Requirements for labeling dietary supplements in Ukraine

Cratia participated in the “Dietary Supplements: Development Strategy” conference on October 12, 2023.

Oksana Oliynichuk, the head of the FMCG department, discussed legislation and the main requirements for labeling dietary supplements, changes in legislation that will come into effect soon, the importance of correct labeling, and the responsibility associated with improperly labeled products.

As Oksana pointed out, labeling is just one of the ways to provide information to the end consumer about a food product. Information about a food product can also be provided in other ways: in any accompanying documents and materials (including “inserts” or “instructions” present in the packaging of some dietary supplements), in oral statements, and other ways, including the use of modern means of remote communication.

Oksana emphasized the importance of complying with all legal requirements (including claims regarding the nutritional value and health benefits) not only for the information directly on the packaging or label but also in the mentioned “inserts” or “instructions,” as they also fall under “information about the food product.” She highlighted that the presence and obligation of such “inserts” or “instructions” for dietary supplements are not required by food legislation, as all mandatory information about the food product must be provided directly on the packaging or label attached to it.

The primary legislation establishing requirements for dietary supplement information consists of a dozen different legislative acts. “Base” documents include the Law of Ukraine “On Information for Consumers on Food Products,” which establishes requirements for all food products, and the “Hygienic Requirements for Dietary Supplements,” which additionally sets requirements specifically related to dietary supplements.

Furthermore, the legislation is constantly updated. For instance, there are three new versions of the Law “On Information for Consumers on Food Products,” which will come into force on different dates: October 26, 2023, November 23, 2023, and September 16, 2026.

Moreover, when changes are made to existing documents or new documents are adopted, there are usually transitional periods during which dietary supplements may not comply with the new requirements, but after the end of these periods, they must comply.

For example, this year, three-year transitional periods have recently ended for:

• Order of the Ministry of Health No. 1145 of May 15, 2020, “Requirements for Claims on the Nutritional Value of Food Products and Claims about the Health Benefits of Food Products,” with the transitional period ending on August 21, 2023.
• Order of the Ministry of Health No. 1613 of July 16, 2020, “Rules for Adding Vitamins, Minerals, and Certain Other Substances to Food Products,” with the transitional period ending on October 2, 2023.

Therefore, it is crucial to continuously monitor all legislative changes, transitional periods, and their expiration dates and to make timely adjustments to the labeling of dietary supplements, as well as the information provided in “inserts,” other accompanying documents and materials, advertisements, online content, and more to bring them in line with the current legislation. Otherwise, dietary supplements with labels that do not comply with legal requirements will be considered incorrectly labeled food products.

According to the Law of Ukraine “On the Basic Principles and Requirements for Safety and Quality of Food Products,” it is prohibited to market improperly labeled products. Such food products are subject to removal from circulation and/or recall. They can only return to the market after ensuring that the labeling is corrected.

Labeling is subject to state control, which is carried out under the Law of Ukraine “On State Control over Compliance with Legislation on Food Products, Feeds, By-Products of Animal Origin, Health, and Animal Welfare.”

Inspections conducted by the State Food Safety and Consumer Protection Service of Ukraine can be either planned according to the approved annual inspection plan or unscheduled, including in response to citizen complaints. For example, the Ministry of Agrarian Policy Order of January 3, 2023, No. 5 specifies the grounds for conducting unscheduled inspections to ensure compliance with food legislation during a state of war. One of these grounds is a complaint from an individual about violations that have harmed their rights, legitimate interests, life, health, the environment, or state security, accompanied by supporting documents or copies of such documents (if available).

In addition, labeling may also be inspected during customs clearance. According to the Law “On State Control over Compliance with Legislation on Food Products, Feeds, By-Products of Animal Origin, Health, and Animal Welfare,” physical inspections of products, regardless of the type of product, should include an examination of packaging materials and labeling on the packaging for compliance with legislation.

Non-compliance with the law carries penalties, including fines. The fines imposed under the Law “On State Control over Compliance with Legislation on Food Products, Feeds, By-Products of Animal Origin, Health, and Animal Welfare” range from nearly UAH 33,000 to UAH 200,000 for legal entities. However, this is not the only financial liability, as the Antimonopoly Committee of Ukraine can also impose fines for misleading and false information on packaging, labels, accompanying documents, advertisements, etc., and these fines are significantly higher.

All of this should serve as a strong incentive to have properly labeled products and to comply with legal requirements. The fundamental principle in food labeling legislation is that the information about the product should not mislead the consumer. The label should provide truthful information about the product, rather than being a creative marketing tool, allowing consumers to make informed choices.

Cratia offers a comprehensive range of services for the registration of dietary supplements, baby food, and food products for special medical purposes in Ukraine:

• Providing consultations regarding the requirements for product legalization.
• Checking the product’s composition, recommended daily intake, and safety indicators.
• Filling of the labeling in Ukrainian, and its verification.
• Submission of notifications for product placement on the market.
• Obtaining voluntary conclusions on quality and safety.

We are well-versed in the legislation of Ukraine and the EU and have extensive experience in conducting such work. We can take charge of and organize the entire process, help you compile the required documentation, and ensure that the procedures are completed within tight timelines.

Preliminary consultations are provided for free, and you can contact us by phone at +38 (044) 332-42-94, 221-71-29, or via email at info@cratia.ua, or arrange a meeting at our office.