China NIFDC Seeks Feedback on Nine Testing Methods for Cosmetics and Toothpaste

1

Skin Absorption: In Vitro Method (Draft)

This method, based on the Test Guideline (TG) 428 by the Organisation for Economic Co-operation and Development (OECD), outlines the fundamental requirements and procedures for in vitro skin absorption testing. It is primarily applicable to cosmetic ingredients composed of a single component. For multi-component ingredients, additional scientific evidence is required to justify the feasibility of applying this method for evaluation.

2

Bovine Corneal Opacity and Permeability (BCOP) Assay (Draft)

This method is developed with reference to OECD TG 437, integrating Chinese domestic laboratory capabilities, equipment availability, and operational considerations. It is designed for evaluating the potential for irreversible eye damage and confirming the non-irritant properties of cosmetic ingredients, applicable to both single substances and mixtures.

3

Collagen Hydrogel—Eye Irritation Test (Draft)

This method specifies the essential principles, requirements, and procedures for conducting an eye irritation test using a collagen hydrogel-based model for cosmetic ingredients. It aims to predict and evaluate whether the tested ingredients cause eye irritation or corrosion.

4

In Chemico Skin Sensitisation: Kinetic Direct Peptide Reactivity Assay (kDPRA) (Draft)

This method presents the fundamental principles, requirements, and procedures for kDPRA. It serves for the toxicological test of cosmetic ingredients, and is suitable for evaluating the potential skin sensitization of single substances, as well as multi-component substances and mixtures with known compositions and contents. 

5

Immunotoxicity Test (Draft)

This method is formulated with reference to S8 Immunotoxicity Studies for Human Pharmaceuticals by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Guideline on Repeated Dose Toxicity by the European Medicines Agency (EMA), etc. It provides the principles, requirements, and procedures for conducting immunotoxicity tests, aiming to assess the likelihood of immunotoxicity reactions in cosmetic ingredients.

6

Li and 42 Kinds of Elements (Draft)

This method specifies the use of Inductively Coupled Plasma Mass Spectrometry (ICP-MS) to measure the concentration of 43 elements in cosmetics and toothpaste. The elements include lithium, beryllium, boron, scandium, vanadium, chromium, manganese, cobalt, nickel, copper, arsenic, selenium, rubidium, strontium, yttrium, zirconium, silver, cadmium, indium, tin, antimony, tellurium, cesium, barium, lanthanum, cerium, praseodymium, neodymium, samarium, europium, gadolinium, terbium, dysprosium, holmium, erbium, thulium, ytterbium, lutetium, mercury, thallium, lead, bismuth, and thorium. 

7

Determination of Total Fluoride in Toothpaste (Draft)

This method specifies the application of gas chromatography for measuring total fluoride content in toothpaste. The existing standard for fluoride testing in toothpaste, GB/T 8372-2017 Toothpaste, has limitations such as lengthy sample preparation, lack of positive confirmation techniques, and the potential damage caused by derivatization reagents to instruments and materials. The new method optimizes these aspects, addressing the shortcomings of the current standard, and filling the gap in fluoride detection within the Safety and Technical Standards for Cosmetics. 

8

Determination of Diethylene Glycol and Glycol in Toothpaste (Draft)

This method is designed to determine the levels of diethylene glycol and glycol in toothpaste using gas chromatography. It utilizes widely accessible analytical techniques commonly used in cosmetic testing laboratories, as well as choosing precise, practical, and operable conditions to ensure both the method's reliability and reproducibility.

9

Test Method for Hard Particles in Toothpaste (Draft)

This method details the testing procedure for hard particles in toothpaste. The standard GB/T 8372-2017 Toothpaste has been the national benchmark for testing hard particles in toothpaste for over 60 years, without any updates to its provisions. The new method builds upon this established standard by refining instrument settings, analytical steps, and result interpretation, ensuring the process is more in tune with current laboratory conditions and available equipment.