In Brazil, there are specific laws that apply to pharmaceutical products, cosmetics, pesticides, sanitizing products, and explosives. However, there is no law applicable to industrial chemicals. In Oct 2018, the National Chemicals Safety Commission (Comitê Nacional Sobre Segurança Química, or CONASQ), along with the Ministry of Environment (Ministério do Meio Ambiente, or MME), published a Preliminary Bill for the Inventory, Evaluation, and Control of Chemical Substances. Brazil is in the process of developing a comprehensive national chemical inventory, which will be established under the proposed chemicals law (Bill 6120/2019), known as Brazil REACH. This bill has been approved by the Commission on Constitution, Justice, and Citizenship (CCJC) and is now (August 2024) set for a vote by the Environment Committee, after which it will be sent to the final committee in the Senate for consideration. If enacted, the law will create the National Inventory of Chemical Substances. This inventory is intended to consolidate information on chemicals produced and imported in Brazil, requiring manufacturers and importers to declare substances in quantities exceeding one tonne per annum (TPA). The information to be submitted includes the identity of the substance, annual production or import volume, recommended uses and hazard classifications according to both the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and Brazilian regulations.
Jun-17-2025
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. Organizations handling chemicals in Brazil are granted a two-year transition period to comply with the new standard. Full compliance is mandatory by July 4, 2025.
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.
Jun-11-2025
Brazil’s National Health Surveillance Agency (ANVISA) has announced a broad revision of its regulatory framework for dietary supplements, updating the official lists of authorised ingredients, usage limits, health claims, and mandatory warning labels.
The changes were issued through Normative Instruction No. 373, published on 5 June 2025, and amend Normative Instruction No. 28 of 2018, which sets the standards for the formulation and labelling of dietary supplements sold in Brazil.
New Additions and Limits for Nutrients and Probiotics
The updated regulation includes the addition of several nutrients, bioactive substances, enzymes, and probiotics to the authorised list for supplements intended for individuals over 4 years old.
Among the notable inclusions are:
Citrus fibres and 2'-fucosyllactose (a prebiotic carbohydrate produced via microbial fermentation).
Chlorella pyrenoidosa powder as a source of vitamin A.
The bioactive gamma-aminobutyric acid (GABA).
Probiotic strains such as Lactobacillus acidophilus DDS-1®, Bacillus coagulans SNZ 1969, and a three-strain combination involving Lactobacillus plantarum and Pediococcus acidilactici.
Minimum and maximum recommended intake levels for these substances have been defined per population group, with specific thresholds set for adults, adolescents, and children over four.
Updated Health Claims and Safety Warnings
ANVISA has also authorised new health claims for certain probiotic strains, including gastrointestinal benefits and relief of intestinal discomfort in adults. However, these claims are restricted to products that meet precise composition and dosage requirements outlined in the regulation’s annexes.
At the same time, complementary labelling requirements have been expanded to include mandatory health warnings, especially for vulnerable populations such as pregnant women, children, and immunocompromised individuals. For example:
Products containing GABA must carry the warning: “This product should not be consumed by pregnant women, breastfeeding women, or children.”
Probiotic supplements must carry more extensive warnings, such as: “This product should not be consumed by infants, young children, pregnant or breastfeeding women, or immunocompromised individuals.”
Two-Year Transition Period for Compliance
Manufacturers have been granted a 24-month period to adapt their product labelling to comply with the new requirements. This applies to supplements that were already authorised under ANVISA's regulatory framework before the publication of the new instruction.
The changes were adopted by ANVISA’s Collegiate Board in a meeting held on 4 June 2025 and signed by the agency’s Acting Director-President, Rômison Rodrigues Mota. For further details, you can find the Normative here (in Portughese).
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