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

On 31 Aug 2017, China MoA issued Announcement 2570 of 2017, releasing two supporting rules for the management of pesticide testing facility: “Rules for the Accreditation on Testing Facility for Pesticide Registration” and “Good Laboratory Practice for the Experimentation of Pesticide Registration”.

  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.

On 4 Aug 2017, the General Office of MoA releases the new format of 5 pesticide licenses: the pesticide registration certificate, the certificate of testing institutions for pesticide registration, experimentation permit for new pesticide registration, the pesticide production license and the pesticide marketing license, which will be utilized for the 3-element approval system under new pesticide regulation.

Uruguay pesticide importation (including formulations, TCs/TKs and adjuvants) decreased from 146.38 million USD in 2015 to 135.29 million USD in 2016. Import value grew from 61.89 million USD in 2006 and reached a peak of 254.03 million USD in 2014. Although importation value has been unstable, the percentages of product categories were generally stable. Herbicide accounted for 60% of the total value, followed by fungicide (16%), insecticide (10%) and others (10%).

On 31 Jul 2017, China MEP released the draft of “Technical Specification of Application and Issuance of Pesticide Pollutant Permit” for consultation until 30 Aug 2017. The draft specifies the information requirement, determination method of emission limits, computation of actual emission, criterion to assess environmental violation, as well as the technical requirements on self-inspection, ledger of environmental management and performance reporting of pollutant permit for pesticide (intermediate) production.

On 12 Jul 2017, the Standardization Administration of China (SAC) issued Announcement 18 of 2017 to promulgate 28 toxicological testing methods for pesticide registration, which will take effect as of 1 Feb 2018 and replace the GB 15670-1995.

On 30 Jun. 2017, China MoA invited public consultation on “Data Requirements for Pesticide Registration” and 5 other supporting rules for new pesticide regulation. The guideline for the determination of technical equivalence was included in the Annex 4 of the “Data Requirements for Pesticide Registration”. Compared with the currently enforceable requirements, “MoA Order 10-Data Requirement on Pesticide regulation (2008)”, the new requirements clearly specify the applicable scope and some of the new criteria have become as stringent as that of developed countries. All of this is expected to reduce new registration of generic pesticide 30% by 2020. A comparative analysis on the scope and criteria is provided to interpret the impacts on me-too pesticide registration. TECHNICAL GRADE ACTIVE INGREDIENT(TGAI) Applicable Scope Currently, technical equivalence determination is mainly utilized for me-too registration, which enjoys considerable data waive and fast-track preference. In the draft, 3 more conditions were added. Conditions subject to mandatory determination: Apply for TGAI(technical grade active ingredient)registration under equivalent product(me-too) category; A TGAI registrant alters the production process/production site; If a formulation alters the source of TGAI, the equivalence determination between new sourced TGAI and the original TGAI should be conducted; If an applicant is seeking registration under equivalent formulation, the equivalence between the TGAIs of the proposed formulation and referenced formulation should prior determined; Tiers and Technical Criteria

On 30 Jun 2017, China MoA issued 6 draft supporting documents related to China’s new pesticide regulation, which includes the most important technical guidance for pesticide registration, “Data Requirement for Pesticide Registration”. MoA will solicit public opinion until 30 Jul 2017. The full content of the 6 drafts are available at MoA’s website: