The 7th Amendment to the EU Cosmetics Directive (Directive 2003/15/EC of 27.02.03) introduced a new legal requirement related to the labelling of 26 specific ingredients (listed in Appendix 2 to this guidance document) if present in a cosmetic product above the following concentration thresholds: 0.001% (10 mg/kg) for leave-on products and 0.01% (100 mg/kg) for rinse-off products.
The labelling requirement is linked to the presence of the substance in concentrations higher than the above-mentioned thresholds, irrespective of the substance’s function and irrespective of its source (i.e. whether added as such or as component of a complex cosmetic ingredient such as botanical extracts, essential oils, fragrance compositions, aroma composition etc.).
For cosmetic products consisting of different components that are mixed immediately prior to application, these thresholds refer to the concentration of the substances in the final mix, as applied to the body. Compliance with the labelling requirement needs to be based on the information received from the suppliers of the ingredients concerned.
For further details, please see the CE/EFFA guidelines on the exchange of information between fragrance suppliers and cosmetic manufacturers, 2003.
- Technical Guidance Document for the Determination of Fragrance Materials in Cosmetic Products - 2006 (1.81 MB) Download
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