New Distributor: Who Holds Your Anvisa Cosmetic Registration?
Changing your Brazilian distributor? Xenia explains when an Anvisa cosmetic registration can move, the 180-day filing window and what to agree before signing.
Brazil
ANVISA cosmetic registration in Brazil
How it works
Five steps from an inquiry to a registered certificate
Typical timelineDays for notification, 6 to 12 months for registration
You send the request
Product name, HS code and technical data, enough for us to scope the route.
Your part
We confirm the route
A specialist confirms the regulations that apply and the document type your product needs.
Our part
Documents and contract
You send the supporting documents; we sign a contract with fixed scope and timeline.
Both sides
Testing and inspection
Laboratory testing, factory inspection and customs clearance, coordinated by us.
Our partYou receive the certificate
Issued, registered, and delivered. We close the project.
Your part
- One named specialist One person owns your file from the first email to the registered certificate.
- Route fixed before testing Scheme, standard and laboratory are settled before a sample is tested, which is where most re-testing starts.
- Registered documents Certificates and declarations issued by accredited bodies and entered in the official register, where customs can look them up.
- Measured by the document The engagement ends when the certificate is issued and registered, whatever the hours took.
The short answer
Your grade decides notification or registration
Cosmetic registration in Brazil is governed by ANVISA Resolution RDC 907/2024, which replaced RDC 752/2022. Cosmetic registration in Brazil is governed by ANVISA Resolution RDC 907/2024, which replaced RDC 752/2022 and splits cosmetics, personal-hygiene products and perfumes into two grades. Grade 1 products go to market by electronic notification. Grade 2 products, those with a specific claim or a restricted ingredient, file technical and safety data with the notification, and a listed subset, sunscreens and products for children among them, still goes through registration, a dossier review that takes months. The grade comes from the regulation and the label copy, and one claim can move a product. In every case the holder is a Brazilian company with a CNPJ and an AFE (Autorização de Funcionamento de Empresa) from ANVISA, and finding that holder is often the longest lead item.
- Two grades RDC 907/2024 splits cosmetics, personal-hygiene products and perfumes into Grade 1 and Grade 2. Grade 1 products go to market by electronic notification.
- Grade 2 files its data A specific claim or a restricted ingredient means technical and safety data go in with the notification. A listed subset, sunscreens and children’s products among them, needs registration: a dossier review that takes months.
- One claim can move a product The grade comes from the regulation and from the label copy.
- A Brazilian holder In every case the holder is a Brazilian company with a CNPJ and an AFE (Autorização de Funcionamento de Empresa) from ANVISA. Finding that holder is often the longest lead item.
Grade 1 or 2
RDC 907/2024 splits cosmetics into two grades. A moisturiser without claims is Grade 1. An SPF, an anti-dandruff claim or a restricted ingredient puts the product in Grade 2.
Settle the label copy before the grade, and the grade before printing.
Days or months
Grade 1 and most Grade 2 products clear by electronic notification in days to weeks. Listed Grade 2 products, sunscreens and children's products among them, wait 6 to 12 months for dossier review.
One word on the label, such as 'anti-wrinkle', can move the grade.
The AFE holder
The holder is a Brazilian company with a CNPJ, an ANVISA AFE covering cosmetics import, and a local health licence. It answers to ANVISA for the product and keeps the technical file.
Check the AFE on ANVISA's public consultation before dossier work starts.
Already started elsewhere
Stuck without a holder whose AFE covers your cosmetics?
The holder sets the critical path most often. The importer lined up has no AFE for cosmetics, or holds one for medical devices, which does not cover them. Other files stop on the formulation: it passes the EU annexes but contains a preservative, colourant or UV filter outside Brazil's own lists. A claim added late moves the product into Grade 2. The EU Product Information File may have gone in without Brazil's structure and Portuguese labelling.
The science comes from you. The formulation with INCI names, the stability data, the safety assessment and the microbiological results exist only inside the manufacturer, and an EU file under Regulation (EC) 1223/2009 supplies most of the evidence for the Brazilian submission. The filing sits with the holder, which answers to ANVISA and keeps the technical file. A change of formulation or claim after filing goes through change control, or through a new submission if the grade moves.
What to send us
Everything here is something to find before the project starts. The first reply says which of it can go into the file as it is.
- The label copy and every claim you intend to print
- The formulation with INCI names and percentages, and any flagged ingredients
- The proposed holder’s CNPJ, and the AFE activities ANVISA lists for it
- The grade you were given, and whatever has been filed with ANVISA
- 2010 Year of foundation
- 1300+ Certification projects
- 40+ Countries served
- 15+ Types of certificates
The people on your file
Meet the teamYou will know the person who handles your certificate.
One specialist owns your file from the first email to the registered certificate. Every one of them has recorded a briefing on their field.
Services
What we do on this route
Each stage is a service of its own, with a page that says what it produces and what it needs from you.
Route assessment
The cheapest stage decides the cost of every stage after it. What a route assessment names, and the four decisions it locks down.
Read the pageProduct testing
Accreditation is per standard and per laboratory, never general. How to choose one the destination accepts, and test once for several markets.
Read the pageTechnical documentation
The file is the certificate’s foundation and it is the manufacturer’s to produce. What it has to contain, and what cannot be written retrospectively.
Read the pageAudit & training
Audits turn a schedule from weeks into months and cannot be compressed. What auditors check, and how to be ready for the first visit.
Read the pageAuthorised representative
Four major markets refuse to certify a foreign manufacturer directly. What the appointment obliges, and why a distributor is the wrong holder.
Read the pageMarking & labelling
A correct certificate and a wrong label still stops at the border. What each market demands on the artwork, and when to check it.
Read the page
Which route does my cosmetic take: notification or registration?
RDC 907/2024 draws the line. Grade 1 covers products whose basic properties do not require detailed proof of safety or efficacy, a shampoo or a moisturiser without claims, and they clear by notification, which ANVISA records without a technical assessment. Grade 2 covers products with a specific purpose or a restricted ingredient: antiperspirants, anti-dandruff shampoos, products for children, anything with an SPF. Most Grade 2 products are notified with their technical data attached. The ones the regulation lists for registration, sunscreens and children's products among them, wait for a dossier review.
A single ingredient or a single claim moves a product upward. "Hydrating" is Grade 1; "anti-wrinkle" or "SPF 15" makes it Grade 2. Settle the label copy before the grade, and the grade before the artwork is printed.
Who can hold the registration in Brazil?
A Brazilian legal entity with a CNPJ, an AFE (Autorização de Funcionamento de Empresa) from ANVISA covering the activity in question, importing cosmetics, and a local health licence (licença sanitária) from the state or municipal vigilância sanitária. An importer without those cannot hold your product however willing it is, and an AFE for medical devices does not cover cosmetics.
The holder is also the legal responsible party. It answers to ANVISA for the product, keeps the technical file and handles recalls. This is the item that sets the critical path most often. Verify the AFE and its listed activities on ANVISA's public consultation before the dossier work starts.
What goes into the dossier?
The formulation with INCI names and percentages, the manufacturing process, stability data, the safety assessment, microbiological results and the Portuguese labelling artwork. Most of it exists only inside the manufacturer and is not something a consultant can generate. Where a product is already sold in the European Union under Regulation (EC) 1223/2009, the Product Information File covers most of the science. It does not cover the form: Brazil expects its own structure, its own required statements and Portuguese labelling.
Some restrictions differ. Brazil keeps its own lists of permitted preservatives, colourants and UV filters, so a formulation that passes the EU annexes can still contain something outside the Brazilian list. Check the ingredient lists first. It is the cheapest check in the project and the one that changes the formulation.
What about supplements and medical devices?
The same logic runs through the other categories ANVISA regulates. Medical devices follow RDC 751/2022: Classes I and II are notified, Classes III and IV are registered, and the holder needs an AFE for devices. Food supplements follow RDC 243/2018. The grade or class decides the route, and the route decides the timeline.
Notification against registration
| Notification | Registration | |
|---|---|---|
| Applies to | Grade 1, and most Grade 2 with technical data | Grade 2 products listed by RDC 907/2024, such as sunscreens and children's products |
| What ANVISA does | Records the filing | Reviews a technical dossier |
| Typical timeline | Days to weeks | 6 to 12 months |
| Holder | Brazilian company with CNPJ, AFE and health licence | Same |
| Validity | Renewable | Renewable, with change control |
| Medical devices (RDC 751/2022) | Classes I and II | Classes III and IV |
A change of formulation or of claim can move a product from one column to the other. Confirm the grade before the artwork is printed.
Frequently asked questions
Is a cosmetic notification the same as a registration?
No. Notification is an electronic filing under RDC 907/2024 that ANVISA records; registration is a dossier review that takes months and is reserved for a listed group of Grade 2 products such as sunscreens and children's cosmetics. A single restricted ingredient or a single claim can move a product between grades.
Can we register in our own name?
Not as a foreign company. The holder must be a Brazilian legal entity with a CNPJ, an AFE from ANVISA for the cosmetics activity, and a local health licence. Check the AFE on ANVISA's public consultation for your exact category before starting the dossier.
Does an EU safety assessment carry over?
The science does. An EU Product Information File under Regulation (EC) 1223/2009 supplies most of the evidence. The form does not: Brazil expects its own dossier structure, its own required statements, its own ingredient lists and Portuguese labelling. Treat the EU file as source material and build the Brazilian submission from it.
What happens when the formulation changes?
It depends on what changed. Minor changes go through change control against the existing filing; a change that alters the grade or introduces a restricted ingredient means a new submission. Reformulation is common, and the regulatory consequence is not proportional to the size of the change.
Keep reading
On cosmetics and health products
Anvisa Post-Market Surveillance: Handling a Cosmetic Complaint
What Anvisa's RDC 894/2024 asks of a cosmetic brand when a consumer in Brazil complains: who answers, the 20-day and 15-day deadlines, records and recalls.
INMETRO and ANVISA: Two Brazilian Routes Compared
INMETRO handles equipment and machinery, ANVISA handles cosmetics and health products. Different stages, different validity, and one shared prerequisite.
Sources
- ANVISA — Governo do Brasil
- Cosméticos (ANVISA) — Governo do Brasil
Tell us what you are exporting
Send the product name, HS code and technical data. You get back the applicable route, the document list and a timeline, before any commitment.