化妝品原料氫化蜂蜜 的安全評估報告
原創(chuàng)評估人: 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/媒體評論人,廣東省日化商會原料安全評估專委會副主任委員等多個化妝品行業(yè)協(xié)會政策法規(guī)專委會委員,在化妝品生產(chǎn)質量管理、新品開發(fā)、法律法規(guī)、安全評估等領域具有15年從業(yè)經(jīng)驗。 日期:2025年11月28日 1012
摘要:氫化蜂蜜(INCI名稱:HYDROGENATED HONEY ),已被廣泛應用于化妝品等個人護理品,在化妝品中使用目的為保濕劑、皮膚保護劑。該原料已收錄于《已使用化妝品原料目錄(2021年版)》序號為05357,不屬于《化妝品安全技術規(guī)范(2015年版)》中的禁用物質,參考《化妝品注冊和備案檢驗項目要求》有關規(guī)定,對該原料的重金屬、微生物、有害物質和穩(wěn)定性等進行了檢測。相關毒理學終點有: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/致敏性、光毒性、光變態(tài)反應/光敏性、遺傳毒性、重復劑量毒性/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險物質為無, 按照《化妝品安全評估技術導則》的要求,基于當前科學認知水平,對氫化蜂蜜可能由化妝品原料帶入、生產(chǎn)過程中產(chǎn)生或帶入的風險物質進行了評估。并且有CIR、SCCS等權威機構評估結論數(shù)據(jù) ,美國化妝品原料評價委員會(CIR)評估結果顯示,濃度不高于(淋洗類為:0.25 %) 時, ,該原料用于化妝品是安全的。 當配方中的添加量低于法規(guī)限值、最高歷史使用量和權威評估機構結果用量聰時,該原料在正常、合理及可預見的使用條件下不會對人體健康造成危害。
關鍵詞:氫化蜂蜜;化妝品原料;安全評估報告;毒理學終點;權威數(shù)據(jù);CIR;駐留類;淋洗類;最高歷史使用量
評估意見:有 淋洗類產(chǎn)品相關評估數(shù)據(jù), 無 駐留類產(chǎn)品相關評估數(shù)據(jù), 經(jīng)評估該原料滿足化妝品完整版安全評估, 可根據(jù)原料在配方中實際應用濃度進行安全評估。
報送碼系統(tǒng)中與【氫化蜂蜜】相關的原料數(shù)量共計: <10 個
序號05357 INCI英文名稱 HYDROGENATED HONEY 標準中文名稱 氫化蜂蜜 日本成分名稱水添ハチミツ 韓國成分名稱?????????? CAS No EC No 可能含有的風險物質無 常規(guī)使用目的保濕劑、皮膚保護劑 備注已上市產(chǎn)品原料使用信息完整版安評可用20250209國際化妝品安全評估數(shù)據(jù)索引
完整版安評可用20250410 化妝品安全技術規(guī)范要求 標簽上必須標印的警告語牙膏技術規(guī)范要求口腔清潔護理用品工業(yè)協(xié)會
牙膏最高歷史使用量(%)
僅供參考不可用完整版安全評估報告 氫化蜂蜜 完整版安全評估報告.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.cliingonj
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.cliingonj
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相關知識
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