Anvisa authorizes the return of the sale of a restricted list of hair ointments; see which ones

The National Health Surveillance Agency (Anvisa) authorized, this Monday (20), the return of the sale of a restricted list of pomades for braiding, modeling or fixing hair. The list is available at Anvisa website.

The agency maintained the precautionary prohibition for products that are not included in the list of authorized products, considering reports of serious adverse events related to eye poisoning.

According to Anvisa, the investigation remains ongoing, but the technical work has already identified that most of the products that caused serious ocular adverse effects present high concentrations of the substance Ceteareth-20.

As a precautionary measure, the precautionary prohibition was maintained for products that are in this condition, allowing the return to the market of part of the products that have this substance below the 20% concentration in their formulas.

Ceteareth-20 is widely used in cosmetic formulations, where it acts as an emulsifying agent. However, it is observed that most products that caused serious ocular adverse effects have high concentrations of Ceteareth-20, which justified the exclusion of products containing up to 20% of the substance in their formulation from the current precautionary measure, according to Anvisa .

Still as a result of the investigation, the regularization processes of several products were reassessed, which resulted in the cancellation of more than 600 processes.

Anvisa informs that inspection measures have been published for specific products and ointments that have a concentration of Ceteareth-20 equal to or greater than 20% in their formulations have been identified. Thus, from the total of approximately 2,500 products that were initially regularized, today there are a total of approximately 930 products that can be returned to the market.

Since the beginning of the year and as part of the investigation, Anvisa has already canceled the authorization of 635 products for reasons such as the use of an unauthorized or out-of-limit ingredient, lack of a statement from the company’s technical manager and failure to submit requested studies and tests.

Understand

The initial decision of precautionary prohibition of all ointments for braiding, styling or fixing hair was adopted due to the growing number of reports of serious adverse events reported to Anvisa and the approach of the Carnival festivities. In these festivities, the use of hairstyles tends to increase, therefore, it was necessary to adopt effective and urgent sanitary measures so that new outbreaks of eye poisoning do not occur.

However, considering that this initial scenario was surpassed and in view of the diligence and investigations carried out, it was possible to reassess the precautionary interdiction measure of all products.

Thus, Anvisa decided to keep off the market, as a precautionary measure, only the products that caused the serious adverse events, in addition to those whose sanitary regularization processes are in disagreement with the current regulations and those that have the concentration of Ceteareth-20 ≥ 20%.

Therefore, the products released are those that have a concentration of less than 20% of the ingredient Ceteareth-20 in their composition, which have not had reports of serious adverse events and whose regularization processes have not been canceled by the Agency.

In a note, Anvisa stated that it will continue to monitor all cases of adverse effects associated with hair ointments and act on those that may cause new events.