Brazil Regulatory News

On the 25th of November 2021, the Brazilian National Congress sanctioned a legislation concerning the mandatory controlled disposal of polychlorinated biphenyls (PCBs). Law 14250/2...

On the 25th of November 2021, the Brazilian National Congress sanctioned a legislation concerning the mandatory controlled disposal of polychlorinated biphenyls (PCBs). Law 14250/2021 complements Decree 5472/2005, which is responsible for promulgating the Stockholm Convention on Persistent Organic Pollutants (POPs) in the country. 

Besides the phasing-out of PCBs, equipment and waste containing PCBs are subject to the decontamination process before being discarded. This includes, for example, materials, oils, fluids, and other operational substances.   

 In addition, businesses handling equipment or residues contaminated with PCBs are required to prepare and submit to the environmental authority an inventory with a list of supplies in stock, operational and stored equipment, and contaminated waste owned. The environmental authority will issue a manual within 180 days for this purpose.  

Law 14250/2021 imposes provisions to all holders of PCBs or contaminated equipment/substance, including the appropriate final destination of its residue/waste. The PCB inventory will have up to 3 years after the date of the law’s publication to be prepared, available and sent to the competent environmental agency

Last Update: 2021-12-20

The Brazilian Deputies’ Chamber approved Law Bill 6.120/2019, which proposes the creation of a national chemical inventory aimed at consolidating information of chemicals imported into the ...

The Brazilian Deputies’ Chamber approved Law Bill 6.120/2019, which proposes the creation of a national chemical inventory aimed at consolidating information of chemicals imported into the national market. 

The Law Bill, having been in the possession of the Deputies’ Chamber Environment and Sustainable Development Commission (CMADS) since early 2019, now seek approval from the other three commissions. In unanimous consent, the legislation is immediately forwarded for official publication. 

The regulation had one amendment supported by deputy Rodrigo Agostinho. The modification brought back essential aspects from the National Committee on Chemical Safety’s proposal presented to the Congress in 2018 which was shelved immediately Bolsonaro’s government took place.  The National Chemical Safety Committee's proposal is still known for its technical criteria and capacity to mediate representatives from the chemical sector, civil society, academia, and NGOs until today.

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 the reworking of the risk management, inspection, infractions, and sanctions activities.  

The proposal is part of the country’s ambition to develop an efficient management of chemicals, given the international trend. However, despite the gradual advancements, it is still uncertain when the proposal would be officially adopted. 

On a regional context, Latin America is fast developing an integrated chemical policy. The most recent cases are Chile and Colombia, which have already enacted the law on comprehensive management of chemical substances in 2021. 

Last Update: 2021-12-20

The Brazilian Deputies’ Chamber approved Law Bill 6.120/2019, which proposes the creation of a national chemical inventory aimed at consolidating information of chemicals present and imported into ...

The Brazilian Deputies’ Chamber approved Law Bill 6.120/2019, which proposes the creation of a national chemical inventory aimed at consolidating information of chemicals present and imported into the national market. 

The Law Bill, once in possession of the Deputies’ Chamber Environment and Sustainable Development Commission (CMADS) since early 2019, now seek approval from the other three commissions. In unanimous consent, the legislation is immediately forwarded for official publication. 

The regulation already suffered one amendment supported by deputy Rodrigo Agostinho. The modification brought back essential aspects from the National Committee on Chemical Safety’s proposal presented to the Congress in 2018 and shelved immediately when Bolsonaro’s government took place.  The National Chemical Safety Committee's proposal is still known for its technical criteria and capacity to mediate representatives from the chemical sector, civil society, academia, and NGOs until today.

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.  

The proposal is part of the country’s ambition to develop a sound management of chemicals, given the international trend. However, despite the gradual advancements, it is still uncertain when the proposal would be officially adopted. 

On a regional context, Latin America is fast developing an integrated chemical policy. The most recent cases are Chile and Colombia, which have already enacted the law on comprehensive management of chemical substances in 2021. 

Last update: 2021-12-17

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

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

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