Quaternary ammonium compounds (QACs) are among the most widely used disinfectants in the world and are used on medical devices, common surfaces, food containers and the human body etc. To assess the risk/hazards posed by these substances the Chinese health inspection and disease control authority sampled 193 commercial QAC disinfectants (on the market since 2009) and analyzed the product origin, composition, use scope, target microbial organisms and label claims. A total of 12 imported and 181 homemade QAC disinfectants were sampled from 21 provinces, consisting of 187 liquid formulations, 5 spray formulations and 1 powdery formulation. Adherence to GB GB26369-2010 was investigated. It was revealed that benzalkoniums, DDAC and DDAB are the most common QACs and over 20% of human-use disinfectants contain excess level of QACs.  

China's food and catering market has grown rapidly and with this growth we have also seen an increase in usage of food use disinfectant products which has led to concerns revolving around food safety. China’s disinfection legal framework is seriously underdeveloped compared with EU and the US who have established complete assessment, registration and authorization system of biocides and food contact substances/materials. In this analysis, we will explore the scope and limitation of Chinese food use disinfectants regulations, as well as the pitfalls to look out for when accessing China’s emerging market. Inventory Management of Food-Use Disinfectants In 2010, former NHFPC issued the “Inventory of Raw Materials/Ingredients for Food-Use Disinfectants”(hereinafter as “the Inventory”), consisting of 47 active ingredients and 21 raw materials allowed for use in the disinfection of food, tableware, food-contact instruments, equipment and packing materials, as well as food containers. Furthermore, food additives that included into the “GB 2760-National Food Safety Standard for Food Additive Use” can also be used as auxiliary components in food-use disinfectants.

China's population is estimated to peak by 2030 reaching 1.5 billion and per capita food demand will be stable at 500 kg annually. To maintain self-sufficiency in food supply, China needs to increase grain output from 617.9 million tons in 2017 to 634 million tons by 2020 and 700 million tons by 2030. This article will take a look at the historical data on grain production and agricultural technology in recent decades. We will also look at the major challenges facing China such as environmental issues, decreased arable land and slow growth in productivity.

Since the last time NHFPC/NHC approved new disinfectant or sterilizer/disinfecting apparatus was back in 2014, when the management of existing products was delegated to provincial departments, hygienic and safety assessment became the only feasible way to have access to the disinfectants and sterilizers market in China. To help improve compliance with China’s disinfectant/sterilizer regulations, this article will focus on the enforceability and most practical issues involved in the premarketing assessment of disinfection products.

In China, disinfection products are defined as disinfectant, sterilizing agent, antimicrobial agent, medical/common disinfector/sterilizer, packed-sterilized articles with sterilization marking, biological and chemical indicators of sterilization effect and various hygiene products including wet wipe and hygiene/disinfection wipes. The definition, classification, national registration/ provincial record filling of novel/existing disinfectant and sterilizer are complete while the legal framework of other disinfection products types is comparatively absent. As disinfectant-carrying wipes are rapidly developing in China, the term “vehicle disinfectant” has been proposed by the NHFPC/NHC and would affect regulation of certain consumer products.  With the rise of emerging infectious diseases such as SARS and human avian Influenza and so on, a sort of wet wipes called "hygiene wet wipe" or "disinfection wet wipe" have appeared on the market and are developing rapidly in China. As wet wipes are traditionally categorized as hygienic products and exempted from premarketing evaluation on its antimicrobial/disinfection claims, safety concerns have long been discussed by regulators. In this article, we will explore the statutory definition, classification, technical criteria, and regulatory forecast of wet wipes. Evolution of Product Definition Wet Wipes refer to fabric or paper-based products used for the cleansing/ germicidal/disinfecting of human body, common surface and other surfaces. The hygienic and germicidal criteria for wet wipe were firstly specified under the “GB 15979-2002: Hygienic Standard for Disposable Sanitary Products” together with other disposable products such as gloves, respirators, sanitary napkins and diapers, etc. In 2011, China issued a national standard exclusively for wet wipes, the “GBT/27728-2011: Wet Wipes”, which classifies wet wipes into human-use wipes and article-u

Pesticide MRL establishment not only protects the integrity of the food supply, but also protects domestic agriculture. China’s response to WTO TBT/SPS notifications varies depending on the impact on trade balance, the value of the commodity, existence of established MRLs and China’s overall trade relationship with the notifying country. Member countries are required to notify other countries of any new or revised regulations which affect trade and to set up offices (official enquiry points) to answer requests for more information on new or existing measures at the WTH level. In regards to pesticide, TBT includes pesticide/chemical registration regulations and measures concerning food safety, production, environmental and labeling, etc., while SPS is more on MRL establishment/amendment/exemption/cancellation, crop grouping and other agricultural or technical practice for pesticide uses. China participated in the WTO TBT/SPS notification activities as early as 2003 and has formed a mature response system to support international trade of agricultural products, protect its domestic agricultural production and consumers. Through the introduction of official comment on MRL notification and studies of recent cases, this article aims to demystify how these WTO MRL notifications impact China's national pesticide MRL establishment. Workflow of Official Comments In the last 2 years, China has made very few WTO notifications on new enactment or amendment of pesticide regulations and the majority of these notifications involved establishment, amendment or cancellation of pesticide MRLs. An official inquiry point was established at the National Quality Standardization Center of Agricultural Product under the MoARA (Ministry of Agricultural and Rural Affair), receiving notifications from 19 countries/regions including the US, EU, Brazil, Canada and New Zealand etc. Each notification will be sent to relevant government body/institutions cover

Since the Nov 1st 2017 implementation of  "MoA Announcement 2569-Data Requirements on Pesticide Registration", subsequent registration applications have been subject to increased data requirements and elevated criteria. Other changes include but not limited to the abolishment of temporary registration and mandatory risk assessment. Compared with the previous regulation, MoA Order 10 of 2008, Announcement 2569 includes significant improvements in text structure and information transparency. A comparative analysis between the new and old version offers useful information to aid companies in adapting to new requirements. Chapter Reorganization in Regulation Text In the 2008 version, hygienic pesticides, rodenticides, biochemical pesticides, microbial pesticides, botanical pesticides, GMOs and natural enemy pesticides are defined as special pesticides and their registration requirements were incorporated in an independent chapter similar to the individual chapters  detailing requirements of new active ingredients, new formulated pesticides, me-too and technical concentrations(TKs). In the main body, each of these chapters consists of 3 sub-chapters, corresponding to the requirements for field trial application, temporary registration and full registration. In the new data requirements, three types of biopesticide have equal chapter allocation as chemical pesticides. The requirements for manufacturing “use product” (TC/TK) and end-use product (formulation) are respectively compiled in 2 sub-chapters.  Furthermore,  “atypical” products including agricultural GMOs and natural enemies have been removed from the new data requirements. GMOS are regulated under agricultural GMO regulations and natural enemies are subject to significantly decreased registration data requirements. Conditions for post registration including use scope expansion, amendment to application method and dose are refined in Chapter VI

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

China’s pesticide MRL regulatory framework (the maximum concentrations of pesticide residues in foods) is underdeveloped compared with other major economies and fails to adequately meet food safety and international trade requirements. China plans to establish 10,000 MRLs by 2020, based on this and on historical trends it is possible to offer the following predictions with regard to future developments in China’s MRL system: Fruits and vegetables will be given priority over grains Proprietary and off-patent pesticides will have MRLs added Prohibited and high risk pesticides will be prioritized Concepts used in Japan’s positive list system which includes population based exposure scenarios and susceptible populations could be implemented As early as 1990, China started pesticide MRL development. Since then numerous MRLs have been developed by China’s various regulatory authorities in the form of national/industrial standards for agricultural produce or food safety/ standards. This multi-sector development has resulted in overlap and inconsistency in both standards, enforcement and supervision. Since 2010, China began the process of reforming it MRL regulatory framework with the aim of deleting, consolidating and updating the MRLs into a unified food safety standard for pesticide MRLs, known as GB 2763. Up to now the standard has been updated three times and the number of MRLs has increased from 873 in 2012 to 4140 in 2016. A total 433 pesticide active ingredients and 286 commodities/ commodity groups are included into GB 2763-2016, covering 70% of the active ingredients approved and most commodities currently consumed in China. Particularly, GB 2763-2016 provides MRLs for all banned/restricted pesticides in all types of commodity. prioritization of fresh edible agriculture produce. Fig.1- Number of MRLs established for Different Commodities 2014 and 2016 Edition Comparison Compa

  Annually, plant nematodes account for 12% of crop losses globally, amounting to some 100 billion USD in losses. It is forecasted that the global nematicide market will reach a value of 1.35 billion USD by the end of 2020 and significant growth will happen in the Asia Pacific and South America region. Currently, the value of the Chinese nematicide market is 500 million CNY, representing only 1% of the total pesticide market. With the increasing occurrence of nematode crop infestations in China, the nematicide market is expected to undergo significant growth.