Dietary Supplements Under New Rules: What Ukraine’s MoH Order No. 203 Changed in 2026

In spring 2026, Ukraine’s dietary supplement market finally got the document it had been waiting for since December 2024. Law No. 4122-IX was adopted long ago, but the technical rules behind it were missing. Manufacturers and importers worked in a “the law exists, the list doesn’t” mode.

MoH Order No. 203 of February 19, 2026 closed that gap. The Ministry of Justice registered it on March 30, it was published in the Official Gazette of Ukraine on April 17, and it has applied since that day.

I read all 129 pages of amendments. Most of it is tables, and the tables hold the things that matter for our patients: how much melatonin a capsule can contain, what red yeast rice must not be combined with, and why the familiar B-complex with 50 mg of pyridoxine no longer qualifies.

Where the new dietary supplement requirements come from

The starting point is Law of Ukraine No. 4122-IX of December 5, 2024. It entered into force on March 27, 2025, and its main requirements started to apply six months later, on September 27, 2025.

The law did three things worth remembering.

First, it gave a new definition. A dietary supplement is now legally a food intended for consumption in small measured amounts as a supplement to the normal diet, a concentrated source of vitamins, minerals or other substances with a nutritional or physiological effect, sold in dose form as a prepackaged food: capsules, lozenges, tablets, sachets, ampoules, dropper bottles.

Second, it introduced notification. A business operator must notify the State Service on Food Safety and Consumer Protection at least 10 working days before placing a supplement on the market for the first time (Article 32-2 of the Law “On Basic Principles and Requirements for Food Safety and Quality”). The Service keeps a public list of these notifications.

Third, it set a transition period. Supplements that met the old rules could be imported and produced until March 27, 2026. They may stay on shelves until their expiry date, but no later than March 27, 2028.

So until 2028, pharmacies will physically stock both “generations” of supplements. Keep that in mind when a patient brings in a bottle and asks whether the dose is fine.

How Order No. 203 changed dietary supplement requirements

The order amends four documents at once: the Hygienic Requirements for Dietary Supplements (Order No. 1114 of 2013), the Requirements for Health Claims (Order No. 1145 of 2020), the Rules for Adding Vitamins and Minerals to Foods (Order No. 1613), and the Requirements for Food Additives (Order No. 45). The first one got the most changes.

Here is how the key points compare.

The first row has the biggest practical effect. The old “no more than three times the norm” formula was vague, because everyone calculated the norm their own way. Linking to the EFSA UL gives a specific number you can check in a minute.

Maximum vitamin and mineral doses in dietary supplements

The new paragraph 2.5 is explicit: the amount of a vitamin or mineral in the recommended daily portion must not exceed the Tolerable Upper Intake Level set by the European Food Safety Authority. EFSA has revised several key ULs over the past three years, so these numbers are recent.

A few adult values I would keep in mind:

Vitamin D: 100 µg (4,000 IU) per day. EFSA confirmed this level in 2023. A supplement with 10,000 IU per daily portion no longer meets this requirement.

Vitamin B6: 12 mg per day. In 2023, EFSA lowered the UL from 25 mg to 12 mg because of the risk of peripheral neuropathy. This is the most painful number for practice: many “nerve support” B-complexes contain 50 mg of pyridoxine or more. As dietary supplements, such products do not comply.

Iron: 40 mg per day. Formally this is a safe level of intake, set by EFSA in 2024 because the data were insufficient for a classic UL. The order explicitly allows the safe level to be used when there is no UL.

For substances with neither a UL nor a safe level from EFSA, the Ministry added its own Table 1 to Annex 1. It has six entries: vitamin B1 up to 100 mg, B2 up to 40 mg, B12 up to 100 µg, vitamin C up to 1,000 mg, vitamin K up to 200 µg, pantothenic acid up to 200 mg (10 mg for pantethine).

1,000 mg of vitamin C is the ceiling for a supplement. Two-gram effervescent “cold season” tablets will no longer pass as a dietary supplement.

The list of permitted forms was also expanded. Annex 2 now includes calcidiol monohydrate, nicotinamide riboside chloride, two salts of methyltetrahydrofolic acid, magnesium L-threonate (see our piece on magnesium and the brain), magnesium citrate malate, iron milk caseinate, chromium-enriched yeast and organic silicon (monomethylsilanetriol). Some of them are marked as novel foods.

Permitted plants, fungi and substances (Annex 3)

This is the largest part of the order, more than 100 pages, and the biggest change to dietary supplement requirements. The logic is simple: if a substance is not in Annex 3 (or on the novel food list), it should not be in a dietary supplement.

The plant section has 906 entries, from okra to jujube. Each one lists the Latin name, family, Ukrainian name, permitted plant parts and restrictions, if any. The mushrooms we covered recently are here too: reishi (Ganoderma lucidum), lion’s mane (Hericium erinaceus), chaga (Inonotus obliquus) and Chinese cordyceps (Ophiocordyceps sinensis).

The list of substances with a physiological effect also includes enzymes, such as bromelain from pineapple. We covered what is known about it in “Bromelain: The Pineapple Enzyme for Cold Season”.

The most useful part for clinicians is the “Restrictions” column. Here is a selection worth knowing.

As a doctor, I was glad to see a few things in this table. The 1.9 mg melatonin limit means that 5 mg and 10 mg capsules, sold for years as a “natural sleep supplement,” can no longer exist in that status. And the list of warnings for melatonin is long, from epilepsy to work that requires heightened attention.

Red yeast rice, whose monacolin K is chemically identical to lovastatin, finally has a clear warning about statins. Before, a patient could easily take atorvastatin and a “natural cholesterol remedy” at the same time.

What is completely banned in supplements

The order rewrote Annex 3 to Rules No. 1613. It now has two sections: banned substances and restricted substances.

Foods, and therefore dietary supplements, may not contain aloe-emodin, emodin or danthron in any preparation, ephedra herb and preparations from Ephedra species, aloe leaf preparations containing hydroxyanthracene derivatives, or yohimbe bark.

The list is short, and it covers exactly the substances that kept turning up in questionable weight loss products, laxative teas and “male potency” products.

The second rule is broader. Active substances of prescription medicines are banned in supplements unless the Ministry has explicitly added them to Annexes 1-3. For pharmacists this is a useful check: if a supplement label shows a name you know from the prescription drug reference, look it up in the list.

Dietary supplement requirements for labeling and advertising

The new wording of paragraph 3.3 bans the following in supplement labeling and advertising:

claims of therapeutic action or pain relief; attributing the ability to prevent, treat or cure disease; thank-you letters, testimonials and advice related to treatment; statements that scare people about their health if they do not buy the supplement.

Health claims are allowed, but only those on the list attached to Order No. 1145, and only under the conditions set there. For example, “magnesium contributes to normal protein synthesis” may be used only for a product that meets the “source of magnesium” criterion. For omega-3, the heart function claim works only if consumers are told that the effect is obtained with a daily intake of 250 mg of EPA and DHA.

Order No. 203 also added a new claim on carbohydrate solutions for trained adults (30-90 g of carbohydrate per hour) and changed the wording for protein, magnesium, zinc and omega-3.

The label now states the amount of each substance per daily portion, and for vitamins and minerals also as a percentage of the reference intakes. These values are averages based on the manufacturer’s laboratory data.

What this means for doctors and pharmacists

For doctors, the main point is this. When a patient says “I only take vitamins,” ask for the product name and check the composition. The new dietary supplement requirements give a simple filter: if the vitamin D, B6 or iron dose is above the EFSA UL, or melatonin is above 1.9 mg, the product is either old stock or not a dietary supplement. Either way, the dose needs a conversation.

Second, interactions. For the first time the regulator has written them into a legal document. Ginkgo with anticoagulants, red yeast rice with statins, ashwagandha with hypnotics, St John’s wort and sunlight. These pairs are worth mentioning to patients without being asked.

For pharmacists the changes are even more concrete. During a consultation you can refer to the order itself: “the label says not to take it on an empty stomach, that is a Ministry of Health requirement.” Patients accept this kind of argument better than a general “it’s better that way.”

One more thing. The transition period lasts until March 27, 2028. If a supplement with an “old” dose is on the shelf, it can be sold legally until its expiry date. That is no reason to recommend it.

Frequently asked questions

Conclusions

Order No. 203 rewrote Ukraine’s dietary supplement requirements along EU lines. Vitamin and mineral doses are capped by EFSA levels, other ingredients are allowed only from a closed list, and risky substances come with specific numbers and label warnings.

For practice, I would remember six numbers: vitamin D 100 µg, B6 12 mg, iron 40 mg, melatonin 1.9 mg, caffeine 400 mg, monacolins under 3 mg. And one date: March 27, 2028, when the last supplements made under the old rules should leave the shelves.

Supplements have not become medicines, and the order says so directly. Talking to patients about them is much easier now, though, because there is a document to point to.

About the Author

Nikolay Bondarenko is a Ukrainian dermatologist and expert in skin diseases.   A graduate of Ukraine's leading medical university, he specializes in diagnosing and treating dermatological issues.   As the author of numerous expert articles, he actively contributes to the development of dermatology and shares his knowledge with the medical community.