Safety is the foremost critical consideration while developing and selling cosmetic goods over the globe. Various nations have different standards for determining the safety of personal care products. In the same way, before sending any cosmetics product to the European market, it should have CPSR. When applied properly and as indicated, a cosmetic should pose no threat to human health.
There must be a Cosmetic Product Safety Report (CPSR) in the Product Information File (PIF). The Cosmetics Regulation 1223/2009 requires the report to be split into two pieces. The objective of the Safety Evaluation in Section B of the CPSR is to show that the beauty product is safe for use.
What is Included in the Product Safety Assessment
The product safety report consists of two sections:
Part A: Information on the Safety of the Beauty Product
The quantitative and qualitative composition of the cosmetic product
The purpose of this CPSR part is to detail the exact ingredients used to make the product. The amount of each raw material used to create the formulation is listed.
- The list of raw materials and components that exist in the completed product’s formulation (quantitative formula)
- The proportions of these chemicals and raw materials (quantitative formula)
- INCI component names and their purposes
- CAS numbers in order to identify formula components correctly.
1. Physical/chemical characteristics and stability of the cosmetic product
This subsection aims to discuss the chemical characteristics of the compounds or mixes employed and the cosmetics product itself. Such standards are essential for a thorough safety evaluation since they may influence the effectiveness of a beauty item.
2. Microbiological quality
The purpose of this segment of the CPSR is to establish the microbiological characteristics of the raw goods (substances or mixtures) and final product.
3. Impurities, traces, and information about the packaging material
The purpose of this part of the CPSR is to determine if the cosmetic product has unintentionally added compounds that may have an effect on its safety. Contaminants are undesirable elements present in raw materials.
4. Normal and reasonably foreseeable use
This part is necessary for the safety evaluator to develop an appropriate visibility scenario. In order to prevent the user from misapplying with the product, the intended users should be effectively conveyed to them.
5. Exposure to the cosmetic product
This assessment is an integral component of risk evaluation and tries to estimate the amount of the beauty product coming into contact with exterior portions of the human body.
6. Exposure to the substances
The purpose of this subsection is to determine the quantity of each substance that comes into interaction with the body’s exterior surfaces, teeth, and oral mucous membranes during routine and possible usage. In the event that compounds are created or emitted during usage, they should also be included in the cosmetic product safety report.
7. Toxicological profile of the substances
The purpose of this portion of the CPSR is to detail the toxicological threat posed by each ingredient in the final product and to assess the possibility of exposure. In order to support their judgement on whether or not a component is safe, the safety analyst for cosmetics must examine relevant endpoints.
8. Undesirable effects and serious undesirable effects
This section’s goal is to check the product’s safety after its introduction to the marketplace and take remedial action if required. The Responsible Person establishes a mechanism to collect data, determine the causation of, and manage the adverse effects resulting from the product’s usage in the Union.
9. Information on the cosmetic product
This part of the report permits the incorporation of any additional details that are not included under any of the other categories of Part A of Annex I to Regulation (EC) No. 1223/2009 but are deemed significant for assessing the product’s safety.
Part B: It includes the conclusion of the safety assessment
- Assessment conclusion
- Warnings and instructions on the packaging
- Assessor’s qualifications and authorisation
In Final Words
The cosmetic product safety report is required for putting a product on the market in the EU. It is essential that your safety assessor addresses the points highlighted in this post.