On 24 Dec 2018, China ICAMA released the full version of GB2763-2018.1(Maximum Residue Limits for 43 Pesticides in Foods) and other 8 testing methods, which were earlier announced by NHC, MoARA and SAMR on 22 Jun 2018. As a supplement to the national MRL regulation, GB2763-2018.1 will be concurrently enforced with the GB2763-2016.

Recently, MoARA officials answered questions on the latest “Special Measures (Negative List) for the Access of Foreign Investment (2018)”, which dramatically loosened market entry restrictions on overseas seed companies. MoARA described the simplification of administrative procedures associated with production and marketing approvals and also the reinforcement of intellectual property protection on patent varieties.

subject to hygienic approval at provincial level, aimed at optimizing administrative procedures and helping reduce the burden of enterprises manufacturing water dispensers, water purifiers, water disinfectors, water distribution device and treatment units, as well as pipes, pipe fittings, coating materials, chemical treatment agents and disinfectants used for drinking water purpose.

China promulgated a new pesticide regulation last year which significantly increased the regulatory compliance obligations of stakeholders in regards to generation of efficacy and safety data. New requirements include the issuance of a positive list of labs accredited to generate required data, elevated technical criteria and the introduction of risk assessment.

In this article REACH24H’s Agrochemical department will offer a distillate of years of experience helping our clients register pesticides in China and share and troubleshoot the most frequently asked questions and problems encountered complying with China’s new pesticide regulatory system.

On 29 Oct 2018, Chinese Ministry of Agriculture and Rural Affairs invited a 30-day consultation on 203 MRLs for 65 pesticide active ingredients.

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 25 Oct 2018, China MoARA released the 1st batch of testing institutes for pesticide registration experimentation. A total of 26 labs have been approved to conduct studies covering product chemistry, efficacy, toxicology, residue, and environmental impact.

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.

In 2017, China promulgated series of new pesticide regulations and significantly raised the market threshold with added data, elevated criteria and narrowed acceptance scope. It is also the first time that MoARA will have to disclose quality standard code and testing method for registered pesticide, which constitute an important part of product chemistry data. Mr. Huang Qiliang from Chinese Academy of Agricultural Sciences joined CRAC 2018 conference in Chengdu to summarize and compare the critical points in dossier preparation for traditional chemical pesticides and biopesticides, as well as introduce the latest official guidelines for pesticide testing and method validation.