The determination is made after investigations have progressed and the substance potentially responsible for the vision damage has been discovered. Since February, all items in the category have been banned after a spike in use-related eye damage cases.
The National Agency for Sanitary Surveillance (Anvisa) once again published updates on hair modeling ointments. On Friday (17.03), the agency outlined a list of products that can return to the market. This measure annuls the decision, published on February 10, which prohibits the marketing and preventive use of all hair ointments.
Why ointment?
The decision follows progress in an investigation that raised with the agency the possible substance that caused burning eyes and temporary blindness. According to the device, “technical work has already determined that most of the products that caused adverse effects delivered high concentrations of Ceteareth-20.”
See the full list here.
The regulatory processes for many products have also been re-evaluated, resulting in the cancellation of more than 600 of them. In addition, inspection procedures have been published for specific products and ointments containing a concentration of Ceteareth-20 equal to or greater than 20% in their formulations have been identified. Thus, of some 2,500 initially regulated products, there are currently some 930 in a position to return to the market.
It is ethoxylated cetostearyl alcohol, which acts as an emulsifier and stabilizer in cosmetic formulas. According to the artwork, the maximum allowed concentration of the component is less than or equal to 20%. Therefore, ointments that complied with current regulations, that have not had reports of serious adverse events and are in the normal settlement process with Anvisa, can be marketed and used again.
Next steps
Products authorized to return to the market must accompany their operations with liability clauses that establish that the product has not been involved in any serious adverse events since it entered the market and that guarantee quality and safety after careful evaluation. The companies have 30 days to present the request, otherwise Anvisa will revoke the authorization.
The agency also decided that companies must develop a communication plan to make it easier for consumers and professionals to understand and disseminate how to use the products correctly.
Investigations are ongoing, with laboratory analysis of products, evaluation of manufacturing processes, inspections of manufacturers, adoption of specific regulatory measures, meetings with specialists with notorious knowledge in the field, interaction with international health authorities, and follow-up on event notifications. related to styling, braiding or setting pomades, says Anfisa.
