Legal consultation on registration of dietary supplements in Ukraine
In June of 2017, we were contacted by a Client, who intended to start producing the plant-based products in Ukraine. The entrepreneur did not understand what category his products fall under and, accordingly, he didn’t know how to make the production fully compliant with the requirements of the law. Therefore, the task of our lawyers was to provide an exhaustive answer to the Client’s questions.
The Client provided us only with the composition of the products that he was going to produce, and noted that the products are intended to be added to the food in order to improve the physiological condition of the human body. We have started to analyze the legislation regarding the classification of goods in this or that category according to these criteria. In the course of our research, we found various options for defining the Client’s product, in particular: food additives, food for special medical purposes, food products for weight control, dietary supplements.
Each type of food products has its own specific characteristics. For example, food for medical purposes are intended for people with eating disorders and shall be used under the medical supervision. Food additives are not usually used independently, they are added to the product during the production to preserve flavor, enhance its taste or other qualities. Weight control products are usually used to replace some of the foods from the everyday diet. So, based on the thorough analysis of the issue, we decided that our Client’s products fell under the dietary supplements category.
According to the Law of Ukraine “On Basic Principles and Requirements for Safety and Quality of Food Products” (hereinafter - the Law), dietary supplements are a kind of food products that shall be consumed in small determined quantities, without replacing a normal human food ration. Such additives are a concentrated source of nutrients (proteins, fats, minerals, etc.). Taking into account all these features, it was concluded that the dietary supplements fully fit the description of the products that the Client intended to produce and distribute.
Another issue we had to study was related to the requirements for the production of dietary supplements in Ukraine. Our specialists had to pay special attention to that issue, because the key objective of the Client was to organize the production process in full compliance with Ukrainian laws and regulations. And that’s a quite logical request, because if the competent authority detects that you fail to meet any of the state guidelines for compliance, this can result in serious consequences for your business.
Today, food products are not subject to the state registration according to the law of Ukraine. Legalization of food products involves obtaining expert opinions on a voluntary basis. Despite this fact, the production of these products must comply with the general sanitary and hygienic requirements in accordance with the Law of Ukraine “On Basic Principles and Requirements for Safety and Quality of Food Products”. The producer of foodstuffs should ensure that production equipment is maintained in a pure and serviceable condition, water used for production meets necessary criteria, workers engaged in production pass medical inspection, production wastes are recycled, products pass laboratory tests under certain criteria. This is not an exhaustive list of requirements for the production process. Thus, our Client needed to obtain documents confirming the conformity of production facilities with the Ukrainian laws and regulations: the Sanitary and Epidemiological Conclusion certifying the conformity of the premises; a document confirming the quality of water; an agreement with the company carrying out the medical examination of the relevant workers; an agreement with the company carrying out recycling of production wastes; conclusion on the product testing in the laboratory. Therefore, apart from the fact that it is not necessary to obtain the Sanitary and Epidemiological Conclusion certifying the conformity of food products, the law of Ukraine sets forth clear criteria to ensure the quality and safe product production.
Thus, the legal consultations of our lawyers have not only helped the Client to get all necessary answers to his questions, but also to properly organize the production of dietary supplements in Ukraine.