The registration of cosmetic products in the European Union (EU) requires compliance with Regulation (EC) No. 1223/2009, which mandates the preparation of a Product Information File (PIF). This essential document consolidates critical information about the product, including its formulation, safety, and stability, ensuring conformity with EU standards. Laboratory tests, such as microbiological control, patch testing, challenge testing, and stability studies, form the foundation of a robust PIF.
Before a cosmetic product can enter the EU market, the PIF must be completed by the designated Responsible Person. This file includes six critical sections, among them the Cosmetic Product Safety Report (CPSR), supported by thorough laboratory testing. These evaluations ensure the product is safe, stable, and effective under intended conditions of use, protecting both consumers and manufacturers from regulatory risks.
Aware of these demands, SHAPYPRO offers three laboratory testing plans designed to meet the needs of cosmetic manufacturers at different stages of product development and registration. This article focuses on the Basic Plan, a solution specifically tailored to address fundamental initial evaluation needs, ensuring that cosmetic products are safe, stable, and compliant with regulations.
The Basic Plan by SHAPYPRO is designed to cover the most essential aspects of the initial evaluation of cosmetic products. It includes three key tests: screening, which identifies potential formulation instabilities; patch testing, which assesses the product’s compatibility with the skin; and challenge testing, which verifies the effectiveness of the preservative system. These tests form a solid foundation for developing a safe and stable product.
Screening for Cosmetic Products
The stability of a cosmetic product is a critical factor in ensuring that it maintains its physical, chemical, and microbiological properties throughout its shelf life. Stability not only guarantees consumer safety but also preserves the product’s quality and effectiveness from production to final use. Stability studies predict the behavior of products under various storage, transport, and usage conditions. SHAPYPRO, committed to the highest international standards such as ISO 21148:2017 and ISO/TR 18811:2018, offers a comprehensive evaluation through three levels of testing: screening, accelerated stability, and long-term stability. This integrated approach addresses potential issues in early stages and evaluates product performance under normal storage conditions.
Screening is the initial phase in stability studies, aiming to identify potential formulation instabilities before final packaging. This stage is crucial as it allows for the detection and correction of issues early in product development, optimizing the formulation before investing in advanced testing or large-scale production.
Screening tests subject products to extreme conditions to evaluate their resistance to external factors, such as temperature variations, mechanical stress, and exposure to light and heat. The results provide a preliminary understanding of how the product will respond to market demands and environmental conditions.
The screening tests include:
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Freeze-thaw cycles
Products are subjected to extreme temperature fluctuations, simulating abrupt environmental changes during transport or storage. These cycles involve alternating between -5°C and 25°C or 4°C and 40°C over 24 hours, repeated for 3 to 6 cycles. This process evaluates physical stability by detecting phase separation or texture changes.
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Mechanical stress
By centrifuging at 3000 rpm for 30 minutes, the resistance of products to mechanical forces during distribution is tested. This is critical for products such as emulsions and gels, which require stability in consistency.
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Light exposure
Products are exposed to natural light to evaluate their susceptibility to oxidation and degradation. A control sample is protected from light for comparison, enabling the identification of color or texture changes that could impact consumer acceptance.
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Thermal stress
Samples are exposed to high temperatures (50°C–80°C) for 72 hours. This test assesses the chemical resistance of components to heat, ensuring product stability even in hot climates.
Screening not only allows for the early identification of potential issues but also significantly reduces the costs associated with product development by preventing late-stage formulation adjustments. Through these preliminary tests, SHAPYPRO helps manufacturers optimize their formulations and proceed confidently to subsequent stages of development.
Challenge Test for Cosmetic Products
The challenge test is a crucial evaluation for determining the effectiveness of the preservative system in cosmetic products. Its main objective is to verify whether the added preservatives can prevent microbial growth during storage and product use. SHAPYPRO performs these tests according to ISO 11930 guidelines, ensuring the product remains microbiologically stable throughout its shelf life.
The procedure begins with the intentional inoculation of the product sample with standardized strains of microorganisms, such as Escherichia coli, Candida albicans, and Pseudomonas aeruginosa. These samples are incubated under controlled conditions, and the number of viable microorganisms is analyzed at intervals of 7, 14, and 28 days. The results are expressed as logarithmic reductions in colony-forming units (CFUs) and must meet specific criteria established by the guidelines.
This approach identifies potential deficiencies in the preservative system and enables manufacturers to adjust the formulation if necessary. The challenge test not only ensures consumer safety but also validates the microbiological stability of the product during manufacturing, transport, and use.
Patch Test for Cosmetic Products
Skin tolerance is a fundamental aspect of cosmetic product safety, ensuring that products do not cause irritation or allergic reactions in consumers. The patch test is a standard method for evaluating a product’s compatibility with different skin types.
The procedure involves applying small amounts of the product onto adhesive patches placed on the skin of human volunteers, typically on the back, due to its uniformity and sensitivity. These patches contain multiple chambers, allowing for the
simultaneous testing of various formulations or concentrations. After 48 hours, the patches are removed, and the skin is evaluated for signs of irritation, such as redness, swelling, or peeling. A second evaluation at 72 hours confirms the results, as some reactions may develop over time.
These tests verify the product’s safety for normal skin and allow specific evaluations on panels of individuals with sensitive skin. Additionally, the results of the patch test support claims such as “suitable for sensitive skin” or “dermatologically tested,” enhancing consumer trust in the brand.
The Basic Plan by SHAPYPRO is designed to address the most critical aspects of initial cosmetic product evaluation. Over 35 structured days, essential tests like the challenge test and patch test are performed to ensure the product’s safety, stability, and regulatory compliance. The results are consolidated into a final report that supports the development of a robust Product Information File (PIF), meeting European regulatory requirements.
Why Choose SHAPYPRO?
Choosing SHAPYPRO means partnering with a trusted ally that combines scientific precision, regulatory compliance, and a highly specialized team. Our services are tailored to optimize each phase of cosmetic development, reducing risks and ensuring consumer confidence. With SHAPYPRO, your product will be backed by high-quality testing and reliable results, ensuring success in a highly competitive market.