China Cosmetics Safety Assessment: Key Insights on Packaging Compatibility Testing

On July 8, 2024, the National Institutes for Food and Drug Control (NIFDC) released the “Technical Guidelines for Compatibility Testing and Assessment of Cosmetics with Packaging Materials” to advance comprehensive safety assessments for cosmetics. These new guidelines detail the requirements, testing procedures, and evaluation methods for ensuring that packaging materials, that come into direct contact with cosmetics, are safe and compatible.

Understanding Compatibility

According to the Guidelines, “compatibility” refers to the interaction between cosmetic products and their packaging. Any interaction should not cause unacceptable changes to either the cosmetic or the packaging. The guidelines emphasize that materials in direct contact with cosmetics must be safe, non-reactive, and free from releasing harmful substances into the product.

Focuses on Compatibility Testing

Physical Compatibility: Assesses whether the cosmetic product and packaging experience any physical changes, such as cracking, absorption, precipitation, or leakage, under different temperature conditions (e.g., high, low, or room temperature).
Chemical Compatibility: Examines whether any chemical reactions occur between the cosmetic and the packaging, such as changes in color, smell, pH, or product separation.
Biological Compatibility: Investigates whether potentially harmful substances from the packaging could migrate into the cosmetic product. This is a critical part of the research that requires specialized testing to ensure safety.

How to Conduct Compatibility Studies

To perform these assessments effectively, the guidelines recommend the following steps:

Collect Data: Identify packaging materials and containers that will come into direct contact with the cosmetic product. Analyze their composition, the nature of their interaction with the product, and relevant manufacturing details.
Perform Extraction Tests: Use suitable solvents to test for extractable substances from the packaging. This helps predict potential leachables that might migrate into the product.
- Solvent Choice: Choose solvents that closely mimic the properties of the cosmetic product, considering factors like pH and polarity.
- Testing Conditions: Use accelerated conditions, such as higher temperatures, to extract as many substances as possible from the packaging.
Conduct Interaction Studies: Include both migration and adsorption tests to measure how much, if any, of the packaging’s components migrate into the product under different conditions, and to ensure no harmful reactions occur.

When conducting migration tests, it is necessary to design targeted experimental protocols based on the type of packaging material and the type of cosmetic product. Below are the key concerns for commonly used packaging categories:

Cosmetic Packaging Material Category	Key Points of Concern in Migration Tests
Plastic	Migration of residual monomers, additives, and their degradation products.
Glass	– Release of alkaline ions affecting cosmetic pH. – Migration of harmful elements. – Migration of additives in tinted glass with light-blocking properties. – Integrity of internal coatings/films, including migration of additives contained in the coatings/films;
Metal	– Migration of metal ions. – Corrosion of metal by cosmetic contents. – Integrity of metal coating before and after testing, including migration of additives in the coating.
Rubber	– Migration of residual monomers, additives, and degradation products. – For rubber parts with coatings/films, integrity of the film and migration of additives within the film.
Ceramic	– Migration of harmful elements from ceramic glaze. – For ceramic containers with internal coatings/films, integrity of the film and migration of additives.
Film Cloth	Migration of additives such as fluorescent brighteners.
Capsule Shells	Migration of additives such as colorants.
Others	Design migration test protocols based on the above concerns to assess compatibility with cosmetics.

Comprehensive Analysis:
- Data Evaluation: Analyze the types and concentrations of substances identified during the extraction and migration tests.
- Compound Identification: Conduct necessary chemical categorization or structural identification of the Leachables.
  - Compliance Check: Ensure that substances meet any existing limits as outlined in the Technical Guidelines Concerning Cosmetics Safety Assessment. For substances without specified limits, perform a safety assessment.
- Integrated Evaluation: If necessary, combine the results from stability tests to holistically assess the interaction between the cosmetic product and its packaging.

Simplified Compatibility Evaluation Criteria

The guidelines also highlight scenarios where compatibility evaluations can be streamlined:

Use of Existing Data: If a new cosmetic product has a similar formulation and is packaged using the same material from the same source, registrants and notifiers can base their compatibility evaluations on prior data, provided they offer clear justifications for doing so.

Accepted Evidence Choice

According to the Q&A published by the National Institutes for Food and Drug Control (NIFDC), when selecting packaging materials for cosmetics, companies can evaluate the compatibility between cosmetics and packaging based on the actual conditions such as the ingredients and risk level of the cosmetics. The assessment methods include but are not limited to:

Assessment Methods:

Simulant Studies: Use appropriate simulant solutions for leachable studies.
Historical Safety Data: Refer to previously conducted safety assessments and reports for similar products.
Cross-referenced Reports: Utilize compatibility studies conducted under food or pharmaceutical standards or company-specific methods.
Supplier Data: Include data or declarations from packaging suppliers or quality control reports.
Stability Test Results: Integrate findings from stability tests as part of a comprehensive safety evaluation.

Cosmetic companies can use one or more of the methods above to evaluate product-packaging compatibility.

REACH24H Take-Home Tips

Diverse Data Collection:
- Extractable/leachable tests,
- Historical safety data of similar products and proven industry practices,
- Supplier data/report.
Comprehensive Test Protocol:
- Compatibility studies conducted under food or pharmaceutical standards,
- Compatibility studies conducted with company-specific methods,
- Compatibility studies combined with stability test.
Regulatory Adherence: Ensure results meet regulations and standards.

Why Trust REACH24H’s Expertise

At REACH24H, we have helped over 1,000 cosmetic companies worldwide achieve compliance. Our innovative regulatory solutions set us apart in the industry. For any questions, contact us at customer@reach24h.com.