Cosmetic product classification

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.

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.

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Cosmetics regulatory servicesCosmetics regulatory services

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.

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.

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Cosmetics regulatory services

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).

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

And what do they say about us?

Pharmaplast began to work with CE.way almost one year ago. CE.way is our cosmetics consultant who look after compilation of PIF, safety assessments and CPNP notifications. In addition to this, CE.way is our European representative as our company is not located in Europe. Working with CE.way has been a joy so far. Their replies are very swift and Mr Tadej is very cooperative, helpful and with a deep knowledge about the cosmetics regulations. In addition to this, CE.way is very cost effective company in comparison with their European counterparts. For all the above reasons, I really recommend CE.way to other cosmetic product manufacturers.

Mena, Egypt

Pharmaplast

Testimonials

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