Anvisa revokes the marketing of new ointments intended for fixing or styling hair.

This decision is related to the updated regulations for products in this category, which were implemented in September this year.

Anvisa has taken the decision to cancel 1,266 notifications of ointments used to fix or style hair, as specified in Resolution-RE 4,972, dated 12/28/2023. The measure is aligned with the initiatives taken by the Agency to ensure the availability of safe products, in accordance with the provisions of RDC 814, dated 09/01/2023.

The measure comes into force immediately, banning the sale of these products. In previous resolutions (RE 3.484, dated 09/14/2023, and RE 4.290, dated 09/11/2023), the Agency previously canceled the sale of 1,741 ointments based on Article 8 of RDC 814/2023.

The cancellations outlined in the resolution released on Friday (12/29) were planned as part of the ongoing actions by Anvisa and are not directly related to the most recent eye irritation events, which are currently under investigation.

Reason for cancellation

Article 8 of RDC 814/2023 establishes that regularization processes for rinse-free hair ointments that meet certain conditions will be cancelled:

• Have the physical form declared as “ointment”.
• Include the term “ointment” in the name or on the label, in any language.
• Be formulated with 20% or more ethoxylated alcohols, including Ceteareth-20 (CAS No. 68439-49-6).
• Be notified during the suspension indicated in Collegiate Board Orders 9 (02/10/2023), 30 (03/17/2023), 31 (03/22/2023) and 59 (06/19/2023).
• Holder companies must have at least one product under their ownership temporarily associated with a serious adverse event notified to Anvisa.

Registration of personal care products, cosmetics and perfumes

The registration of hair ointments is now mandatory under the Anvisa RDC 814/2023. This procedure, which involves a prior assessment, ensures that products comply with the necessary regulations before being released onto the market. Since the implementation of this resolution, products notified in the (Personal Hygiene, Cosmetics and Perfume Products Registration Automation System) SGAS are being canceled. The notification process previously used is no longer permissible for this category of products.

It should be noted that the manufacture or sale of cancelled and unauthorized products is considered a health infraction, subject to penalties in accordance with Law 6.437/1977.

Which ointments are authorized?

Anvisa emphasizes that only products listed as authorized can be manufactured and sold, according to Article 9 of RDC 814/2023. Failure to comply with this regulation is considered a health infraction, subject to the penalties of Law 6.437/1977. RE 3.566/2023 bans all products that are not on the List of Authorized Ointments.

Check out the page with guidelines on ointments for braiding or styling hair.

The Agency is working with local health authorities in the state of Rio de Janeiro to understand the problem and its seriousness. The aim is to take the necessary measures to protect public health and respond quickly to the risks identified.

Know more:

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