Brazil Regulatory News

ANVISA has taken a significant step toward ensuring transparency and consumer safety within the personal care product industry. With the introduction of a new Normative Instruction, ANVISA is set to r...

ANVISA has taken a significant step toward ensuring transparency and consumer safety within the personal care product industry. With the introduction of a new Normative Instruction, ANVISA is set to regulate the inclusion of declarations of new formulations on the labeling of personal hygiene products, cosmetics, and perfumes when formula modifications occur. 

Outlined in Instruction No. 243, this new measure mandates manufacturers to prominently display the term "new formula" on the labels of reformulated sanitizing products falling under ANVISA's regulatory purview, for a stipulated period of at least 90 days. The prescribed phrasing should be rendered in a bold, capital-letter font with a minimum height of 1 mm, sharply contrasting with the label's background color. 

Moreover, labels must also incorporate the phrase "new formula" in instances where alterations to the product entail revisions in any of the following aspects: Stated concentration, usage instructions, precautionary or advisory measures and promised benefits of use 

Scheduled for implementation on the 18th of August, this update builds upon a resolution from April that originally established labeling and prerequisites for sanitizing products boasting antimicrobial attributes. 

In a separate development, ANVISA is actively soliciting input from the public regarding a proposition that seeks to modernize the prerequisites governing classification, labeling, and packaging of personal hygiene products, cosmetics, and perfumes. Interested parties are encouraged to submit their comments prior to the looming deadline of the 18th of August. 

The new Normative Instruction aligns with ANVISA's overarching goal of ensuring consumer safety and enhancing transparency within the personal care product sector. By requiring clear and prominent declarations for modified products, ANVISA intends to empower consumers to make informed choices while promoting responsible practices within the industry. 

In a significant move that underscores Brazil's commitment to consumer safety and the regulation of cosmetic products, the National Health Surveillance Agency of Brazil (ANVISA) has introduced new...

In a significant move that underscores Brazil's commitment to consumer safety and the regulation of cosmetic products, the National Health Surveillance Agency of Brazil (ANVISA) has introduced new measures that impact the personal care industry. As of August 11, 2023, ANVISA's Resolution RDC 806/2023 has come into effect, ushering in changes to the list of substances that are prohibited in personal hygiene products, cosmetics, and perfumes. Notably, the updated resolution includes two prominent substances, climbazole and zinc pyrithione, which are now prohibited in cosmetics within Brazil.

Climbazole, a chemical recognized for its use in anti-dandruff agents, has been subjected to stringent regulations. The new resolution dictates that cosmetic products cannot contain climbazole in concentrations exceeding 2%. Similarly, zinc pyrithione, a preservative commonly employed in cosmetic formulations, is now limited to a maximum concentration of 1% in cosmetic products.

The implementation of these new regulations necessitates swift action from cosmetics manufacturers and producers. Businesses operating within the cosmetic industry in Brazil must fully comply with the stipulations laid out in the resolution by August 11, 2024. This compliance deadline serves as a clear indication of ANVISA's commitment to ensuring that the personal care products available to consumers meet the highest safety standards.

ANVISA's decision to update its list of prohibited substances was driven by a desire to align with international standards and best practices. The updated resolution, RDC 806/2023, is an evolution of a 2021 regulation, and it also incorporates the Mercosur technical regulation GMC 35/22. This technical regulation, shared by the four Mercosur member countries, defines the permissible substances for use in personal hygiene products, cosmetics, and perfumes. ANVISA's integration of these guidelines demonstrates its dedication to harmonizing with regional and global standards, fostering a safer environment for consumers.

It's worth noting that both climbazole and zinc pyrithione have been subjects of regulatory attention and scrutiny in various parts of the world. Within the European Union (EU), zinc pyrithione's use in cosmetic products was officially prohibited as of March 2022. This EU regulation reflected a commitment to consumer safety and aligning with scientific findings concerning this particular substance. Additionally, climbazole, while not completely banned in cosmetics in the EU, was restricted for use in new cosmetic products as of 2019. Furthermore, it has been under evaluation due to its potential classification as an endocrine disruptor—a classification that underscores the importance of its careful regulation.

ANVISA's decision to include climbazole and zinc pyrithione in its list of prohibited cosmetic substances reinforces its mission to safeguard consumers' health and well-being. By setting specific concentration limits and compliance deadlines, the agency is driving manufacturers to reevaluate their formulations and ensure that their products are in line with the new regulatory framework. This move not only benefits consumers by guaranteeing the safety of cosmetic products but also supports the broader personal care industry by promoting responsible manufacturing practices.

The Brazilian Health Regulatory Agency (Anvisa) has approved a regulation that allows the use of the Single Import Declaration (Duimp) as an alternative for the importation of goods and products subje...

The Brazilian Health Regulatory Agency (Anvisa) has approved a regulation that allows the use of the Single Import Declaration (Duimp) as an alternative for the importation of goods and products subject to Anvisa's non-automatic licensing approval within the Siscomex system. The decision was made unanimously during the public meeting of the directors on August 2nd.

The use of Duimp and other modules available on the Single Foreign Trade Portal will contribute to a more efficient health control of imports, in addition to avoiding the need to submit required documents to all relevant foreign trade agencies. As a result, a significant reduction in costs for the regulated sector in administrative activities and storage time is expected. For instance, the latter directly affects the efficiency of national and international logistics chains.

Outlined below are the primary components of the new RDC:

Understanding Duimp and Its Applicability The Duimp serves as a gateway for importing goods and products that require ANVISA's approval through the non-automatic licensing process within the Integrated Foreign Trade System (Siscomex). This mechanism offers an alternative route for the importation of items that are subject to health scrutiny under non-automatic licensing within Siscomex. With the introduction of the new RDC, the incorporation of import approval via Duimp for various product categories requiring health oversight will be introduced gradually. The specific list of products and the rollout timeline will be announced on the official websites of both ANVISA and Siscomex in the days to come.

Licenses, Permits, Certificates, and Other Essential Documents (LPCO) Utilizing Duimp for imports necessitates adhering to ANVISA's prerequisite for obtaining licenses, permits, or other essential documents, which must be registered using the LPCO module on the Single Foreign Trade Portal. Importers are obligated to ascertain the necessity for presenting LPCO and securing ANVISA's approval before initiating the Duimp registration process.

Transition Phase and Flexibility ANVISA has stipulated a transitional phase during which importers can opt to use Duimp or maintain the traditional import procedure via the Siscomex Import License. This transitional period will remain in effect until the full migration of import processes to the Single Foreign Trade Portal is finalized.

Gains for the Regulated Sector This pivotal shift carries significant advantages for the sector as it entails:

(i) Streamlining import-related health checks, as all pertinent import process data will be consolidated within the Single Foreign Trade Portal.

(ii) Diminishing the requirement to furnish mandatory information and documents to various foreign trade regulatory bodies, thereby enhancing risk management as a primary operational focal point.

As a result, substantial cost reductions are anticipated within the sector, particularly in terms of administrative functions associated with the import process and the duration for which products are stored prior to completion of the importation procedure.

The industrialized state of São Paulo, known for setting the environmental standards in Brazil, has taken a pioneering step in promoting sustainability within the mining sector.  Starting from J...

The industrialized state of São Paulo, known for setting the environmental standards in Brazil, has taken a pioneering step in promoting sustainability within the mining sector. 

Starting from July this year, the decree number 67.409, issued on December 28, 2022, comes into effect in the state of São Paulo, establishing the requirement for a registry of companies that want to sell products and by-products - CADMINÉRIO and establishes procedures for their acquisition by the Government of the State of São Paulo. 

The measure is celebrated by the construction sector - sand and crushed rocks firstly - as it is seen as another step towards self-regulation, requiring that aggregates purchased and used in projects in the State of São Paulo be supplied by companies compliant with mineral, environmental, and tax regulations. 

Now, the sector's aspiration is that, in its regulation, transportation will also be required to comply with legal weight limits, a request the industry has been fighting for over the past few years. 

The Brazilian Association of Technical Standards (ABNT) released on July 3 of 2023, a significant update to the ABNT NBR14725 Standard, which governs the classification and labeling of chemicals. Thi...

The Brazilian Association of Technical Standards (ABNT) released on July 3 of 2023, a significant update to the ABNT NBR14725 Standard, which governs the classification and labeling of chemicals. This update marks the most substantial revision of the standard in over a decade, bringing important changes that align Brazil's regulations with international standards, particularly the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). 

Key Changes and Enhancements: The updated ABNT NBR14725 Standard introduces several notable changes, aimed at improving chemical classification, labeling, and hazard communication. Let's explore some of the key updates: 

• Structural Reorganization: One of the prominent modifications is the reorganization of the standard's structure. Previously divided into four parts, the new version consolidates all the content into a single, more extensive and comprehensive section, making it easier for users to navigate and understand the requirements. 

• Alignment with GHS: The updated ABNT NBR14725 Standard is based on the seventh revision of the GHS Purple Book. By adopting this GHS version, Brazil's regulations now closely align with international standards, promoting consistency and harmonization in chemical classification and labeling practices. 

• New Hazard Classes: Two new hazard classes have been included in the classification system. The first is "Desensitized Explosives," which addresses substances that have been treated to reduce their explosive properties. The second is "Ozone Depleting," which focuses on chemicals that pose a risk to the ozone layer. 

• Modified Labeling Elements: The labeling requirements have been revised, with changes in hazard statements (H phrases) and precautionary statements (P phrases). New H and P phrases have been added, providing more specific information about potential hazards and necessary precautions. Existing phrases have also undergone modifications to enhance clarity and accuracy. 

• Communication of Hazard: The updated standard introduces new rules for labeling small packaging. These regulations ensure that even the smallest containers carry essential information about the hazardous nature of the contained substances, enhancing safety measures and risk awareness. 

• Revised Safety Data Sheet (SDS): The standard introduces a change in the terminology used for Safety Data Sheets (SDS). Formerly known as Material Safety Data Sheets (MSDS), they will now be referred to as SDS, aligning the Brazilian naming convention with international standards. The content and structure of SDS remain largely unchanged, maintaining the requirement of 16 sections, each providing crucial information about chemical properties, handling, and safety measures. 

Impact and Compliance: The update to ABNT NBR14725 has significant implications for companies handling chemicals in Brazil. Here are some key considerations: 

• Mandatory Updates: All companies are required to update their existing Safety Data Sheets (SDSs) to comply with the new standard. The change in document nomenclature necessitates revisions to ensure consistency and alignment with the updated requirements. Additionally, labels may need to be revised and updated to reflect the modified hazard statements and precautionary phrases. 

• Time and Cost Implications: Achieving compliance with the updated regulations may require additional investments in resources and expertise. Companies might need to allocate time and funds for training employees, acquiring specialized technologies, and reviewing and updating their SDSs and labels. The magnitude of these tasks will depend on the size of the company and the number of products in its portfolio. 

• Revised Classification: Due to changes in concentration limits, some products previously classified may no longer require classification under the updated standard. However, it's important to note that this change does not apply universally, except for the inclusion of the new hazard class "Desensitized Explosives." 

The updated ABNT NBR14725 Standard brings significant changes to the classification and labeling of chemicals in Brazil. By aligning with the 7th GHS revision and incorporating new hazard classes, the standard enhances hazard communication and harmonizes Brazil's regulations with international practices. Companies should promptly assess the impact of these changes, ensuring timely compliance with the updated requirements by reviewing and updating their Safety Data Sheets and labels. 

Access to the NBR 14725 standard is via the ABNT Catalog website, through the link: ABNT Catálogo (abntcatalogo.com.br)

Price to aquire the new regulation is R$ 244.10 reais (50 US$) and is available only in Portuguese.

The Constitution, Justice, and Citizenship Commission (CCJC) of Brazil on 9th of May 2023, granted their approval to the preliminary Draft Law of National Inventory of Chemical Substances (PL6120/19)...

The Constitution, Justice, and Citizenship Commission (CCJC) of Brazil on 9^th of May 2023, granted their approval to the preliminary Draft Law of National Inventory of Chemical Substances (PL6120/19), also known as the Projeto de Lei do Inventário Nacional de Substâncias Químicas. As part of the legislative process in Brazil, the Federal Senate, or Senado Federal, will now undertake the discussion and evaluation of the Law. If the Law is approved by the Federal Senate and enacted into law, Brazil will join Chile, Colombia and Peru as South American nations that have implemented some form of national chemical management scheme.

With a concise length of only eight pages, the preliminary Law leaves various aspects open for further development. Nonetheless, the fourteen Articles provide significant insight into the government's perspective on the management of chemical substances. The "Rationale" section, located at the end of the draft Law, extensively elaborates on these viewpoints. While acknowledging chemical substances as the fundamental building blocks of life and the key components used in manufacturing products, Brazil also recognizes the potential dangers and risks associated with these substances if not properly managed. Despite the presence of multiple chemical substance registries in the country, Brazil highlights the absence of a comprehensive analysis regarding the potential risks posed by each substance. Consequently, an all-encompassing inventory and registration mechanism should be established.

From this standpoint, the government advocates for a comprehensive approach to managing chemical substances in the country, with an emphasis on knowledge-based prevention throughout their life cycle. The Law also aims to reduce fatalities and illnesses caused by hazardous chemical products, enhance water quality by minimizing exposure, provide training to the healthcare sector on managing poisonings and related illnesses, promote the correct use of these products, and address several other aspects. Finally, the government outlines three specific areas of action to be achieved through the implementation of the Law:

• Acquiring missing information about substances entering the country, particularly those intended for industrial use.
• Facilitating interaction among existing information systems to prevent redundancy in efforts by citizens and the government.
• Establishing a comprehensive mechanism for assessing hazardous substances that integrates a technical perspective on environmental care, health, and production.

You can check the full document here: Compliance Library of Brazil Regulatory Region | GPC Gateway

On 9 May 2023 the Brazilian Chamber of Deputies approved Bill 6120/2019. The Bill will now move on to the Senate for consideration. It is now set to be reviewed by the Environment Committee (CMA) and ...

On 9 May 2023 the Brazilian Chamber of Deputies approved Bill 6120/2019. The Bill will now move on to the Senate for consideration. It is now set to be reviewed by the Environment Committee (CMA) and the Committee on Social Affairs (CAS). The Bill had been shelved since 2019 when President Bolsonaro came into office.

If Bill 6120/2019 is approved in Senate and signed into law it would:

• Establish a National Inventory of Chemical Substances

• Adopt GHS as the mandatory classification system

• Set up an Assessment Committee to assess the risks of the substances and recommend risk management measures

So far, the only Latin American countries that have implemented national chemicals legislation are Chile and Colombia. According to a statement made by Melissa Owen, founder of law practise Ambiente Legal, on LinkedIn there is ‘a distinct possibility that the Bill could be approved as early as this year’ making Brazil the third country in the region to adopt a national chemical legislation.