GB/T 42763-2023Guideline for safety assessment of oral care and cleansing products (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents" drafting: Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents: This document is proposed by China National Light Industry Council: This document is under the jurisdiction of the National Oral Care Products Standardization Technical Committee (SAC/TC492): This document was drafted by: Heilongjiang Academy of Light Industry Science, Beijing Procter & Gamble Technology Co:, Ltd:, Shanghai Mega Clean Daily Chemical Co:, Ltd:, Wei Meizi Industrial (Guangdong) Co:, Ltd:, Lion Daily Chemicals (Qingdao) Co:, Ltd:, Jiangxi Chengzhi Daily Chemicals Co:, Ltd:, Chongqing Dengkang Dental Nursing Products Co:, Ltd:, Zhongshan Duomei Chemical Co:, Ltd:, Nice Group Co:, Ltd:, Suzhou Qingxin Health Technology Co:, Ltd:, Liuzhou LMZ Co:, Ltd:, Infinitus (China) Co:, Ltd:, Haolai Chemical (Zhongshan) Co:, Ltd:, Huaian Zongheng Biotechnology Co:, Ltd: Huaiyin Branch of the company, Guangdong Jiuke Biotechnology Co:, Ltd:, Guangzhou Qiancai Cosmetics Co:, Ltd:, Yunnan Baiyao Group Health Products Co:, Ltd:, Suzhou Jinmao Daily Chemicals Co:, Ltd:, Hoyikang Biotechnology (Guangzhou) Co:, Ltd:, Dandong Kangchiling Toothpaste Co:, Ltd: Division, Unilever (China) Co:, Ltd:, Johnson & Johnson (China) Co:, Ltd:, Guangzhou Institute of Quality Supervision and Inspection, Fujian Aijieli Daily Chemical Co:, Ltd: company: The main drafters of this document: Sun Dongfang, Wang Ying, Zheng Wei, Shi Yilei, Chen Minshan, Liu Jing, Xu Haiyan, Dong Haide, Lei Xiquan, Peng Yan, Mao Jianlin, Hu Yongzhi, Gao Yan, He Qiying, Da Chengzhu, Jiang Shan, Xu Chunsheng, Zhang Zhiwei, Chen Jianfen, Li Yiping, Cao Ning, Li Xinyu, Le Ying, Li Xuan, Zhang Xiuying, Li Yiqing, Chen Wanjin: Guidelines for Safety Assessment of Oral Cleaning and Care Products

1 Scope

GB/T 42763-2023 gives guidance on the safety assessment of oral care and cleansing products. Toothpaste and mouthwash are an unusual exposure case: the product is applied to a highly permeable mucosa, twice a day for a lifetime, beginning in infancy, and a proportion of every dose is swallowed - which is why the assessment cannot be borrowed from cosmetics applied to skin. The standard sets the information required for the assessment, covering the physicochemical properties of the raw materials, the toxicological information and the human safety data, and then the safety assessment of the raw materials with the assessment itself and the procedure to be followed. It took effect on 1 December 2023.

This document provides general principles, procedures and conditions for the safety assessment of finished products and raw materials of oral care products (toothpaste and mouthwash) guide: This document is applicable to the safety assessment of finished oral care products and raw materials:

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document:

GB 22115 Specification for Toothpaste Raw Materials

GB/T 35919 Classification and Terminology of Oral Cleaning and Care Products

3 Terms and Definitions

The following terms and definitions defined in GB/T 35919 apply to this document: 3:

1 Act on human teeth, oral mucosa or dentures by scrubbing, gargling, rubbing, spraying, scraping, sticking or other similar methods to achieve Daily products for cleaning, reducing bad odors, grooming, maintaining and keeping them in good condition:

Note: This document refers specifically to toothpaste and mouthwash: [Source: GB/T 35919-2018, 2:2:1] 3:2 hazard hazard The property of a chemical (raw material or hazardous substance) to have an adverse effect on the human body under exposure conditions: 3:3 risk risk Under exposure conditions, the possibility and characteristics of a chemical (raw material or risk substance) causing harmful effects or adverse reactions to users: 3:4 risk assessment risk assessment The process of systematically and scientifically analyzing the possibility of adverse health effects or adverse reactions resulting from exposure to a hazardous factor or condition:

Note: It usually includes four steps: hazard identification, dose-response relationship assessment, exposure assessment and risk characterization: 3:5 A level of exposure to a chemical that is not expected to present a risk to human health: