Registration of nutritional supplement in Kazakhstan

vitamins

There are a variety of opinions on the biologically active additives, their harm and benefits. Use of biologically active additives is up to one`s choice. Prior to buying biologically active additives it is vital to check if an additive is registered by an authorized body in the field of sanitary and epidemiological welfare of population of the Eurasian Economic Union. 

How to find out whether a biologically active additive is registered in Kazakhstan? 

What a biologically active additive is?

Biologically active additives involve additives to products aimed at improving health upon their regular use and contain components of natural or identical to natural biologically active substances in order to enrich a diet. However, biologically active additives are not considered as pharmaceuticals. 

If you decide to use biologically active additives in your daily diet, do not forget to check the state registration of a biologically active additive in Kazakhstan. Like any product, biologically active additives are subject to compulsory state registration. State registration/re-registration of biologically active additives in the country is carried out by the Sanitary and Epidemiological Control Committee under Ministry of Health of the Republic of Kazakhstan. Information about registration of a biologically active additive you are interested in can be found in the Unified Register of Certificates on State Registration published on the official website of the Eurasian Economic Commission and via the information system "One-stop window for export/import operations", "Register of Certificates on State Registration" section.  

How to register biologically active additives and other types of products?

To register a biologically active additive it is necessary: 

  • for obtaining a state registration certificate:

to service provider:   

  1. Application;

а) for products manufactured in the customs territory of the Eurasian Economic Union (hereinafter: EEU):

  1. Copies of documents certified by a producer based on which the products are manufactured:
  • standard or organizational standard, technical condition;
  • manufacturing specification;
  • formulation.
  1. Written notification from a manufacturer (producer) certifying that the manufactured products comply with the requirements of documents based on which the products are manufactured. The following is accepted as a notification: copies of quality certificate, safety (quality) certificate, quality certificates certified by a manufacturer (producer) or a letter from a  manufacturer (one of the listed documents is to be provided).
  2. Document from a manufacturer (producer) on application (operation, use) of products (instruction, guidance, recommendation) (one of the listed documents) or a copy certified by an applicant.
  3. Copies of labels (packages) and their models certified by an applicant.
  4. Original copy of sampling certificate issued by laboratories (centers) accredited (certified) in national accreditation (certification) systems and included in the Unified Register of Certification Bodies and Test Laboratories (Centers) of the EEU.
  5. Original copy of studies (tests) issued by laboratories (centers) accredited (certified) in national accreditation (certification) systems and included in the Unified Register of Certification Bodies and Test Laboratories (Centers) of the EEU.
  6. Original copy of a scientific report issued by a profile scientific institute or profile scientific center executing activities in the field.
  7. Original copy of expert evaluation issued by a profile scientific institute or profile scientific center executing activities in the field.
  8. In cases when a manufacturer uses nanomaterials in perfume and cosmetics, it is necessary to provide information about the nanomaterial, including its chemical name, particle size, and physical and chemical properties.

б) for products manufactured outside the customs territory of the Eurasian Economic Union: 

  1. Copies of documents certified by a producer based on which the products are manufactured:
  • international standard or standard of a foreign state;
  • technical condition or specification;
  • manufacturing specification;
  • formulation or information about contents.
  1. Document from a manufacturer (producer) on application (operation, use) of products (instruction, guidance, recommendation) (one of the listed documents) or a copy certified by an applicant.
  2. Written notification from the manufacturer (producer) that the products manufactured by him meet the requirements of the documents in accordance with which it is manufactured. As a notification, we accept: a copy of the quality certificate, the safety (quality) data sheet, the certificate of analysis, the quality certificate, the certificate of free sale or the letter of the manufacturer of the product (one of the listed documents is provided).
  3. Copies of labels (packages) and their models certified by an applicant.
  4. Copy of a document issued by a competent health authority (other state authorized body) of a  country in which the products are manufactured that confirm safety and permit free circulation of this product on the territory of the state of a manufacturer (producer) or information of a manufacturer (producer) on the absence of the need for such a document.
  5. Original copy of studies (tests) issued by laboratories (centers) accredited (certified) in national accreditation (certification) systems and included in the Unified Register of Certification Bodies and Test Laboratories (Centers) of the EEU.
  6. Original copy of a scientific report issued by a profile scientific institute or profile scientific center executing activities in the field.
  7. Original copy of expert evaluation issued by a profile scientific institute or profile scientific center executing activities in the field.
  8. Copies of documents confirming the import of product samples into the EEU territory.
  9. In cases when a manufacturer uses nanomaterials in perfume and cosmetics, it is necessary to provide information about the nanomaterial, including its chemical name, particle size, and physical and chemical properties.

Requirements for biologically active additives subject to registration:  

The conditions required for registration of biologically active additives include availability of a label and instructions with information necessary for a consumer:

  • product name, production form;
  • a manufacturer's trademark (if any);
  • information on the ingredient composition, indicating the exact amount (grams, milligrams, milliliters, percentage) of components contained in them, nutritional value (energy value, protein, fat, carbohydrates, vitamins and microelements, indicating the percentage of physiological daily requirements, amino acid composition, content of biologically active substances);
  • information on the properties of biologically active additives, their purpose, recommendations for use;
  • name of the regulatory document, the requirements of which should be applied to biologically active additives;
  • name (company name), location (legal address) of a manufacturer, packer (if a manufacturer is a packer himself/herself);
  • nominal quantity of a packaging unit (mass or volume), the number of doses and their nominal quantity (mass or volume);
  • batch number, production date, shelf life, storage conditions;
  • an indication that a biologically active additive is not a medicine;
  • information on the state registration of a biologically active additive with indication of the number and date;
  • nformation on contraindications for use in case of certain types of diseases.

It is not allowed to sale biologically active additives:

  • without state registration;
  • expired;
  • in the absence of proper sales conditions;
  • without a label, and also in the event if information on a label does not correspond to information agreed upon during the state registration.

Availability of a state registration certificate issued under the procedure approved by an authorized body in the field of sanitary and epidemiological welfare of the population serves as confirmation of biologically active additives safety.

Last update: 19.08.2021