Сirculation of dietary supplements under the new rules – analysis of requirements

Abstract

Purpose of the work. To analyze the requirements in the field of circulation of dietary supplements (hereinafter referred to as DD) in Europe and Ukraine and assess the changes that await DD market operators after the adoption of the new Law No. 4122-IX "On Amendments to Certain Laws of Ukraine on Improving the Regulation of the Production and Circulation of Dietary Supplements, and on Regulating Other Issues in the Sphere of Healthcare" (hereinafter referred to as the Law). Materials and methods. Analysis of current European legislation in the field of circulation of dietary supplements and new provisions of Law No. 4122-IX "On Amendments to Certain Laws of Ukraine on Improving the Regulation of the Production and Circulation of Dietary Supplements, and on Regulating Other Issues in the Sphere of Health Care". The analysis was carried out using bibliographical, system-structural methods and the method of traditional analysis. Research results. In the EU Member States, the circulation of food (dietary) supplements is classified as a subject of legal regulation of the legislation on the circulation and safety of food products. In order to regulate the DD market in order to establish proper control over such products and implement EU standards provided for by Directive 2002/46/EC, Ukraine adopted a Law aimed at improving control over the DD market and harmonizing Ukrainian legislation with European ones. The Law introduces a DD notification procedure and strengthens responsibility for the production and sale of dietary supplements that do not meet the requirements of current legislation, in particular, it introduces significant fines for unscrupulous entrepreneurs. According to the Law, DD that met the requirements of the legislation in force before the entry into force of the specified Law, but do not meet the updated requirements, may be imported into the territory of Ukraine, manufactured and/or put into circulation within a year after the law enters into force. Such dietary supplements may be in circulation until the minimum shelf life or the “use by…” date, but not longer than three years from the date of entry into force of this Law. According to the requirements of the Law, market operators are obliged, within six months from the date of entry into force of the Law, to submit to the State Service for Food Safety and Consumer Protection a notification of the intention to first place a dietary supplement in circulation, which was in circulation on the territory of Ukraine before the entry into force of this Law and is planned to be put into circulation after the entry into force of this Law. Conclusions. It has been established that in Europe the main supervisory authority is the European Food Safety Authority, and the circulation of dietary supplements takes place in accordance with the requirements of Directive 2002/46/EC. In addition, each country has its own legislation in the field of circulation of the specified products, which supplements the requirements of the Directive. With the entry into force of the Law No. 4122-IX "On Amendments to Certain Laws of Ukraine on Improving the Regulation of the Production and Circulation of Dietary Supplements, and on Regulating Other Issues in the Sphere of Health Care", notification of dietary supplements is being introduced in Ukraine. However, for the effective implementation of the law, it is necessary to introduce a mechanism for examining documents prior to the notification of the introduction of dietary supplements into circulation (to make a decision on compliance/non-compliance). In addition, in order to confirm the safety of dietary supplements, it is necessary to provide for laboratory tests. An operating system of registers of permitted/unpermitted substances with nutritional and physiological properties and plant substances and their maximum quantities should also be created, and mechanisms for the functioning and updating of registers should be developed.