化妝品原料蜂蜜的安全評(píng)估信息Safety Assessment of mel Ingredients as Used in Cosmetics

原創(chuàng)評(píng)估人： 李錦聰 李錦聰，化妝品違禁詞網(wǎng)創(chuàng)始人，知名化妝品法規(guī)博主/媒體評(píng)論人，廣東省日化商會(huì)原料安全評(píng)估專委會(huì)副主任委員等多個(gè)化妝品行業(yè)協(xié)會(huì)政策法規(guī)專委會(huì)委員，在化妝品生產(chǎn)質(zhì)量管理、新品開發(fā)、法律法規(guī)、安全評(píng)估等領(lǐng)域具有15年從業(yè)經(jīng)驗(yàn)。 日期：2025年11月28日

摘要：蜂蜜（INCI名稱：MEL ；CAS號(hào)：8028-66-8 ），已被廣泛應(yīng)用于化妝品等個(gè)人護(hù)理品，在化妝品中使用目的為保濕劑、潤膚劑。該原料已收錄于《已使用化妝品原料目錄（2021年版）》序號(hào)為02341，不屬于《化妝品安全技術(shù)規(guī)范（2015年版）》中的禁用物質(zhì)，參考《化妝品注冊(cè)和備案檢驗(yàn)項(xiàng)目要求》有關(guān)規(guī)定，對(duì)該原料的重金屬、微生物、有害物質(zhì)和穩(wěn)定性等進(jìn)行了檢測。相關(guān)毒理學(xué)終點(diǎn)有：經(jīng)口/經(jīng)皮急性毒性（LD50）、皮膚和眼刺激性/腐蝕性、皮膚變態(tài)反應(yīng)/致敏性、光毒性、光變態(tài)反應(yīng)/光敏性、遺傳毒性、重復(fù)劑量毒性/亞慢性（NOAEL/BMD）、生殖發(fā)育毒性、慢性毒性/致癌性等。該原料可能含有的風(fēng)險(xiǎn)物質(zhì)為獸藥殘留、農(nóng)藥殘留， 按照《化妝品安全評(píng)估技術(shù)導(dǎo)則》的要求，基于當(dāng)前科學(xué)認(rèn)知水平，對(duì)蜂蜜可能由化妝品原料帶入、生產(chǎn)過程中產(chǎn)生或帶入的風(fēng)險(xiǎn)物質(zhì)進(jìn)行了評(píng)估。在《已使用化妝品原料目錄（2021年版）》中淋洗類產(chǎn)品最高歷史使用量為25%， 駐留類產(chǎn)品最高歷史使用量為10%， 并且有CIR、SCCS等權(quán)威機(jī)構(gòu)評(píng)估結(jié)論數(shù)據(jù) ，美國化妝品原料評(píng)價(jià)委員會(huì)（CIR）評(píng)估結(jié)果顯示，濃度不高于（淋洗類為：22 %） （駐留類為：3 %） 時(shí)， ，該原料用于化妝品是安全的。 當(dāng)配方中的添加量低于該濃度時(shí)，該原料在正常、合理及可預(yù)見的使用條件下不會(huì)對(duì)人體健康造成危害。

關(guān)鍵詞：蜂蜜;化妝品原料;安全評(píng)估報(bào)告;毒理學(xué)終點(diǎn);權(quán)威數(shù)據(jù);CIR;駐留類;淋洗類;最高歷史使用量

評(píng)估意見：有 淋洗類產(chǎn)品相關(guān)評(píng)估數(shù)據(jù)， 有 駐留類產(chǎn)品相關(guān)評(píng)估數(shù)據(jù)， 經(jīng)評(píng)估該原料滿足化妝品完整版安全評(píng)估, 可根據(jù)原料在配方中實(shí)際應(yīng)用濃度進(jìn)行安全評(píng)估。

報(bào)送碼系統(tǒng)中與【蜂蜜】相關(guān)的原料數(shù)量共計(jì): 544 個(gè)

序號(hào)02341 INCI英文名稱 MEL 標(biāo)準(zhǔn)中文名稱 蜂蜜 日本成分名稱ハチミツ 韓國成分名稱? CAS No8028-66-8 EC No8028-66-8 可能含有的風(fēng)險(xiǎn)物質(zhì)獸藥殘留、農(nóng)藥殘留 常規(guī)使用目的保濕劑、潤膚劑 備注已上市產(chǎn)品原料使用信息
完整版安評(píng)可用20250209國際化妝品安全評(píng)估數(shù)據(jù)索引
完整版安評(píng)可用20250410 化妝品安全技術(shù)規(guī)范要求 標(biāo)簽上必須標(biāo)印的警告語牙膏技術(shù)規(guī)范要求口腔清潔護(hù)理用品工業(yè)協(xié)會(huì)
牙膏最高歷史使用量（%）
僅供參考不可用0.3完整版安全評(píng)估報(bào)告 蜂蜜 完整版安全評(píng)估報(bào)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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