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化妆品出口东盟检测要求

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东盟十国组成：文莱、柬埔寨、印度尼西亚、老挝、马来西亚、缅甸、菲律宾、新加坡、泰国、越南

Cosmetic articles including: haircare, skincare products and products for care of the teeth and mouth (e.g. Shampoo, cream, lotion, lipstick, nail polish, toothpastes) 

所有东盟国家要求在产品测试完成后都需要在本国监管机构注册, 进口国注册，基本都是国内的企业付款注册(十国都是一样的流程)

产品测试要求如下：

No.
编号 		Test items
测试项目 		Test Required
测试要求 		Limit
限值 		Test Method
测试方法 		Turn around time
周期
1 *Toxicological risk assessment (TRA)-on the formulation
毒理学风险评估(TRA) - 基于配方 		Mandatory in ACD
东盟化妆品指令强制要求 		Review the hazard, exposure and risk on the full ingredient and evaluate the safety of the product by a Toxicologist
由毒理学家审查所有成分的危害、暴露和风险，并评估产品的安全性 		10 working days after all required information have been collected
在收集所有所需资料后10个工作日内
2 *Product Information File(PIF)
产品信息文件 		Mandatory in ACD
东盟化妆品指令强制要求 		Documentation of the submitted product information
提交的产品信息的文档 		14 (after all required information is received)
在收集所有所需资料后14个工作日内
3 Microbial contamination
微生物污染测试 		Mandatory in ACD
东盟化妆品指令强制要求 		需氧菌落总数及霉菌和酵母的限量要求：
三岁以下的儿童产品；用于眼部和粘液膜部位的产品–不超过500 cfu/g or ml
其他产品–不超过 1000 cfu/g or ml
致病菌（金葡、铜绿、白念）不得检出 		EP 9.0 2.6.12 and 2.6.13 / BP 2017/ USP 40 chapter 61&62 7 工作日
4 *Efficacy of antimicrobial
preservation
防腐性能测试  		Mandatory in ACD
东盟化妆品指令强制要求 		>99.9% on Day 7 and No increase on Day 14, 21 & 28 for bacteria and Candida albicans
>90% on Day 28 and No increase on Day 7,14, 21 & 28 for Aspergillus niger
细菌和白色念珠菌在第7天达到99.9%，在第14、21和28天没有增加
黑曲霉第28天90%，第7、14、21和28天无增加 		ASEAN method 35-40工作日
5 Heavy metal contamination
(Pb, Cd, Hg, As)
重金属污染测试（铅、汞、砷）  		Mandatory in ACD
东盟化妆品指令强制要求 		Pb:20mg/kg
As:5mg/kg
Hg:1mg/kg
Cd:5mg/kg (for Thailand, 3mg/kg) 		refer to ACMTHA05, analysis was performed by ICP MS,
MDL=0.5mg/kg for each item 		7 工作日
6 1,4-dioxane
1,4-二氧六环 		Mandatory in ACD
东盟化妆品指令强制要求 		NMT 25 mg/kg or 25 mgl/L (25ppm), effective
19 June 2020
NMT 10mg/kg or 10mg/L (10ppm), effective
19 June 2023 		STSC 2015 HS-GC-MS,
MDL=1mg/kg 		7 工作日
7 *Ingredient and Package
Label Review
成分审核、包装标识评估 		Mandatory in ACD
东盟化妆品指令强制要求 		Review the Full ingredient and package label based on the regulatory requirement, against those prohibited and restricted listed in the regulation
根据法规中列出的禁止和限制的内容，审查全成分和包装标签 		10 working days after all required information have been collected
在收集所有所需资料后10个工作日内
8 Stability test-At least test for 3 month
稳定性测试-至少测试3个月 		Quality assurance
质量保证条款 		on request
9 Lead, cadmium, mercury and chromium (VI) on container
容器上的铅、镉、汞和六价铬 		Quality assurance
质量保证条款 		In house method 7 工作日
high risk chemical test
高风险化学试验
10 Methanol-for products contain ethanol or isopropyl alcohol
甲醇-用于含有乙醇或异丙醇的产品 		Quality assurance
质量保证条款 		5 % (as a % ethanol and isopropyl alcohol) for denaturant for ethanol and isopropyl alcohol
5%(以%乙醇和异丙醇计)为乙醇和异丙醇变性剂 		STSC 2015, HS-GC-MS
GC-FID/GC-MS, MDL=50 mg/kg 		7 工作日



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