China Authority (ICAMA) Update: New Guidance Documents Open to Public Consultation

China MOA (Ministry of Agriculture, P.R.China), ICAMA (Institute Control of Agrochemicals, MOA) released 9 draft guidance documents with relevance for the Crop Protection industry. The draft guidance documents (GD) were released on September 21, 2017 and are open for commenting until October 23, 2017. Please contact knoell Shanghai if you need further details, translation of the technical guidance (all in Mandarin) or support during the commenting period.

These guidance documents aim at facilitating the implementation of the new Chinese regulation for registration of plant protection products, with a focus on Microbials registration and Environmental Safety (Environmental fate and Ecotoxicology Risk Assessment) for chemical entities, laying down options for higher-tier risk-assessment. The knoell team in China is actively participating in the consultation phase of the guidance documents. Translation services of the draft GDs, performed by experts in the respective area, can be provided by our Chinese-speaking team of regulatory scientists (located in China, Germany  and other European knoell offices)

List of draft guidance documents under consultation:

• Test Guidelines on chronic contact toxicity of chemical pesticides to insect natural enemy
  • Part 1: Ladybird
  • Part 2: Trichogramma
• Guidance on Aquatic (Sediment) Dissipation/ Degradation for Chemical Pesticide
• Multi-residue analytical methods for pesticides in water
• Environmental reproduction test guidelines for microbial pesticides
  • Part 1: Soil
  • Part 2: Water
  • Part 3: Leaf of plant
• Guidance Document on aquatic toxicity testing of difficult pesticides
• Guideline on Myriophyllum Spicatum toxicity test for chemical pesticides

For further information and requests for support please contact knoell regulatory team in China (Dr. He Xiaohua, xhe@knoell.com, +86 21 6199 2001).

Our knoell team in China has deep experience in evaluating the available Chinese environmental fate models and higher-tier option for environmental risk assessment:

• Development of environmental risk assessment and regulatory strategies
• Kinetic evaluations according to FOCUS Kinetics
• Standard and higher-tier modelling for China (TOPRice, ChinaPEARL, PRAESS and others)
• Higher-tier modelling strategies
  • Exploratory modelling
  • Customized scenario building
  • Research, compilation and processing of spatial data by GIS
• Ecotoxicology assessments, including higher-tier risk assessment
• Preparation of environmental risk assessment report for all protection goals