What’s the difference between China’s disinfection products, EU biocides, and antimicrobial pesticides in the U.S.? To help enterprises better understand China’s disinfection products classification system, today we will introduce the detailed definitions and types of disinfection products in China.

On August 24, the Korean Ministry of Environment issued the Notification 2020-182 to amend the list of existing biocidal substances subject to deferred approval. South Korea enacted the “Act on the Safety Management of Household Chemical Products and Biocides(K-BPR)” in 2018, requiring manufacturers and importers of biocidal substance to obtain a substance approval from the Ministry. Biocidal substances used in biocidal products or treated articles placed in Korea before December 31, 2018, are allowed to be designated as “existing biocidal substances subject to deferred approval” and manufactured or imported without obtaining the approval within their grace period if their producers and manufacturers fulfilled reporting and submission obligations: Notify MoE the basic information on the substance before June 30, 2019, including name, trade name and use type, etc.; Submit to the MoE the plan for the application of substance approval within 1 year after the substance being designated as the existing substance. For substance manufactured or imported by multiple companies, the plan shall be submitted separately and one of the companies can be selected as the representative of data submitter for the joint submission. The data can also be used by other applicants not yet participate in the joint submission through MoE’s data compensation system. If the manufacturer or importer failed to submit the plan or application for substance approval, the notified substance will be deemed as difficult to submit the data within the grace period and manufacturer or importer will be prohibited from business activities. If all manufacturers and importers of the substance were prohibited, the designation of the substance will be canceled. On December 31, 2019, MoE issued the Notification 2019-249 and a total of 741 substances were designated as the existing substances. The chemical name, CAS number, use type, grace period, and notifying co

On April 20, the Chinese Standardization Administration (SAC) released the full contents of 14 national standards for disinfectants, disinfecting instruments, medical electrical equipment including critical care ventilators, of which the most notable one is “GB 388750-2020 Lists of Material and Restricted Substances in Disinfectants”, a mandatory standard without prior consultation, but due to take effect starting from November 1, 2020. Mandatory National Standards Issued under the SAC Announcement 7 of 2020 No. Code and Name Replacement Effective Date 1 GB 9706.1-2020 Medical Electrical Equipment-Part 1: General Requirements for Basic Safety and Essential Performance 医用电气设备 第1部分:基本安全和基本性能的通用要求 GB 9706.1-2007, GB9706.15-2008 2023/5/1 2 GB 9706.212-2020 Medical Electrical Equipment—Part 2-12: Particular Requirements for Basic Safety and Essential Performance of Critical Care Ventilators 医用电气设备 第2-12部分:重症护理呼吸机的基本安全和基本性能专用要求 GB 9706.28-2006 2023/5/1 3 GB 9706.237-2020 Medical Electrical Equipment—Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment 医用电气设备 第2-37部分:超声诊断和监护设备的基本安全和基本性能专用要求 GB 9706.9-2008 2023/5/1 4 GB 27948-2020 General Requirements for Air Disinfectant 空气消毒剂通用要求 GB 27948-2011 2020/11/1 5 GB 27949-2020 General Requirements of Disinfectant of Medical Instruments 医疗器械消毒剂通用要求 GB/T 27949-2011 2020/11/1 6 GB 27950-2020 General Requirements for Hand Disinfectant 手消毒剂通用要求 GB 27950-201

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.

1.[EU BPR]The First opinion on Union authorization was adopted The Biocidal Products Committee (BPC) supported applications for EU-wide access to the market  of two biocidal product families containing iodine/PVP-iodine for use in veterinary hygiene on 20 December 2017. It is the first opinion supporting applications for Union authorization which means that it is realized successfully that companies are allowed to place their biocidal products on the market throughout the entire Union with one authorization form. 2.[US EPA-FIFRA]Pesticide Registration Improvement Extension Act (PRIA 4) will recently be updated PRIA 3 is about to expire and PRIA 4 will enable after PRIA 3 is invalid. While PRIA 3 was originally set to expire December 8, 2017, now for the duration of that Continuing Resolution period, it has been extended until January 19, 2018. When PRIA 4 is expected to be enabled, a number of new registration types, such as disinfectant devices identification, will be added, as well as additional review costs. 3.[Chinese disinfectant products] The relevant standards for relevant Chinese disinfectant products are to be issued. NHFPC (National Health and Family Planning Commission) is working to formulate or revise relevant standards for disinfection products, including the classified catalogue of disinfection products, hygienic safety evaluation, test contents, disinfecting wipes, etc. These are expected to be announced in the first half year of 2018. 4.[EU BPR]Draft guidance for identifying endocrine disruptors was issued This draft guidance for identifying endocrine disruptors which will be used to evaluate pesticides and biocides has been developed by the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) with the support of the Commission’s Joint Research Centre (JRC). ECHA and EFSA are inviting interested parties to comment on the draft guidance document for the identification of endocrine disruptors under EU legisl

In the United States, the overarching regulation on pesticide management is the Federal Insecticide, Fungicide, and Rodenticide Act(FIFRA), which specifies the definition of a pesticide as: any substance or mixture of substances intended for preventing, destroying, repelling or mitigating any pest, or use as a plant regulator, defoliant, or desiccant, as well as any nitrogen stabilizer. On day two of the Chemical Regulatory Annual Conference, Mr. Robert Kiefer from Reach24H USA introduced the regulatory system of pesticide and antimicrobial products in the US. Overview of Requirements for US Pesticide Registration Laws and Regulations All pesticides (including imported pesticide) sold or distributed in the US are required to be registered with the Environmental Protection Agency (EPA).However, if the substance falls under the category of liquid chemical sterilizing agent, nitrogen stabilizer, human drug, animal drug, animal feeds (vitamin hormone products) or is intended to aid the growth of desirable plants, it is excluded from regulation by FIFRA. In addition, pesticides are regulated by the EPA under a series of supporting regulations. The name and EPA’s function under associated regulations are summarized as follow: Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) – requires all pesticides sold or distributed in the U.S. (including imported pesticides) to be registered by EPA Federal Food, Drug and Cosmetic Act (FFDCA) – requires EPA to set pesticide residue tolerances for all pesticides used in or on food Food Quality Protection Act of 1996 (FQPA) – established safety criteria of “reasonable certainty of no harm”, and EPA must review pesticide registrations every 15 years Pesticide Registration Improvement Act of 2003 (PRIA) – established pesticide registration fees and defined Agency  timelines Regulations implementing the pesticide statutes a

The last change and development of China disinfectants management are frequent and significant. what has  happened and what's the new requirements of regulatory compliance in China? what's the most relevant issues?

Biocidal products in China are classified and administrated as different kinds of commercial products in terms of their various application targets and application areas, the 23 types of products in the EU BPR are regulated as pesticides, veterinary drugs, medicines, food or feed additives, disinfectants, drinking water-relevant products, etc. in China.