Standard test procedures for the identification of containers or packaging - Standard test procedures for the identification of safety requirements, etc
Regulations on approval of Household chemical products subject to Safety confirmation	National Institute of Environmental Research Notice No. 2018-72	2018-12-31	Regulation on the data requirement, preparation method, approval standards, etc. for dossiers submission to manage the transferred product category from KFDA covered by K-BPR. The transferred product category from KFDA as follows. △ Anti-bacterial disinfectants for humidifier △ Pest-control, preventing, repellent, attracting insecticide for hygiene △ Sterilizer and Disinfectants for prevention of infectious disease △ Insecticides for prevention of infectious disease △ Rodenticides for prevention of infectious disease △ other disinfectants for quarantine area
Regulation on testing methods for biocides	National Institute of Environmental Research Notice No. 2018-73	2018-12-31	Regulation of detailed test method for hazard test method regarding active substances or biocidal products. - Test field of physico-chemical properties or biological properties - Test field of environmental hazard - Test field of animal and human health hazard
Low-risk active substances	Ministry of Environment Notice 2019-27	2019-01-24	Low-risk active substances were designated. : 19 substances
Regulation on the designation, evaluation and management of testing and inspection authority for household chemical product and biocide	National Institute of Environmental Research	2019-01-31	Regulations on testing and inspection authority of household chemical products and biocides - A previous testing and inspection authority for the self-inspection of the product of risk concern under K REACH will be designated as the testing and inspection authority of the confirmation field of the household chemical products subject to the safety confirmation. Its designation valid up until 5 years. (January 1st 2019~December 31st 2024)
Regulation on the safety container and packaging of biocidal products	Ministry of Environment Notice 2019-37	2019-02-01	Regulation for the requirements regarding the safety containers and packaging of biocidal products
Designation of safe chemical products and safety ∙ labelling	Ministry of Environment Notice 2019-45	2019-02-12	Designation and safety ∙ labelling of the household chemical products subject to safety confirmation. - Types (product types) of the household chemical products subject to safety confirmation - Setting up the safety standard for each product type and identifying the safety standard per product type - Labelling indication and method per product type

Unlike EU-BPR, the scope of K-BPR coverage is not only Biocides, but also Household chemical products subject to safety confirmation.

Chemtopia Co., Ltd. provides corresponding services to comply with amended and legislated regulations :

· Chemical registration service including Pre-registration, OR service, Read-across or QSAR approach, CSR preparation, Data sharing and negotiation
· Chemical inventory for regulatory tracking
· Support of regulatory monitoring and volume tracking with chemical management system
· Provision of domestic and foreign chemical regulatory database
· MSDS and label authoring system
· Test arranging & its monitoring with domestic and foreign test institutes

This newsletter is available in Korean, English, and Japanese

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