Cosmetics · Brazil, EU, UK, USA, Canada
Your cosmetics, ready for every market
Each market asks for safety evidence, a company that answers for the product and a compliant label. We plan the order and the files, so what you build once counts in the next market.
Where do you want to sell?
In short
How market access for cosmetics works
Each market asks a named company to answer for every cosmetic: the holder in Brazil, the Responsible Person in the EU and the UK, the responsible person on the label in the US, the manufacturer or importer in Canada. That company keeps the safety evidence and the product file, makes sure the label complies and handles the notification, listing or registration. Sobel prepares this for ANVISA, Regulation (EC) No 1223/2009, the UK rules, MoCRA and Health Canada, in the order that fits your business.
Last updated 7 Nov 2026 · Reviewed by Sobel’s regulatory team
Your markets
What each market asks for
Cosmetics in Brazil
How Sobel helps
Grau and route, formula and label review, and the filing.
Cosmetics in Brazil →Overview only: your route is confirmed in your plan.
Cosmetics in the European Union
How Sobel helps
Responsible Person, CPSR, product information file, label review and CPNP notification.
Cosmetics in the EU →Overview only: your route is confirmed in your plan.
Cosmetics in Great Britain
How Sobel helps
CPSR for Great Britain, SCPN notification and label review.
Cosmetics in the UK →Overview only: your route is confirmed in your plan.
Cosmetics in the United States
How Sobel helps
Facility registration, product listing, safety substantiation, label review and your U.S. Agent.
Cosmetics in the US →Overview only: your route is confirmed in your plan.
Cosmetics in Canada
How Sobel helps
The notification, the Hotlist review and bilingual label review.
Cosmetics in Canada →Overview only: your route is confirmed in your plan.
Sources: ANVISA RDC 907/2024, 814/2023, 894/2024 · Regulation (EC) No 1223/2009 · GOV.UK SCPN · FDA (MoCRA) · Health Canada CNF guide.
Already selling in one market?
Your next market doesn’t start from zero
Most of the science behind a cosmetic travels. We show what can be reused, what needs adapting and what is new, before you spend on the next market.
- Exact formula (INCI and %)
- Raw material data
- Stability and microbiology
- Safety evidence and tests
- Formula check against local lists
- Safety report format
- Claims and label wording
- Local responsible company
- Notification, listing or registration
- Label in the local language
Example: sold in the EU, now Brazil
Your EU safety report and product file support the Brazilian file. ANVISA adds its own ingredient lists and route, a Brazilian holder and the label in Portuguese.
What we do for cosmetics
From safety to shelf, one team
Files, labels and filing
Your company in the market
- EU Responsible Person Sobel →
- U.S. Agent Sobel →
- UK Responsible Person Partner →
- Brazilian holder Partner →
In Brazil and the UK, through a qualified, approved partner.
Where are you today?
Start from your moment
Launching a new product
The route, the safety evidence and the label right the first time.
Talk to a specialistExpanding to another market
See what you can reuse before you spend on the next market.
What travelsKeeping products compliant
New rules, changed formulas, label updates and post-market.
Ongoing supportStuck at ANVISA
A filing questioned, rejected or cancelled: what to do now.
Product stuck at ANVISA
Why Sobel
Regulation as a business decision, not a checklist.
Four disciplines work on every project, in the same team, from the first decision to post-market.
“We know how auditors think, because we’ve been one of them.”
Maik Endler · Founder and CEO · Mechanical engineer, trained in Germany · Former BSI auditor (Notified Body) · Industry experience at Sirona (now Dentsply Sirona)
Meet the team →Classification and market sequence decided first. The right class from day one avoids rework.
Biological, clinical and toxicological evaluation by our own Clinical Evidence & Product Safety team.
ANVISA, FDA, EU MDR, MHRA and Health Canada, coordinated together.
A dedicated technology team builds the workflows that keep every project traceable and on time.
Questions, answered
Frequently asked questions
Do cosmetics need approval before they are sold? +
In the EU, the UK, the US and Canada, no: the responsible company notifies or lists the product and keeps the safety evidence. In Brazil, most products are notified too, but some groups, such as sunscreens, hair straighteners and insect repellents, need ANVISA registration before sale.
What is a Responsible Person? +
In the EU and the UK, the company established in that market that answers for each cosmetic: it keeps the product information file, holds the safety report and makes the notification. Sobel acts as your EU Responsible Person; in the UK, through a qualified partner.
Can one safety report work for the EU, the UK and Brazil? +
The science behind it can. The EU safety report is the base for Great Britain and supports the Brazilian file, but each market checks the formula against its own lists and asks for its own notification and label.
Who holds a cosmetic product in Brazil? +
Only a Brazilian company with an ANVISA operating authorisation (AFE) for cosmetics. If your company is outside Brazil, Sobel offers this through a qualified, approved partner.
Do you act as Responsible Person or U.S. Agent? +
Yes. Sobel acts directly as EU Responsible Person and as U.S. Agent through its own companies in Europe and the US. The Brazilian holder and the UK Responsible Person are offered through qualified, approved partners.
