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How to Comply with the new K-BPR Requirements for Biocidal Products to Enter the Korean Market

Late pre-registration of existing active substances is available before manufacture or import for enterprises to obtain the grace period. From 2021, foreign manufacturers can appoint OR in Korea to fulfill notification of biocidal active substances and authorization of biocidal products.

After the Humidifier Disinfectant Scandal happened in South Korea in 2011, which may have caused thousands of deaths, the safety of household chemical products is attracting more concern from people across South Korea. To standardize the consumer chemical products in the Korean market, the Ministry of Environment (MOE) issued the Act on Safety Management of Household Chemical Products and Biocidal Products (K-BPR) on January 1st, 2019. An amendment to the K-BPR Act was approved on Mar 24th, 2020, and entered into force from January 1st, 2021[OJR1] . The Act involves household chemical products and biocidal products, and for the biocidal products, the three supervision objects are active substances, biocidal products, and treated articles.

Who shall fulfill the K-BPR obligations?

  1. Domestic manufacturers or importers of South Korea

  2. For foreign manufacturers, they could appoint an only representative (OR) based in South Korea to fulfill notification of biocidal active substances and authorization of biocidal products from January 1st, 2021. 

How to comply with K-BPR?

  1. Active Substances

    Existing Active Substances

    Active substances that had already been circulated in the market before1 Jan 2019 when K-BPR was implemented shall be identified as existing active substances. For such substances, after pre-registration or late pre-registration application to the authority, a grace period of up to ten years is applicable based on uses. The approval of the existing active substances shall be completed following the steps below within the corresponding grace period:

    • Pre-registration or late pre-registration: Enterprises that manufacture active substances and biocidal products in South Korea or export such substances and products to South Korea shall fulfill the pre-registration between January 1st, 2019 and June 30th, 2019, to list relevant substances in the inventory of existing active substances and obtain the grace period for approval. The inventory of existing active substances shall be dynamically updated by the authority and published to the public every half-year on the CHEMP website. Currently, 740+ existing active substances have been published. Late pre-registration has been required before the manufacturing and importation of active substances for obtaining the grace period since March 24th, 2020.

    • Preparation and submission of the approval application plan: The submission of an application plan for active substance approval is required for obtaining the grace period for approval after the pre-registration or late pre-registration. By reviewing the plan, the authority will analyze the enterprise’s registration strategy and whether the formal registration of active substances can be completed within the grace period, and finally determine whether to grant the grace period. According to the K-BPR Act, the biocidal products can be sorted into 4 categories and further into 15 types, for corresponding active substances that pre-registered or late pre-registered and the approval application plan is submitted, the longest grace period could be up to the end of 2029.

    • Approval of active substances: According to the amendment to K-BPR Act, joint submission is adopted for the approval application, thereby reducing repeated experiments and work, and unnecessary resource consumption. As required by authorities, as of the end of December 2020, the selection of the leader registrants (LR) has been completed, and some consortiums have also started the formal registration.

New Active Substances

For active substances not listed in the inventory of existing active substances, namely the new active substances, no grace period is provided, enterprises must obtain approval before manufacturing or importation in South Korea.

    2. Biocidal Products

Enterprise that intends to manufacture or import biocidal products for circulation in Korea must obtain approval for the biocidal products first. The prerequisite for applying for biocide product approval is that the active substance contained in the product has been approved. A grace period is also provided for the approval of biocidal products, meaning two years are added to the active substance approval grace period.

    3. Treated Articles

A treated article refers to a product that uses biocidal products for ancillary purposes such as removing harmful organisms, in addition to the main purpose of the product. Active substances and biocidal products used in treated articles shall be approved by the K-BPR.

Supervision

During the COVID-19 pandemic, the demand for biocide products has increased. Recently, the Ministry of Environment (MOE) has publicized 10 products that have not fulfilled the K-BPR notification obligations and had been circulated illegally, such products were recalled and banned from circulation. In the K-BPR amendment, with increasing the fine to a maximum of 70 million won, it also imposes an additional 7 years of imprisonment for those who break the law. At the same time, in order to strengthen supervision, MOE awarded 50,000 to 300,000 won in bonuses for reporting illegal household chemical products. 

Suggestions

  1. The late pre-registration started on March 4th, 2020, stakeholders shall complete it as soon as possible to obtain the grace period, list the active substance in the inventory, and join the consortium for joint submission.

  2. For enterprises whose active substances have been listed, they shall submit the approval application plan before the specified deadline, to guarantee the validity of the grace period.

  3. For the approval of active substances, the deadline for the first batch of products is the end of 2022, related product types including disinfectants, algaecides, rodenticides, insecticides and repellents. Enterprises involved in the trade of such products in South Korea shall start the active substance approval application in hurry, so as not to influence their business.

  4. The OR system has come into effect on January 1st, 2021. Appointing an OR could help enterprises strive for trade initiative and ensure that trade secrets are not leaked at the same time, this is great news for companies not based in Korea. Non-Korean companies can appoint a qualified OR to fulfill K-BPR compliance obligations as soon as possible.

Of the three types of approval mentioned above, approval of biocide active substances (existing substances / new substances) and biocide products can be performed by an OR.  REACH24H has started OR agency business by our Korean branch office.

Please contact us via email at chemical@chemlinked.com if you are interested.

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