歐盟化妝品安全報告CPSR | EU Cosmetic Product Safety Report (CPSR)

歐盟委員會發布的《歐盟化妝品法規》（第1223/2009號法規（EC））于2013年7月11日生效，取代了舊法規《化妝品指令》（第76/768/EEC號指令），并在歐洲經濟區（EEA）國家以及挪威、冰島和列支敦士登作為國家法律實施。

*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.*

法規要求所有化妝品上市前需開展化妝品安全評估，提交化妝品安全報告CPSR（Cosmetic Product Safety Report）。CPSR報告包括化妝品安全信息和化妝品安全評估兩大部分。前者是收集的所有供進行安全評估所需的數據，后者是安全評估員關于產品安全性的意見。

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.

化妝品安全信息包括10部分內容： | Cosmetic Product Safety Information includes 10 sections:

化妝品的定量和定性組成 | Quantitative and qualitative composition of the cosmetic product

化妝品的物理/化學特性及穩定性 | Physical/chemical characteristics and stability of the cosmetic product

微生物質量 | Microbiological quality

雜質、痕量物質及包裝材料信息 | Information on impurities, trace substances, and packaging materials

正常和合理可預見的使用 | Normal and reasonably foreseeable use

化妝品暴露信息 | Exposure to the cosmetic product

暴露物質 | Exposure to substances

物質的毒理學研究 | Toxicological profile of substances

不良反應和嚴重的不良反應 | Undesirable effects and serious undesirable effects

關于化妝品的信息 | Information on the cosmetic product

化妝品安全評估包含4部分內容： | Cosmetic Product Safety Assessment includes 4 sections:

評估結論 | Assessment conclusion

標簽警示語和使用說明 | Labelled warnings and instructions for use

推論 | Reasoning

評估員的資質證明和審批 | Assessor's credentials and approval

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

產品基本信息包含產品名稱、產品描述（例如物理狀態、顏色、預期用途）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號和百分比，以及每種成分的使用目的； | Formulation ingredient information including CAS numbers and percentages for each ingredient, and the purpose of each ingredient.

所有成分的安全數據表 MSDS（Material Safety Data Sheet）； | Material Safety Data Sheets (MSDS/SDS) for all ingredients.

合格證明COA（Certificate of Compliance）或質量規格說明； | Certificate of Analysis (COA) or quality specification statements.

過敏香精測試報告和IFRA（International Fragrance Association）證書； | Allergen testing report for fragrances and IFRA (International Fragrance Association) Certificate.

產品的微生物質量測試報告； | Microbiological quality test report of the finished product.

產品的防腐劑挑戰測試報告； | Preservative challenge test report of the product.

產品的穩定性測試報告； | Stability test report of the product.

產品的包裝兼容性測試報告、內包裝材料信息、重金屬測試報告； | Packaging compatibility test report, information on inner packaging materials, heavy metals test report.

產品配方的重金屬測試報告，包括鉛、砷、汞、銻、鎘、鎳； | Heavy metals test report for the product formulation, including lead, arsenic, mercury, antimony, cadmium, nickel.

產品配方的風險性物質測試； | Testing for hazardous substances in the product formulation.

產品照片和最終產品的標簽原圖； | Product photos and the original label artwork of the final product.

良好生產規范證書（GMP）或審核報告； | Good Manufacturing Practice (GMP) certificate or audit report.

無納米材料聲明。 | Declaration on the absence/presence of nanomaterials.

我們的服務 | Our Services

歐盟化妝品安全報告CPSR | EU Cosmetic Product Safety Report (CPSR)

歐盟化妝品CPNP通報 | EU Cosmetic Product Notification Portal (CPNP) Notification

歐盟化妝品PIF | EU Cosmetic Product Information File (PIF)

歐盟化妝品配方/包裝審核 | EU Cosmetic Formulation/Packaging Review

歐盟化妝品責任人 | EU Cosmetic Responsible Person

歐盟化妝品合規咨詢 | EU Cosmetic Compliance Consulting

歐盟化妝品合規檢測 | EU Cosmetic Compliance Testing