Brazil Regulatory News

Brazil's health regulatory agency, ANVISA recently announced a proposal to amend Resolution RDC 778/2023, which governs food additives and adjuvants in food technology. This proposed resolution s...

Brazil's health regulatory agency, ANVISA recently announced a proposal to amend Resolution RDC 778/2023, which governs food additives and adjuvants in food technology. This proposed resolution seeks to establish a maximum tolerable residual limit for ethylene oxide in food additives, aiming to enhance consumer protection.

Ethylene Oxide Regulation

The proposed amendment to RDC 778/2023 introduces a crucial regulation concerning ethylene oxide levels in food additives. Specifically, it sets a maximum tolerable residual limit of 0.01 mg/kg for ethylene oxide in food additives. Ethylene oxide is a chemical used in various industrial processes, and its presence in food additives must be carefully controlled to ensure consumer safety.

Exceptions for Certain Food Additives

While the proposed regulation imposes strict limits on ethylene oxide, it includes exceptions for specific food additives. These exceptions apply to food additives that comply with the identity, purity, and composition specifications established by JECFA (Joint FAO/WHO Expert Committee on Food Additives) or FCC (Food Chemicals Codex). The listed food additives exempt from the maximum tolerable residual limit are as follows:

1. Polyoxyethylene (20) sorbitan monolaurate, polysorbate 20, INS 432
2. Polyoxyethylene (20) sorbitan monooleate, polysorbate 80, INS 433
3. Polyoxyethylene (20) sorbitan monopalmitate, polysorbate 40, INS 434
4. Polyoxyethylene (20) sorbitan monostearate, polysorbate 60, INS 435
5. Polyoxyethylene triestearate (20) sorbitan, polysorbate 65, INS 436
6. Grafted copolymer of polyvinyl alcohol (PVA) and polyethylene glycol (PEG), INS 1209
7. Polyethylene glycol, INS 1209

These additives, when meeting the specified criteria, will not be subject to the ethylene oxide limit, ensuring that they continue to be safe for consumption.

Public Consultation

ANVISA has initiated a public consultation period to gather feedback and comments from stakeholders and the general public. Interested parties are encouraged to submit their comments and suggestions regarding this proposed regulation within 45 days of the issuance of the public notice, which was posted on August 23, 2023. 

Ensuring Food Safety

The proposed regulation of ethylene oxide in food additives underscores ANVISA's dedication to ensuring the safety and quality of food products in Brazil. By setting a clear limit and providing exceptions for additives meeting stringent criteria, ANVISA aims to protect consumers from potential health risks associated with ethylene oxide exposure.

This important regulatory change reflects ANVISA's ongoing efforts to adapt and enhance food safety standards, aligning with international best practices while considering the unique needs of the Brazilian population. To submit your comments and engage in the public consultation process, visit ANVISA's official website.

Brazil has taken substantial strides towards regulating per- and polyfluoroalkyl substances (PFAS). The introduction of Brazil's National PFAS Control Policy Bill No. 2726/2023 in the Chamber of D...

Brazil has taken substantial strides towards regulating per- and polyfluoroalkyl substances (PFAS). The introduction of Brazil's National PFAS Control Policy Bill No. 2726/2023 in the Chamber of Deputies marks a significant leap forward in establishing a comprehensive national framework for PFAS control.

The proposed policy casts a broad net, with a primary focus on environmental preservation and sustainable practices. It places a solemn responsibility on federal, state, and municipal public authorities to rigorously enforce and execute the policy. Moreover, it imposes a mandate on companies and industries that employ PFAS, compelling them to furnish annual reports on PFAS consumption and disposal.

This legislative endeavor outlines a series of measures designed to gradually diminish the prevalence of PFAS in products and manufacturing processes. Additionally, it wields its influence to launch public awareness campaigns, aimed at educating citizens about the inherent health and environmental hazards posed by PFAS. The bill also underscores the significance of research into technologies for remediating PFAS contamination.

In terms of procedural advancement, the bill has made its way through the initial of four approval Commissions as of July 4th, 2023. Should it secure approval from all four Commissions, it will proceed directly to the Senate for voting. In cases where it gains approval from some commissions while facing rejection from others, it will be brought before the Plenary of the Chamber of Deputies for further scrutiny before making its way to the Senate.

The acting President Geraldo Alckmin has signed a decree on the 24th of this month, reestablishing a beneficial tax regime. This development marks a pivotal step towards revitalizing a sector that ser...

The acting President Geraldo Alckmin has signed a decree on the 24th of this month, reestablishing a beneficial tax regime. This development marks a pivotal step towards revitalizing a sector that serves as a central point for the nation's industrial production.

The decree pertains to the revival of the Special Regime for the Chemical Industry (Reiq), which extends tax exemptions to the sector. By bringing back this specialized regime, the Brazilian government aims to enhance the competitive landscape for chemical businesses, which play a pivotal role in generating both direct and indirect employment opportunities. Notably, the chemical industry accounts for a substantial 11% of the country's industrial GDP, a figure underscored by data from the Brazilian Chemical Industry Association (Abiquim).

Scheduled for publication in the Federal Official Gazette on the 25th, this decree is set to redefine the trajectory of the chemical industry. "This sector plays a strategic role in the neo-industrialization initiative and the overall fortification of the industry. Reiq stands as a crucial driver for market competitiveness, job creation, and income generation," remarked President Alckmin.

However, the impact of this decree transcends mere tax exemptions. In addition to restoring previous tax conditions, the new legislation introduces supplementary credits for companies willing to invest in expanding their production capacities or embarking on the establishment of new plants, particularly those harnessing natural gas for fertilizer production.

Established in 2013, Reiq holds the key to enhancing the chemical industry's resilience. It entails the exemption of PIS/Cofins taxes on core products pivotal to the first- and second-generation petrochemical domain. The resulting downstream products encompass an array of essential goods, including fertilizers, active medicinal ingredients, plastics, fibers, rubbers, paints, and inputs for the food and beverage sector. By mitigating cost disparities between local chemical enterprises and their global counterparts, this scheme bolsters the industry's competitive prowess on a global scale.

A comprehensive study conducted by the esteemed Getúlio Vargas Foundation (FGV) in 2021 underscores the profound impact of Reiq. The benefits of this regime cascade beyond the confines of the chemical industry, permeating the entire Brazilian economy. The study revealed an upswing in revenue, heightened productivity, and the preservation of employment opportunities. Intriguingly, projections from the study hinted at the possibility of an annual productivity plunge ranging from R$2.7 billion to R$5.7 billion within the sector if the benefits were to be rescinded.

Furthermore, the study sheds light on Reiq's potential to inject up to R$5.5 billion into the GDP, coupled with a yearly influx of no less than R$2 billion in tax revenue. These numbers underscore the substantial economic gains this specialized tax regime can usher in.

The newly signed decree, however, comes with certain commitments. Chemical plants and industries are expected to forge formal agreements with the Special Secretariat of the Federal Revenue of Brazil, encompassing various stipulations. These commitments encompass compliance with occupational health and safety regulations, adherence to environmentally restorative actions, maintenance of fiscal regularity, procurement of verified emissions reductions certificates, and sustaining workforce levels equivalent to, or exceeding, those present on January 1, 2022.

As this rejuvenated tax regime takes center stage, a vigilant eye will be cast on its implementation. The meticulous oversight of the scheme will be undertaken by various entities, including the Secretariat for Industrial Development, Innovation, Trade, and Services (SDIC), operating in synergy with the Federal Revenue Service, the Ministry of Labor and Employment, and the Ministry of the Environment and Climate Change.

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.