Regulation 1223/2009 on Cosmetic Products (the Cosmetics Regulation) contain rules on the supply and sale of cosmetics products in the EU. It sets out a number of important requirements in relation to cosmetic products, including prohibitions and restrictions on certain substances, a requirement for a responsible person based in the EU and labelling requirements.
It is your responsibility to comply with the Cosmetics Regulation. This material is for informational purposes only. It is not intended as legal advice. We encourage you to consult your legal counsel if you have questions about the laws and regulations concerning your product.
The Cosmetics Regulation applies to any cosmetic product supplied or sold to in the EU. A cosmetic product can be broadly described as a substance or mixture that is intended to be applied to the human body (including the skin, hair, nails, lips, external genital organs, teeth and mucous membranes of the oral cavity) for the purposes of cleaning, perfuming, changing its appearance, protection, keeping the body or that part of the body in good condition or correcting body odours. Examples of cosmetics products range from antiperspirants to soap, make-up to toothpaste, sun lotion to perfume.
The Cosmetics Regulation is a complex piece of legislation that has a number of important requirements that must be complied with before a cosmetic product can be sold in the EU. In particular, (i) restrictions on what a cosmetic product can contain if it is to be sold in the EU, (ii) the requirement to have a responsible person based in the EU, (iii) key labelling information that must be provided with the product and on the product packaging, and (iv) a requirement to keep a product information file detailing proof of compliance for each cosmetic.
The information provided is not an exhaustive description of the relevant requirements, and you are encouraged to seek advice on ensuring compliance with the Cosmetics Regulation.
The Cosmetics Regulation sets out certain restrictions on what a cosmetics product can contain. Certain substances are prohibited and cannot be used in cosmetics in the EU in any circumstances (see Annex II of the Cosmetics Regulation), other substances can only be used if that use complies with the relevant restrictions (see Annex III of the Cosmetics Regulation. In addition,
Lastly, Cosmetic products containing nanomaterials must be specifically notified to the European Commission.
There must be a responsible person, based in the EU, for every cosmetic product. The responsible person is responsible for ensuring that each cosmetic product complies with the requirements of the Cosmetics Regulation. They may be a natural or a legal person and will either be the manufacturer, importer or a mandated person or entity, depending on the circumstances. In limited circumstances, a distributor can be the responsible person if they modify a cosmetic product in a way that could affect the cosmetic product’s compliance with the Cosmetics Regulation. The contact information of the responsible person (name and EU address) must be on the container and packaging of each cosmetic product.
There are mandatory labelling requirements that set out the information that must be included on the product and its packaging. This information includes: name or registered name and the EU address of the responsible person, country of origin information (if imported), nominal content/, date of minimum durability, precautions for use, batch number, function (unless clear) and ingredients.
Certain key information must be translated into the language(s) of the EU countries in which the cosmetics products will be sold.
In addition, some specific information must be submitted into the Cosmetic Product Notification Portal before a cosmetic product can be sold in the EU.
The responsible person must keep a product information file for a period of ten years from the date on which the last batch of the cosmetic product was supplied or sold on the EU market. The product information file must also be readily accessible in electronic or other format at the responsible person’s address. This address must be indicated on the label. The product information file should contain: (i) a description of the cosmetic product; (ii) the cosmetic product safety report; (iii) a description of the manufacturing method and a statement on compliance with good manufacturing practice; (iv) proof of the effect claimed for the cosmetic product, where justified by the nature or the effect of the cosmetic product; and (v) data on any animal testing. This information should be updated as necessary.
Where a responsible person considers or has reason to believe a product is not in conformity with the Cosmetics Regulation must immediately take the necessary corrective measures to bring the product into conformity, withdraw it or recall it, as appropriate. Where that cosmetic product presents a risk to human health, the responsible person must immediately inform the competent authority where the product has been made available and where the product information file is accessible, giving details of, in particular, the non-compliance and corrective measures taken.
Responsible persons are under an obligation to cooperate with the competent authorities and, if requested to, cooperate on any action to eliminate the risks posed by products that they have made available. Responsible persons must respond to a reasoned request from an authority to provide the information and documentation necessary to demonstrate conformity with the requirements that they were under an obligation to check.
Cosmetic products must, on the container and packaging, include the following information. This must be in indelible, easily legible and visible lettering:
Cosmetic products must, on the container and packaging include the following information. If it is not possible for this information to be on the container and packaging, it must be included on a leaflet, label, tape, tag or card enclosed or attached to the product. Unless impracticable, abbreviated information or an applicable symbol can also be used.
For more information on the Cosmetics Regulation, visit the following sites: