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News on Worldwide Cosmetics Regulations - Focus Brazil

Dr. Annelie Struessmann – Jul 21, 2010

The National Health Surveillance Agency (Agēncia Nacional de Vigilância Sanitária – ANVISA) is the Brazilian regulatory agency with responsibility for ensuring hygiene and safety of drugs, food, medical devices and cosmetic products. The Agency maintains a website with all pertinent information on regulatory requirements towards the products and industries of focus and it also offers the application procedures for fulfilling the necessary compliance steps. Although an English edition of the website is provided, this does not contain all comprehensive information, therefore for all regulatory principles and application steps it is necessary to refer to the site edited in Portuguese language1. Brazil is a member of Mercosul [Mercado Comum do Sul (port.) - Southern Common Market - Mercosur (span.)]. As such the country adopted and translated the Mercosur resolutions on cosmetics and personal care products into national law during the past years. A list of GMC (Grupo Mercado Común) resolutions with the respective translation is given on ANVISA’s website2. A key element of the cosmetics legislation is the pre-marketing approval for manufacturing sites with requirements for local manufacturers, importers and distributors. Good manufacturing practices apply according to the standard described in the Mercosur Handbook...

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