Brazil ANVISA Artisanal Cosmetics Regulation 2026: RDC 1,045 & IN 474 Compliance Guide

What Brazil’s New Simplified Framework Means for Artisanal Cosmetics, Personal Hygiene Products and Perfumes

Brazil’s National Health Surveillance Agency (ANVISA) has introduced a dedicated regulatory framework for artisanal personal hygiene products, cosmetics and perfumes.

RDC No. 1,045/2026 establishes simplified regulatory and sanitary requirements for eligible artisanal products, while IN No. 474/2026 establishes the applicable product categories, permitted claims and mandatory warnings.

The new framework is significant for small-scale producers because eligible artisanal products receive regulatory relief from certain conventional ANVISA requirements.

Under the framework, qualifying products are exempt from ANVISA registration or notification, and artisanal producers do not require a Company Operating Authorization (AFE). Local sanitary licensing is subject to the framework's simplified approach and subsequent verification.

Both measures become effective 60 days after publication.

For artisanal manufacturers and businesses selling cosmetics in Brazil, the changes create new opportunities but also introduce specific requirements concerning product eligibility, manufacturing practices, claims, safety, labelling and sales channels.

Companies should therefore determine whether their products genuinely meet the artisanal criteria before relying on the simplified framework.

Why Brazil’s Artisanal Cosmetics Framework Matters

Brazil has traditionally maintained a structured regulatory framework for cosmetics, personal hygiene products and perfumes.

The new artisanal framework recognizes that certain small-scale products may have characteristics that justify a simplified regulatory approach.

However, regulatory relief does not eliminate the producer's responsibility for product safety.

Eligible producers remain responsible for:

• Product quality
• Product safety
• Raw-material controls
• Manufacturing hygiene
• Cleaning
• Storage
• Final-product assessment
• Correct labelling
• Permitted claims
• Compliance with sanitary requirements

The framework therefore represents simplification of regulatory procedures, rather than an exemption from product-safety obligations.

What Are RDC 1,045/2026 and IN 474/2026?

The two regulatory instruments work together.

RDC 1,045/2026 establishes the general simplified sanitary and regulatory framework for artisanal personal hygiene products, cosmetics and perfumes.

IN 474/2026 provides greater specificity by establishing:

• Eligible product categories
• Permitted claims
• Mandatory warnings
• Product-specific conditions

Key Regulatory Changes

The critical consideration is that not every handmade or small-batch cosmetic automatically qualifies.

What Products Are Eligible?

The framework covers specific categories of artisanal products.

Eligible categories include:

• Alcohol-based perfumery products
• Air fresheners
• Solid bath or immersion products
• Solid soaps
• Solid shampoos
• Solid conditioners
• Body oils
• Body butters
• Solid underarm deodorants

The product must also satisfy the applicable conditions concerning manufacturing, formulation, risk and claims.

Eligible Product Categories

Companies should verify the precise product classification and conditions under IN 474/2026 before marketing a product as artisanal.

Who Qualifies as an Artisanal Producer?

The simplified framework is intended for genuinely artisanal production.

Production should be:

• Predominantly manual
• Small-scale
• Fully controlled by the producer
• Based on relatively simple formulations and processes
• Associated with low inherent and microbiological risk
• Produced without outsourcing manufacturing stages

This distinction is important for businesses that describe themselves commercially as "handmade" but operate larger-scale manufacturing processes.

A product being marketed as handmade, natural or artisanal does not by itself establish eligibility.

Outsourcing Restrictions

One of the important considerations is control over production.

The artisanal framework requires the producer to maintain control of manufacturing and does not permit outsourcing of production stages in a manner inconsistent with the regulatory criteria.

Companies using third-party manufacturers, contract manufacturing arrangements or outsourced production should therefore carefully assess whether their business model meets the definition of artisanal production.

This is particularly important for brands that combine:

• Small-batch production
• Private-label manufacturing
• Contract manufacturing
• Third-party filling
• Outsourced packaging
• External processing

A regulatory assessment should be completed before relying on the simplified pathway.

Regulatory Relief for Eligible Products

One of the most significant advantages of the new framework is the reduction in conventional regulatory requirements for qualifying products.

Eligible artisanal products are exempt from:

ANVISA registration/notification

and producers do not require:

Company Operating Authorization (AFE)

The framework also establishes a simplified approach to local sanitary licensing, with subsequent verification by the competent authorities.

This may reduce the administrative burden for small producers entering or operating in the Brazilian cosmetics market.

However, regulatory relief does not mean that products are exempt from inspection or sanitary controls.

Claims Restrictions

Claims are a critical part of determining whether a product can operate under the artisanal framework.

Only specified simple sensory or basic functional claims are permitted.

Higher risk claims are restricted according to the product category.

Examples of claims that may create regulatory concerns include claims relating to:

• Therapeutic effects
• Antibacterial activity
• Antiperspirant performance
• Disease treatment
• Medical effects
• Other higher-risk functional effects

Claims Compliance Considerations

Companies should therefore conduct a claim-by-claim assessment rather than if a product qualifies solely because of its formulation or manufacturing method.

Safety Responsibilities Remain with the Producer

The simplified framework does not transfer responsibility for safety to ANVISA.

Artisanal producers remain directly responsible for ensuring that their products meet applicable safety and quality requirements.

Key areas include:

• Raw-material selection
• Ingredient controls
• Manufacturing hygiene
• Equipment cleaning
• Production conditions
• Storage
• Contamination control
• Final-product assessment
• Product traceability
• Complaint handling

Small-scale production should not be interpreted as lower responsibility for consumer safety.

Labelling Requirements

Labelling is another important compliance area.

Labels for eligible artisanal products must include applicable information such as:

• Ingredient information
• Manufacturing date
• Expiration date
• Production address
• Net quantity
• Applicable warnings
• Required product information
• The statement "PRODUTO ARTESANAL"

The framework also establishes a maximum shelf life of 12 months.

Artisanal Cosmetics Label Checklist

Companies should review artwork before commercialization to ensure all mandatory information is correctly presented.

Sales Channels for Artisanal Products

The new framework also recognizes several sales channels.

Direct sales may occur through:

• Producer premises
• Artisanal fairs
• Events
• Door-to-door sales
• Producer-owned websites
• Social media
• Online marketplaces

Sales can also be supported by applicable family members or employees.

This is particularly relevant to small cosmetic businesses that rely heavily on Instagram, social commerce, websites and artisanal markets.

However, digital sales do not remove the underlying product-safety and labelling obligations.

Who Should Pay Attention?

The framework may be particularly relevant to:

Practical ANVISA Compliance Roadmap

A practical implementation approach can include:

1. Identify the product category.

Determine whether the product falls within one of the categories established under IN 474/2026.

2. Assess manufacturing conditions.

Confirm that production is predominantly manual, small-scale and controlled by the producer.

3. Review formulation risk.

Evaluate whether the formulation and manufacturing process meet the applicable low-risk criteria.

4. Review outsourcing.

Determine whether any production stage is outsourced and whether this affects eligibility.

5. Assess claims.

Review all front-label, packaging, website and social-media claims.

6. Conduct a safety review.

Confirm raw material, hygiene, storage and final-product controls.

7. Review labels.

Verify ingredients, dates, address, quantity, warnings and the required artisanal statement.

8. Establish self-life controls.

Ensure the product does not exceed the applicable 12-month maximum shelf life.

9. Review sales channels.

Confirm that online and offline sales arrangements remain consistent with the applicable requirements.

10. Prepare for inspection.

Maintain appropriate records and procedures to demonstrate compliance to sanitary authorities.

What Happens if a Producer Is Non-Compliant?

State and municipal health surveillance authorities retain inspection powers.

Non-compliance with the applicable sanitary requirements may constitute a sanitary infringement.

Producers should therefore maintain appropriate evidence demonstrated:

• Formulation details
• Raw material controls
• Production practices
• Sanitation procedures
• Safety measures
• Labelling compliance
• Storage requirements
• Product evaluations
• Required sales information

The absence of conventional ANVISA registration or notification should not be interpreted as an absence of regulatory oversight.

Frequently Asked Questions

1. What is RDC 1,045/2026?

RDC 1,045/2026 establishes Brazil's simplified sanitary and regulatory framework for eligible artisanal personal hygiene products, cosmetics and perfumes.

2. What does IN 474/2026 establish?

IN 474/2026 specifies eligible product categories, permitted claims and applicable warnings under the artisanal framework.

3. Do eligible artisanal cosmetics require ANVISA notification?

Eligible products covered by the framework are exempt from ANVISA registration/notification, provided they meet the applicable criteria.

4. Is an AFE required?

The framework provides that eligible artisanal producers do not require a Company Operating Authorization (AFE).

5. Are all handmade cosmetics eligible?

No. Products must satisfy the applicable criteria concerning category, manufacturing method, scale, risk, formulation, claims and other requirements.

6. Can artisanal products be sold online?

The framework permits direct sales through producer-owned websites, social media and marketplaces, subject to applicable requirements.

7. Are therapeutic claims allowed?

Therapeutic and other higher-risk claims are restricted under the framework. Producers should assess claims against the product category and IN 474/2026.

8. What is the maximum shelf life?

The framework establishes a maximum shelf life of 12 months for covered artisanal products.

9. Can production be outsourced?

The eligibility criteria require production to be controlled by the producer and do not permit outsourcing of production stages in a manner inconsistent with the artisanal framework.

10. Who can inspect artisanal producers?

State and municipal health surveillance authorities retain inspection powers, and non-compliance may constitute a sanitary infringement.

Conclusion

ANVISA's RDC 1,045/2026 and IN 474/2026 introduce an important new regulatory pathway for Brazil's artisanal cosmetics, personal hygiene and perfume sector.

The framework can provide significant regulatory relief for qualifying small-scale producers through exemption from conventional ANVISA registration/notification and AFE requirements.

However, eligibility depends on meeting specific conditions concerning product category, manufacturing method, scale, risk, claims, safety and labelling.

For artisanal cosmetic businesses, the key priority should therefore be to determine whether their products genuinely qualify before relying on the simplified framework.

Companies should also remember that regulatory simplification does not remove responsibility for product safety, quality, labelling or sanitary compliance.

A structured assessment can help producers take advantage of the simplified framework while reducing the risk of non-compliance with Brazil's evolving cosmetics requirements.

How Maven Regulatory Solutions Can Help

Maven Regulatory Solutions can support companies with:

• Brazil ANVISA cosmetic regulatory assessments
• RDC 1,045/2026 applicability assessments
• IN 474/2026 product category assessments
• Artisanal product classification
• Cosmetic formulation review
• Product safety assessment
• Claims and advertising review
• ANVISA regulatory strategy
• Cosmetic labelling and artwork review
• Ingredient compliance assessment
• Shelf-life assessment
• Manufacturing and sanitary compliance review
• Regulatory gap assessments
• Product portfolio screening
• Market-entry support
• Regulatory intelligence
• Lifecycle compliance support

Our approach helps artisanal producers, cosmetic brands and international companies understand Brazil's evolving regulatory framework and determine the appropriate pathway for safe, compliant and commercially viable cosmetic products in the Brazilian market.