Brazil Regulatory News

According to notifications from World Trade Organization (WTO), several resolutions for medical devices are proposed to enter into force with the earliest start being on May 2, 2022, by the Brazilian ...

According to notifications from World Trade Organization (WTO), several resolutions for medical devices are proposed to enter into force with the earliest start being on May 2, 2022, by the Brazilian Health Regulatory Agency. Earlier in March 2022, Brazilian Health Regulatory Agency (ANVISA) announced a few regulations regarding technical requirements and defined criteria for medical devices.

In alignment with International Medical Device Regulators Forum (IMDRF) and its issued document IMDRF/RPS WG/N9 (Edition 3), ANVISA has also provided resolutions focusing on regularizing the software-form of medical devices (Software as a Medical Device - SaMD). Another resolution is issued on hardware medical devices including in vitro diagnostic products and the Good Manufacturing Practices (GMPs) required are issued and further incorporated into the MERCOSUR system.

Resolutions aforementioned are mostly expected to start from May 2, 2022, with no applicable final date for comments; whereas resolution for SaMD (i.e. Resolution - RDC number 657) is scheduled to be adopted from July 1, 2022.

On April 14, 2022, the Brazilian government approved the National Solid Waste Plan previously foreseen by the National Solid Waste Policy of 2010. Their main objective is to support solid waste manage...

On April 14, 2022, the Brazilian government approved the National Solid Waste Plan previously foreseen by the National Solid Waste Policy of 2010. Their main objective is to support solid waste management and planning in federal, state, and municipal spheres.

After 12 years, Decree 11043 of 2022 plans for long-term development. Within its 20 years’ timeframe, the National Solid Waste Plan is divided into phases. Initially, the urban waste is diagnosed nationally, contemplating the national and international best practices addressing the issue.

New mechanisms are supporting the compilation of information and population awareness. This is the case of the National Information System on Solid Waste Management (SNIR), displaying legal text, regulations, waste generation characteristics, reverse logistics schemes (Extended Producer Responsibility - EPR), reports, and on.

Among the main goals, the following are highlighted:

• The elimination of dumping places until 2024
• Until 2040, recover at least 48% of the generated mass (recycling, energy, and biologic waste)
• Until 2040, 95% of municipalities will offer a formal contract for cooperative and waste collectors
• Recover 50% of all packing material through reverse logistics in 2040
• Highly improve energy generation on varied decomposing waste sources, benefiting more than 27 million households
• Recycling 25% of waste from civil construction until 2040

The National Solid Waste Plan will be updated every four years to assess progress in diverse sectors and evaluate investment gaps. Businesses in Brazil shall pay close attention and assure compliance with the provisions.

The national solid waste plan can be viewed here.

In Brazil, the Globally Harmonized System (GHS) of classification and labeling is established by the Brazilian National Standards Organization (ABNT) standard and officially implemented by Regulatory ...

In Brazil, the Globally Harmonized System (GHS) of classification and labeling is established by the Brazilian National Standards Organization (ABNT) standard and officially implemented by Regulatory Norm (NR) 26. Currently, chemical classification and labeling in Brazil follow the GHS 5^th revision.

ABNT proposed updating the GHS version utilized in Brazil and its requirements. Currently, there are two projects under public consultation for this purpose. First, ABNT made available a draft document proposing to update general aspects of the GHS, classification, safety data sheet (SDS), and labeling of chemicals – called ABNT 14725 revision. Accordingly, ABNT also proposed to bring up-to-date the requirements of hazardous chemical residues, referred waste SDS, and related labeling under ABNT 16725 revision.

In addition to updating exigencies and modifying the national standard to the GHS 7^th revision, ABNT aims to consolidate the reference into a single document – which today is distributed among four different standards. Both revision projects are in the second stage and open for public consultation until April 28, 2022.

Interested parties may express their concerns via the ABNT official website until the referred date. The final version and publication are planned for September 2022.

The new Resolution 589/2021 entered into force in Brazil in January, 2022,. The National Health Surveillance Agency (ANVISA) Resolution revises three pieces of national legislation on food contact ...

The new Resolution 589/2021 entered into force in Brazil in January, 2022,. The National Health Surveillance Agency (ANVISA) Resolution revises three pieces of national legislation on food contact materials and articles:

·       Resolution 105/1999: General provisions for plastics in food contact

·       Resolution 56/2012: Positive list for plastics in food contact

·       Resolution 88/2016: Cellulosic materials, packaging and equipment intended to come into contact with food

The modifications of Resolution 589/2021 complements and transpose MERCOSUR Resolutions 19/2021, 20/2021 and 21/2021 into national law on food contact materials and articles. Main modification includes:

·       In Resolution 105/1999: Amends the requirements for overall migration and new requirements for coatings that are applied on containers

·       In Resolution 56/2012: Specific migration of primary aromatic amines, adds several substances to Part I and revisions on Part IV of the annex.

·       In Resolution 88/2016: adds three entries and amends another one to the positive list, all with specifications

Businesses dealing with food contact material articles have 12 months to comply with the requirements established in the standard. Therefore, the deadline is to be on January 3, 2023.

In February 2022, the Brazilian Health Regulatory Agency (ANVISA) submitted a proposal for including substances/organisms as active ingredients into authorized monographs authorized in Brazil. The ...

In February 2022, the Brazilian Health Regulatory Agency (ANVISA) submitted a proposal for including substances/organisms as active ingredients into authorized monographs authorized in Brazil. The proposal IS open for public consultation for 60 days counting from its publication.

Such active ingredients may be used in agrochemicals, sanitizers, disinfectants, and wood preservatives. Along with the list, the following substances are being considered, respecting the following contribution deadlines:

The intention to include the substances/organisms in the authorized list has been communicated to the World Trade Organization.

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