The first step of the regulatory process is to determine if your product falls within the scope of the cosmetic regulation. A cosmetic product in Europe and UK is defined in the EU Regulation 1223/2009 (Article 2.1.a) as follows: ‘cosmetic product’ means 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.

The decision of whether a certain product is considered as a cosmetic product in Europe or UK has to be made on the basis of a case-by-case assessment, taking all characteristics of the product into account. Cosmesafe can help you determine whether your product is a cosmetic in Europe and UK.

Cosmesafe can conduct both stability and compatibility tests on your products. Stability and compatibility testing determine whether a product meets all the required standards of quality, functionality, safety, and aesthetics under the normal conditions of transport and handling and different storage situations, including sunlight, high temperatures, freezing temperatures, and more. The stability test establishes the appropriate shelf life as well as the package’s ability to produce the product from its environment. Compatibility tests show the compatibility between the product and its packaging.

According to ISO 29621, every cosmetic manufacturer has to ensure that the product, as purchased, is free from the numbers and types of microorganisms that could affect product quality and safety, and that it will not be adversely affected by microorganisms introduced during normal product use.

The challenge test also known as the presertvative efficacy test (PET) was developed to ensure these safety and quality issues are met before a product is sold on the market. In essence, the challenge test checks how effective the preservative system in a product is by introducing microorganisms and seeing if they grow in the cosmetic product. The challenge test is required for most cosmetics, but some of them are exempt from this test as they are qualified as microbiologically low-risk products.

The challenge test is an important part of the Product Information File, and it should be included in the Cosmetic Product Safety Report (CPSR). 

Cosmesafe can conduct the challenge test, which is an important step in the qualification process.

Any cosmetic product that is placed on the market must have a Product Information File (PIF). It is kept and made available to the authorities by the Responsible Person, at the same exact address indicated on the product. It must be kept for 10 years after the last production batch has been placed on the market. Furthermore, it must be regularly updated in case of change in the formula or raw material supplier. The DIP must also be translated into the language of the Member State(s) in which it is marketed so it can be understood by the local authorities.
In general, the DIP contains the formulation of the product, the specifications of the raw materials as well as the packaging and the tests carried out on the cosmetic product.

Cosmesafe can guide you through all the required documentation for the PIF and prepares the PIF.

Cosmetic products can not be placed on the market without compliant labels. Whether in the EU or UK, there are specific rules and requirements that need to be applied. Labels must be easily legible and must contain several specific information: certain things have to be written on the labels, others are prohibited. Labels also need to be translated into the different official languages of each country the product will be sold in. An imporant aspect of the labelling are also cosmetic product claims. Every claim present on the cosmetic product must be substantiated with respect to the 6 common criteria published in the EU Regulation 655/2013 which are: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making.

Cosmesafe can help you determine whether your product labels meet all the regulatory requirements and work with you to make them compliant.

Before your product can be sold in the market, the Responsible Person must submit a notification on the CPNP (Cosmetic Product Notification Portal). This CPNP is a notification and not a registration, but it has specific rules that must be followed for your product to be allowed to circulate.

Cosmesafe can help you gather the required information and submit to CPNP in order to start selling your products.

The transitional period has come to a close on 31 December 2020. Companies now must comply to the UK cosmetic regulation. Cosmetic products that are intended to be sold in Great Britain must be notified on the SCPN (Submit Cosmetic Product Notifications).

Existing products on the GB market: For cosmetic products available to GB consumers that have already been notified using the EU’s Cosmetic Products Notification Portal (CPNP) before 1 January 2021, you will have until 31 March 2021 to notify your cosmetic products using the UK’s Submit cosmetic product notifications service.

New products for the GB market: For cosmetic products that have not been notified on the EU’s CPNP and are being placed on the GB market after 31 December 2020, you will need to notify these products using the UK’s Submit cosmetic product notifications service before they can be placed on the GB market.

For products that were previously on the EU market before 1 January 2021: All product packaging must bear the name and address of the UK Responsible Person from 31 December 2022.