The safety of cosmetics is a growing priority for both regulators and consumers. In Brazil, Anvisa establishes clear guidelines on toxicological evaluation and safety requirements for ingredients and finished products. This article explores what is currently required, with a focus on RDC 752/2022, addressing critical points for companies and professionals working in the sector.

Cosmetic toxicology is the study of the adverse effects that a substance or mixture can cause when applied to the human body. It involves a detailed analysis of the safety of the ingredients, the final formulation and the expected exposure during normal use of the product.

This assessment considers:

• Concentration and function of the ingredients;
• Route of exposure (topical, accidental oral, inhalation);
• Frequency and time of use;
• Target population (adults, children, pregnant women);
• Available toxicological data (in vitro, in vivo or computer modeling).

Current regulatory requirements – RDC 752/2022

RDC 752/2022 regulates the regulation of personal care products, cosmetics and perfumes in Brazil. It replaced previous standards and introduced a clearer approach to the need for proof of toxicological safety.

Main points:

• Mandatory Safety Dossier for Grade 2 products (with specific claims, use in sensitive areas, or with potential risk);
• Presentation of toxicological data on ingredients, especially for new substances or those with restricted use;
• Use of scientific literature, international databases (such as the European Union’s SCCS) and validated alternative methods;
• Prohibition of substances listed on the List of Prohibited Substances (Annex III of IN 76/2020).

Assembling a Safety Dossier

The safety dossier is a technical document that compiles relevant information to prove that the product is safe under normal conditions of use.

Essential elements:

• Technical data sheet and ingredient specifications;
• Information on the purity, impurities and origin of the raw material;
• Toxicological Risk Assessment (TRA);
• Consumer exposure profile;
• Stability considerations and chemical interactions between components.

Alternatives to animal testing

With the advance of science and ethical pressure, there is a growing movement towards the use of alternative methods to animal experimentation, such as:

• In vitro tests (e.g. eye irritation test on an artificial cornea model);
• Computational models (QSAR);
• Historical data on safe use.

These methods are accepted by Anvisa as long as they are validated by international bodies such as the OECD.