Cosmetics for human use

• Regulation (EC) No 1223/2009 — Cosmetic Products
• Regulation (EC) No 1272/2008 — CLP for classified mixtures
• Regulation (EU) No 655/2013 — common criteria for claims

Who has to appoint one

Every cosmetic product placed on the EU market must have a designated responsible person established in the Union, and no product may be placed on the market without one. For a manufacturer inside the Union that is the manufacturer itself. For a product manufactured outside the Union it is the importer for each product it places on the market, unless the manufacturer designates a responsible person established in the Union by written mandate, which that person must accept in writing. A distributor becomes the responsible person if it markets the product under its own name or trade mark, or modifies a product already on the market in a way that affects conformity — including translating the label into a new language, which is a step many private-label sellers do not realise makes them responsible.

Thresholds and exemptions

None whatsoever. Free samples, sachets, gifts with purchase and hotel amenities are all placed on the market. There is no small-business exemption and no minimum quantity, and the obligation applies from the first unit made available, including through a marketplace listing.

What must appear on the label

Indelibly, legibly and visibly on the container and the packaging: the name and address of the responsible person, with the member state of origin indicated for imported products. The nominal content by weight or volume. The date of minimum durability, or the period-after-opening symbol where durability exceeds thirty months. Particular precautions for use, including those in Annexes III to VI. The batch number or reference identifying the product. The function of the product unless clear from presentation. The list of ingredients in descending order of weight using INCI nomenclature, headed 'Ingredients', with fragrance allergens listed individually above the thresholds. Nanomaterials must carry '(nano)' after the ingredient name.

Marketplace fields

Marketplaces increasingly request the CPNP notification reference and the responsible person's EU details before allowing a cosmetic listing, and both Amazon and TikTok Shop suppress cosmetics where these are missing. The ingredient list must appear in the listing itself. Sunscreens, whitening products, hair dyes and products with claims about acne, hair loss or wrinkles receive additional scrutiny, and claims that stray into medicinal territory get the listing removed rather than corrected.

Documentation you must hold

A Product Information File kept at the responsible person's address and accessible to authorities in the language of the member state. It contains the product description, the Cosmetic Product Safety Report in two parts — Part A the safety information, Part B the assessment signed by a qualified safety assessor holding a recognised pharmacy, toxicology, medicine or similar qualification — the method of manufacture and a statement of compliance with good manufacturing practice, proof of the claimed effect where justified, and data on animal testing. Notification through the Cosmetic Products Notification Portal must be made before the product is placed on the market, including the frame formulation for poison centres and, for products containing nanomaterials, a separate notification six months in advance.

Standards and testing

Stability and compatibility testing with the packaging, to support the durability date or period after opening. Microbiological challenge testing under ISO 11930, or a justification that the product is low-risk under ISO 29621. Heavy metal and impurity screening. Verification against the concentration limits and conditions in the Annexes, in particular the preservatives in Annex V and the UV filters in Annex VI. Sun protection factor testing under ISO 24444 or the in-vitro alternatives where an SPF is claimed. Substantiation studies for any efficacy claim, since the common criteria require evidence proportionate to the claim.

Language requirements

The particulars that protect health — precautions for use, function, durability and, in most member states, the warnings — must be in the language determined by the law of each member state where the product is made available. The ingredient list stays in INCI and is not translated. Several states, including France, Italy, Spain and Poland, enforce national-language labelling strictly on cosmetics, and a sticker over the original label is acceptable only if it is durable and does not obscure mandatory information.

When it applies

Notification in the CPNP and the completed Product Information File must both exist before the first unit is placed on the market — not before the first inspection. Serious undesirable effects must be notified to the competent authority without delay once known. Any change to the formulation, packaging or claims requires the file and the notification to be updated before the changed product is sold.

How long records are kept

The Product Information File must be kept for ten years after the last batch was placed on the market, and be readily accessible in electronic or other format at the address on the label. The responsible person must be able to produce it within the timeframe the authority sets, which in practice is days, not weeks.

What happens if you do not comply

Withdrawal or recall ordered by the national authority, a Safety Gate alert naming the product, and destruction of stock at the importer's expense. Cosmetics are one of the few areas where several member states attach criminal liability to the responsible person personally, particularly France, Italy and Spain, where placing an unnotified or unsafe cosmetic on the market can lead to prosecution rather than an administrative fine. Border rejections are frequent for products from third countries without a CPNP reference.

Who enforces it

National competent authorities for cosmetics, usually within the health ministry or medicines agency, coordinated through the CPNP and the Safety Gate. Poison centres receive the frame formulation. Customs check the responsible person's address and the notification at import.

Where the boundary lies

This is a heavier regime than GPSR and an Article 16 responsible person does not satisfy it: the cosmetics responsible person must hold the Product Information File and stand behind a safety report signed by a qualified assessor. Three boundaries recur. Products for animals are never cosmetics, however similar the formula. A product claiming to treat or prevent disease — acne, eczema, hair loss — is a medicinal product and needs a marketing authorisation. A device that acts mechanically rather than by substance, such as a dermaroller, is a medical device. Toothpaste, deodorant, sunscreen and hair dye are all cosmetics despite intuitions to the contrary.

Questions we are asked

Can the same company be our responsible person for cosmetics and for GPSR products?

Only if it explicitly accepts the cosmetics duties, which include holding the Product Information File and dealing with serious undesirable effects. They are distinct legal roles under distinct regulations, and a GPSR mandate does not extend to cosmetics.

We have a US safety assessment — is that acceptable?

Generally not. The EU requires a Cosmetic Product Safety Report structured under Annex I and signed by an assessor with a qualification recognised in a member state, and it must address the EU Annex restrictions, which differ substantially from US rules.

Do we need to notify each variant separately?

Yes, each product and each shade range must be notified in the CPNP, though shade ranges can often be grouped in a single notification where the formulation differs only in colourants.

Who is liable if the product harms someone?

The responsible person is the entity the authority addresses and can be sanctioned. That is precisely why the role is not clerical, and why the mandate must give access to the formulation and the safety report rather than a promise of cooperation.