Understanding the EU Cosmetics Regulation

“All cosmetic products placed on the European Union (EU) market must comply with the EU Cosmetic Regulation (EC) No. 1223/2009. Legislation which has been in force since July 2013. The objective of this new law is to protect consumers. It protects them from potential health hazards and to help them make informed decisions when purchasing cosmetic products. ”

Complying with the requirements of this regulation is critical for all individuals and corporations who want to sell their cosmetic products in the EU. Discussed here are some important regulatory-related questions that cosmetic companies should ask themselves before placing their products on the EU market:

You can find answers about:

• Is my product a cosmetics?
• What are the documents required before placing the product on the EU market?
• What are the test that my cosmetics product need to undergo?
• How do I ensure the safety of my cosmetics products?
• Are there any requirements for manufacturing facilities producing cosmetics products?
• Are the labels on my products compliant with the EU regulations?
• Do I have to register products before placing them on the EU market?
• Who will ensure compliance of my products with the EU cosmetics regulation?

  Is my product a cosmetic?

Firstly the company needs to determine if their products indeed fall within the scope of the EU cosmetics regulation and would be classified as a cosmetic in the EU. The term cosmetic products covers a wide range of products, but not every product that we may consider to be cosmetics in everyday life, would be actually classified as a cosmetic product in the EU. A cosmetic product is defined in the EU cosmetics regulation as: “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.

Sometimes it is difficult to classify a product, because an individual product can at the same time have characteristics of both cosmetics and medical devices, cosmetics and biocides, cosmetics and toys, etc. These are the so-called borderline products where classification has to be made on a case-by-case basis taking into account all of the characteristics of the product. The claims made on the product can have a decisive impact on the classification of such products. The intended function does, among others, not in elude products presented as having properties for treating or preventing disease in Human Beings. Products intended to be ingested, inhaled, injected or implanted in the human body also do not fall within the definition of cosmetic products even if their purpose is cosmetic in nature. Bear in mind that some preparations are classified as cosmetics in the EU, which are not elsewhere, and vice versa

Furthermore, it is not enough for the product only to have the correct site of application, purpose and claims. The company also has to assure that the composition of the cosmetic product is in line with the EU cosmetics requirements. Cosmetic products should not contain prohibited ingredients listed in Annex II of the regulation, follow limitations on the use of restricted substances (Annex III), and need to conform to the requirements concerning colorants (Annex IV), preservatives (Annex V) and UV filters 〈Annex VI). In addition, the regulation provides instructions for products containing nanomaterials and substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR substances)・ In general, CMR substances are banned except in certain cases・