According to point 7 “safety assessment of cosmetic products” of the “Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)”, we can know that compared to the simplified version of the safety assessment, the full version of the safety assessment adds 2 assessment project requirements. The specific evaluation recommendations are as follows.
1. Product Physical and Chemical Stability Evaluation
1.1 Relevant physical and chemical indicators should be evaluated based on the specific conditions of the product to determine the stability of the product and ensure the stable quality of each batch of cosmetics on the market. Generally, the following parameters are included:
(1) Physical state;
(2) Dosage form (emulsion, powder, etc.);
(3) Sensory characteristics (color, smell, etc.);
(4) pH value (under what temperature conditions);
(5) Viscosity (under what temperature conditions);
(6) Other aspects according to specific needs.
1.2 Confirm whether there are chemical and/or biological interactions between raw materials and consider potential safety risks arising from interactions. If there are potential safety risks, the assessment should be carried out in conjunction with relevant literature research data or physical and chemical experimental data.
1.3 Evaluate the physical and chemical stability of containers or carriers in direct contact with the contents and their compatibility with the product. The stability of the container can be evaluated by referring to the packaging or carrier supplier’s safety information or safety statement.
1.4 For cosmetics with similar formula systems and the same packaging materials, the physical and chemical stability can be evaluated based on existing information and experimental data, but the reasons should be explained and the situation should be explained.
1.5 How to understand material stability and packaging material compatibility
1.5.1 Stability studies: designed to evaluate the ability of a product to maintain desired physical, chemical and microbiological properties as well as functional and sensory properties when stored and used by consumers under appropriate conditions.
More simply, the purpose of a stability study is to determine the shelf life of a product and to assess whether the product in the package is stable under the market conditions in which it is sold and used. “Market conditions” include conditions during distribution (transportation), warehouse storage and use. Therefore, stability studies can be considered as a prerequisite for ensuring product quality. Cosmetics need to be tested for stability.
1.5.2 Packaging material compatibility: If the inner packaging material has been determined, it can be conducted in parallel with the stability test under the same conditions to verify the possible interaction between the product and the packaging materials in direct contact, mainly including physical compatibility properties, chemical compatibility and biocompatibility, such as absorption, migration, corrosion and other phenomena that may affect product performance.
1.6 Reference Standards of Stability and Compatibility
1.6.1 Relevant Foreign Standards That Can Be Referred to:
(1) International Organization for Standardization ISO/TR 18811-2018 “Cosmetics – Guidelines on thestability testing of cosmetic products”
(2) CTFA/Colipa “Guidelines on Stability Testing of Cosmetic Products”
(3) PCPC “Guideline for lndustry – The Stability Testing of Cosmetics”
1.6.2 Relevant Domestic Standards That Can Be Referred to
(1) T/SHFCA 002-2021 “Guiding Principles for Stability Testing of Cosmetics”
(2) T/GDCQMA 002-2023 “Cosmetic Stability Test Specifications”
2. Product Microbiological Evaluation
2.1 Microbial contamination of cosmetics usually comes from the introduction of raw materials, product preparation and filling processes, and consumer use. Children’s cosmetics and eye/lip cosmetics should pay special attention to microbial contamination.
2.2 For cosmetics in the research and development stage, the effectiveness of their preservative systems can be evaluated with reference to internationally accepted standards or methods.
2.3 For products with the same anti-corrosion system and similar formulas, existing information and experimental data can be referred to for product safety evaluation. According to product characteristics, they are products that are not susceptible to microbial contamination, that is, non-aqueous products, products based on organic solvents, and aqueous products such as water activity <0.7, ethanol content >20% (volume), high/low pH value (≥10 Or ≤3), products with a filling temperature higher than 65°C, products that are disposable or whose packaging cannot be opened, etc. These products do not need to be evaluated for antiseptic effectiveness, but the cosmetics safety assessor should explain the relevant situation.
2.4 How to Understand Anti-corrosion Challenges
2.4.1 Anti-corrosion challenge: Anti-corrosion challenge test is an important item in cosmetics testing. This method is to add a certain amount of representative microorganisms to cosmetics to simulate the potential possibility of high-intensity microbial contamination during the production and use of cosmetics and the optimal conditions for microbial growth in nature. After the samples were cultured for a certain time, the number of microorganisms in the samples were tested respectively, and the anti-corrosion efficacy of cosmetics was evaluated according to the change of the number of microorganisms in the samples.
2.4.2 Anti-corrosion Challenge Standard Reference
(1) United States Pharmacopeia USP 40. <51> Antimicrobial Effectiveness Testing;
(2) European Pharmacopoeia EP <9.0> 5.1.3 Efficacy of Antimicrobial Preservation;
(3) American Personal Care Products Association PCPC 2016. Microbiology Guidelines;
(4) International Organization for Standardization ISO 11930-2019 Cosmetics-Microbiology-Evaluation of the antimicrobial protection of a cosmetic production;
(5) T/SHRH 017-2019 “Cosmetic Anticorrosion Challenge Test”.
