Cosmetic labelling requirements: mandatory information under Article 19, with checklist

Article 19(1) lists what container and packaging must bear: (a) the name or registered name and address of the responsible person, (b) the nominal content at the time of packaging, (c) the date of minimum durability, (d) particular precautions to be observed in use, (e) the batch number or the reference for identifying the product, (f) the function of the product unless it is clear from its presentation, and (g) the list of ingredients.

The particulars must be indelible, easily legible and clearly visible. The ingredient list may appear on the packaging alone. Where the batch number cannot go on the container because the product is too small, the packaging is sufficient as well.

Name and address may be abbreviated as long as the person and their address can be identified from the abbreviation. If several addresses appear, the one where the Product Information File is readily accessible must be highlighted. For imported products, the country of origin must be stated.

The nominal content is given by weight or volume. Packages containing less than 5 g or 5 ml, free samples and single-application packs are exempt. For pre-packages normally sold as a number of items, the number of items is enough, and even that is not required if it is easy to see from the outside.

The date of minimum durability states until when the product, stored under appropriate conditions, continues to fulfil its initial function and remains safe. It is preceded by the symbol in point 3 of Annex VII or the words “best used before the end of”, and consists of month and year, or day, month and year, supplemented where necessary by storage conditions.

For products with a minimum durability of more than 30 months, no date is required. Instead the label states how long the product can be used safely after opening, with the symbol in point 2 of Annex VII followed by the period in months and/or years, unless the concept of durability after opening is not relevant. Both rely on sound stability data.

Particular precautions include at least those listed for certain substances in Annexes III to VI, plus any special precautionary information for products for professional use. Which warnings a product needs therefore follows from the formula. Part B of the safety report also records which warnings and instructions of use belong on the label.

Where, for practical reasons, a precaution does not fit on the label, it may go on an enclosed or attached leaflet, label, tape, tag or card. The container then refers to it by abbreviated information or the symbol in point 1 of Annex VII.

The batch number links the product on the shelf to its manufacture and is a precondition for traceability and recalls. The function only needs stating if it is not clear from the presentation.

The ingredient list is preceded by the term “ingredients” and names the ingredients in descending order of weight at the time they are added, using the common ingredient names from the glossary under Article 33. Special rules apply to perfume, nanomaterials, colorants and ingredients below 1 per cent.

The language of the nominal content, minimum durability, precautions and function is determined by the law of the Member State in which the product is made available to the end user. In Germany, section 4 of the Cosmetics Ordinance (Kosmetik-Verordnung) requires these particulars in German. The ingredient list, by contrast, uses the common ingredient names of the glossary.

If you supply several countries, settle the language requirements per target market before printing. A distributor who translates the labelling for another country on their own initiative must submit information to the Commission through the CPNP.

Where, for soap, bath balls and other small products, the ingredients cannot for practical reasons be put on a label, tag, tape, card or enclosed leaflet, they must appear on a notice in immediate proximity to the container in which the product is offered for sale.

For products that are not pre-packaged, or are packaged at the point of sale at the purchaser’s request or pre-packaged for immediate sale, the Member States set the rules for how the particulars are given.

Do the responsible person’s name and address match the notification and the place where the Product Information File is kept? Is the nominal content correct? Has it been decided whether a date of minimum durability or a period after opening applies, and do stability data support it? Have all warnings from the annexes and from the safety report been included?

Is there a field for the batch number? Does the ingredient list match the current formula version, in the right order and with the glossary names? Are the language requirements of the target market met? And is the final label ready for the CPNP notification?