The classification of products is very important in navigating the regulatory landscape. Cosmetic products are often borderline with other classifications of products on the market. Furthermore, cosmetics are not an exclusive class of products – meaning they can be both cosmetics and another type of product. In this article we will go into the varying product types which border cosmetics and discuss their classification.
Classification of Cosmetic Products Series
To learn more about the differences in classification across regional regulations, explore our classification of cosmetic products series:
Classification of Cosmetic Products
Regulation
All cosmetics marketed with the European Union are regulated under the Cosmetic Regulation (Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products).
The classification of a cosmetic is not exclusive to many other product categories, however, there are exemptions listed in this article.
Definition
The definition of a cosmetic product is outlined in Article 2, point a:
“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”
This definition states where a cosmetic should be placed (external part of the human body) and the function it should have. The definition states “exclusively or mainly”, which opens up cosmetics to be borderline products if they mainly perform cosmetic functions, but have additional non-cosmetic functions/benefits. This is why a product can be both a cosmetic and another classification.
Examples
Anti-dandruff Shampoo
Anti-dandruff shampoos are designed to be placed with the hair system and epidermis (hair & scalp) with a view to cleaning and keeping in good condition.
Zinc pyrithione is the active ingredient used in Head & Shoulders. It is a permitted cosmetic ingredient and is only restricted for use in leave-on hair care preparations at a maximum concentration of 0.1% and as a preservative at 1.0% in hair care preparations. When used in rinse-off hair care preparations, there is no listed restriction.
Sunscreen
Sunscreen products are designed to be placed with the epidermis with a view to protecting the skin.
The EU Cosmetic Regulation contains a list of approved UV filters (Annex VI List of UV Filters Allowed in Cosmetic Products).
In many other regulations around the world, sunscreens are not viewed as cosmetics due to the vigorous efficacy testing the product must undergo and the short and long term safety implications of such products.
There is an additional piece of legislation relating directly to sunscreen products (Commission Recommendation of 22 September 2006 on the efficacy of sunscreen products and the claims made relating thereto). This is a recommendation, and therefore, companies are not required to comply with this legislative text. The text provides recommended warnings and precautions to place on the packaging of the product, such as “over-exposure to the sun is a serious health threat”, as well as guidance on sunscreen claims.
Toothpaste
Toothpastes are classified as cosmetics in the European Union, however, there are specific restrictions in place for fluoride containing ingredients. The maximum concentration of fluoride is 0.15% or 1500 parts per million (ppm) according to the EU cosmetic regulation, however, it’s fluoride-containing ingredients which are added into cosmetics, not fluoride itself.
All fluoride containing ingredients are restricted and found in Annex III of the cosmetic regulation.
Soap
The EU cosmetic regulation does not differentiate between a liquid soap, body wash, solid soap or traditional soap. All of these products are designed to cleanse the human body and be in contact with the epidermis alone.
Classification of General Products
Regulation
All general products in the European Union are regulated under the General Product Safety Regulation (Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC).
This regulation is applicable to all products (including cosmetic products), although some sections may be omitted due to existing regulatory requirements.
Definition
The definition of a general product is defined in Article 3, point 1:
“any item, whether or not it is interconnected to other items, supplied or made available, whether for consideration or not, including in the context of providing a service, which is intended for consumers or is likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them”
Examples
Cosmetic Kits
Kits (an assortment of products) can be difficult to regulate due to multiple items being in one ‘product’. Cosmetic kits primarily contain cosmetic products (makeup, toiletries, nail products etc.), but they may also contain general products (makeup brushes, mirrors, hair brush, nail accessories). Therefore, these kits would be regulated as both cosmetic products and general products – both the Cosmetic Regulation and General Product Safety Regulation would apply.
Brushes (Tooth, Hair, Makeup)
Brushes are commonly sold alongside cosmetic products. They are not chemical mixtures or preparations, however the composition of the materials must still conform to other regulations (REACH). The brushes will still require testing to ensure their safety.
Cotton Pads/Buds
Cotton pads are often referred to as ‘cosmetic devices’ which is not a regulatory established term. It takes reference from medical devices and cosmetic products (of which they are neither). Medical devices are regulated under the Medical Devices Regulation, but because these products have no medicinal function, they are classified as general products.
Tweezers
Tweezers, similarly to brushes, are general products. They have no medicinal uses and are not chemical mixtures or substances. It is important to note that the intended use of these products should be clear, for example, not intended for surgical use. If the tweezers are used for medical use (invasive tweezers), then they would be regulated under the Medical Devices Regulation.
Classification of Non-prescription/Prescription Drugs
Regulation
All non-prescription/prescription drugs are regulated under Medicinal Products Regulation (Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use).
The Directives which have relevance to drugs include the Medical Products for Human Use Directive (Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use).
The classification of a cosmetic and a medicine are exclusive. A product cannot be both a cosmetic and a medicine, they are either or.
Definition
The definitions laid down in Article 1 of Directive 2001/83/EC and those laid down in Article 1 of Directive 2001/82/EC shall apply for the purposes of this Regulation.
The definitions of medicinal products are defined in Article 1, point 1 & 2 of Directive 2001/82/EC:
Proprietary medicinal product: “any ready-prepared medicinal product placed on the market under a special name and in a special pack.”
Medicinal product: “any substance or combination of substances presented for treating or preventing disease in human beings.
Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product.”
The definition of a veterinary medicinal product is defined in Article 1, point 2 of Directive 2001/82/EC.
Veterinary medicinal product: “Any substance or combination of substances presented for treating or preventing disease in animals.
Any substance or combination of substances which may be administered to animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in animals is likewise considered a veterinary medicinal product.”
Examples
Eczema (Atopic Dermatitis) & Psoriasis Skin Preparations
Eczema, psoriasis and dermatitis are all skin conditions. The skin in these lesions is significantly different to healthy skin. If a product is designed to manage, prevent, or treat skin conditions, it is not classified as a cosmetic – instead it is classified as a non-prescription or prescription drug.
One of the most commonly prescribed medications for all types of eczema is topical corticosteroids, or steroids for short, which can reduce inflammation and itching so that the skin can begin to heal.
Calcineurin inhibitors, such as tacrolimus and pimecrolimus, are ointments or creams that reduce the activity of the immune system and help to reduce inflammation. They’re sometimes used to treat psoriasis affecting sensitive areas, such as the face, the genitals and folds in the skin, if steroid creams are not effective.
Anti Acne Face Cream/Wash
The definition of a medicinal product includes “preventing disease”, which allows space for interpretation along the cosmetic-drug interface. Cosmetics can keep the skin “in good condition”, and keeping the skin in good condition could lead to the prevention of acne proliferation. Cleansing, moisturising and applying skincare products to the face has shown to reduce acne lesions, which are cosmetic functions – so does that mean that cosmetics can prevent disease? Yes, but claiming to do so may shift the product from being classified as a cosmetic to a medicine.
Anti Cavity Toothpaste
Although it is advised not to claim that the function of a cosmetic product is not to prevent disease (as this could fall under the Medicinal Products Regulation), some types of cosmetics can claim such activity. Toothpaste and other oral care products are a great example of this. A toothpaste cannot claim to reduce or repair cavities, however, it can prevent the formation of cavities. “Anti-cavity” is not a permitted claim as it insinuates that it will get rid of cavities.
Skin Condition Claims
It is understood that consumers of cosmetic products may wish to know whether the product is suitable for patients with existing skin conditions. The below phrase (with the exact wording) may be used on pack, provided it is not a main claim and doesn’t distract from the cosmetic nature of the product:
“Also suitable (or safe) for people who may be prone to eczema / psoriasis / dermatitis / rosacea / acne / spots”
However, stating that a cosmetic product is designed for a specific skin condition is not permitted for cosmetic products, and therefore, the product would be classified as a medicine. Example:
“For eczema/dermatitis/psoriasis etc. prone skin”
Classification of Biocides
Regulation
All biocide products are regulated under the Biocidal Products Regulation (Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products).
Biocides are not exclusive to other product classifications. Biocidal products can be both biocides and medicines or both biocides and cosmetics (depending on their presentation, claims and function).
Definition
The definition of a biocidal product is defined in Article 3, point 1a)
“any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.”
Examples
Antibacterial Hand Wash
Antibacterial hand washes are designed to either destroy or render harmless microorganisms which are then washed off. Alcohol is often used to kill bacteria in hand wash preparations.
Antibacterial products can be placed at the cosmetic-biocide interface. These two classifications are not mutually exclusive. If a product is designed to kill bacteria, it is a biocide, but if the main function is a cosmetic one (e.g. cleansing) and it has additional cosmetic benefits (e.g. moisturising), then the product is considered both a biocide and a cosmetic.
Antibacterial Face Wash
Antibacterial face washes are commonly used to treat diseases such as acne vulgaris. Acne lesions are caused by the proliferation of Cutibacterium Acnes, a gram-positive bacteria. The destruction or rendering harmless of this microorganism is considered a biocidal action, but the effect is that of treating a disease, therefore, the product would be considered both biocidal and medicinal.
Antibacterial Surface Wipes
Antibacterial surface wipes are classified as biocides alone, because unlike hand washes or face washes, they are not designed to be placed in contact with the human body.
Although they do interact with the skin (when being used with bear hands), it is not a part of their intended use – this exposure scenario is taken into consideration when producing a safety report.
Classification of Herbal Medicinal Products
Regulation
All herbal medicinal products are regulated as medicinal products, therefore, the above medical product regulations apply. There is an additional Herbal Medicinal Product Directive (Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use).
Herbal medicines are a subcategory of medicinal products. All the regulatory requirements for medicines apply to herbal medicinal products.
Herbal medicinal products are an exclusive classification (as they are a subcategory of medicines), and therefore, a herbal medicine cannot also be classified as cosmetic.
Definition
The definition of a herbal medicinal product is defined in Article 1, point 30 of Directive 2004/24/EC:
“any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations.”
The definition of a traditional herbal medicinal product is defined in Article 1, point 29 of Directive 2004/24/EC:
“a herbal medicinal product that fulfils the conditions laid down in Article 16a(1)”
“(a) they have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment;
(b) they are exclusively for administration in accordance with a specified strength and posology;
(c) they are an oral, external and/or inhalation preparation;
(d) the period of traditional use as laid down in Article 16c(1)(c) has elapsed;
(e) the data on the traditional use of the medicinal product are sufficient; in particular the product proves not to be harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long-standing use and experience.”
Examples
Herbal Skin/Cuticle Oil
Skin oils and cuticle oils are traditionally viewed as cosmetic products due to their area of application and function (e.g. skin to moisturise). However, if the product meets the definition of a herbal medical product (e.g. contains active herbal substances) and claims to provide skincare benefits through these active substances – the product is classified as a herbal medicinal product alone (not a cosmetic).
Herbal Brow/Scalp Oil
A common herbal medicinal product on the market is hair growth serum based on plant extracts. If these products claim to perform a physiological action (e.g. help with hair growth), they are considered herbal medicinal products. However, if this claim was not made, and the product was presented as a cosmetic (packaging, labelling, look & feel), the product would be classified as a cosmetic alone.
Food Supplements
Herbal medicinal products can be ingested, and therefore, may also fall under the classification of food supplements. Food supplements are regulated by the Food Supplements Directive (Directive 2002/46/EC Of The European Parliament And Of The Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements).
Food supplements cannot also be classified as cosmetics, as supplements are ingested, whereas cosmetics can only be placed with the external parts of the human body and oral cavity.
Classification of Toys
Regulation
All toys are regulated under the Toy Safety Directive (Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys).
Toys are not an exclusive classification. Toys can be classified as other products such as cosmetics if they fulfill the definitions of both product categories.
Definition
The definition of a chemical toy is defined in Article 3, point 22 of Directive 2009/48/EC:
“a toy intended for the direct handling of chemical substances and mixtures and which is used in a manner appropriate to a given age-group and under the supervision of an adult”
The definition of a cosmetic kit is defined in Article 3, point 24 of Directive 2009/48/EC:
“a toy the purpose of which is to assist a child to learn to make products such as fragrances, soaps, creams, shampoos, bath foams, glosses, lipsticks, other make-up, tooth-paste and conditioners”
Examples
Bath Wand
Bath products are very popular for children. Essentially, a bath wand is a bath bomb with a stick attached. These products are stirred into the bath water by children, providing cleansing and entertainment for the child. Because bath wands fulfill the definition of a cosmetic (placed in contact with the epidermis and provides cleansing action), and a chemical toy (handling of chemicals by children), they are classified as both cosmetics and toys.
Make Your Own Bath Bomb Kit
Bath bomb kits are intended for use by children and involve chemicals. These bath bombs are not sold as finished cosmetic products, however, they are often regulated as such. They are classified as chemical substances, therefore REACH & CLP Regulations apply. Bath bomb kits meet the definition of a cosmetic kit under the Toy Safety Regulations, so they are regulated as toys, chemicals and cosmetics.
Disney Makeup Kit
Makeup kits, and any multi-item kit containing cosmetics intended for children are classified as both cosmetics and toys. The normal and foreseeable use of the product is that the child will use the makeup or cosmetics with an element of play. This means it falls under the classification of a chemical toy.
Classification of Chemical Substances/Mixtures
Regulation
All chemical substances and mixtures are regulated by both the REACH Regulation (Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC) and the CLP Regulation (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006).
Definition
The definition of a substance is defined in Article 3 point 1 of the Regulation (EC) No 1907/2006:
“a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.”
The definition of a preparation is defined in Article 3 point 2 of the Regulation (EC) No 1907/2006:
“a mixture or solution composed of two or more substances.”
The definition of a mixture is defined in Article 2, point 8 of the Regulation (EC) No 1272/2008:
“a mixture or solution composed of two or more substances.”
Examples
Nail/Eyelash/Brow Glue
Cosmetic glue products are often miss-classified as cosmetics because they are placed in contact with the external parts of the human body (epidermis, hair or nails). However, it’s important to remember that a cosmetic must primarily perform a cosmetic function, of which adhesion is not one.
Glues are however preparations and mixtures, therefore they are regulated by CLP and REACH Regulations.
Cosmetics are also regulated by CLP and REACH Regulations, however cosmetics are exempt from CLP labelling (unlike cosmetic glues/adhesives).
Classification of Medical Devices
Regulation
All medical devices are regulated under the Medical Devices Regulation (Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC).
Definition
The definition of a medical device is defined in Article 2, point 1 of Regulation (EU) 2017/745:
“any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations
- and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means
The following products shall also be deemed to be medical devices:
- devices for the control or support of conception
- products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.”
Examples
Red Light Therapy Mask
Light emitting diode (LED) masks designed to provide skincare benefits through light therapy are considered medical devices because they potentially prevent and/or treat skin concerns (blemishes, acne, premature ageing). More importantly, they are designed to modify the physiological processes in the skin.
These products are not composed of chemical substances or mixtures, therefore they cannot be classified as cosmetics, although they may have cosmetic benefits.
Laser Hair Removers
Laser hair removal products are designed to modify the physiological processes of the pilosebaceous unit. More specifically, to prevent cell division (mitosis) in the hair bulb which prevents hair growth.
Altering cell division is a highly physiological action which does not fit into the function of a cosmetic, therefore, these products are classified as medical devices alone.
