Am I Affected by Brazil REACH?

Applicability under Law 15.022/2024

Does Brazil’s chemical regulation apply to your company?

Law 15.022/2024 establishes the National Inventory of Chemical Substances and imposes registration obligations on companies that manufacture or import chemical substances in Brazil above defined quantity thresholds. 

The obligation to register substances rests with Brazilian manufacturers and importers. 

You are likely affected if: 

— You manufacture or import chemical substances in Brazil above 1 ton per year  

— Your products enter Brazil through distributors or multiple importers  

— You supply chemical substances to the Brazilian market from outside Brazil  

— You do not have full visibility into how registration obligations are distributed across your supply chain 

Foreign companies supplying the Brazilian market do not themselves hold registration obligations under the law, but their substances must be registered by the Brazilian importer — meaning foreign suppliers increasingly face requests from customers to confirm registration status or support the registration process. Foreign companies can take advantage of the OR option offered in Brazil. 

Who is directly affected

Brazilian manufacturers of chemical substances

If you manufacture chemical substances in Brazil at or above 1 ton per year (based on the average of the last three years, assessed individually for each manufacturer), you are required to register those substances in the National Inventory. 

Importers of chemical substances into Brazil

If you import chemical substances into Brazil at or above 1 ton per year (based on the average of the last three years, assessed individually for each importer), you are required to register those substances. This obligation applies to the substance as such and to substances used as ingredients in mixtures — but not to mixtures themselves or to articles. 

Foreign manufacturers and suppliers

If you supply chemical substances to the Brazilian market — directly or through distributors — you do not hold a direct registration obligation. However, your Brazilian importers do, and they will increasingly require confirmation that substances are registered or that the registration process is being managed. Foreign manufacturers have the option of appointing a Brazilian Exclusive Representative to manage registration obligations centrally across their supply chain. 

Key registration trigger: quantity threshold

The registration obligation is triggered when a substance is manufactured or imported in Brazil at 1 ton or more per year, calculated as the average of the last three years, assessed individually for each manufacturer or importer.  

The threshold applies to:

• Substances as such 
• Substances used as ingredients in mixtures (assessed per ingredient, not per mixture) 
• Polymers, except those classified as low concern under implementing regulations 

The threshold does not apply to: 

• Mixtures as such (only their substance ingredients are assessed individually) 
• Articles 
• Monomeric units forming part of a polymer structure 
• Additives used solely to preserve polymer stability 
• Substances in excluded categories under Article 3 of the Law (see below) 

What must be registered

Registration concerns individual chemical substances — not product names, mixtures, or articles. For a mixture, each substance ingredient must be assessed separately against the threshold. 

Substances subject to registration include: 

• Substances manufactured or imported as such 
• Substance ingredients in mixtures, assessed individually against the threshold 
• Polymers (except low-concern polymers as defined in implementing regulations) 

Not subject to registration: 

• Mixtures as such 
• Articles 
• Monomeric units forming part of a polymer structure 
• Additives used solely to preserve polymer stability 
• Substances in development or used exclusively for scientific research 
• Non-isolated reaction intermediates 
• Substances in excluded categories under Article 3 of the Law 

Key exemptions

Article 3 of the Law excludes a significant number of substance categories from the framework entirely. Key exclusions include:

• Radioactive substances 
• Substances in development or used exclusively for scientific research 
• Non-isolated reaction intermediates 
• Substances used solely for national defense 
• Residues and waste 
• Substances under customs supervision not subject to any treatment or transformation 
• Substances resulting from unintentional reactions during storage or from environmental exposure (to air, sunlight, moisture, or microorganisms) 
• Regulated product categories subject to their own legislation, including: foods and food additives, pharmaceuticals and active pharmaceutical ingredients, medical gases, medical devices, agrochemicals and related products, cosmetics and personal care products, sanitizers, veterinary products, animal feed products, fertilizers and inoculants, wood preservatives, and environmental remediators 
• Certain unprocessed or minimally processed natural-origin materials, including natural substances, ores and mineral concentrates, certain fats and essential oils extracted by milling or pressing, and glass, frits and ceramics — provided they are not chemically modified and do not contain substances classified as hazardous under GHS criteria 
• Narcotics, psychotropics, and immunosuppressants 
• Substances used exclusively as tobacco ingredients 
• Structural metal alloys in specified forms (sheets, foils, strips, billets, ingots, beams, and similar structural forms) 
• Explosives and accessories 

Important: Several of these exclusions are conditional. Natural-origin materials lose their excluded status if chemically modified or if they contain substances classified as hazardous under GHS criteria. Detailed interpretation will depend on implementing regulations and regulatory guidance. 

Situations companies commonly encounter

• A Brazilian importer asks a foreign supplier to confirm whether a substance will be registered 
• A formulator in Brazil needs to determine which of its substance ingredients are in scope 
• A foreign manufacturer with multiple Brazilian distributors wants to manage registration consistently across all of them 
• A company is unsure whether its products qualify as substances, mixtures, or articles under the law 

What to do next

1. Identify chemical substances in scope — whether as manufacturer, importer, or supplier to the Brazilian market 
2. Estimate annual quantities per substance against the 1-ton threshold 
3. Determine how registration obligations sit across your supply chain 
4. Assess whether any of your substances or products fall within an excluded category 
5. Monitor implementing regulations and regulatory guidance as they develop 

A basic substance list is sufficient for an initial assessment. 

This page provides general guidance based on Law No. 15.022/2024 as publicly available. It is not legal advice and implementation details may evolve.