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化妆品原料洋蔷薇（ROSA CENTIFOLIA）花蜡的安全评估报告

花匠小妙招
2025-09-12 16:17

Safety Assessment of rosa centifolia flower wax 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09月12日 1007

摘要：洋蔷薇（ROSA CENTIFOLIA）花蜡（INCI名称：ROSA CENTIFOLIA FLOWER WAX ），来源于被子植物门 Angiospermae >> 蔷薇科 Rosaceae >> 蔷薇属 Rosa 植物，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皮肤保护剂。该原料已收录于《已使用化妆品原料目录（2021年版）》序号为07449，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，对洋蔷薇（ROSA CENTIFOLIA）花蜡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）》中驻留类产品最高历史使用量为1.55%，暂时未检索到CIR、SCCS等相关权威机构评估结论数据，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：洋蔷薇（ROSA CENTIFOLIA）花蜡;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，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【洋蔷薇（ROSA CENTIFOLIA）花蜡】相关的原料数量共计: ＜10 个

序号07449 INCI英文名称 ROSA CENTIFOLIA FLOWER WAX 标准中文名称洋蔷薇（ROSA CENTIFOLIA）花蜡日本成分名称センチフォリアバラ花ロウ韩国成分名称프로방스장미꽃왁스 CAS No EC No283-289-8 可能含有的风险物质农药残留常规使用目的皮肤保护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（%）
仅供参考不可用完整版安全评估报告洋蔷薇（ROSA CENTIFOLIA）花蜡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 12 Rosa centifolia-derived ingredients as used in cosmetic formulations. The majority of these ingredients are reported to function in cosmetics as skin-conditioning agents. Rosa centifolia-derived ingredients comprise constituents that may cause adverse effects. Because final product formulations may contain multiple botanicals, each possibly containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. With Rosa centifolia-derived ingredients, the Panel was concerned about the presence of potential sensitizers (e.g., citronellol and geraniol) in cosmetics. Additionally, industry should use good manufacturing practices to minimize impurities, such as heavy metals and pesticide residues. The Panel considered the available data and concluded that 9 Rosa centifolia-derived ingredients (i.e., the flower-, bud-, and stem-derived ingredients) are safe in cosmetics in the present practices of use and concentration described in this safety assessment when formulated to be non-sensitizing. Additionally, the Panel also concluded that the available data are insufficient to make a determination that the remaining 3 Rosa centifolia-derived ingredients are safe under the intended conditions of use in cosmetic formulations.ilinojgnc

CONCLUSION: The Expert Panel for Cosmetic Ingredient Safety concluded that the following 9 Rosa centifolia-derived ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment when formulated to be non-sensitizing:
ROSA CENTIFOLIA EXTRACT*, ROSA CENTIFOLIA FLOWER*, ROSA CENTIFOLIA FLOWER WAX*, ROSA CENTIFOLIA FLOWER POWDER*
*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 the product categories and at concentrations comparable to others in this group.ilinojgnc

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

CIR Conclusion：The Expert Panel for Cosmetic Ingredient Safety concluded that the following 9 Rosa centifolia-derived ingredients are safein cosmetics in the present practices of use and concentration described in this safety assessment when formulated to benon-sensitizing: Rosa Centifolia Flower Wax Finding: SQ - safe for use in cosmetics, with qualifications. Citation: Final Report Available from CIR 03/2023

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