The latest overhaul of China’s disinfection product regulation goes back as far as 2002, when all related technical matters were simultaneously compiled into the "Technical Standard for Disinfection (version 2002)". The 200-page document offered great value to authorities and testing institutes in assessing product quality, safety, and efficacy, the precondition for entering China's market. After years of regulatory reform, the premarketing surveillance of non-new disinfection products has been delegated to the health department at the provincial level, and regulatory studies can be conducted either by enterprises or third-party testing institutes (CMA-accredited). To improve compliance, help enterprises and testing facility comply and align with international practices, some of the product specifications, testing methods, and technical practice were revised, supplemented, and released in the form of national/industrial standards. Early this year, the Chinese Standardization Administration (SAC) announced seven disinfectant-related standards to be implemented on October 1. Two of these standards related to efficacy evaluation in the most common scenarios. This article explains the enforceability, product scope, and other elements affecting product qualification, etc. to keep overseas enterprises up-to-date with best practices. GB/T 38502-2020 Test Method of Bactericidal Effect of Disinfectant in laboratory GB/T 38504-2020 Evaluation Method of Disinfection Effect of Spray Disinfection PREMARKETING ASSESSMENT AND RECORDING FILING OF DISINFECTION PRODUCTS Currently, enterprises of Class I and Class II disinfection products need to complete a comprehensive evaluation on the product label, manual, test data, product standard/enterprise standard, hygienic license (homemade product)/documentary evidence & customs declaration (imported product), product formula(disinfectants, anti-microbial agents and sterilization indicators) or comp

On April 9th, 2020, the Chinese National Pesticide MRL Review Committee announced a government procurement program for pesticide MRL regulation development. Successful tenderers will be required to complete a series of MRL-related research and field trials within the next year.

On April 8th, 2020, China MoARA released a new draft regulation, explaining the target, mechanism, post-registration obligation, and criteria for a periodic and special re-evaluation of registered pesticides.

The Chinese Standardization Administration (SAC) has recently released the full content of 7 national standards regarding the toxicological study, storage stability test, efficacy evaluation and production management of disinfectants, all of which will be implemented on October 1, 2020.

On 23 March 2020, the Chinese Ministry of Agricultural and Rural Affairs released the Announcement 280 to designates 9 testing institutes for the regulatory study of pesticide products.

The Chinese Ministry of Agricultural and Rural Affairs consulted on March 18, 2020 a daft list of active ingredients of biopesticides registered in China. The list includes 47 microbial ingredients, 38 biochemical ingredients and 26 botanical ingredients, which help applicants to distinguish biopesticides from chemical pesticides, as well as the effective implementation of “fast-track” registration.

In response to the tight supply of disinfectants caused by 2019 Novel Coronavirus(2019-nCoV), on February 3, 2020, the National Health Committee released "The Emergency Product Launching Notification of Disinfectants during Prevention And Control Period of Pneumonia Outbreak Caused by 2019-nCoV". Under this emergency measure, China has opened a "Green Channel," entailing expedited and exceptional market access for four types of disinfectants, including alcohol disinfectant, chlorine-containing disinfectant, chlorine dioxide disinfectant, and peracetic acid disinfectant placing on China market (see below). According to the Notification: Disinfectants that use alcohol as the active substance can be placed on the Chinese market after completing content tests either by the manufacturers (for the domestic disinfectants) or by Chinese legal entity (for the imported disinfectants) or 3rd party laboratories. For hand-application alcohol disinfectants, the alcohol concentration in the disinfectants should be higher than 60% (V/V). The raw materials used in ethanol disinfectants shall conform to the requirements regulated in the national standard “GB26373-2010 Hygienic Standard for Alcohol Disinfectants," and ethanol concentration should be 70% - 80% (V/V); Chlorine-containing disinfectants, chlorine dioxide disinfectants, and peroxyacetic acid disinfectants can be placed on the Chinese market after completing the content test and pH test and compliant with related standards. The period of validity for “84” liquid disinfectants containing sodium hypochlorite should be limited to 3 months, with the exception that products can be distributed and used until expiration date supported by the qualified stability test data. The producers of disinfectants already on the market that has completed record filing are encouraged to expand their production by adding new production lines, new plants, and production sites. The dis

On 30 Dec 2019, the Chinese Ministry of Agricultural and Rural Affairs released 192 GM crops to be issued with GMO safety certificate, of which 3 were homegrown grain crops with herbicide-tolerant and insect-resistant traits. Since the last time China approved food GM crops was in 2009, this move was interpreted by some analysts as another attempt to promote the commercial plantation of GM grain crops. Seed companies thus became increasingly sought after by investors on the stock market as GM grain crops would be commercially planted as soon as the next 2 or 3 years. Homegrown GM Food Crops Only GM crops issued with GMO biosafety certificates can be imported and consumed in China, but there are two more administrative steps to commercializing a plantation: the crop variety examination and the seed license. In 2009, MoA (now known as MoARA) issued 3 GMO safety certificates to 2 insect-resistant rice varieties developed by HZAU( Huazhong Agricultural University) and 1 transgenic phytase maize co-developed by CAAS( Chinese Academy of Agricultural Science) and Origin Seed, but the remaining procedures were stalled due to strong public opposition after a series of GM food-related scandals. The GM grain crops announced this time are 2 maize and 1 soybean developed by indigenous institutions, and the traits and permitted planting regions are as follows: GM Food Crop Developer Trait Region DBN Maize Da Bei Nong Group Bt Cry1Ab, CP4 EPSPS Spring maize zone in Northern China Dual-resistant Maize Ruifeng Biotech and Zhejiang University Cry1Ab/Cry2Aj, G10evo EPSPS SHZD Soybean Shanghai Jiao Tong University Glyphosate-tolerant soybean zone in Southern China Analyzing Necessity Given the fact that no biosafety certi

In response to the tension supply of disinfectants caused by 2019 Novel Coronavirus, the National Health Commission announced on Feb. 3 that disinfectants containing alcohols, chlorines, chlorine dioxide and peroxyacetic acid can be temporarily exempted from full record-filing formality at provincial health department.