Thursday, 01 August 2024 / Published in Cosmetics, News

Cosmetic Packaging Compatibility Testing Guidelines Released

Cosmetic Packaging Compatibility Testing Guidelines were released by the National Institutes for Food and Drug Control (NIFDC) on July 8, 2024, as part of a significant regulatory update aimed at standardizing safety evaluation practices for cosmetics. The release aligns with the existing regulatory framework established by the “Cosmetics Supervision and Administration Regulation” and the “Cosmetics Safety Evaluation Technical Guidelines (2021 Edition).” The announcement contained 3 annexes; this article focuses on: Annex 3: Technical Guidelines for Cosmetic Packaging Compatibility Testing.

Refer to our other articles on:

Annex 1: Technical Guidelines for Cosmetics Stability Testing

Annex 2: Technical Guidelines for Cosmetic Challenge Testing

The guidelines in “Annex 3: Technical Guide for Compatibility Testing and Evaluation of Cosmetics and Packaging Materials” are mandatory for the registration or notification of cosmetic products in China. Adherence to these guidelines is essential for obtaining approval from the China National Medical Products Administration (NMPA) for cosmetic products intended for the Chinese market.

Description:

Cosmetics registrants may use national standards, technical specifications, industry standards, international standards, this guideline, or self-built methods for relevant research and include these findings in the safety assessment report.

Scope:

The guidelines outline the requirements, methods, and result evaluation criteria for the compatibility testing of cosmetics and packaging materials.

Terms and Definitions:

Extractables: Substances that can be extracted from cosmetic packaging materials by solvents, including additives, residual monomers, and degradation products.
Leachables: Substances that migrate from packaging materials into cosmetics during migration tests.

Test Requirements:

Packaging Materials: Must be safe and free from harmful chemical reactions with cosmetics. Compatibility studies should ensure no safety risks from interactions between cosmetics and packaging materials.
Evaluation Criteria: Compatibility studies must assess whether packaging materials interact with cosmetics in a way that could impact product safety and quality.

Test Methods:

Extraction Test: Conducted using solvents to obtain extractables and predict potential leachables. The solvent should mimic the physical and chemical properties of the cosmetics.
Interaction Studies: Includes migration and adsorption tests under accelerated and long-term conditions to assess the migration of ingredients and any reactions.

Plastic: Test for residual monomers, additives, and degradation products.
Glass: Assess alkaline ion release, harmful element migration, and coating integrity.
Metals: Test for metal ion migration, corrosion, and coating integrity.
Rubber: Similar to plastics, focusing on films and additive migration.
Ceramic: Assess harmful element migration from glazes and coating integrity.
Membrane Cloth and Capsule Shell: Test for additives such as fluorescent brighteners and colorants.
Miscellaneous: Design migration tests based on material concerns.

Outcome Evaluation:

Cosmetic manufacturers must conduct a systematic analysis of extractables and leachables data, considering physical and chemical properties, product forms, formulas, process conditions, and packaging materials, to provide a comprehensive evaluation basis and conclusions in a compatibility evaluation report.

Impact for cosmetic manufacturers:

Mandatory Compliance: Companies must conduct cosmetic packaging compatibility tests as part of the registration and notification process for cosmetic products in China. This includes extraction tests and interaction studies to ensure the products’ quality and safety over time.

Documentation Requirements: Detailed test reports and cosmetic packaging compatibility testing evaluation results must be included in the registration dossier. These reports should demonstrate that the product maintains its intended quality under specified storage conditions.

Regulatory Approval: Without adherence to these compatibility testing requirements, companies cannot successfully register or notify their cosmetic products in China. This regulatory approval is crucial for legal market entry and continued product distribution in the region.

Quality Assurance: Ensuring product compatibility through these tests helps in maintaining high standards of quality and consumer safety, which is a key concern for regulatory authorities.

Safety Assessment Report: The findings from cosmetic packaging compatibility tests must be integrated into the safety assessment report, which is a critical component of the registration and notification submission.

In summary, conducting these cosmetic packaging compatibility tests is not only a regulatory requirement but also a critical aspect of ensuring that cosmetic products are safe, effective, and reliable throughout their shelf life in the Chinese market. Compliance with these guidelines is essential for successful product registration and market access in China.