Need help with your CPSR?
What is a CPSR?
A Cosmetic Product Safety Report (CPSR) is a legal document that can only be prepared by a person who has formal qualifications in the relevant fields, to ensure the safety of your cosmetic formulations and finished cosmetic products.
Cosmetic products being placed on the European and UK markets must comply with strict regulatory laws to ensure the protection and safety of consumers. The CPSR must be compiled before the product is placed on the market.
Inter Scientific can offer you turnkey cosmetic services in the UK and Europe.
Regulation EC No 1223/2009 states, “In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.- Article 10 (1) of Regulation (EC) No 1223/2009.”
Applicable information and evaluations
For the CPSR, you are required to submit the properties of your cosmetic product which include; the composition, physical and chemical characteristics, purity and stability of the substances, the packaging which intends to be used, and also details of the normal and possible use of the product.
Before your product can be approved, physical tests and evaluations must be carried out to demonstrate the safety of your product. From these tests, you must be able to provide details of the microbiological specifications of the product and also a local toxicity evaluation, along with details of the stability of the product when stored under various conditions.
The CPSR also requires additional information regarding data on undesirable effects, serious undesirable effects, any other relevant information regarding studies on human volunteers or risk, and calculations of data for exposure to the cosmetic product. This information includes the site and surface area of application, amount of product required, the toxicological effect of exposure per unit area of skin or bodyweight, etc. For more information on undesirable and serious undesirable effects, read our cosmetovigilance blog.
Responsible Person services
Inter Scientific also offers responsible person (RP) services to our clients selling products in both the UK and throughout Europe. The purpose of the RP is to ensure the continuous compliance of the entire product dossier, including the CPSR which is essential to the Product Information File (PIF) and is required for the distribution of the cosmetic product. The RP can also notify your products in the relevant notification portals and report to the authorities regarding inspection and monitoring on your behalf.
By assigning Inter Scientific as your RP, we can track changes in any and all applicable EU or UK cosmetics regulations and advise you on how to stay fully compliant in the ever-changing field of cosmetic regulation, while also serving your best commercial interests. This will allow for a more accurate regulatory process and the smoother and faster placement of your cosmetic product on the market, most especially regarding notification submission and any communication with authorities.
We can help
Our experts can provide your cosmetics company with the complete scientific and regulatory support required to comply with Regulation (EC) No 1223/2009.
In the research and development phase of your cosmetic products, Inter Scientific can help you conduct pre-evaluations of your cosmetic formulas to verify acceptable safety margins for each ingredient. Our Cosmetics team will guide you through the necessary tests, analytical, toxicological, or microbiological, to ensure the safety of your product.
If the list of requirements for a CPSR seems overwhelming, contact us today! Inter Scientific offers a bespoke cosmetic service, which supports your collection of all the relevant information to evaluate the safety of your product, along with enabling us to act as your cosmetics Responsible Person.
For additional information on our full cosmetic service, see our Cosmetics page.