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

Unilateral acceptance of test reports from overseas GLP laboratory will no longer be supported. A transitional period before the implementation of this new stipulation is being considered. On 1 Nov 2017 China begins practical implementation of new pesticide regulations. After this date all subsequent pesticide registration applications will be reviewed under new data requirements. New regulation specifies that test reports should be issued by a MoA-recognized testing facilities or overseas labs from a country or organization which have signed MAD (Mutual/ multilateral Acceptance of Data) agreement with China. The report from overseas OECD GLP labs (which China has recognized for decades) will no longer be usable in China. During the 9th Chemical Regulatory Annual Conference, Mr. Chen Tiechun from ICAMA introduced how GLP principles will be adopted for laboratory monitoring and shared with the audience the latest MAD achievements.   Experimentation Management under New Pesticide Regulatory System In the past transparent and clear requirements on laboratory testing have not been available, requirements were based on ICAMA’s on laboratory inspection guidance and MoA’s voluntary measures on GLP-compliance. In fact there was no strong legislative or regulatory basis managing this aspect of pesticide administration in China. Under the new legislation, a ministerial regulation (which will parallel the regulations managing registration, production, marketing and management) was promulgated and two new mandatory supporting rules on laboratory accreditation and GLP management have been issued issued under the MoA Announcement 2570. Under this new framework testing labs are regarded as other business entities such as registrant, producers and dealers:  

On 17 Oct 2017, China MoA disclosed the expert panelists nominated for the forthcoming 9th National Committee on Pesticide Registration for public consultation until 31 Oct 2017.

On 30 Sep 2017, the Chinese Ministry of Agricultures issued the Announcement 2586, “Guideline for the Establishment of Pesticide Acute Reference Dose (ARfD)”. The guild will serve as the technical basis for MRL establishment and dietary risk assessment of pesticides in China.

The SCOPSR (State Commission for Public Sector Reform) office has recently approved the establishment of a new authority called “Pesticide Management Agency”. The new authority will operate under MoA’s Department of Plantation Management and take comprehensive charge of industrial planning, administrative approval, supervision and sanctions in the pesticide sector.

On 30 Sep 2017, China MoA released 10 draft documents on pesticide residue monitoring and will solicit public opinion until 31 Oct 2017.

On 13 Sep. 2017, China MoA detailed new data requirements for pesticide registration.The required data consists of study reports, risk assessment reports, sample of product, impurity and analytical standard, product quality specification, testing methods, label and manual templates, material safety data sheet, summary report, statement on non-infringement of intellectual property, cited reference and documentary evidence.

On 20 Sep 2017, China ICAMA released 9 draft testing guidelines on pesticide environmental impact study and will solicit public opinion until 23 Oct 2017.

On 18 Aug 2017, China MoA released the meeting minutes of the 21st session of the 8th National Expert Committee of Pesticide Registration. The session was held in Beijing on 31 Jul during which 27 new active ingredients were reviewed, of which 9 were herbicides, 8 insecticides, 5 fungicides, 4 plant growth regulators (PGRs) and 1 insect pheromone.

On 19 Sep 2017, China ICAMA released 7 application forms for pesticide administration approval: production license, marketing license and record filing of Registration experimentation.