EAC认证集团(俄罗斯认证测试中心)中国代表处
ОБЩЕСТВО С ОГРАНИЧЕННОЙ ОТВЕТСТВЕННОСТЬЮ "ТЕСТ СЕРТ"
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我们专业开展海关联盟trcu认证(EAC认证),俄罗斯(GOST认证,俄罗斯防火认证,俄罗斯计量认证,俄罗斯医疗器械认证,保健品化妆品食品注册认证)乌克兰(乌克兰技术法规认证,乌克兰卫生证书,乌克兰医疗器械注册),哈萨克斯坦(GOST-K认证,计量认证,GGTN许可,豁免函,医疗器械注册),乌兹别克斯坦认证,乌兹别克斯坦医疗器械注册
海关联盟国家卫生注册证书(state hygienic registration certificate)-SGR
国家卫生注册证书-state hygienic registration certificate(也称为 SGR)确认产品符合欧亚经济联盟卫生法规。
2010年7月1日实行国家卫生注册(state hygienic registration certificate)。
从那时起,国家卫生注册-state hygienic registration certificate取代了俄罗斯卫生证书。在 EAEU 中引入了统一国家注册程序是确认产品对人类健康的安全性符合卫生流行病学和卫生要求。
法律框架
根据2010年5月28日欧亚经济联盟第299 号决议“关于在关税同盟实施卫生措施”,俄罗斯联邦、白俄罗斯和哈萨克斯坦关税区对货物实施了统一的卫生流行病学和卫生要求接受国家卫生流行病学监督。
在俄罗斯,国家卫生注册-state hygienic registration certificate和生产数据评估证书的颁发由联邦消费者保护和消费者权利监督局 (Rospotrebnadzor) 负责。注册义务以《单一货物清单》中所列的所有产品为依据,根据欧亚经济联盟的决定,在关税同盟的海关边境和关税区作为相应货物接受卫生和流行病监管(控制) 2010 年 5 月 28 日第 299 号。没有货物的国家卫生注册证书,就无法申请EAC证书或EAC声明,从而无法将产品进口到关境。
Rosstandart 或 Rospotrebnadzor 认可的认证机构负责颁发国家注册证书-state hygienic registration certificate。注册程序包括对制造商文件的分析以及实验室测试,在某些情况下,还包括对生产的检查。所有国家卫生登记证书都登记在一个统一的登记册中并保存在那里。
在俄罗斯、哈萨克斯坦和白俄罗斯之间的关税同盟中,产品国家卫生注册证书(state hygienic registration certificate)有效期为无限期。
国家卫生注册证书(state hygienic registration certificate)可由进口商和制造商申请。
应用领域
根据2010年5月28日 EAEU第 299号的决定,以下产品需要注册:
饮料
化妆品
卫生产品
日用化学品
油漆、清漆、腻子、底漆等。
儿童服装
3岁以下儿童产品
特殊食品包括婴儿食品、孕妇食品、减肥食品、运动员食品
来自转基因生物的食物
食品补充剂
需要注册的产品的完整列表可在此处获得。
SGR注册流程
注册是在技术文件和经认可的测试机构提供的测试报告的分析基础上进行的,也可能在现场生产审核的基础上进行。
通常,SGR注册过程包括以下步骤:
步骤:向EAEU认可的认证机构提出申请
步骤:认证机构审核文件,选择认证方案
步骤:产品分类和样品选择
步骤:测试
步骤:制造审核(如果技术法规提供)
步骤:颁发SGR注册证书
步骤:认证产品的监督(如果需要)
SGR国家卫生注册证所需文件:
申请国家登记证书需要以下文件:
注册申请
MSDS 安全数据表
详细的产品描述,用户手册
数据表
带有消费者信息的标签副本
有关制造商及其地址的信息
产品组成(百分比)
现有证书:ISO、DIN、CE、CB
产品样品
根据认证产品的类型,可能需要额外的文件和证书。
所有文件必须翻译成俄文并经过公证。
在对指定机构中的所有文档和测试报告进行分析后,将对结果进行评估。
符合要求的国家卫生注册证书(state hygienic registration certificate),并进入国家卫生部统一登记册。
The certificate on the state hygienic registration (also called SGR) confirms the conformity of the products with the sanitary-hygienic regulations of the Eurasian Economic Union.
The state hygienic registration was introduced on July,1 2010.
Since then, the state hygienic registration has replaced national systems of hygienic certification. This has resulted in the introduction of an uniform procedure in the EAEU which confirms the safety of products for human health and compliance with sanitary-epidemiologic and hygienic requirements.
Legal framework
In accordance with the decision of the EAEU № 299 of 28.05.2010 "On application of sanitary measures in the Customs Union" in the customs territory of the Russian Federation, Belarus and Kazakhstan, uniform sanitary-epidemiologic and hygienic requirements have been introduced for goods which are subject to sanitary-epidemiological supervision.
In Russia the issuing of certificates on the state hygienic registration and evaluation of the production data is carried out by the Federal Service for the supervision of consumer protection and consumer rights (Rospotrebnadzor). The obligation to register is subject to all products listed in the Single List of Goods, subject to sanitary-and-epidemiologic supervision (control) on the customs border and customs area of the Customs union as corresponding goods in accordance with the decision of the EAEU № 299 of 28.05.2010. Without the certificate on the state hygienic registration of the goods, it is impossible to apply for an EAC Certificate or an EAC Declaration and thus to import the products into the customs territory.
The certification authorities accredited by Rosstandart or Rospotrebnadzor are responsible for issuing certificates of state registration. The registration procedure includes an analysis of the manufacturer's documentation as well as laboratory tests and, in some cases, an inspection of the production. All certificates of state hygienic registration are entered in a uniform register and kept there.
The certificate on the state hygienic registration of products is unlimited in the customs union between Russia, Kazakhstan and Belarus.
The certificate of the state hygienic registration can be applied for by the importer and by the manufacturer.
Application area
Regarding the decision of the EAEU № 299 of 28.05.2010 the following products are subject to registration:
drinks
cosmetics
products of body hygiene
household chemicals
paints, varnishes, putty, primers, etc.
clothing for children
products for children under 3 years
special food including baby food, food for pregnant women, dietary food, food for sportsmen
food from genetically modified organisms
food supplements
The complete list of products subject to registration is available here.
The procedure of SGR registration
The registration is carried out on the analytical basis of the technical documentation and the test report provided by accredited test bodies, and possibly on the basis of an on-site a production audit.
As a rule, the SGR registration process consists of the following steps:
Step: Application to an accredited certification body in the EAEU
Step: Examination of the documents by the certification body and selection of the scheme of EAC certification
Step: Classification of the products and selection of samples
Step: Tests and examinations
Step: Manufacturing audit (if provided by the Technical Regulation)
Step: Issuance of the EAC certificate
Step: Surveillance of the certified products (if required)
Required documents
We develop and translate the technical documentation, which is needed for EAC Certificat or EAC Declaration according to technical regulations
The following documents are required to apply for the certificate on the state registration:
application for registration
SDS Safety Data Sheet
detailed product description, user manual
data sheet
copies of the labels with information for consumers
information about the manufacturer and his address
composition of products (in percentages)
existing certificates: ISO, DIN, CE, CB
product samples
Depending on the type of certified products, additional documents and certificates may be required.
All documents must be translated into Russian and notarized.
After analyzing all documentation and test reports in a notified body, the results are evaluated.
If the product meets the requirements, a certificate on the state hygienic registration is handed over and the product is entered into the uniform register.
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俄罗斯测试认证中心中国代表处
ОБЩЕСТВО С ОГРАНИЧЕННОЙ ОТВЕТСТВЕННОСТЬЮ "ТЕСТ СЕРТ"
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