Brazil Regulatory News

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...

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

On June 24th 2020 the National Institute of Metrology, Quality and Technology (Instituto Nacional de Metrologia, Qualidade e Tecnologia – INMETRO) published Directive 217/2020and this Directive ...

On June 24th 2020 the National Institute of Metrology, Quality and Technology (Instituto Nacional de Metrologia, Qualidade e Tecnologia – INMETRO) published Directive 217/2020and this Directive is intended to revise two other Directives, and amends:

• The INMETRO Directive 563/2016, about Technical Regulation and Conformity Assessment Requirements for Toys
• The INMETRO Directive 481/2010, about the Conformity Assessment Requirements for School Items

Important deadlines in Directive 563/2016 were, among others:

• From January 1st, 2022, domestic manufacturers and importers must manufacture and import toys in accordance
• From January 1st, 2023, manufacturer and importers must commercialize toys in conformity
• From July 1st, 2025 distribution and retailers must trade harmonized toys

The Brazilian government has notified The World Trade Organization (WTO) in July 2020. The modification is intended to determine whether toys fulfill requirements, focus on safety and accident prevention, through third parties certification.

All toys must be certified by a certification agent recognized by the INMETRO’s General Coordination for Accreditation (Coordenação Geral de Acreditação - CGCRE).

The INMETRO 217/2020 can be accessed here. 

Brazil's National Chemical Safety Commission, Conasq, has approved a draft law for the industrial chemicals sector, paving the way for enactment by April.

Brazil's National Chemical Safety Commission (Conasq) has nudged plans for an industrial chemicals regulation a little closer to completion