Cosmetics Classification in Europe: Case Studies
Explore EU cosmetics regulations as we delve into product classifications, from nail glue to sunscreens. Find out more in our article.
Cosmetics Classification in Europe
When interested in introducing products to the European market, one of the first questions that manufacturers and brand owners have is: is my product considered a cosmetic product under the classification of cosmetics in Europe?
It is very important to define this from the beginning, and to do so we can start by taking into account the definition of a "cosmetic product" mentioned in the EU Cosmetics Regulation 1223/2009 (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02009R1223-20221006&from=IT):
‘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;
A classification is often obtained after having made a case-by-case analysis, taking into account not only the definition of cosmetic product but also the following:
- The main function (must be cosmetic).
- The claims declared on the labelling.
- The mode of application.
- The presentation.
All these aspects play a very important role in the classification of the product and they are not always in line with the definition of a cosmetic product.
However, even taking the above into account, there are products for which it can be difficult to determine their classification correctly.
We will describe various types of products below and explain how they fall within the cosmetics classification in Europe.
According to the European Chemicals Agency (ECHA), an Essential Oil is a “volatile part of a natural product, which can be obtained by distillation, steam distillation or expression (the latter in the case of citrus fruits). It contains mostly volatile hydrocarbons. Essential oils are derived from various sections of plants. The oil is "essential" in the sense that it carries a distinctive scent, or essence of the plan.”
Are essential oils classified as cosmetic products in the EU?
Essential oils can be used as ingredients of cosmetic products, functioning as cosmetic active ingredients, or fragrances.
Pure essential oils can be classified as cosmetic products if all its characteristics align with the definition of a cosmetic product.
We give a few examples below:
Essential oils tend to contain considerable amounts of skin sensitizing substances. Therefore, besides the Europe cosmetics classification, companies must consider the restrictions and limits of use established by the EU Cosmetics Regulation 1223/2009 and by the International Fragrance Association (IFRA) (https://ifrafragrance.org/). Also, companies must know about the amount of Allergens present in the essential oil and provide an Allergen certificate.
Pain Relief Massage Oils:
Are pain relief massage oils classified as cosmetic products in the EU?
Pain relief massage oils are not classified as cosmetic products. Pain relief is a therapeutic function and is not included in the definition of a cosmetic product.
How are sunscreens classified under EU law?
According to the EU law, sunscreens are classified as cosmetic products.
What are the EU regulations for sunscreens?
In order to market sunscreens in Europe, they must undergo efficacy tests since they need to have a minimum efficacy (UVB and UVA protection). Likewise, the EU regulation mentions different types of claims that are authorized and not authorized to be used on sunscreens. For more information you can consult the Commission Recommendation on the efficacy of sunscreen products and the claims made relating thereto (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32006H0647).
What is the current regulation regarding classification for antimicrobial products?
Products with antimicrobial claims are not classified as cosmetic products and fall under the biocidal regulation.
However, an antimicrobial product can be considered a cosmetic if all of its claims are those of a cosmetic, for example: cleaning, perfuming, protecting, correcting body odours, etc.
Regarding mouthwashes and dental gels, they are allowed to have a “secondary” antimicrobial claim if its main function is cosmetic.
Nail Glue and Lash Glue:
What is the cosmetics classification for nail glue and lash glue within the EU?
Currently, these products and their adhesive functions are not clearly detailed in the EU Cosmetics Regulation.
Several aspects of these products may suggest that they are cosmetic products, such as the fact that their final intention is to modify the appearance of nails and eyelashes and that they are applied to external parts of the human body. However, there is nothing official regarding its classification.
For this reason, if you want to introduce this type of product to the European market, it is recommended to consult with each of the member states, since each of them could interpret the classification of this type of products differently.
How is toothpaste classified under EU law?
Toothpaste is classified as cosmetic product under EU law.
However, Spain has its own classification for toothpastes. This product is classified as a Personal Care Product and must follow a different process in order to be authorized for sale in this member state.
Can cosmetic products within the EU allowed to contain active ingredients?
Cosmetic products can have active ingredients within its composition. The mere fact of containing active ingredients does not affect the cosmetics classification in Europe. It must be analyzed on a case-by-case basis, since it must be confirmed that said active ingredients do not have pharmacological, physiological, immunological, or metabolic effects that may cause the product to be classified as a medicinal product.
Products with active ingredients claiming cosmetic benefits only can be classified as cosmetic products under the EU Cosmetics Regulation.
Cannabidiol (CBD) is a phytocannabinoid obtained from many species of the Cannabis genus. CBD is known to have beneficial properties for the skin such as antioxidant, anti-sebum, and hydrating properties among others.
CBD products could contain Tetrahydrocannabinol (THC), the psychoactive phytocannabinoid present in the Cannabis plant.
Are cosmetic products containing CBD allowed in the EU?
Cosmetic products that contain CBD are allowed in the EU as long as the restrictions imposed on the raw material and the cosmetic finished product are complied with.
For instance, THC levels need to be quantified and kept low, being present only as an impurity. The maximum accepted limit of THC may vary between member states, so the laws of each state should be consulted to ensure compliance.