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Regulatory Information

Cosmetics must be labelled with specific information. The Regulation (EC) No 1223/2009 states the following:

Cosmetic products are substances * or mixtures of substances intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, etc.) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.

Free movement of these products in the internal market is permitted if they comply with this Regulation.

Market surveillance
A responsible person established in the Community shall be designated for each product placed on the market. This person shall ensure compliance of the products with the rules set out in the Regulation. In particular, they shall ensure compliance with requirements relating to human health, safety and consumer information. They shall maintain a product information file accessible to the public authorities.

In order to ensure product traceability, responsible persons shall identify the distributors to whom they supply the cosmetic product: for a period of three years following the date on which the batch of the cosmetic product was made available to the distributor. The same applies to all other persons involved in the supply chain.

In case of product non-compliance, the responsible person shall take measures to render it compliant, withdraw it from the market or recall it to the manufacturing company in all Member States where the product is available. Where the responsible person does not take all appropriate measures, the competent national authorities may take the necessary corrective measures.

If a product which complies with the requirements of the Regulation presents or could present a serious risk to human health, the competent national authority shall take all necessary provisional measures to withdraw, recall or restrict the availability of the product on the market.

Limitations for certain substances
The Annexes of this Regulation give a list of prohibited substances (Annex II) or restricted substances (Annex III) with respect to use in cosmetic products. Certain colorants (other than those in Annex IV), preservatives (other than those in Annex V) and UV-filters (other than those in Annex VI) are also prohibited.

The Regulation prohibits the use of substances recognised as carcinogenic, mutagenic or toxic for reproduction (classified as CMR), apart from in exceptional cases. It provides for a high level of protection of human health where nanomaterials are used in cosmetic products.

Consumer information
Product labelling contributes to consumer protection. Containers or packaging must bear written information in indelible, easily legible and visible lettering. This information concerns:

  • the name or registered name and the address of the responsible person;
  • the country of origin for imported products;
  • the weight or volume of the content at the time of packaging;
  • a use-by date for products kept in appropriate conditions;
  • precautions for use, including for cosmetics for professional use;
  • the batch number of manufacture or the reference for identifying the cosmetic product;
  • the list of ingredients, i.e. any substance or mixture intentionally used in the product during the process of manufacturing.

The language of the information shall be determined by the Member State where the product is made available to the end user.

Animal testing
Animal testing must be replaced by alternative methods. The Regulation prohibits the performance of animal testing in the European Union for:

  • finished products,
  • ingredients or combinations of ingredients.

The Regulation also prohibits the placing on the European Union market of:

  • products where the final formulation has been the subject of animal testing;
  • products containing ingredients or combinations of ingredients which have been the subject of animal testing.

A derogation from the ban relating to placing products on the market shall be granted until 11 March 2013 in order to test repeated-dose toxicity, the effects of certain substances on reproduction and to study toxicokinetics *.

In exceptional circumstances, Member States may request the Commission to grant a derogation, after consulting the Scientific Committee for Consumer Safety (SCCS), if an ingredient in wide use which cannot be replaced gives rise to serious concerns.

Ingredient labelling

The facts
The labels on all cosmetic and personal care products must contain a list of ingredients used. This information is identical for the same product across the European Union.

Some people may be allergic to one or more ingredients that are used in cosmetic products. These allergies must first be diagnosed by a doctor, who will advise the patient of the relevant ingredient name(s). Then, by checking the ingredients on the label, the patient knows which products to avoid.

If the container is in an outer package (e.g. a carton) the labelling will be on the carton. If there is no outer packaging the labelling will be on the container.

For products that are small and difficult to label, there are special exceptions. Here the ingredient listing may be on a leaflet, this being indicated by the use of a hand pointing to an open book logo on the outer packaging.

Alternatively, the ingredient listing should be displayed close to where the product is offered for sale.

The principles
The nomenclature for use in the ingredient declaration is set out in the cosmetic inventory, known as INCI (International Nomenclature for Cosmetic Ingredients). The INCI list can be viewed online on the European Commission website for cosmetics. It was published as Commission Decision 96/335/EC and is amended by Commission Decision 2006/257/EC.

This list contains over 6000 ingredient names and will be updated by the European Commission.

The INCI names (International Nomenclature for Cosmetic Ingredients) for “chemical” ingredients are based principally on the International Dictionary produced by the US trade association for cosmetic and personal care products.

Because of the number of European languages, with more to follow in the future, it was necessary for the Commission to find a European solution for colours, “common” names and plant names. This being essential to maintain the free circulation of products in the European Union.

Their decisions were:

  • Colours the international nomenclature of the Colour Index (CI) followed by five numbers, e.g. CI 42053
  • Ingredients of plant origin the Linnean nomenclature, used by botanists worldwide,
  • “Common” names e.g. water, milk and honey, the name given in the European Pharmacopoeia.

There are also conventions for:

  • “Parfum” indicating the presence of perfume,
  • “Aroma” indicating the presence of flavour,
  • [+/- …] means the product (decorative cosmetics only) may contain any or all of the colours listed.

The look
Below we have illustrated the contents requirements of ingredient labelling.

1. The INCI name which appears in the European Cosmetics Inventory.
2. The generic name for any perfume ingredient or composition.
3. The generic name for flavour.
4. [+/- …] For decorative cosmetics marketed in several shades, all colouring agents used in the range may be listed preceded by the words ‘may contain’ or ‘+/-‘.
5. Colours listed by Colour Index Number (may be listed in any order).