Why classification comes first
Almost every question about a sun protection label has the same first step: what kind of product is it, in law? The answer determines which rules apply, who assesses it, what evidence is required and what may be said about it.
In the United Kingdom the answer is that it is a cosmetic product. That places it under the cosmetics regime rather than under the rules for medicines or medical devices, and the consequences run through the entire label.
It also explains a difference that puzzles people comparing British and American packs. A sunscreen in the United States is regulated as an over the counter drug, which is why its pack carries a Drug Facts panel and a prescriptive vocabulary. The product is broadly similar; the classification is not.
The definition doing the work
A cosmetic product is defined by reference to substances intended to be placed in contact with the external parts of the human body with a view to cleaning, perfuming, changing appearance, protecting, keeping in good condition or correcting body odours. Protecting is in the list, which is why a sun protection product sits comfortably inside the definition.
The definition is about intended purpose rather than about composition, which is why the boundary is a matter of presentation as well as of ingredients. A product presented as preventing or treating disease is being presented as a medicinal product, and the MHRA publishes guidance on how that determination is made. That is the boundary examined below.
The framework in the United Kingdom
The substantive requirements come from the cosmetics regulation as retained in United Kingdom law, and the enforcement machinery comes from the Cosmetic Products Enforcement Regulations 2013, which create the offences and the enforcement powers.
The main obligations are these. Each product must have a responsible person, established in Great Britain for the Great Britain market, whose name and address appear on the pack. That person must hold a product information file containing a safety assessment prepared by a suitably qualified assessor, together with the evidence for effects claimed. The product must be notified before being placed on the market. Only permitted ultraviolet filters may be used, at permitted concentrations, from the annex to the regulation. And the labelling must carry the mandatory particulars, in English.
What there is not, and this surprises people, is any pre-market approval. Nobody licenses a sun protection product before it goes on sale. The system places the obligation on the responsible person and provides for enforcement afterwards.
The positive list of filters
One element of the cosmetics regime that functions differently from the rest deserves emphasis, because it is unusually strict.
Ultraviolet filters are controlled by a positive list. Only substances included in the relevant annex to the regulation may be used as ultraviolet filters in cosmetic products, and each entry carries a maximum concentration and any conditions of use. A substance not on the list may not be used at all, regardless of what evidence a manufacturer holds.
This is a stronger control than applies to most cosmetic ingredients, and it means that every filter in every legally sold sun protection product in Great Britain has been through a safety evaluation at a level above the individual product. The list is amended over time as scientific opinions are issued.
| Question | Answer for a UK sun protection product |
|---|---|
| Product class | A cosmetic product |
| Pre-market approval | None |
| Who carries the obligations | The responsible person, named on the pack |
| Ingredient control | A positive list of permitted ultraviolet filters with maximum concentrations |
| Safety documentation | A safety assessment within the product information file |
| Claims rules | The common criteria for cosmetic claims, plus the advertising codes |
| Enforcement | Under the Cosmetic Products Enforcement Regulations 2013 |
Framework of this publication. It describes how published rules and guidance fit together and is not a measurement, a survey or a study.
The boundary with medicinal products
A product can move out of the cosmetics regime through what is said about it. The determination of whether something is a medicinal product looks at presentation as well as at function: a product presented as having properties for treating or preventing disease in human beings can fall within the definition.
For sun protection products this boundary is live rather than theoretical. Claims about preventing a disease are the clearest case. Claims framed around treatment, cure or medical outcome move in the same direction. The MHRA operates a process for determining borderline cases and publishes guidance on the criteria.
The consequences of crossing the line are substantial, because the medicinal regime requires a marketing authorisation, which is a different order of obligation entirely. A business does not drift into that position by accident so much as by copywriting.
And with medical devices
A separate boundary exists with medical devices, which are regulated under their own framework and which achieve their principal intended action by means other than pharmacological, immunological or metabolic. Certain products presented for specific medical purposes can fall there.
For ordinary sun protection products this boundary is rarely reached. It becomes relevant for products presented for use in specific clinical contexts, and it is another reason that presentation, rather than formulation alone, determines the regime.
What the classification means for claims
Because a sun protection product is a cosmetic, its claims are governed by the common criteria for cosmetic claims: truthfulness, evidential support, fairness, legal compliance, and allowing a consumer to make an informed decision. Those criteria are general, and they do most of the work that specific labelling rules do in other regimes.
This is the structural reason British sun protection labelling looks the way it does. There is no prescribed panel of text, no mandated warnings specific to sunscreen, no defined term equivalent to broad spectrum in the American sense. Instead there is a general obligation not to mislead, supplemented by a European Commission recommendation that everybody follows.
Whether that is a better or worse arrangement than a prescriptive one is a real question. A general standard adapts as the science changes; a prescriptive one is clearer to comply with and clearer to enforce. The subject is examined in how other jurisdictions classify sunscreen.
A note on internal differences
The framework applying in Northern Ireland differs from that applying in Great Britain in ways that follow from the wider constitutional arrangements, including in relation to which regime applies and where the responsible person must be established. Businesses placing products across the United Kingdom need to establish which requirements apply to which market rather than assuming a single answer.
We flag the point rather than setting it out, because it changes, and because a labelling publication should not pretend to be a compliance service. The United Kingdom government publishes guidance on placing cosmetic products on the market and it is the correct starting point.
The mandatory particulars
Separate from claims, the cosmetics regime prescribes a list of particulars that must appear on the packaging. They are unglamorous and they are the part of the label that is actually required, as opposed to conventional.
They include the name and address of the responsible person, the nominal content by weight or volume, the date of minimum durability or the period after opening, particular precautions for use, the batch number or reference identifying the product, the function of the product where it is not clear from the presentation, and the list of ingredients in the required nomenclature and order.
Two of those are worth noticing on a sun protection pack specifically. The function requirement is why a pack states in some form that it is a sun protection product, and the ingredient list is where the ultraviolet filters appear under their standardised names, which is the only place a reader can see what is actually doing the work.
What the mandatory list does not include is the protection factor, the protection category or the ultraviolet A mark. Those are conventions rather than requirements, which is the point made at length in the European recommendation behind the label. The parts of the label that a reader treats as most official are the parts with the least formal standing.
What this means for a reader
Three things. Nobody approved this product before it went on sale, and that is by design rather than by oversight. Somebody named on the pack is legally responsible for it, and that name is worth noticing. And the strongest control in the whole regime applies to the ultraviolet filters, which are the part of the product doing the work.
What to take from this
A cosmetic, not a drug. No pre-market approval, a responsible person carrying the obligations, a positive list controlling the filters, general claims criteria rather than prescriptive labelling, and a boundary with the medicinal regime that is crossed by wording rather than by formulation.