Cosmetic product safety report: ensuring compliance before going to market.
Our team of qualified safety assessors and experts in the field of cosmetics regulation provides guidance and support throughout the CPSR process. We are well-versed in the common mistakes made by businesses during the CPSR process, such as inadequate data collection, incomplete safety reports, and insufficient testing. With our expertise, we can help you avoid these pitfalls and ensure that your cosmetic products comply with the regulations outlined in the EU’s Regulation EC No 1223.
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What exactly is a Cosmetic Product Safety Report (CPSR)?
A Cosmetic Product Safety Report (CPSR) is a detailed document that outlines the safety and compliance of a cosmetic product according to the regulatory requirements in the European Union (EU) market. It includes information on the product’s quantitative and qualitative composition, packaging materials, stability, and chemical characteristics, as well as any necessary tests and undesirable effects information.
A CPSR is required for all cosmetic products sold in the EU and must be prepared by a qualified safety assessor or responsible person.
Cosmetic safety reports require an impartial and objective evaluation of product safety, which cosmetic brands may not be able to provide due to their potential vested interest in the safety report outcome.
Why using several test organisms is necessary?
Candida albicans, Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus strains most commonly used in preservation efficacy test because they represent the major types of microorganisms that can cause spoilage, infections, or skin irritation in cosmetic products. Candida albicans is a common fungal strain that can cause skin infections, particularly in people with weakened immune systems. It is a good indicator of the ability of a cosmetic product to resist fungal contamination with direct contact.
Escherichia coli is a gram-negative bacterium that is commonly found in the human gut and is often used as an indicator of fecal contamination. In cosmetic products, it can cause skin irritation and infections.
Pseudomonas aeruginosa is a gram-negative bacterium that is commonly found in water and soil. It can cause skin infections and is a good indicator of the ability of a cosmetic product to resist bacterial contamination.
Staphylococcus aureus is a gram-positive bacterium that is commonly found on the skin. It is a major cause of skin infections and is a good indicator of the ability of a cosmetic product to resist contamination.
What information should be
included in the report?
A Cosmetic Product Safety Report (CPSR) should include the following information:
Part A (Cosmetic Product Safety assessment)
• Product Information, including product description, intended use, and instructions for use.
• Qualitative and Quantitative Composition, listing all ingredients in the product, their functions, and their concentrations.
• Physical/Chemical Characteristics and Stability, covering aspects such as pH, viscosity, and shelf life.
• Microbiological Quality, assessing the presence of any harmful microorganisms.
• Impurities, Trace Elements, and Microbiological Quality of Water, if relevant.
• Packaging Material, covering the materials used and their compatibility with the product.
In summary, Part A of the CPSR covers the physical and chemical properties of the product, while Part B focuses on the safety assessment of the product and its ingredients. It is important to note that Part B can only be completed once all the necessary data from Part A has been collected and analyzed.
Part B: Reasoning
•Cosmetic Product Safety Assessment, covering the safety assessment of the product and its ingredients.
•Toxicological Profile of the Substances, including potential toxic effects and exposure limits.
•Undesirable Effects Information, listing any adverse reactions that may occur from product use.
•Normal and Reasonably Foreseeable Use Exposure, assessing the potential exposure of the product to consumers under normal and foreseeable conditions.
•Exposure to Substances, assessing the exposure to any harmful substances or impurities present in the product.
•Necessary Tests, including any relevant tests conducted to assess the safety and quality of the product.
•Scientific Reasoning for the Safety Assessment, detailing the scientific methods used to assess the safety of the product.
Who can write a cosmetic product safety report?
A cosmetic safety assessment must be performed by a qualified safety assessor or a responsible person who possesses the right qualifications and experience in the field of cosmetic product safety. The safety assessor must have in-depth knowledge of cosmetic ingredients, their toxicological profiles, and the relevant safety regulations and guidelines.
In addition, the safety assessor must be able to conduct a comprehensive safety assessment of the product and its ingredients, including assessing potential exposure and undesirable effects information. The responsible person is responsible for ensuring the safety and compliance of the cosmetic product and must have access to the necessary data and information to complete the CPSR. It is essential to engage a qualified safety assessor or responsible person to ensure the
CPSR meets the required standards and regulatory requirements for cosmetic products sold in the European Union (EU) market.
Requirements to Sell in Europe and the UK
To sell any cosmetic product in the European Union (EU) and the United Kingdom (UK), there are four essential elements that brand owners and businesses must have in place. Firstly, a Cosmetic Product Safety Report (CPSR) and a Product Information File (PIF) are required to ensure the safety and compliance of the product according to the regulatory requirements. The CPSR covers the safety assessment and necessary tests of the product, while the PIF contains comprehensive data and information on the product’s formulation, manufacturing, and labeling.
Secondly, a compliant label and its claims must be in place, which adhere to the strict regulations outlined in the EU’s Regulation EC No 1223. The label should include clear and accurate information on the product’s ingredients, function, and directions for use.
Thirdly, notification to the European portal CPNP and the UK portal SCPN is required if the intention is to export and sell the product in both markets. This notification allows the regulatory authorities to access information on the product and ensure compliance with the relevant regulations.
Finally, legal representation in the EU and the UK, in the form of a Responsible Person, is required to ensure that the cosmetic product meets all the necessary regulations and standards. The Responsible Person is responsible for ensuring the safety and compliance of the product and must have access to the necessary data and information to complete the CPSR and PIF.
In summary, to sell cosmetic products in the EU and the UK, it is crucial to have a CPSR and PIF, a compliant label, notification to the relevant portals, and legal representation in both markets. It is important to adhere to these requirements to ensure the safety and compliance of the cosmetic product and avoid any legal or regulatory issues.
