What ANVISA registration means for an importer

The short answer

ANVISA registration is not one procedure. For food, there are three possible tracks: Registro, a full registration needed before sale; Notificação, a lighter filing also needed before sale; and Comunicação de Início de Fabricação ou Importação, a notice to the local sanitary authority after which sale can start at once. For cosmetics, perfumery and hygiene products, the split is between Grau 1, notified, and Grau 2, registered.

Registro is the only track where ANVISA has to complete a technical review before the product can legally reach the market. Notificação lets a company sell as soon as the filing is submitted and accepted, without waiting for that review. Comunicação is not a review at all: it is a notice filed with a state, municipal or district sanitary authority, and sale can start on submission.

The current rules are RDC 843/2024 and IN 281/2024 for food, in force since 1 September 2024, and RDC 907/2024 for cosmetics, in force since 23 September 2024. Both replaced earlier norms: RDC 843/2024 replaced RDC 27/2010, and RDC 907/2024 replaced RDC 752/2022, along with RDC 841/2023 and article 13 of RDC 814/2023. Commercial material that still cites RDC 27/2010 or RDC 752/2022 by number is describing rules that are no longer in force, even though the underlying structure of tracks by risk level carried over into the new acts.

Which track applies to a specific product, and what each one requires, is covered section by section below.

Who has to deal with ANVISA, and who goes to MAPA instead

ANVISA is not the only agency involved in bringing a food product into Brazil. MAPA, the Ministry of Agriculture and Livestock, covers a separate set of categories, and placing a product with the wrong agency at the planning stage sends the whole filing down the wrong document trail.

MAPA's scope covers products of animal origin: meat, dairy, eggs, honey, fish and their derivatives, along with beverages in general and plant products sold unprocessed. ANVISA's scope covers goods with a sanitary risk profile: processed foods, packaged water, food additives, contaminants, pesticide residues and veterinary drug residues, plus cosmetics, perfumery, hygiene products, supplements and sanitising products.

Some commercial sources describe the boundary with a fixed percentage of animal content. That figure could not be traced to any published rule in the course of preparing this page, and the industry source that repeats it describes it as a general classification rather than a legal threshold. Treat the boundary as qualitative rather than numerical: it turns on what the product is and does, not on a fixed cutoff, and a product that mixes animal and plant ingredients, or sits near a category edge, is worth confirming with the relevant agency before a launch plan is built around an assumption.

A separate page covers MAPA's own registration requirements for products of animal origin and beverages: MAPA registration for products of animal origin.

Within ANVISA's own scope, the food rules and the cosmetics rules sit on separate legal instruments, with separate tracks and separate timelines, covered in the next two sections.

The three tracks for food

RDC 843/2024 sets out three tracks for food, each tied to its own annex, with IN 281/2024 supplying the category lists and forms.

Track	Filed with	Before sale
Registro (Anexo I)	ANVISA	The heaviest of the three tracks
Notificação (Anexo II)	ANVISA	The middle track, lighter than Registro
Comunicação de Início de Fabricação ou Importação (Anexo III)	Local sanitary authority (state, municipal or district)	No review; sale can start on filing

Registro is the heaviest of the three. Which categories fall into it is set by Anexo I of RDC 843/2024, and the pre-sale effect of each food track is not something the sources used for this page state in terms, so confirm it against the current annex for the product in question.

Notificação applies to a middle group of products, filed with ANVISA but without the full technical review that Registro requires. Supplements containing probiotics or enzymes fall into this track specifically, under article 33(VI) of RDC 843/2024, rather than into the lighter Comunicação track that some importers expect for a supplement style product.

Comunicação de Início de Fabricação ou Importação is the lightest of the three, and it is not filed with ANVISA at all. The form goes to the state, municipal or district sanitary authority, using the model in Anexo XI of IN 281/2024. There is no waiting period built into the procedure: a company can start selling once the notice is filed, the filing does not expire, and the authority keeps the right to inspect after the fact rather than before.

The category list currently covered by Comunicação includes chocolate and cocoa products, candy and chewing gum, vegetable oils and fats, mineral and natural water, and a group of bakery items: breads, biscuits, whole grain and processed cereals, brans, flours and pasta. This list comes from a municipal sanitary authority's published citation of IN 281/2024, not from the official gazette text directly, since the Diário Oficial page for IN 281/2024 did not render for direct citation while preparing this page. It should be treated as reliable but secondary, and checked against the current Anexo III before a product is assumed to qualify.

For planning purposes, the distinction that matters is simple. Registro sets the launch date around ANVISA's own review. Notificação and Comunicação do not. Placing a product in Registro when it in fact qualifies for a lighter track, or the reverse, changes the timeline by months either way.

Cosmetics, perfumery and hygiene products: Grau 1 and Grau 2

Cosmetics, perfumery and personal hygiene products follow RDC 907/2024, in force since 23 September 2024, which replaced RDC 752/2022, RDC 841/2023 and article 13 of RDC 814/2023 under its own article 51. The risk based split from the earlier rules carried over: Grau 1 products are notified, Grau 2 products are registered.

Grau 1 covers the general run of cosmetics, perfumery and hygiene products, meaning those not named on the Grau 2 list below. The filing is a Notificação, and a company can sell once it is submitted and accepted, without waiting for ANVISA to complete a review. The government services page for this filing states an estimated service time of up to 3 calendar days. That figure is the portal's own administrative estimate for processing the filing, not a deadline written into the text of RDC 907/2024 itself.

Grau 2 is defined by a specific list in article 34 of RDC 907/2024: nine categories, named individually. Whether other annexes of the resolution extend Grau 2 beyond that article was not confirmed while preparing this page, so treat article 34 as the list to check first rather than as a closed universe.

Category	Portuguese term (article 34)
Tanning product	bronzeador
Hand sanitising gel	gel antisséptico para as mãos
Hair straightening product	produto para alisar os cabelos
Combined hair straightening and dyeing product	produto para alisar e tingir os cabelos
Hair waving product	produto para ondular os cabelos
Sunscreen	protetor solar
Sunscreen for children	protetor solar infantil
Insect repellent	repelente de insetos
Insect repellent for children	repelente de insetos infantil

Two points are worth stating precisely, because older material written against RDC 752/2022 sometimes gets them wrong. There is no separate anti-ageing category on this list: if a product is not also a sunscreen or another named item, article 34 does not place it in Grau 2 on that basis alone. And there is no general category for children's products: the only two children's items named are sunscreen and insect repellent for children specifically, not a broader class covering other cosmetics marketed for children.

Grau 2 requires ANVISA to complete a full technical review before the product can be sold. The government services page states an estimated service time of up to 150 calendar days for this filing, again the portal's own administrative estimate rather than a deadline set in the text of the RDC.

For a launch plan, the practical effect is that a sunscreen, a tanning product, a hair straightening or waving product, a combined straightening and dyeing product, an insect repellent, or a hand sanitising gel needs to be budgeted for a Registro timeline from the outset, while a product outside the article 34 list is filed as a Notificação instead. Where a formulation combines a named function with something else, such as a sunscreen that also claims to repel insects, checking which categories on the list it touches is worth doing before a launch date is set.

AFE and the responsible technical professional

Separately from the registration status of any single product, a company that manufactures, distributes, stores, transports, imports or exports products covered by Lei 6.360/1976 needs its own authorisation to operate: the Autorização de Funcionamento de Empresa, AFE, granted under article 50 of that law. Article 1 of the same law places hygiene products, cosmetics and perfumes within its scope, so an importer of those categories needs AFE regardless of whether the specific product it imports is a Grau 1 or Grau 2 item under RDC 907/2024.

The law also requires a responsible technical professional. Article 8 states that no manufacturing establishment can operate without the effective assistance and responsibility of a legally qualified technician, and article 53 requires a sufficient number of such professionals for the operations involved.

Food products and supplements sit outside this particular requirement. Food is not among the categories listed in the scope of Lei 6.360/1976, so the AFE requirement is generally read as not applying to it. That follows from the scope list rather than from an explicit exclusion, and a company bringing in food or supplements follows the RDC 843/2024 and IN 281/2024 track described above.

On the certificate question specifically: ANVISA's own published FAQ on the Certificado de Boas Práticas de Fabricação, CBPF, the Brazilian equivalent of a GMP certificate, states that holding the certificate is not mandatory for a company's regular operation, even though compliance with the underlying manufacturing practices is expected in substance. Whether a specific Grau 2 registration separately requires a CBPF from the foreign manufacturing site as a condition of that filing was not something confirmed while preparing this page, and it is worth checking case by case rather than assuming either answer.

Dietary supplements

Dietary supplements run on their own pair of rules, RDC 243/2018 and IN 28/2018, which set out positive lists of permitted constituents, usage limits, permitted claims and the complementary labelling requirements specific to this category. A public consultation opened in April 2025, CP 1325/2025, proposed amendments to both instruments together with RDC 839/2023, which confirms they were in force as of that date. Their status as of today has not been independently reconfirmed for this page.

An ingredient that is not on the positive list cannot be added to a supplement formulation on the strength of approval abroad. It has to go through a separate procedure first, Autorização de Uso de Novos Alimentos e Novos Ingredientes, under RDC 839/2023, before it can be used.

Since RDC 843/2024 and IN 281/2024 took effect on 1 September 2024, supplement notifications have needed more supporting documentation than before, including stability data and certificates of analysis. The same source states that the positive lists in RDC 243/2018 were not themselves changed by that transition, and that a separate adjustment period for supplements ran through 1 September 2025. All three points come from a Brazilian testing laboratory's published summary rather than from the acts.

One category gets a specific procedural note under the current food rules. Supplements containing probiotics or enzymes go through Notificação, under article 33(VI) of RDC 843/2024, rather than through the Comunicação track available to some other food categories.

Sources

• Food tracks and the Comunicação route: RDC 843/2024, official English PDF, gov.br/anvisa, articles 3, 30, 33(VI), 40(IV) and 41; in force since 1 September 2024, replacing RDC 27/2010. Gov.br/anvisa page on dispensa de registro for the filing point and no-wait rule for Comunicação.
• Comunicação category list (chocolate and cocoa products, candy and chewing gum, vegetable oils and fats, mineral and natural water, bakery items): a municipal sanitary authority's published citation of IN 281/2024. Secondary source; the official gazette text of IN 281/2024 did not render for direct citation while preparing this page.
• Cosmetics tracks and the Grau 2 list: RDC 907/2024, official PDF, antigo.anvisa.gov.br, articles 34 and 51; in force since 23 September 2024, replacing RDC 752/2022, RDC 841/2023 and article 13 of RDC 814/2023. Estimated service times of 3 and 150 calendar days from the gov.br/servicos pages for cosmetics Notificação and Registro.
• AFE and the responsible technical professional: Lei 6.360/1976, planalto.gov.br, articles 1, 8, 50 and 53.
• CBPF (GMP certificate) not being mandatory: ANVISA's published FAQ on Certificado de Boas Práticas de Fabricação, gov.br/anvisa.
• Dietary supplements: RDC 243/2018 and IN 28/2018, status as of the CP 1325/2025 public consultation, gov.br/participamaisbrasil, opened 17 April 2025. Documentation changes for supplement notifications after 1 September 2024: a specialised regulatory consultancy's published summary, secondary source.
• ANVISA/MAPA boundary: a food safety industry publication, secondary source. A commonly cited numerical threshold for animal ingredient content could not be traced to a published rule and is not used on this page.

Facts on this page were checked on 7 September 2026. RDC 843/2024, IN 281/2024 and RDC 907/2024 all took effect in September 2024, and Brazilian sanitary regulation is revised often. Check the current text of each act before relying on any date, track or category listed here.