The registration of cosmetic products in the European Union (EU) requires compliance with Regulation (EC) No. 1223/2009. This regulation mandates the preparation of a Product Information File (PIF). This document consolidates critical details about the product, including its formulation, safety, and stability. It ensures compliance with EU standards.
Laboratory tests, such as microbiological control, challenge testing, and stability studies, form the foundation of a robust PIF. Before a cosmetic products are included in the EU market, the PIF must be completed by the designated Responsible Person. The PIF consists of six essential sections, including the Cosmetic Product Safety Report (CPSR). This report relies on exhaustive laboratory testing to confirm that the product is safe, stable, and effective under intended use conditions.
To support manufacturers, SHAPYPRO offers three analytical plans. These plans cater to different stages of cosmetic product development and registration. This article focuses on the Standard Plan, a solution specifically designed to assess microbiological safety and accelerated stability. It provides essential data to optimize formulations and predict product shelf life.
Standard Plan Overview
The Standard Plan expands on the Basic Plan, incorporating more advanced analyses. These evaluations ensure that products remain microbiologically safe and stable over time. This plan includes three mandatory tests:
- Cosmetic Microbiological Control (Optional) – Verifies the absence of unwanted microorganisms in formulations. It ensures compliance with microbiological limits outlined in ISO 17516:2014.
- Challenge Test – Evaluates the preservative system’s effectiveness in preventing microbial growth. It guarantees the microbiological stability of the product.
- Cosmetic Accelerated Stability – Predicts the product’s behavior under extreme temperature and humidity conditions within a shortened timeframe. This test provides vital information about shelf life.
This plan is ideal for manufacturers seeking a comprehensive validation of their formulations before launching products. By choosing the Standard Plan, SHAPYPRO ensures manufacturers comply with regulatory standards while maintaining product safety and stability.
Cosmetic Microbiological Control
Microbiological safety is a key aspect of cosmetic product development. Contamination by microorganisms can compromise both product quality and consumer safety. Bacteria, yeasts, or molds may deteriorate formulations, reducing their stability and efficacy. Moreover, microbial contamination can pose health risks, especially in products applied to the skin or mucous membranes.
Regulation (EC) No. 1223/2009 ensures that cosmetic products sold in the EU are safe for consumers. This includes strict microbiological limits. Manufacturers must evaluate potential microbiological contamination and ensure formulations resist harmful microorganism growth throughout shelf life.
As part of the Standard Plan, SHAPYPRO offers optional microbiological control. This process confirms that products meet microbiological quality standards, such as ISO 17516:2014. This standard defines microbiological limits based on product type:
- Stricter requirements apply to items for children under three years old, eye-area products, and those for mucous membranes.
- General-use cosmetics have regulated but more flexible microbiological thresholds.
The analysis starts with sample preparation under aseptic conditions to prevent external contamination. The sample is then inoculated in culture media to detect and quantify microorganisms. The total microbial load is assessed, ensuring it stays within acceptable limits. Additionally, yeast and mold are analyzed to prevent fungal growth, which can affect stability.
Pathogen detection is crucial. Harmful microorganisms like Staphylococcus aureus, Pseudomonas aeruginosa, and Escherichia coli must be entirely absent from cosmetic products.
By conducting microbiological control early, manufacturers can identify contamination risks and take corrective actions. If microbial counts exceed established limits, adjustments can be made to the formulation or manufacturing process to ensure compliance.
Challenge Test
The challenge test evaluates the preservative system’s ability to inhibit microbial growth. This test ensures that the product remains free from contamination during storage and use. SHAPYPRO follows ISO 11930 guidelines to guarantee product protection throughout its shelf life.
The procedure involves intentional inoculation of the product sample with standardized microorganisms, such as:
- Escherichia coli
- Candida albicans
- Pseudomonas aeruginosa
- Staphylococcus aureus
- Aspergillus brasiliensis
- Or ultimately, several microorganisms are being included, such as Burkholderia cepacian, enterobacter gergoviae or Salmonella spp
Samples are then incubated under controlled conditions. Over time, the number of viable microorganisms is analyzed to measure the preservative system’s effectiveness. Results are expressed as logarithmic reductions in colony-forming units (CFUs). The test must meet specific criteria outlined in ISO 11930.
The challenge test is crucial for:
- Ensuring consumer safety by verifying that the preservative system works effectively.
- Validating microbiological stability to prevent contamination risks during manufacturing, transportation, or use.
- Optimizing preservative concentrations to maintain safety while avoiding irritation or toxicity.
With this test, SHAPYPRO helps manufacturers meet high cosmetic safety and quality standards.
Cosmetic Accelerated Stability
A cosmetic product’s stability affects its safety, efficacy, and market acceptance. If a product degrades before its expiration date, it may:
- Lose effectiveness
- Alter in texture, color, or scent
- Pose potential health risks
The accelerated stability test, included in SHAPYPRO’s Standard Plan, predicts product behavior over a shorter period. It does this by exposing samples to extreme environmental conditions.
This method is based on the Arrhenius principle, which states that higher temperatures accelerate chemical and physical reactions. By simulating aging, it detects potential formulation changes without waiting months or years.
Samples are stored at:
- 40°C ± 2°C temperature
- 75% ± 5% relative humidity
- 90-day period with evaluations every 30 days
Throughout the test, various critical parameters are analyzed, including:
- Viscosity
- pH levels
- Appearance
- Texture compatibility with packaging
The accelerated stability test helps manufacturers:
- Identify formulation weaknesses early
- Predict product shelf life
- Reduce the risk of recalls
- Ensure compliance with regulatory requirements
Why Choose SHAPYPRO?
Choosing SHAPYPRO means working with a strategic partner that combines:
- Scientific precision
- Regulatory compliance
- A highly specialized team
Our services help manufacturers reduce risks and enhance consumer confidence. With SHAPYPRO, your product benefits from high-quality testing and reliable results, ensuring success in a competitive market.