欧盟化妆品安全报告CPSR | EU Cosmetic Product Safety Report (CPSR)

欧盟委员会发布的《欧盟化妆品法规》（第1223/2009号法规（EC））于2013年7月11日生效，取代了旧法规《化妆品指令》（第76/768/EEC号指令），并在欧洲经济区（EEA）国家以及挪威、冰岛和列支敦士登作为国家法律实施。

*The EU Commission's Regulation (EC) No 1223/2009 on cosmetics, effective from July 11, 2013, replaced the previous Cosmetics Directive (76/768/EEC) and is implemented as national law in European Economic Area (EEA) countries, as well as in Norway, Iceland, and Liechtenstein.*

法规要求所有化妆品上市前需开展化妆品安全评估，提交化妆品安全报告CPSR（Cosmetic Product Safety Report）。CPSR报告包括化妆品安全信息和化妆品安全评估两大部分。前者是收集的所有供进行安全评估所需的数据，后者是安全评估员关于产品安全性的意见。

The regulation requires that all cosmetic products undergo a safety assessment and have a Cosmetic Product Safety Report (CPSR) completed before being placed on the market. The CPSR consists of two main parts: the Cosmetic Product Safety Information and the Cosmetic Product Safety Assessment. The former comprises all collected data necessary for the safety assessment, while the latter is the safety assessor's opinion on the product's safety.

化妆品安全信息包括10部分内容： | Cosmetic Product Safety Information includes 10 sections:

化妆品的定量和定性组成 | Quantitative and qualitative composition of the cosmetic product

化妆品的物理/化学特性及稳定性 | Physical/chemical characteristics and stability of the cosmetic product

微生物质量 | Microbiological quality

杂质、痕量物质及包装材料信息 | Information on impurities, trace substances, and packaging materials

正常和合理可预见的使用 | Normal and reasonably foreseeable use

化妆品暴露信息 | Exposure to the cosmetic product

暴露物质 | Exposure to substances

物质的毒理学研究 | Toxicological profile of substances

不良反应和严重的不良反应 | Undesirable effects and serious undesirable effects

关于化妆品的信息 | Information on the cosmetic product

化妆品安全评估包含4部分内容： | Cosmetic Product Safety Assessment includes 4 sections:

评估结论 | Assessment conclusion

标签警示语和使用说明 | Labelled warnings and instructions for use

推论 | Reasoning

评估员的资质证明和审批 | Assessor's credentials and approval

完成CPSR需要提交一系列准确完整的材料，包括： | Completing the CPSR requires submitting a series of accurate and complete materials, including:

产品基本信息包含产品名称、产品描述（例如物理状态、颜色、预期用途）等； | Basic product information including product name, product description (e.g., physical state, color, intended use), etc.

配方成分信息包括各成分的CAS号和百分比，以及每种成分的使用目的； | Formulation ingredient information including CAS numbers and percentages for each ingredient, and the purpose of each ingredient.

所有成分的安全数据表 MSDS（Material Safety Data Sheet）； | Material Safety Data Sheets (MSDS/SDS) for all ingredients.

合格证明COA（Certificate of Compliance）或质量规格说明； | Certificate of Analysis (COA) or quality specification statements.

过敏香精测试报告和IFRA（International Fragrance Association）证书； | Allergen testing report for fragrances and IFRA (International Fragrance Association) Certificate.

产品的微生物质量测试报告； | Microbiological quality test report of the finished product.

产品的防腐剂挑战测试报告； | Preservative challenge test report of the product.

产品的稳定性测试报告； | Stability test report of the product.

产品的包装兼容性测试报告、内包装材料信息、重金属测试报告； | Packaging compatibility test report, information on inner packaging materials, heavy metals test report.

产品配方的重金属测试报告，包括铅、砷、汞、锑、镉、镍； | Heavy metals test report for the product formulation, including lead, arsenic, mercury, antimony, cadmium, nickel.

产品配方的风险性物质测试； | Testing for hazardous substances in the product formulation.

产品照片和最终产品的标签原图； | Product photos and the original label artwork of the final product.

良好生产规范证书（GMP）或审核报告； | Good Manufacturing Practice (GMP) certificate or audit report.

无纳米材料声明。 | Declaration on the absence/presence of nanomaterials.

我们的服务 | Our Services

欧盟化妆品安全报告CPSR | EU Cosmetic Product Safety Report (CPSR)

欧盟化妆品CPNP通报 | EU Cosmetic Product Notification Portal (CPNP) Notification

欧盟化妆品PIF | EU Cosmetic Product Information File (PIF)

欧盟化妆品配方/包装审核 | EU Cosmetic Formulation/Packaging Review

欧盟化妆品责任人 | EU Cosmetic Responsible Person

欧盟化妆品合规咨询 | EU Cosmetic Compliance Consulting

欧盟化妆品合规检测 | EU Cosmetic Compliance Testing