The main legislative act that regulates the import and circulation of infant food products (including functional infant nutrition) is the Law of Ukraine “On Infant Nutrition”. This Law obliges to receive a State Sanitary and Epidemiological Expertise Report (hereinafter the Conclusion) for this category of food products.
Infant nutrition is a food product designed by the central executive authority in the field of health for special dietary consumption, specially processed designed to meet the dietary needs of infants and early childhood.
Functional infant nutrition is infant food that contains medicinal products as components and/or is proposed to prevent or alleviate the course of disease in a child with special dietary needs, including the cases of congenital or acquired impaired assimilation of certain food substances, their intolerance and/or certain diseases.
The product is classified as infant food based on the age criterion: the product is intended for children aged under 3 years. Food products for children aged over 3 years do not belong to the “infant nutrition” category.
Prior to making a decision on the import of infant food into Ukraine, it is required to make sure that the composition, intended use and recommended daily dose of the product meets the requirements of national legislation. These requirements are the following:
- minimum and maximum values of the content of vitamins and mineral substances in the product, calculated on the basis of RDI (recommended daily intake);
- list of prohibited food additives (E-index);
- product intended use (indications for use);
- definition of the consumer age category.
To obtain Conclusion on infant food, it is required:
- to prepare a set of documents in accordance with the requirements of Ukrainian national legislation. The documentation includes administrative data, information on the product quality and safety, draft national documents (labeling).
- to submit the set of documents and samples to the competent authority for examination and testing.
- if the testing results are positive, to obtain the Conclusion itself.
The Conclusion is issued in the name of the Applicant company, which can be both a resident and non-resident of Ukraine. The Applicant should appoint a person responsible for receiving complaints in Ukraine. The name and contact details of this person will be indicated on the product labeling.
The labeling text for infant food should be developed on the basis of a number of Ukrainian national legislative acts and agreed (approved) by the experts of the competent authorities. Changing the labeling text causes the need for re-approval of the text.
Ukrainian national legislation also contains other requirements for the labeling of infant food:
● labeling language should be Ukrainian, and information in other languages may also be present;
● the minimum font size is set by law, and, starting from August 6, 2019, the font size requirements has been changed;
● starting from January 1, 2021, the product labeling should contain data in SI units.
The law does not prohibit the use of stickers.
Please pay attention to the fact that, starting from August 6, 2019, the Law of Ukraine “On Information for Consumers on Food Products” came into force. It introduces a number of significant changes to the labeling:
● increase in the size of the minimum font on the packaging;
● highlighting of allergens and substances which can cause intolerance;
● indication of the country of origin of the main ingredient;
● changes in a number of wordings (e.g., “better use before ...”) and others.
This legislative act is applicable to all food products, including infant food.
The Conclusion is issued for a period of 5 years. To extend its validity period for the next 5 years, you should carry out a procedure that is completely similar to the new procedure.
Cratia offers a range of work for infant nutrition registration in Ukraine:
- examination of the product composition, the recommended daily intake, safety parameters, and providing the necessary consultations;
- preparation of the set of documents (including draft labeling and additional supporting documents) and obtaining samples;
- organization of expert examination and testing, obtaining the SES Conclusion.
As a result of our work, you will get authorization document giving the right to import and sell infant food in Ukraine.