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ANVISA approves alternative methods to animal testing

The Brazilian Health Surveillance Agency (ANVISA) adopted on July 30, 2015 a Resolution [1] which should reduce the need to use animals in tests required for the registration of drugs, cosmetics and health and cleaning products, among others.

"Pursuant to the new rule, alternative methods to animal testing already recognized in the country by the National Council for the Control of Animal Experiments (CONCEA) will lead companies to stop using animals since these methods provide the same levels of safety and efficacy assessments of products. In practice, a company that needs to perform an eye irritation test, for example, shall use alternative methods instead of testing on animals, as for eye irritation there are validated alternatives in Brazil," says the Agency.

CONCEA is the entity that is responsible for the recognition of alternative methods in Brazil. To date, CONCEA has already approved 17 alternative methods. Among them are alternative procedures for assessing skin irritation, ocular irritation and acute dermal toxicity. In September last year, CONCEA published the list of these 17 validated methods, and concerned companies have until 2019 to fully stop the corresponding animal tests.

Resolução Normativa Nº 18, de 24 de setembro de 2014

ANVISA’s recent decision ensures that the alternative methods validated by the CONCEA are accepted by the Agency, even if they are not quoted in specific product standards and even if a product standard does require animal testing.

The new resolution was published in the Official Gazette on August 10, 2015:

Resolução - RDC Nº 35, de 7 de agosto de 2015 - ANVISA

Source: ANVISA


[1Resolução - RDC Nº 35, de 7 de agosto de 2015 - ANVISA, que dispõe sobre a aceitação dos métodos alternativos de experimentação animal reconhecidos pelo Conselho Nacional de Controle de Experimentação Animal - CONCEA

© 2015 - Brazil Beauty News -

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