US vs UK and EU Cosmetics Rules: A Side-by-Side Guide for Brands Using Cosmetic Compliance UK EU

The first order from Texas felt like a milestone. The brand had a CPSR for every product, a PIF, an SCPN notification and a clean label, and it assumed the American customer was buying a compliant product. In one sense she was: the product was safe and well made. In every legal sense, the brand had just placed an unregistered, unlisted product with an EU format label and a UK responsible person address on the US market. The UK and EU regulate cosmetics through Regulation (EC) No 1223/2009 and its retained version enforced through the Cosmetic Products Enforcement Regulations 2013. The United States regulates them through the Modernization of Cosmetics Regulation Act of 2022, administered by the FDA. The two systems share a philosophy and differ in almost every mechanism.

This guide puts the two side by side, topic by topic: how safety is demonstrated, what has to be registered or notified and by whom, who is responsible and where they must be, how ingredients are controlled, which products change category between the markets, how labelling and ingredient naming differ, how claims are policed, what happens after sale, how allergens and animal testing are handled, and what a UK or EU brand can reuse when it crosses the Atlantic. It ends with the practical sequence for the brand with the Texas order, which is about a month of work, most of it reading.

The philosophy they shareSide by side

Neither system approves cosmetics before sale. Both place the burden on the business to ensure the product is safe and to hold the evidence, and both give regulators powers to inspect, to demand that evidence and to act against unsafe products, including ordering product recalls where a genuine risk is found. Where they part company is in how much they prescribe. The UK and eu cosmetic regulation sets out exactly what the evidence must be, who may produce it, where it must be kept and how the product must be recorded before sale. MoCRA sets out that evidence must exist and that the product and its facility must be on record, and leaves the form of the evidence to the responsible person's judgement. A brand used to one system tends to over or underestimate the other: UK brands assume the US is lax because there is no CPSR, and US brands assume the EU is impossible because there is.

Side by side

Safety: prescribed versus adequate

The UK and EU require a Cosmetic Product Safety Report in the two part Annex I format, signed by a person holding a university qualification in pharmacy, toxicology, medicine or a similar discipline, kept in a Product Information File for ten years. These requirements sit under UK cosmetics regulation and the eu cosmetics regulation respectively, both of which trace back to Regulation (EC) No 1223/2009 on the EU side. MoCRA requires the responsible person to ensure and maintain records supporting adequate substantiation that the product is safe, defined as tests, studies, research, analyses or other evidence that qualified experts would consider sufficient, with no prescribed format and no prescribed qualification for whoever compiles it. For a brand that already holds a CPSR and a PIF, the US requirement is essentially met by the same documents, provided they cover the product as sold in the US. For a US brand entering the UK or EU, the reverse is not true: a safety dossier compiled by an unqualified person in a US format must be rebuilt as a CPSR. Our guide to what a CPSR is explains the prescribed side.

Recording the product: notification versus registration and listing

In the UK and EU the Responsible Person notifies each product through SCPN or CPNP before sale, free of charge, declaring category, frame formulation, label and responsible person; the notification records the product and enables poison centres and surveillance of potential risks associated with cosmetic products. In the US the facility that manufactures the product must be registered with the FDA and renewed every two years, and each product must be listed through Cosmetics Direct before marketing or within 120 days, with annual updates; a foreign facility must appoint a US agent. Registration and listing are more demanding than notification and carry their own timelines, and a UK notification does nothing for the US. Our guide to MoCRA registration and listing covers the mechanics.

Who is responsible, and where they must be

Both systems name a responsible entity on the label, but the establishment rules differ. The UK and EU Responsible Person must be established in the market, so a UK brand needs an EU Responsible Person for EU sales and vice versa. The US responsible person is whichever of the manufacturer, packer or distributor appears on the label, wherever established, but the label must carry a US address, telephone number or electronic contact for adverse events, and a foreign facility must have a US agent. A UK brand can therefore be its own US responsible person, which it cannot be for the EU, but it needs a US contact and a US agent for its facility. In every market, this entity is also who ends up handling undesirable effects reported by consumers, and who is expected to act if a product recall becomes necessary.

Ingredients: where the systems differ most

The UK and EU annexes prohibit more than a thousand substances, restrict hundreds with conditions, and permit colourants, preservatives and UV filters only from positive lists. The US prohibits or restricts a short list of substances by regulation, permits most others if the responsible person can substantiate their safety, and applies a strict positive list only to colour additives, which must be listed and in some cases batch certified by the FDA. The consequences run both ways. Ingredients restricted or banned under uk cosmetic regulation and its EU counterpart, including certain preservatives, fragrance materials and hair dye components, are used in US products, so a US formula entering the UK needs a full annex screen. Colour additives permitted in the UK and EU are not all permitted in the US, and US colour additive names and certification requirements are their own system, so a UK colour cosmetic entering the US needs a colour review. And US sunscreens use filters the UK and EU do not permit, while UK and EU sunscreens use filters the US has not approved, so sunscreens rarely cross without reformulation. These are exactly the kind of regulatory issues a brand needs to resolve before relying on a single cosmetic compliance file across both markets, since ingredient safety for one market does not automatically translate to the other.

Products that change category

The most expensive surprise for a UK or EU brand is discovering that a cosmetic here is a drug there. In the US, any product intended to affect the structure or function of the body or to treat or prevent disease is a drug, and the FDA treats sun protection, acne treatment, dandruff control, antiperspirant action, skin lightening and several other functions as drug claims. A UK mineral sunscreen, an anti dandruff shampoo with a permitted active, an antiperspirant and a blemish treatment are cosmetics here and over the counter drugs in the US, subject to monographs, drug facts labelling, drug listing and drug GMP. Some can be sold in the US by following the relevant monograph; some cannot without a drug approval. The reverse is gentler: US cosmetics presented cosmetically are generally cosmetics here, but their claims must be checked against the medicinal line, and a product's intended use, not just its ingredient list, is what determines which side of that line it falls on. Getting this wrong carries real consumer safety implications on both sides of the Atlantic, since cosmetic product safety assumes a product has been assessed and labelled for the category it actually sits in.

Labelling: not a translation

A UK or EU label cannot be used in the US by changing the address. US labelling follows the Fair Packaging and Labeling Act and FDA cosmetic labelling regulations, with a principal display panel carrying the identity and net contents in US customary units as well as metric, an ingredient declaration using common or usual names in descending order with the word fragrance rather than Parfum and water rather than Aqua, the responsible person's name and place of business, the MoCRA adverse event contact, and any required warnings, all in English. Period after opening symbols and best before dates are not US concepts. The UK and EU label is built around Article 19, INCI nomenclature, the Responsible Person address in the market, allergen declarations and the PAO or durability date. Both markets can often be served from one carton with two panels, but each panel must be built to its own rules and reviewed as such.

Claims

The UK and EU apply six common criteria to cosmetic claims and prohibit medicinal claims outright. The US applies Federal Trade Commission substantiation rules to advertising and FDA rules to labelling, and its decisive line is between cosmetic and drug claims: a claim that a product affects the structure or function of the body or treats a condition makes it a drug. The boundary sits in a similar place but not identically. Anti ageing claims about the appearance of wrinkles are cosmetic in both; claims to stimulate collagen are drug claims in the US and medicinal in the UK and EU; claims about sun protection are cosmetic here and drug claims there. A claims review for each market is part of any transatlantic launch.

After sale: vigilance in both

Both systems require the business to record adverse reactions and report serious ones. The UK and EU require undesirable effects to be logged and serious undesirable effects reported without delay, treated as within twenty days. MoCRA requires serious adverse events to be reported to the FDA within fifteen business days and records to be kept for six years. A single complaints log serves both, provided the reporting routes and timelines for each market are known. Our guide to cosmetovigilance covers the UK and EU side.

Allergens, animal testing and GMP

The UK and EU require named fragrance allergens on labels above thresholds, with the EU list expanding from 2026; MoCRA directed the FDA to make an allergen labelling rule, which follows. The UK and EU ban animal testing of cosmetics and the marketing of animal tested cosmetics; the US has no federal ban, although several states have banned the sale of newly animal tested cosmetics, and testing is not required. The UK and EU require GMP with ISO 22716 as the presumed standard; MoCRA directed the FDA to make a GMP rule expected to align with the same standard. In each case a brand meeting the UK and EU requirement is at or ahead of the US requirement, which is the general pattern: the UK and EU documentation is the more demanding foundation, and the US adds registration, listing, labelling and category work on top.

What a UK or EU brand can reuse in the US

• The CPSR and PIF. As safety substantiation, provided they cover the US version of the product.
• GMP documentation and batch records. Directly.
• Supplier documents. Directly, with a colour additive check.
• The complaints log. With the US reporting route added.
• The formula. Usually, except sunscreens, acne, dandruff and antiperspirant products and formulas containing US restricted colours or substances.

What it cannot reuse

• The label. Rebuilt to US rules.
• The notification. Facility registration and product listing instead.
• Sun protection, acne, dandruff and antiperspirant claims. Drug territory.
• The Responsible Person address. A US contact is needed.
• The assumption that a compliant product is compliant everywhere.

A worked example: the Texas order, done properly

The brand has six products: a body butter, a body oil, a lip balm, a shampoo bar, a mineral SPF moisturiser and an anti dandruff scalp treatment. A US review sorts them in an afternoon. Four are cosmetics in the US and can proceed. The SPF moisturiser is a drug and cannot be sold as a cosmetic; it is dropped from the US range. The scalp treatment's dandruff claim makes it a drug; it is relaunched in the US as a soothing scalp oil with the claim removed, which the assessor confirms is consistent with the CPSR. The brand registers its UK facility with the FDA and appoints a US agent, rebuilds the label for the five products with a US panel, lists them through Cosmetics Direct, adds the US reporting route to its complaints log, and files its CPSRs and PIFs as the US substantiation. Six weeks after the first Texas order it is selling five products lawfully in the US, and it has learned that the sixth needs a different route. Our guides to MoCRA and choosing between MoCRA software and a consultant carry the detail.

Myths we hear

• The US has no cosmetics regulation. It has MoCRA, with registration, listing, substantiation and reporting duties.
• My CPSR means I am compliant in the US. It is your substantiation; you still need registration, listing and a US label.
• Sunscreen is a cosmetic everywhere. It is a drug in the US.
• A US ingredient list is the same as an INCI list. Naming conventions differ.
• The EU is impossible for US brands. It is prescriptive; a qualified assessor and a PIF make it entirely achievable.

What to do this week

• Sort your range into US cosmetic and US drug categories.
• Screen your colourants against the US colour additive list.
• Decide who will be the US responsible person and the US agent.
• Draft a US label panel for one product and have it reviewed.
• Add the FDA reporting route to your complaints log.

Phoenix works from London, Tallinn and Pensacola, so the same team that wrote your CPSR can register your facility, list your products and review your US labels. A consultation sorts a range into its US categories in one call, and our MoCRA listing service handles the rest. The Texas order was a milestone. The second one can be a compliant one.

Official sources and legislation

• FDA: Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
• FDA cosmetics home
• Regulation (EC) No 1223/2009 on cosmetic products
• Cosmetic Products Enforcement Regulations 2013
• OPSS guidance on cosmetic products regulations

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.