Ukraine may tighten control over the production and circulation of dietary supplements: what is at stake
Kyiv • UNN
Ukraine plans to strengthen the regulation of dietary supplements by defining clear mechanisms for their production and circulation, and approving lists of permitted substances and doses. The document also strengthens responsibility for the production and sale of food supplements that do not meet legal requirements.
The Cabinet of Ministers has approved the draft Law "On Amendments to Certain Laws of Ukraine on Improving Regulation of Production and Circulation of Food Additives". The document proposes to increase responsibility for the production and sale of food additives that do not meet legal requirements. This was announced by the government's representative in the parliament Taras Melnychuk, reports UNN.
The Draft Law "On Amendments to Certain Laws of Ukraine on Improving Regulation of Production and Circulation of Food Supplements" was approved. The Draft Law proposes to bring the term "dietary supplement" in line with the requirements of the Directive of the European Parliament and of the Council of 10.06.2002 N 2002/46/EC "On the Approximation of the Laws of the Member States on Food Supplements", in particular, it is proposed to replace the term "dietary supplement" with the term "food supplement"
As stated in by the Ministry of Health, due to the existing gaps in the state control system, unscrupulous business entities commit abuses, in particular, fail to register medicines and sell them under the guise of food supplements (dietary supplements).
Disorders that pose a threat to health may include:
- the presence of active pharmaceutical ingredients in food additives, including prescription ingredients that can be used exclusively for the manufacture of medicines;
- absence of the declared nutrients (proteins, fats, carbohydrates, vitamins, minerals) in the food supplement;
- non-compliance of the labeling of food additives with the established requirements, in particular, the indication that they have a therapeutic effect.
The Ministry of Health indicated that the draft law defines clear mechanisms for the introduction of food supplements into circulation, as well as requirements for substances that can be used for their production: vitamins, minerals and other substances with nutritional or physiological effects.
According to the document, the agency will be able to approve the list of such substances and the maximum permissible doses allowed for use in food supplements. The draft law also strengthens responsibility for the production and sale of dietary supplements). that do not meet the requirements of the law.
In addition, the law establishes the procedure for submitting notifications on the introduction of food additives into circulation, maintaining a list of such notifications and posting them on the official website of the State Service of Ukraine on Food Safety and Consumer Protection.
The draft law defines clear mechanisms for the introduction of food supplements, as well as requirements for substances that can be used for their production: vitamins, minerals and other substances with nutritional or physiological effects. It also allows the Ministry of Health to approve the list of such substances and the maximum permissible doses allowed for use in food supplements. The document also strengthens responsibility for the production and sale of food supplements that do not meet the requirements of the law.
In addition, it establishes the procedure for submitting notifications on the introduction of food additives, maintaining a list of such notifications and posting them on the official website of the State Service of Ukraine on Food Safety and Consumer Protection.
Currently, there are numerous cases when medicines are registered under the guise of dietary supplements. This misleads consumers and poses risks to human health. Therefore, we need to eliminate the existing legislative gaps so that the registration and circulation of both medicines that are clinically tested and have proven efficacy and dietary supplements that do not have such proven efficacy are clearly regulated and no manipulations are possible.