• Regulation
  • CCM - Rospotrebnadzor
  • Required documents for state registration

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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