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Before being placed on the Brazilian market, every cosmetic product must follow ANVISA RDC resolution No. 752/22.

The formulator must use ingredients that are permitted for use, with concentrations within the maximum limit permitted according to ANVISA's restrictive lists.

Furthermore, it must be formulated so that there is no chemical reaction between the ingredients, with changes to their intrinsic properties.

The formulated cosmetic product must be stable during the product's estimated shelf life and must not be subject to contamination by microorganisms during the product's use by the consumer.

These are the standard steps in the development of any cosmetic. However, even following RDC No. 752/22 and carrying out clinical safety trials in accordance with the ANVISA Safety Guide, there are still many cases of irritation, allergies, blindness and wound formation on the scalp and skin caused by cosmetic products.

These occurrences can affect the company's sales, tarnish the brand, and even require the product to be removed from the market and cause sales to be prohibited. How to avoid this critical point for cosmetic companies and how to reduce this public health problem?

In Europe (through regulation (EC) 1223/2009), and recently in the United States (through the FDA MoCRA Act of 2022), it is mandatory that a safety dossier drawn up by a certified senior professional be attached to the product registration (“ safety advisor”).

Even before carrying out any test, clinical or non-clinical, to prove safety, this certified professional (or safety evaluator) evaluates the frequency, method of use, quantity of the product along with the concentrations and intrinsic properties and toxicological profile. of each ingredient in the cosmetic formulation.

After this first analysis, the safety assessor decides whether there is a need to carry out any further tests.

If necessary, it indicates the best testing protocols validated and accepted by regulatory bodies in accordance with the testing strategies already established by the OECD (Organization for Economic Co-operation and Development, OECD).

Do you want to know more about this topic and how to correctly launch a product on the market?

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