The necessary documents and information for the state registration of the first introduced products imported into the territory of the Russian Federation for the first time

For the purposes 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:

1. statement,
2. copies of the documents according to which the products are manufactured (standards, specifications, regulations, technological instructions, specifications, recipes, information about the composition), certified by the manufacturer (manufacturer);
3. a written notification of the manufacturer (manufacturer) that the products (product samples) manufactured by him meet the requirements of the documents in accordance with which it is manufactured (as a notification, copies of the quality certificate, safety data sheet (quality), quality certificates certified by the manufacturer (manufacturer), or a letter from the manufacturer (one of the following is provided listed documents);
4. the manufacturer's (manufacturer's) document on the use (operation, use) of controlled goods (instructions, guidelines, regulations, recommendations) or its copy certified by the applicant (if available);
5. copies of labels (packages) or their layouts for controlled goods, certified by the applicant;
6. copies of documents on the specific activity of a biologically active food additive (for preparations containing unknown components, unofficial prescriptions), certified by the applicant;
7. act of sampling (samples);
8. manufacturer's (manufacturer's) declarations on the presence of genetically engineered (transgenic) organisms, nanomaterials, hormones, pesticides in food products;
9. protocols of research (tests) (acts of hygienic examination), scientific reports, expert opinions extract from the Unified State Register of Legal Entities or the Unified State Register of Individual Entrepreneurs (optional);

FOR CONTROLLED GOODS MANUFACTURED OUTSIDE THE CUSTOMS TERRITORY OF THE CUSTOMS UNION:

1. statement;    
2. copies of the documents according to which the products are manufactured (standards, specifications, regulations, technological instructions, specifications, recipes, information about the composition), certified in accordance with the legislation of the Party in which the state registration is carried out;    
3. manufacturer's (manufacturer's) declarations on the presence of genetically engineered organisms, nanomaterials, hormones, pesticides in food products;    
4. the manufacturer's (manufacturer's) document on the use (operation, use) of controlled goods (instructions, guidelines, regulations, recommendations) or its copy certified by the applicant (if available);    
5. written notification of the manufacturer (manufacturer) that the products manufactured by him (product samples) meet the requirements of the documents in accordance with which it is manufactured (as a notification, copies of the quality certificate, safety data sheet (quality), certificate of analysis, certificate of quality, certificate of free sale or manufacturer's letter certified in accordance with with the legislation of the Party in which the state registration is carried out (one of the listed documents is provided);    
6. copies of product labels (packaging) certified by the applicant;    
7. originals or copies of documents on the specific activity of a biologically active food additive (for preparations containing unknown components, unofficial prescriptions), certified in accordance with the legislation of the Party in which the state registration is carried out;    
8. originals or copies of documents on the toxicological characteristics of the drug (for pesticides, agrochemicals, protective agents and plant growth regulators), certified in accordance with the legislation of the Party in which the state registration is carried out;    
9. a copy of the document of the competent health authorities (other state authorized bodies) of the country in which the biologically active food additive, food additive, disinfectant (disinsection, deratization) means, cosmetic products are produced, confirming the safety and allowing the free circulation of these products on the territory of the manufacturing state (manufacturer), certified in accordance with the legislation of the Party, in which the registration is carried out, or the manufacturer's information about the absence of the need to issue such a document;   
10. protocols of research (tests) (acts of hygienic examination), scientific reports, expert opinions;    
11. copies of documents confirming the import of samples of controlled goods into the customs territory of the Customs Union, certified in accordance with the legislation of the Party in which the state registration is carried out;

Translations of the manufacturer's (manufacturer's) documents in foreign languages must be certified in accordance with the legislation of the Party in which the state registration is carried out.

The applicant is responsible for the accuracy of the documents provided for the purpose of issuing a document confirming the safety of products (goods).

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• SGR
• Certificate of state registration

List of products (goods) subject to state registration

1. Certain types of food products.

Specialized food products include:

1.  food products for baby food, including drinking water for baby food;
2. food products for dietary therapeutic and dietary preventive nutrition;
3. natural mineral, therapeutic and canteen, therapeutic mineral water with a mineralization of more than 1 mg / dm3 or with less mineralization, containing biologically active substances in an amount not lower than balneological norms;
4. food products for athletes, pregnant and lactating women;
5. biologically active food additives (dietary supplements).

The Technical Regulations of the Customs Union TR CU 021/2011 "On food safety" from 01.07.2013 defined the state registration of specialized food products and new types of food products.

New type of food products - food products (including food additives and flavorings) not previously used by humans for food in the customs territory of the Customs Union, namely: with a new or intentionally modified primary molecular structure; consisting of or isolated from microorganisms, microscopic fungi and algae, plants, isolated from animals, obtained from GMOs or with their nanomaterials and nanotechnology products; with the exception of food products obtained by traditional methods, which are in circulation and, by virtue of experience, are considered safe.

2. Cosmetic products; oral hygiene products and productsmouth.

In accordance with the technical regulations "On the safety of perfumery and cosmetic products", state registration is maintained for the following products:

• perfumery and cosmetic products for artificial tanning;
• perfumery and cosmetic products for skin whitening (lightening);
• cosmetics for tattooing;
• intimate cosmetics;
• perfumery and cosmetic products of individual protection of the skin from the effects of harmful production factors;
• children's cosmetics;
• perfumery and cosmetic products for chemical coloring, lightening and highlighting of hair;
• perfumery and cosmetic products for perming and straightening hair;
• perfumery and cosmetic products manufactured using nanomaterials;
• perfumery and cosmetic products for depilation;
• peels;
• fluoride—containing oral hygiene products, the mass fraction of fluorides in which exceeds 0.15% (for liquid oral hygiene products - 0.05%);
• teeth whitening products containing hydrogen peroxide or other components that emit hydrogen peroxide, including carbamide peroxide and zinc peroxide, with a concentration of hydrogen peroxide (as an ingredient or released) 0.1% — 6.0%.).

3. Disinfectants, disinsection and deratization agents (for use in everyday life, in medical institutions and other facilities (except for those used in veterinary medicine and repellent agents related to dermatological personal protective equipment from the effects of biological factors (insects) used in industrial production).
4. Household chemicals.
5. Potentially dangerous chemical and biological substances and preparations made on their basis that pose a potential danger to humans (except medicines), individual substances (compounds) of natural or artificial origin, capable of producing, using, transporting, processing, as well as in domestic conditions to have an adverse effect on human health and the environment.
6. Materials, equipment, devices and other technical means of water treatment intended for use in domestic drinking water supply systems.
7. Personal hygiene items for children and adults; household items for children up to three years old: dishes and products used for feeding children, items for hygienic child care; clothing for children (first layer).

In accordance with the technical regulations "On the safety of products intended for children and adolescents", state registration with subsequent declaration of conformity is maintained for the following products:

• milk nipples, pacifiers made of latex, rubber or silicone;
• single-use sanitary and hygienic products (diapers, underpants, diapers, hygienic cotton swabs (for nose and ears));
• tableware, cutlery for children under 3 years old (cups, saucers, drinking bowls, plates, bowls, spoons, forks, bottles and other similar products for food);
• toothbrushes, electric toothbrushes powered by chemical current sources, gum massagers and other similar products for children under 3 years old;
• products 1-goknitted and textile linen layers for children up to 3 years old;
• knitted hosiery products of the 1st layer for children up to 3 years old;
• hats (summer) of the 1st layer are knitted and made of textile materials for children up to 3 years old.

8. Products intended for contact with food (except dishes, cutlery, technological equipment).

In accordance with the technical regulations "On Packaging Safety" from 01.07.2012, packaging, including food packaging, is not subject to state registration.

Raw materials, active substances intended by the manufacturer (manufacturer) exclusively for the production of perfumery and cosmetic products, household chemicals, plant protection products and disinfection, disinfection and deratization products, as well as pharmaceutical industry products, are not subject to state registration.

Products (goods) manufactured for the first time and imported into the customs territory for the first time are subject to state registrationThe EAEU specified in paragraphs 1-6 and included in the following table

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• SGR
• Certificate of state registration

Unified List of products (goods) subject to state sanitary and epidemiological supervision (control) at the customs border and the customs territory of the EAEU

1. Food products (products in natural or processed form, consumed by humans), including those obtained using genetically engineered (transgenic) organisms (from the following groups of the unified Commodity Nomenclature of Foreign Economic Activity of the Eurasian Economic Union (TNForeign economic activityThe EAEU): 02 - 05, 07 - 25, 27 - 29, 32 - 34, 35). - The paragraph is given in the wording of the Decision of the Customs Union Commission No. 566 of 02.03.2011
2. Products (goods) for children: games and toys, bed linen, clothing, shoes, textbooks, furniture, strollers, bags (satchels, backpacks, briefcases, etc.), diaries and similar products, notebooks, other stationery (goods) made of paper and cardboard, stationery or school supplies, artificial polymer and synthetic materials for the manufacture of products (goods) of the children's assortment (from the following groupsHSThe EAEU: 32, 34, 39, 40, 42 - 44, 46, 48 - 56, 60 - 65, 87, 94, 95). - The paragraph is given in the wording of the Decision of the Customs Union Commission No. 828 of 18.10.2011 and the Decision of the Council of the Eurasian Economic Commission No. 82 of 02.12.2015
3. Materials, equipment, substances, devices used in the field of domestic drinking water supply and wastewater treatment, in swimming pools (from the following groups of the Customs Code of the EAEU: 25, 38 - 40, 48, 84, 85). - The paragraph is given in the wording of the Decision of the Customs Union Commission No. 828 of 18.10.2011
4. Perfumery and cosmetics, oral hygiene products (from the group of HS EAEU 33).
5. Chemical and petrochemical products for industrial purposes, products (goods) household chemicals, paints and varnishes (from the following groups of the EAEU HS: 32 - 34, 38). - the paragraph is given in the wording of the Decision of the Customs Union Commission No. 566 of 02.03.2011
6. Polymer, synthetic and other materials intended for use in construction, transport, as well as for the manufacture of furniture and other household items; furniture; textile sewing and knitting materials containing chemical fibers and textile auxiliaries; artificial and synthetic leather and textile materials for the manufacture of clothing and footwear (from the following groups of TN EEU Foreign Economic Activity: 32, 39, 40, 42 - 44, 45, 46, 48, 50, 51, 52, 53, 54, 55 - 60, 69, 94). - The paragraph is given in the wording of the Decision of the Customs Union Commission No. 566 of 02.03.2011 and the Decision of the Customs Union Commission No. 828 of 18.10.2011
7. Products of mechanical engineering and instrumentation for industrial, medical and household purposes, except spare parts for vehicles and household appliances (except those in contact with drinking water and food products) (from the following groups of the EAEU HS: 38, 84, 85, 90, 94). - the paragraph is given in the wording of the Decision of the Customs Union Commission No. 828 from 18.10.2011
8. Publishing products: educational publications and manuals for general secondary and higher educational institutions, book and magazine publications for children and adolescents (from the following groups of the EAEU FEA: 48, 49).
9. Products made of natural raw materials that are processed during the production process (coloring, impregnation, etc.) (from the following groups of the EAEU HS: 25, 43, 44, 46, 50 - 53). - The paragraph is given in the wording of the Decision of the Customs Union Commission No. 828 of 18.10.2011
10. Materials for products (products) in contact with human skin, clothing, shoes (from the following groups of the Customs Code of the EAEU: 30, 39, 40, 42, 43, 48, 50 - 65, 67, 68, 82, 96). - The paragraph is given in the wording of the Decision of the Customs Union Commission No. 828 of 18.10.2011
11. Products, products that are a source of ionizing radiation, including generating, as well as products and products (goods) containing radioactive substances (from the following groups of the EAEU HS: 25, 26, 28, 68, 69, 72, 74 - 76, 78 - 81, 84, 87).
12. Construction raw materials and materials in which the content of radioactive substances is regulated by hygienic standards, including industrial waste for recycling and use in the national economy, scrap of ferrous and non-ferrous metals (scrap metal) (from the following groups of the EAEU FEA: 25, 26, 28, 68, 69, 72, 74 - 76, 78-81, 84, 87).
13. Tobacco products and tobacco raw materials (from the EAEU HS group 24).
14. Personal protective equipment (from the following groups of the Customs Code of the EAEU: 39, 40, 64, 65, 90). - The paragraph is given in the wording of the Decision of the Customs Union Commission No. 828 of 18.10.2011
15. Pesticides and agrochemicals (from the following groups of the EAEU HS: 31, 38).
16. Materials, products and equipment in contact with food products (from the following groups of the EAEU HS: 39, 40, 44, 45, 46, 47, 48, 56, 63, 69, 70, 73, 74, 76, 82, 85, 96). - the paragraph is given in the wording of the Commission's Decision Customs Union No. 828 dated 18.10.2011
17. Equipment, materials for air treatment, air purification and filtration (from the following groups of the EAEU HS: 38 - 40, 48, 52 - 56, 59, 60, 84, 85). - The paragraph is given in the wording of the Decision of the Customs Union Commission No. 828 of 18.10.2011
18. Anti-icing reagents (from the EAEU HS group 38). 19. Other products (goods) for which temporary sanitary measures have been introduced by one of the member States of the Eurasian Economic Union (from the following EAEU HS groups: 02-96). - paragraph as amended by the Decision of the Council of the Eurasian Economic Commission No. 82 of 02.12.2015

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