Cosmetic or medicinal claim? Questions for review

Preserve the presentation before asking for a classification review

A product-boundary question concerns more than one word in a caption. Collect the formulation revision, intended use, application, label, instructions, images, website copy and promotional context. Record the exact market and what the customer is being led to expect.

HPRA's claims guidance identifies medical-nature claims as incompatible with cosmetic claims. Its classification service page links to the Guide to Definition of a Human Medicine, issue ADV-G0003-8. That guide discusses presentation, purpose and borderline categories. The current EU cosmetic definition is in Article 2 of Regulation 1223/2009.

Use authority examples for the review question

HPRA's guide discusses wording about treating conditions such as eczema and distinguishes it from appropriately scoped moisturising claims. This is a reason to examine the product's full presentation and function, rather than classifying it by a cosmetic-style pack or a short list of ingredients.

The worked review file proposes two synthetic presentations for the same fictional cream: Moisturises dry skin and Treats eczema. These hypothetical presentations identify the material to bring to a specialist review. The file deliberately contains no approved wording or final product classification. Even the first statement still needs its evidence and context reviewed.

Keep the facts and the interpretation separate

Record what is actually supplied and what remains unknown. A maker can provide the artwork and intended use; that does not establish the legal category. Keep the specialist's question, reasoning and eventual scope as separate fields.

The example supplies no real formulation, mechanism evidence, clinical material or finished-product report. Its next task is to obtain the complete presentation and ask the appropriate specialist to identify the relevant boundary issue. Changing one phrase does not prove that the rest of the presentation has been resolved.

Escalate through the agreed route

Within the workspace, attach the question to the exact product revision and route it to specialist QC. Routine product support should help locate the record and cannot issue the classification finding. Frances owns the specialist review route; this does not assert that every possible boundary decision is within one person's professional scope.

Where a formal authority classification is needed, use the authority's published procedure. HPRA's page describes its request process and indicates that fees apply. Agree the request, appropriate professional input and any cost with the business owner before taking that external step. This guide sends no request and makes no appointment.

Review a proposed change as a new context

Retain the earlier wording and finding when a website, formula or intended use changes. Give the reviewer the new presentation rather than saying the product is already approved. Record which channels and revisions a finding actually covers.

This authority example concerns Ireland/EU. GB and NI require their own current scope and classification routes; the example does not issue a shared UK verdict. Use the claims hub for the released evidence and wording tasks, and keep unresolved classification questions visible until the appropriate decision is recorded.

Sources and legal dates