Putting a logo on a wet wipe sachet can make the brand responsible for a cosmetic product. Restaurant buyers often treat the wipe as a table accessory, like a napkin. EU law does not: a lotion-soaked wipe made to clean skin is a cosmetic product under the Cosmetics Regulation, and the sachet is the container that must carry the legally required information. This guide summarises the official texts and is not legal advice; confirm your position with the competent authority or a regulatory consultant.
Are wet wipes cosmetics under EU law?
Yes, in most cases. Regulation (EC) No 1223/2009 defines a cosmetic product as a substance or mixture intended to be placed in contact with the external parts of the human body, including the epidermis, with a view exclusively or mainly to cleaning, perfuming, protecting or keeping them in good condition. A refreshing hand wipe fits.
Three points follow from the definition and related provisions:
- The end user can be a consumer or a professional, and the regulation applies either way (Article 2(1)(f)).
- "Making available on the market" includes supply in the course of a commercial activity "whether in return for payment or free of charge" (Article 2(1)(g)). A wipe given to diners with the meal is not exempt because it has no price.
- The regulation applies to the finished product: wipe, lotion and any fragrance together, not the nonwoven alone.
The answer changes in two cases. A wipe sold or presented as a disinfectant or antibacterial product makes biocidal claims, which fall under a separate regime (the Biocidal Products Regulation). Wipes for cleaning tables or surfaces are household or professional cleaning products, not cosmetics. This guide covers skin-cleansing refreshing towels only. Single-use plastic rules for the same product are covered in Wet Wipes and the Single-Use Plastics Rules.
Who is the responsible person for a branded wet wipe?
The responsible person is the legal or natural person established in the EU who is designated under Article 4 and ensures the product complies. Only products with a designated responsible person may be placed on the EU market. Which company holds the role depends on who makes, imports and brands the product. Article 4 sets the rules in order:
- A product made in the EU: the manufacturer established in the EU is the responsible person, and may designate another EU-established person by written mandate.
- A product made outside the EU: the manufacturer designates an EU-established person by written mandate, or the importer is the responsible person for each imported product.
- A distributor becomes the responsible person if it places a product on the market under its own name or trademark, or modifies a product so that compliance may be affected.
"Manufacturer" is also defined broadly: a person who manufactures the product or has it designed or manufactured, and markets it under its name or trademark (Article 2(1)(d)). A restaurant group that has wipes made to its specification and sells or distributes them under its brand can therefore fit the manufacturer definition, which is why the brand owner often cannot treat the wipe as someone else's product.
| Situation | Likely role | Point to confirm |
|---|---|---|
| EU filler makes finished wipes under its own brand, restaurant buys and gives them out | Filler is manufacturer and responsible person | The restaurant's logo is not on the wipe or only as an addition |
| Restaurant orders wipes made to its own design and brand from a filler | Brand owner may be the manufacturer; an EU filler may hold the role by mandate | Written mandate and who signs the safety report |
| Finished wipes imported from outside the EU | Importer is the responsible person, or a mandated EU person | Importer accepts the role in writing |
| Distributor sells finished wipes under its own brand | Distributor becomes responsible person | Distributor takes on the full file |
These are patterns, not conclusions. The contract and the facts decide, and the supplier terms should say in writing who holds the role. In a project with 9 Packaging, the printed sachet is the packaging item. Who sources and fills the wipe, and who is responsible person for your market, is agreed at quotation.
What duties does the responsible person carry?
The responsible person must be able to show that the product is safe and compliant, keep the paperwork, notify the product, and put compliant information on the label. The main duties are set out below with their legal source.
- Safety. The product must be safe under normal or reasonably foreseeable use, taking account of presentation, labelling and instructions (Article 3).
- Good manufacturing practice. Manufacture must follow GMP (Article 8); compliance is presumed where it follows the relevant harmonised standard, which for cosmetics is EN ISO 22716.
- Safety assessment. Before placing the product on the market, a cosmetic product safety report is set up under Annex I (Article 10(1)). The assessment is done by a person with a university-level qualification in pharmacy, toxicology, medicine or a similar discipline (Article 10(2)). The report covers the relevant characteristics of the packaging material, in particular purity and stability (Annex I, Part A, point 4). That is why the sachet laminate belongs in the dossier; see Wet Wipe Sachet Materials.
- Product information file. A file, kept for ten years after the last batch is placed on the market (Article 11).
- Notification. Before placement, the responsible person submits the product details electronically to the Commission through the Cosmetic Products Notification Portal (CPNP) (Article 13).
- Claims. Text, names, trade marks, pictures and other signs must not imply characteristics or functions the product does not have (Article 20).
- Reporting. Serious undesirable effects must be notified to the authority of the Member State where they occurred (Article 23).
These duties cannot sit with a restaurant's marketing team or with the sachet printer. The party named on the label has to be an organisation that can hold the file and answer an inspector.
What must a wet wipe sachet label show?
Article 19 requires the container and the packaging to carry specified information in indelible, easily legible and visible lettering. A sachet is both container and packaging, so the information sits on the sachet itself.
| Item | Requirement on the sachet | Practical note |
|---|---|---|
| Responsible person | Name or registered name and address; country of origin if imported | Needed even on the smallest sachet |
| Nominal content | By weight or volume, except for packs under 5 g or 5 ml, free samples and single-application packs | A single-use towel is normally treated as a single-application pack; confirm with the assessor |
| Durability | Date of minimum durability, or the period-after-opening symbol where durability exceeds 30 months | Durability follows the shelf-life stability work |
| Precautions | Particular precautions in use and any set out in Annexes III to VI | For example, for fragrance allergens or preservatives |
| Batch | Batch number or reference; on the packaging alone if the product is too small | Printed or coded at fill |
| Function | Unless clear from presentation | A "refreshing towel" is normally clear |
| Ingredients | Full ingredient list, preceded by "Ingredients", in INCI names, descending weight order | Fragrance allergens named individually above the legal threshold |
Article 19(2) allows the precautions and the ingredients to be given on an enclosed leaflet, label, tape, tag or card, but only where it is impossible for practical reasons to put them on the pack, and the pack must then carry the "refer to enclosed information" symbol. A restaurant sachet usually has room for a small ingredient list on the reverse, so the exception is hard to justify. The article does not state a minimum type size, but the lettering must be easily legible and visible; plan the layout with real type, not a thumbnail.
The language of several items (content, durability, precautions, function) is set by the law of the Member State where the product reaches the end user (Article 19(5)). Ingredients use the INCI names. In a multi-country programme, the sachet therefore needs a language version for each market, and the responsible person's details can stay constant.
The fragrance allergen list is longer since Regulation (EU) 2023/1545, and citrus fragrances commonly trigger limonene and similar declarations; see Wet Wipe Sizes, Lotions and Fragrances.
Other information competes for the same small face: the "PLASTIC IN PRODUCT" marking if the wipe contains plastic, disposal instructions and packaging sorting marks. Draft the cosmetic information first, because the formula and the legal entity fix it, and build the layout around it.
What are the UK and US rules for branded wipes?
The UK keeps its own version of the Cosmetics Regulation. In Great Britain a cosmetic product placed on the market needs a UK responsible person, and the product must be notified through the Office for Product Safety and Standards (OPSS) notification service before it is sold. Northern Ireland continues to apply the EU Cosmetics Regulation under the Windsor Framework, so EU rules and the CPNP are the reference for sales there. GOV.UK also describes transitional arrangements for the address on the label. Check the current guidance on both points. The separate UK ban on plastic-containing wipes is covered in Wet Wipes and the Single-Use Plastics Rules.
In the United States, the Food and Drug Administration regulates cosmetics under the Federal Food, Drug, and Cosmetic Act, as expanded by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). FDA describes requirements including facility registration and product listing by a "responsible person", defined as the manufacturer, packer or distributor whose name is on the label. Products with antiseptic or other therapeutic claims can be drugs rather than cosmetics, with a different route. For US-bound projects, take advice before finalising claims; the general US picture is in US Foodservice Packaging Regulations.
What should a buyer settle before approving sachet artwork?
Resolve these before artwork, because the label depends on each answer:
- Who is the responsible person for each market, in writing, and has that person accepted the role?
- Who formulates the lotion, who signs the safety report, and is the packaging material included in it?
- What are the exact ingredients, including fragrance and preservatives, in INCI names?
- What durability or period-after-opening applies, and what batch coding is used?
- Which markets, hence which languages, and which additional marking (plastic marking, UK or national requirements)?
- What claims will the sachet make? Keep copy to what is documented: a scent description is fine; skin benefit or antibacterial claims need evidence and may change the legal route.
Send the answers, the markets and the sachet size through the contact page. The Custom Printed Wet Wipes hub shows how sachet, wipe and paperwork fit together, and Food-Contact Packaging Compliance covers the separate rules for packaging that touches food.