Regulatory compliance for chemical, cosmetic and biocidal products.
COSMETICS
Cosmetic product labelling
Services
Alchemy Compliance can advise on most aspects of marketing cosmetic products.
The Cosmetics Directive (76/768/EEC), guidance documents, and trading standards legislation all affect the labelling of cosmetic products. The main focus is on the ingredients list, using INCI names, claims concerning animal testing, and claims regarding function (eg sun-protection factor) or contents (fragrance-free).
Further information
76/768/EEC, Article 6 (abridged and amended)
1. Member States shall take all measures necessary to ensure that cosmetic products may be marketed only if their packaging, containers or labels bear the following information in indelible, easily legible and visible lettering:
- the name and the address or registered office of the manufacturer or the person responsible for marketing the cosmetic product who is established within the Community. Such information may be abbreviated in so far as the abbreviation makes it generally possible to identify the undertaking. Member States may require that the country of origin be specified for goods manufactured outside the Community;
- the nominal content at the time of packaging, given by weight or by volume, except in the case of packaging containing less than five grams of five millilitres, free samples and single-application packs; for pre-packages normally sold as a number of items, for which details of weight or volume are not significant, the content need not be given provided the number of items appears on the packaging. This information need not be given if the number of items is easy to see from the outside or if the product is normally only sold individually;
- the date of minimum durability shall be indicated by the words: ‘best before the end of’ followed by either:
- the date itself, or
- details of where it appears on the packaging
If necessary, this information shall be supplemented by an indication of the conditions which must be satisfied to guarantee the stated durability.
Indication of the date of durability shall not be mandatory for cosmetic products with a minimum durability of more than 30 months. For such products, there shall be an indication of the period of time after opening for which the product can be used without any harm to the consumer. This information shall be indicated by the symbol given in Annex VIIIa (open cream jar), followed by the period (in months and or years);
- particular precautions to be observed in use, especially those listed in the column ‘conditions of use and warnings which must be printed on the label’ in Annexes III (restricted substances), IV (colouring agents), VI (preservatives) and VII (UV filters), as well as any special precautionary information on cosmetics for professional use (eg hairdressing).
Where this is impossible for practical reasons, an enclosed leaflet must contain the information to which the consumer is referred either by abbreviated information or the symbol given in Annex VIII (open book), which must appear on the container and the packaging;
- the batch number of manufacture or the reference for identifying the goods. Where this is impossible for practical reasons because the cosmetic products are too small, such information need appear only on the packaging;
- the function of the product, unless it is clear from the presentation of the product;
- a list of ingredients in descending order of weight. That list shall be preceded by the word ‘ingredients’. Where that is impossible for practical reasons, an enclosed leaflet must contain the ingredients to which the consumer is referred either by abbreviated information or the symbol given in Annex VIII (open book), which must appear on the packaging.
The following shall not, however, be regarded as ingredients:
- impurities in the raw materials used
(ii) subsidiary technical materials used in the preparation but not present in the final product
(iii) materials used in strictly necessary quantities as solvents or as carriers for perfume and aromatic compositions
Perfume and aromatic compositions and their raw materials shall be referred to by the word ‘perfume’ or ‘aroma’. However, the presence of substances, the mention of which is required under the column ‘other limitations and requirements’ in Annex III (substances subject to restrictions), shall be indicated in the list irrespective of their function in the product.
Ingredients in concentrations of less than 1% may be listed in any order after those in concentrations of more than 1%.
Colouring agents may be listed in any order after the other ingredients, in accordance with the colour index number or denomination adopted in Annex IV (colouring agents).
An ingredient must be identified by the common name referred to in Article 7(2) (common ingredients nomenclature – INCI names) or, failing that, by one of the names referred to in Article 5a (2), first indent (CTFA name, European Pharmacopoeia name, those recommended by the WHO, EINECS names, IUPAC, CAS and colour index numbers).
The Commission may adopt criteria and conditions for the non-inclusion of one or more ingredients on the list used for the labelling of cosmetic products, under which a manufacturer may, for reasons of trade secrecy, apply not to include one or more ingredients on the list.
Further Guidance on Ingredient labelling
COLIPA (the European Cosmetic, Toiletry, and Perfumery Association) has issued further interpretation of the legislation and recommendations as follows (Guidelines on Ingredient Labelling in the European Union for the Cosmetic Industry, COLIPA, September 1995):
- INCI name: The common name for ingredient labelling referred to in the EU regulations is known as the INCI (International Nomenclature Cosmetic Ingredient) name.
- Colorants: In the EU, it is mandatory to use the nomenclature listed in Annex IV (to 76/768/EEC), ie the Colour Index (CI) number. If an ingredient that is a colorant is used for another purpose, the alternative INCI name, and not the CI number, should be used (eg titanium dioxide).
- General terms: For ‘ingredients’: INGREDIENTS; for ‘perfume’: PARFUM; for ‘flavour’: AROMA. For ‘may contain’: precede the ingredients list by the sign ‘+/–’ and enclose all in square brackets, eg [+/– CI 77491, CI 77492, CI 77499, CI 77891].
- Botanicals: Cosmetic ingredients directly derived from plants are described as botanicals. For botanicals, the INCI nomenclature is based on the LINNÉ system, whereby the genus and species of the plant in Latin are used. The INCI nomenclature for botanicals is different from that practiced in the USA. Cosmetic ingredients that have undergone chemical modification are named according to the normal INCI nomenclature. Their names are not based on the LINNÉ system.
Ethanol: For products containing denatured ethanol, there are two ways to list, either the single INCI name ‘alcohol denat’, or the INCI name alcohol plus the specific INCI name for the denaturant (which should be ordered in the list of ingredients according to its concentration). For undenatured alcohol, use the INCI name ‘alcohol’. Note alcohol as a carrier for perfume need not be declared [Article 6.1 (g)].
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