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俄罗斯保健品注册,俄罗斯滋补品注册,俄罗斯保健食品注册,State Registration,俄罗斯保健药品注册

 海关联盟国家注册证书(SR-CU)
State Registration certificate
海关联盟介绍(Таможенный союз)
2007年10月6日成立海关联盟,成员国为:白俄罗斯、哈萨克斯坦和俄罗斯。海关联盟理事会是国家元首和政府首脑间组成的最高水平的权利机构。
海关联盟国家注册证适用已经是5个国家:亚美尼亚和吉尔吉斯,俄罗斯、白俄罗斯、哈萨克斯坦
 Белоруссии, Казахстана и России, Армении и Киргизии
 
 海关联盟主要海关法规:2009年11月27日,俄罗斯、白俄罗斯和哈萨克斯坦三国元首共同签署了包括《海关同盟海关法典》在内的9个文件。俄罗斯已新修订的《关税同盟海关法典》取代原来的《海关法典》。《关税同盟海关法典》的有关规定基本符合《WTO海关估价协议》的要求。
 
海关联盟市场准入要求: 
 英文:State Registration Certificate within the Territory of the Custom Union也简称海关联盟SR-CU国家注册证。从2010年7月1日开始,由于关税同盟(俄罗斯 、哈萨克斯坦 、 白俄罗斯)成立,卫生证书(卫生流行病学结论)统一被海关联盟国家注册证书取代。
 
 
国家注册证书法规生效日:2010年7月1日开始
 
国家注册证书有效期:无限期
 
国家注册证书适用范围:关税同盟(俄罗斯 、哈萨克斯坦 、 白俄罗斯、亚美尼亚,吉尔吉斯坦)任何国家和区域。
 
国家注册证书申请公司:任何公司均可以持证
 
国家证书签发机构: 俄罗斯卫生部,哈萨克斯坦卫生部,白俄罗斯卫生部,亚美尼亚卫生部、吉尔吉斯坦卫生部
 
 
保健品和生物活性添加剂适用的法规为:
 
ТР ТС 021/2011 О безопасности пищевой продукции关于食品的安全性 2013.7.1
ТР ТС 027/2012 О безопасности отдельных видов специализированной пищевой продукции, в том числе диетического лечебного и диетического профилактического питания关于一些专门食品,如食疗食品以及饮食预防营养品的安全性 2013.7.1
ТР ТС 029/2012 Требования безопасности пищевых добавок, ароматизаторов и технологических вспомогательных средств食品添加剂,香料和加工助剂安全性要求 2013.7.1
 
 
认证时间:工业化学品1-2个月,其他产品3-4个月;
 
测试样品:需要
 
需要的文件:
1、委托书(样本可提供)
2、由第三方颁发的证书,证明产品的安全性(自由销售证书,健康证书)
3、组件的百分比和/或制定的成分组成
4、产品规格(膳食补充剂的包装上的信息+描述)
5、制造商测试协议(如果有)
6、原产地标签
7、生产技术方案 - 如果
8、合格证书/ GMP标准生产和/或国际标准化组织(ISO)和/或HACCP——存在 - 
9、样品(4 /200克,每件)
10、 制造商出具的,申明无PD农药,激素,精神药品、振奋剂,使用转基因生物和纳米技术——可以自己编写
11、联邦注册实体公司代理副本+加盖表格
12、带有表明海关允许进口标志的样品发票(任何运输文件)
 
 Required documents: 
1. Power of Attorney (sample available) 
2. A certificate issued by a third party, certifying the safety of products (certificates of free sale, certificate of health) 
3. Ingredient composition with the percentage of components and / or formulation 
4. The specification for the product (information on packaging of dietary supplements + description) 
5. Test protocols from the manufacturer (if available) 
6. Original Label 
7. Technological scheme of production - if 
8. Certificate of Conformity / Declaration of GMP standard production and / or ISO and / or HACCP - the presence of 
9. Samples (200 g / of 4. Per item) 
10. The declaration of the manufacturer in the absence of PD pesticides, hormones, psychotropic drugs and potent substances and ingredients derived from GMOs and the use of nanotechnology - can prepare themselves 
11. copy extracts from the Unified State Register of legal entities of the firm by proxy + stamped sheets or 
12. Invoice (any transport document) for the samples with a mark of customs that allowed importation 
 
 
 
其他饮用水消毒化学品和保健品等管制产品要求提供资料:
1、企业需要提供英文或俄文的:MSDS (Material Safety Data Sheet)即化学品安全说明书,亦可译为化学品安全技术说明书或化学品安全数据说明书
2、申请书
3、营业执照、组织代码证、生产许可证(需要俄罗斯驻中国大使馆公证)
4、俄文产品使用说明书
5、质量管理体系证书(HACCP食品安全管理体系,BRC,ISO-22716化妆品行业国际标准,ISO 22000食品安全管理体系,GMP标准,欧盟饲料添加剂预混料质量体系(FAMI QS))
6、制造商生物相容性申明。制造商关于存在基因工程、纳米材料、激素、食品中的农药改变生物体的申明;
7、俄文外包装(必须);
8、商标注册证书(没有可以不提供)。
9、正本或特定生物活性添加剂在食物中使用的文件的副本(含不明成分的,非正式的信件),保证与所在国家注册的一致;
10、毒理分析报告。
11、自由销售证书
12、研究(测试)的协议,科学报告,专家判断和论文
 
 
State Registration Certificate within the Territory of the Custom Union
 
свидетельство о государственной регистрацииFrom now on, the state registration certificate of the Custom Union (CU SRC) will be a document proving compliance of products with sanitary and epidemiological regulations and will be valid within the territory of three countries of the Custom Union (the Russian Federation, the Republic of Belarus and Kazakhstan), and will replace the sanitation and epidemiological conclusions (as a result of the Custom Union Agreement on sanitary measures adopted on 01.07.2010).
 
Execution of state registration certificates of the Custom Union
 
The certificate confirming product safety is issued by the Federal Supervision Agency for Customer Protection and Human Welfare according a small list of products. This procedure can be carried out by territorial bodies of the Rospotrebnadzor.
 
 
 
The following parties can be the applicant party for an execution:
 
The manufacturer (producer) of goods in case of product registration produced in the territory of the Custom Union;
The manufacturer (producer) or importer (producer) of goods in case of product registration produced outside the territory of the Custom Union.
The applicant party can contact Rospotrebnadzor or use the services of an accredited certification body.
 
A period of the certificate execution cannot exceed 30 days from the date of the applicant party’s inquiry.
 
An order of execution includes the following steps:
 
reception and registration of applications;
expertise of the submitted set of documents and the results of laboratory tests of the registered good of conformity of uniform sanitary requirements;
coordination of the required data with the Party’s legislation (the party of the Custom Union), where the registration is carried out;
entry of data about registered goods to the Register of state registration certificates;
Execution and issuance of a certificate.
The customer should provide the required set of documentation along with an application for a certificate. The documents in a foreign language must be provided with a notary certified translation and have an Apostille.
The cost of certificates and declarations execution can be verified by a shanghai SEC manager.
 
The following products are subject to the official registration in the territory of the Custom Union:
 
Mineral water, bottled drinking water, tonic beverages and alcoholic products;
Specialized food products including infant food, dietetic foods, sport nutrition; BAAs to food, raw materials for BAAs production, organic products.
The food products received by means of usage of genetically modified organisms.
Beauty care products, goods and items of oral hygiene.
Disinfecting, delousing and exterminating products.
Household products.
Hygiene items for children and adults.
Goods designed for a contact with a food (except housewares, eating utensils and process equipment) and others.
The full list is on the Federal Supervision Agency for Customer Protection and Human Welfare website (www.rospotrebnadzor.ru)
 
What document should be executed if the products are not included on the list of the official registration of the Custom Union, but has been subject to sanitary-epidemiological expertise earlier?
A document confirming the product’s compliance with applicable requirements is necessary for current products. Therefore, a GOST R declaration of conformity must be executed with the participation of a third party (a testing laboratory or certification body).
 
 Компания: «Shanghai Economic Cooperation Industrial Equipment Testing Co.,Ltd.»
海关联盟官方中国公司:上海经合工业设备检测有限公司
Телефон: 0086-021-36411223  61498039 
Факс: 0086-021-61498001 
Контактное лицо: Lingcheng YU   18621862553
E-mail: eac@cu-tr.org   gost@gost.org.cn   
skype:gostchina  
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Msn:gost-r@msn.com
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