What the rules ask for
- A responsible person established in the EU for each product: for an imported product, the importer, unless it designates another person by written mandate, accepted in writing (Article 4).
- A product information file, kept for 10 years after the last batch is placed on the market, at the address on the label, in a language the authorities of that Member State easily understand: a product description, the safety report, the method of manufacture with a statement on good manufacturing practice, proof of claimed effects where justified, and animal testing data (Article 11).
- A cosmetic product safety report: Part A with the safety data of Annex I, and Part B, the safety assessment, carried out by a person with a university qualification in pharmacy, toxicology, medicine or a similar discipline (Article 10).
- A notification in the Cosmetic Products Notification Portal before the product is placed on the market (Article 13); how it works: CPNP notification.
- A label with the items of Article 19(1), from the responsible person's name and address to the ingredient list.
The ingredient list and the date on the label
From your formula, the kit writes the ingredient list in descending order of weight, preceded by "Ingredients", with "(nano)" after each nanomaterial. It does so only when every row has an INCI name and a percentage and the rows add up to exactly 100 %; otherwise the file says why and leaves TO COMPLETE. From the minimum durability you type, it states what the label needs: a date of minimum durability for 30 months or less, a period after opening above 30 months.
What is in the files
- for each product, an index of the product information file, point by point of Article 11(2);
- the safety report Part A, with your composition table and the ten sections of Annex I, and Part B pages for your safety assessor;
- a label check of each item of Article 19(1), with your text beside each, and the CPNP notification data of Article 13;
- a good manufacturing practice statement for the manufacturer (Article 8, EN ISO 22716), and a read-me with what the kit leaves out.
What the kit does not do
It does not carry out or sign the safety assessment, calculate exposure or margins of safety, or screen your ingredients against the prohibited and restricted substances of Annexes II to VI or the fragrance allergens: an exact name match would miss the many entries that name groups of substances. It does not notify the CPNP or act as your responsible person. Whatever you leave empty is marked TO COMPLETE, and the kit never writes that a product is safe or complies.
Nothing you type leaves your browser; the files are built on your device. Templates, not legal advice. The files are in English; check that the authority of the Member State where the file is kept accepts English, and translate the label text into the languages of the countries where you sell (Article 19(5)).
Sources
- Regulation (EC) No 1223/2009 on cosmetic products, consolidated text of 18 May 2026: Articles 4, 8, 10, 11, 13 and 19, Annexes I and VII
- Commission Implementing Decision 2013/674/EU: guidelines on Annex I (the cosmetic product safety report)
- Commission Regulation (EU) No 655/2013: common criteria for claims on cosmetic products