ETS Certification

What you need to know to complete the notification

Requirements for the circulation and notification of dietary supplements are regulated by the Law of Ukraine "On the Basic Principles and Requirements for the Safety and Quality of Food Products" and the Law of Ukraine "On Amendments to Certain Laws of Ukraine Regarding the Improvement of Regulation of the Production and Circulation of Dietary Supplements and Other Healthcare Matters."

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The law defines the concept of a "Dietary Supplement".

A dietary supplement is a food product that:

• is intended for consumption in small, defined quantities as a supplement to a regular diet, either alone or in combination with other food products;

• is a concentrated source of vitamins, minerals, or other substances with a nutritional or physiological effect;

• is sold in measured doses as a packaged food product in the form of capsules, lozenges, tablets, sachets, liquid ampoules, dropper bottles, or other similar forms of liquids and/or powders.

Please assess whether your product meets the above definition and falls within this classification.

 

Steps to take before notification:

• conduct an expert review of the dietary supplement's composition and prepare the dossier documentation;

• verify whether the product falls under transitional provisions;

• adapt the composition to comply with the new rules;

• carry out an expert review of all consumer labeling (primary, secondary, and package insert) and develop labeling in accordance with current Ukrainian legislation;

• submit the notification for initial market entry or for continuation of lawful circulation.

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Laboratory testing is required to confirm the purity of finished dietary supplements. Testing is a mandatory step — products cannot be placed on the market without it.

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Food safety requirements establish maximum permissible levels for certain undesirable substances. These requirements are designed to ensure product safety by preventing food products with hazardous substance concentrations above established limits from reaching the market. Contaminants that exceed the threshold values set out in the regulatory annex render a product ineligible for market circulation.

The requirements apply to all participants in the food chain — from primary production through to retail.

Market operators must apply good practices to minimize contamination at all stages and take maximum levels into account when assessing the safety of raw materials and the final product with regard to possible contamination.

 

Main categories of contaminants to be assessed:

• Heavy metals

• Polycyclic aromatic hydrocarbons (PAH)

• Other contaminants: pesticides, dioxins, furans, perchlorates, and other residual substances.

 

A market operator intending to place a dietary supplement on the market for the first time must notify the competent authority of this intention no later than 10 business days before market entry, by submitting a formal notification.

The notification must include the following information:

1. Name of the dietary supplement;

2. Details of the market operator (legal entity or individual), including name, registered address, registration details, and contact information (phone, fax, email);

3. Individual registration number of the facility, registered in accordance with Article 25 of the applicable Law;

4. Dosage form of the dietary supplement;

5. List of ingredients and quantities of vitamins, minerals, and other substances with a nutritional or physiological effect contained in the dietary supplement;

6. Contact details of the person responsible for submitting the notification and for subsequent communication with representatives of the competent authority regarding the information contained in the notification

Together with the notification, the market operator must submit a sample label (sticker) of the packaged dietary supplement in the Ukrainian language.