Editor’s note: This article is the eleventh in a series covering the EU requirements for cosmetic products; see the previous: Part I (European Regulations), Part II (Responsible Person), Part III (PIF compliance), Part IV (Cosmetic Product Safety Report), Part V (data mandate), Part VI (risk assessment), Part VII (sensitization test), Part VIII (preservatives), Part IX (stability) and Part X (toxicity).
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Editor’s note: This article is the eleventh in a series covering the EU requirements for cosmetic products; see the previous: Part I (European Regulations), Part II (Responsible Person), Part III (PIF compliance), Part IV (Cosmetic Product Safety Report), Part V (data mandate), Part VI (risk assessment), Part VII (sensitization test), Part VIII (preservatives), Part IX (stability) and Part X (toxicity).
European Commission (EC) Cosmetics Regulation No. 1223/2009 is the main regulatory framework for finished cosmetic products placed on the European market.1 Within this framework, the availability of information to consumers is a key objective and is outlined in two major articles of chapter VI: labeling (Article 19) and product claims (Article 20). This column focuses on labeling; product claims will follow in part 12.
Labeling Requirements
According to the regulation, “Cosmetic products shall be made available on the [European] market only where the container and packaging of cosmetic products bear the [listed] information in indelible, easily legible and visible lettering (Article 19.1).”
Here, container refers to the primary package in direct contact with the product; packaging refers to the secondary package containing one or more containers. This rule applies to all cosmetic products, whether sold in shops, through vending machines, by mail order, via the Internet, applied by professionals or made available in hotels, spas, etc.2
Information Specifications
The regulation requires the following information be included on product labels (Article 19.1).
a) The name and the address of the Responsible Person, along with the country of origin for cosmetic products imported into the EU;
b) The nominal content by weight or volume (in kg/g, L/mL). Exemptions include small containers of less than 5 g or 5 mL or product, free samples and single-application packs;
c) The date of minimum durability or period after opening;
d) Any particular precautions to be observed during use; warnings required by the regulation are detailed in Annexes III through VI, column I;
e) The batch number of manufacture 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 (INCI names), preceded by the term Ingredients.
Note that items a) through f) must appear on the label of both the container and the packaging for each product. Item g) may be indicated on the packaging alone. Also, perfume and aromatic compositions and their raw materials should be referred to as parfum or aroma.
Descending Order and ‘Nano’ Designation
Regarding g), all ingredients must be listed in descending order according to their weight in the formula; however, ingredients present in concentrations of less than 1% may be listed in any order after the ingredients in higher concentrations. Colorants other than those intended to color hair may also be listed in any order after the other ingredients. Furthermore, ingredients present in the formula as nanomaterials must be clearly indicated as such by including the word nano after them.
According to the regulation, an incomplete listing of ingredients would be considered as misleading. Also, except for the ingredient list, the language of the information printed on the label shall be determined by the law of the Member State where the product is made available to the end user. Finally, some information must be indicated using a symbol, such as the “best used before” date or “period after opening” time.
