Overview
Building a cosmetic safety dossier is no longer just a local requirement. With increasing alignment to international standards, ANVISA now demands a well-structured set of documents proving product and ingredient safety — especially for functional cosmetics. In this blog, we’ll show you how to create a robust dossier based on Brazilian regulations and global benchmarks such as ISO 16128, EU CosIng, and SCCS guidance.
Introduction
Cosmetic safety is a regulatory priority both in Brazil and globally. Although cosmetics are not considered medicines, they must guarantee safe use, especially when applied to skin, mucous membranes, or near the eyes.
With the publication of RDC No. 752/2022, ANVISA reinforced the need for toxicological evaluation and traceability of ingredients, aligning Brazil more closely with international practices. For companies, this means that the safety dossier is no longer optional — it’s a strategic requirement.
What is a Cosmetic Safety Dossier
It is a structured document that compiles scientific, toxicological, and technical data proving the safety of a cosmetic product under normal or foreseeable use.
Minimum required content:
- Complete formulation (qualitative and quantitative)
- Toxicological profiles of ingredients (e.g., LD50, irritation, sensitization)
- Purity and origin of raw materials
- Microbiological specifications
- Exposure assessment (frequency, target population, body area)
- Safety studies (in vitro, clinical, or literature-based)
- Safety Assessor Report signed by a qualified toxicologist
What to Consider for International Convergence
For companies exporting or aligning with global markets, it’s essential to follow references such as:
International Reference | Application in Brazil |
EU CosIng / SCCS Notes of Guidance | Ingredient safety evaluation and restrictions |
ISO 16128 | Defines natural and organic cosmetic ingredients |
ISO/TR 24422:2021 | Guides safety and efficacy testing |
Colipa Guidelines | Standard for dermatological and ocular testing |
Toxicological Evaluation: A Critical Point
- Must consider
- Exposure routes (dermal, oral, inhalation)
- Target population (adults, infants, pregnant women
- Final ingredient concentration
- Interaction between ingredient
- History of adverse reactions (cosmetovigilance)
✅ Tip: Keep safety data and scientific literature from suppliers updated and validated.
Best Practices for Dossier Preparation
- Structure in clear sections (technical sheets, studies, certificates)
- Use reliable and current scientific sources
- Include a formal safety declaration signed by a qualified professional
- Ensure traceability of data and suppliers
- Use digital platforms to archive and update dossiers
Conclusion
A complete and internationally-aligned cosmetic safety dossier is more than a regulatory requirement — it is a trust-building tool that protects your brand and opens doors to new markets.
For companies in the sector, investing in a strategic dossier process provides
- Faster product approvals
- Fewer regulatory setbacks
- Enhanced brand reputation
- Readiness for export and global audits
Final checklist for your cosmetic safety dossier:
✅ Updated toxicological data
✅ Exposure evaluation by use and target group
✅ Scientific evidence supporting claims
✅ Signed report from a qualified assessor
✅ Alignment with international norms
GRP Brazil
If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
References
Learn more about Anvisa. For the link, click here
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.