How Can I Make Sure My Cosmetic Formula Is Compliant in Different Markets? A Practical Method for the UK, EU, US and Beyond

The question arrives in almost every first conversation: we want to sell in the UK, the EU, the United States and maybe Canada, so how do we make one formula that works everywhere? The good news is that the formula usually can be shared. The less welcome news is that almost everything around it cannot. The UK and EU regulate cosmetics through Regulation (EC) No 1223/2009 and the UK version enforced through the Cosmetic Products Enforcement Regulations 2013, the United States through MoCRA and the FDA, and every other market through its own system, and each has its own ingredient lists, its own assessment requirement, its own responsible party, its own notification and its own label. A formula that ignores any of them is compliant nowhere it is sold.

This guide gives you a method rather than a list of countries, because the countries change and the method does not. It explains why the formula can be shared but the compliance cannot, how to screen ingredients across markets and apply the strictest rule, how the UK and EU differ from each other and from the US, which product categories change status between markets, how safety assessment, responsible parties, notification and labelling work per market, how to sequence a multi market launch, a worked example of a face cream going to four markets, and the mistakes that make one formula compliant in none. Phoenix works from London, Tallinn and Pensacola and does this for brands every week.

Why can the formula be shared but the compliance cannot?

Because every market controls two different things. The first is what may be in the product: which ingredients are banned, restricted or permitted only from a list. The second is how the product is brought to market: who is responsible, what evidence of safety must exist, what must be filed with the authorities and what the label must say. The first can be satisfied once for all markets by formulating to the strictest rule for each ingredient. The second cannot, because each market requires its own responsible party, its own filing and its own label format, and no market accepts another's paperwork as its own. A brand that understands this split stops asking whether one formula works everywhere and starts asking which markets to screen for and which procedures to run.

How do I screen a formula against several markets at once?

Start with a complete ingredient list with INCI names, CAS numbers and exact percentages, and for each ingredient check its status in each target market. In the UK and EU that means the annexes: is it prohibited under Annex II, restricted under Annex III with a maximum or condition, and if it is a colourant, preservative or UV filter, is it on the positive list in Annex IV, V or VI for the intended use. In the US it means the FDA's prohibited and restricted list, the colour additive regulations, and whether the ingredient or its claim makes the product a drug. In Canada it means the Cosmetic Ingredient Hotlist. In other markets it means their own lists. Record the tightest limit for each ingredient across all target markets, and formulate at or below it. Where an ingredient is prohibited in any target market, it comes out. Where a colourant or filter is not on a market's positive list, it comes out for that market or the product is not sold there. The output is a formula that clears every list at once.

Why are the UK and EU no longer one market for this purpose?

Great Britain kept the EU regulation as domestic law at the end of 2020, but the two texts have been amended separately since. The EU has added prohibitions and restrictions through regular omnibus regulations following opinions of the Scientific Committee on Consumer Safety, and has expanded the fragrance allergen list with deadlines in 2026 and 2028; Great Britain has adopted some changes later, some differently and some not at all. An ingredient can therefore be permitted in one and restricted in the other.

The practical consequence is that a UK and EU cosmetic formula must be screened against both sets of annexes and formulated to the stricter position for each ingredient. A cosmetic chemist developing the product needs to consider the active ingredients, preservatives and other formulation components against the requirements of both markets, while the safety report must say it has assessed both. Our guide to dual market CPSRs covers this in depth.

Which products change category between markets?

This is the question that catches brands after they have formulated. In the UK and EU, sunscreens, anti-dandruff shampoos, antiperspirants, blemish products and skin-lightening products are cosmetics when presented cosmetically. In the US they are over-the-counter drugs, with monographs, drug labelling and drug registration, and some cannot be sold without a drug approval.

In the other direction, products with a therapeutic presentation lawful somewhere else may be medicines in the UK and EU. The rule is to classify the cosmetic product in every target market before formulating, because a category change is not a labelling fix. Our guides to US versus UK and EU rules and borderline classification walk through the boundaries.

How does safety assessment work per market?

The UK and EU require a Cosmetic Product Safety Report in the fixed Annex I format, signed by a person with a specified qualification, held in a Product Information File for ten years. A single report can cover both if it assesses against both regulations and says so.

The US requires the responsible person to hold adequate safety substantiation in any form qualified experts would accept, and a UK or EU CPSR and PIF are strong substantiation provided they cover the product as sold in the US. Canada, Australia and most other markets require the business to hold evidence of safety without prescribing the format, and again the CPSR serves.

For a cosmetic formulation, the assessment therefore needs to reflect the actual quantitative formula, intended use, exposure and relevant active ingredients. Where the formulation contains separate oil and water phases, the safety and stability evidence needs to reflect the finished product rather than simply the individual raw materials.

So the assessment is largely done once, well, in the UK and EU format, and reused; what changes per market is the ingredient screen it must include and the product category it must reflect.

Who has to be responsible in each market?

Every market names a responsible party on the label, and the establishment rules differ. The UK and EU require a Responsible Person established in the market, so a UK brand needs an EU Responsible Person for EU sales and vice versa, and Northern Ireland needs an EU or NI one.

The US names the manufacturer, packer or distributor on the label as the responsible person, wherever established, but requires a US contact for adverse events and a US agent for a foreign facility. Canada requires a Canadian address for the responsible party.

Phoenix provides UK and EU Responsible Person services from London and Tallinn and supports US registration from Pensacola, and the point for planning is that each market's responsible party is a cost and a relationship to set up before the first sale.

What must be filed with the authorities in each market?

The UK requires notification through SCPN before sale; the EU through CPNP; both are free and both are per product. The US requires facility registration and product listing with the FDA, renewed and updated. Canada requires a Cosmetic Notification Form within ten days of first sale.

Other markets range from notification to full registration with pre-market review, China being the most demanding. None of these filings is accepted by any other market. A multi-market launch therefore has a filing per market, made by that market's responsible party, and the notification references live in each market's file.

Our guide to cosmetic formulas and frame formulations explains the UK and EU composition declaration, while our MoCRA guide covers the US side.

Can one label serve several markets?

Sometimes, and it is worth designing for. The UK and EU share the Article 19 format, INCI nomenclature and the allergen and PAO conventions, so one label carrying both Responsible Person addresses, the longer EU allergen list and the languages of the countries of sale serves both.

The US has its own format: principal display panel, net contents in US units, common or usual ingredient names, the responsible person and adverse event contact, and no PAO. A carton can carry a UK and EU panel and a US panel, but each is built to its own rules and reviewed as such.

Canada requires bilingual labelling and INCI names. The practical approach is one core artwork with market panels, reviewed per market before print, rather than one label translated.

For brands developing a new product, the cosmetic formula should also be considered alongside shelf life, preservatives, stability and safety, and the overall sensory experience. A cosmetic chemist may need to assess how changes to the water phase or oil phase affect preservation, stability, safety testing and the finished product's performance.

A well-documented formulation should therefore connect the quantitative formula with its trade name, raw materials, active ingredients, preservatives and intended use. This gives the safety assessor the information needed to evaluate the product consistently across the UK and EU markets.

How should I sequence a multi market launch?

• Choose the markets now, including ones you want in two years. The ingredient screen is cheap to run for an extra market at the start and expensive to run after formulation.
• Classify the product in every market. Cosmetic everywhere, or a drug or medicine somewhere.
• Screen every ingredient against every market and record the strictest rule. Formulate to it.
• Commission one CPSR that assesses against the UK and EU regulations and reflects the US version of the product. Reuse it as substantiation everywhere.
• Set up the responsible party in each market. Before the first sale.
• Build the label as core artwork plus market panels. Review each panel.
• File per market. SCPN, CPNP, FDA listing, Canadian notification, others.
• Run one complaints log with each market's reporting route.
• Diarise a review per market. The annexes and lists change on different timetables.

A worked example: a face cream going to four markets

A UK brand plans a hydrating face cream for Great Britain, the EU, the US and Canada. The ingredient screen finds that one preservative in the original formula is permitted in the UK but restricted to a lower level in the EU, so the formula adopts the EU level. A botanical extract is on the Canadian Hotlist with a condition, so the formula meets it. The colourant is on every list for face use. The fragrance's allergen statement is obtained against the expanded EU list and the label is designed to carry it. The product makes no claim that would make it a drug in the US, and the brand removes a line about calming irritation that the assessor flags as borderline. One CPSR assesses against both the UK and EU regulations and notes the US and Canadian versions are identical in formula. The brand is its own GB Responsible Person, appoints an Estonian Responsible Person for the EU, names itself as US responsible person with a US contact and a US agent for its facility, and appoints a Canadian address. It notifies through SCPN and CPNP, registers and lists with the FDA, and files the Canadian form. The carton carries a UK and EU panel in English, French and German and a US panel, with the Canadian bilingual requirement met by the French. One formula, one report, four passports, all issued before the first shipment.

What about markets beyond the UK, EU and US?

The same method applies with different lists and procedures. Canada's Hotlist and notification form are close cousins of the EU system. Australia treats cosmetics as industrial chemicals with its own introduction rules and a separate scheme for sunscreens. ASEAN countries follow a harmonised directive modelled on the EU regulation with national notification. China requires registration or filing with its own permitted ingredient inventory and, for some products, testing in China, and its animal testing history matters for brands that market as cruelty free. Japan and Korea have quasi drug categories that pull some cosmetics into stricter regimes. The screen and the classification come first every time, and a brand that has built a UK and EU file has done the hardest part for most of them.

What are the mistakes that make one formula compliant in none?

• Formulating first and screening later. A prohibited ingredient in one market means reformulation for all.
• Assuming a UK CPSR covers the EU, or the reverse. The annexes have diverged; the report must cite both.
• Using one Responsible Person for two markets. Establishment rules forbid it.
• Translating the label instead of rebuilding it. US and UK formats differ in structure, not language.
• Selling a sunscreen in the US as a cosmetic. It is a drug there.
• Treating notification in one market as covering another. Every filing is per market.
• Forgetting Northern Ireland It is the EU regime inside the UK.
  

Myths we hear

• If it is legal in the EU it is legal everywhere. The EU is strict on ingredients but other markets have their own lists and procedures.
• A US brand can use its FDA listing in the UK. The UK needs a CPSR, a PIF, a Responsible Person and SCPN.
• One notification covers the EU and the UK. CPNP and SCPN are separate.
• The formula has to change for every market. Usually it does not, if screened to the strictest rule first.
• Multi market is only for big brands. A market stall brand selling to Ireland on Etsy is multi market.

What to do this week

• List every market you sell in now and every one you want in two years.
• Classify each product in each market: cosmetic, drug, medicine or other.
• Run the ingredient screen across all of them and record the strictest rule per ingredient.
• Check whether your CPSR cites both the UK and EU regulations.
• Name the responsible party, filing and label format for each market in one table.

The formula can travel. The compliance is built market by market, and a consultation will map exactly what your range needs for each one before you spend on any of them. Our related guides on importing cosmetics and US versus UK and EU rules go deeper on the two crossings brands make most.

Official sources and legislation

• Regulation (EC) No 1223/2009 on cosmetic products
• Cosmetic Products Enforcement Regulations 2013
• FDA: Modernization of Cosmetics Regulation Act (MoCRA)
• Scientific Committee on Consumer Safety (SCCS)
• OPSS guidance on cosmetic products regulations
• Submit cosmetic product notifications (SCPN)

Disclaimer: This article is general information, not legal advice. Regulations change and product decisions depend on your exact formulation, claims and market. Have your product assessed by a qualified professional before sale.