Recall: hand sanitiser pulled from US shelves over hidden methanol
An alcohol-based hand sanitiser made in Mexico was recalled after testing found undeclared methanol. What happened, and the controls that prevent it.
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Service · Global regulatory
One formula. Every market it’s headed for.
CSL regulatory specialists prepare the files, run the tests they depend on, and check your label and claims against each market’s rules before you ship, then keep you compliant as the rules change.
Guires Cosmetic Science Lab
Cosmetic Regulatory Services from Guires CSL
Cosmetic regulatory services for every market you sell in. Work with a cosmetic regulatory consultant team that prepares safety files, handles cosmetic registration and notification, runs cosmetic label review including fragrance allergen labelling, and keeps you current as cosmetic regulations change.
Start your project with Guires CSLMarkets
What we deliver, market by market.
Pick your launch list. We build one testing and safety plan that satisfies all of them.
- We act as your UK Responsible Person
- We review your formula against UK rules
- We prepare your UK safety assessment
- We compile and hold your PIF
- We notify on SCPN
- We review your labels
- We register your facility with FDA
- We act as your US Agent
- We list your products
- We build your safety substantiation
- We review your labels
- We set up adverse event handling
- We check cosmetic vs drug
- We handle the OTC drug route
- We classify your product
- We screen against the Hotlist
- We file your Cosmetic Notification Form
- We review your bilingual labels
- We prepare DIN or NPN applications
- We prepare your Saudi eCosma dossier
- We prepare your UAE registration
- We check your formula against GSO standards
- We prepare Arabic labels
- We arrange your export documents
- We support halal certification
- We check your formula against the ASEAN annexes
- We build your ASEAN PIF
- We prepare country notifications
- We localise your labels
- We prepare you for Indonesia’s halal rule
- We track renewals
- We act as your authorised Indian agent
- We file your import registration
- We support manufacturing licences
- We test against BIS standards
- We review your labels
- We answer CDSCO queries
- We categorise your ingredients under AICIS
- We support your AICIS registration
- We review your labels
- We manage the TGA route for sunscreens
- We test sunscreens to AS/NZS 2604
- We check New Zealand compliance
More markets
Beyond our core eight.
For these markets we prepare dossiers with in-country regulatory partners.
| Market | Authority & framework | What to expect |
|---|---|---|
| China | NMPA · CSAR | Registration or notification, with a China-based responsible person; efficacy claims need supporting evidence. |
| Japan | MHLW · PMD Act | Cosmetics notification; quasi-drugs need approval. |
| South Korea | MFDS · Cosmetics Act | Functional cosmetics (whitening, anti-wrinkle, UV) need review. |
| Brazil | ANVISA · MERCOSUR | Grade 1 and Grade 2 products follow different routes. |
| Türkiye | TİTCK · ÜTS | Product notification on the product tracking system. |
| Switzerland | Swiss cosmetics ordinance | Swiss responsible person and labelling rules. |
Compliance retainers
Stay compliant after launch.
Rules change every year. A retainer keeps your portfolio current without a new project each time.
Regulatory watch
Alerts when an ingredient in your portfolio is restricted or banned in one of your markets.
Label reviews
New SKUs, shades and pack sizes reviewed before print.
File maintenance
Safety reports, PIFs and notifications updated when formulas or suppliers change.
Export documents
Free Sale Certificates and the export papers importers ask for.
Expert on call
A named regulatory specialist for your team's questions.
Non-animal safety methods.
Our safety work relies on validated in-vitro models, ingredient safety data and supervised human studies, so your product qualifies in markets that ban animal testing.
Market insights from Guires CSL scientists
Stay ahead in regulatory work with regulation updates, the latest research, ingredient spotlights, recalls and market trends, written by the Guires CSL formulation, testing, clinical and regulatory teams.
Explore market insights
Questions
Asked before we start.
Do you act as our EU or UK Responsible Person?
Yes. The Responsible Person must be established in the EU or UK, so the role is held by an EU- or UK-established legal entity named in your agreement. It holds your Product Information File and handles notifications and authority requests.
Can one safety assessment cover several markets?
A full EU-format safety assessment is the strongest base. We adapt it and add market-specific documents rather than starting again for each country.
How long does a market file take?
Timelines depend on the market and the tests already done. We give dates per market in your proposal.
Guires CSL quality, compliance and safety
Every regulatory work project at Guires CSL runs inside an ISO 9001 certified quality system, with documented methods, calibrated instruments, traceable raw materials and reviewed reports, so the results behind your product can be checked and defended.
Guires CSL quality & accreditations
In their words
What clients say.
“Ingredient choices and product positioning were assessed before we committed to the final formula, leaving room for changes without disrupting our development schedule.”
“For our new market entry, their team organised the technical requirements and flagged documentation gaps that needed additional supplier or safety data.”
“Formulation details, ingredient documentation and claims considerations now sit within one structured compliance process, making our product information far easier to manage.”
Insights
Related reading.
Guidance from our formulation, testing and regulatory teams on the topics this page covers.
MoCRA for brands outside the US: what you need before you ship
Facility registration, product listing, US Agent, safety substantiation and adverse event reporting, in the order to tackle them.
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One sunscreen, four markets: choosing UV filters that travel
Building a filter system accepted in the EU, US, Australia and ASEAN.
Read articleSectors & applications
Regulatory for every sector and application
Guires CSL prepares safety files, notifications and label reviews for products in all of these sectors, with the claims for each application checked against the rules of your markets.
Sectors
Skin careSerums, moisturisers, cleansers, masksExplore 
Sun careSPF, tinted SPF, after-sunExplore 
Hair & scalp careShampoo, conditioner, serums, oilsExplore 
Colour cosmeticsFace, lip, eye and nailExplore 
Body wash & body careWashes, shower oils, lotions, scrubsExplore +6More sectorsPersonal care & hygiene, Men's grooming, Baby & kids and moreSee all Applications
Anti-ageing & wrinklesFine lines, firmness, elasticityExplore 
Acne & oil controlBlemishes, shine, poresExplore 
Hyperpigmentation & even toneDark spots, uneven toneExplore 
Hydration & barrier repairMoisture, barrier, drynessExplore 
Sensitive skin & rednessCalming, low-irritation formulasExplore +5More applicationsSun protection, Hair fall & hair growth, Dandruff & scalp health and moreSee all Evidence-based
From published evidence to a product that passes regulatory review
Every Guires CSL regulatory work project starts from published science and ends with evidence regulators and retailers accept: data from the literature where it exists, and tests, in vitro studies and clinical trials where it does not.
Published evidencePeer-reviewed randomised controlled trials behind the actives we formulate with, linked to PubMed.Explore Standards and regulationsTechnical guides to ISO 11930, the EU CPSR and the terms that decide whether a product can go to market.Explore Evidence we createStability, safety, in vitro and clinical data generated for your product, planned around the claims you want to make.Explore Proof from projectsCase studies showing how the evidence was built and what clients received.Explore
Start a project
Create your next product with CSL.
Our formulation chemists, testing scientists and regulatory specialists work alongside your team, from the first brief to a market-ready product. Bring a brief, a benchmark or just an idea: a scientist will reply within one working day with next steps and an indicative scope.