Liliana Teles
CEO / Regulatory Affairs & Quality Assurance Director
Cosmetic Products
Cosmetic Products
Safety, notification and the legal role in each market: EU, UK and US.
We take a cosmetic product from formula to market, and stay with it after launch. In the EU we can be your EU Responsible Person, and in Great Britain your UK Responsible Person. In the US we can be your US Agent.
Roles we take on:
For brands, manufacturers and importers of cosmetic products: hair care, make-up, skin care, fragrances and perfumes, nail care. Artisanal and small-scale ranges carry the same legal requirements as industrial ones, and we work with both.
Markets: the 30 EEA countries (the 27 EU member states plus Iceland, Liechtenstein and Norway), the UK (Great Britain), and the US under MoCRA (Modernization of Cosmetics Regulation Act of 2022).
Where will you sell?
Pick one market or several. The route below marks which steps apply and which legal role attaches in each one. The steps follow the usual order of the work, not a legal sequence.
This is the route for a cosmetic product sold in the EU. To map your markets, talk to us about your product.
EU
- Formula and testing. Formula checked against the Cosmetics Regulation; tests planned and coordinated with external laboratories. (Regulation (EC) No 1223/2009; ISO 11930; ISO 17516)
- Safety report and product file. Cosmetic Product Safety Report (CPSR) signed by a safety assessor, and the Product Information File (PIF). (Regulation (EC) No 1223/2009; Regulation (EU) 2023/1545; SCCS guidance) We can act as cosmetic safety assessor.
- Label, ingredients and claims. Label, INCI list and claims reviewed together. (Regulation (EC) No 1223/2009, Article 19(2); Regulation (EU) No 655/2013 (Claims Regulation); Commission Recommendation 2006/647/EC)
- EU Responsible Person and CPNP notification. We act as your EU Responsible Person and notify on the Cosmetic Products Notification Portal (CPNP). (Regulation (EC) No 1223/2009, Article 4) We can act as EU Responsible Person.
- After launch. Cosmetovigilance and serious undesirable effects, inside the EU Responsible Person service; regulatory monitoring on request. (Regulation (EC) No 1223/2009)
Alongside the route: Manufacturing quality. ISO 22716 for your production site. For sites that also export to the US, we tell you whether FDA cGMP applies to what you sell there.
Beyond the route. We cover Canada, China and Brazil; other markets on request.
A first map, not a regulatory conclusion. Our responsibility starts when you engage us.
Formula and testing
A safety report can only be signed on a formula that holds up and on test results that answer the right questions. We review the formula against the rules of each market you plan to sell in, put the raw-material documentation in order, and plan the tests. External laboratories run them. We coordinate them; we are not a laboratory.
More on Formula and testing
What you get
- A formula review report. Each ingredient checked against the rules of your target markets (EU, UK, US), with change control when the formula moves.
- Raw-material documentation, per material. The supplier and manufacturer documents the safety assessor will need, reviewed and organised. Where you keep them in a Product Lifecycle Management (PLM) system, we work inside it.
- A testing strategy. Which studies the product needs, in what order, and which it does not.
- Laboratory coordination. Studies run by external laboratories, followed by us, with one report per study.
- Supplier checks. Qualification of the manufacturer and verification of your suppliers’ good manufacturing practice.
Why this step comes first
The safety assessor works from three inputs: the formula, the data on each raw material, and the test results. If one is missing or out of date, the safety report waits for it. A problem found here means changing a formula. Found at sign-off, it can also mean repeating tests.
The studies we coordinate: stability, Certificate of Analysis (CoA), packaging compatibility, water activity, challenge test, microbiological analysis, and dermatological and efficacy testing.
Not every product needs all of them. For a solid product, a water-activity study under defined thresholds can waive the challenge test and the microbiological analysis. We check that before any test is booked.
If the formula is still being developed, we can also support that work, from benchmarking to validating the composition.
Questions on this step
Do you run the tests yourselves?
No. External laboratories run them. We define what is tested and why, coordinate the laboratories, and take the results into the safety report.
How long does testing take?
The test windows set the pace, and some cannot be shortened. Stability testing is the usual example. If your launch date leaves no room for it, we say so at the start and show what can run in parallel.
Our formula is already sold in the EU. Is it ready for the US?
Not by default. The review checks the formula against each target market separately. For the US it continues in the US formula and label review.
Do we need efficacy tests?
Only for claims that rely on them. We plan efficacy testing around the claims you intend to make, which are reviewed at step 3.
- References
- Regulation (EC) No 1223/2009 · ISO 11930 (microbiology and preservation) · ISO 17516 (microbiology)
- Deliverables
- formula review report · documentation package per raw material · testing strategy · one report per laboratory study
Safety report and product file
The Cosmetic Product Safety Report (CPSR) and the Product Information File (PIF) are the core of a cosmetic product's compliance under Regulation (EC) No 1223/2009. We prepare both. The CPSR is signed by a safety assessor, and that signature is a conclusion, not a conditional opinion.
More on Safety report and product file
What you get
- A CPSR, Parts A and B, in English, signed by a qualified safety assessor. We produce it in three phases, or validate a report you have prepared.
- A PIF in English, or the validation of a file you have prepared. Where we are your EU Responsible Person, we keep the PIF available.
- A fragrance allergen update under Regulation (EU) 2023/1545, in one of two forms: the CPSR and PIF updated, or the INCI list and the notification on the Cosmetic Products Notification Portal (CPNP) updated.
- A review of a file someone else prepared or notified, with a gap analysis that covers the label and the claims.
What the signature means
A safety assessor’s sign-off is a professional conclusion. We do not sign a report and record, beside it, that further testing would be advisable. If the data are not there, the gap is closed first, by scoped testing or by changing what the product claims, and then the report is signed.
The same applies to products near a border. Products for intimate use or contact with mucous membranes can drift towards medical device or biocide territory. For those products, framing for external use only and avoiding therapeutic or efficacy claims keep the product defensibly cosmetic. If it is still open whether a product is cosmetic or medicinal, we document the risk and you accept it in writing before the CPSR is signed.
The assessment follows the Cosmetics Regulation and the guidance of the Scientific Committee on Consumer Safety (SCCS).
Questions on this step
We already have a CPSR. Can you work with it?
Yes. We can validate a CPSR or a PIF prepared by you or by another provider and tell you what is missing. If the product is already notified, the review also covers the label and the claims.
We also sell in Great Britain. Does that change anything?
Tell us at the start. The UK Responsible Person reviews the product file before the product is notified on Submit Cosmetic Product Notification (SCPN), so the file has to be ready for both markets.
What do the new fragrance allergen rules mean for our files?
Regulation (EU) 2023/1545 changes how fragrance allergens are labelled. Products affected need their files and labels updated: either the CPSR and PIF, or the INCI list and the CPNP notification, depending on what has changed.
When can the report be signed?
When its inputs are in: the formula review, the raw-material data and the test results. Once those are complete, we can tell you whether your date holds.
- References
- Regulation (EC) No 1223/2009 · Regulation (EU) 2023/1545 · SCCS guidance
- Deliverables
- CPSR (Parts A and B) · PIF · phase reports · validation findings · updated CPSR, PIF, INCI list or CPNP notification · gap-analysis report
Label, ingredients and claims
We review the label, the INCI list and the claims as one piece of work, because each changes the others. A product name can be a claim. An allergen in the formula has to reach the ingredient list. A claim needs its evidence before it reaches the pack. For the US, the review is a separate one, against US rules.
More on Label, ingredients and claims
What you get
- A Labelling Review Report. The label checked, including the INCI list and the allergens, with instructions to bring it into compliance.
- An INCI list prepared and validated for each product.
- Claims substantiation, claim by claim. First a viability analysis: can this claim be supported? Then a substantiation report based on the literature, with its references.
- A US formula and label review. For the US market: formula and label reviewed against US rules, including California’s Proposition 65, and the California ingredient notification.
Three positions we hold
A trade name can be a claim. A product name with a functional term in it, “Prebiotic” for example, has to be substantiated under the Claims Regulation like any other claim. We review names with the claims, not after them.
Legibility is enforced even without a number. Neither the EU nor Great Britain sets a legal minimum font size, but easy legibility is enforceable. The Cosmetics Europe guideline points to an x-height of about 0.9 mm, roughly 5 to 6 pt. We use it as the working reference.
Small packs have an option. Article 19(2) of Regulation (EC) No 1223/2009 allows the ingredient list to move off the pack to a leaflet. When the pack is too small, we check whether that route fits.
Questions on this step
When should the label be reviewed?
Before the artwork is final. A review after printing can still find what needs to change, but then the change means a reprint.
Do you test whether a claim is true?
We substantiate claims from the published literature. Where a claim needs a test, an efficacy study for instance, we plan it and coordinate an external laboratory (step 1). We do not run tests ourselves.
Can our EU label be used in the US?
Not as it stands. The US review checks the formula and the label against the FD&C Act, the FPLA, the California Safe Cosmetics Act and Proposition 65.
What slows a review down?
A claim the literature does not support. Then a test is needed, and the claim waits for its result. Send the full claims list with the artwork, and we tell you which claims stand on the literature and which need a test.
- References
- Regulation (EC) No 1223/2009, Article 19(2) · Regulation (EU) No 655/2013 (Claims Regulation) · Commission Recommendation 2006/647/EC · US: FD&C Act; FPLA; California Safe Cosmetics Act; Proposition 65
- Deliverables
- Labelling Review Report · INCI list per product · viability analysis and substantiation report per claim · US formula and label review with the California notification
Responsible Person and notification
A cosmetic product reaches the EU market with a Responsible Person named for it, under Article 4 of Regulation (EC) No 1223/2009. We can take that role in the EU and as UK Responsible Person in Great Britain, act as your US Agent under MoCRA (Modernization of Cosmetics Regulation Act of 2022), and notify the product in each market. A different entity of the firm contracts in each market.
Roles at this step: EU Responsible Person · UK Responsible Person · US Agent · Responsible Technician (Portugal)
More on Responsible Person and notification
What you get, by market
EU: EU Responsible Person and CPNP notification We act as your EU Responsible Person, with a registered address. We notify the product on the Cosmetic Products Notification Portal (CPNP) and keep the notification up to date, review the documents, keep the Product Information File (PIF) available and handle cosmetovigilance. Contracted by CRITICAL CATALYST – Health Consulting, Lda. Also available as one package per product: Cosmetic Product Safety Report (CPSR), PIF, label review and CPNP notification under the EU Responsible Person.
UK (Great Britain): UK Responsible Person and SCPN notification We act as your UK Responsible Person, with a UK address. We review the PIF, notify your products on Submit Cosmetic Product Notification (SCPN) and act as the contact point for the Office for Product Safety and Standards (OPSS). Contracted by CRITICAL CATALYST LTD, London. Can be combined with the EU Responsible Person.
US: US Agent, facility registration and product listing We act as your US Agent and your contact point with the FDA. We register the facility, list the products and handle the identifiers this needs: a DUNS (Data Universal Numbering System) number and an FDA Establishment Identifier (FEI). We renew the registration when it falls due. Contracted by CRITICAL CATALYST LLC.
Portugal: Responsible Technician Depending on what you do in Portugal (manufacture, import or distribute), a Responsible Technician under Decreto-Lei n.º 189/2008 may be required. Where the role applies, we can take it on. The Responsible Technician is the contact point with INFARMED, requests the conformity document for imports and exports, keeps the PIF up to date, supports the CPNP notification, handles serious undesirable effects and supports distribution practice. What the role covers depends on whether you manufacture, import or distribute.
This role is not the EU Responsible Person. Nor is it the Technical Manager for medical-device distribution, which has the same Portuguese name.
One notification per formula on the market
The notification follows the product as it is sold. If two formulations of a product are on the market at the same time, each needs its own CPNP notification. If one formulation replaces the other, the existing notification can be updated. We check this whenever a formula changes, so the notification and the product on the shelf match.
Questions on this step
Can a firm based in Portugal be our UK Responsible Person, or our US Agent?
Yes. UK work and the UK Responsible Person role are contracted by CRITICAL CATALYST LTD, with its office in London. US work and the US Agent role are contracted by CRITICAL CATALYST LLC, with its office in Wyoming.
Do you need our product file to act as Responsible Person?
Yes. The EU Responsible Person keeps the PIF available, and the UK Responsible Person reviews it before notifying. If the file is not ready, step 2 comes first.
We changed the formula. New notification, or an update?
If the new formula replaces the old one, the existing CPNP notification is updated. If both stay on the market, the new one needs its own notification.
How long until we can sell?
Notification follows a complete product file. When the file is complete, the notification is not what sets the date. When it is not, the missing part does, and we tell you which.
- References
- Regulation (EC) No 1223/2009, Article 4 · Schedule 34 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (UK) · Modernization of Cosmetics Regulation Act of 2022 (MoCRA, US) · Decreto-Lei n.º 189/2008
- Deliverables
- appointment as EU Responsible Person · CPNP notification and updates · UK designation and address · SCPN notifications · FDA facility registration and product listing number · INFARMED conformity document request
After launch
Once a product is on sale, two things need watching: how it behaves in use, and how the rules change around it. We handle cosmetovigilance as part of the EU Responsible Person and Portuguese Responsible Technician roles. For the US, we can set up an adverse-event system under MoCRA (Modernization of Cosmetics Regulation Act of 2022). And we follow the rules that apply to your products, and publish a monitoring report once a month.
Roles at this step: EU Responsible Person · Responsible Technician (Portugal) · US Agent
More on After launch
What you get
- Cosmetovigilance and serious undesirable effects support, inside the EU Responsible Person or Responsible Technician service. It is not sold on its own: it comes with the role.
- A US adverse-event management system under MoCRA, separate from EU cosmetovigilance: procedures, a notification form, a contingency plan, a review of each event, trend reports, training, and a contact point with the FDA.
- Regulatory monitoring for cosmetics, on request: updates on the rules that apply to your products, or a monitoring procedure for your own team, with training.
- A regulatory or technical opinion on a raw material, with the documents that go with it: a technical and regulatory dossier, CLP labelling information, a claim-substantiation dossier, a safety data sheet in Portuguese and English.
When the rules change
Regulatory monitoring is about the rules. Cosmetovigilance is about the product. They are separate pieces of work, and a product on the market needs both.
An example of the first. Commission Regulation (EU) 2026/909 amends the annexes of Regulation (EC) No 1223/2009 for several substances, among them benzyl salicylate, citral, triphenyl phosphate and DHHB. For a product already on sale, a change like this can reach the formula, the safety report, the product file, the label and the notification. We check which of your products contain the substances and what has to change in each.
Questions on this step
What if the rules change after our product is on the market?
That is what regulatory monitoring is for. If you take it on with us, when a change reaches your products we tell you which ones and what has to be updated: formula, safety report, label or notification.
Is cosmetovigilance a separate service?
No. It is part of the EU Responsible Person service and of the Responsible Technician service in Portugal.
We also sell in the US. Does EU cosmetovigilance cover it?
No. MoCRA has its own adverse-event requirements. We set up a separate system for them.
Who do we ask about a briefing?
Use Ask the team for this area on any briefing or monitoring report. Our team replies to every question.
- References
- Regulation (EC) No 1223/2009 · Modernization of Cosmetics Regulation Act of 2022 (MoCRA, US) · Commission Regulation (EU) 2026/909 (example)
- Deliverables
- cosmetovigilance and serious-effect handling inside the role · US adverse-event procedures, form, contingency plan, event reviews, trend reports, training · monitoring updates or a monitoring procedure with training · technical opinion and dossier
Manufacturing quality
Alongside the route
Manufacturing quality runs alongside the product route, not after it. We build quality systems to ISO 22716 and audit them. For exporters of cosmetics or over-the-counter drugs to the US, we also build to FDA current good manufacturing practice (cGMP). The two are not interchangeable: a site that meets one does not meet the other by default.
More on Manufacturing quality
What you get
- An ISO 22716 quality system. It starts with a diagnosis of how you work today. Then the document set across ten areas, follow-up visits, an internal audit, and support with the corrective actions.
- An ISO 22716 internal audit. A first-party audit of your site: an audit plan, a report with findings, and a review of your corrective-action plan.
- An FDA cGMP quality system for exporters of cosmetics or over-the-counter drugs to the US: from the formula review to preparing for an FDA inspection, with procedures, a quality manual, GMP training and a pre-inspection report.
Built on how you already work
The diagnosis shows what exists, what is missing and what only needs to be recorded. The system is then built on your own practice, so your team can run it after we leave. How far the work goes depends on that gap and on how quickly your team adopts the new procedures; we can say more once the diagnosis is done.
FDA cGMP (21 CFR 210 and 211) is the US reference our exporting clients are asked to meet, and the one an FDA inspection works to for over-the-counter drugs. A site that sells in Europe and exports to the US may need to show both; we tell you which applies to what you sell.
Questions on this step
We are a small or artisanal producer. Does this apply to us?
Yes. Artisanal and small-scale producers carry the same legal requirements as industrial ones. The diagnosis keeps the system in proportion to the size of the site.
We already work to ISO 22716. Is that enough to export to the US?
ISO 22716 and FDA cGMP are not interchangeable. Whether the FDA reference applies depends on what you sell in the US and to whom. We review what your ISO 22716 system already covers and build what the FDA reference adds.
Can you check the manufacturers and suppliers we use?
Yes, as part of the formula and testing step: we qualify the manufacturer and verify your suppliers' good manufacturing practice.
- References
- ISO 22716:2007 (adopted in Europe as EN ISO 22716:2008) · ISO 19011:2018 (audit method) · 21 CFR 210 and 211 (US)
- Deliverables
- diagnosis · quality system documents · internal audit plan and report · corrective-action review · FDA cGMP procedures, quality manual, GMP training and pre-inspection report
Other export markets
Beyond the route
Outside the EU, the UK and the US, each market sets its own rules for formulas, ingredients and labels. We review the product and its label market by market, and support the notification or registration that market asks for. We cover Canada, China and Brazil; other markets on request.
More on Other export markets
What you get
- Canada. The formula, ingredients and label reviewed against the Food and Drugs Act, the Cosmetic Regulations, the Cosmetic Ingredients Hotlist and the CPLA, and the product notified to Health Canada.
- China. The product and its label reviewed for the Chinese market, including a review of the trade name.
- Brazil. For ingredient suppliers: a technical dossier for a cosmetic ingredient, in the sections ANVISA requires under RDC 409/2020. It starts with a list of missing data and a plan to fill it, and we support you through ANVISA’s questions.
- Chemical inventories, on request. Essential oils and fragrance raw materials reviewed against national and regional chemical inventories, with one compliance report per material.
Start from the EU file, but don’t assume it travels
Each review starts from what you already have: the formula, the product file and the EU label. It reports what has to change for the market in question, and what can stay. A formula that is compliant in the EU is not, by that fact, compliant elsewhere, and a label is reviewed against the target market’s own texts.
The Brazil dossier works at a different level. It is about an ingredient, not a finished product, so it is not the product file and does not replace one.
Questions on this step
Our market is not listed. Can you help?
Ask us. Canada, China and Brazil are the markets we cover; others are on request, and we will tell you plainly whether we take one on.
Is the Brazil dossier for our finished product?
No. It covers a cosmetic ingredient and is prepared for ANVISA. For a finished product, the review starts from the product file.
Do we need to finish the EU route first?
Not necessarily, but the export review starts from the formula review and the product file, so having them ready shortens the questions we come back with. Tell us your markets at the start, and the formula review in step 1 can cover them.
What do you need from us to start?
The formula, the product file and the label you sell in the EU, and the market you are aiming at. For a chemical-inventory review, the full data for each material: the review starts once all of it is in.
- References
- Canada: Food and Drugs Act; Cosmetic Regulations; Cosmetic Ingredients Hotlist; CPLA; Health Canada · Brazil: RDC 409/2020 (ANVISA)
- Deliverables
- review report per product and market · Health Canada notification · trade-name review (China) · ANVISA ingredient dossier sections with a missing-data list · compliance report per material (chemical inventories)
The legal roles are described under Regulatory roles.
How we work on cosmetics
- A sign-off is a conclusion. When a safety assessor signs a CPSR, that is a professional conclusion, not a conditional opinion. We do not approve a file and note alongside it that further tests would be advisable.
- We are not a laboratory. We plan the tests and coordinate external laboratories. We say so whenever testing comes up.
- Borderline products are put in writing. If it is still open whether a product is cosmetic or medicinal, the risk is documented and you accept it in writing before the CPSR is signed.
- Honest about dates. If a launch date leaves no room for a mandatory test window, stability testing for example, we tell you, and we show what can run in parallel.
People
Leads regulatory affairs and quality assurance for medical devices and cosmetics: ISO 13485 quality systems, CE-marking roadmaps, EN ISO 14971 risk management, cosmetic product safety reports and claims.
Marta Pinto
Cosmetic Products Regulatory Affairs Manager
Cosmetic Products
Runs the day-to-day cosmetics practice: cosmetic product safety reports and product information files, notification, claims and label compliance.
Who contracts, by market. CRITICAL CATALYST LTD (London) for UK work and the UK Responsible Person. CRITICAL CATALYST LLC (Wyoming) for US work and the US Agent. CRITICAL CATALYST - Health Consulting, Lda. (Portugal) for the EU and every other market.
What is changing in cosmetics
Our regulatory monitoring reports on cosmetic products, published since 2023 and now once a month, are in Briefings too, each dated to the rules at the time.
European Commission requests SCCS Opinion on the safety of Cyclamen Aldehyde
Ingredient: CYCLAMEN ALDEHYDE
Date of publication: 8 June 2026
The Scientific Committee on Consumer Safety (SCCS) has accepted a mandate to assess the safety of Cyclamen Aldehyde, following potential classification as a reproductive toxicant under the CLP Regulation.
European Union will ban and restrict new substances in cosmetics – Omnibus Act IX
Topic: OMNIBUS ACT IX - COSMETICS REGULATION
Date of publication: 28 July 2026
The European Commission notified the WTO about the draft Omnibus Act IX, proposing amendments to Annexes II, III, and V of the EU Cosmetics Regulation.
European Cosmetics Regulation – Updates on Cosmetic Ingredients
Topic: NEW RESTRICTIONS ON COSMETIC INGREDIENTS
Date of publication: 13 January 2026
The European Commission published Commission Regulation (EU) 2026/78, which brings new restrictions on several cosmetic ingredients that were classified as Carcinogenic, Mutagenic or Toxic for Reproduction (CMR).
United Kingdom publishes Technical Report on the Classification and Labelling of Talc
Ingredient: TALC
Date of publication: January 2026
The United Kingdom (UK) Health and Safety Executive (HSE) has published a technical report concluding that Talc does not warrant carcinogenicity classification, diverging from ECHA's Risk Assessment Committee (RAC) opinion supporting Category 1B classification.
Questions we hear at the start
Can a firm based in Portugal act for us in the UK and the US?
Yes. UK work and the UK Responsible Person role are contracted by CRITICAL CATALYST LTD, with its office in London. US work and the US Agent role are contracted by CRITICAL CATALYST LLC, with its office in Wyoming.
Do you run the laboratory tests?
No. We define the testing strategy, coordinate external laboratories and read the results into the safety report.
We already have a safety report from another provider. Can you work with it?
Yes. We can validate a CPSR or a PIF you or someone else prepared, and report the gaps, including the label and the claims.
What sets the date?
Three things: the test windows the product needs, how complete your raw-material documentation is, and how many markets you sell in. Once we have seen the formula and the file, we tell you whether your date is realistic.
Tell us the product, the market and the date.
We will tell you which steps apply, which role you need, and whether the date is realistic. Our team replies to every enquiry.
Follow an area
One email when an area publishes, in the language you choose. Nothing else.
Talk to us
Tell us the product, the market and the date you are working to. If the date is not realistic, we will say so.
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