What is it called?
The Cosmetic Products Regulation (EC) 1223/2009 governs the placing on the market of cosmetic products and replaced the Cosmetics Directive (Directive 76/768/EEC).
What is it about?
The Cosmetic Products Regulation lays down the rules for the placing and making available on the market of finished cosmetic products in the EU.
The Cosmetic Products Regulation is complemented by the Common Criteria Regulation 655/2013 that sets out criteria for the justification of claims used for cosmetic products and Commission Implementing Decision of 25 November 2013 on the safety assessment for cosmetics.
Key requirements of the Cosmetic Products Regulation include:
- All cosmetic products must undergo a safety assessment and be accompanied by a safety report before they can be placed on the EU market;
- All cosmetic products need to be registered in the EU Cosmetic Products Notification Portal;
- The manufacture of cosmetic products must comply with good manufacturing practices;
- Cosmetics packaging must include a range of information, including, for example, the name and address of the responsible person, precautions of use and list of ingredients;
- Labelling information must include, among other things, the name and address of the responsible person, a list of ingredients, to be expressed using the common ingredient names, precautions of use, the validity period of the cosmetic products, and the function of the cosmetic product (unless this is already clear from its presentation).
The Cosmetic Products Regulation also contains a list of the substances that are prohibited, restricted or authorised for use in cosmetic products and sets out rules on the use of nanomaterials.
Who and what does it apply to?
The Cosmetic Products Regulation applies to EU manufacturers, importers and distributors of cosmetic products.
Importantly, the Cosmetic Products Regulation creates the role of the 'responsible person' and provides that:
- Only cosmetic products for which a responsible person is appointed can be placed on the market; and
- For each cosmetic product placed on the market, the responsible person must ensure compliance with the relevant obligations.
The Cosmetic Products Regulation applies to "cosmetic products". Cosmetic product is defined 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".
Typical examples of cosmetic products include perfumes, make-up, shampoos, soaps, skin care products and toothpastes. There is sometimes a fine line between what qualifies as a "cosmetic product" or another type of product, such as medicinal products, biocidal products, toys or medical devices. In such cases, the assessment as to whether a product qualifies as a cosmetic product or a product subject to a different regulatory regime will need to be evaluated on a case-by-case basis, taking into account all the circumstances, including the claims that are made about the product.
Why does it matter?
The Cosmetic Products Regulation is the main piece of legislation applying to cosmetic products in the EU. Failure to comply with the provisions of the Cosmetic Products Regulation exposes economic operators to possible enforcement action by the Member States' regulators, including corrective actions, withdrawals and recalls, as well as penalties.
As part of the Chemicals Strategy for Sustainability ("the CSS"), the Commission is now working on a targeted revision of the Cosmetic Products Regulation, alongside with the targeted revision of the EU chemicals framework. The Commission is expected to publish the legislative proposal for the revision of the Cosmetic Products Regulation in the course of 2023. It is worth noting that the regulatory framework for cosmetics has been recently amended in the US (for more insights visit Cooley's blog here).
Where can I find it?
The Cosmetic Products Regulation can be found here.
Is there any guidance?
Yes, the Commission published guidance documents on:
- Cosmetic claims
- Serious undesirable effects reporting
- Borderline products
- Cosmetic products notification portal.
In addition, the Scientific Committee on Consumer Safety has published notes of guidance for the testing of cosmetic ingredients and their safety.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.