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.

On June 10, 2022, the Organisation for Economic Cooperation and Development (OECD) approved specific roadmaps for States accession, after the first steps for accession discussions in January 2022. Fro...

On June 10, 2022, the Organisation for Economic Cooperation and Development (OECD) approved specific roadmaps for States accession, after the first steps for accession discussions in January 2022. From the original list, Brazil, Bulgaria, Croatia, Peru, and Romania were accepted; Argentina, unfortunately, was not accepted.

The roadmap has specificities for each country's ascension and establishes the process and defines the conditions for such. OECD will conduct technical examinations in areas such as trade, investment, anti-corruption, environmental information, and SME & Entrepreneurship.

For Brazil and Peru, the acceptance came as a recognition of their efforts to adhere to and align the countries’ standards with international best practices. Brazil confirms 112 adhered instruments out of 257 requested by the Organization, while Peru ratified its continuing endeavors.

What does it mean for chemicals?

While Latin American countries have been progressing towards sound management of chemicals, OECD has been a relevant influence in the region. Four Latin American countries – Chile, Costa Rica, Colombia, and Mexico – are already part of the organization, and not by coincidence, Chile and Colombia are the only ones to have recently enacted a chemical framework.

Even when considering non-OECD members, countries in close relation with the Organization are ahead. This is the case, for example, of Argentina, Brazil, and Peru, whereas all these countries have at least a draft of chemical management regulations that have been accessed by their respective legislators.

In relation to chemicals, OECD requires members states to comply with core principles, which are highlighted in the following examples:

• Acceptance of the Mutual Acceptance of Data and in accordance with the Principles of Good Laboratory Practice and Test Guidelines
• Harmonization of chemical and safety policies
• Implementation of a systematic and comprehensive industrial chemicals management system

From June 1-3, 2022, the Latin America Regulatory Cooperation Forum (LARCF) hosted a two-day event to exchange information and progress toward sound management of chemicals across the region. LARCF ha...

From June 1-3, 2022, the Latin America Regulatory Cooperation Forum (LARCF) hosted a two-day event to exchange information and progress toward sound management of chemicals across the region. LARCF has been front running with events and cooperation partnerships in Latin America, bringing together more than 100 regional industry members.

In the Virtual Annual Meeting, attendees learned more about the steps, challenges, and implementation of diverse instruments across several countries. To summarize a few, the meeting addressed the following:

• Colombia's fresh chemical framework implementation and the support from the National Industry Association (ANDI) in the development of chemical policy.
• Chile’s recent chemical regulation and chemical classification process aligned with their policy implementation.
• Insights from the chemical management in Asia-Pacific Economic Cooperation (APEC), including a regulatory convergence proposal.
• Peru’s chemical proposal has been updated and this indicates that it will soon be submitted to the executive power and there will be additional chemical efforts regarding international chemical instruments implementation.
• Past and future work performed by the Intergovernmental Network on Chemicals and Waste for Latin America and the Caribbean, aligned with United Nations Environment Programme support.
• Further capacity building and activities performed together with Strategic Approach to International Chemicals Management (SAICAM) and United Nations Institute for Training and Research (UNITAR) – tools, documents, and training programmes.

Latin American countries are aware of the importance of chemical instruments to trade, environment, and safety. Such meetings are crucial to strengthening management implementation and cooperation in the region.

It was also announced that LARCF plans to publish guidelines for chemical prioritization later this year, besides the Roadmap for Sound Management of Chemicals and Chemical Inventory Guidelines published in April 2021 and March 2022, respectively.

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.

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 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.

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.