Anyone who makes a cosmetic product available to the public in Great Britain, including a creator launching an own-brand range, has legal duties before it goes on sale. This article explains what UK government guidance and the retained legislation say about the responsible person, the safety assessment, the product information file, notification and labelling. It describes Great Britain only; Northern Ireland and the EU follow different arrangements.
Which rules cover cosmetics in Great Britain?
According to GOV.UK guidance on making cosmetic products available to consumers in Great Britain (first published 4 October 2021), the framework is Regulation (EC) No 1223/2009 as amended by the 2019 EU Exit regulations. The guidance applies to products available to the public in Great Britain, including those sold, given away (free samples, for example) or used on the public by professionals. It does not cover Northern Ireland.
Product safety and labelling duties are separate from advertising rules, which in the UK are handled by the Advertising Standards Authority. Readers interested in that side can see the article on beauty filters in cosmetics ads.
Who is the “responsible person”?
GOV.UK says every cosmetic product available to consumers must have a responsible person. This can be a business or an individual, including a sole trader. It can be the manufacturer, the importer, a distributor that sells the product under its own brand, or a company or person appointed by the manufacturer or importer.
The responsible person must have a UK established address. According to the guidance, mail-forwarding and PO box addresses do not count. Among their duties, the guidance lists:
- ensuring the product is safe;
- knowing the ingredients and any restrictions on them;
- keeping the product information file;
- notifying the government’s Office for Product Safety and Standards (OPSS) before the product is made available;
- reporting serious undesirable effects; and
- being able to prove any marketing claims.
The guidance does not set out how these duties apply to online sales specifically. The article’s own reading is that the duties attach to the product being made available to consumers in Great Britain, whichever channel is used, but the source does not say this in terms.
What does the safety assessment involve?
Before a product is made available, a qualified safety assessor must check its safety, and the responsible person must make sure this happens. Under Article 10 of the Regulation, the assessment must consider the intended use and the expected systemic exposure to ingredients, and use a weight-of-evidence approach. GOV.UK says the assessor should hold a university degree in pharmacy, toxicology, medicine or a similar discipline.
The cosmetic product safety report has two parts, according to GOV.UK:
| Part | Provided by | What it covers |
|---|---|---|
| Part A | Responsible person | Ingredients and concentrations, physical and chemical properties, stability, microbial quality, preservatives, impurities, packaging, likely use and likely user exposure |
| Part B | Safety assessor | The safety conclusion, any warnings or instructions, the scientific reasoning, and the assessor’s details and qualifications |
The Regulation also requires the report to be kept up to date.
What goes into the product information file, and for how long?
The responsible person must keep a product information file (PIF) in English for each product. GOV.UK lists four contents: a product description, the product safety report, evidence of good manufacturing practice, and evidence of the product’s effects. Article 11 of the Regulation adds that the file must be accessible to the competent authorities at the address given in the notification.
Good manufacturing practice can be shown through the ISO 22716 standard, which GOV.UK describes as common but not the only route.
A worked example of the retention period
Both GOV.UK and Article 11 say the file must be kept for ten years after the last batch of the product is made available. Illustrative arithmetic: if the final batch of a shade were made available in March 2027, the file for that shade would need to be retained until March 2037. A later batch restarts the count, so a product that stays on sale for years carries its file for years after that.
How does notification work?
Before a product is made available in Great Britain, the responsible person must submit product information to OPSS through the government’s cosmetic product notification service. Article 13 describes what is notified, including:
- the product category and name;
- the responsible person’s name and the address where the PIF is kept;
- an urgent contact person;
- whether nanomaterials are present;
- the names and identification numbers of any substances classed as carcinogenic, mutagenic or toxic for reproduction in the most serious categories (1A and 1B); and
- the formulation, in a form allowing prompt and appropriate medical treatment if needed.
Article 13 also says the original labelling and, where legible, a photograph of the packaging must be notified, and that changes must be updated without delay. GOV.UK adds that certain nanomaterials, and new colourants, UV-filters or preservatives not on the permitted lists, need extra notification or a safety dossier.
What must appear on the label?
Article 19 says the container and packaging must carry certain information in “indelible, easily legible and visible lettering”. The list is:
| Label item | What it means |
|---|---|
| Responsible person | Name and address; country of origin if imported |
| Quantity | Weight or volume |
| Durability | Date until which the product can be used |
| Precautions | Particular precautions for use |
| Batch | Batch number or other identification reference |
| Function | What the product does, unless clear from its presentation |
| Ingredients | A list headed “ingredients”; nanomaterials marked “(nano)” |
Some exceptions apply. According to GOV.UK, the weight or volume and the usage date may not be required for contents under 5 grams or 5 millilitres, such as free samples and single-application packs. Article 19 also says products with a durability of more than 30 months need not show a date, but must show a period of use after opening instead. Thirty months is two and a half years. Where space is limited, GOV.UK says precautions and ingredients can go on a leaflet marked with a symbol.
Are there limits on what a label or name can claim?
Yes. Article 20 says that labels, names, trade marks, images and other signs must not imply that a product has characteristics or functions it does not have. GOV.UK repeats that labelling and advertising must not imply features the product lacks. The responsible person must also make sure claim wording meets the common criteria set out in the Annex to Commission Regulation (EU) No 655/2013.
A “no animal tests” statement is allowed only if neither the manufacturer nor its suppliers have tested the finished product, its prototype or its ingredients on animals, or used ingredients that others tested on animals for new cosmetic development. Environmental wording is a separate area, covered in the article on green claims in fashion and beauty.
Which ingredients are restricted, and what if a user is harmed?
GOV.UK says Annex 3 of the Regulation lists prohibited and restricted substances. Colourants, preservatives and UV-filters work on a positive list: only substances listed in Annexes 4, 5 or 6 may be used, with their restrictions. Substances classified as carcinogenic, mutagenic or toxic for reproduction are banned, subject to a process of exemptions for the lower category 2 substances, which a scientific advisory group assesses.
If a reaction leaves someone temporarily or permanently unable to carry out usual day-to-day tasks, GOV.UK says the responsible person must report it to OPSS immediately. Examples given include disability, hospitalisation, congenital abnormalities, risk to life and death. Allergic reactions, irritation and cosmetic acne do not need to be reported under this duty, according to the same guidance.
Conclusion: a chain of accountability, not a single form
The GB framework puts a named person at the centre, backed by a qualified safety assessment, a file kept for ten years, notification before sale and a label carrying specific information. As of the guidance’s published version, it applies to Great Britain and not Northern Ireland, where the responsible person must instead be established in Northern Ireland or the EU.
The guidance covers products given away as well as sold. The article’s own reading, not the source’s, is that this logic would apply to a “dupe” or a limited collaboration that is a cosmetic product made available to the public in Great Britain. The article on beauty and fashion dupes looks at how such products are discussed.
This article is general information based on published guidance, not legal or regulatory advice; rules and guidance change, so check the current official pages.
Sources: GOV.UK (Making cosmetic products available to consumers in Great Britain); legislation.gov.uk (Regulation (EC) No 1223/2009, Chapter III); legislation.gov.uk (Regulation (EC) No 1223/2009, Chapter VI)
