ISO
18th May, 2020

Main instruments of legislation regulating the production of dietary supplements in Ukraine

Dietary supplements in Ukraine are defined as food products. Therefore, in their production, it is necessary to adhere to the norms that apply to food. In our country, the main instrument of legislation regulating the production of DS is the Law on Basic Principles and Requirements to Food Safety and Quality. This document:

• Discusses the issues of hygiene of products, production process, premises, transport, equipment, inventory, as well as employees dealing with dietary supplements.

• Considers the main points in relation to the production and turnover of active components, including new supplements and ingredients.

• States the requirements to exported products and conditions for importing food products into the country.

• Discusses the point of product quality control.

Illustration

DSs cannot be produced and are not allowed to be sold in the territory of Ukraine, without compliance with the requirements of this law.

Composition of dietary supplements

According to Order 1114 "On Approval of Hygienic Requirements to Dietary Supplements", they may include:

• Vitamin components.

• Mineral compounds.

• Nonessential amino acids and essential amino acids.

• Omega acids.

• Dietary fibre.

• Parts of plants and herb extracts.

The document specifies a list of vitamin and mineral components and the forms in which they can be used. 13 vitamins and about 17 minerals are recommended for the production of supplements, in the form of the safest and most easily digestible compounds.

Concentration of active agents in DSs

The amount of active agents that come with a dietary supplement should correspond to the physiological needs of the body. Only in this case, the supplement will give the expected effect.

The norm of nutrients per day required by a person at different ages is fixed by Order No. 1073 "On Approval of the Norms of the Physiological Needs of the Population of Ukraine in Basic Food Substances and Energy". The standards indicate the volume of intake for:

• Protein.

• Fat.

• Carbohydrates.

• Mineral substances.

• Vitamins.

In addition, the average energy expenditure for men and women for basal metabolism and for different levels of physical activity are calculated.

Supplements containing insufficient amounts of compounds can be completely ineffective, and those which include an excess of one or another component may lead to the development of undesirable side effects.

According to current regulations, DSs may contain at least 15% of the daily value of a substance. The maximum quantity is selected based on scientifically based safety standards and taking into account the compounds coming from other food products.

Requirements to packaging and advertising

Dietary supplements must only be sold packaged in a well-regulated dosage. The packaging must indicate that it is a food supplement and list the main ingredients. The mandatory labels must specify the following:

• Do not exceed the daily dose.

• The supplement is not a substitution for a nutritious diet.

• Keep away from children.

Since DSs are an additional source of nutrients, you can not write about their therapeutic effect when advertising them.

DSs quality control

To control the quality of dietary supplements produced in our country, the HACCP system has been introduced (Hazard Analysis and Critical Control Points). It helps assess risks and manage harmful factors in each enterprise. Its application is provided by Order No. 590 "On Approval of Requirements to Development, Implementation and Application of HACCP System". The system implies the control of:

• all stages of production,

• raw materials and additional materials,

• storage methods,

• DSs sales

To perform inspection according to this system, certain control points are used, where the identified problems can be corrected, prevented, and minimized. Thanks to HACCP system, it is possible to significantly reduce the likelihood of chemical and biological contamination of the product.

When purchasing DS or ordering contract production, preference should be given to companies that fully comply with all the requirements of Ukrainian legislation. Astrafarm is exactly such pharmaceutical company in Ukraine. The most advanced technologies are implemented in the production and the quality of dietary supplements is constantly monitored.