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Much more than reducing time and cost, safety assessment can predict the occurrence of adverse effects depending on how the product is used by the consumer.
The company must follow all requirements imposed by the regulatory bodies of the country in which the product will be sold, but this alone is not enough to place a safe product on the market. A recent example that we can cite is the occurrence of temporary blindness and severe eye and skin irritation caused by Hair Braiding and Styling Ointment. Until 2023, this product was classified as Grade 1, with notification from ANVISA for market launch. The vast majority of companies that manufacture this product have not carried out any clinical safety tests, some have carried out standard skin compatibility and sensitivity clinical studies. These studies did not predict ocular exposure, and therefore did not predict the occurrence of eye damage.
RDC Nº814/2023 amends RDC Nº752/22 and establishes the conditions for the registration and commercialization of Hair Braiding and Styling Pomades. Among the conditions is the presentation of a SAFETY ASSESSMENT of the product, a dossier, not only the safety test, and also a declaration from the company certifying that the product is safe.
RDC Nº752/22 (amended by RDC Nº814/2023) describes that the company is responsible for “ensuring that the product does not constitute a health risk when used in accordance with the instructions for use and other measures contained in the product's sales packaging during its period of validity”.
The safety assessment includes the toxicological study of the ingredients present in the formulation before carrying out any clinical study. In addition to checking whether there are any regulatory restrictions on the use of ingredients, according to the restrictive lists, the study analyzes possible interactions between the molecules present in the formula, evaluates the manufacturing process, calculates the safety margin of each ingredient (MoS) and indicates which studies must be carried out to prove that the product is safe according to its method of use.
Your company can reduce the time and cost of launching your products with the analysis of your formulas carried out by a safety assessor (Safety Assessor).
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