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GPC - Global Product Compliance

Brazil updates resolution concerning the active substance Glyphosate


Labelling risk assessment active ingredient

On January 4th, 2021, the Brazilian National Health Surveillance Agency (ANVISA) addendum, concerning the active substance Glyphosate (G01), entered into force. The resolution RDC 441/2020 applies to all technical and formulated products registered or to be registered in Brazil. The resolution defines:

  • The inclusion of formaldehyde (1g/kg) among contaminants of toxicological importance
  • Addition of Acceptable Operator Exposure Level (AOEL) of 0.1 mg/kg of body weight per day, and Acute Reference Dose (ArfD) of 0.5 mg/kg of body weight
  • Change in Acceptable Daily Intake (ADI) to 0.5 mg/kg body weight
  • The Glyphosate residues definition now applies for compliance with Maximum Residue Limit, and dietary risk assessment (sum of Glyphosate and AMPA), expressed as Glyphosate
  • Prohibition of polyoxyethylene amine (POEA) above 20%

In addition to the changes, the resolution determines that package inserts and labels shall be revisited to include information on the use of drift reduction technology in the following cases:

  • It is mandatory to use 50% drift reduction technology for doses above 1.800g/ha in coastal, stationary, semi-stationary, and tractor applications; and
  • obligation to use 50% drift reduction technology and five-meter boundary for doses above 3,700g/ha in the same circumstances.

Companies have 180 days from the publication of the resolution to update package inserts and labels.

Manufacturers and users must pay special attention to the regulation to ensure compliance and avoid unnecessary exposure.

Source: WTO Notification 

Update: 2021-01-12