化妆品安全技术规范. Safety and Technical Standards for Cosmetics. Translated by Chemlinked. China Food and Drug Administration (CFDA)

Transcription

1 Safety and Technical Standards for Cosmetics 化妆品安全技术规范 China Food and Drug Administration (CFDA) Translated by Chemlinked Release Date 2015/12/23 Implementation Date 2016/12/01

2 Disclaimer This is an unofficial document provided by ChemLinked (chemlinked.com/en/), a division of REACH24H Consulting Group, as an informational service to assist non-chinese companies. This document should only be used as a reference and in case of any discrepancy between the English and Chinese versions the original Chinese version shall prevail. ChemLinked is a unique portal to must-know Asia Pacific Chemical, Cosmetic, Food, Agrochemical regulatory issues. Nondisclosure: You may not disclose this document to anyone else without the written permission of ChemLinked. For further clarification and questions, please contact us: contact@chemlinked.com

3 Content CHAPTER 1 OVERVIEW CHAPTER 2 PROHIBITED/RESTRICTED INGREDIENTS USED IN COSMETICS PROHIBITED INGREDIENTS USED IN COSMETICS (1) (2) (LIST 1) PROHIBITED PLANT/ANIMAL INGREDIENTS USED IN COSMETICS (1) (2) (3) (LIST 2) RESTRICTED INGREDIENTS USED IN COSMETICS (LIST 3) CHAPTER 3 PERMITTED INGREDIENTS USED IN COSMETICS (1) (LIST 4) PERMITTED PRESERVATIVES USED IN COSMETICS (1) (LIST 4) PERMITTED SUNSCREENS USED IN COSMETICS (1) (LIST 5) PERMITTED COLORANTS USED IN COSMETICS (1) (LIST 6) PERMITTED HAIR DYES USED IN COSMETICS (1)(2) (LIST 7) CHAPTER 4 PHYSICAL AND CHEMICAL TESTING METHODS FOR COSMETICS GENERAL PRINCIPLES PH Mercury Lead Arsenic Cadmium Li and 36 kinds of elements Nd and 14 kinds of elements Ethanolamine and other 4 materials Test in votro of protection against UVA TESTING METHODS OF PROHIBITED INGREDIENTS Fluconazole and other 8 materials Minocycline hydrochloride and other 6 kinds of material Enoxacin and other 9 materials Estriol and the Other 6 Materials Minoxidil and other 6 kinds of material Methyl coumarin

4 2.7 8-methoxypsoralen and other 3 materials Psoralen and other 3 materials Aminoazobenzene and Benzidine Biphenyl-4-ylamine and its salts Acid Yellow 36 and other 4 materials α-chlorotoluene Aminocaproic Acid Cantharidin Benzo [а] pyrene Acrylamide Chlormethine Desloratadine and other 14 kinds of components Dioxane Diethylene glycol Ethylene oxide and Methyloxirane Methanol IV 2.23 Procainamide and other 6 kinds of components VI 2.24 Diethyl maleate Minoxidil Hydroquinone and phenol Asbestos Tretinoin and Isotretinoin Vitamin D2 and Vitamin D Dimethylphthalate and 9 kinds of material Dibutylphthalate and 7 kinds of components Dichloromethane and other 14 kinds of components Ethanol and other 36 kinds of components TESTING METHODS OF RESTRICTED INGREDIENTS α-hydroxy Acid Selenium Disulfide Hydrogen peroxide Resorcinol Soluble zinc salt Quinine

5 3.7 Boric Acid and Borate Oxyquinoline Thioglycollic Acid Salicylic acid Musk ketone Free Hydroxide Total Selenium TESTING METHODS OF PRESERVATIVES Benzyl alcohol Benzoic acid and sodium benzoate Phenoxyisopropanol Benzalkonium chloride Benzethonium chloride, Ammonium chloride and Cetalkonium Chloride Formaldehyde Chloromethyl Isothiazolinone and Other 11 kinds of Components Chlorphenesin Triclocarban Sorbic Acid and Dehydroacetic Salicylic acid and other 4 components TESTING METHODS OF SUNSCREENS Phenylbenzimidazole Sulfonic Acid and Other 14 Kinds of Components Denzophenone Titanium dioxide Diethylamino Hydroxybenzoyl Hexyl Benzoate Diethylhexyl butamido triazone Benzylidene camphor sulfonic acid Zinc oxide TESTING METHODS OF COLORANTS Basic orange 31 and other 6 kinds of components Colorant CI and other 9 kinds of components TESTING METHODS OF HAIR COLORANTS p-phenylenediamine and other 7 kinds of components p-phenylenediamine and Other 31 Kinds of Components

6 CHAPTER 5 METHODS OF MICROBIOLOGICAL TEST GENERAL PRINCIPLES AEROBIC BACTERIAL COUNT THERMOTOLERANT COLIFORM BACTERIA PSEUDOMONAS AERUGINOSA STAPHYLOCOCCUS AUREUS MOLDS AND YEAST COUNT CHAPTER 6 METHODS OF TOXICOLOGICAL TEST GENERAL PRINCIPLES ACUTE ORAL TOXICITY TEST ACUTE DERMAL TOXICITY TEST DERMAL IRRITATION/CORROSION TEST ACUTE EYE IRRITATION/CORROSION TEST SKIN SENSITISATION TEST SKIN PHOTOTOXICITY TEST SALMONELLA TYPHIMURIUM/REVERSE MUTATION ASSAY IN VITRO MAMMALIAN CELLS CHROMOSOME ABERRATION TEST IN VITRO MAMMALIAN CELL GENE MUTATION TEST IN VIVO MAMMALIAN BONE MARROW CELL CHROMOSOME ABERRATION TEST MAMMALIAN ERYTHROCYTE MICRONUCLEUS TEST TESTICLE CELLS CHROMOSOME ABERRATION TEST SUBCHRONIC ORAL TOXICITY TEST SUBCHRONIC DERMAL TOXICITY TEST TERATOGENICITY TEST COMBINED CHRONIC TOXICITY / CARCINOGENICITY TEST CHAPTER 7 HUMAN BODY SAFETY TESTING METHOD GENERAL PRINCIPLES HUMAN SKIN PATCH TEST SAFETY EVALUATION OF USING TESTS OF COSMETICS ON HUMAN BODY CHAPTER 8 HUMAN BODY EFFICACY EVALUATION TESTING METHOD

7 1 GENERAL PRINCIPLES DETERMINATION METHODS OF SUN PROTECTION FACTOR (SPF) * DETERMINATION METHODS OF SUNSCREEN WATER RESISTANT PERFORMANCE * DETERMINATION METHODS FOR PFA OF SUNSCREEN COSMETICS

8 Chapter 1 Overview 1. Scope This standard specifies the technical safety requirements, including the general requirements, restricted and forbidden ingredients, and test and evaluation methods. This standard applies to all the cosmetics that are manufactured and operated in the People s Republic of China, except those only for sale abroad. 2. Terms and definitions This standard adopts the following terms and definitions: 1.1 Cosmetic ingredient: ingredient used in the cosmetics formula. 1.2 New cosmetic ingredient: natural or synthetic ingredient that are used in the cosmetic production for the first time in China. 1.3 Prohibited ingredient: substance forbidden to use in cosmetics 1.4 Restricted ingredient: substance that can be used in cosmetics under certain conditions. 1.5 Preservative: ingredient added in cosmetics to restrain the growth of the microbes. 1.6 Sunscreen: ingredient added in cosmetics to protect the skin from being harmed by specific ultraviolet ray by absorbing, reflecting and scattering the sunlight. 1.7 Coloring agent: ingredient added in cosmetics to present certain colors by absorbing and reflecting the light. 1.8 Hair dyeing agent: ingredient added in cosmetics to change the color of the hair by absorbing and reflecting the light. Hair dyes in Annex 2 List 6 are excluded. 1.9 Rinse-off cosmetics: cosmetics should be washed off after use on human surface (skin, hair, fingernail, lip and so on).

9 2.10 Leave-on cosmetics: cosmetics other than rinse-off cosmetics Eye cosmetics: cosmetics used on the skin around the eye and eyelash Lip cosmetics: cosmetics used on the lip Body cosmetics: cosmetics used on the body skin, excluding the head skin Skin cosmetics: cosmetics used on the skin Children cosmetics: cosmetics for children Professional use: should be operated by trained professionals Packaging materials: materials that directly contact the cosmetic ingredients or cosmetics containers Safety risk materials: materials having potential risks to human health that are brought in with the cosmetic ingredients or packaging materials or are generated during the production, transportation and storage. 3. General safety standards of cosmetics 3.1 General requirements All cosmetics should go through safety risk assessment to ensure they do not have adverse effect to human health under normal, appropriate and foreseeable use conditions Manufacture of cosmetics should comply with Hygienic Standard for Production Enterprises of Cosmetics. The manufacturing techniques applied should be scientific and reasonable and should guarantee the product safety.

10 3.1.3 All cosmetics should go through relevant necessary tests before entering the market. The test methods include physical-chemical testing methods, microbiological testing methods, toxicological testing methods and human safety trials Cosmetics shall comply with standards pertaining to product quality and safety. Cosmetics shall pass the quality inspection before leaving the factory. 3.2 Requirement on product formula Cosmetic formula shall not contain the prohibited ingredients included in the List 1 and 2 of chapter 2. If some prohibited substances are present in cosmetics as impurities, which during the production process cannot be technically avoided, the content shall not exceed the limitation specified in relevant national standards; in case of lacking relevant national standards, safety risk assessment should be carried out to ensure the product will not cause adverse effects to human health under normal, appropriate and foreseeable use conditions If any ingredient of the product formula is included in the List 3 of chapter 2 Restricted ingredients in Cosmetics. The use shall meet the requirement specified in the list Preservatives, sun-screening agents, coloring agents and hair dyes in product formula shall be listed in list 4-7 of chapter 3, and shall meet the use requirements specified in the lists. 3.3 Requirements on the microbiological indicators: The microbiological test data of cosmetics should meet the limitation specified in Table 1 Table 1 Limitation of microbiological indicators in cosmetics