ICCR关注议题：技术差异和趋势分析

doi:10.3969/j.issn.1001-1803.2021.11.013

摘要/Abstract

摘要：

综述了2008~2020年期间国际化妆品监管合作组织（ICCR）在化妆品监管和技术领域的关注议题、技术性文件及研究进展,对其技术趋势进行分析,并比较其与我国的主要差异,展望了我国化妆品科学的未来发展方向。提出对我国化妆品技术法规持续动态修订以不断提高技术标准,重点追踪ICCR在安全性评价、纳米原料、ISO标准评议、致敏物质等方面的技术进展,加快替代方法的开发验证以及组合策略的研究应用,建立健全我国化妆品纳米原料和纳米技术相关监管和技术体系,并关注ICCR在下一代风险评估、微生物组学等专业领域的前瞻性研究。为配合《化妆品监督管理条例》的发布实施,加快相应的技术支撑和技术储备。

关键词: 化妆品, 国际化妆品监管合作组织, 监管, 技术差异, 趋势分析

Abstract:

The topics of concern that the International Cooperation on Cosmetics Regulation （ICCR） has focused on from 2008 to 2020 have been reviewed. Corresponding technical documents and research progress in regulations and technologies of cosmetics have also been reviewed. Trend analysis and technical comparison have been completed. The prospects of future cosmetic science in China have been discussed. It is proposed to revise the technical regulations dynamically to continuously improve the standards. Technical progress of ICCR in several directions can be followed up, especially in safety evaluation, nanomaterials, ISO standard evaluation and allergens. The development and verification of alternative methods, as well as the study and application of integrated strategies, should be accelerated. The regulatory system for nanomaterials and the technical system for nanotechnology in cosmetics should be established and improved in China. In addition, attentions can also be paid to some advanced research work of ICCR, for example, the next generation risk assessment and microbiome. To implement the Regulations on the Supervision and Administration of Cosmetics, corresponding technical support and technical preparation should be speeded up.

Key words: cosmetics, ICCR, supervision, technical comparison, trend analysis

中图分类号:

TQ658

苏哲,罗飞亚,邢书霞,王钢力. ICCR关注议题：技术差异和趋势分析[J]. 日用化学工业, 2021, 51(11): 1125-1133.

Su Zhe,Luo Feiya,Xing Shuxia,Wang Gangli. Technical comparison and trend analysis on the topics that ICCR are concerned with[J]. China Surfactant Detergent & Cosmetics, 2021, 51(11): 1125-1133.

图/表 4

表 1

ICCR主要关注议题及技术性文件"

议题	序号	ICCR报告主题	发布时间
（一）痕量物质	1	化妆品产品中痕量杂质和/或污染物的处理原则 Principles for the Handling of Traces of Impurities and/or Contaminants in Cosmetic Products	2011-04
	2	关于化妆品产品中可接受的铅含量的考虑 Considerations on Acceptable Lead Levels in Cosmetic Products	2013-12
	3	化妆品产品中可接受的汞的痕量水平的建议 Recommendation for Acceptable Trace Mercury Levels in Cosmetic Products	2016-09
	4	关于化妆品产品中可接受的1,4-二噁烷痕量水平的考虑 Considerations on Acceptable Trace Level of 1,4-Dioxane in Cosmetic Products	2017-02
（二）安全性评价	1	化妆品产品安全性评价原则 Principles of Cosmetic Product Safety Assessment	2011-05
	2	化妆品原料安全性评价组合策略：第一部分 Integrated Strategies for Safety Assessments of Cosmetic Ingredients: Part 1	2017-10
	3	化妆品原料安全性评价组合策略：第二部分 Integrated Strategies for Safety Assessment of Cosmetic Ingredients: Part 2	2018-11
（三）动物替代试验	1	替代试验方法国际合作（ICATM）框架 Framework for International Cooperation on Alternative Test Methods （ICATM）	2008-10
	2	动物替代试验方法在ICCR地区的监管框架下的适用性 Applicability of Animal Testing Alternatives in Regulatory Frameworks within ICCR Regions	2012-09
	3	ICCR的化妆品产品和原料动物替代试验方法目录 Inventory of Validated Alternatives to Animal Testing Applicable for Cosmetic Products and Their Ingredients in all ICCR Regions	2013-11
	4	用于化妆品原料安全性评价的计算机模拟方法 In Silico Approaches for Safety Assessment of Cosmetic Ingredients	2014-07
	5	ICCR的化妆品产品和原料动物替代试验方法目录 Inventory of Validated Alternatives to Animal Testing Applicable for Cosmetic Products and Their Ingredients in all ICCR Regions	2020-11
（四）纳米技术/纳米原料	1	ICCR-2化妆品中纳米技术的联合小组报告 ICCR-2 Association Panel Report Nanotechnology in Cosmetics	2008-10
	2	化妆品产品中的纳米技术：标准和检测方法 Nanotechnology in Cosmetic Products: Criteria and Methods of Detection	2010-07
	3	关于化妆品产品中纳米材料使用情况的调查 Associations Survey of Nanomaterials Used in Cosmetic Products	2011-06
	4	纳米材料表征测量现有方法 Currently Available Methods for Characterization of Nanomaterials	2011-06
	5	纳米材料表征Ⅱ—在复杂介质中的不溶性、生物稳定性和粒径测量 Characterization of Nanomaterials Ⅱ-Insolubility, Biopersistence and Size Measurement in Complex Media	2012-07
	6	纳米材料表征Ⅲ—在复杂介质中的溶解度、稳定性、持久性和粒径测量 Characterization of Nanomaterials Ⅲ-Solubility, Stability & Persistence and Size Measurement in Complex Media	2013-05
	7	化妆品纳米原料的安全性评价方法 Safety Approaches to Nanomaterials in Cosmetics	2013-11
（五）国际标准	1	化妆品国际标准 International Standards in Cosmetics	2016-08
（六）检测方法	1	关于ISO发布的化妆品分析方法国际标准的审议 Review of International Standards on Analytical Methods for Cosmetics Defined by ISO	2018-10
（七）致敏物质	1	化妆品和个人护理产品中的致敏物质：监管方法的比较 Allergens in Cosmetics and Personal Care Products: Comparison of Jurisdictional Regulatory Approaches	2014-07
	2	建立化妆品和个人护理产品中潜在致敏物质权威列表所采取方法的调查—过敏原Ⅱ：第一部分 Survey of Approaches Undertaken to Develop Authoritative Lists of Potential Allergens in Cosmetics and Personal Care Products-Allergens Ⅱ: Part 1	2017-02
	3	用于识别潜在皮肤致敏物质的替代安全性评价工具 Alternative Safety Assessment Tools for Identifying Potential Dermal Allergens	2019-10
（八）微生物	1	微生物限值：ISO-17516 Microbiological Limits-International Organization for Standardization （ISO） ISO-17516	2016-08
	2	对ISO-17516中涉及各项ISO标准的审议 Review of ISO Standards Embedded in International Organization for Standardization （ISO） ISO-17516	2017-10
	3	ISO微生物标准的审议：化妆品防腐与产品保护指南 Review of ISO Microbiological Standards: Guidelines for Cosmetic Preservation and Product Protection	2017-10
（九）产品防腐	1	关于化妆品防腐剂的常见技术性问答 General and Technical Frequently Asked Questions （FAQs） on Preservatives in Cosmetics	2015-12
（九）产品防腐	2	获得适当防腐剂配伍应考虑的主要科学要素和原则概述 Overview of Key Scientific Elements and Principles to Be Considered in Ensuring Access to an Appropriate Palette of Preservatives	2019-10

表 1

表 2

表 3

图 1

参考文献 31

[1]	ICCR. Principles for the Handling of Traces of Impurities and/or Contaminants in Cosmetic Products[EB/OL].[2020-12-26]. https://www.iccr-cosmetics.org//downloads/topics/2011-04_iccr_principles_for_handling_traces_in_cosmetics.pdf.
[2]	ICCR. Considerations on Acceptable Lead Levels in Cosmetic Products[EB/OL].[2020-12-26]. https://www.iccr-cosmetics.org//downloads/topics/2013-12_recommendation_on_lead_traces_in_cosmetics.pdf.
[3]	ICCR. Recommendation for Acceptable Trace Mercury Levels in Cosmetic Products[EB/OL].[2020-12-26]. https://www.iccr-cosmetics.org//downloads/topics/iccr_wg_report_recommendation_for_acceptable_trace_mercury_levels_in_cosmetic_products.pdf.
[4]	ICCR. Considerations on Acceptable Trace Level of 1,4-Dioxane in Cosmetic Products[EB/OL].[2020-12-26]. https://www.iccr-cosmetics.org//downloads/topics/iccr_14-dioxane_final_2017.pdf.
[5]	ICCR. International Cooperation on Cosmetic Regulation (ICCR-2)[EB/OL].[2020-12-26]. https://www.iccr-cosmetics.org/meetings.
[6]	ICCR. International Cooperation on Cosmetics Regulation (ICCR) Outcomes of the Meeting Held July 10-13, 2012[EB/OL]. [2020-12-26]. https://www.iccr-cosmetics.org/meetings.
[7]	ICCR. Inventory of validated Alternatives to Animal Testing applicable for cosmetic products and their ingredients in all ICCR Regions-Report[EB/OL].[2020-12-26]. https://www.iccr-cosmetics.org//downloads/topics/2013-11_iccr_inventory_of_alternatives_to_animal_test_methods_-_report-1.pdf.
[8]	ICCR. Inventory of validated Alternatives to Animal Testing applicable for cosmetic products and their ingredients in all ICCR Regions-Overview[EB/OL].[2020-12-26]. https://www.iccr-cosmetics.org//downloads/topics/2013-11_iccr_inventory_of_alternatives_to_animal_test_methods_-_overview.pdf.
[9]	ICCR. Inventory of validated Alternatives to Animal Testing Applicable for Cosmetic Products and Their Ingredients in All ICCR Regions[EB/OL].[2020-12-26]. https://www.iccr-cosmetics.org//downloads/topics/2020-12%20-%20iccr%20inventory%20of%20alternatives%20to%20animal%20test%20methods%20-%20table.pdf.
[10]	ICCR. International Cooperation on Cosmetics Regulation (ICCR) Eighth Annual Meeting held in Ottawa, Canada from July 8-10, 2014[EB/OL]. [2020-12-26]. https://www.iccr-cosmetics.org/meetings.
[11]	ICCR. Principles of Cosmetic Product Safety Assessment[EB/OL].[2020-12-26]. https://www.iccr-cosmetics.org//downloads/topics/2011-05_iccr_principles_of_cosmetic_product_safety_assessment.pdf.
[12]	ICCR. Integrated Strategies for Safety Assessments of Cosmetic Ingredients - Part I[EB/OL].[2020-12-26]. https://www.iccr-cosmetics.org//downloads/topics/iccr-11_jwg_integrated_strategies_integrated_strategies_for_safety_assessments_of_cosmetic_ingredients_-_part_i.pdf.
[13]	ICCR. Integrated Strategies for Safety Assessment of Cosmetic Ingredients: Part 2[EB/OL].[2020-12-26]. https://www.iccr-cosmetics.org//downloads/topics/iccr_integrated_strategies_for_safety_assessment_of_cosmetic_ingredients_part_2.pdf.
[14]	Cote I, Anastas P T, Birnbaum L S, et al. Advancing the next generation of health risk assessment[J]. Environ. Health Perspect, 2012, 120(11):1499-1502. doi: 10.1289/ehp.1104870
[15]	ICCR. ICCR-2 Association Panel Report Nanotechnology in Cosmetics[EB/OL].[2021-01-17]. https://www.iccr-cosmetics.org//downloads/topics/2008-10_association_panel_report_on_nanotechnology_in_cosmetics.pdf.
[16]	ICCR. Nanotechnology in Cosmetic Products: Criteria and Methods of Detection[EB/OL].[2021-01-17]. https://www.iccr-cosmetics.org//downloads/topics/2010-07_nanotechnology_in_cosmetics_criteria_and_methods_for_detection.pdf.
[17]	ICCR. Associations Survey of Nanomaterials Used in Cosmetic Products[EB/OL].[2021-01-17]. https://www.iccr-cosmetics.org//downloads/topics/2011-06_iccr_associations_survey_of_nano _materials_in_cosmetics.pdf.
[18]	ICCR. Currently Available Methods for Characterization of Nanomaterials[EB/OL].[2021-01-17]. https://www.iccr-cosmetics.org//downloads/topics/2011-06_characterization_approaches_to_nanomaterials_in_cosmetics.pdf.
[19]	ICCR. Characterization of Nanomaterials II-Insolubility, Biopersistence and Size Measurement in Complex Media[EB/OL].[2021-01-17]. https://www.iccr-cosmetics.org//downloads/topics/2012-07_characterization_approaches_to_nanomaterials_in_cosmetics_ii.pdf.
[20]	ICCR. Characterization of Nanomaterials III Solubility, Stability & Persistence and Size Measurement in Complex Media[EB/OL].[2021-01-17]. https://www.iccr-cosmetics.org//downloads/topics/2013-05_characterization_approaches_to_nanomaterials_in_cosmetics_iii.pdf.
[21]	ICCR. Safety Approaches to Nanomaterials in Cosmetics[EB/OL].[2021-01-17]. https://www.iccr-cosmetics.org//downloads/topics/2013-11_safety_approaches_to_nanomaterials_in_cosmetics.pdf.
[22]	ICCR. Allergens in Cosmetics and Personal Care Products: Comparison of Jurisdictional Regulatory Approaches[EB/OLB].[2020-12-26]. https://www.iccr-cosmetics.org//downloads/topics/2014-07_allergens_-_comparison_of_regulatory_approaches.pdf.
[23]	ICCR. Survey of Approaches Undertaken to Develop Authoritative Lists of Potential Allergens in Cosmetics and Personal Care Products-Allergens II: Part 1[EB/OL].[2020-12-26]. https://www.iccr-cosmetics.org//downloads/topics/allergens_ii__part_1_final_jan_2017.pdf.
[24]	ICCR. Alternative Safety Assessment Tools for Identifying Potential Dermal Allergens[EB/OL].[2020-12-26]. https://www.iccr-cosmetics.org//downloads/topics/2019-10_alternative_safety_assessment_tools_for_identifying_potential_dermal_allergens.pdf.
[25]	ICCR. International Standards in Cosmetics[EB/OL].[2021-01-17]. https://www.iccr-cosmetics.org//downloads/topics/iccr_wg_report_international_standards_2016-07-13.pdf.
[26]	ICCR. 14 th Annual Meeting held virtually from December 7-9, 2020[EB/OL]. [2021-01-17]. https://www.iccr-cosmetics.org/meetings.
[27]	ICCR. 12th Annual Meeting Held in Tokyo, Japan from July 10-12, 2018[EB/OL]. [2021-01-17]. https://www.iccr-cosmetics.org/meetings.
[28]	US Federal Food and Drug Administration. Electronic Code of Federal Regulations, Title 21, § 700.13[EB/OL]. [2021-01-17]. https://www.ecfr.gov/current/title-21/part-700/subpart-b.
[29]	ICCR. Alternative Safety Assessment Tools for Identifying Potential Dermal Allergens[EB/OL].[2020-12-26]. https://www.iccr-cosmetics.org//downloads/topics/2019-10_alternative_safety_assessment_tools_for_identifying_potential_dermal_allergens.pdf.
[30]	Su Z, Luo F, Zhang F, et al. A discussion of supervision and latest research progress about cosmetic nanomaterials worldwide[J]. Chinese Pharmaceutical Affairs, 2021, 35(2):227-236.
[31]	National People’s Congress. Minamata Convention on Mercury (Chinese Version)[EB/OL]. [2021-01-18]. http://www.npc.gov.cn/wxzl/gongbao/2016-07/11/content_1994472.htm.

痕量物质	ICCR推荐限值	《化妆品安全技术规范》（2015年版）要求限值
铅	≤10 ppm	10 mg/kg
汞	≤1 ppm（以总汞计）	1 mg/kg（含有机汞防腐剂的眼部化妆品除外）
1,4-二噁烷	第一阶段≤25 ppm,第二阶段≤10 ppm	30 mg/kg