Cosmetics Labeling Requirements Under EU Regulation 1223/2009

Regulation 1223/2009 covers cosmetics labeling requirements in the EU. To help your company comply with the regulation, this article explains the important details you need to put in the cosmetic product label.

Labeling is an essential aspect of selling cosmetic products. This is why the EU has developed specific requirements for the labeling of cosmetic products placed on the EU market.

Two Types of Packaging

• Container – Comes in direct contact with the product.
• Outer Packaging – Designed to contain one or more containers.

Cosmetics Labeling Requirements

Both the container and outer packaging must include all information. The lettering must be legible, indelible, and visible.

The following details have to appear on the labels:

• Name and address of the responsible person
• Product’s country of origin for cosmetic products imported into the EU
• Highlight the address where the Product Information File is readily accessible
• Nominal quantity or content

This applies to the indication of the weight and volume.

           Only put ‘℮’ sign on the label if the requirements of the directive 76/211/EEC are met.

Exceptions apply to packages containing less than 5g or 5ml. The same goes for free samples and single application packs.

In some cases, you can replace this by identifying the number of items in the packaging.

• Expiration date

This includes the date of minimum durability symbol. It shows the expiration date or ‘best use before the end of”.

If necessary, mention conditions, which must be satisfied, to ensure the stated durability.

The expiration date is not mandatory for cosmetic products with a minimum durability of more than 30 months.

The period of time after opening (PAO) applies to cosmetic products with an expiration date of more than 30 months.

It includes the PAO symbol and the number of months or years the product is still safe to use after it has been opened.

However, PAO is not relevant for single-use products or products with low microbiological risk.

• Particular precautions for use

Labels must indicate particular precautions to be observed during the course of the use of cosmetic products. These include those listed in Annexes III to VI.

           Consider precautions for use mentioned in the safety assessment.

Finally, this covers special precautionary information on cosmetic products for professional use. Example: “Avoid contact with eyes”.

• Batch number

This states the reference for identifying the cosmetic product. If the product is too small, the batch number may appear only on the outer packaging.

• The function of the cosmetic product

Mention unless it is clear from the product’s presentation.

• List of ingredients

Use the heading ‘ingredients’ for the list. Companies may indicate the list on the outer packaging alone.

Write ingredients in descending order by concentration and according to their INCI denomination.

List ingredients with a concentration of less than 1% in any order after those with a concentration of more than 1%.

On the other hand, you may list colorants in any order after the other cosmetic ingredients. Yet, make sure to use CI (Colour Index) nomenclature.

Meanwhile, you must indicate nanomaterials, which should be followed by the term [nano].

For perfumes and aromatic compositions, refer to them as “perfume” or “aroma”.

Certain Exceptions: What if it’s Impossible to Mention Information on the Label?

There are practical reasons why you can’t indicate particular precautions for use and a list of ingredients on the label.

If this is the case, mention the information on an attached or enclosed card, tag, leaflet, label, or tape. If it’s impossible, place the information in the immediate proximity to the container.

Put the ‘open book symbol’ on the container and/or on the outer packaging.

Language Requirements

The EU is composed of several countries with different languages. Hence, you must translate information that appears on the labels.

• Nominal content
• Expiration date (if wording ‘best before the end of’ is used)
• Particular precautions for use
• The function of the cosmetic product

Make sure to translate these details into the official languages of the countries where the product is going to be sold. Some countries even request more than one language on the label.

Product Claims

Manufacturers indicate various claims for their cosmetic products on the labels. They must ensure that the claims follow the definition of cosmetic products in the EU. Similarly, manufacturers must validate any claim.

According to Regulation 1223/2009, Article 20.1, “In the labeling, making available on the market and advertising of cosmetic products, text, names, trademarks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have”.

Therefore, you must provide proof of the effect claimed for the claims that appear on the labels.

Summing It Up

Adhering to the labeling requirements of EU Regulation 1223/2009 is one of the key aspects of successfully selling cosmetic products in the EU market.

For more information about entering the global market for cosmetics, please don’t hesitate to contact QSE Academy for assistance. You may also check our blogs and toolkits.

QSE Academy has developed toolkits and packages to help your cosmetics company begin this process and comply with the ISO 22716 standard.