化妆品安全报告-CPSR(Cosmetic Product Safety Report)

 
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化妆品安全报告-CPSR(Cosmetic Product Safety Report),CPSR是欧盟所有化妆品进入市场的强制性文件,因为它证明了化妆品的安全性和有效性,对化妆品的毒理学评估。 这是为化妆品的产品定制的,当化妆品进入欧盟市场时候就表明它已由合格的安全评估员正式评估,并符合最新的欧盟法规(特别是法规EU 1223/2009)和英国脱欧后的法规。

CPSR代表化妆品安全报告,但通常被称为安全评估

化妆品在英国和欧盟上市销售之前需要CPSR毒理学评估。

必须由合格的安全评估员完成

CPSR 分为 2 个部分。


CPSR代表化妆品安全报告,但通常被称为安全评估

包括摘要、产品简介、产品配方、配方中各成分的安全评估、可能存在的风险物质评估、风险控制措施或建议、安全评估结论、安全评估人员等内容。


化妆品在英国和欧盟上市销售之前需要CPSR毒理学评估。

根据法规(ECNo 1223/2009,当化妆品在正常和合理可预见的使用条件下使用时,需要对人体保证健康和安全。所有投放欧盟市场的化妆品必须由合格人员进行安全评估。化妆品产品安全报告(CPSR)应完成并包含在产品信息文件(PIF)中。


化妆品毒理学安全评估员

毒理学安全评估员的要求是一个训练有素,需要拥有公认的大学的相关学位和药学、毒理学、医学、类似学科的大学理论和实践研究课程或成员国认可的同等课程资质文凭具且有相关专业证书的人


CPSR 由两部分(A 部分和 B 部分)组成,至少应包含以下信息:

A部分: 化妆品安全信息

化妆品的定量和定性成分

化妆品的物理/化学特性和稳定性

微生物质量

包装材料的杂质、痕迹、信息

正常和合理可预见的使用

接触化妆品

接触物质

物质的毒理学特征

不良影响和严重不良影响

关于化妆品的信息


B部分: 化妆品安全评估

评估结论

贴有标签的警告和使用说明

论证

评估员的全权证书和对B部分的批准



Test or certification item 测试或认证名称: 化妆品安全报告 Cosmetic Product Safety Report
 
Test or certification info 测试和认证相关内容:
 
files for CPSR certification 需要准备的材料
- 1 set of formulation
- MSDS for all raw materials
- Fragrance doc. 
- Microbial Test Report
- Challenge Test Report
- Stability Test Report
- Packaging Material Report
- Label artwork
- Any nano-material used?
- Specification and Certificate of analysis of raw materials and packaging materials
- Specification of finished product
- Undesirable effects and serious adverse events
 
1、产品重金属检测报告
2
、产品微生物测试报告
3
、产品防腐挑战测试报告
4
、产品稳定性测试报告
5
、产品其他风险物质测试报告(需根据配方判断是否需要)
6
、包装材料重金属检测报告
7
、产品每个成分COAMSDS报告(可向原料供应商索要,要英文的,若没有的我司可办理)
8
、若含香精的,还需提供香精IFRA,MSDS,26种过敏原报告(可向原料供应商索要,要英文的,若没有的,我司可办理)
9
、工厂GMPC证书
 
Norm refer 涉及法规: Regulation(EC)1223/2009Directive 76/768 EEC
 
Refer products 涉及产品:  化妆品
 
Lead time 周期:  常规服务 regular service 35 工作日 working days ( URGENT service, to be confirm, 加急服务待定 )
 
Sample size 送样规格:  on request 待定 
 
Sample for reference 参考图片:
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Sample Report 报告样本:
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