The Cosmetic Products Regulation, (EC) no 1223/2009 governs the regulatory framework for cosmetic products placed on the EU market. The regulation replaced the Cosmetic products Directive, 76/768/EC, which had been subject to substantial revision since it was first introduced in 1976.
Regulations are directly acting in Member States (MS) i.e. do not require transposition into national legislation.
A Cosmetic is:
"any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) 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".
The Cosmetics Regulation introduced a number of changes from Directive 76/768/EC, including a requirement to establish a Responsible Person (RP) within the Community, before placing a cosmetic product on the market.
In most instances, the RP will be the manufacturer. However, for imported cosmetic products from third countries, each importer is required to be the RP for the cosmetic product being placed on the market.
Distributors may also gain RP status, in the case that the cosmetic product is modified, affecting compliance, or placed on the market under the distributor name, or trade mark. Distributors that do not have RP statues are still required to undertake a number of duties e.g. to ensure that the labelling is in conformance with requirements.
Duties of Responsible persons
Colourants, preservatives and UV-filters, including those that are nanomaterials, must be explicitly authorised for use in cosmetic products.
The following information is required according to Article 19 of the CPR:
Where it is impossible to include the information on the label for practical reasons e.g. container size, the information may be included within an attached leaflet, label, tape, tag or card. It may also be enclosed with the cosmetic product.
MS are responsible for determining the requirements for unpackaged products, packaged at point of sale.
Page published 03 January 2020
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