Bez kategorii June 5 2025

Sensitive Products in a Nutshell – In Practice.Part III: Resolutions of the Team for Food Supplements – The Latest Resolution on Tablet Splitting.

The Resolutions of the Team for Food Supplements are official positions and recommendations issued by the Team operating under the Chief Sanitary Inspectorate (GIS) in Poland, functioning within the framework of the Sanitary and Epidemiological Council. Their main goal is to assess the safety of using various substances in food supplements, as well as to protect public health, ensure consumer safety, and align Polish regulations with EU legislation. Although these resolutions do not have legal force, they serve as advisory opinions and are practically used by the GIS when evaluating notifications of food supplements.

The resolutions include, among other things, lists of prohibited substances such as yohimbine, DMAA, SARMs, or ibutamoren, which are not allowed to be used in food supplements. They also specify the maximum recommended levels of vitamins and minerals—for example, vitamin D is limited to 2000 IU for adults up to the age of 75 and 4000 IU for those above that age, while vitamin B6 has been limited to 6 mg per day starting in 2024. Additionally, the resolutions contain labeling and warning recommendations, such as the requirement to inform consumers that the product should not be consumed by individuals taking anticoagulants containing vitamin K antagonists (e.g., warfarin and acenocoumarol) in the case of supplements containing vitamin K.

In practice, many questions arise regarding the nature of these resolutions—whether they constitute law, customary practice, or scientific guidelines with significant authority, and what real impact they have on ongoing proceedings. It is important to understand who considers them and why, and whether they should be taken into account in research and development processes, the design and launch of new products, updates to quantitative and qualitative compositions, internal systems, product withdrawals from the market, packaging design, as well as advertising, marketing, and educational campaigns.

In the context of administrative and judicial proceedings, questions arise about the type of arguments that should be used before the Chief Sanitary Inspectorate (GIS) in explanatory proceedings concerning the status of a product, before the Provincial Sanitary Inspectorates (PPIS) in control proceedings—both those conducted in parallel with GIS proceedings and those following their conclusion—as well as during court proceedings. There is also consideration of the possibility of challenging the resolutions—either globally or on a case-by-case basis, in relation to specific substances or products, and the scientific literature on which the resolutions are based. The question arises whether it is possible to demand their update in light of the latest scientific knowledge.

Additional concerns relate to products placed on the market from outside the EU, as well as those distributed in Poland but first introduced in another EU country, which do not comply with the resolutions. It is also important to consider how one can influence the content and application of the resolutions—both in specific proceedings and through changing the perception of the industry, conducting product research, publishing scientific papers, engaging in educational and promotional activities, or participating in industry organizations.

New Resolution on Tablet Splitting

On May 7, 2025, the Team for Food Supplements issued Resolution No. 1/2025, in which it expressed an opinion on establishing requirements in cases where the labeling of a food supplement includes instructions for use involving tablet splitting.

The resolution was issued pursuant to Article 9(2b)(1) of the Act on the State Sanitary Inspection. It sets out the conditions that must be met for information about the possibility of tablet splitting to be included on the packaging of a food supplement. In particular:

  1. Tablet splitting is permitted, provided that the entire tablet does not exceed the maximum daily amounts of individual substances.
  2. The manufacturer or responsible entity must ensure that each portion resulting from splitting the tablet contains the appropriate, declared amount of vitamins, minerals, or other substances with nutritional or physiological effects.
  3. The tablet must have an appropriate score line that allows consumers to split it evenly and easily. The product should be in a form that facilitates such division.
  4. The product labeling should include precise instructions regarding both the recommended portion for consumption and the method of tablet splitting.

The resolution entered into force on the date it was adopted, although it was published on June 2, 2025.

Resolution No. 1/2025 of the Team for Food Supplements, dated May 7, 2025, carries significant practical and regulatory implications for food supplement manufacturers, distributors, and supervisory authorities.

The resolution may influence the standardization of labeling practices for supplements that allow tablet splitting. It introduces criteria for the admissibility of information about tablet splitting on the labeling of food supplements. Until now, there have been no precise guidelines in this area, which has led to inconsistent market practices. However, the proposed guidelines may raise concerns in relation to actual practice, particularly regarding the condition that tablet splitting is permitted only if the entire tablet does not exceed the maximum daily amounts of individual substances.

The resolution may have implications for the liability of manufacturers and importers.

Manufacturers should:

Failure to meet these conditions may result in the labeling being challenged by supervisory authorities, and in extreme cases — the product being withdrawn from the market.

What is also important is that this undoubtedly contributes to strengthening consumer protection.

The purpose of the resolution is to increase the safety of food supplement use by consumers. Splitting tablets without appropriate information may lead to:

The new guidelines aim to prevent this by promoting clarity and reliability in labeling.

Moreover, the resolution is practically significant for the course of inspections conducted by authorities. Although the resolution does not have the force of law, it represents the official position of the advisory body to the State Sanitary Inspection. In practice, it may be used by:

It is worth considering, in the daily practice of running a business, the need to update documentation, processes, production practices, as well as labeling and packaging.

Companies that have so far used labeling related to tablet splitting will need to:

If you have any questions regarding the resolutions of the Team for Food Supplements or other concerns related to labeling, marking, communication, advertising, and promotion of your products, please feel free to contact us at: office@ajlaw.pl and juchanska@ajlaw.pl.

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