Our expert regulatory team guides you through this process, ensuring your product meets all necessary legal requirements for smooth entry into these key markets, minimising delays and ensuring consumer safety.
The primary regulation laying down the rules for placing cosmetic products in the European Union (EU) and Northern Ireland (NI) is Regulation (EC) No 1223/2009. Following Brexit, cosmetic products marketed in Great Britain (GB) are regulated under the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019.
In Europe, a cosmetic product is described as any substance or mixture intended to be placed in contact with the external parts of the human body 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.
Before a cosmetic product can be sold in the European Union or the United Kingdom (UK), the responsible person must submit a notification for the product.
At Inter Scientific, we support cosmetic companies in ensuring the regulatory compliance of their products and access to the EU and UK markets.
The cosmetic regulations in the EU and UK include a list of prohibited substances in cosmetic products, along with specific restrictions on certain ingredients. These regulations are frequently updated, with new prohibitions and restrictions added each year. Therefore, it is crucial to regularly revise the regulatory status of the ingredients in cosmetic products to ensure compliance with the latest legislation. We verify the regulatory compliance of the ingredients in the cosmetic formulation against EU and UK legislation.
Responsible persons must ensure that the cosmetic product has undergone a safety assessment. This assessment is documented in the Cosmetic Product Safety Report (CPSR), which is structured in two distinct parts: PART A and PART B.
PART A contains the safety information on the cosmetic product. This section includes the following details:
PART B contains the product safety assessment and includes the following:
We perform toxicological assessments and create the CPSR for cosmetic products.
The packaging and containers of cosmetic products display the following elements in indelible, easily legible and visible lettering:
Exceptions are considered where, for practical reasons, it is not possible to include all the required information on the label.
Additionally, the claims made on the cosmetic product labelling are subject to COMMISSION REGULATION (EU) No 655/2013. This regulation outlines the common criteria for the justification of claims made in cosmetic products. The claims should be assessed based on the six criteria specified in the legislation: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making.
We conduct revisions of cosmetic labelling revisions to ensure that both the label elements and the claims comply with the legislation.
Only cosmetic products that have a designated responsible person shall be placed on the market. The person responsible must be located in the EU for products placed in the EU and NI markets, whereas the person responsible must be located in GB for products marketed there. The responsible person must ensure that the cosmetic product complies with the applicable regulations. Therefore, the responsible person must notify the cosmetic product to the authorities when introducing the product to the market.
We can act as the responsible person for cosmetic products in both the EU and UK markets.
Take the next step in compliance excellence. Contact us today to initiate a discussion or learn more about our offerings.