Anvisa Post-Market Surveillance: Handling a Cosmetic Complaint

What changed for cosmetics in Brazil in 2025?

On 28 August 2025 Anvisa’s RDC 894/2024 came into force. It replaced RDC 332/2005 and made one thing mandatory for the first time: reporting serious adverse events caused by cosmetics. The duty sits with the company that holds the product’s registration or notification, not with the shop that sold the jar.

I chose this topic because brands plan the wrong half of Brazil. They spend months on the Anvisa route into the market and almost nothing on the day the first complaint arrives, which is the day a product can leave the market again.

Anvisa had reasons to tighten the rule. In 2023 it received 654 reports of adverse events with cosmetics, about 7.5 times the 2022 figure, and 85% of them were eye reactions associated with hair-styling products. In February 2023 it banned all hair pomades in Brazil, every brand, including ones nobody had complained about. In March it let back only the products on an authorised list.

Who answers a complaint about your cosmetic in Brazil?

The registration or notification holder answers, and Anvisa’s own Q&A says this holds whatever the commercial arrangement is. If your Brazilian importer registered the product in its own name, the database and the deadlines are the importer’s, while the brand on the jar is still yours.

What the holder must have in place under RDC 894/2024:

The call centre can be a contractor. The responsible person cannot. For a foreign brand that is the real decision: either your importer holds the product and runs cosmetovigilance for it, or you need your own holder in Brazil and a resident specialist who can read your formula.

What are the deadlines once a complaint arrives?

It depends on what the complaint turns out to be. A serious adverse event must reach Anvisa through Notivisa within 20 calendar days of your company learning about it. A safety signal, a pattern across several reports, has 15 business days.

Two things here catch people out. First, consumers can report directly through e-Notivisa with a gov.br account, and the report is forwarded to the manufacturer or distributor, so Anvisa may know about your complaint before your team does. Second, misuse goes into the database too. I would not let anyone on a team decide alone that “the customer used it wrong, so it doesn’t count”. Write it down and let the responsible person assess it. I also count the 20 days from the moment a complaint reaches anyone working for the brand, including a contractor’s call centre, because “we only saw the email later” will not move the date.

What can Anvisa do after a complaint?

While causality is being assessed, RDC 894/2024 allows a temporary suspension of sales. Under Law 6.360/1976 Anvisa can suspend the manufacture and sale of a registered product suspected of harming health. Inspections can come unannounced. A breach of the rule is a sanitary infraction under Law 6.437/1977, and the penalties run from a warning through fines to cancellation of the registration.

Fines double for a repeat infraction. I have found no recall deadline in days written for cosmetics. The good manufacturing practice rule, RDC 48/2013, says the authorities must be told of a recall decision immediately, and the final recall report has to reconcile the quantities distributed with the quantities recovered. Anvisa publishes recalls, and the order often follows the company’s own announcement: in 2025 Rioquímica recalled products with preservatives above their limits, triclosan at 0.512% against a 0.3% maximum.

What should a foreign brand set up before the first complaint?

My list, in the order I would do it:

1. Write into the distribution contract who holds the registration and who is the responsible person.
2. Put the customer service and cosmetovigilance contact on the label in Portuguese, and test that someone answers it.
3. Give the responsible person in Brazil the technical file: formula, safety and stability data, batch coding. RDC 752/2022 already requires the holder to keep most of it available to Anvisa, and nobody can assess causality without it.
4. Keep batch records for at least a year after each batch expires, so you can recall one batch and not the whole brand.
5. Register with Notivisa before you need it.

My view: RDC 894/2024 is a fair rule, and a brand that already watches its products will barely notice it. What it punishes is distance: a formula that lives abroad, a holder in Brazil who cannot read it, and a complaint inbox nobody checks in Portuguese. If that describes your setup, fix it before the first shipment, not after the first complaint. If you are still choosing who holds your products in Brazil, our Anvisa page explains how we handle registration.

Who answers the phone for your brand in Brazil today: your importer, a call centre or someone who knows the formula? Write to me through the form below.

Sources

• RDC 894/2024, good cosmetovigilance practices, Diário Oficial da União, 28 August 2024
• Questions and answers on RDC 894/2024, 4th edition, Anvisa, October 2025
• New rule makes reporting serious adverse events with cosmetics mandatory, Anvisa, 11 August 2025
• Reporting a problem with a regulated product (e-Notivisa), gov.br
• Post-market monitoring bulletin, second half of 2023, Anvisa
• Hair pomades: products allowed back on the market, Anvisa, March 2023
• Recall of Rioquímica cosmetics, Anvisa, September 2025
• RDC 48/2013, good manufacturing practices for cosmetics, Ministry of Health
• Law 6.437/1977, sanitary infractions and penalties, Federal Senate
• Law 6.360/1976, health surveillance of products, Federal Senate
• RDC 752/2022, cosmetics regularisation, São Paulo State Health Department copy