In this article
The short answer
Your product is a cosmetic if it goes on the outside of the body, the teeth or the inside of the mouth, and its main job is to clean, perfume, change appearance, protect, keep in good condition or correct body odour. It stops being one if you present it as treating or preventing a disease, or if it works pharmacologically (that makes it a medicine), if its main purpose is killing germs or pests (a biocide), or if it serves a medical purpose by physical means (a medical device). Regulators judge what the product does and how you sell it, not what you call it, and the answer decides whether you need a CPSR or a completely different approval.
Key takeaways
- Work out what the product legally is before you buy any compliance work. A CPSR only exists for cosmetics.
- The UK and EU cosmetic definition has three parts: where it is applied, that it is for humans, and what it is mainly for. Miss one and it is not a cosmetic.
- Words on the label, the website, social posts and even quoted reviews count. "Heals", "treats" and named conditions put you in medicine territory.
- Hand sanitisers are biocides. A hand wash sold mainly on killing germs is likely to be treated as one too, however gentle the formula.
- Most borderline problems are fixed by rewording, not reformulating. The exception is a product with a genuinely pharmacological ingredient at an active dose.
- The US draws the line differently: sunscreens, antiperspirants, fluoride toothpaste and anti-dandruff shampoos are OTC drugs there, even though they are cosmetics in the UK and EU.
Here is a kind of enquiry we see all the time. A small brand sends a lip balm for a safety report. Lovely formula: beeswax, shea, a little calendula. The label says "heals cold sores". No assessor can write a CPSR for it, and not because anything in the tin is unsafe. A product sold to heal cold sores is a medicine, and no cosmetic safety assessment can change that. The fix usually takes ten minutes: new wording about softening and protecting dry lips. The formula does not need to change.
That is the whole borderline problem in one story. Before you ask what paperwork you need, you have to answer a simpler question: what have I actually made? In the UK and EU every product applied to the body lands in one regime, and the regime decides your costs, your regulator and whether you can sell it at all.
The cosmetic definition, in three parts
Article 2 of Regulation (EC) No 1223/2009 defines a cosmetic product, and Great Britain uses the same wording through the retained regulation and the Cosmetic Products Enforcement Regulations 2013. A cosmetic is a substance or mixture intended to be placed in contact with the external parts of the human body, or the teeth and the mucous membranes of the mouth, exclusively or mainly to clean, perfume, change appearance, protect, keep in good condition or correct body odours.
Read it as three tests, and a product must pass all three:
- Where does it go? Skin, hair, nails, lips, external genital organs, teeth or inside the mouth. Products that are injected, swallowed or used inside the vagina are out.
- Who is it for? People. A dog shampoo is not a cosmetic, however human the formula.
- What is it mainly for? One of the six cosmetic purposes. A secondary benefit is fine; the main purpose is what counts.
If a product meets all three and is not caught by another regime, it is a cosmetic however you market it. If it misses one, it is something else.
When a cosmetic becomes a medicine
Under the Human Medicines Regulations 2012, a medicinal product is one presented as treating or preventing disease, or one that can restore, correct or modify physiological functions through a pharmacological, immunological or metabolic action. That gives regulators two separate routes to call your product a medicine.
Presentation. This is how the product comes across to an ordinary shopper. A cream that "treats eczema", a serum that "cures acne" or a scalp oil that "stops hair loss" is presented as a medicine, even if it is mostly sunflower oil. Presentation is wider than the label. It includes the product name, the website, Instagram captions, packaging images and customer reviews you quote or share.
Function. This is what the product really does in the body. An eyelash serum containing a prostaglandin analogue grows lashes through a drug action, so it is a medicine whatever the wording. Rewording will not help a product like that.
In the UK the MHRA makes the call. Its borderline products guidance explains how it decides, publishes its final determinations and offers an advice form if you want a view before launch. We have covered two of the most common traps in more detail: anti-itch creams and hair loss products.
Try this on your own range
Print your label and product page and circle every verb. Cleanses, softens, moisturises, perfumes, protects, conditions and refreshes are cosmetic verbs. Treats, heals, cures, relieves, prevents, repairs damage and stimulates growth are medicinal ones. Each of those was a classification decision, whether you meant it or not.
Cosmetic vs biocide: the germ-killing question
A biocidal product is one meant to destroy, deter, render harmless or control harmful organisms by chemical or biological means. In Great Britain it falls under the Biocidal Products Regulation, enforced by the HSE, which needs approved active substances and an authorised product. That is a slow, expensive route that very few small brands can take on.
For cosmetic businesses this usually comes up with hand products and repellents. Hand sanitiser is a biocide, full stop: its job is to kill microorganisms. Insect repellent sprays and lotions are biocides too. The harder case is hand wash. A hand wash whose main purpose is cleaning stays a cosmetic, even with a preservative in it, because that preservative protects the product, not your hands. Put "kills 99.9% of germs" or "antibacterial protection" on the front and you are telling regulators that disinfection is the point. At that stage it is likely to be treated as a biocide, and your CPSR no longer covers it.
Where medical devices begin
A medical device serves a medical purpose, such as treating or relieving an injury or condition, but works mainly by physical means rather than drug action. In Great Britain devices fall under the Medical Devices Regulations 2002 and need conformity assessment and UKCA or CE marking, not a CPSR.
The overlap with cosmetics is in substance-based products: barrier creams for broken or damaged skin, wound gels, dry eye drops, hydrocolloid spot patches sold to heal blemishes, and most personal lubricants. The deciding factor is purpose. A barrier cream that protects healthy skin from cold wind is a cosmetic. The same cream sold to protect skin around a wound is a device.
Products that are none of these
If it is not applied to the body, it is not a cosmetic. Candles, wax melts, reed diffusers, room sprays, decorative bath bombs sold as ornaments, cleaning products and pet grooming products all sit under general product safety and chemical labelling rules. They need a toxicological risk assessment rather than a CPSR, and our guide to TRA vs CPSR explains the difference. Products meant to be eaten, such as beauty supplements and edible body products, belong to food law.
Borderline cosmetic products, with answers
These come up in our inbox nearly every week. The classification shown is the usual outcome in the UK and EU; a final decision always depends on the full presentation and formula.
| Product as sold | Usual classification | Why |
|---|---|---|
| Lip balm that "heals cold sores" | Medicine (presentation) | Claims to treat a disease. Sold to soften and protect lips, the same balm is a cosmetic. |
| Hand sanitiser gel | Biocide | Main purpose is killing microorganisms on the skin. |
| Hand wash sold on "kills 99.9% of germs" | Likely biocide | Disinfection is presented as the main purpose. |
| Hand wash that cleans, with a preservative | Cosmetic | Cleaning is the purpose; the preservative protects the product, not the user. |
| Fluoride toothpaste | Cosmetic (UK/EU) | Cosmetic up to 0.15% fluorine under Annex III. An OTC drug in the US. |
| Tooth whitening with hydrogen peroxide | Cosmetic within strict limits | Over 0.1% and up to 6% only via dental professionals, never for under-18s. Above 6% it cannot be a cosmetic. |
| Sunscreen | Cosmetic (UK/EU) | Protecting skin is a cosmetic function. An OTC drug in the US. |
| Anti-dandruff shampoo | Usually cosmetic | Controlling visible flakes is cosmetic. Claims to treat seborrhoeic dermatitis or psoriasis are medicinal. |
| Scalp serum that "regrows hair" | Medicine (presentation) | Claims to restore a physiological function. |
| Eyelash serum with a prostaglandin analogue | Medicine (function) | Real pharmacological action on hair growth, whatever the wording. |
| Massage oil for soft, nourished skin | Cosmetic | Conditioning the skin. |
| Massage oil that "relieves muscle pain" | Medicine (presentation) | Claims to relieve a symptom. |
| Nappy balm that protects skin | Cosmetic | Protecting healthy skin. |
| Nappy balm that "treats nappy rash" | Medicine (presentation) | Claims to treat a condition. |
| Insect repellent spray | Biocide | Repels pests (product type 19). |
| Head lice treatment | Medicine or medical device | Treats an infestation; dimeticone types are usually devices. |
| Tattoo aftercare "for healing" | Medicine or device | Presented for healing broken skin. |
| Candle, wax melt, room spray | Not a cosmetic | Not applied to the body. General product safety and CLP apply. |
The US draws the line in a different place
If you also sell in the United States, do not assume the UK answer carries over. The FDA treats a product as a drug when it is intended to affect the structure or function of the body or to treat or prevent disease, and some everyday cosmetics fall on the drug side there. Sunscreens, antiperspirants, anti-dandruff shampoos and fluoride toothpastes are over-the-counter drugs in the US. Many are regulated as both cosmetic and drug, with drug facts labelling. The FDA's page Is it a cosmetic, a drug, or both? is the place to start.
Why the classification decides everything
Classification is not a box you tick at the end. It sets the whole compliance route:
- Cosmetic: CPSR, PIF, Responsible Person, SCPN or CPNP notification and a compliant label. Anyone can do it with the right support.
- Medicine: a marketing authorisation or registration from the MHRA. For most small brands that is out of reach.
- Biocide: approved active substances and product authorisation under the biocides regime.
- Medical device: technical documentation, conformity assessment, a quality system and UKCA or CE marking.
Get it wrong one way and you are trading illegally, which is where every cosmetic with a medical claim already sits. Get it wrong the other way and you pay for a device file for a product that only ever needed a CPSR.
A worked example: one brand, three calendula products
A small brand sells a calendula balm, a calendula cream and a calendula wash. The balm is sold to soothe and protect dry, chapped skin, so it is a cosmetic. The cream's product page quotes a customer saying it "cleared my eczema in a week". By publishing that review, the brand has made the claim its own, and the cream is now presented as a medicine. The wash is described as a gentle cleanser, but a newsletter calls it "antibacterial", which puts it on the biocide side of the line.
The three formulas are close to identical. The brand took the testimonial down, removed "antibacterial" from its emails and archived the old posts. All three products then needed only a CPSR each. The whole fix was an afternoon of editing, and it kept the brand out of a regime it could never have met.
How to get a decision you can rely on
For most products, the definition and the table above give a clear answer. For genuine grey areas:
- Use the MHRA's borderline advice service for a view on medicines and devices.
- Ask the HSE where a biocidal purpose is in question.
- Check the European Commission's borderline products manual, which is binding on no one but is still widely used in the UK as a reference.
- Run the product through our free borderline product classification tool.
- Ask your safety assessor up front. A good one will tell you before starting whether the product can be assessed as a cosmetic at all.
Whatever you conclude, write the reasoning into your Product Information File. If Trading Standards ever ask why you treated something as a cosmetic, a dated written analysis is a much better answer than "we assumed". Our guide to cosmetic claims covers how to keep the wording itself defensible.
A lip balm like the one at the start can go on sale as a cosmetic with a better label and the same tin. Most borderline products are like that: one sentence away from the right side of the line.
Related reading on the Phoenix blog
- Anti-itch creams: cosmetic or medicinal?
- Hair loss products: cosmetic or medicinal in the UK and EU?
- Cosmetic claims that are not allowed
- TRA vs CPSR: which safety assessment does your product need?
Myths we hear
- If every ingredient is cosmetic, the product is a cosmetic. How you present it is a test in its own right. A cosmetic formula sold to treat eczema is a medicine by presentation.
- A CPSR proves my product is a cosmetic. The CPSR assumes the classification is already right. A good assessor will refuse to assess a medicine or biocide as a cosmetic.
- Natural products cannot be medicines. The tests look at claims and effect, not origin. A herbal balm that "heals cold sores" is presented as a medicine.
- "Antibacterial" is just a marketing word. Regulators read it as a claim to control microbes, and it can push a hand wash into the biocides regime.
- Calling it a cosmetic keeps the MHRA away. The definitions are applied objectively. The MHRA can and does determine that products sold as cosmetics are medicines.
What to do this week
- Write one plain sentence for each product saying what it is for.
- Go through every label, product page, email and social post and circle the verbs.
- Reword anything that treats, heals, cures, prevents a condition or kills germs, or accept that the product belongs in another regime.
- Check any active ingredient that could have a pharmacological effect at the level you use it.
- Run each product through the Phoenix borderline classification tool and save the result.
- Record your classification reasoning in the PIF so you can answer a regulator in writing.
Frequently asked questions
What is the legal definition of a cosmetic in the UK?
The UK uses the same definition as the EU, in Article 2 of Regulation (EC) No 1223/2009 as retained in GB law. A cosmetic is a substance or mixture placed on the external parts of the human body, the teeth or the mucous membranes of the mouth, exclusively or mainly to clean, perfume, change appearance, protect, keep in good condition or correct body odours.
Can a cosmetic formula be classed as a medicine?
Yes, in two ways. By presentation, if you sell it as treating or preventing a disease, whatever it contains. By function, if it contains an ingredient at a level that has a real pharmacological, immunological or metabolic effect on the body, whatever the label says.
Is hand sanitiser a cosmetic or a biocide?
A biocide. Its main purpose is killing microorganisms on the skin, so it falls under the Biocidal Products Regulation (product type 1, human hygiene), which the HSE enforces in Great Britain. A hand wash whose main purpose is cleaning, with a preservative to keep the product stable, stays a cosmetic.
Is sunscreen a cosmetic?
In the UK and EU, yes. Protecting the skin is a cosmetic function, and sunscreens follow the cosmetic UV filter, SPF testing and labelling rules. In the United States sunscreen is regulated by the FDA as an over-the-counter drug.
Is a personal lubricant a cosmetic or a medical device?
Most personal lubricants are sold as medical devices, especially those for internal use or for use with condoms. A product applied only to the external genital area for comfort or moisture, with no medical purpose, can be a cosmetic. The intended use and how you describe it decide.
How do I fix a product that has become a medicine by presentation?
Change the claims, not the formula. Swap treating, healing, curing and named conditions for cosmetic language about cleansing, softening, protecting and comfort, and remove testimonials that make medical claims. Products that are medicines by function cannot be fixed with wording.
Who decides borderline cases in the UK?
The MHRA decides whether a product is a medicine or a medical device and offers a borderline advice service. The HSE handles biocides. Trading Standards enforce the cosmetics rules, with OPSS as national regulator. The European Commission's borderline manual is not binding in Great Britain but is still a useful reference.
Why does classification matter before I order a CPSR?
Because each classification leads to a different route. A cosmetic needs a CPSR, PIF, Responsible Person, notification and compliant label. A medicine needs a marketing authorisation, a biocide needs an authorised product with approved actives, and a device needs conformity assessment and UKCA or CE marking. Getting it wrong means either illegal sales or money spent on the wrong paperwork.
Official sources and legislation
- Regulation (EC) No 1223/2009 on cosmetic products, Article 2 (legislation.gov.uk)
- Cosmetic Products Enforcement Regulations 2013 (legislation.gov.uk)
- Human Medicines Regulations 2012, regulation 2 (legislation.gov.uk)
- MHRA: borderline products, how to tell if your product is a medicine (GOV.UK)
- Biocidal Products Regulation (EU) No 528/2012 as it applies in GB (legislation.gov.uk)
- HSE: biocides
- Medical Devices Regulations 2002 (legislation.gov.uk)
- European Commission: borderline products and the cosmetics manual
- FDA: Is it a cosmetic, a drug, or both?
- OPSS: making cosmetic products available to consumers in Great Britain (GOV.UK)
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