Dietary supplements and weight control

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 over 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”.

Dietary supplement (food supplements) is a food product taken in small certain amounts in addition to the regular diet, which is a concentrated source of nutrients including, but not limited to proteins, fats, carbohydrates, vitamins, and mineral substances, and is manufactured in tablets, capsules, dragees, powders, liquids or other forms.

Food product 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.

Prior to making a decision on the import of dietary supplement into Ukraine, it is required to make sure that the composition, intended use and recommended daily dose of the product meet 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;
• if required, obtaining the permit from independent pediatrician.

Dietary supplements (food supplements), with the exception of the newest ones, are not included in the list of the products that are subject to mandatory registration.

When imported, the product must be accompanied by an international certificate or other document which proves the safety of food product and issued by the competent authority of the country of origin or the exporting country.

International certificate is a health certificate, an international veterinary certificate or other document issued by the competent authority of the country of origin or of the exporting country and proves the animal’s health and/or safety of food product, feedstuff, hay, straw or animal by-product (Law of Ukraine “On State Control over Compliance with Legislation on Food, Feedstuffs, Animal By-products, Animal Health and Well-being” dated October 4, 2018).

Ukrainian national legislation contains strict requirements for dietary supplement labeling:

• 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 will be changed;
• labeling should contain certain information, such as nutritional and energy values, method of administration and recommended daily dose, warnings and contraindications, name and location of the importer and the person responsible for receiving complaints from consumers, etc.;
• starting from January 1, 2021, the product labeling should contain data expressed 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 dietary supplements (food supplements), food products for special medical purposes and weight control food products.

The requirements of the Law of Ukraine “On Basic Requirements for the Safety and Quality of Food Products” stipulate that market operators are responsible for the quality and safety of products that are being sold, and for the labeling non-compliance with the effective requirements.

Therefore, large retail and pharmacy networks, with the entry into force of amendments to the Law of Ukraine “On Basic Requirements for the Safety and Quality of Food Products” (dated May 20, 2015), began to treat with more caution the products not accompanying by accustomed documents issued by the Sanitary Service, which could confirm the product safety and labeling correctness.

Cratia offers legalization in Ukraine of dietary supplements (food supplements), food products for special medical purposes and food products for weight control:

1. examination of the product composition and supporting documents (including “international certificate”), providing all the necessary consultations;
2. preparation of additional supporting documents;
3. organization of laboratory tests and obtaining conclusion on product safety;
4. development of draft labeling (sticker or packaging), as well as, when required, instructions (leaflet).

As a result of our work, you will receive the document confirming the product safety, assigning to it the appropriate status in Ukraine and containing the labeling text in accordance with effective Ukrainian national legislation.