China: NIFDC Announces New Technical Guidelines for Cosmetic Stability, Preservative Challenge, and Packaging Compatibility Testing and Evaluation

The National Institutes for Food and Drug Control (NIFDC) formulated three new technical documents to facilitate the industry in cosmetic safety assessment and standardize an orderly implementation of the assessment system. The technical guidelines including:

• Technical Guidelines for Cosmetic Stability Testing and Evaluation

• Technical Guidelines for Challenge Testing and Evaluation of Cosmetic Preservatives

• Technical Guidelines for Compatibility Testing and Evaluation of Cosmetics and Packaging Materials

i)  Technical Guidelines for Cosmetic Stability Testing and Evaluation

Cosmetics manufacturers must conduct stability tests as part of the regulatory requirements during China's registration and notification procedures. The tests include accelerated tests, influencing factor tests, and long-term tests. Manufacturers must record all findings in the safety assessment report and include them together in the registration dossier. These detailed reports are proof that cosmetics products are qualified to be marketed

Test Requirements:

• Test Samples – conduct stability tests on at least one batch of samples that are equivalent to the post-marketing cosmetics in terms of production procedures, formulation, and packaging.

• Pilot Projects – stability tests should accurately represent the cosmetic’s characteristics and include details tailored to the products’ specifications.

• Test Frequency – Frequency is set based on the test item with a comprehensive explanation provided.

ii) Technical Guidelines for Challenge Testing and Evaluation of Cosmetic Preservatives

This guidance advises manufacturers to perform antiseptic efficacy testing on cosmetics products. Additionally, anti-corrosion efficacy evaluation tests are required to ensure a robust preservative level of the products. The findings later must be attached to the registration dossier to support product registration in China.

Additionally, manufacturers are provided with two testing options: outsourcing and in-house testing. Each method offers distinct benefits. Outsourcing to third-party labs can reduce costs, while in-house testing allows manufacturers to maintain stronger control over the testing procedures.

Test Requirements & Methods needed are:

• Anti-corrosion Efficacy Evaluation Test

• Anti-corrosion Challenge Test

• Essential Equipment and Materials

• Microbial Testing and Strain Preparation

• Compliance and Reporting
  

iii) Technical Guidelines for Compatibility Testing and Evaluation of Cosmetics and Packaging Materials

To ensure a thorough compatibility evaluation, manufacturers must systematically assess extractable and leachable data, including physical and chemical properties, product forms, formulas, process conditions, and packaging materials, and present these findings in a comprehensive report.

Test Methods: Extraction Test, Interaction Studies

Test Requirements: Packaging Materials, Evaluation Criteria

Source: National Institute for Food and Drug Control (NIFDC)

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