Rospotrebnadzor 卫生证书要求
Q:Will the Sanitary-Epidemiological conclusions and the certificate of the Government registration given out before July 1st 2010 operate on the territory of the Russian federation?2010年6月1日前颁发的政府
注册证书和
卫生学结论会在俄罗斯联邦领域内适用吗?
A: Yes, they will operate on the territory of the Russian federation till January 1st 2012. Their operation won’t extend on the territory of other state-participants of the customs union. Besides, possibility of obtaining documents, which were standing out earlier for acknowledgment of conforming of production with safety requirements according to the national legislation of one of the states-parties (the certificate of the Government registration) for application only on territory of the state which have given out such document, will be retained till January 1st 2011. 是的,直到2012年1月1日前都适用。他们的运作不会在其他关税同盟参与国的领土内扩展。可能获得的文件,其中常设早前为符合安全生产要求的确认根据的国家缔约方(政府注册证书申请一个国家的立法)只能在已获得国家领土出这样的文件,将保留至2011年1月1日。
Q:What documents, confirming safety of production, will be issued since July 1st 2010? 从2010年7月1日开始,关于安全生产确认,什么文件为颁布?
A: Certificates of the Government registration of the Customs Union, valid for the whole territory of the state-participants of the Customs Union, will be issued since July 1st. Possibility of obtaining the certificates of the Government registration according to the legislation of the Russian Federation is also retained till January 1st 2011. 关税联盟参与国领域内有效的关税联盟政府注册证书将会在7月1日颁布适用。根据俄罗斯联邦立法,国家注册证书可能获得的文件将保留至2011年1月1日。
Q:Who can be the applicant on obtaining of the certificate of the Government registration of the customs union? 谁能成为获得关税联盟国家注册证书的申请者?
A: The applicant can be: 申请者可以是:
For products made on customs territory of the Customs Union- the producer (manufacturer) of the products; 关税联盟领域内生产的产品-产品生产商(制造商)
For products made beyond the customs territory of the Customs Union - the producer (manufacturer), the supplier (importer) of the products. 关税联盟外生产的产品-生产商(制造商),产品供应商(进口商)
Q:What products are subject to the Government registration on the territory of the Customs Union? 关税联盟领域内政府注册的产品有哪些?
A: The following products are subject of the Government registration: 以下产品在政府注册范围内:
Mineral water (natural-table mineral waters, medicinal-table, medicinal), bottled drinking water, packaged in capacity (including for use in baby food), tonics, alcoholic production, including low alcohol production, beer. 矿泉水(天然矿泉水表,药用表,药用),瓶装饮用水,包装能力(在婴儿食物中使用含),滋补品,酒类生产,包括生产低酒精啤酒。
Specialized foodstuff, including products of baby food, products for pregnant and feeding women, products dietary (medical and preventive)a food, products for a food of sportsmen (further - specialized foodstuff); biologically active additives to food, raw materials for manufacture of biologically active additives to food, organic products. 专业食品,包括婴儿食品,孕妇和哺乳期妇女,饮食产品(医疗和预防)食品,运动员食品产品(深加工食物);生物活性添加剂,生产原料食品生物活性添加剂,有机产品。
The foodstuff received with use of transgenic organisms, including genetically modified microorganisms.转基因生食物,包括转基因微生物
Food additives, complex food additives, flavours, vegetative extracts as flavor substances and raw components, starting cultures of microorganisms and bacterial ferments, technological auxiliary means, including fermental preparations. 食品添加剂,复合食品添加剂,香料,作为原料成分和风味物质,微生物和细菌开始发酵,技术辅助手段,包括发酵提取物制剂的文化营养。
Cosmetic production; means and products of hygiene of an oral cavity. 化妆品生产;口腔卫生产品和方式
Disinfectants, pest and deratization tools(for using in home, in hospitals and other facilities (except used in veterinary medicine)). 消毒剂,虫害和灭鼠工具(在家里、医院和其他场所使用,兽医用药除外)
The household chemical goods. 日用化工品
Potentially dangerous chemical and biological substances and the preparations made on their basis representing potential danger to the person (except medical products),the individual substances (compounds) of natural or synthetic origin capable in conditions of production, use, transportation, processing, and also in living conditions have adverse effects on human health and the environment. 有潜在危险的化学和生物物质以及他们代表的潜在危险的人的基础上所作的准备工作,(医疗产品除外),天然或人工合成的个人物质(化合物),使用,运输,加工,生活条件中对人类健康和环境产生不利影响。
Materials, equipment, devices and other technical means of water preparation intended for use in systems of drinking-water supply. 材料,设备,装置和其他技术制备的以饮用水供应系统的使用为目的的手段。
Subjects of personal hygiene for children and adults; subjects of children's use till three years: ware and the products used for a food of children, subjects of hygienic care of the child; clothes for children (the first layer).儿童和成年人的个人卫生科目; 3年以内儿童的科目:儿童食品和洁具,对儿童卫生保健的对象所使用的产品,儿童服装(第一层)。
11. The products intended for contact to foodstuff (except ware, dining facilities, the process equipment). Import and the reference of the products specified in points 1 – 11 of this section is carried out in the presence of a document confirming their safety according to points 17 and 30 of the Procedure for Government Sanitary and Epidemiological supervision (control) of persons and vehicles, crossing customs border of the customs union, products moved through the customs border of the customs union and on the customs border of the customs union. 为了接触到食品的产品(不包括洁具,餐饮设施,工艺设备)。本节1-11点指定的产品和进口,根据政府对人员和车辆的卫生和流行病监督(控制)第17和30点要求,在穿越关税联盟边境时,产品通过关税联盟边境,以其在关税联盟边境,出示文件确认其安全性。
• Q: What documents will be issued on products which was subject to Sanitary-Epidemiological expertise with delivery of the Sanitary-Epidemiological conclusions, but now is not included in the list of products which are subject to the Government registration on territory of the customs union?产品需要什么文件?这些产品之前属于卫生-流行病学,递交卫生-流行病学结论,但是现在不包含在关税联盟领域内的政府注册名单之内。
A: For such products the documents confirming the accordance will be issued: principally-declarations of the conformity, made with third party attraction. 这些产品需要签发一致性文件::主要-一致性申明,受第三方的吸引
cost of registration preliminary 1500EUR - one month + test reports 4000 EUR - work for lifetime in Russia Belarus Kazakhstan
初步登记费用1500EUR - 1个月+测试报告4000欧元 –俄罗斯 白俄罗斯,哈萨克斯坦可以使用
如果制作注册证书,GOST R证书将不需要。
样品测试可豁免?不,这产品不是..我希望它能够在未来更便宜,因为没有注册签发...只有少数实验室在做这些测试。
是的,新的法律将在不久后申效,但不是现在。
cost of registration preliminary 1500EUR - one month + test reports 4000 EUR - work for lifetime in Russia Belarus Kazakhstan
if make registartion, gost r certificate is not needed
for other products which were health certificate will be health declaration - but no info from government right now
Can be exempted the sample test?no, for this products no.. i hope it could get cheaper in the future, as no registrations was issued it... and only few labaratories are doing these tests
yes, new laws should work normally soon. but not now\
propilenglicol - the price for the registration will be 2500EUR, including tests - but that's not for sure preliminary
certificate works for 3 countries for long life until some new laws .. time from 3 to 4 months
and the samples will be needed
propilenglicol - 为注册价格将2500EUR,包括测试 - 但这不是初步肯定
3长寿的国家证书工程,直至一些新的法律..时间从3至4个月
和样品将需要
samples in case it's a liquid 500 ml..
要求资料:
1. reference info about device including all technical data, field of use, the principal of use, farmacological effects and so on. 2. document about company registration in china 3. power of attorney 4. every international certificates, licenses, declarations. 5. EMS test reports, test reporst about medical features (from two independant oranisations), toxicological tests 6. manual 7.manual for customer use