COSMETIC PRODUCT SAFETY REPORT | CPSR

The Cosmetic Product Safety Report (CPSR) is the most important part of the Product Information File (PIF). It includes data on raw materials, finished products, packaging, and other essential information required for the safety assessment of the final product. A CPSR is a comprehensive document that verifies the safety of a cosmetic product for consumer use. While many assume it is only a few pages long, a CPSR can be quite extensive. For example: The requirements for the formation of a CPSR are listed in Annex I of the EU Cosmetics Regulation (EC) N° 1223/2009 and consist of two distinct parts with the following elements:

Part A: Cosmetic Product Safety Information

• Qualitative and quantitative composition of the cosmetic product (INCI name of ingredients and their functions, CAS numbers of ingredients, an accurate composition of the cosmetic product presented as a list of raw materials and ingredients, accurate concentrations of listed ingredients). In order to properly form a list of ingredients, it is necessary to provide all relevant documents accompanying the raw materials. These documents are supplied by the manufacturer of raw materials and includes the Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS) and certificates of analysis (CoA) for each raw material.
• Physical/chemical characteristics and stability of the cosmetic product (physical/chemical characteristics of the raw materials and physical/chemical characteristics of the finished product (appearance of the product (texture, colour, odour), pH, viscosity, specific gravity, etc.) should be supported by information on the product's stability in predictable storage conditions obtained from stability tests (accelerated aging tests, cyclic temperature stress tests)).
• Microbiological quality (the microbiological specification of the raw materials supplied by the manufacturer of raw materials, the microbiological stability of the finished cosmetic product tested in its original packaging – challenge test and microbiological test).
• Impurities, traces, and information about the packaging material (information on impurities and traces in the raw materials are usually found in the MSDS, TDS, or CoA). Information on the packaging material – relevant data on the primary and secondary packaging found in the packaging specifications which include information about the manufacturer, type of the material from which the packaging is made, and packaging dimensions. Data on primary packaging (packaging that is in direct contact with the product) are especially important. It is best to provide a Food Grade Statement (confirmation that packaging is suitable for contact with food). If there is no Food Grade Statement, it is necessary to perform the relevant tests (compatibility test, migration test) on the finished product in its original packaging. Additionally, it should be performed package leak test, as well as a visual inspection of the packaging for damage. The manufacturers of raw materials for the package and the manufacturers of the packaging should provide MSDS of the packaging raw materials.
• Normal and reasonably foreseeable use (the product's labelling with warnings and instructions for use).
• Exposure to the cosmetic product (the quantity estimation of the product applied, duration and frequency of the product use, data on the sites and surface areas of the product application, data on the normal and reasonably foreseeable exposure routes, and the exposed populations).
• Exposure to the substances (data on the amount of each substance contained in the cosmetic product coming into contact with a human body under the normal and reasonably foreseeable use of the cosmetic product).
• Toxicological profile of the substances (calculation of the MoS where possible).
• Undesirable effects and serious undesirable effects (data on adverse effects in or after using the cosmetic product).

Part B: Cosmetic Product Safety Assessment Report
(Assessment of the expert assessor)

• Assessment conclusion (Safety Assessor concludes whether the cosmetic product is safe or not).
• Labelled warnings and instructions for use (important for the safe use of the cosmetic product).
• Reasoning (explanations provided by the Safety Assessor for their conclusion regarding the safety of the cosmetic product).
• Assessor's credentials and approval of part B.

In addition to the documents required for CPSR completion, you should provide the following documents: description and/or diagram of the manufacturing process of the cosmetic product prepared according to the GMP guidelines, GMP declaration, nanomaterials, CMR and animal testing declarations, proofs for claimed effects (experimental and/or theoretical), PAO (Period After Opening) and/or expiration date determination (experimental and/or theoretical) required for PIF completion. After we get the mentioned documents you submitted, we will review them and perform their checking and verification. The more information you provide, the quicker the process should be. Also, you should provide the exact product name under which the product will be registered within the European portal CPNP. Together with the name of the product, a code unique for each product must be given. All documents relating to the cosmetic product must have the exact name of the product in order to avoid confusion.

Finally, the submitted documents could be sorted and arranged into a complete PIF. Along with writing the CPSR, this process usually takes about 10 working days to complete the PIF.

CPSR Writing (Part A and Part B) services for products with: Additional fee for CPSR Writing (Part A and Part B) for specialized products: Baby care products, children's products, anti-aging products, eye-area cosmetics, intimate hygiene products, and others + €100. This service includes:

Including CPSR writing - Part A and Part B for products with: The service includes: Additionally, if you are the Responsible Person and are placing your product on the EU market, we provide guidance and support with product notification on the CPNP portal. Please note that our services do not include acting as the Responsible Person for the EU market. For such services, we recommend considering well-known, trusted agencies like Obelis or CEway. These agencies are widely recognized for their expertise in regulatory compliance and can provide the necessary services. Need a professional CPSR and complete PIF? Contact us to ensure your documentation meets all regulatory requirements with confidence.