Registration of food supplements

Functioning of the common market for special food products within the EAEU is carried out in accordance with the Agreement on the Eurasian Economic Union of May 29, 2014, the Decision of the Customs Union Commission of May 28, 2010 № 299 “Unified sanitary-epidemiological and hygienic requirements for products (goods) subject to sanitary-epidemiological supervision (control)”, as well as in accordance with acts of the Eurasian Economic Commission in the field of food products circulation.

Specialized food products are subject to state registration under the “centralized” procedure according to the EAEU Technical Regulations, the main of which is the Technical Regulations CU 021/2011 “On food safety”. Registration gives the right to circulate products in all countries of the Eurasian Economic Union: Belarus, Russia, Kazakhstan, Armenia and Kyrgyzstan. However, national language and labeling requirements should be taken into account.

Speciality food products include:

  • biologically active food additives (BAA);
  • food products to feed athletes;
  • food products to feed pregnant and lactating women;
  • food products for child nutrition;
  • food products for dietetic therapeutic and dietetic preventive nutrition;
  • natural mineral water, therapeutic table water, therapeutic mineral water with salinity exceeding 1 mg/dm3 or with less salinity containing biologically active substances in an amount not lower than balneological norms;

State registration of specialized food products of foreign production is performed before their import to the EAEU customs territory.

Common mark of the product circulation on the EAEU market must be affixed on the food product prior to it’s placing on the market. The mark is affixed to the package of each individual food product, and indicates compliance with the requirements of all applicable EAEU Technical Regulations and passing the assessment of conformity.

The manufacturer, Applicant and importer shall be responsible for the quality and safety of food products and for compliance with the requirements of Technical regulations.

Registration (assessment of conformity) of the food product should be initiated by the Applicant, resident of the EAEU member state. The Applicant shall be obliged to ensure conformity of food products to the requirements established by all applicable Technical regulations of the EAEU.

Prior to the registration procedure it can be required to conduct research (testing) of samples of specialized food products in accredited testing laboratories in the territory of the EAEU member states. Thus, it is possible to present the state registration procedure in following steps:

  • Conduct research (testing) of samples in an accredited testing laboratory;
  • Expert examination of the Application, results of studies (tests) and other necessary documents which confirm safety and conformity of the products to the requirements of the EAEU Technical regulations;
  • Issue of a certificate of conformity and entry of information into the common register of specialized food products.

Prior to the registration we advice to perform feasibility study: to check the product composition, quality, safety and labeling requirements for compliance with the requirements of EAEC Technical Regulations, for example:

  • Technical Regulations 021/2011 “On Food Safety”, in particular Annex 7 “List of Plants and Products of Their Processing, Objects of Animal Origin, Microorganisms, Fungi and Biologically Active Substances Banned for Use in the Composition of Biologically Active Food Additives”;
  • Technical Regulation 029/2012 “Safety requirements for food additives, flavourings and technological aids”;
  • Technical Regulation 022/2011 “Food products with regard to their labelling”;
  • for products intended for use by children – Annex 8 of TR CU 021/2011 “Types of plant raw materials for use in the production of biologically active food additives for children from 3 to 14 years old and children’s herbal teas (tea drinks) for young children”;
  • for products  intended for use by children – Annex 9 of TR CU 021/2011 “Vitamins and mineral salts used in the production of baby food products”;
  • for products  intended for use by children – Annex 10 of TR CU 021/2011 “Pesticides prohibited for use in the production of food (edible) raw materials intended for the production of food products for child nutrition”
  • for products containing oils and/or fats – Technical Regulation 024/2011 “Technical Regulations for Fat and Oil Products”.

Requirements for the labelling of special food products are specified in Technical Regulation 022/2011 “Foodstuffs with regard to their labelling”. Language of the labeling is Russian and national languages of the EAEU member states.

The state registration of the specialized food products is permanent (or until the changes in the name and/or in the formulation of the product) and is valid on the territory of all the EAEU Member States: Belarus, Russia, Kazakhstan, Armenia and Kyrgyzstan.

Cratia provides professional services on registration (conformity assessment) of special food products in EAEU. We have an excellent knowledge of national legislation, necessary experience and resources. 

To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office

Сообщить о побочной реакции



    (name, formulation, dose and route(s) of administration, date of therapy start)

    Contact form