Dietary Supplements and other Food Products
"The food industry is seeing a clear trend towards heightened safety and quality standards, driven by recent legislative changes. Notably, dietary supplements demand particular attention, as their regulatory framework is set for a comprehensive transformation," states Lidiia Sanzharovska, Associate Partner.
The food industry operates within a complex regulatory landscape, demanding strict adherence to numerous legal provisions for both manufacturers and distributors. For instance: (1) The supply of dietary supplements necessitates simultaneous compliance with food safety and quality regulations, customs legislations and specific hygienic standards; (2) Dietary supplement labeling requires adherence to general food labeling requirements, as well as specific supplement regulations and provisions designed to prevent unfair competition unfair competition. Notably, food product labeling is governed by a separate, dedicated law, highlighting the breadth of this regulatory framework.
Particular attention should be paid to the significant changes in the regulation of the production and distribution of dietary supplements, due to the adoption of Law No. 4122-IX of December 5, 2024. Upon its enactment, this law will revise the product circulation process, update compositional requirements, and introduce new offenses within the sector.
Our team comprises qualified professionals specialising in regulation of dietary supplements and other food products. We maintain a deep understanding of current sector-specific legislation and proactively monitor regulatory developments. Leveraging our expertise, we offer comprehensive legal support for food product supply and distribution in Ukraine, addressing both individual inquiries and providing full-scale legal counsel.
SERVICES
Our main areas of expertise include:
- State registration of food production/distribution facility. Preparation and support the filing of an application for state registration of a facility.
- Operational permit. Preparation and support the filing of an application for an operational permit and support during inspection audit.
- Label compliance check. Checking food product labeling for compliance with the requirements of safety legislation and individual quality indicators of food products, information for consumers regarding food products, the functioning and use of the Ukrainian language as the state language, protection from unfair competition, the requirements of applicable regulatory acts; we will provide relevant recommendations.
- Legal advice on specific issues. Compliance with requirements for the production, distribution, labeling, customs clearance, advertising and promotion of dietary supplements and other food products.
- Comprehensive legal support. Support for the establishment of a business entity with relevant classification of types of economic activity (KVED); developing the mechanics of contractual registration of relations on the import of products; preparation of a package of necessary agreements and other documents (supply agreement, provision of marketing services, etc.); analysis of labeling and packaging; consultations on issues of customs clearance of products.
A separate area of our expertise is comprehensive analysis of dietary supplement labeling and composition, including:
- Analysis of the instructions for use, packaging and other labeling elements of a dietary supplement for compliance with the requirements of current regulatory acts of Ukraine, namely:
- Law of Ukraine On the Basic Principles and Requirements for the Safety and Quality of Food Products;
- Law of Ukraine On Information for Consumers about Food Products;
- Law of Ukraine On Protection from Unfair Competition;
- Law of Ukraine On Ensuring the Functioning of the Ukrainian Language as the State Language;
- Hygienic requirements for dietary supplements as per Order of the Ministry of Health of Ukraine No. 1114 of December 19, 2013.
- Analysis of the instructions for use, packaging and other labeling elements of a dietary supplement for compliance with the requirements of revised Law of Ukraine On Protection of Consumer Rights No. 3153-I of June 10, 2023.
- Composition requirements determined by current national regulations;
- Composition requirements defined in the EU and individual EU countries (mainly France, Poland, Italy, Germany);
- Composition requirements determined by the list of vitamins, minerals and other substances and their maximum allowable doses for dietary supplements (following approval of the relevant list by the Ministry of Health of Ukraine).
RECENT PROJECTS
- Legal advice to market operators on the terms of dietary supplement distribution in Ukraine.
- Legal advice on advertising and promoting dietary supplements in Ukraine.
- Support for a market operator in obtaining state registration of facilities for the distribution of food products.
- Developing contractual frameworks for registration of relations on the import of dietary supplements.
- Analysis of labeling and composition of over 70 dietary supplements of domestic and international manufacturers.
- Consulting on specific issues related to the import and circulation of dietary supplements.
- Consulting on the introduction of food products for special medical purposes into circulation in Ukraine.
- Full support for the import of dietary supplements ordered by a pharmacy chain.
- Analysis of international experience in distinguishing dietary supplements, medical devices and medicinal products.
- Communication with representatives of customs authorities, the State Service of Ukraine on Food Safety and Consumer Protection and customs brokers to represent clients' interests.
