T/ZYNY 003-2025 Technical Specifications for the Quality of External Skin Products
T/ZYNY 003-2025
Basic Information
Scope
Scope: This specification applies to various external products directly applied to, adhered to, or sprayed on the human skin surface for non-medical diagnostic and treatment purposes, including moisturizers, creams, serums, gels, ointments, patches, sprays, and other common dosage forms, for the purposes of skincare, preventing or alleviating skin discomfort, etc. Main Technical Content: V. Raw Material and Auxiliary Requirements 1. Natural Raw Materials: Plant extracts and animal-derived raw materials shall be of clear and traceable sources, and their extraction processes shall comply with clean production requirements to ensure no pesticide residues, excessive heavy metal content, or harmful microbial contamination. The quality of the extracts shall meet the corresponding industry or enterprise internal control standards, and the active ingredient content of plant extracts shall be within the prescribed range. 2. Chemically Synthesized Raw Materials: The purity shall meet the standards for pharmaceutical or cosmetic grade, with impurity content controlled within safe limits that do not affect efficacy. The production process shall follow good manufacturing practices, have a stable synthesis process and quality control procedures. 3. Mineral Raw Materials: They shall undergo fine screening and purification treatment to ensure that the content of heavy metals (such as lead, mercury, arsenic, etc.) is far below the threshold that endangers human health, comply with the Cosmetics Safety Technical Regulations, and have stable physicochemical properties with no irritation to the skin. Auxiliary Materials: 1. Emulsifiers: They shall have good emulsifying performance, enable stable mixing of oil-water systems, be non-toxic and non-irritating, and not deteriorate during the product shelf life. Common emulsifiers such as cetyl stearyl ethanolate - 20 shall meet the quality standards for food or cosmetic auxiliary materials. 2. Preservatives: Given that externa