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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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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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

We were looking for a stand-alone service, not too sure what to expect... The professionalism, the assistance and the responsiveness were very much appreciated, amongst the best we have ever experienced.

Carol, Switzerland

Alpure

We are a small manufacturing company located in the US. We recently used CE.way Regulatory Consultants to help guide us through the Cosmetic regulatory changes that have taken place in the EU. They were instrumental in helping us understand the new laws and streamline the entire process. I would highly recommend their services.

Lena and Clay, USA

IBP

We didn't have any knowledge about the registration process for cosmetics in EU and were very concerned about this, but we met CE.way and they gave us whole packages of consultation and support. It was really helpful and we could do the registration without any problem. We will definitely ask CE.way again when we have new product to register in EU.

Masa, Japan

Nash Corporation

We used Tadej and CE.way for EU compliance with our products. He was very helpful and worked directly with our lab which made the process much easier for us. Tadej worked with me directly on all of our products to make sure I had the right documents. I really liked the attention to detail and how I could work with the owner of the company directly. I would highly recommend their services.

Steve, Canada

Curly Hair Solutions

Tadej from CE.way is the best consultant I've ever worked with. It's a great luck that we've found him. He is knowledgeable, fast, helpful & always ready to answer a million questions that we have. We had no exposure to cosmetics market before, so we didn't even know where to start. So he helped us to do EVERYTHING. The quality of service for the amount of money that we pay is absolutely the best! BIG THANK YOU to you Tadej & we'll definitely keep working with you!

Natalia, USA

Hi Tadej, Thank you for your highly professional approach, extremely helpful information and advice on getting our product registration under way and completed in record time! What we thought to be a very tiresome and laborious task was made quick and simple. Thank you again! The Thermitek Team.

Rene, Greece

Funkitup

It's been our first time lodging an application for EU Compliance. Although a big task, Tadej from CE.way made it as painless as possible. His patience and help were invaluable. He was so responsive and was available at all times to work with myself and my manufacturers. We now have our first round of product successfully assessed and notified. I will be placing our next round asap for notification, I can't recommend CE.way highly enough, thanks Tadej - Heather Spierings Eye of Horus Cosmetics.

Heather, Australia

RA Cosmetics

CE.way offers professional and reliable service. The team is diligent and extremely helpful throughout the whole process. We are very satisfied the way the work was executed. We definitely recommend CE.way to others.

Tamar, USA

Nuvision

CE.way made the whole EU process easy to understand. They were very responsive to all our needs.

James, USA

Eufora

This is a major investment for a small business like ours and it took me a few years to find a company (CE.way) that I felt comfortable working with! That speaks volume to my appreciation of the quality of your communications with me.

Vivian, USA

VB cosmetics

Our company had a great experience with CE.way. They were very organized and provided us with a detailed roadmap of exactly what we needed to gather on our end for them to put together our Product Information File and complete the notification process for the EU. They continued to help us along the way, providing quick feedback on any changes we needed to make to a document for it to work and reminders on what we still needed to provide. They are organized, knowledgeable, fast, and attentive; I would absolutely recommend them to any companies looking to get their products approved in the EU.

Cyrus, USA

SBBM

CE.way's assistance was tremendous, helping our company navigate the EU cosmetic regulation and efficiently get products to market.

Mike, USA

Inverness

Our cooperation with Tadej and his team at CE.way Consultants aimed to assist us to launch our products in UK for the first time. Tadej is a very hands on and always quick with his responses. The process was smooth and beyond our expectations in terms of cost savings and the speed with which we accomplished our goal. We look forward to working with them again.

Ruta, UK

Art de Parfum

We are really appreciate your speedy replies and clear and understandable guide. As there are a lot of differences in cosmetic regulations between Japan and EU first we thought that it would be hard to make all necessary procedures for our products compliance with EU laws, but thanks for your prompt support, all procedures were made smoothly. And now we are successfully selling MT Metatron in EU. We also thinking to expand our other brands in EU and when we start - definitely will ask your company for assist again.

Olga, Japan

MT Cosmetics, Inc.

After a less than pleasurable experience with another company, we found CE.way and we can honestly say that it could not be more beneficial for our brand. The whole notification process is made as easy as possible. The people at CE.way are all very accessible, knowledgeable and always ready to answer questions. CE.way is a great asset to our company and we are grateful for all the help and support we receive. Navigating through all rules and regulations alone is impossible, with the team at CE.way, we have the best support that we could ask for. Highly recommended in all aspects from their support to their reliable service!

Daniel, USA

NCLA

Testimonials

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