Brazil Regulatory News

The Law Bill 6.120/2019 is in possession of the Environment and Sustainable Development Commission (CMADS) of the Deputies’ Chamber since early December 2019, aiming to create the National Inven...

The Law Bill 6.120/2019 is in possession of the Environment and Sustainable Development Commission (CMADS) of the Deputies’ Chamber since early December 2019, aiming to create the National Inventory of Chemical Substances in order to consolidate an information base on chemical substances produced or imported into the country.

After 15 months long waited, the legislation received a designated rapporteur only in March 2021 and had a five-meeting deadline for amendments established. After CMADS, the bill has three more commissions to go before enters into force. The Law Bill 6.120/2019 is expected to pave the way for a national chemical policy.

After the deadlines for amendments expired, only one amendment was presented in the Lower House. Supported by deputy Rodrigo Agostinho (former chairman of the environment committee of the Chamber of Deputies), the revision intends to bring back important aspects from the (National Committee on Chemical Safety) CONASQ’s proposal, present to the Congress in 2018 and shelved immediately when Bolsonaro’s government took place.

The modification highlights are related to the reestablishment of the Technical Committee for the Evaluation of Chemical Substances and the Deliberative Committee for Chemical Substances and rework the risk management, inspection, infractions, and sanctions activities.

Despite the gradual advancements, it is still uncertain when the proposal may be put to vote. If all three committees approve the bill, there is no president sanction needed.

Last update: 2021-05-30

On April 8, 2021, the Brazilian Health Regulatory Agency (ANVISA) opened a public consultation on the criteria for conducting Pesticide Residue Studies and for the es...

On April 8, 2021, the Brazilian Health Regulatory Agency (ANVISA) opened a public consultation on the criteria for conducting Pesticide Residue Studies and for the establishment of Maximum Residue Limits (MRL). The proposal intends to adopt the most recent opinion from the international scenario to the national territory, ensuring a continuous improvement in the quality of pesticide residue’ evaluation. 

The main keys can be summarized as follow: 

• Increases the number of field trials from 4 to 8, with the possibility that half of the trials come from other countries (decreases calculation uncertainty) 

• Use of the principle of proportionality to extrapolate the result of studies for the MLR establishment 

• Turns mandatory the studies’ data be registered on ANVISA’s data bank for inclusion or change into MLR 

• Define criteria for inclusion on monographs the conformities for MLR and risk assessment 

• Adopts international homogenization tools  

• Establish the standard MLR of ≤ 0,01 mg/kg in case of new substances and farming crops 

The interested public can send contributions from April 15, 2021, to June 16, 2021, using this form. 

Further information is available on ANVISA’s webpage.  

Last update: 2021-04-03

Brazil is the world’s largest user of pesticides and has been the market for many agrochemical companies. The Brazilian Health Regulatory Agency (ANVISA), agency responsible for toxicological assessment, submitted several modification proposals regarding pesticides and their residues. Such proposals are open to public consultation with different deadlines. 

MRL - Maximum residue level; SI - Safety interval; ARfD - Acute Reference Dose; NA - not applicable; NFU - Non-food use 

Further, the agency published on March 17, 2021, on the official gazette the new adoptions for 12 agrochemicals: 

MRL - Maximum residue level; SI - Safety interval; ARfD - Acute Reference Dose; NA - not applicable; NFU – Non-food use 

The country has been breaking the annual pesticide registration record since 2016. In 2020 alone, 493 new registrations were made. Besides de country be the largest consumer, it is the main market for highly hazardous pesticides (HPP). 

The activity can be seen as a continuation of the revision tasks started in February 2021, and present a strong link with the new National Fertilizer Plan proposal, scheduled for the 2nd or 3rd quarter. 

Interested parties have 60 days (counted from the publication) to submit suggestions by e-mail cp.toxicologia@anvisa.gov.br. Further information is available on ANVISA’s webpage.  

last update: 2021-03-31

The Law Bill 6.120/2019 is in possession of the Environment and Sustainable Development Commission (CMADS) of the Deputies’ Chamber since early December 2019, aiming to create the National Inven...

The Law Bill 6.120/2019 is in possession of the Environment and Sustainable Development Commission (CMADS) of the Deputies’ Chamber since early December 2019, aiming to create the National Inventory of Chemical Substances in order to consolidate an information base on chemical substances produced or imported into the country. 

After 15 months long waited, the legislation received a designated rapporteur only in March 2021 and had a five-meeting deadline for amendments established. After CMADS, the bill has three more commissions to go before enters into force. The Law Bill 6.120/2019 is expected to pave the way for a national chemical policy. 

The proposal is part of the country’s ambition to develop a sound management of chemicals, given the international trend. On a regional context, Chile was the first country in Latin America to publish guidelines for its national inventory back in February 2021. 

Last update: 2021-03-31

The Brazilian Health Regulatory Agency (ANVISA) has been submitting several proposals of the country’s agrochemical standards to the WTO in February. All of the modification proposals are open to public consultation until April 4th, 2021.

These proposals can be seen as a part of the National Fertilizer Plan and the country’s determination to enhance registration of pesticides. Most of WTO notifications are related to the modification of Maximum Residue Limit (MRL), Safety Interval (SI), and Acute Reference Dose (ARfD).

The correlation of chemicals and modifications is displayed in the following table.

The agency also included de following chemicals/organisms in the list of the active ingredients of pesticides, household cleaning products and wood preservatives:

Among the substances highlighted previously, only C58 and C18 underwent changes in cultivations, of which are summarized as

Interested parties can submit suggestions by e-mail cp.toxicologia@anvisa.gov.br using this form.

Update: 2021-02-20

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.