Chemistry and manufacture (Part 2)

Chemistry and manufacture of agricultural chemicals

This is a guideline about the sorts of information an applicant may choose to submit to address the safety criteria for chemistry and manufacture as part of applications for:

• approval of an active constituent
• registration of an agricultural chemical product
• approval of a label
• variations to an approved active constituent including
  • a change in the manufacturing process
  • identification of impurities
  • a change in concentration of impurities
  • a change in final purity of the active constituent
  • a change in the method of analysis
  • a change to the manufacturing site
• approval of a new source of an active constituent
• variations to a registered agricultural chemical product
• the issue of a permit.

Chemistry and manufacture includes aspects of:

• the active constituent
• the formulated agricultural chemical product
• the manufacturing process
• quality control
• specifications
• batch analysis
• storage stability
• analytical methods
• packaging and labelling.