For domestical manufacturers

Manufacture and circulation of food products (including domestically manufactured dietary supplements) 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”.

Dietary supplement (food supplement) 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.

Prior to making a decision to start production of a dietary supplement, it is required to develop the Technical Conditions for such manufacture, as well as make sure that the product composition, intended use and the recommended daily dose are in compliance with 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, with the exception of the newest ones, are not included in the list of the products that are subject to mandatory registration.

The main document regulating the manufacture of dietary supplements in Ukraine is the Technical Conditions.

Technical Conditions (TC) document is a document approved by the market operator which defines the technical requirements for food products and/or processes for their production.

The Technical Conditions are subject to mandatory approval by the State Service of Ukraine on Food Safety and Consumer Protection, which is executed as the Conclusion of the State Sanitary and Epidemiological Expertise (hereinafter, Conclusion).

For manufacturers who carry out activities related to the manufacture and/or storage of food products of animal origin, availability of operational permit is the mandatory requirement.

Operational permit is an authorization document issued by the competent authority to the food market operator based on the results of inspection of its facilities for compliance with the requirements of sanitary measures.

For food market operators whose activities do not require an operational permit, the mandatory requirement is registration of manufacturing facilities used at any stage of a food product production and/or circulation, and, as a result, their including into the state register of manufacturing facilities.

Also, a food safety management system developed on the basis of HACCP (Hazard Analysis and Critical Control Points) principles must be available at the facility. The purpose of the system is to identify, evaluate and control the hazards that are critical to food safety. It is important that, since the entry into force of Section VII of the Law of Ukraine “On Basic Principles and Requirements for Food Safety and Quality” (September 20, 2016), all domestic market operators related to the food industry are required to develop and implement a food product safety system based on the HACCP principles, except for those engaged in primary production. Please pay attention that this section has different transition periods, which are determined depending on the market operator’s field of activity.

Primary production is the production and cultivation of products, including harvesting, milking, raising animals before slaughter, hunting animals, fishing and harvesting wild plants.

State control over the implementation of permanent HACCP procedures at all facilities is provided by the State Service of Ukraine on Food Safety and Consumer Protection.

Cratia offers legalization of domestically manufactured dietary supplements of national production:

1. conducting pre-audit of the proposed manufacturing site, evaluation of the available documents and preparation of the plan of actions;
2. development and registration of manufacture Technical Conditions;
3. organization of obtaining the Conclusion on the manufacture Technical Conditions;
4. examination of the product composition and supporting documents, providing all the necessary consultations;
5. organization of laboratory tests and the receipt of the product safety report and classification of the product as a Dietary Supplement;
6. development of draft labeling (sticker or packaging), as well as, when required, instructions (package insert).

As a result of our work, you will receive a Conclusion of the State Sanitary and Epidemiological Expertise on the manufacture Technical Conditions, the report from an authorized organization on the manufacture Technical Conditions, as well as the document confirming the product safety, assigning to it the appropriate status in Ukraine and containing the labeling text in accordance with effective national legislation.