On 30 Jan 2019, the National Health Commission published 6 voluntary hygienic standards for biocidal products, which will take effect on 1 Jul 2019. Among them, the “WS/T 650-2019 Evaluating Method for Efficacy of Antibacterial and Bacteriostasis” was firstly issued. The standard specifies 13 testing methods, procedures the application scope and criteria for commonly used items with antimicrobial claim including hand cleaner, sprays, gels, wet wipe, facial mask, sanitary towel, diaper, towel, underwear, socks, fabric, plastics, floorboards and tiles, etc. These antimicrobial products are mostly categorized as the Category II disinfection products but comparatively in a regulatory grey zone because most of them are not yet included into the pre-marketing assessment. Considering the complicacy of product type and feature, WS/T 650-2019 can be an evident progress and these commonly used antimicrobial products are likely to be brought into supervision after NHC made adequate clarification on product definition/scope, necessity of risk/safety assessment and relevant evaluation guidelines.

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.

On 12 Oct 2018, China NHC released the hygienic standard “WS 628-2018 Technical Requirements for the hygiene and safety evaluation of disinfection products”, which will be mandatorily implemented starting on the 1st of Mar 2019. The new standard includes some technical amendments to a former ministerial regulation, “Rules on the Hygienic and Safety Assessment on Disinfection Products”. Prior to marketing existing Category I and Category II disinfection products in China, producers and importers need to conduct hygiene and safety assessment and file the assessment report at provincial health departments. WS 628-2018 will be enforced in parallel with the ministerial rules. Producers and importers need to comply with the technical requirements in product testing, sample preparation and report compilation and follow the administrative requirements set forth in the rules.

On 22 Jun 2018, China NHC revealed that the final edition of the mandatory hygienic standard “Technical Requirements for the Hygienic Safety Assessment on Disinfection Products” has been submitted to the SAC (Standardization Administration) for final approval and promulgation.

On 30 May 2018, the Korean Ministry of Environments opened a 40-day public consultation on 2 draft regulations in support of the “Law 1511-Act on the Safety Management of Household Chemical Products and Biocides”. The Act was promulgated on 20 Mar 2018 and will be implemented on the 1st of Jan 2019.

On 25 Apr 2018, Shanghai NHC hosted an internal workshop to clarify common technical and regulatory issues which arose during the trial opening of the national electronic filing system of disinfection products. The new system collects safety assessment reports, product information and company details of all existing disinfection products. It was also revealed that a new inventory of antimicrobial ingredients is expected to be released this year which will define the scope of general household products and disinfection products. In future household products using biocidal ingredients and ambiguous efficacy labeling claims will no longer be able to evade filing or NHC's apprval requirements.

China NHC recently revealed that the amendment to the national standard, “GB 26369-2010 hygienic standard for quaternary ammonium disinfectants”, has been finalized and the revised edition has been submitted to the SAC (Standardization Administration) for final approval.

On 20 March 2018, South Korea officially enacted its biocide regulation, “Law 15511-Act on the Safety Management of Household Chemical Products and Biocides”. This regulation comprises 60 articles organized into 7 chapters plus 5 articles in the Annex.  The new regulation establishes a fundamental framework of safety verification on household chemical products and pre-approval of biocidal substances and products. Depending on the notification and application plan of existing biocidal substances, K-BPR will offer different grace periods for biocidal substances and products. Some deadlines will be due as early as 2020 while others have been extended until 2032. All deadlines and corresponding eligibility criteria/clauses are summarized below.

On 9 Apr 2018, the Korean Ministry of Environment (MOE) opened a10-day investigation on biocidal substances used in biocidal products. Korean manufacturers and importers of biocidal products at and above medium-size are requested to fill and submit a questionnaire by 18 April. This move is will serve as a foundation for implementation of the pre-approval system introduced by “Law 15511-Act on the safety Management of Household Chemical Products and Biocides” which begins on the 1st of Jan 2019.

On 30 Mar 2018, Korea officially enacted the “Law 15511-Act on the Safety Management of Household Chemical Products and Biocides (K-BPR)”, which will take effect on 1st Jan 2019. The regulation majorly governs the labeling, approval, authorization and post-management of household chemical products, biocidal products and biocide-treated articles.