Artwork: obligations on the label

You can find the checklist for primary and/or secondary artwork at the end of this article

Artwork parts

First of all, we need to know which artworks have to comply to Article 19. The answer is easy, all of them. The artwork can consist of the following parts:

• Primary artwork: this is the label placed on the packaging material that comes into direct contact with the cosmetic product. For example the label on a jar, or the print on a tube.
• Secondary artwork: this is the label/artwork of the packaging where the cosmetic product is placed in. For example a box or a toiletry bag where the cosmetic product is placed in.
• Tertiairy artwork (leaflet): some products can contain a leaflet, on this piece of paper additional information is added.

There is always a primary artwork, but a secondary artwork and tertiairy artwork (leaflet) are optional.

Information on obligatory parts

• Name and address of the Responsible Person
• Country of origin in case of import outside the EU
• Nominal content
• Expiry date
• Warnings and special precautions for use
• Batchcode or -number
• Product name
• Function of the product
• Ingredient declaration 

Name and address of the Responsible Person

The name and address of the Responsible Person, who is placing the product on the market. This is the physical address, consisting of at least the zip code and the house number.

Country of origin

When a product has been produced outside the European Union, this has to be stated on the product or packaging mention. For example, "made in the USA"

Nominal content

The quantity of the product is indicated in milli-liters (ml) or grams (g). Exception: stating the nominal content is not mandatory if the packaging contains less than 5 ml/grams or if the product is for single use.
For products for single use, the number of pieces must be stated if this is not immediately visible.

Expiry date

To inform about the shelf-life, there is a shelf-life symbol or date printed on the product. The shelf-life symbol can be an open jar (PAO) or an hourglass symbol with the expiration date . The opened jar gives the Period After Opening in which the product is in optimal condition quality can be used. This period is indicated by the number of months (M). The digit with the
month indication can be placed in the jar or next to the jar. The symbol appears on cosmetic products that have an unopened shelf life of more than 30 months. In some cases an expiry date is not relevant: for example, for products that are only used once used. There is no need to mention anything about the shelf life. On products that have a stability of less than 30 months, it is indicated 'best before' or the hourglass symbol with the expiration date.

If you are unsure of which expiry symbol you can use or the indicated shelf life  read more here

Warnings and instructions of use

If a warning is needed for safe use, then is stated on the label. For example: “avoid contact with the eyes”. If there is a special storage advice applies to the product, it will also be displayed on the label.

Batchcode or number

For example: one hundred liters of showergel contained in the same production round has been made, is filled in five hundred showergel bottles. These five hundred showergel bottles receive one unique batch number. If ever in doubt exist about the quality of a product, then it can be
checked whether this applies to the entire batch.

Product name

This is the commercial name of the product.

Function of the product

Description of the product, for example face mask, lip balm, after sun or shaving cream. The function of the cosmetic product must be stated on the packaging unless this is clearly stated on the packaging or product name. 

Ingredient declaration 

All ingredients in the product must be declared on the packaging. To put the ingredients uniformly on cosmetics so-called INCI names are used. INCI stands for International Nomenclature Cosmetic Ingredients. The INCI declaration should start with 'Ingredients:'. Then the INCI names on the packaging are listed in descending order. Ingredients containing less than 1% in the endproduct, can be placed in random order mentioned at the end of the ingredient listing. 

Colorants are added with their CI code. If your product is not a hair dye, you may place them at the end of the INCI declaration, despite of their concentration in the end product. 
INCIs that are Nanomaterials, should contain the word 'NANO' in brackets after the INCI name. For perfume allergens, there are tresholds in use to determine wether or not they must be mentioned on the INCI declaration.

For the correct INCI declaration you can go to 'INCI declarations' within your Project in the SkinApp.

Other mandatory information

Based on your product type, container or ingredients used, other information may need to be added. We will give you feedback on what is needed.

For sunscreens read more here

For aerosols read more here

 

Checklist for artwork combinations

The following elements need to be added to the primary and/or secondary artwork. Secondary artwork can be either a box around the primary packaging, or a leaflet added to the primary packaging.

Primary artwork only:

• Product name
• Responsible person name and address
  • Address: at least postcode + number; enough to be able to send a letter
• Product function (in official language(s) of market country)
  • If product function is clear from the packaging, e.g. for a lipstick or nail polish, function does not need to be specified further
• Expiration date (in official language(s) of market country)
• Weight or volume (if > 5 g or 5 mL) (in official language(s) of market country)
  • if product is free sample: not obligatory
• Country of origin, in case the product is imported into the EU
• Warnings, if applicable (in official language(s) of market country)
• Ingredient list, starting with Ingredients:, followed by the official INCI names.
  • Any additions can be made in brackets, e.g. Aqua (Water); Helianthus Annuus (Sunflower) Seed Oil
  • Note: Water (Aqua) is not allowed!

Primary and secondary artwork:

If both primary and secondary packaging is used, then the following is obligatory on each part.

Primary

• Responsible person name and address
  • Address: at least postcode + number; enough to be able to send a letter
• Country of origin (if relevant)
  • “Made in...” should be present at the artwork when the product is made outside of the EU.

• Nominal content (if relevant)
• Expiration date (if relevant)
• Product function (in official language(s) of market country)
  • If product function is clear from the packaging, e.g. for a lipstick or nail polish, function does not need to be specified further

• A hand-in-open-book symbol, if particular precautions are not stated on primary (e.g. recycling information for France, Italy and/or Spain when there is not enough space)
• Note: the INCI declaration is not obligatory on the primary packaging in this case

Secondary

• RP name and address
• Country of origin (if relevant)
  • “Made in...” should be present at the artwork when the product is made outside of the EU.
• Nominal content (if relevant)
• Expiration date (if relevant)
• Particular precautions (if applicable, and if no leaflet is used for this)
• Product function (in official language(s) of market country)
  • If product function is clear from the packaging, e.g. for a lipstick or nail polish, function does not need to be specified further
• Ingredient list, starting with Ingredients:, followed by the official INCI names. (unless leaflet is used for this)
  • Any additions can be made in brackets, e.g. Aqua (Water); Helianthus Annuus (Sunflower) Seed Oil
  • Note: Water (Aqua) is not allowed!

• When applicable, recycling information for France, Italy and/or Spain

If a leaflet is present, then the Hand-in-open-book-symbol shall be present on the secondary packaging.