General principles
ICCR defines General Safety Assessment as:
“The Safety assessment of cosmetic ingredients is not a standardized procedure, but should be performed on case-by case basis using the best science. In particular, checklist approaches and decisions based on hazard alone are considered inappropriate and not adequate to thoroughly assess safety. The safety assessment of cosmetic ingredients involves a systematic stepwise approach that starts from conservative assumptions and includes refined approaches, as required and/ or appropriate. The safety assessments should utilize the most up to date approaches available while taking into account current legal/regulatory requirements.”
ICCR defines the Safety Assessment process as:
- Ingredient characterization through relevant physico-chemical data, purity and profile of impurities and chemical structure of constituent ingredients comprising a product.
- Assessment of all relevant toxicological hazard information. Data on closely related structural analogues, and structure –activity modeling data, may be considered.
- Considerations with regard to the stability of ingredients and product formulation as well as their microbiological status.
- Exposure assessment including an understanding of how the product is used: the amount, frequency, and duration of intended use; and target users.
- Calculation of safety or exposure margins (as appropriate), using the relevant dose metric for the endpoint considered
- Post Market Surveillance to support continued product safety
The role of the product safety assessment
The product safety assessment must be established in accordance with Annex I of the Cosmetic Regulation.
It’s the part of the PIF that assesses the safety of your cosmetic product.
What must include the Product Safety Assessment?
There are two distinct parts in the product safety report:
PART A: INFORMATION ON THE SAFETY OF THE COSMETIC PRODUCT
The purpose of Part A is to collect all necessary data to perform the product safety assessment. It contains:
1. Quantitative and qualitative composition of the cosmetic product
The aim of this CPSR section is to provide the product formulation. It describes how much of each raw ingredient is in the formulation.
This section should include:
- The list of raw materials and ingredients that appear in the composition of the finished product (quantitative formula)
- The concentrations of these raw materials and ingredients (quantitative formula)
- INCI names of ingredients, their functions
- CAS numbers so as to properly identify ingredients used in the formula
NB: For fragrances and aromatic compositions the name and code number for the fragrance or flavor is required as well as the name of the supplier.
You also need to be compliant with the Annex III on allergens contained in your product, i.e. provide allergen statements and IFRA certificates for vegetal extracts and fragrances.
2. Physical/chemical characteristics and stability of the cosmetic product
The aim of this section is to describe the relevant chemical specifications of the substances or mixtures used and the cosmetic product itself. These specifications are crucial for an appropriate safety assessment, as they may influence the safety of a cosmetic product.
You have to provide:
- The physico-chemical specifications of the raw materials and the finished product
- Information on the product’s stability in predictable storage conditions
3. Microbiological quality
The aim of this section of the cosmetic product safety report is to determine the acceptable microbiological specifications of the raw materials (substances or mixture) and finished product from a microbiological point of view.
You have to provide:
- The microbiological specifications of the raw materials and of the finished product
- The conservation test of the cosmetic product
You will obtain this data from:
- Your formulator and regulatory department
- The microbiological expert, the quality manager
- The raw material supplier
4. Impurities, traces, and information about the packaging material
The aim of this CPSR section is to assess whether the cosmetic product contains substances that have not been intentionally added to the formulation, and that may have an impact on its safety
Impurities are unintended substances in raw materials.
You have to provide:
- Data concerning the impurities and traces in the raw materials and/or in the finished product
- Relevant data on the packaging materials
5. Normal and reasonably foreseeable use
This section is essential for the safety assessor to be able to determine a relevant exposure scenario. The intended use should be appropriately communicated to the consumer in order to avoid misuse of the product.
You need to take into account:
- The labeling
- The use instruction
You have to gather data from:
- The regulatory department of the cosmetic brand
6. Exposure to the cosmetic product
The exposure assessment is an essential element of risk assessment and aims to quantify the amount of cosmetic product coming into contact with external parts of human body or teeth and the mucous membranes of the oral cavity under normal or reasonably foreseeable use for each use and the frequency of use.
You have to gather data from:
- The regulatory department of the cosmetic brand
- The formulator
7. Exposure to the substances
The objective of this section is to calculate the amount of each substance coming into contact with external parts of the human body, teeth and mucous membranes of the oral cavity under normal and reasonably foreseeable use. Where substances are generated or released during the use of the product these should also be taken into consideration in the cosmetic product safety report.
You have to gather data from:
- The safety assessor
8. Toxicological profile of the substances
The aim of this section of the cosmetic product safety report is to describe the toxicological hazard of each of the substances in the finished product and determine the potential exposure. The cosmetic safety assessor needs to consider suitable endpoints to justify their decision as to whether an ingredient is safe.
You have to gather data from:
- The Safety assessor
- The toxicologist
- The regulatory department
9. Undesirable effects and serious undesirable effect
The aim of this section is to monitor the safety of the product after it has been placed on the market and take corrective measures when necessary. The Responsible Person sets up a system to collect data, establish the causality of, and manage the undesirable effects caused by the product after its use in the Union.
Information on undesirable effects and serious undesirable effects is to be included in the cosmetic product safety report, kept up –to-date and made available to the safety assessor, who may revise their assessment or take the information into account when assessing similar products.
10. Information on the cosmetic product
That section of the cosmetic product safety report allows the inclusion of any additional information which is not covered under the other headings of Part A of Annex I to Regulation (EC) No 1223/2009, but is considered relevant in order to carry out the safety assessment of the product.
WHAT MUST PART B CONTAIN?
In accordance with Annex I of the Cosmetic Regulation 1223/2009, the safety assessment of the cosmetic product must be performed by a qualified safety assessor.
Part B contains:
The conclusion of the safety assessment: The safety assessor states whether the product is:
- Safe
- Safe with restrictions
- Not safe for human health under normal and foreseeable use.
Warnings and operating instructions that must be displayed on the label: you have to explicitly enumerate the special precautions for use that have to be on the label (at least those that are mentioned in Annexes III to IV according with the product’s ingredients) in order to ensure a safe use of the cosmetic product.
Scientific reasoning: it is the part where the Safety Assessor explains in a clear, relevant and precise manner the way he or she could conclude about the safety of the cosmetic product (analysis of the relevance and quality of the data, etc.).
References of the person in charge of the assessment and approval of Part B.
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