Dietary Supplements in Ukraine in 2026: New Rules, Notification, and Labeling

Author: Expert Team (Technology and Legal Departments), Bio Light

The dietary supplements market in Ukraine is undergoing the most significant regulatory transformation in recent years. Law No. 4122-IX, adopted in December 2024, has fundamentally changed the rules of the game: from manufacturing and labeling to the procedure for placing products on the market. The transition period ends in March 2026, and only a few days remain for adaptation.

In this article, as a contract manufacturer of dietary supplements, we explain in simple terms the key changes and practical steps that need to be taken right now.

What Law No. 4122-IX Changed

On March 26, 2025, Law of Ukraine No. 4122-IX “On Amendments to Certain Laws of Ukraine Regarding the Improvement of Regulation of the Production and Circulation of Dietary Supplements” entered into force, and on September 27, 2025, it was put into effect. This is the main document that aligned Ukrainian legislation with EU Directive 2002/46/EC.

Key Changes

Clear definition of a dietary supplement. The law now clearly defines a dietary supplement as a food product intended to supplement the normal diet, containing concentrated sources of nutrients or other substances with a nutritional or physiological effect. This definitively distinguishes dietary supplements from medicinal products.

Notification instead of registration. What the market previously referred to as “registration of dietary supplements” has now been abolished. Instead, a simpler procedure applies — notification of the State Service of Ukraine on Food Safety and Consumer Protection regarding the intention to place a product on the market for the first time. However, full responsibility for product safety lies with the market operator.

Lists of permitted substances and maximum doses. The Ministry of Health has been granted authority to approve lists of permitted vitamins, minerals, and other substances, along with their maximum allowable doses. The draft amendments to Order No. 1114 introduce a clear hierarchy of assessment: first EFSA limits (Upper Limit → Safe Level), then national tables.

Significant increase in penalties. Fines for violations reach up to UAH 640,000 for legal entities. The practice of the Antimonopoly Committee of Ukraine (AMCU) already shows that fines for misleading information about dietary supplements can reach tens of millions of hryvnias.

Notification: How It Works

Notification (officially — “notification of the intention to place a product on the market for the first time”) is a mandatory procedure without which the sale of a dietary supplement is illegal.

When to submit a notification:

First placement of a new product on the market — 10 working days before sales begin.
Changes to mandatory information on the label or packaging material — resubmission is required.
Products already on the market before March 26, 2025 — had to be submitted within 6 months (deadline was September 27, 2025).

What the document package includes:

Completed notification form (Order of the Ministry of Agrarian Policy No. 244).
Sample label (sticker) in the official language.
Documents confirming circulation in the EU (if the product is already sold in EU countries).
Cover letter on the official letterhead of the market operator.

❗ IMPORTANT: The name of the supplement in the notification must match the name on the label. Submission follows the principle “one notification — one document package.” It can be submitted by mail (1 B. Hrinchenko St., Kyiv, 01001) or via email: info@dpss.gov.ua

Penalties in 2026: Real Figures

Taking into account the minimum wage in 2026 (UAH 8,647), fines are as follows:

Sale without notification: UAH 389,115 (legal entities) / UAH 345,880 (sole proprietors).
Labeling does not match the notification: UAH 640,000 (legal entities) / UAH 600,000 (sole proprietors).
Violation of composition requirements: UAH 640,000 (legal entities) / UAH 600,000 (sole proprietors).
Misleading allergen information: ~UAH 259,410 (legal entities) / ~UAH 172,940 (sole proprietors).
Therapeutic claims (AMCU): up to tens of millions of hryvnias.

⚠️ AMCU PRACTICE: In December 2025, the AMCU fined three companies over UAH 40 million in total for disseminating misleading information about the properties of dietary supplements. Claims such as “normalizes digestion,” “detoxifies,” and “fast-acting” were classified as therapeutic claims.

Labeling Requirements: What to Pay Attention To

In addition to notification, legislation imposes strict requirements on label content. Labeling must include the following mandatory elements (Order of the Ministry of Health No. 1114, Law No. 2639-VIII):

The wording “DIETARY SUPPLEMENT.”
Full composition with the quantity of each ingredient.
Recommended daily dose and the statement “Do not exceed the recommended daily dose.”
“Not to be used as a substitute for a varied diet.”
“Keep out of reach of children.”
Name and address of the market operator with EDRPOU code.
Expiry date, storage conditions, batch number.
Allergens (highlighted in the text).

Prohibited on the label: Any claims related to treatment, diagnosis, or prevention of diseases — even in negative form. For example, the phrase “This product is not intended to diagnose, treat, or prevent any disease” is also a violation because it contains medical terminology. The correct wording is: “Not a medicinal product.”

Key Dates Timeline

26.03.2025: Law No. 4122-IX entered into force.
27.09.2025: Law put into effect. Notification mandatory for new products.
27.09.2025: Deadline for notifications for products already on the market.
26.03.2026: End of the transition period. All dietary supplements must comply with new requirements.
27.03.2028: Maximum period for circulation of legacy products.

What Manufacturers Should Do Right Now

Check notification status. If you have not yet submitted a notification to the State Service on Food Safety and Consumer Protection — do it immediately. Selling without notification results in fines from UAH 345,000 to 389,000.
Conduct a label audit. Check each product for all mandatory labeling elements: EDRPOU code, three mandatory warnings, dosages, allergens.
Remove prohibited wording. Any references to treatment, diagnosis, specific diseases, or claims like “fast-acting” or “normalizes digestion” must be removed from labels and marketing materials.
Verify dosages. Active ingredient levels must not exceed maximum permissible limits. Special attention should be paid to elemental content. From our experience at Bio Light, the most common issues arise when recalculating doses of elemental magnesium, zinc, and B vitamins under new EFSA limits. Therefore, our team always audits formulas for clients before production launch.
Prepare for the end of the transition period. After March 26, 2026, placing non-compliant products on the market will be impossible.

Turnkey Dietary Supplement Manufacturing by Bio Light LLC

We manufacture dietary supplements in full compliance with 2025–2026 regulatory requirements. What you get:
✓ A ready-to-market product with fully compliant labeling.
✓ Label text verified in accordance with Law No. 4122-IX, Law No. 2639-VIII, and Order of the Ministry of Health No. 1114.
✓ Assistance with preparing notification documentation.
✓ Dosage verification in accordance with EFSA limits and national standards.

This article was prepared by the Bio Light LLC team, Zaporizhzhia. The material is for informational purposes only and does not constitute legal advice. For final decisions, we recommend consulting a qualified specialist. Key sources: Law of Ukraine No. 4122-IX dated 05.12.2024; Law of Ukraine No. 2639-VIII dated 06.12.2018; Order of the Ministry of Health No. 1114 dated 19.12.2013; explanations of the State Service on Food Safety and Consumer Protection regarding notification; AMCU decisions from December 2025.