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Registration of dietary supplements, medical and infant nutritions

The import and circulation of food products is regulated by the main Food Law of Ukraine “On Basic Principles and Requirements for the Safety and Quality of Food Products”, the Law of Ukraine “On State Control of Compliance with Laws on Food Products, Feedstuffs, Animal By-products, Animal Health and Well-being”, and also, starting from August 6, 2019, by the Law of Ukraine “On Information for Consumers about Food Products”.

The requirements of the main Law define a list of products that are subject to mandatory registration in Ukraine. These products are the following:

●     newest food products;

●     food additives;

●     flavors, excluding separate group of flavors defined by the central executive authority;

●     enzymes;

●     accessorial materials for processing, and materials that come into contact with food products, as well as those ones that are put into circulation and/or first used within the territory of Ukraine;

●     drinking water, which is planned to be classified as “mineral drinking water”. 

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”.

Thus, the legislation of Ukraine defines the following types of special food products: 

Biologically active supplement are dietary supplements (food supplements) that are classified as food products taken in small certain amounts in addition to the regular diet, which are concentrated sources of nutrients including, but not limited to proteins, fats, carbohydrates, vitamins, and mineral substances, and are manufactured in tablets, capsules, dragees, powders, liquids or other forms.

Medical nutrition (food products for special medical purposes)is a specially developed and manufactured product that is consumed under the physician’s supervision. The product is intended for partial or complete replacement of the normal diet in patients with limited, weakened or impaired ability to take, digest, and assimilate usual food products or certain nutrients contained in them, or their metabolites. Products for special medical purposes can also be prescribed to completely or partially feed the patients with other needs identified by the doctors, which cannot be met by modifying the usual diet. 

A food product for weight control is a specially produced food product intended to be taken while maintaining a low-calorie diet to reduce body weight, which replaces the daily diet provided that it is taken in accordance with the recommendations given by the market operator.

Sport nutrition is classified as a food product or as a dietary supplement (food supplement) according to current legislation, depending on its composition.

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.

This type of food products is regulated by the Law of Ukraine “On Infant Nutrition”.

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.

Registration of food supplements, medical nutrition and food products for weight control in Ukraine is simplified, however, market operators (supermarkets, pharmacies, specialized stores) almost always ask supplier to provide documentation confirming compliance with safety and quality requirements.

Registration of infant nutrition in Ukraine is a mandatory requirement for import and sale. During registration, tests of samples are performed, the conclusion of the competent authority is issued and the labeling text is approved.

In August 2019, new labeling requirements concerning all food products have entered into force. The requirements establish the minimum font size on the package, the highlighting of allergens, etc.
 

Cratia company offers registration of food supplements, medical nutrition, products for weight control and infant food products in Ukraine. As a result of our work, you will get a full set of authorization documentation, labeling and recommendations required for import and sale of the products within the territory of Ukraine.

Consultations are free. Just contact us by e-mail info@cratia.ua or by phone: +38 (044) 332-42-94, 221-71-29, or visit our office.