Brazil Regulatory News

In May 2022, the Brazilian National Health Surveillance Agency (ANVISA) modified the procedures for low-risk sanitizers issuing Resolution of the Collegiate Board (Resolução da Diretoria Colegiada -...

In May 2022, the Brazilian National Health Surveillance Agency (ANVISA) modified the procedures for low-risk sanitizers issuing Resolution of the Collegiate Board (Resolução da Diretoria Colegiada -RDC) 692 . The change is intended to facilitate the process and reduce paperwork.

Referred to as "risk 1" sanitizers, the low-risk sanitizers are now required to notify the agency exclusively through the online notification system. In addition, risk 1 sanitizers are exempted from registration, and their notification is exempted from revalidation. The declaration of interest for continued commercialization lasts ten years.

Accordingly, "Risk 2" sanitizers had their registry validity extended for a similar period. The validity period of registration granted before is October 16, 2019, which is accordingly extended to 10 years, counted from the granting of the registration.

Risk 1 sanitizers differ from risk 2 sanitizers in the absence of corrosive characteristics, antimicrobial activity, disinfestation action, and they are not based on viable microorganisms, while these attributes are used for risk 2 sanitizers classification. In addition, risk 1 sanitizers may not contain inorganic acids [Hydrofluoric (HF), Nitric (HNO3), Sulfuric (H2SO4)] in their formulation or release related salts during product usage.

Accordingly, ANVISA updated the list of permitted preservative substances for the formulation of sanitizing products. The Normative Instruction (Instrução Normativa – IN) 153/2022 displays 46 substances by chemical name, CAS number, and maximum permitted concentration limit.

Latin American countries have been constantly improving their chemical management instruments in the last few years. Among several meetings and discussions, countries are motivated to pursue the imple...

Latin American countries have been constantly improving their chemical management instruments in the last few years. Among several meetings and discussions, countries are motivated to pursue the implementation of their national chemical policy.

The Latin American Regulatory Cooperation Forum (LARCF) has been front running with events and cooperation partnerships in the region, bringing together more than 100 regional industry members. The most recent meeting (April 2022) once again shed light on the risk approach to chemical management, highlighting the importance of national chemical inventories.

In the published document, Risk Approach in the Management of Industrial Chemical Substances and Products – Inventories, the Forum explains the importance of chemical inventories in driving chemical policies forward. However, it recognizes that inventories need to be accompanied by mechanisms to identify substances and mixtures offering unreasonable risks to health and the environment, i.e., substance prioritization, risk assessment, and measures for risk management.

The report also insists that governments develop inventories open to data exchange as individual and isolated inventories often bring duplication of data, delay trades, and increased expenses. The OECD Mutual Acceptance of Data (MAD) is pointed out as a solution in this case.

LARCF has already published a Roadmap for Sound Management of Industrial Chemicals in September 2020 and seeks future publications and guidelines related to substance prioritization, risk assessment, and risk management.

From a regional perspective, only Chile and Colombia have implemented their national chemical inventories. In contrast, other countries still have to figure out their implementing regulations and/or ways to drive the process forward in the political scenario.

The Brazilian Health Regulatory Agency (ANVISA) is responsible for regulating and approving guidelines and use of pharmaceutical drugs, sanitary standards, and regulation of the food industry. In the ...

The Brazilian Health Regulatory Agency (ANVISA) is responsible for regulating and approving guidelines and use of pharmaceutical drugs, sanitary standards, and regulation of the food industry. In the last month, ANVISA has proposed modifications to active ingredients employed in agrochemicals and revised provisions for personal hygiene products.

Through Normative Instructions (IN), ANVISA proposes to include the following active ingredients in the ingredient list used in Agrochemicals, Sanitizing Disinfectants and Wood Condoms, which is regulated by IN 103/2021:

In addition, proposal 1085 aims to modify substances present in IN 103/2021 annexes, i.e., the frequent need for toxicological assessment or reassessment of referred active ingredients. Proposal 1089 also intends to revise further 15 active ingredients with a public consultation open until June 5, 2022.

In a resolution published in May 2022, ANVISA also targeted disposable personal hygiene products. Among the list, brushes and sticks for oral hygiene, dental floss and tape, disposable sanitary pads, menstrual cups and swabs went under new regularization rules. RDC 640/2022 also defines the classification, technical requirements, and labeling instructions for such products to be marketable in Brazil.

Among the directives, ANVISA requires that product owners submit a notification via the online portal containing product technical information. Product owners can look up which detailed data is mandatory in RDC 640/2022 Annex I, to know to which extent they should be present.

Furthermore, ingredients that may migrate to the skin and/or mucous membranes must comply with the requirements set out in the respective lists of substances for personal care products, cosmetics and perfumes, according to their classification.

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.

The Brazilian Health Regulatory Agency notifies World Trade Organization (WTO) of several resolutions for cosmetics and personal hygiene products which are proposed to enter into force with the earlie...

The Brazilian Health Regulatory Agency notifies World Trade Organization (WTO) of several resolutions for cosmetics and personal hygiene products which are proposed to enter into force with the earliest start being on May 2, 2022. Earlier in March 2022, Brazilian Health Regulatory Agency (ANVISA) announced a few regulations regarding technical requirements and defined criteria for either labelling or composition of applicable products.

For product manufacture, the conditions for chemical use of lead acetate, formaldehyde, paraformaldehyde and pyrogallol are stated, which also internalizes another resolution from the national legal system MERCOSUR (GMC MERCOSUR Resolution number 48/2010).

Extra attention has been put on personal hygiene products (PHPs) as much as on cosmetics, especially on detailed information displayed such as labelling of composition, warnings, and technical definitions like the inclusion of substance concentration, etc. General rules for exporting Brazilian-made products and temporary regulations applicable with regard to the emergency international public health state under SARS-CoV-2 are also proposed; for instance, on the manufacture and marketing of antiseptic preparations or sanitizers.

Resolutions aforementioned are mostly expected to start from May 2, 2022, with no applicable final date for comments; whereas resolution for the obligation to label product composition in Portuguese (i.e. Resolution - RDC number 646)’s entry date is scheduled for November 1, 2023.

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.

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.