South Korea to Release K-BPR Key Implementation Details
On March 20, 2018, the South Korean government officially promulgated law No. 15511 (K-BPR), which will be officially put into effect on January 1, 2019, with a sub-decree to be issued in December.
On September 3, 2018, the Ministry of Environment (MoE) of South Korea held a seminar to assist with the interpretation of K-BPR and to discuss implementation details. The first Biocidal Substance Information Exchange Forum (Biocidal SIEF) was officially held on September 20-21, 2018. Biocidal SIEF is a voluntary organization of manufacturers and importers in Korea which participate in the regulatory implementation. The seminar and SIEF outlined the main K-BPR concerns put forward by companies, and MoE provided valuable answers.
1、Meeting Highlighs
i. Under section 5 of law No. 15511, K-BPR does not apply to:
| a) Health Functional Food under Article 3 (1) of the Act on Health Functional Foods;
b) Military Goods under Article 2 of the Military Goods Management Act and Article 3 (2) of the Defense Business Act [excluding general merchandise pursuant to Article 3 of the Military Goods Management Act]; c) Pesticides, natural plant protection agents, raw materials and pesticide application equipment under Article 2, Paragraph 1, 2, 3 and 3 of the Pesticide Control Act; d) Water treatment agents under Article 3 (5) of the Food Regulation; e) 5 A single-meal feed under Article 2 (2) of the Feed Control Act and supplementary feed (supplementary feed); f) Treatment materials according to Article 2 (10) of the Ship Equilibrium Water Management Act; g) Food, food additives, utensils, containers and packaging in accordance with the provisions of Article 2, 1, 2, 4 and 5 of the Food Sanitation Act; h) Medicines under Article 2 (4) of the Pharmaceutical Affairs Act, non-medicinal products under the same Article 7, and veterinary drugs and quasi-drugs in accordance with Article 85 (1); i) Sanitary supplies under Article 2 (1) of the Sanitary Products Management Act; j) Medical equipment according to the main text of Article 2 (1); k) Cosmetics according to Article 2 (1) of the Cosmetics Act. |
At the meeting, the parties suggested that the role of biocidal products for pharmaceuticals, quasi-drugs, cosmetics and sanitary products be clarified. Also, it was recommended that guidelines on the efficacy of biocidal products be introduced. Moreover, Antifoulant was indicated as a typical biocidal product with environmental impact. Eventhough its impact on the human health and the environment may be regarded as limited, it should not be excluded from K-BPR.
ii. According to the requirements of K-BPR, the classification is as follows:
| Biocidal Substances | Chemical substances, natural substances or microorganisms with the function of removing, detoxifying or suppressing harmful organisms |
| Biocidal Products | Products whose main purpose is ti remove harmful organisms |
| Biocide-treated Articles | Articles for which Biocidal Products are used for its subordinate purposes other than its main purposes |
Some companies asked: If the original drug contains preservatives, can it be considered a biocide-treated good?
MoE rejected this idea, and stated it would exempt the preservatives contained in the original drug from a sub-decree to be issued at the end of the year.
iii. Notification of existing biocidal substances
Details of the notification will be included in the sub-decree to be issued at the end of 2018.
iv. Agent system
The agent system will allow overseas companies to obtain the approval of biocidal substances and biocidal products as well as the notification of existing biocidal substances. The agent’s responsibilities depend on the terms of the contract between the foreign company and the agent. The specific agent system will be stipulated in the implementation rules issued at the end of this year.
v. Information required for product safety inspection:
| a) Name, address and contact information of the biocide product producers or importer;
b) Photo and instruction manual of biocide products; c) All components, content, purpose and use of the biocide product; d) Copy of the Safety Standard Inspection Report e) Display the appearance or package sample of the biocide product for each item |
MoE explained it would disclose the components, content, purpose and use of the active substances and planned to revise the labeling of the product.
1、Countermeasures by company
i. Notification of existing biocidal substances
The deadline for notification of existing biocidal substances of K-BPR is June 2019, which overlaps with the notification time of chemical substances K-REACH. Overseas companies present in the Korean market should prepare their notifications as soon as possible.
ii. Distinguishing types of biocides
Clearly distinguish between biocidal substances, biocidal products, biocide-treated articles. In particular, the approval biocidal substances and biocidal products is confirmed. No approval is required for biocide-treated articles, but biocidal substances and biocidal products contained in biocide-treated articles must be approved.
iii. Biocidal SIEF
Biocidal SIEF, Korea Biocidal Products Council, is a non-official meeting joining voluntary producers and importers from South Korea to oversee implementation. The first meeting was held from September 20 to 21, 2018. About 95 companies participated in the meeting, and those who have the intention to participate in the meeting need to apply to the ministry of environment. For overseas companies, the SIEF can be carried out through agents.
REACH24H CONCULTING GROUP CHINA is regularly following up on the regulations of biocides and will continue releasing the most updated information. We recommend that in order to ensure an orderly and responsible product authorization, companies with business within the South Korean market stay up to date on the latest developments.
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