Northbank Media/A field guide to sun protection under real conditions/No product is named, rated or ranked

Who regulates sunscreen in the UK, and who to tell when a claim is wrong

The UK map: cosmetics law, the Office for Product Safety and Standards, trading standards, the ASA and the CAP codes, and where the MHRA does and does not sit.

UKRegulatorsComplaints
Who regulates it, elemental outdoor abstraction
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The short answer

Sunscreen in the UK is a cosmetic product, governed by the retained EU Cosmetic Products Regulation. Product compliance and safety sit with the Office for Product Safety and Standards working alongside local authority trading standards. Advertising claims are policed by the Advertising Standards Authority against the CAP and BCAP codes. The MHRA regulates medicines and medical devices, which is a different category, and it is the reason a sunscreen is not licensed like a drug here.

People assume sunscreen must be tightly licensed, in the way a medicine is. In the UK it is not, and knowing why explains a lot about what the label does and does not have to tell you.

Sunscreen is a cosmetic product

The governing instrument is Regulation (EC) No 1223/2009 on cosmetic products, retained in UK law after EU exit as the UK Cosmetics Regulation. It requires, among much else, that a responsible person be identified for each product placed on the market, that a product information file including a safety assessment be held and made available to enforcement authorities, that only permitted ultraviolet filters be used within their permitted limits, and that claims comply with the common criteria set out in Commission Regulation (EU) No 655/2013, also retained.

That is a real framework with real obligations. What it is not is a pre market licensing system. There is no approval number, no marketing authorisation, and no regulator signing off each product before it goes on sale. Compliance is the responsibility of the person placing the product on the market, and enforcement is after the fact.

The Office for Product Safety and Standards

The Office for Product Safety and Standards is the national regulator for product safety in Great Britain and is the body with national responsibility for cosmetics regulation. It works alongside local authority trading standards services, which carry out enforcement locally, and it maintains the national approach to product safety incidents and non compliance.

If a product on sale in the UK appears not to comply with cosmetics law, that is the enforcement route: trading standards through your local authority, with OPSS operating nationally.

The Advertising Standards Authority

Claims made in advertising, which includes marketing on a company's own website and in social media, fall under the CAP and BCAP codes and are policed by the Advertising Standards Authority. The codes require that objective claims be capable of substantiation and that marketing communications must not materially mislead.

This is the route that has historically dealt with overstated sun protection claims in the UK, and it is the route available to a member of the public who sees a claim they believe cannot be supported. Complaints are free to make and are considered on their merits.

The practical division is worth remembering: what is on the pack is a product compliance matter, what is in the advertisement is an advertising matter, and the same words can be both.

Where the MHRA sits, and does not

The Medicines and Healthcare products Regulatory Agency regulates medicines and medical devices in the UK. A conventional sunscreen is neither, so the MHRA is not its regulator. The reason this matters is comparative: in the United States, sunscreen is regulated as an over the counter drug by the Food and Drug Administration, which is why an American pack carries a Drug Facts panel. The category difference explains the labelling difference. See our note on the United States position.

Where a product makes a genuinely medicinal claim, the boundary can move, and the categorisation of borderline products is itself a regulatory question. That is beyond what a field guide should attempt, and we do not attempt it.

What a soft claim is worth

Label decoder

Dermatologically tested

What it certifies

That some form of testing involving a dermatologist or a dermatological protocol was carried out. It is a claim like any other, so under the common criteria for cosmetic claims retained in UK law the manufacturer must hold evidence supporting it.

What it does not

It does not tell you what was tested, how many people were involved, what the result was, or whether anything passed. It is not a sun protection claim at all, and it carries no information about factor, ultraviolet A performance or water resistance.

The general test for a reader is whether a claim points at a procedure. Water resistant points at an immersion procedure. A factor points at an in vivo test method. The UVA circle points at a defined ratio. Dermatologically tested, non greasy, sport, for sensitive skin and reef safe point at nothing you can inspect, which does not make them false but does make them uninformative.

The responsible person, and why it appears on the pack

Every cosmetic product placed on the UK market must have a responsible person established in the UK, whose name and address appear on the label. It is the least glamorous line on any pack and one of the more useful ones, because it identifies who is accountable for compliance.

That person is required to keep a product information file, including a safety assessment carried out by a suitably qualified assessor, and to make it available to the enforcement authorities on request. They are also required to hold the evidence supporting every claim made about the product, under the common criteria. This is where a water resistance result, an ultraviolet A determination or a substantiation for a softer descriptor actually lives.

What it means for a reader is that the evidence exists somewhere and is not published. You cannot request it, but a regulator can. That asymmetry is a fair description of the whole consumer position in this category: a great deal has been assessed, and almost none of it is visible from the shelf. Reading the claims that point at published procedures is the closest a shopper can get, which is what our standards notes are for.

How to raise something

  • A misleading advertisement, including a website or a social post: the Advertising Standards Authority.
  • A non compliant product on sale, including labelling that appears to breach cosmetics law: local authority trading standards, with OPSS nationally.
  • A reaction to a product: speak to a pharmacist or your GP. Manufacturers also have obligations regarding serious undesirable effects under cosmetics law.
  • A general question about sun safety: the NHS, the British Association of Dermatologists and Cancer Research UK all publish public guidance.

Serious undesirable effects, and what happens when a product harms someone

The retained cosmetics framework includes an obligation on the responsible person and on distributors to notify the competent authority of serious undesirable effects, and to provide information about the product concerned. It is one of the few parts of the framework that operates after a product is on the market and in use.

For a member of the public, the practical route is more prosaic. A reaction to a product is something to raise with a pharmacist or a GP, both because you may need advice and because clinicians are part of how patterns get noticed. It is also worth telling the manufacturer directly, since they carry the notification obligation and cannot act on something they have not been told about.

We are not the right destination for a report of this kind, and we do not collect them. What we can do is set out where the obligation sits, which is not obvious from anything printed on a pack.

What is not verifiable

We do not publish enforcement outcomes, we do not name products or companies, and we do not characterise any particular pack as compliant or non compliant. We are a field guide, not a regulator and not a complaints service. What we can do is set out who does what, so that a reader who sees something wrong knows where it goes.

The map in one paragraph

Cosmetics law sets the rules. The responsible person must hold the evidence. OPSS and trading standards enforce the product. The ASA enforces the advertising. The MHRA is elsewhere. And none of them can make you apply enough or reapply, which remains the part of the system that fails most often.

Questions

Is UK sunscreen approved by a regulator before it goes on sale?

No. Sunscreen is a cosmetic product under the retained UK Cosmetics Regulation, which places obligations on the responsible person, including a safety assessment and a product information file, but there is no pre market licensing or approval number.

Who do I complain to about a misleading sunscreen advert?

The Advertising Standards Authority, which applies the CAP and BCAP codes. Complaints are free and are considered on their merits.

Who enforces sunscreen labelling on the pack?

Local authority trading standards, with the Office for Product Safety and Standards holding national responsibility for cosmetics regulation in Great Britain.

Does the MHRA regulate sunscreen?

No. The MHRA regulates medicines and medical devices. A conventional sunscreen is a cosmetic in the UK, which is why it is labelled differently from an American pack, where sunscreen is an over the counter drug.

What does dermatologically tested mean?

That some testing involving a dermatologist or dermatological protocol was carried out, and the manufacturer must hold evidence for the claim. It does not tell you what was tested, on how many people, or what the outcome was, and it says nothing about sun protection performance.

Sources

  1. Office for Product Safety and Standards
  2. Medicines and Healthcare products Regulatory Agency
  3. Advertising Standards Authority, the CAP and BCAP advertising codes
  4. Regulation (EC) No 1223/2009 on cosmetic products, retained in UK law
  5. Commission Regulation (EU) No 655/2013, common criteria for cosmetic claims

Standards are cited by number. We publish no measurements of our own and repeat no figure we cannot attribute.

No commercial links. This article contains no affiliate links, no sponsored content, no paid placement and no commercial links of any kind. Waterproof SPF names, rates and ranks no sunscreen, brand or retailer, and publishes no test measurements of its own. Published by Northbank Media. Our funding model is set out in full on the about page.

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