化妆品原料蜂蜜 的安全评估报告

化妆品原料蜂蜜的安全评估信息Safety Assessment of mel Ingredients as Used in Cosmetics

原创评估人： 李锦聪 李锦聪，化妆品违禁词网创始人，知名化妆品法规博主/媒体评论人，广东省日化商会原料安全评估专委会副主任委员等多个化妆品行业协会政策法规专委会委员，在化妆品生产质量管理、新品开发、法律法规、安全评估等领域具有15年从业经验。 日期：2025年11月28日

摘要：蜂蜜（INCI名称：MEL ；CAS号：8028-66-8 ），已被广泛应用于化妆品等个人护理品，在化妆品中使用目的为保湿剂、润肤剂。该原料已收录于《已使用化妆品原料目录（2021年版）》序号为02341，不属于《化妆品安全技术规范（2015年版）》中的禁用物质，参考《化妆品注册和备案检验项目要求》有关规定，对该原料的重金属、微生物、有害物质和稳定性等进行了检测。相关毒理学终点有：经口/经皮急性毒性（LD50）、皮肤和眼刺激性/腐蚀性、皮肤变态反应/致敏性、光毒性、光变态反应/光敏性、遗传毒性、重复剂量毒性/亚慢性（NOAEL/BMD）、生殖发育毒性、慢性毒性/致癌性等。该原料可能含有的风险物质为兽药残留、农药残留， 按照《化妆品安全评估技术导则》的要求，基于当前科学认知水平，对蜂蜜可能由化妆品原料带入、生产过程中产生或带入的风险物质进行了评估。在《已使用化妆品原料目录（2021年版）》中淋洗类产品最高历史使用量为25%， 驻留类产品最高历史使用量为10%， 并且有CIR、SCCS等权威机构评估结论数据 ，美国化妆品原料评价委员会（CIR）评估结果显示，浓度不高于（淋洗类为：22 %） （驻留类为：3 %） 时， ，该原料用于化妆品是安全的。 当配方中的添加量低于该浓度时，该原料在正常、合理及可预见的使用条件下不会对人体健康造成危害。

关键词：蜂蜜;化妆品原料;安全评估报告;毒理学终点;权威数据;CIR;驻留类;淋洗类;最高历史使用量

评估意见：有 淋洗类产品相关评估数据， 有 驻留类产品相关评估数据， 经评估该原料满足化妆品完整版安全评估, 可根据原料在配方中实际应用浓度进行安全评估。

报送码系统中与【蜂蜜】相关的原料数量共计: 544 个

序号02341 INCI英文名称 MEL 标准中文名称 蜂蜜 日本成分名称ハチミツ 韩国成分名称꿀 CAS No8028-66-8 EC No8028-66-8 可能含有的风险物质兽药残留、农药残留 常规使用目的保湿剂、润肤剂 备注已上市产品原料使用信息
完整版安评可用20250209国际化妆品安全评估数据索引
完整版安评可用20250410 化妆品安全技术规范要求 标签上必须标印的警告语牙膏技术规范要求口腔清洁护理用品工业协会
牙膏最高历史使用量（%）
仅供参考不可用0.3完整版安全评估报告 蜂蜜 完整版安全评估报告.pdf

Assessment conclusions by international authoritative cosmetic safety assessment agencies:

ABSTRACT: The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 7 honey-derived ingredients. All of these ingredients are reported to function in cosmetics as skin-conditioning agents. The Panel considered the available data relating to the safety of these ingredients in cosmetic formulations. Because impurities, particularly pesticides and endotoxins, may be present in these ingredients, formulators should continue to use good manufacturing practices to monitor and limit these possible impurities. The Panel concluded the honey-derived ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment.ijlgoinnc

CONCLUSION: The Expert Panel for Cosmetic Ingredient Safety concluded that the following honey-derived ingredients are safe in cosmetics in the present practices of use and concentrations described in the safety assessment.
HYDROLYZED HONEY PROTEIN*
*Not reported to be in current use. Were ingredients in this group not in current use to be used in the future, the expectation is that they would be used in product categories and at concentrations comparable to others in this group.ijlgoinnc

CITE: Safety Assessment of Honey-Derived Ingredients as Used in Cosmetics

CIR Conclusion：S - Safe in the present practices of use and concentration. Ingredient, concentration, and use information are available in documents discoverable at CIR. Citation: Final Report 06/2020 Available from CIR

International Authorities: Andean CommunityAssociation of Southeast Asian Nations (ASEAN)Caribbean Community (CARICOM)East African Community (EAC)Central American Customs Union (CACU)Cosmetic Ingredient Review (CIR)Eurasian Economic Union (EAEU)European Union (EU)Global TreatiesGulf Cooperation Council (GCC)Southern Common Market (MERCOSUR)Security Assessment Database: INCI namesCAS numberschemical/technical namesadditional terms will be used as appropriatePubmedToxnet(includes Toxline; HSDB; ChemIDPlus; DART; IRIS; CCRIS; CPDB; GENE-TOX)ScifinderwINCIFDA databasesFDA search databasesEAFUSGRAS listingSCOGS databaseIndirect Food AdditivesDrug Approvals and DatabaseFDA Orange BookOTC ingredient listinactive ingredients approved for drugsHPVIS(EPA High-Production Volume Info Systems)NIOSH(National Institute for Occupational Safety and Health)NTIS(National Technical Information Service)NTP(National Toxicology Program)Office of Dietary SupplementsFEMA(Flavor & Extract Manufacturers Association)EU CosIng databaseECHA(European Chemicals Agency – REACH dossiers)ECETOC(European Centre for Ecotoxicology and Toxicology of Chemicals)European Medicines Agency (EMA)IUCLID(International Uniform Chemical Information Database)OECD SIDS(Organisation for Economic Co-operation and Development Screening Info Data Sets)SCCS(Scientific Committee for Consumer Safety) opinionsNICNAS (Australian National Industrial Chemical Notification and Assessment Scheme)International Programme on Chemical SafetyFAO(Food and Agriculture Organization of the United Nations)WHO(World Health Organization) technical reportsDr. Duke’sTaxonomy databaseGRIN(U.S. National Plant Germplasm System)Sigma Aldrich plant profilerAmerican Herbal Products Association Botanical Safety Handbook (database) European Medicines Agency Herbal MedicinesAGRICOLA(National Agricultural Library NAL Catalog)The Seasoning and Spice Association List of Culinary Herbs and SpicesIFRA(International Fragrance Association)RIFM(Research Institute for Fragrance Materials)Country Region: ChinaJapanKoreaIndiaPakistanAfghanistanIranSaudi ArabiaIsraelTurkeyRussiaGermanyFranceItalySpainUnited KingdomPolandUkraineSwedenGreeceEgyptSudanKenyaNigeriaSouth AfricaGhanaMoroccoAlgeriaTunisiaEthiopiaUnited StatesCanadaMexicoCubaJamaicaPanamaHaitiDominican RepublicGuatemalaHondurasBrazilArgentinaPeruChileColombiaVenezuelaUruguayParaguayBoliviaEcuadorAustraliaNew ZealandPapua New GuineaSolomon IslandsVanuatuFijiSamoaKiribatiNauruMarshall Islands

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