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Regulatory - 07/2018

Brazil has agreed upon simplifying the regulations of children cosmetics

On 3rd July 2018, the Brazilian cosmetics sector has been introduced with another regulatory breakthrough by the ABIHPEC. A modification to Resolution RDC 07/2015[1] was approved by Jarbas Barbosa, the president of Health Surveillance Agency (ANVISA). The purpose of this amendment was to simplify the regulations that are designed for the children cosmetic products. Now, this amendment has enabled the production companies to place their products on the market without worrying about any kind of registration.

The regulatory move is made based on the technical and administrative requirements of the people. And the amendment is applicable to perfumes, cosmetics, and toiletries that are placed on Brazilian market.

The children’s products are now migrated to the registration exemption from compulsory registration and this is the major change made as a result of public consultation. There are only a few products left that are subject to registration such as hair straighteners, insect repellents, antiseptic gels for hands, and sunscreens. The children won’t suffer from any kind of problem as a result of this move. The Manager of GHCOS said that the registration is not required for these products because they are considered to be less harmful in most parts of the world.

The ABIHPEC claims that the efficacy and safety requirements won’t be affected by the regulatory change. In fact, the regulatory is playing an essential role in enhancing the innovation by reducing the bureaucracy.

This breakthrough is going to facilitate the customers by providing them an increased access to key health products. And it will also enable the personal care market to enjoy a better predictability for launching the new items. Renata Amaral, the manager of technical and regulatory affairs at ABIHPEC says that we are focused on simplifying the administrative processes and we are trying to meet the standards of most advanced countries by introducing new regulations for the low-risk products.

The Board of Directors at ANVISA claim that the need to increase in-market control is reinforced by the changes that are made in the RDC 07/2015. According to the Brazilian law since 1976, the manufacturers are required to follow all the rules and regulations that are implied by the regulatory authorities. And before the products are placed on the market, the manufacturers are supposed to conduct several tests to make sure that the products are safe to use.

It is just an administrative change that is made to the procedure of regulating Children’s Products. It means that they are not going to modify the technical requirements that are provided by RDC 15/15.


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