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EU/UK cosmetics regulation
Cosmetic product classification
Before any product can be placed on the market, it must first be correctly classified according to the applicable legislation. Product classification determines which regulatory framework applies and therefore affects all subsequent compliance requirements, including documentation, testing, labelling and market notification.
This page describes the cosmetic product classification principles applicable in the EU and the UK. Similar classification requirements exist in other markets we serve, although the legal definitions and interpretation may differ. Information on market-specific classification requirements can be found on the respective country and regional pages.
Regulatory definition
EU/UK cosmetic product definition
Not every product that we may consider cosmetic product in our everyday life would be classified as a cosmetic in regulatory terms. The first step in cosmetic product registration in any country therefore is to correctly classify your product. In order to do that, you have to know the definition of a cosmetic product.
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)
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.
Why correct classification is important
Incorrect classification may result in:
- applying the wrong legislation
- incorrect product claims
- unnecessary testing
- rejected notifications
- enforcement action
- product withdrawal from the market
Conversely, correct classification ensures that the appropriate regulatory pathway is followed from the outset.
Classification criteria
Compound / Preparation
Classification criteria
Compound / Preparation
The product has to be a:
- Substance
- Mixture
Based on the definition of the cosmetic products, products that may seem to be cosmetics, like nail wraps, a toothbrush or false eyelashes, 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. Any kind of tools, machines, objects etc. can't be classified cosmetics.
Classification criteria
Site of application
Classification criteria
Site of application
The product has to be intended to be placed in contact with:
- External parts of the human body
- Epidermis
- Hair system
- Nails
- External genital organs
- Teeth
- Mucous membranes of the oral cavity
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 therefore aren't cosmetics, even though their primary function is also to change appearance.
Classification criteria
Purpose
Classification criteria
Purpose
The purpose of the product has to be exclusively or mainly to:
- Clean
- Perfume
- Change appearance
- Protect
- Keep in good condition
- Correct body odours
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 the function of exclusively or mainly to clean, perfume, change appearance, protect, keep in good condition or correct 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 important to note that acne, for example, are also considered a disease, so anti-acne products aren't classified as cosmetics. 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.
Classification criteria
Composition
Classification criteria
Composition
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).
Check your formula complianceEU & UK cosmetics
Classes of cosmetic products in the EU and the UK
Cosmetic products may include:
- Creams, emulsions, lotions, gels and oils for the skin
- Face masks
- Tinted bases (liquids, pastes, powders)
- Make-up powders
- After-bath powders
- Hygienic powders
- Toilet soaps
- Deodorant soaps
- Perfumes, toilet waters and eau de Cologne
- Bath and shower preparations (salts, foams, oils, gels)
- Depilatories
- Deodorants and antiperspirants
- Hair colorants
- Products for waving, straightening and fixing hair
- Hair-setting products
- Hair-conditioning products (lotions, creams, oils)
- Hairdressing products (lotions, lacquers, brilliantines)
- Shaving products (creams, foams, lotions)
- Make-up and products removing make-up
- Products intended for application to the lips
- Products for care of the teeth and the mouth
- Products for nail care and make-up
- Products for external intimate hygiene
- Sunbathing products
- Products for tanning without sun
- Skin-whitening products
- Anti-wrinkle products
Our process
How we assess classification
01
Formulation Review
We review the product formulation.
02
Purpose Assessment
We assess the intended use of the product.
03
Claims Evaluation
We evaluate all marketing claims.
04
Application Analysis
We analyze the mode and site of application.
05
Regulatory Comparison
We compare against existing regulatory guidance.
Related services
Related services
CE.way can offer various services related to cosmetic product classification. We can offer:
Client reviews
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