According to the resolution DRC 07/2015 of the 10th of February 2015, a large part of products that are classified as risk grade 2 [1] will now be exempt from registration. These products will only have to be notified to health authorities before being placed on the market, with the exception of product categories that are submitted to specific regulations (sunscreens, insect repellents, products for children, as well as alcohol gel products and hair straighteners). Products classified as risk grade 1 were already exempt from registration.
Shorter delays
Advance notification is a simplified administrative procedure to inform ANVISA about the intention of placing a product on the market. As a consequence, products of Grade 1 and Grade 2 submitted to the procedure can be placed on the market as soon as the notification is confirmed on the ANVISA’s web portal. Products of Grade 2 that remain subject to registration can only be placed on the market when the official registration is granted and published in the Official Gazette. Registration generally requires about 60 days, while the notification is usually completed within 48 hours.
The control of products exempt from registration will be carried out through procedures including periodic and random controls, as well as market monitoring including the control and analysis of products available on retail shelves.
Products with the higher level of risk
Products that still need to be registered are listed in Annex VIII of Resolution RDC 07/2015. The list includes tanning products, hair straightening products, sunscreens, insect repellents, antiseptic hand gels and children’s products. “Considering their higher level of risk, these products remain submitted to analyses performed by the Agency,” said the AVINSA.
The new rule aims at providing more flexibility to the sector and enabling the Agency to focus its analyses of products with the higher level of risk.
Red tape reduction
“This is a historic change for the personal care, perfumery and cosmetic industry,” said the Brazilian Association of the Cosmetic, Toiletry and Perfumery Industry (ABIHPEC).
"We have debated this issue since 2008 and we celebrate now another step forward for the Brazilian industry, which comes closer from global practices. This achievement will provide greater predictability to the industry to launch products, resulting in a more competitive and innovative market. It will also speed up consumer access to the industry’s products and help improve health, well being and quality of life," said João Carlos Basilio, President of the ABIHPEC.
Technical and safety requirements applicable to cosmetic products remain unchanged. The person responsible for marketing cosmetics must “ensure that the product does present any risk to health when used in accordance with the instructions," says the article 10 of the new resolution.
