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Before you start digging into the EU and UK cosmetics regulation and their requirements, it is important to determine if your product indeed falls within the scope of the cosmetic legislation.
A cosmetic product in Europe and UK is defined in the Regulation 1223/2009 as follows:
|‘cosmetic product’ means 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. (EU Regulation 1223/2009, Article 2.1.a)|
Based on the definition of the cosmetic products, products that may seem to be cosmetics, like nail wraps, a comb or a toothbrush, therefore aren’t cosmetics, even though they are placed in contact with the external parts of the human body, and their primary function is to change appearance, but they wouldn’t be considered a substance or a mixture.
Since products have to be placed in contact with the external parts of the human body or with the teeth and the mucous membranes of the oral cavity, any product intended to be ingested, inhaled, injected or implanted into the human body would also not be considered a cosmetic product in the EU or the UK. Breast implants then aren’t cosmetics, even though their primary function is also to change appearance.
The assessment of whether a product is a cosmetic product has to be made on the basis of a case-by-case assessment, taking into account all characteristics of the products.
The product has to be a:
Classification of the product often depends on the claims which the manufacturer makes for that product. This is especially the case with the so called borderline products, where products have characteristics of more than one product category, and it is therefore difficult to classify them. Cosmetic products can be on the borderline with medical devices, pharmaceuticals, biocides, toys etc. Cosmetic products should have, according to the Regulation 1223/2009, the function of exclusively or mainly to cleaning, perfuming, changing appearance, protecting, keeping in good condition or correcting body odours. The intended function does, among others, not include products presented as having properties for treating or preventing disease in human beings. Therefore mentioning or visually presenting any diseases on cosmetic product labels is not allowed, and neither is using words or phrases which present a medicinal intent.
It is not enough for the product only to be a substance or a mixture, and have the right site of application, purpose and claims, but it also has to have the correct composition. Cosmetic products should not contain certain prohibited ingredients (listed in the Regulation 1223/2009 Annex II), obey guidelines on restricted substances (restrictions are laid down in Annex III), and need to conform with the requirements connected with colorants (Annex IV), preservatives (Annex V) and UV filters (Annex VI).
Cosmetic product may include:
A correct product classification is vital in order to determine which EU Directive or Regulation applies for the product.