This section is entirely devoted to the registration of goods in the bodies of Rospotrebnadzor of the Customs Union with the registration of a Certificate of State Registration (SGR).
In the territory of the Russian Federation, the main document confirming the compliance of products with hygienic and sanitary-epidemiological requirements until 2010 was the sanitary-epidemiological conclusion (SEZ). Since the entry into force of the Agreement on sanitary measures of the Customs Union on 01.07.2010, the document that essentially replaced the FEZ was the Certificate of State Registration (SGR).In the territory of the Russian Federation, the main document confirming the compliance of products with hygienic and sanitary-epidemiological requirements until 2010 was the sanitary-epidemiological conclusion (SEZ). Since the entry into force of the agreement on sanitary measures of the Customs Union on 01.07.2010, the document that essentially replaced the FEZ was the Certificate of State Registration (SGR).
The SRS is valid on the territory of the entire customs union and is issued for compliance with the Unified Sanitary Rules.
The full list of products is approved and published on the website www.rospotrebnadzor.ru
Not all goods produced and put into circulation on the territory of the Customs Union are subject to state registration, but only those included in the list of goods subject to registration.
- Specialized food products: dietary supplements (raw materials for the production of dietary supplements), dietary and diabetic food, baby food, sports nutrition, organic products;
- Mineral (medicinal and table) water, alcoholic beverages, tonic drinks;
- Food products obtained using genetically engineered organisms;
- Household chemicals products;
- Cosmetics with an active effect on the skin (scrubs, peels, bleaching and coloring agents, etc.);
- Personal hygiene items for children and adults;
- Disinfection, disinfection and deratization products;
- Products intended for contact with food (except for technological equipment, dishes, and cutlery);
- Consultation on registration;
- Assistance with importation and proper registration of samples;
- Registration and submission of an application for product testing;
- Assistance in preparing a package of documents for registration;
- Getting an expert opinion;
- Submission of documents for registration;
- Receiving the SRS and transmitting it to the Customer
- Conducting laboratory tests;
- Making an expert opinion;
- Registration of a certificate of state registration.
- Applicationfor registration;
- Product safety documents (safety data sheet, MSDS or similar);
- Composition documents (specification, composition certificate, INCI);
- Sample of marking for compliance with the requirements of the Customs Union;
- Documents on the basis of which the product is produced (TU, SRT, GOST, GMP, ISO, HACCP);
- Other documents provided for this type of product.
Regulatory documentation:
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Dietary supplements and special nutrition
Biologically active additives are a set of biologically active substances used as an additive to food or introduced into its composition. Dietary supplements are not a medicine in the traditional sense, but they provide the human body with the necessary substances, thereby normalizing and improving the condition of certain internal organs, as well as reducing the risk of occurrence and development of a wide range of diseases.
Special nutrition includes products such as:
Sports nutrition (contains vitamins and minerals that exceed the daily consumption standards established by law);
Baby food (more stringent standards for acidity and other indicators apply to the diet of children of different ages than is provided for the diet of adults);
Nutrition for pregnant and lactating women (contains a special complex of nutrients necessary for recovery or additional nutrition of the body)
Dietary and diabetic nutrition (the composition of these products allows you to achieve the necessary results with the right diet to normalize the metabolic processes in the body)
The procedure for registration of dietary supplements and other special nutrition is very similar in its essence and contains the same stages and has a similar set of documents.
- Collecting documents
- Analysis of the composition for patency by indicators of admissibility
- Analysis of required documents and their sufficiency
- Creating an application
- Referral for research
- Interaction with the laboratory
- Making a decision to the Council
- Expert opinion
- Certificate of state registration.
- Microbiological indicators
- Content of toxic elements
- Pesticides (for dietary supplements with plant components)
- Acceptable levels of radionuclides
- Confirmation of the required amount of biologically active substances
- Other indicators provided for the declared composition
The standard period of testing/examination of dietary supplements is 60 days, registration-30 days, provided that the experts do not comment on the submitted documents.
Only approved components can be used as biologically active substances in dietary supplements. The component is approved for use in dietary supplements if it:
The SGR has no expiration date, but the same product can only be registered once! (you can't get a CGR for the same dietary supplement from the same manufacturer twice).
For the purpose of issuing a document confirming the safety of products, the following documents are submitted, unless otherwise provided by the technical regulations of the Customs Union:
For products manufactured in the customs territory of the Customs Union.
For controlled goods manufactured outside the customs territory of the Customs Union.
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Государственная регистрация химикатов.
Вся бытовая и многая промышленная химия, которая производится или продается на территории страны и в рамках Таможенного Союза, обязательно проходит процедуру государственной регистрации с выдачей Свидетельства о государственной регистрации (СГР). Это необходимая мера, без которой невозможна продажа и экспорт товаров этой группы. Выдача Свидетельства о государственной регистрации (СГР) указывает на полную безопасность изделия, а также на соответствие его состава заявленным характеристикам и принятым в ТС нормам.
Изделия, подлежащие госрегистрации, указаны в техрегламентах и во втором перечне Решении КТС №299 от 28.05.2010 года.
- бытовая химия (чистящие, моющие, отбеливающие, дезинфицирующие средства);
- полироли;
- клеевые составы;
- текстильные красители;
- освежители;
- косметическая продукция (краски для волос, реагенты для химической завивки, краски для татуажа, пилинги, средства интимной гигиены и ухода за ротовой полостью, детская косметика и другие товары согласно Приложению №12 ТР ТС 009/2011);
- лечебное диетическое и спортивное, детское питание в виде смесей, пюре, пищевые продукты для кормящих и беременных женщин, пищевые добавки и другие виды специализированного питания (ТР ТС 021/2011);
- детские изделия: соски, зубные щетки, средства индивидуального ухода, белье первого слоя для малышей и некоторые другие изделия (ТР ТС 007, ТР ТС 017).
- Специализированное спортивное питание подлежит обязательному санитарно-эпидемиологическому контролю. Для реализации подобной продукции необходимо получить свидетельство о государственной регистрации, которое будет подтверждать безопасность состава спортпита и возможность употребления питания в пищу. Получение СГР на спортивное питание
Свидетельство о государственной регистрации является официальным документом, который выдается органами Роспотребнадзора и подтверждает соответствие продукции санитарно-эпидемиологическим и гигиеническим требованиям к подконтрольным товарам.
Единый реестр был создан с целью передачи информации об оформленных СГР в общий доступ. Благодаря реестру процесс регулирования торговли на территории ЕАЭС существенно упрощается, а государственный контроль ведется более эффективно. За формирование и своевременное обновление единого реестра отвечает специальная комиссия.
Срок действия – государственной регистрации химии бессрочно
Заявителем может любое юридическое лицо или индивидуальный предприниматель, зарегистрированные на территории ЕАЭС. Остальным контрагентам потребуется действовать через представителя-резидента экономического союза.
Занимает около 1,5 месяцев, так как требует сбора большого количества документов. Выдается СГР однократно на весь период промышленного изготовления или поставок спортпита.
- Подготовка досье и образцов продукции для испытаний с целью государственной регистрации
- Лабораторная экспертиза образцов продукции
- Оформление протоколов испытаний и экспертного заключения
- Подача досье и экспертного заключения в Роспотребнадзор для целей государственной регистрации продукции
- Получение свидетельства о государственной регистрации
- Заявка;
- Нормативный документ (ТУ, ГОСТ, СТО и т.д.);
- Рецептура или состав;
- Паспорт безопасности -Изготовление Паспорта (Сертификата) входит в обязанности той фирмы, которая производит данный химический товар, поэтому на одно и то же вещество можно обнаружить несколько документов MSDS.
- Договор аренды на производственное помещение либо право собственности;
- Регистрационные документы (ОГРН, ИНН, выписка из ЕГРЮЛ);
- Этикетка в соответствии с едиными требованиями;
- Техническое описание;
- Список может быть неокончательным для ряда продуктов
- Заявка;
- Паспорта безопасности продукции (MSDS);
- Этикетка в соответствии с едиными требованиями;
- Техническое описание/TDS;
- Документы системы менеджмента качества при наличии;
- Иные документы предусмотренные законодательством.
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Perfume and cosmetic products
Perfume and cosmetic products are substances or mixtures of substances intended to be applied directly to the external human skin (skin, hair, nails, lips and external genitalia) or on the teeth and oral mucosa with the sole or main purpose of cleaning them, changing their appearance, giving a pleasant smell, and/or correction of body odor, and/or protection, and/or maintenance in good condition, and/or care for them.
- TR CU 009/2011
- Perfume and cosmetic products for artificial tanning;
- Perfume and cosmetic products for skin lightening and whitening;
- Cosmetics for tattooing;
- Cosmetic products for intimate hygiene;
- Perfume and cosmetic products intended for individual protection of the skin from harmful industrial factors;
- Cosmetics intended for children under 14 years of age;
- Perfume and cosmetic products used for chemical coloring, lightening and highlighting of hair;
- Perfume and cosmetic products intended for perming and straightening hair;
- Perfumery and cosmetic products, in the manufacture of which nanomaterials were used;
- Products for removing unwanted body hair (for depilation);
- Peels;
- Fluoride-containing products intended for oral hygiene that contain fluorides (if the mass fraction of fluorides exceeds 0.15%, for liquid oral hygiene products-0.05%);
- Oral hygiene products made on the basis of hydrogen peroxide, including urea peroxide and zinc peroxide, which emit hydrogen peroxide, and designed to whiten tooth enamel.
- Preparation of dossiers and product samples for testing for state registration;
- Laboratory examination of product samples;
- Preparation of test reports and expert opinion (for state registration purposes);
- Submission of dossiers to Rospotrebnadzor for state registration of products;
- Obtaining a certificate of state registration.
The period for obtaining state registration of cosmetic products is from 1 to 3 months, depending on the tests performed.
- Application
- Regulatory document (TU, GOST, SRT, etc.);
- Recipe;
- Label (front and back) in an electronically editable format;
- ISO/GMP Certificate;
- Product Description;
- Lease agreement for production areas or ownership rights;
- Registration documents (OGRN, TIN, extract from the Unified State Register of Legal Entities);
- Quality certificate from the manufacturer
- Application
- Formulation (INCI indicating the percentage of content);
- Label (front and back sides) in electronic editable format in Russian according to the requirements of TR CU 009/2011;
- ISO/GMP Certificate;
- Product description, required.;
- Registration documents for the importer (OGRN, TIN, extract from the Unified State Register of Legal Entities);
- Agreement (contract) for the supply of products;
Regulatory documentation:
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Пищевая добавка
Пищевая добавка – это соединение натуральных и искусственных ингредиентов с целью придания пище определенных свойств. Зачастую добавки используют в качестве источника витаминов, микроэлементов и др. веществ.
Наша компания имеет многолетний опыт взаимодействия соосуществляющей настоящие регистрационные действия, позволяющий выполнять работы на самом высоком уровне.
На территории Евразийского экономического союза регистрацию пищевой добавки осуществляет в РФ Федеральная служба Роспотребнадзора.
Срок получения свидетельства о государственной регистрации примерно 2- 3 месяца.
Срок действия свидетельства о регистрации – бессрочно.
Оформлять СГР необходимо до начала производства или же до подписания договора об импорте добавок.
- - заявка;
- - копии учредительных документов (ИНН, ОГРН, Статистика, Устав, договор аренды производственного помещения, выписка из ЕГРЮЛ);
- - нормативный документ по которому производится пищевая добавка (ТУ, ГОСТ, СТО);
- - технологическая инструкция;
- - информация по составу и по применению пищевой добавки (если это не указано в ТУ);
- - макет этикетки;
- - образцы продукции.
- - заявка;
- - спецификация на пищевую добавку (перевод обязательно);
- - сертификат свободной торговли (FreeSale) либо, сертификат государственных органов подтверждающих безопасность пищевой добавок (перевод обязательно);
- - информация по составу и применению пищевой добавки (перевод обязательно);
- - макет этикетки;
- - образцы продукции;
- - CMR инвойс с отметкой Роспотребнадзора о том, что образцы разрешены для ввоза на территорию России.
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Expert opinion of Rospotrebnadzor
For products that are not subject to state registration and are not included in the list of products subject to state sanitary and epidemiological supervision (control), you can get a voluntary expert opinion (EZ) issued in the Russian Federation by Rospotrebnadzor.
Expert opinion of Rospotrebnadzor – a document that confirms the compliance of products with the unified sanitary, epidemiological and hygienic requirements for products.
Execution of an expert opinion is carried out within 7 days to 1.5 months from the date of submission of documents to Rospotrebnadzor.
An expert opinion is a perpetual document issued for an indefinite period. Despite the indefinite validity of this document, please keep in mind that in some cases it needs to be updated:
- Changes to the manufacturer's address.
- Name change.
- Complete or partial reorganization.
- Transition to another field of activity.
- New product usage areas.
An expert opinion is issued for goods subject to sanitary and epidemiological supervision (control), according to the UNIFIED LIST OF PRODUCTS (GOODS) SUBJECT TO STATE SANITARY AND EPIDEMIOLOGICAL SUPERVISION (CONTROL) AT THE CUSTOMS BORDER AND CUSTOMS TERRITORY OF THE EURASIAN ECONOMIC UNION
To obtain a conclusion, the applicant must submit a package of documents to Rospotrebnadzor.
To pass the expert assessment, you must provide the following information:
- Name and description of controlled products, foreign economic activity codes;
- Name of the recipient company, TIN and OGRN, constituent and statutory information;
- Technical documentation for products – recipes, technological instructions, technical and technological maps;
- Data on the legality of the operation of commercial space (lease agreements, certificate of ownership);
- Application for conducting a sanitary inspection;
- Data about manufacturers and suppliers (if you are not a manufacturer);
- Delivery contract, invoice.
To obtain a conclusion, the applicant must submit a package of documents to Rospotrebnadzor: - GOST, or technical specifications (TU), in accordance with which the product is manufactured;
- Lease agreement, or documents confirming ownership of production areas;
- Details of the applicant company (TIN,OGRN, OKVED);
- Scanned copy of the label (if any).
- If the product is imported, the applicant must provide::
- Completed application form;
- Full technical description of the products for which the expert opinion will be issued;
- Draft product label.
- Additional documents required for obtaining an expert opinion on chemical products:
- MSDS Safety Data Sheet and its notarized translation into Russian;
- TDS technical data and their translation into Russian;
- Instructions for use.
You can provide information in electronic format, but it is necessary that scans and copies are clearly readable, so that all signs and symbols are clearly visible. In addition, foreign documents must be translated into Russian.
- Preparation of information, filling out the application, providing all information to us;
- Review of documentation by experts and send it to Rospotrebnadzor;
- Organization of laboratory tests and preparation of the study protocol;
- Evaluation of the received verification results;
- Making an expert opinion in the Rospotrebnadzor register and issuing it to the customer.
Our company has many years of experience in cooperation with relevant structures, which allows us to perform work at the highest level.
Regulatory documentation:
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