What is a CPSR?
If you want to create and sell your own cosmetics, then a Cosmetic Product Safety Report (CPSR) is a legal requirement that must be written by a certified chemist. Also known as a Safety Assessment, a CPSR is a legal document required to ensure the safety of all cosmetic products placed on the retail market. You will need a CPSR regardless of whether you are making your own product from scratch or buying a cosmetic base from a supplier and adding your own scents etc.
Our cosmetic product safety report comprises the following:
PART A – Cosmetic Product Safety Information
- Composition of the Cosmetic Product
The qualitative and quantitative composition of the cosmetic product shall be provided, including the chemical identity of the substances. This information should include the chemical name, INCI (International Nomenclature of Cosmetic Ingredients), CAS (Chemical Abstracts Service), and EINECS/ELINCS (European Inventory of Existing Commercial Chemical Substances/European List of Notified Chemical Substances) numbers, where possible. It should also include the intended function of each substance. In the case of perfume and aromatic compositions, the name, code number, and identity of the supplier should be described.
- Physical and Chemical Characteristics and Stability
The physical and chemical characteristics of the substances or mixtures, as well as the cosmetic product itself, should be provided. This includes information on the appearance, odor, pH, viscosity, and any other relevant properties. The stability of the cosmetic product under reasonably foreseeable storage conditions should also be described.
- Microbiological Quality
The microbiological specifications of the substances or mixtures used in the cosmetic product, as well as the finished product, should be outlined. Special attention should be given to cosmetics that are used around the eyes, on mucous membranes, on damaged skin, on children under three years of age, on elderly people, and on individuals with compromised immune responses. Results of preservation challenge tests should be included.
- Impurities, Traces, and Packaging Material
The purity of the substances and mixtures used in the cosmetic product should be addressed. If there are traces of prohibited substances, evidence should be provided to demonstrate their technical unavoidability. The relevant characteristics of the packaging material, particularly in terms of purity and stability, should also be described.
- Normal and Reasonably Foreseeable Use
The normal and reasonably foreseeable use of the cosmetic product should be explained. This may include information on the intended application, such as a facial moisturizer or body lotion.
- Exposure to the Cosmetic Product
Data on the exposure to the cosmetic product should be provided, taking into consideration the following factors:
- Site(s) of application
- Surface area(s) of application
- Amount of product applied
- Duration and frequency of use
- Normal and reasonably foreseeable exposure routes
- Targeted population(s)
The calculation of exposure should consider toxicological effects per unit area of skin or per unit of body weight. The possibility of secondary exposure through routes other than direct application, such as non-intended inhalation or ingestion, should also be considered. Particular attention should be given to the impact of particle sizes, including nanomaterials, on exposure.
- Exposure to the Substances
Toxicological data on exposure to the substances contained in the cosmetic product should be provided.
- Toxicological Profile of the Substances
The toxicological profile of the substances contained in the cosmetic product should be evaluated. This should include an assessment of local toxicity (skin and eye irritation), skin sensitization, and, if applicable, photo-induced toxicity resulting from UV absorption. All significant routes of absorption, systemic effects, and the margin of safety (MoS) based on a no observed adverse effects level (NOAEL) should be considered. If these considerations are not included, a justification should be provided. The potential impact of particle sizes, impurities, and substance interactions on the toxicological profile should be given special attention. The source of information should be clearly identified.
- Undesirable Effects
All available data on the undesirable effects and serious undesirable effects of the cosmetic product, as well as relevant statistical data, should be provided.
- Additional Information
Any other relevant information should be included, such as existing studies conducted on human volunteers or confirmed findings from risk assessments in related areas.
PART B – Safety Assessment of the Cosmetic Product
- Assessment Conclusion
A clear statement regarding the safety of the cosmetic product should be provided based on the gathered information and analysis.
- Label Warnings and Instructions for Use
An assessment should be made to determine if any specific warnings or instructions need to be included on the product label to ensure safe usage.
- Reasoning
The scientific reasoning behind the safety assessment conclusion should be explained, detailing the methodology, data analysis, and considerations taken into account during the evaluation process.
Additionally, the following specific assessments should be conducted:
a) Assessment for Cosmetic Products Intended for Children Under the Age of Three: A separate assessment should be conducted specifically for cosmetic products intended for use on children under the age of three, considering their unique characteristics and potential vulnerabilities.
b) Assessment for Cosmetic Products Intended for External Intimate Hygiene: A specific assessment should be carried out for cosmetic products intended exclusively for use in external intimate hygiene, taking into account the sensitive nature of this area and potential risks associated with product use.
c) Assessment of Interactions: Possible interactions between the substances contained in the cosmetic product should be assessed to determine if any adverse effects may arise from their combination.
d) Consideration of Different Toxicological Profiles: The different toxicological profiles of the substances used in the cosmetic product should be carefully considered, providing justification for their inclusion or exclusion in the formulation.
e) Impacts of Stability on Safety: The impact of the product’s stability on its safety should be evaluated, ensuring that the stability of the cosmetic product does not compromise its overall safety.
By conducting these assessments and providing appropriate justifications and explanations, a comprehensive safety assessment of the cosmetic product can be achieved.
How to order?
Please do feel free to email us if you have any questions at all. When you are ready to get a quote for cosmetic safety assessment, simply email your formulations and we will be happy to help. Message us on chat if you have questions
When you have your quote, you decide whether you want to proceed. We have a wide range of payment options to suit everyone.
Download our CPSR Template form if you’d like a quote without obligation!
