Regulation (EC) No 1223/2009 sets the legal framework for cosmetic products in the European Union. It outlines the requirements for labelling, packaging, and safety, with a focus on protecting human health and promoting consumer safety. Understanding this regulation is paramount for suppliers who wish to market their products within the EU, as non-compliance can lead to significant penalties, including product recalls and market withdrawal.
Key Components of Ingredient Labelling
Every cosmetic product must have a clear list of all ingredients used, listed in descending order of their concentration. The only exceptions are ingredients present at a concentration of less than 1%, which can be listed in any order after those above this threshold.
All ingredients present in the cosmetic product must be listed, except:
- Impurities in raw materials used;
- Subsidiary technical materials used in the preparation but not present in the final product;
- Materials used in strictly necessary quantities as solvents or as carriers for perfume and aromatic compositions.
Common Name and INCI Nomenclature
One of the first things you need to know is the International Nomenclature of Cosmetic Ingredients (INCI). The INCI names are standardized names recognized globally, making it easy for consumers and regulatory bodies to identify the ingredients in your products. Each ingredient used in cosmetics must be listed using its INCI name on the label.
EU Specific Nomenclature for;
- Perfume ingredients: all as “PARFUM”
- Flavouring ingredients: all as “AROMA”
- Cosmetic colorants: CI number (not for hair dyes)
- Plant materials: Latin name under “LINNÉ” system (genus and species), followed by the part of the plant (when applicable) and type of derivative
- Denatured ethanol: as “ALCOHOL DENAT”
Clear Indication of Allergens
Another important aspect of ingredient labelling is the declaration of allergens. Regulation requires that 82 (56 when group name is used) specific allergens must be highlighted in the ingredient list when present in a concentration of 0.001% or more (leave-on products) or 0.01% or more (rinse-off products). This ensures consumers are adequately informed of any potential risks. For more information see our article: “New Allergen Labelling”.
The term “may contain / [+/-]” for Colour Variations
For decorative cosmetic products marketed in several colour shades, all colouring agents in the range may be listed, provided that the words ‘may contain’ or the symbol +/- are added. This will allow the use of a common ingredient labelling for a whole colour range of similar products. Colipa advises that the wording “may contain” can be replaced by the sign “+/-” followed by the relevant INCI names, all enclosed in square brackets.
Example:
INGREDIENTS: Aqua, Cyclohexasiloxane, Mica, Polybutene, Quaternium-18 Hectorite, Polymethylmethacrylate, Persea Gratissima Leaf Extract, Cera Alba, Propylene Carbonate, Methylparaben, Phenoxyethanol, Propylparaben, [+/- CI 77491, CI 77492, CI 77499, CI 77891].
Preparing the ingredient list for your labels can be challenging. Let our expert team review and/or prepare the compliant ingredient labelling for you. To ensure your cosmetic product labels are compliant, check out our Cosmetic Label Review service!
