Chemistry and manufacture (Part 2)

Chemistry and manufacture of agricultural chemicals

This page provides links to guidance documents about the sorts of information an applicant may submit to address the safety criteria as they relate to chemistry and manufacture as part of applications for:

• approval of a new active constituent
• approval of a new source of an existing active constituent
• variations to an approved active constituent, including a change:
  • in concentration or identities of impurities
  • in final purity of the active constituent
  • to the manufacturing site
• registration of an agricultural chemical product containing a new or existing active constituent
• variations to a registered agricultural chemical product
• issuance of a permit.

Chemistry and manufacture assessments include consideration of:

• the active constituent
• the formulation type
• the manufacturing process
• quality control
• specifications for the product, product constituents and containers
• batch analysis
• storage stability
• analytical methods
• packaging and labelling (active and other constituent statements, storage and disposal statements and expiry dates for date-controlled products).