Brazil Regulatory News

On February 9, 2022, the National Health Surveillance Agency (ANVISA) published a resolution addressing ultraviolet (UV) filters allowed to be present in cosmetics. In addition, Resolution 600 form...

On February 9, 2022, the National Health Surveillance Agency (ANVISA) published a resolution addressing ultraviolet (UV) filters allowed to be present in cosmetics. In addition, Resolution 600 formally adopts MERCOSUR's resolution 44/2015 amended by MERCOSUR 14/2021.

In summary, Resolution 600  allows 36 UV filters in cosmetics, establishes a maximum concentration limit for each substance, and enacts other limitations for specific substances. An important detail is that the list only includes those substances added into sunscreen products focused on avoiding damage caused by UV rays. Among the substances are:

Failure to comply with the provisions constitutes a sanitary infraction. Businesses should check the complete list and how the resolution might impact their activities.

On January 12, 2022, the Brazilian government issued a Regulatory Decree for the National Waste Policy, officialized and published by Law 12.305 on August 2010. The Regulatory Decree 10.936 does n...

On January 12, 2022, the Brazilian government issued a Regulatory Decree for the National Waste Policy, officialized and published by Law 12.305 on August 2010. The Regulatory Decree 10.936 does not repeal the existing version; instead, it ratifies and details the legislation's applicability.

The new Decree has an embracing scope whereby manufacturers, importers, distributors, traders, and consumers must observe the correctly packaging, segregation, and final destination of generated residues. It includes, for example, a segregation collection system and the reverse logistics plan.

Another important aspect is the inclusion of collectors’ cooperatives and associations of reusable and recyclable materials, which play a relevant role throughout the national territory. Finally, the National Registry of Hazard Operators and the National Information System for Waste Management is created to keep records, collect information, publish reports, and track performance goals.

It is recommended that all interested parties scrutinize the new Decree to ensure a safe and proper operation.

Last Update: 2022-02-11

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