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:
-
Cosmetic product with ~25 ingredients – CPSR is typically 70–100 pages.
-
Cosmetic product with ~50 ingredients – CPSR is typically 120–160 pages.
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).
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.
Additionally, if you do not have, we could prepare for you, the following documents necessary to complete the PIF:
description and/or diagram of the manufacturing process of the cosmetic product prepared according to the GMP guidelines (Good Manufacturing Practice) and
GMP declaration, nanomaterials, CMR (Carcinogenic, Mutagenic, or toxic for Reproduction) and
animal testing declarations, proof for claimed effects (theoretical), PAO (Period After Opening)
determination (theoretical) if it is stated on the product.
The cost per document from €60.
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.
Please, note that different pack variations and sizes of the same product only need one PIF, while any change in the composition of product which include change of any ingredient (exept minor changes, like color, perfume) or its concentration lead to formation of the new product. In that case the new, separate PIF should be prepared.
A complete PIF is prepared in two clearly defined phases.
This approach makes it possible to assess the status of the existing documentation at the outset, identify any deficiencies and define what is required to proceed with the preparation of the complete Product Information File (PIF).
PHASE 1 – Documentation Review
The first phase is a mandatory initial step and includes a review of the completeness of the product documentation and identification of any deficiencies.
Based on the documentation provided, we determine whether the conditions for proceeding with the professional work are met and identify any data or documents that need to be supplemented.
The client receives an overview of the findings and the required additions.
Phase 1 can also be ordered as a standalone service. If the client subsequently proceeds with PIF preparation for the same product and the same relevant version of the formulation and documentation, the professional review already performed is not charged again.
PHASE 2 – PIF Preparation and Finalisation
The second phase begins once the data and documents required for the professional
assessment have been provided and any deficiencies preventing further work have been resolved.
Phase 2 includes:
-
regulatory review of existing claims and/or marketing descriptive text based on the provided formulation and supporting documentation;
-
safety assessment and preparation of the Cosmetic Product Safety Report (CPSR);
-
regulatory review of the final label and packaging artwork;
-
completion, structuring, final review and compilation of the documentation into an electronic PIF.
Example - Cosmetic Product Safety Report (CPSR)
Special Categories of Cosmetic Products
For certain categories of cosmetic products, additional professional evaluation is required, taking into account their intended use, area of application and/or target population, such as:
-
products for babies and young children;
-
products intended for the eye area;
-
lip products;
-
products for intimate care;
-
sunscreen products.
For these categories, an additional fee applies, depending on the type of product and the scope of the required safety assessment.
PRICE FOR PREPARATION OF A COMPLETE PIF
The price depends on the type and complexity of the product, the scope and quality of the documentation provided, the number of ingredients and the professional work required.
The final scope of the service and price are confirmed before work begins.
Important:
A complete PIF covers one product and one agreed final formulation.
The PIF can be completed once all data and documentation required for the professional assessment have been provided.
Before the formulation and other confidential documentation are submitted, a Non-Disclosure Agreement (NDA) is concluded.
Laboratory testing, translations, CPNP notification and the
Responsible Person service
are not included in the price of the complete PIF unless separately agreed.
If you are the
Responsible Person placing the product on the EU market, we can also provide support with product notification through the
CPNP portal.
Other services for cosmetic products
Do you need a CPSR and a complete PIF?
Contact us to ensure your documentation meets all regulatory requirements with confidence.