The regulatory move is a consequence of the public consultation on the technical and administrative requirements applicable toiletries, cosmetics and perfumes placed on the Brazilian market.
"The main change resulting from the public consultation is the migration of children’s products from compulsory registration to registration exemption. The only products remaining subject to registration are: sunscreens, insect repellents, hair straighteners and antiseptic gels for the hands. The move will not put children at risk. These products are considered as low risk and, in most parts of the world, registration is not required," said João Tavares Neto, Manager of the Hygiene, Perfume, Cosmetic and Sanitation Products Directorate (GHCOS) at ANVISA.
According to ABIHPEC, the regulatory change does not alter efficacy and safety requirements but reduces bureaucracy thus enhancing innovation.
"This breakthrough is very important for providing consumers with an increased access to key health products; and for the Brazilian personal care industry, which will enjoy a greater predictability for the launch of new products. We are making progress in simplifying administrative processes and gradually putting the sector in line with the more advanced countries in relation to low risk products," said Renata Amaral, manager of Technical and Regulatory Affairs at ABIHPEC.
According to ANVISA’s Board of Directors, the change in the RDC 07/2015 reinforces the need to increase in-market control. As required by Brazilian law since 1976, it is the responsibility of the manufacturer to comply with all the rules and regulations and to carry out all the tests to place safe products on the market.
The improvement of the procedure for regulating Children’s Products only refers to an administrative change, this means that all the technical requirements provided by RDC 15/15 will not be modified.