Cosmetic Product Safety Report / Product Information File

A Cosmetic product MUST be safe for human use before it can be placed in the market. The CPSR is the way that Responsible Persons must demonstrate the safety of their products. The CPSR is mandatory, every cosmetic product in the EU and the UK markets must be safely assessed. 

According to the requirements of article 10 of the EU and the UK Cosmetic Regulations, the CPSR should be performed by a qualified assessor, called the Cosmetic Safety Assessor. 

The safety assessor will consider the following: 

• · the general toxicological profile of each ingredient used;
• · the chemical structure of each ingredient;
• · the level of exposure of each ingredient;
• · the specific exposure characteristics of the areas on which the cosmetic product will be applied; 
• · the specific exposure characteristics of the class of individuals for whom the cosmetic product is intended; and
• · any impurities, traces, as well as the packaging material.

What needs to be covered by the safety assessor is listed in Annex I of both the EU and the UK cosmetic regulations. 

The qualifications of the Cosmetic Safety Assessor are stated in article 10 of the EU and the UK cosmetic regulations:

"The cosmetic product safety assessment, as set out in Part B of Annex I shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State (EU) / by the Secretary of State (UK)."

If the manufacturing company has a qualified person internally, the CPSR can be performed in-house, otherwise, a third-party qualified assessor should be used. 

YES!

The origin of a raw material (synthetic or natural) doesn’t speak for its safety. The annexes of the EU and the UK cosmetic regulations (INGREDIENTS PROHIBITED OR RESTRICTED DUE TO SAFETY REASONS) contain several natural ingredients, as well as synthetic ingredients, which means that any raw material can have a toxicological profile of concern. 

The CPSR is required for ALL cosmetic products, regardless of their origin, so a product containing only natural ingredients must also be safely assessed. 

The CPSR is performed based on documentation, the safety assessor does not need to see the finished product. To allow the safety assessor to formulate an assessment conclusion, the product must be stability and compatibility tested, and its preservative system must be challenged.

The results of these tests are essential for the safety assessor job.  

• List of Ingredients (INCI)
• Quantities in percentage (%)
• Material Safety Data Sheet (MSDS) for each ingredient / raw material 
• IFRA certificates (when applicable)
• Allergen declarations (when applicable)
• Packaging / Labelling information 
• Product Specification (weight, colour, pH, odour, solubility, density, viscosity...)
• Targeted population (age group)
• Conditions of use, e.g, frequency, amount...
• Nanomaterials declaration (when applicable)
• Data or information on Serious Undesirable Effects (when available)
• Stability and Packaging Compatibility Test Reports on finished product 
• Microbiological (Total viable count and specific pathogens) and Preservative Challenge test report*

*Some products are exempt of Microbiological and Preservative Challenge test. 

Part A Cosmetic Product Safety Information

• quantitative & qualitative composition
• physical/chemical characteristics and stability
• microbial quality
• impurities, traces and the packaging material
• normal and reasonably foreseeable use
• exposure to the product
• exposure to the substances
• toxicological profile of the substances
• undesirable effects and seriously undesirable effects
• other relevant information on the product

Part B – Cosmetic Product Safety Assessment

• an overall conclusion concerning the cosmetic product. This should indicate if the product is either safe for use or safe for use with restrictions. The conclusion should be based on the data presented in Part A of the Assessment.
• Any mandatory labelling requirements should be listed. It is the task of the safety assessor to determine which warnings or instructions of use, in addition to those listed in Annexes III to VI, need to be labelled to ensure the safe use of the product.
• Detailed reasoning for the final safety assessment should comprise a risk–based analysis, using ‘an appropriate weight of evidence approach for reviewing data from all existing sources’.
• The safety assessment should include the name and address of the safety assessor including proof of qualifications; it should be signed and dated by the safety assessor.
• The safety assessment should be reviewed and revised on a regular basis. In particular, this should be done when new data is available that might alter the safety conclusion outlined above.

Article 11 sets out the requirements relating to the Product Information File (PIF), and the detail of the information and data that should be contained concerning:

• Description of the cosmetic product
• Composition of the cosmetic product
• Packaging/Labelling
• The Cosmetic Product Safety Report
• Method of manufacture and GMP
• Nature and proof of effect of the product
• Animal testing

The PIF must be kept for a period of ten years after the date the last batch of the cosmetic product was placed on the market.

The Responsible Person must make the PIF readily accessible to a competent authority at the address notified, in accordance with Article 13.

The PIF should be a ‘living document’ and should be updated as necessary. For instance, it should be updated when changes are made to the CPSR, such as the addition of new test data.

•  Product Composition: List of ingredients (INCI), quantities in %
• Packaging / Labelling: packaging description, product specifications, a photo or pdf of the label/artwork
• Manufacturing files: GMP certificate / declaration, Animal testing declaration
• Claims: data of proof of the effect claimed for the cosmetic product 
• Tests: stability and packaging compatibility test report, Microbiological test reports 
• CPSR: cosmetic product safety reports