Cosmetic Products

• Product Information File (PIF)
• Cosmetic Product Safety Reports (CPSR)
• Safety assessment
• Non-clinical safety studies
• Notification submission
• Cosmetovigilance (CV)

We offer Responsible Person services to our clients selling products in both the UK and throughout Europe. A Responsible Person makes sure your cosmetic products include:

• A physical address in the EU/UK where the Product Information File is kept readily accessible to the local competent authority.
• Product claims substantiation and evidence thereof.
• Correct cosmetic product labelling.
• A Product Information File (PIF) confirming compliance with the regulation, that products were produced according to Good Manufacturing Practice (GMP), that the safety assessment has been conducted, etc.
• Cosmetic Product notification through appropriate portal.
• Communication of any undesirable or serious undesirable effects to the competent authorities.
• In case of non-conformity of the product with the EU/UK regulation, taking appropriate measures including recall, removal of the products or taking corrective action to bring that product into conformity

• Stability testing (expose to changes in temperature, humidity, UV light and mechanical stress)
• Microbiological testing
• AMES testing
• Compatibility testing
• Physical testing
• Skin sensitization testing

With our in-house European Qualified Person we can offer:

• Design, Implementation and Auditing of Quality Management Systems for; GMP and ISO 9001
• Bespoke Method Development and Validation

Products which contain CBD and are intended for use on the skin or lips will likely be considered as cosmetic products in the UK and EU. Products which are vaped or intended for human consumption would not usually be classed as cosmetics.

Hand sanitiser generally falls under one of two regulatory frameworks: cosmetic or medicinal products/medical devices. If a claim is made on a product such as ‘kills coronavirus’, then the product would ordinarily be deemed a medicinal product and not as a cosmetic product.

A PIF contains the following information:

• Description of the cosmetic product 
• Cosmetic Product Safety Report (CPSR)
• Description of the method of manufacture and a statement on compliance with Good Manufacturing Practice (GMP)
• Proof of the effect claimed for the cosmetic product
• Data on animal testing

A Responsible Person is responsible for ensuring cosmetic product compliance for products sold in the EU and UK. They must be indicated on the product labelling and they are responsible for the PIF.

The RP may be responsible for the Cosmetic Product Safety Report (CPSR), which is contained in the PIF, provided the RP is qualified in pharmacy, toxicology, medicine, biochemistry, pharmacology or similar.

Yes. In order to place products in the market in the EU or UK, a RP is required, unless the manufacturer is based in the jurisdiction where the products are to be sold and they themselves adopt the responsibility of the RP.

The Responsible Person is responsible for ensuring that cosmetic products are compliant on the market and shall have the power to make corrective actions to ensure regulatory compliance. Details of the RP should also be included on the product for identification purposes. The RP is responsible for the PIF and provides this to the competent authority if requested.

For a cosmetic product manufactured within EU 27 or the UK, the manufacturer may designate a third party as the RP. For a cosmetic product imported into EU 27 or the UK, the importer may designate a RP within EU 27 or the UK respectively. This RP must be within the EU 27 for cosmetic products sold in the EU, while the RP must be in the UK for cosmetic products sold in the UK, i.e. the RP must be based in the jurisdiction where the products are to be sold. The designation of a third party as RP should be conducted by written mandate, as should the acceptance by the RP.

Yes.

Claims on cosmetic products are tightly regulated by Commission Regulation 655/2013 on Cosmetic Claims. Claims pertaining to medical benefits are prohibited on Cosmetic Products.

A safety assessment is required prior to placing a cosmetic product on the market, according to Directive 76/768/EEC. This is the responsibility of the RP. 

To conduct a safety assessment, the RP must assess the intended product use, the systemic exposure from the individual ingredients in the final formulation, a weight-of-evidence approach when reviewing data, non-clinical safety studies and keeping the CPSR up to date.

The CSPR can only be carried out by a person who has formal qualifications upon completion of a university course in relevant fields including toxicology, medicine, pharmacy or a similar discipline.

Good Manufacturing Practice or GMP is a set of standards intended to ensure that cosmetic products are manufactured consistently and to high quality. An international standard for GMP for Cosmetic Products (ISO 22716) is generally adhered to by cosmetic product manufacturers in order to comply with regulatory requirements.

Animal testing of cosmetic products has been prohibited in the EU since September 11, 2004. Alternative, ethical testing methods are required for cosmetic products.