Placing cosmetics on the market – regulatory essentials
Cosmetics Regulation 1223/2009 for finished cosmetic products placed on the EU market
Not only medicinal products but also cosmetics are subject to certain regulations and requirements that you must remember to meet before your product can be placed on the market. The main legal framework for finished cosmetic products placed on the EU market is Regulation (EC) No 1223/2009 of November 2009. This Regulation provides information on safety assessment, product dossier, labelling and the obligations of the responsible person. It also contains 6 annexes, including: a description of the cosmetic product safety report, a list of substances prohibited in cosmetic products, a list of substances which cosmetic products must not contain, except subject to the restrictions laid down and also a list of colorants, preservatives and UV-filters allowed in cosmetic products.
As mentioned earlier, the Regulation defines obligations of a responsible person, so let's find out what that term means.
Cosmetic Products Regulation provides that only cosmetic products for which a “responsible person” has been designated may be placed on the EU market. The responsible person for a cosmetic product manufactured within the Community, which is not subsequently exported and imported into the Community, is the manufacturer established within the Community. However, the responsible person may also be designated by the manufacturer, on the basis of a written authorisation. The requirement is that the person must be established within the Community. For imported products, this role is fulfilled by each importer.
The responsible person is essential, as they:
- are responsible for ensuring compliance with the Regulation,
- immediately take the corrective measures necessary to ensure compliance of cosmetic product,
- withdraw it from the market or recall it from end users, if applicable,
- cooperate with national authorities in any action to eliminate the risks posed by the cosmetic products which have been made available by the responsible person on the market.
Another element that you need to be aware of before placing cosmetic on the market is, of course, the preparation of its documentation, called Product Information File (PIF).
The most important part of the PIF is the cosmetic product safety report.
The responsible person is required to ensure that the cosmetic product has undergone a safety assessment, on the basis of the relevant information. It also ensures:
- consideration in the safety assessment of the intended use of the cosmetic product and the anticipated systemic exposure to the individual ingredients in the final formulation,
- the application of an appropriate weight-of-evidence approach in the safety assessment when reviewing data from all existing sources,
- updating the cosmetic product safety report, taking into account additional relevant post-marketing information.
The cosmetic product safety report should be clearly written, as well as adequately justified and easy to understand.
The report consists of two parts. Part A is intended to collect all data necessary for the safety assessment of the product. This information should enable the person conducting the safety assessment to clearly identify and quantify, based on the identified hazards, what risks the cosmetic product may pose to human health. Part B presents the conclusion of the product safety assessment with an explanation of the scientific reasoning based on the data from Part A of the report. The cosmetic product safety assessment, set out in Part B of Annex I of Regulation No 1223/2009, is carried out by an expert having the appropriate qualifications. Therefore, it is crucial that the responsible person and the person conducting the safety assessment work closely together to ensure that the safety of the product is properly assessed and documented and, when applicable, that the assessment is kept up to date.
In addition, the PIF should also include the following:
- clear description of the cosmetic product,
- description of the method of manufacture and statement of compliance with Good Manufacturing Practice (GMP),
- proof of the claimed effect of the product,
- animal testing data.
Moreover, the documentation should be updated and made available to the competent authorities, if necessary, for market surveillance purposes. This applies for a 10-year period after the last batch of product was placed on the market.
As a final step before placing the cosmetic product on the market, the Responsible Person shall submit to the European Commission information required in Article 13 of Cosmetic Product Regulation, including:
- category of cosmetic product and its name or names, enabling its specific identification;
- name and address of the responsible person where the product information file is made readily accessible;
- country of origin in the case of import.
For this purpose, you will need to use Cosmetic Product Notification Portal (CPNP). CPNP is a free of charge online notification system created for the implementation of Cosmetic Products Regulation. Questions and answers covering the most frequently raised issues and a tutorial on how to request access on CPNP are available on CPNP website.
When a product has been notified in the CPNP, there is no need for any further notification at national level within the EU. You should also remember that the Responsible Person has the obligation to enter in the CPNP the original label of the product when the product is first placed on the market.
It is worth noting that the notification of a cosmetic product in the CPNP database is not equivalent to confirming the qualification of the product as a cosmetic, allowing its marketing, safety certification or meeting the requirements imposed by law.
As you can see, there are many things that have to be considered before placing cosmetic product on the market. It is essential to know the requirements for these products, as well as the limitations on the substances that cosmetics may contain. Additionally, the classification of a product as a cosmetic product itself may be problematic. To help with product qualification, European Commission has developed and is continuously updating a manual to facilitate the assessment of whether a product is a cosmetic product (available on https://ec.europa.eu/growth/sectors/cosmetics/products/borderline-products/), as well as other guidelines.
Thus, in view of all the information presented, it is crucial to understand the current regulations, so that you can comply with all of their requirements.
If you need support in the classification of your product or other aspects related to the introduction of cosmetics to the market, please contact us. Our experts will be happy to answer all your questions!