Registration of food supplements

The import and circulation of food products is regulated by the Law of Ukraine “On Basic Principles and Requirements for the Safety and Quality of Food Products”, the Law of Ukraine “On State Control over Observance of Legislation on Food, Feed, By-Products of Animal Origin, Animal Health and Welfare”, and also (since August 6, 2019) by the Law of Ukraine “On Information for Consumers on Food Products”.

The requirements of the main food law establish a list of products that are subject to mandatory registration in Ukraine. Such products include:

  • latest food products;
  • nutritional supplements;
  • flavors, with the exception of a separate group of flavors defined by the Сentral Executive Authority;
  • enzymes;
  • auxiliary materials for processing, and materials in contact with food products, as well as those that are put into circulation and/or first used in Ukraine;
  • drinking water, which is planned to be classified as “mineral drinking water”.

The main legislative act that regulates the import and circulation of baby food (including functional baby food) is the Law of Ukraine “On Baby Food”.

Thus, the legislation of Ukraine defines the following types of special foods:

Dietary supplements are dietary supplements that are classified as a food product consumed in small certain amounts in addition to the usual diet, and is a concentrated source of nutrients, including proteins, fats, carbohydrates, vitamins, minerals (this list is not exclusive), and is made in tablets, capsules, dragees, powders, liquids or other forms.

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

A food product for weight control is a specially made food product intended to be consumed while maintaining a low-calorie diet to reduce weight, which when consumed according to the instructions of the market operator replaces the daily diet.

Sports nutrition according to current legislation is classified as a food product or as a dietary supplement depending on its composition.

Baby nutrition is a food product designed by the Central Executive Authority in Healthcare for special dietary consumption, specially processed or designed to meet the nutritional requirements of infants and young children. This type of food product is regulated by the Law of Ukraine “On Baby Food”.

Functional baby food is baby food that contains medicinal products as a component and/or is proposed for the prevention or mitigation of a child’s illness with special dietary needs, including congenital or acquired disorders of the absorption of certain nutrients, their intolerance and/or certain diseases.

Registration of dietary supplements, medical nutrition and food products for weight control is simplified in Ukraine, but market operators (supermarkets, pharmacies, special shops) almost always require a supplier to provide a package of documents to confirm compliance with safety and quality requirements.

Registration of baby food in Ukraine is a mandatory requirement for import and sale. During registration, tests of samples are carried out, the conclusion of the competent authority is drawn up and the labeling is approved.

 

Labeling

According to the Law of Ukraine “On Ensuring the Functioning of the Ukrainian Language as a State Language”, labeling of food products is made in Ukrainian.

Placement of information is allowed with sticker label.

In August 2019, new labeling requirements entered into force for all food products, which established the minimum font size on the package, the marking of allergens, etc., including:

  • mandatory marking of substances or products that cause allergies or intolerances;
  • indication of temporal characteristics in the form “Best before…” or “Best before the end…”;
  • the necessity to indicate the country of origin of the food product or ingredient (if applicable);
  • harmonization of the form of providing nutritional information with European requirements;
  • indication of data on the market operator responsible for information about the food product;
  • new concepts of “official name”, “habitual name”, “descriptive name”, “minimum shelf life”, etc. have been introduced;
  • requirements for distance selling.

Since these changes significantly affect the labeling of food products, a three-year transitional period was determined (until August 6, 2022), during which production and/or putting into circulation of products that meet the requirements of previous legislation is allowed. Such food products may be in circulation until the terminal consumption date or the shelf-life expiration.

Starting January 1, 2021, food labeling should be carried out with measurement units of the International System of Units (SI) (kilograms, centimeters, liters, etc.) in the Latin letters.

 

Cratia provides professional services on registration of specialized food products in Ukraine. 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