In the case in question, the authorities of both instances completely ignored expert evidence submitted by the party – including an opinion from a scientific institution authorized to verify food classification under Article 31(1)(2) of the Act on Food Safety and Nutrition and entered into the relevant list of the Ministry of Health – deeming that since the assessment of product classification belongs to GIS, the opinions of experts or scientific institutions on this matter are irrelevant.

The Voivodeship Administrative Court in Łódź thus addressed a practical issue of extreme importance for the food industry: can local sanitary inspection authorities base their decision to prohibit marketing solely on the position of GIS, while ignoring scientific evidence submitted by the party? The court’s answer is categorical and constitutes an important signal for the entire market.

From notification to GIS to prohibition of marketing

The case concerned an entrepreneur who notified GIS of the intention to place a product on the territory of the Republic of Poland for the first time as a dietary food for special medical purposes. The notification was made under Article 29(1) of the Act on Food Safety and Nutrition, which is an obligation for any entity intending to market food supplements, FSMP, fortified foods, or infant formulas.

The Chief Sanitary Inspector initiated explanatory proceedings under Article 30(1) of the Act on Food Safety and Nutrition, culminating in a letter informing the company that, in its assessment, the notified product did not meet the definition of FSMP set out in Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 and the requirements of Commission Delegated Regulation (EU) 2016/128 of 25 September 2015.

GIS conveyed its position to the local authorities, for whom it became the direct impulse to initiate proceedings under Article 8 of the Act on Food Safety and Nutrition. Despite the scientific explanations provided by the party, the State County Sanitary Inspector issued a decision prohibiting the marketing of the product as food for special medical purposes, fully sharing the position of GIS expressed in the letter concluding the explanatory proceedings. The appellate authority (PWIS) upheld it, arguing, among other things, that the PPIS was actually entitled and obliged to take into account the position of GIS in its ruling.

The authorities, in line with GIS, reiterated that the entrepreneur had not demonstrated that in the disease conditions indicated on the labeling there was a special requirement for specific ingredients of the product and that the product met those needs. In their view, the product could at most function on the market as a food supplement for healthy and sick individuals, but not as FSMP.

Parallel issues regarding GIS proceedings and the nature of its act

The significance of the judgment of the WSA in Łódź is best seen against the background of the earlier dispute over the legal nature of the GIS letter itself. Initially, the WSA in Warsaw ruled that this document was merely informative in nature and was not subject to review by administrative courts. It was only the Supreme Administrative Court (NSA) that changed this assessment, indicating that the GIS letter is an act in the field of public administration that can be challenged in court. This paved the way for judicial verification of the authority’s position.

The dispute over the product’s classification lasted for several years and returned to the docket multiple times. Crucial significance was attached to the position of the NSA, which emphasized that GIS cannot resolve a case solely on the basis of its own assessment if there are doubts requiring specialized knowledge. In such situations, the authority should use expert opinions. As a result, the WSA in Warsaw set aside the GIS position, holding that the evidentiary material had not been sufficiently clarified. However, the case remains ongoing.

The development of the parallel case was of great importance to the optics of the WSA in Łódź. The entrepreneur repeatedly applied for suspension of the proceedings until the final judgment on the GIS act. The WSA in Łódź ultimately refused to suspend, arguing that the decision under Article 8 of the Act on Food Safety and Nutrition is entirely independent, and its legality is not directly conditional on the outcome of the case concerning the GIS letter. It was precisely this thesis that became the foundation of the breakthrough ruling.

A decision under Article 8 of the Act on Food Safety and Nutrition is an independent ruling

A key element of the considerations of the WSA in Łódź was the interpretation of the legal nature of the proceedings conducted under Article 8 of the Act on Food Safety and Nutrition. According to this provision, the competent PPIS, by way of a decision, prohibits the marketing or orders the withdrawal from the market of a product that does not meet the requirements specified in Chapter II of the Act.

The WSA unequivocally stated that the decision under Article 8 of the Act on Food Safety and Nutrition ‘is not in the nature of a secondary enforcement act relative to the position of GIS’. It is an independent administrative decision that authoritatively determines the rights of a party. Since the legislator entrusted this competence to the County Sanitary Inspector, it is that authority that has an absolute duty to independently establish and prove that the grounds for prohibiting marketing have occurred.

The court strongly emphasized that a general statement by the authority is not enough. Non-compliance of a product with legal requirements cannot be assumed in advance by the authorities, nor presumed based on the position of another authority. It must be precisely demonstrated during fair evidentiary proceedings, with absolute respect for the principles of administrative procedure.

Although the court acknowledged that the duty of proper product classification rests on the entrepreneur, this responsibility does not relieve the authority of its own procedural obligations. When issuing a prohibiting decision, the authority must independently prove why the classification made by the entrepreneur is incorrect. The result of the explanatory proceedings before GIS can, of course, be an important element of the case file; however, it does not relieve the PPIS and PWIS of the duty to evaluate evidence. The authority may share the position of GIS, but it must substantiate why it does so, based on what findings of its own and in relation to what specific evidence.

An interesting argument raised by the Court was also the inconsistency of the sanitary authorities themselves. The authorities refused to suspend the proceedings claiming that the GIS act did not constitute a preliminary question, but at the same time, in the substantive ruling, they treated that very same GIS act as decisive and determinative for the entire case. The WSA in Łódź called out this action: since the GIS letter did not condition the issuance of the decision, it could only be one of many pieces of evidence subject to objective evaluation.

The role of scientific evidence submitted by the entrepreneur

Another extremely important thread from the practical perspective of food industry companies is the approach of authorities to external expert opinions. In the case in question, the company submitted an extensive scientific and medical study as well as an opinion from a scientific institution. The authorities ignored this evidence, explaining that since competence for assessing classification lies with GIS, expert opinions are irrelevant in this matter.

The WSA in Łódź considered such action to be a gross violation of administrative procedure. The court indicated that an authority cannot rule out the significance of specialized evidence in advance. The sanitary authority had every right to subject this evidence to substantive criticism – it could have found that the opinion did not address all the criteria of the FSMP definition, that it did not demonstrate a special nutritional need of patients, or that it referred only to general physiological benefits. However, it had to do so by way of an analytical evaluation of the evidence, reasoned in the decision. Dismissing a scientific opinion with a one-sentence statement that ‘classification belongs to GIS’ was directly termed by the court as evading the evaluation of evidence, which constitutes a drastic violation of the rules. The party’s documents should have been thoroughly confronted with the substantive legal criteria.

A five-step test for the classification of food for special medical purposes

In order to structure the method of substantive processing in FSMP cases, the Voivodeship Administrative Court formulated a five-step classification test on which authorities ruling under Article 8 of the Act on Food Safety and Nutrition should rely. This test stems directly from the analysis of Article 2(2)(g) of Regulation No 609/2013 and the provisions of Commission Delegated Regulation (EU) 2016/128.

According to the court’s guidelines, for an authority in proceedings under Article 8 of the Act on Food Safety and Nutrition to effectively challenge an FSMP classification, it must jointly examine five key elements:

1. First, determine whether the given product is specially processed or specially formulated food.
2. Second, precisely specify for which concrete group of patients the product is intended.
3. Third, indicate the disease, disorder, or medical condition from which the special medical nutritional needs of the patient directly result.
4. Fourth, conduct a substantive assessment of whether the composition, form, as well as recommended dosage and method of use of the product are in fact adapted to those specific patient needs.
5. Fifth, it is necessary to clarify whether the dietary management of these patients cannot actually be achieved solely by modifying their normal diet.

The court also noted that the mere reference by an entrepreneur to the beneficial or physiological effect of ingredients does not determine that we are dealing with food for special medical purposes. At the same time, however, a mere statement by the sanepid that a given product could be consumed by healthy individuals, or that similar ingredients occur in ordinary food supplements, is not sufficient to issue a prohibition on marketing. The authority’s assertions must in each case refer to the specific product, its exact composition, designed labeling, and the intended use declared by the manufacturer, supported by appropriate documentation.

A fundamental flaw of the set-aside decisions of the PPIS and PWIS was that the justifications for these acts did not show that the full classification test described above had been conducted. The authorities treated the central headquarters’ position as decisive, denying any significance to the party’s evidentiary material. Such action by the authorities violated procedural provisions in a manner that could have had a significant impact on the final outcome of the administrative case – in the view of the WSA, it cannot be ruled out that after a thorough analysis of the opinion of the competent scientific unit, the PPIS ruling would have been completely different.

Significance of the judgment for the food business

The judgment of the WSA in Łódź (along with its comprehensive guidelines for further proceedings) is a ruling of fundamental importance for the entire Life Science sector. Entrepreneurs operating in the market for food for special medical purposes and food supplements have thus gained a powerful weapon in combating often arbitrary decisions by local sanitary inspectorates.

Several universal conclusions flow from the ruling:

• Local sanepid authorities (PPIS and PWIS) can no longer treat letters from the Chief Sanitary Inspector as decisive for the case. They must conduct proceedings themselves and independently prove the non-compliance of a product with the law.
• An entrepreneur who submits reliable opinions from scientific units or experts cannot be ignored by the sanepid. The authority is obliged to engage in a substantive debate with such an opinion.
• A sanepid seeking to prohibit the marketing of a product as FSMP must conduct a multi-step classification test, taking into account, among other things, the specificity of the composition, intended use for patients, and the objective impossibility of meeting needs with an ordinary diet. General statements will not hold up in court.
  

The recommendation for the authority re-examining the case is now to conduct the proceedings thoroughly, taking into account the specialized evidence submitted by the party. Time will tell whether the sanitary inspection authorities can handle the substantive burden placed on them by the administrative courts, but for participants in the food market, this is undoubtedly a step toward the rule of law and business stability.

If you have a problem with a prohibition on marketing products or an order for their withdrawal, please contact us: ajlaw.pl eoleszczuk-romanska@ajlaw.pl office@ajlaw.pl

Chemical safety of food is becoming one of the key challenges for the modern food sector. Growing regulatory requirements, increasingly advanced analytical methods, and new approaches to risk assessment mean that food producers, importers, and distributors must constantly monitor the compliance of their products with applicable standards.

The article addresses issues including:

• Legal foundations and the specifics of dietary supplements
• Modern analytics: from extraction to precise measurements
• Analytical research methodology, including sample preparation and instrumental-measurement techniques
• Liability of entities and market supervision
• Challenges of the future: the “cocktail effect” mechanism and CAGs groups
• Most frequently questioned raw materials
• Recommendations for business

We invite you to read the article! For more information, please contact Attorney Diskau at adiskau@ajlaw.pl.

On 12 August 2026, new restrictive environmental requirements introduced by the PPWR will come into force, covering the entire life cycle of all types of packaging and the waste generated from them. The regulations establish a comprehensive framework for Extended Producer Responsibility (EPR), mechanisms for preventing packaging waste generation, as well as precise guidelines for the separate collection, processing, and recycling of such waste. They also contain an inconspicuous general clause that covers, among other things, microplastics.

What does the law consider to be microplastic?

The foundation of this concern is Entry 78 of Annex XVII to Regulation (EC) No. 1907/2006 – the so-called REACH Regulation – which is already in force. This provision introduced into the legal framework the concept of solid synthetic polymers, commonly known as microplastics, and set an ambitious objective for the market: the elimination of intentionally added solid polymer particles.

The definition of microplastic covers solid synthetic polymers (therefore liquid polymers are outside the scope of the definition), insoluble materials with a size of ≤ 5 mm (particles, granules, powders, etc.), and fibres up to 15 mm in length, provided they are very thin (the ratio of particle length to diameter is > 3). The definition applies where the synthetic polymer constitutes at least 1% of the mass of the particle concerned. Furthermore, if the polymer forms only a layer on a particle (e.g. a coating), the entire particle is treated as microplastic.

It is worth emphasizing that not every polymer is prohibited. The legislator has provided important exemptions for substances which, despite their structure, do not exhibit a negative environmental impact in the form of microparticles. Excluded from the definition are natural polymers that have not been chemically modified (e.g. cellulose, starch, chitin), biodegradable polymers (which decompose in accordance with the rigorous tests specified in Appendix 15 to the REACH Regulation), soluble polymers (in accordance with Appendix 16 to the REACH Regulation), and polymers that are not organic (i.e. contain no carbon atoms in their structure).

For food manufacturers, the key issue is not the wording of the prohibition itself but a precise understanding of its boundaries. For the remaining polymers, the most important distinction remains the division between mixtures and articles, supplemented by a system of so-called conditional exemptions. Point 5 of Entry 78 of REACH contains a catalogue of situations in which microplastics—although still considered microplastics—may legally remain on the market. First, the prohibition does not apply to substances separated through technical means (point 5(a)). Second—and crucially for printing—the law recognizes situations where the physical properties of microparticles are permanently altered, for example through the curing of ink (point 5(b)). Finally, particles permanently incorporated into a solid matrix are exempted (point 5(c)), allowing finished bottles or films to be treated as safe “articles”.

Classic examples include inks, varnishes, and adhesives. While in a container they may contain microplastics, once applied to a film and cured, they form a uniform coating and lose their particulate form. As a result, finished food-contact materials such as PET bottles, trays, or printed laminates are treated by REACH as “articles”. From a legislative perspective, this means that the polymers forming their structure are permanently bound, creating a kind of “safe harbour” for food manufacturers.

The problem arises one level lower in the supply chain. Before they are applied to packaging, inks, varnishes, and adhesives are classified as mixtures. Particular attention should be paid here to the exemption concerning use in industrial installations. European legislators allow the use of such substances where the risk of uncontrolled release into the environment is minimized through technical measures or where the substance is permanently contained by technical means throughout its final use (point 6). However, if they contain microplastics, their use in industrial processes is permitted only on condition that stringent reporting obligations towards the European Chemicals Agency (ECHA) are fulfilled.

This is precisely where the responsibility of the food manufacturer arises. Although the food manufacturer does not itself place microplastics on the market, its operational security depends on the reliability of its packaging suppliers. Failure by a printing company or laminate manufacturer to report emissions may result in supply chain disruptions or challenges to the legality of the manufacturing process of the entire component. Therefore, the need for mutual communication among the various entities within the value chain must be emphasized. A lack of knowledge regarding the microplastic reporting status of a subcontractor constitutes a risk that cannot be unequivocally mitigated merely by including a general “REACH and PPWR compliance” clause in a contract.

Food additives

Attention should also be paid to the specific situation of food additives. Under point 4(b)(iii) of the aforementioned regulation, additives falling within the scope of Regulation 1333/2008 benefit from an exemption from the sales prohibition. However, this is a conditional exemption.

From 17 October 2026, a manufacturer of a food additive containing microplastics will be required to provide detailed Instructions for Safe Use and Disposal (IFUD), and from 17 October 2025 must report annually the mass of the substance placed on the market.

For food manufacturers and quality departments, this means the need to verify whether raw material documentation contains these specific legally required elements.

PPWR and REACH – synergy or contradiction?

Another element of this legal puzzle is Article 5 of the PPWR, which emphasizes the minimization of substances of concern and operates in synergy with the aforementioned REACH provisions. This article expressly prohibits the placing on the market of packaging containing substances that negatively affect recycling or safety, or, for example, packaging containing microplastics, which have already been preliminarily identified in the preamble of the regulation as a threat to human health.

Entry 78 of Annex XVII to Regulation (EC) No. 1907/2006 REACH does not cover, for example, natural (unmodified) polymers, nor polymers for which scientific evidence of biodegradability and water solubility has been established. However, do they meet the recyclability requirements of the PPWR? This is a task for R&D departments, which must reconcile these two legal regimes.

For entities placing food products on the market, the foundation remains the general obligation to ensure food safety and purity, together with the resulting legal liability. This creates a new reality in which packaging assessment does not end with functionality. Packaging must be viewed through the prism of physical durability, the so-called “wear and tear” factor. If a barrier coating or print layer, originally consisting of mixtures containing microplastics, flakes off or abrades into the product, the exemption arising from the article status collapses—precisely because of the synergy between all these regulations. In such a scenario, the issue is no longer merely a breach of environmental standards but, above all, a violation of general food law (Regulation 178/2002) with regard to physical contamination of food.

Where should risks be sought? Critical points in the supply chain

Mapping the presence of microplastics within a facility requires examining the production process from four different perspectives, each carrying a different set of legal risks:

Finished articles: Printed film, trays, or bottles are treated as articles, meaning there is no prohibition on placing them on the market. REACH-related risk is low here; however, food manufacturers should focus on their physical durability (the wear and tear aspect) to avoid particle migration into the product.

Packaging chemistry (inks, varnishes, adhesives): The situation here is more complex. As raw materials (mixtures), they may contain microplastics, but their use is permitted under the so-called derogation for industrial applications. The key obligation of a food manufacturer in this case is supplier auditing—there must be certainty that the supplier fulfils reporting obligations to ECHA and provides the required safe-use instructions.

Technical raw materials (masterbatches and additives): Similar to packaging chemistry, masterbatches used in plastic production are subject to process reporting obligations. At this point, declarations of compliance are of strategic importance—suppliers should be required to provide firm confirmation that these raw materials are being placed on the market in accordance with the new requirements of Entry 78 REACH.

Food additives: This is the area of highest and most direct risk. If colourants used in a facility are classified as microplastics, the food manufacturer becomes the entity directly responsible for possessing safe-use instructions and reporting to ECHA. Here, the exemption from the prohibition (arising from Regulation 1333/2008) is strictly conditional upon fulfilling these formal requirements.

Food safety – the overriding priority

Under Article 14 of Regulation (EC) No. 178/2002, no unsafe food may be placed on the market. The presence of polymer microparticles that could migrate unintentionally from packaging (for example, due to the flaking of printed layers) constitutes physical contamination. This synergy is reinforced by the provisions of Regulation (EC) No. 1935/2004, which state that food-contact materials must not transfer their constituents to food in quantities that could endanger human health, and Regulation (EC) No. 2023/2006, which imposes an obligation on manufacturers to maintain rigorous process controls to eliminate contamination risks at every stage.

The interaction of these regulations with the forthcoming PPWR creates a new reality in which packaging assessment does not end with functionality. Packaging must be viewed through the lens of physical durability, the so-called wear and tear factor. If a barrier coating undergoes mechanical degradation, the exemption arising from the permanent containment of the polymer (under point 5 of REACH) becomes irrelevant in light of the aforementioned standards, and the manufacturer may face violations of food safety requirements.

Recommendations for businesses

How, then, should these processes be managed so that the law becomes a tool supporting business rather than a barrier? The key lies in changing the approach to contracting and auditing. At AJ LAW Partners, we recommend that our clients introduce precise cooperation clauses into supplier agreements. It is becoming standard practice to require the provision of full chemical composition data or confirmation of microplastic reporting within as little as three days from a request. Such stringent deadlines do not stem from a lack of trust but from the requirements of Entry 78 of Annex XVII to the REACH Regulation—inspection authorities will give a business only 30 days to provide a complete response. Without a rapid information pathway from suppliers, a food manufacturer remains vulnerable during inspections. The prompt delivery of up-to-date test results and detailed packaging specifications by suppliers will be essential.

In summary, regulations concerning microplastics signal that the era of general declarations has come to an end. Bearing in mind the golden principle of food safety and the fact that microplastics have already been identified in regulatory preambles as a potential health hazard, the market now requires an investigative approach to every element of packaging. Today, brand value is built not only on product taste but above all on evidence of its safety. In this new micro-reality, transparency and cooperation are the currency that should ensure peace of mind during inspections.

This article presents only selected aspects of the issues discussed. The scope of the topics covered is much broader and requires in-depth specialist analysis. The information contained herein is general and educational in nature—it does not constitute legal advice or a legal opinion within the meaning of applicable laws. Every case requires an individual approach, taking into account the specifics of the particular situation, and this is precisely what we do at AJ LAW.

All recommendations, comments, and studies presented are protected by law and constitute the intellectual property of their author; they may not be copied or used in any manner contrary to law or their intended purpose.

To obtain binding advice tailored to your specific circumstances, it is always recommended to consult a professional advisor or lawyer.

AJ LAW Law Firm

office@ajlaw.pl

Edyta Oleszczuk-Romańska
Legal Counsel at AJ LAW Partners
e.oleszczuk-romanska@ajlaw.pl

The legal foundations and the specific nature of dietary supplements

The foundation of the European control system is Regulation (EC) No 396/2005, which in a casuistic manner defines Maximum Residue Levels (MRLs). This act introduces a key presumption: if no specific limit has been established for a given active substance in a particular product, a strict default level of only 0.01 mg/kg applies.

Key legal acts:

Regulation (EC) No 396/2005: establishes MRL limits for over 300 food products and hundreds of active substances. If no specific limit is defined for a given substance, the so-called default level of 0.01 mg/kg applies.

Regulation (EC) No 1107/2009: regulates the process of placing plant protection products on the market, with a focus on risk assessment prior to the approval of substances.

The Polish Act on Food and Nutrition Safety (Journal of Laws 2006 No. 171, item 1225): a national law implementing EU directives, defining the competences of control authorities (Sanitary Inspection, IJHARS).

It is worth emphasizing that, under the law, dietary supplements are classified as food, which imposes on them the same obligations arising from the above regulation.

However, a significant interpretative difficulty arises in relation to plant extracts. Pursuant to Article 20 of Regulation 396/2005, when assessing the compliance of a processed product, so-called processing factors must be taken into account. This means that processes such as drying or extraction may naturally concentrate pesticide residues, which requires food business operators (FBOs) not only to conduct testing but also to possess detailed technological documentation justifying the final analytical result.

Processing factors: pursuant to Article 20 of Regulation 396/2005, when assessing supplements containing plant extracts, changes in residue concentrations resulting from drying or extraction processes must be taken into account.

Cross-contamination: multi-ingredient supplements require analysis of each component separately, taking into account its botanical origin.

Modern analytics: from extraction to precise measurement

Detecting trace amounts of chemical substances in complex matrices such as herbs or plant oils requires technologies that go beyond standard quality tests. Currently, the gold standard in accredited laboratories is the QuEChERS method, which, thanks to multi-stage extraction and purification, allows pesticides to be isolated with minimal interference from pigments or organic acids.

A true breakthrough, however, is the application of hyphenated techniques such as liquid chromatography (LC-MS/MS) and gas chromatography (GC-MS/MS) combined with tandem mass spectrometry. These enable the simultaneous identification of hundreds of compounds in a single measurement cycle with extraordinary sensitivity. In a legal context, the result of such testing constitutes key evidence in the process of verifying compliance of a batch with EU requirements, particularly in cases involving border rejection of goods or proceedings before the Sanitary Inspection.

Analytical testing methodology

Sample preparation – the QuEChERS method

Currently, the “gold standard” in laboratories is the QuEChERS method (Quick, Easy, Cheap, Effective, Rugged, and Safe). This process consists of two stages:

Extraction: the use of acetonitrile and salts (e.g. magnesium sulfate) to isolate pesticides from the sample.

Clean-up (d-SPE): dispersive solid-phase extraction that removes organic acids, pigments (chlorophyll), and sugars from the extract that could interfere with the reading.

2. Instrumental and measurement techniques

Modern analytics uses hyphenated techniques combining chromatography with mass spectrometry:

LC-MS/MS (liquid chromatography with mass spectrometry): used for determining polar and non-volatile pesticides. It is crucial in testing dietary supplements containing thermolabile plant compounds.

GC-MS/MS (gas chromatography with mass spectrometry): ideal for volatile and non-polar substances.

Modern Triple Quadrupole (QqQ) systems allow simultaneous monitoring of hundreds of compounds (so-called multi-residue methods) in a single measurement cycle, achieving detection limits significantly below the standard 0.01 mg/kg.

Responsibility of operators and market surveillance

According to the principle of traceability, the manufacturer or the entity placing the product on the market bears full responsibility for ensuring that the product does not exceed MRL limits.

The RASFF system

When laboratory tests show exceedances of limits, the information is transmitted to the RASFF (Rapid Alert System for Food and Feed). In the case of dietary supplements, the most common causes of alerts are:

The presence of ethylene oxide (a disinfecting agent banned in the EU).

Exceedances of limits in raw materials originating from third countries (e.g. India, China).

Risk analysis and sampling criteria

Control authorities (in Poland mainly the Chief Sanitary Inspectorate) apply a risk-based approach. Dietary supplements based on herbs and extracts are treated as “high-risk” products due to the natural ability of plants to accumulate contaminants from soil and the technological processes that concentrate active substances.

Future challenges: synergy and the cocktail effect

The most fascinating, and at the same time concerning, direction of the evolution of food law is the shift from examining isolated substances toward Cumulative Risk Assessment (CRA). The previous practice, in which each pesticide was assessed separately, is giving way to a holistic model. Science, followed by lawmakers, recognizes the phenomenon of the so-called “cocktail effect.” It consists in the fact that a mixture of several different pesticides—each of which individually complies with the limits—may exert a combined harmful effect on a specific organ, such as the thyroid or the nervous system.

The European Food Safety Authority (EFSA) is working on implementing Cumulative Assessment Groups (CAGs), which in the near future may force a change in the way the safety of product batches is calculated. From the perspective of a legal blog, it is worth noting that this may lead to a situation where a product that formally complies with all MRL limits is deemed unsafe due to the total toxicological dose.

Market monitoring and the early warning system

In the risk management process, the RASFF system is an invaluable tool. Analysis of alerts from recent years shows a clear trend: most violations concern raw materials imported from third countries such as India, China, or Egypt. The problem of ethylene oxide in sesame seeds or turmeric has become a symbol of the difficulties faced by the global supply chain. For lawyers and quality managers, this means the need to abandon passive reliance on supplier certificates in favor of active monitoring of legislation and regular independent testing.

The future of food control will be based on “non-target screening” methods, which instead of searching for specific known substances, will scan products for any chemical anomalies. In the era of the “Farm to Fork” strategy, aiming to reduce pesticide use by 50%, transparency and analytical precision are becoming the foundation of a safe food business.

Most frequently challenged raw materials (High-Risk Materials)

Raw material – Main hazard (substance) – Country of origin (statistically)
Sesame seeds – Ethylene oxide (EtO), chlorpyrifos – India, Nigeria
Turmeric and ginger – Ethylene oxide, multi-residue pesticides – India, Vietnam, China
Rice (mainly Basmati) – Carbendazim, thiamethoxam – India, Pakistan
Tea (green and black) – Anthraquinone, chlorpyrifos, acetamiprid – China, Sri Lanka
Dried herbs (e.g. coriander) – Chlorpyrifos, profenofos – Egypt, Turkey
Goji berries – Carbofuran, propargite – China

Why are these raw materials problematic?

Ethylene oxide (EtO): this is the absolute “record holder” of recent years. Although technically a fumigation (disinfection) agent, it is banned in food in the EU due to its carcinogenic properties. The problem mainly concerns raw materials from Asia, where it is used to combat Salmonella in spices.

Chlorpyrifos: this substance was withdrawn from use in the EU in 2020 (MRL reduced to the limit of detection). Since in many non-EU countries it is still a cheap and effective insecticide, it is very frequently detected in laboratory tests during import controls.

Matrix complexity: raw materials such as tea or spices have a very complex chemical composition (rich in essential oils and tannins). This complicates analysis and requires advanced sample clean-up using d-SPE to avoid false-positive results.

How to read RASFF reports in practice?

The RASFF system divides notifications into three main categories, allowing companies to assess the severity of the issue:

Alert: a serious risk; the product is already on the market; requires immediate recall.

Information exchange: a risk has been identified, but the product may not yet be on the market or the risk is lower.

Border rejection: the safest situation for the importer—the product has not been allowed into the EU, preventing costly withdrawal procedures from store shelves.

Recommendations for business (supplements and food)

To minimize the risk associated with the “cocktail effect” and new regulations, it is worth implementing the following steps:

Supplier audit: do not rely solely on the supplier’s certificate (CoA). Conduct your own random testing in accredited laboratories in Europe.

Legislative monitoring: MRL thresholds change dynamically. A substance that is permitted today at 0.1 mg/kg may be reduced to 0.01 mg/kg within six months.

Multi-residue testing: always commission full-spectrum testing (so-called screening for 500+ substances), rather than tests for selected pesticides only.

This article presents only selected aspects of the discussed topic. The scope of the issues is much broader and requires in-depth, specialized analysis. The information contained herein is general and educational in nature and does not constitute legal advice or a legal opinion within the meaning of applicable laws. Each case requires an individual approach, taking into account the specifics of the given situation, and this is precisely what we address at AJ LAW.

All recommendations, comments, and materials presented are protected by law and constitute the property of their author; they may not be copied or used in a manner contrary to the law or their intended purpose.

In order to obtain binding advice tailored to your situation, it is always recommended to contact a professional advisor or lawyer.

AJ LAW Law Firm

office@ajlaw.pl

+48 507 667 690

Aleksandra Diskau – Attorney-at-law

+48 506 144 611

Dr. Joanna Uchańska – Attorney-at-law, court mediator

The debate titled “A Time of Major Decisions – What’s Next for the Dietary Supplements Industry?” will take place on November 26 at 3:15 PM and will bring together leading representatives of the dietary supplements sector, experts, opinion leaders, and representatives of industry institutions. The meeting will provide a space for collective reflection on the strategic directions of development for this highly dynamic sector, which today faces numerous regulatory, technological, and market changes.

The panel will feature distinguished experts representing various segments of the market:

• Dr. Eng. Barbara Wielgos (Olimp Labs) – specialist in product innovation and the development of production technologies,
• Justyna Dąbrowska (Activlab / Unipro Sp. z o.o.) – expert in brand communication strategy and product image building,
• Dominik Liwocz (Olimp Labs) – head of production and specialist in maintenance engineering,
• Bartosz Demianiuk (National Council of Dietary Supplements and Nutrients) – representative of an industry organization supporting dialogue with regulators,
• Jacek Ostrowski (Komarko) – practitioner in production technology and logistics.

During the more than hour-long discussion, participants will address four key areas that will define the condition and competitiveness of the dietary supplements market in the coming years:

1. Strategic directions for industry development – where is the dietary supplements market in Poland and worldwide heading, and which global trends will shape its future?
2. The production facility of the future – what technological investments and modernizations are necessary to meet quality, regulatory, and market requirements?
3. Quality and regulatory compliance – how will changing legal regulations in the European Union and Poland affect the functioning of companies in the sector?
4. Business model and competitiveness – does the future belong to contract manufacturing, the development of proprietary brands, or perhaps an entirely new business model?

The discussion during the debate is intended not only to serve as an expert panel, but above all as an inspiring meeting of practitioners who shape the Polish dietary supplements market on a daily basis. It is the exchange of knowledge, experience, and open perspectives on upcoming challenges that makes this debate one of the most anticipated events of this year’s Congress.

Our firm’s participation in this event is yet another demonstration of AJ LAW’s strong commitment to the development of the pharmaceutical and supplements sector — both through regulatory and legal support and through active engagement in dialogue between businesses, experts, and public institutions.

About the event

FoodFakty Summit is one of the most important events in the Polish food industry, dedicated to the future of food, innovation, safety, and legal regulations. The meeting brings together representatives of science, business, industry organizations, and public administration, creating a space for the exchange of knowledge, experience, and best practices in the field of “food of tomorrow.”

Attorney Joanna Uchańska will speak on November 6, 2025 (Thursday) during the thematic session:
“Supplements and Health-Promoting Products – Challenges Beyond Labeling and Product Specifications”
Time: 2:00 PM – 3:30 PM
Track: Food of Tomorrow

Title of Attorney Joanna Uchańska’s presentation:
“How to Design Dietary Supplements in Compliance with the Law and Market Expectations. An Introduction from the Perspective of an Industry Organization – What You Need to Know but No One Else Will Tell You.”

In her presentation, Attorney Joanna Uchańska will discuss the current legal and practical challenges in the process of designing and bringing dietary supplements to market. She will address issues related to the interpretation of regulations, labeling, health claims, and compliance with EU and national requirements. She will also present the perspective of an industry organization in the context of collaboration between the sector and regulators, as well as initiatives aimed at ensuring the safety and quality of health-promoting products.

Attorney Joanna Uchańska’s participation in the FoodFakty Summit 2025 confirms AJ LAW’s strong position in the fields of food law, pharmaceutical law, and regulations concerning dietary supplements. It is also another example of the firm’s experts’ active engagement in industry debates, which have a tangible impact on the development of law and market practices in Poland.

During the event, participants will have the opportunity to ask Attorney Joanna Uchańska questions regarding, among others:

• the interpretation of current food and pharmaceutical law regulations,
• product compliance with EU requirements and national regulations,
• strategies for bringing dietary supplements to market,
• legal risks related to marketing communication and product labeling,
• practical aspects of cooperation with supervisory authorities (GIS, URPL, EFSA).

AJ LAW provides comprehensive advisory services in these areas, including, among others:

• product and documentation compliance audits,
• support in the registration and notification process of dietary supplements and medicinal products,
• representation before administrative authorities and courts,
• development of legally compliant communication strategies,
• ongoing regulatory advisory services for manufacturers, importers, and distributors.

Thanks to its many years of experience and interdisciplinary approach, AJ LAW supports clients in operating effectively and safely in the regulated products market.

For years, AJ LAW has been supporting entrepreneurs in the food and pharmaceutical sectors, advising on product compliance, advertising, labeling, notifications, and strategies for bringing innovative solutions to market.

See you in Łódź!

We warmly invite you to participate in the FoodFakty Summit 2025 and to attend Attorney Joanna Uchańska’s presentation during the thematic session Food of Tomorrow on November 6, 2025, at 2:00 PM.
The event will take place in person in Łódź and will bring together leading representatives from the food sector, regulators, and industry experts.

More information about the conference: FoodFakty Summit Żywność Jutra – food4tomorrow – 5-6.11.2025 Łódź – Przegląd Rynku Spożywczego

However, the adoption of the amendment by the European Parliament does not mean an immediate ban on the use of the mentioned names for plant-based products. The vote is part of a so-called negotiating mandate, which paves the way for further legislative work involving the Council of the European Union and the European Commission. Only after these negotiations are completed and the regulations are formally adopted by all EU institutions can the changes come into effect. Therefore, it is necessary to remain vigilant regarding this potential regulatory change.

Context of previous legislative actions

It is worth recalling that the European Parliament had previously considered similar proposals. Amendment No. 169, which proposed a ban on using names such as “burger” or “steak” for meat substitutes, was rejected. Similarly, Amendment No. 172, concerning restrictions on the naming of plant-based products resembling dairy products, did not gain support. As a result, under current law, it is possible to use terms such as “style,” “alternative,” “substitute,” or “flavored” alongside the names of dairy products. The use of adjectives like “buttery” or “creamy” is also permitted, provided it does not mislead the consumer.

Current labeling rules and enforcement practices

Despite the absence of explicit bans, current food labeling regulations require that the information provided on labels must not be misleading. A practical example of this principle in action is an inspection carried out by the Trade Quality Inspection of Agricultural and Food Products, which challenged the name of a cream-like product that contained only 1% cream, even though this was emphasized in the product’s name.

Such phenomena indicate that the interpretation of regulations can be dynamic and dependent on the practices of supervisory authorities, as well as subsequent changes in the law. Therefore, businesses should exercise particular caution when designing trade names and marketing communications for plant-based products.

Market trends and consumer changes

Alongside the development of regulations, significant changes in consumer trends are being observed.

Market forecasts indicate a dynamic growth in the value of the global meat substitute market—from USD 20.7 billion in 2020 to USD 23.2 billion in 2024, and in the long term, potentially up to USD 140 billion by 2029. This growth is also reflected in the development of the plant-based product segment in Europe, which may lead to increased interest in regulations concerning their presentation and labeling.

Recommendations for businesses

In light of the above information, businesses operating in the plant-based product sector should:

• monitor the legislative process at the EU level, particularly the actions of the European Parliament, the Council of the EU, and the European Commission;
• analyze evolving consumer preferences and adjust communication and branding strategies in accordance with applicable legal standards;
• consult with experts in food law and intellectual property to ensure compliance with current and future regulations;
• take into account the practices of supervisory authorities, including the Trade Quality Inspection of Agricultural and Food Products, when designing product names and labels.

Given the growing importance of the plant-based sector and its expansion into international markets, it is also advisable to consider protecting product names and technologies through the registration of trademarks and patents.

[1] https://www.europarl.europa.eu/doceo/document/TA-10-2025-0214_PL.pdf

[2] https://www.europarl.europa.eu/doceo/document/A-8-2019-0198_EN.pdf#page=169 

[3] https://www.europarl.europa.eu/doceo/document/A-8-2019-0198_EN.pdf#page=172

[4] https://www.gov.pl/web/ijhars/jakosc-handlowa-przetworow-mlecznych-i-znakowanie-wyrobow-mlekopodobnych

[5] https://trendsfestival.com/globaltrendsreport/sustainability/losing-a-taste-for-meat,7.html

The session was opened by the Chair of the Team, MP Katarzyna Stachowicz, together with Secretary Adam Gomoła. In her speech, she recalled the words of Hippocrates: “Let food be thy medicine and medicine be thy food”, which became the symbolic motto of the meeting.

Right at the beginning of the proceedings, a voice was heard that gave the event a clear substantive structure. Dr. Joanna Uchańska, legal counsel from our Law Firm, opened the expert part by providing a concise summary of the previous meeting and introducing participants to the subject of pro-health food in the context of education. In her address, she highlighted five pillars on which a responsible approach to functional food should be based: law, quality, public health, economic condition, and—as a fundamental element—legislation. It was this last pillar, relating to systemic legal frameworks, that became the starting point for further reflection on the need for coherent and transparent regulations.

Dr. Uchańska also reminded that following the previous session, at the initiative of Chairwoman Katarzyna Stachowicz, two important parliamentary documents were submitted:

• Interpellation No. 9972 of May 22, 2025, addressed to the Ministry of Education, containing questions about the implementation of regulations concerning food in educational institutions, support for schools in conducting nutritional education, and possible programs directed at parents. In its response, the Ministry pointed, among other things, to the introduction, starting September 1, 2025, of a new, non-compulsory subject called “health education” in grades IV–VIII of primary schools as well as in secondary schools. The response also emphasized the importance of developing health literacy, which includes the ability to recognize health needs, monitor one’s own health status, and promote a healthy lifestyle.
• Inquiry No. 2494 of May 22, 2025, addressed to the Minister of Health, concerning the availability of epidemiological data, ongoing prevention programs, the costs of treating diet-related diseases, and planned strategic actions in the field of public health. In the response, it was indicated that diet-related diseases include, among others, non-insulin-dependent diabetes, obesity, and polycystic ovary syndrome. The Polish Society for the Treatment of Obesity, citing a report by the Supreme Audit Office (NIK), estimates that over 65% of Poles (approx. 24 million) are overweight, and nearly 30% (approx. 11 million) suffer from obesity.

In the next part of the session, experts from the Expert Council of the National Council of Supplements and Nutritional Products took the floor. Dr. Andrzej Balicki, legal counsel, discussed regulatory and informational challenges, pointing to the need for greater transparency and the implementation of a nutrivigilance system. Dr. Eng. Katarzyna Wolnicka presented an overview of effective nutritional education programs for children and adolescents, while Prof. Krzysztof Durkalec-Michalski, PhD, Eng., from the University of Physical Education, emphasized the importance of physical activity and responsible supplementation in the health prevention of the younger generation.

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An important contribution to the discussion came from Professor Jan Gąsiorek, PhD, who drew attention to the risks associated with the use of unverified dietary supplements of unknown origin and the negative effects of excessive screen time among children. He pointed to the need to focus educational efforts in smaller towns and emphasized the importance of the visual aspect of food products for the youngest consumers.

Dr. Tomasz Białas from IJHARS presented the role of labels as a source of consumer knowledge, while the Team Secretary, Adam Gomoła, provided information about the submitted interpellations to the Ministry of Education and the Ministry of Sport concerning the sustainability of pro-health programs.

In the open discussion, contributions were made, among others, by Dr. Ewa Butkiewicz, Alicja Buczek, Aleksandra Płońska from the Ministry of Health, Dorota Wojcieszek from the Ministry of National Education, Dr. Katarzyna Suchoszek – expert of the Expert Council of the National Council of Supplements and Nutritional Products, Prof. Katarzyna Stoś, Head of the Department of Nutrition and Food Nutritional Value at the National Institute of Public Health – National Hygiene Institute, and Prof. Iwona Wawer, who emphasized the role of pharmacists as health educators and “first-contact doctors.”

Materials and access to the recording

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The full recording of the meeting of the Parliamentary Team on Pro-Health Food and Nutrition held on September 11, 2025, is available at:
🔗 Video recording of the meeting – Parlamentarny Zespół ds. Żywności Prozdrowotnej i Żywienia – Sejm Rzeczypospolitej Polskiej

All presentations, including the legal material by Dr. Joanna Uchańska titled “Pro-Health Food and Healthy Nutrition in Education”, are available for download on the Team’s website.

Our Commitment

As a Law Firm, we actively monitor all legislative activities and initiatives undertaken in Parliament in the areas of public health, pro-health food, and supplementation. We stay up to date with regulatory processes, analyze their impact on the market, and support our clients in adapting to the evolving legal landscape. Our involvement in the work of the Team is not merely observational—it represents a tangible contribution to shaping a safe and responsible market.

Factual background of the case

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The case concerned a dietary supplement placed on the market by an entrepreneur who included, among other things, the terms “dosage” and “composition” on the product label. Following an inspection, the sanitary authority concluded that the use of the term “dosage” could imply medicinal properties of the product, which is not permissible for foodstuffs, and that the use of the word “composition” instead of “ingredients” violated the provisions of Regulation (EU) No 1169/2011 of the European Parliament and of the Council. As a result, the authority issued an administrative decision ordering a change in the labeling and imposed a financial penalty.

The case, which was ultimately resolved by the Supreme Administrative Court in its judgment of May 6, 2025 (case no. II GSK 1813/24), originated from a decision issued on December 16, 2020, by the Lower Silesian Provincial Sanitary Inspector. In that decision, the authority imposed seventeen separate financial penalties on the entrepreneur for irregularities in the presentation and advertising of seventeen different food products, including dietary supplements.

After the entrepreneur filed an appeal, the Chief Sanitary Inspector annulled the decision of the Lower Silesian Provincial Sanitary Inspector in its entirety and ruled on the merits of the case, imposing two financial penalties: the first in the amount of PLN 15,000 for violations of the provisions on health and nutrition claims (Article 103(1)(1) of the Food and Nutrition Safety Act), and the second in the amount of PLN 10,000 for violations of the provisions on dietary supplement labeling (Article 103(1)(1b)(c) of the same Act). The violations concerned, among other things, the use on the website and in promotional materials of terms such as “dosage” and “composition” instead of “ingredients,” which, in the opinion of the Chief Sanitary Inspector, was inconsistent with Regulation (EU) No 1169/2011 and the Regulation of the Minister of Health of October 9, 2007.

The entrepreneur challenged the decision of the Chief Sanitary Inspector before the Provincial Administrative Court in Warsaw, which, in its judgment of February 8, 2024 (case no. V SA/Wa 944/23), annulled the decision of the Chief Sanitary Inspector. According to the Court, the Inspector had violated both substantive and procedural law, including by incorrectly classifying the use of the terms “dosage” and “composition” as violations of Regulation (EU) No 1169/2011. The Court emphasized that removing these alleged infringements from the description of the violation could have affected the amount of the financial penalty imposed.

Moreover, the Provincial Administrative Court held that in the contested decision the Chief Sanitary Inspector failed to present the violations concerning the presentation and advertising of one of the products – “S[…]” – even though the decision also applied to that food product. The lack of a description of violations with respect to this product constituted a breach of administrative procedure provisions, in particular Articles 7, 77 § 1, 80, and 107 § 3 of the Code of Administrative Procedure, since the appellate authority’s decision annulled the first-instance authority’s decision in its entirety and ruled on the merits of the case. This required a full presentation of all established violations with respect to each product covered by the proceedings.

In all other respects, the Provincial Administrative Court accepted the authority’s findings and their legal assessment; however, the identified procedural deficiencies and the misinterpretation of substantive provisions resulted in the annulment of the Chief Sanitary Inspector’s decision.

The Chief Sanitary Inspector disagreed with the Provincial Administrative Court’s judgment and filed a cassation complaint with the Supreme Administrative Court, challenging the ruling in its entirety. In the cassation complaint, the Inspector alleged, among other things, an incorrect interpretation of Article 103(1)(1b)(c) of the Food and Nutrition Safety Act in connection with Article 7(1)(a) and (b) and Article 18(1) of Regulation (EU) No 1169/2011, as well as §5(2)(3) of the Regulation of the Minister of Health. The Inspector argued that the use of the terms “dosage” and “composition” instead of “ingredients” constituted a violation of food law provisions, and that the Provincial Administrative Court’s challenge of this was unjustified. Furthermore, procedural violations were alleged, which could have had a significant impact on the outcome of the case, emphasizing that the authority had taken all necessary actions to clarify the factual circumstances.

Legal framework – regulations on dietary supplements

According to the Act of August 25, 2006, on Food Safety and Nutrition, a dietary supplement is a food product intended to supplement the normal diet, being a concentrated source of vitamins, minerals, or other substances with a nutritional or physiological effect, and placed on the market in a form that allows for dosage. Dietary supplements may not have medicinal properties within the meaning of pharmaceutical law, and their labeling, presentation, and advertising must not suggest that a balanced diet fails to provide sufficient amounts of nutrients.

The Regulation of the Minister of Health of October 9, 2007, and Regulation (EU) No 1169/2011 of the European Parliament and of the Council set out detailed requirements regarding the composition and labeling of dietary supplements. These regulations require, among other things, the indication “dietary supplement,” the name of the category of nutrients, the recommended daily portion, a warning not to exceed this portion, and information that the supplement should not be used as a substitute for a varied diet. This information must be provided in Polish, in a clear and durable manner.

Regulations on dietary supplements in Poland result from the implementation of European Union provisions, in particular Directive 2002/46/EC and Regulation 1169/2011. The aim of these regulations was to ensure a high level of consumer protection, transparency of information, and harmonization of the internal market. In Poland, these provisions were implemented through the Act on Food Safety and Nutrition and the implementing regulations of the Minister of Health. Over the years, these regulations have been amended multiple times, including with regard to maximum doses of active ingredients, mandatory warnings, and notification procedures.

Supreme Administrative Court’s assessment

The Supreme Administrative Court, examining the cassation complaint filed by the Chief Sanitary Inspector, conducted a comprehensive assessment of both substantive and procedural allegations, addressing the interpretation of the Food Safety and Nutrition Act, the Regulation of the Minister of Health, and Regulation No. 1169/2011. Although the reasoning of the Provincial Administrative Court’s judgment contained certain interpretative errors, the Supreme Administrative Court found that its operative part was in accordance with the law, which justified the dismissal of the cassation complaint under Article 184 of the Code of Administrative Court Procedure.

Allegation concerning the term “dosage”

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The key issue in dispute was whether the use of the term “dosage” on a dietary supplement label could be considered a violation of Article 7(1)(b) of Regulation No. 1169/2011, which prohibits attributing to food products effects or properties they do not possess. The Chief Sanitary Inspector argued that the use of this term could suggest that the product has medicinal properties, thereby misleading the consumer.

The Supreme Administrative Court did not share this argument, pointing out that dietary supplements are food products intended to be consumed in small, measured single quantities, as defined by law (Article 3(3)(39) of the Food Safety and Nutrition Act) and Directive 2002/46/EC. According to Article 27(2) of the Act, the labeling of a dietary supplement must include information on how to use it, which corresponds to the concept of the “recommended daily portion” (§5(2)(3) and (4) of the Regulation of the Minister of Health). The Court held that there is no reason not to treat this portion as a dose, and that the term “dosage” is consistent with the function of a dietary supplement and does not imply medicinal effects, provided it is not accompanied by therapeutic claims.

The Court emphasized that the Regulation of the Minister of Health was issued pursuant to statutory delegation and cannot be interpreted in a manner inconsistent with the law, as provided by Article 92(1) of the Constitution of the Republic of Poland. Furthermore, according to Article 6(3)(b) and (c) of Directive 2002/46/EC, the EU legislator treats the terms “recommended portion” and “recommended dose” as equivalent, which further confirms the permissibility of using the term “dosage” in the context of dietary supplements.

Allegation concerning the term “composition” instead of “ingredients”

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The Supreme Administrative Court upheld the allegation concerning the incorrect interpretation of Article 18(1) of Regulation No. 1169/2011 by the Provincial Administrative Court. The first-instance court had considered the Chief Sanitary Inspector’s classification of the use of the heading “composition” as a violation to be excessive formalism. However, the Supreme Administrative Court pointed out that, pursuant to Article 9(1)(b) and Article 18(1) of the Regulation, the list of ingredients must be preceded by a heading containing the word “ingredients.” The exception to this rule, set out in Article 16(2), applies only to very small packages, which was not relevant in this case. Consequently, the Court agreed with the Chief Sanitary Inspector on the legitimacy of challenging the entrepreneur’s product labeling in this respect.

The Supreme Administrative Court also addressed the procedural allegation concerning the lack of a description of violations related to the presentation and advertising of the products. The first-instance court correctly noted that the Chief Sanitary Inspector’s decision, which annulled the DPWIS decision in its entirety and ruled on the merits, should have included a full description of violations for each product covered by the proceedings. The authority did not dispute that a procedural lapse had occurred and attempted to rectify it only at the cassation stage, which constituted a belated analysis of the evidentiary material.

The Supreme Administrative Court reminded that administrative courts do not conduct evidentiary proceedings but supervise the activities of public administration for compliance with the law (Articles 3 §1 of the Code of Administrative Court Procedure and Articles 1 §1 and §2 of the Act on the System of Administrative Courts). Accordingly, the obligation to collect and evaluate evidence rests with the administrative authority, and any failure to fulfill this duty cannot be remedied during judicial proceedings.

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In summary, taking the above into account, the Supreme Administrative Court held that, despite certain errors in the reasoning of the Provincial Administrative Court’s judgment, its operative part was in accordance with the law. The Court emphasized that the violation of Article 18(1) of Regulation No. 1169/2011 could have affected the amount of the imposed penalty, but not the justification for annulling the Chief Sanitary Inspector’s decision. Accordingly, pursuant to Article 184 in fine of the Code of Administrative Court Procedure, the Supreme Administrative Court dismissed the cassation complaint and upheld the Provincial Administrative Court’s judgment.

Regarding the use of the heading “composition,” the Supreme Administrative Court held that although Regulation 1169/2011 requires the use of the term “ingredients,” an extended form, e.g., “supplement composition,” does not violate the provisions, provided that the term is not entirely omitted. The Court emphasized that the administrative authority should precisely describe each violation, and the absence of such a description in the decision may lead to its annulment due to a breach of administrative procedure.

The Supreme Administrative Court’s judgment highlights the necessity of applying a purposive and functional interpretation when assessing the compliance of dietary supplement labeling with legal provisions, marking a significant shift in the previous practice of sanitary inspection authorities and administrative courts.

In reviewing the cassation complaint, the Supreme Administrative Court held that in the case of dietary supplements, the term “dosage” may be used provided it does not imply medicinal properties but refers solely to the recommended portion for consumption. The Court emphasized that a dietary supplement is intended to be consumed in small, measured single quantities, which justifies the use of the term “dosage” in an informational context.

Regarding the use of the heading “composition,” the Supreme Administrative Court held that an extended form, e.g., “supplement composition,” does not violate the regulations, provided that the term “ingredients” is not entirely omitted.

Analysis of the terms “dosage,” “serving,” and “ingredients” – implications for the industry

The term “dosage,” although associated with medicinal products, in the context of dietary supplements refers to the recommended portion for consumption, as confirmed by the definition in the Food Safety and Nutrition Act. “Serving” refers to the technical aspect of dividing the product into single consumption units, which is relevant when formulating usage instructions. “Ingredients” is the term required by Regulation 1169/2011 as the heading for the list of substances present in the product, whereas “composition” is a colloquial term that may only be used as part of an extended heading, e.g., “supplement composition.”

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The Supreme Administrative Court held that the use of the term “dosage” in the context of dietary supplements is permissible, provided it does not suggest medicinal properties of the product. This means that manufacturers may use this term in consumption instructions, as long as it does not blur the line between a food product and a medicinal product.

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This provides greater flexibility in consumer communication, particularly regarding usage instructions.

The Supreme Administrative Court indicated that although Regulation 1169/2011 requires the use of the term “ingredients,” an extended form, e.g., “supplement composition,” does not violate the regulations, provided that the term is not entirely omitted.

This gives manufacturers the possibility to use more understandable and aesthetically pleasing graphic forms on labels, without the risk of them being automatically deemed non-compliant with the law.

Related case law – other judgments in dietary supplement cases

To fully understand the significance of the Supreme Administrative Court’s judgment II GSK 1244/22, it is also necessary to refer to other rulings of administrative courts that in recent years have shaped the interpretative practice regarding the labeling of dietary supplements, as well as the boundaries of permissible marketing and informational communication concerning these products. Although issued in separate proceedings, these rulings constitute an important complement to the interpretation of food and pharmaceutical law, and their analysis allows for the identification of judicial trends and the assessment of risk areas for manufacturers.

Of particular note is the Supreme Administrative Court’s judgment II GSK 1813/24 of May 6, 2025, in which the Court unequivocally confirmed the permissibility of using the term “dosage” on dietary supplement labeling, provided it is not accompanied by any suggestion of medicinal effects. The Court pointed out that although this term is traditionally associated with medicinal products, in the context of dietary supplements it refers to the technical aspect of consuming the product in a specified amount, which aligns with its definition as a food product intended to be consumed in small, measured portions. This ruling represents an important affirmation of the position expressed in judgment II GSK 1244/22 and strengthens the argumentation of entrepreneurs in disputes with sanitary inspection authorities.

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A review of the above rulings allows the conclusion that the case law concerning dietary supplements is moving toward greater precision and formalization of labeling requirements, while simultaneously recognizing the need for a rational interpretation of the regulations in the context of the product’s function and its perception by consumers. Manufacturers are advised to monitor current case law and adapt their informational practices to the prevailing standards of legal interpretation.

Recommendations for entrepreneurs

Entrepreneurs should conduct an audit of their product labeling, taking into account the guidelines arising from the Supreme Administrative Court’s judgment. It is important to ensure that information on labels is formulated precisely, to avoid wording that suggests medicinal effects, and to document all administrative decisions in a manner that allows for their effective challenge. It is also advisable to implement compliance procedures in line with the resolutions of the Dietary Supplements Team, which, although not legally binding, may influence the inspection practices of the Chief Sanitary Inspectorate.

The judgment emphasizes that administrative authorities must precisely indicate violations in their decisions. For manufacturers, this means that during inspections they should request a clear and detailed justification of any decision, and in its absence, they have a stronger position in appeal or court proceedings.

In light of the judgment, manufacturers should conduct an audit of their product labeling, taking into account the new interpretations. This concerns not only terminology but also the presentation of information, graphic proportions, and the placement of warnings.

The judgment may influence the way advertising and informational campaigns are conducted. Manufacturers can communicate more freely about the method of consuming a supplement; however, they must avoid any suggestions related to treatment, disease prevention, or effects on specific medical conditions. The line between information and therapeutic suggestion remains thin and requires particular caution.

Future outlook

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The Supreme Administrative Court’s judgment may serve as an impetus for the amendment of national regulations, particularly regarding the clarification of terminology used in dietary supplement labeling. An increase in legal disputes concerning the interpretation of these provisions can be expected, as well as a likely intensification of educational activities by regulatory authorities and industry organizations. The dietary supplement industry, facing regulatory challenges, should strive for greater transparency, legal compliance, and dialogue with administrative authorities.

Companies that were previously penalized for using terms such as “dosage” or “composition” may consider various legal measures, relying on current Supreme Administrative Court case law. The judgment opens the way for new arguments in challenging decisions that were based on an overly literal interpretation of the regulations.

For detailed questions regarding classification, please contact us at office@ajlaw.pl or juchanska@ajlaw.pl

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:

• Ensure uniform composition in each part of the tablet after splitting,
• Provide an appropriate physical form of the tablet (e.g., a score line),
• Develop precise instructions for splitting and dosing.

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:

• Incorrect dosing,
• Uneven intake of substances,
• Improper use by elderly individuals.

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:

• Voivodeship Sanitary and Epidemiological Stations,
• Chief Sanitary Inspectorate,
• And in some cases, also by the Chief Pharmaceutical Inspectorate (GIF), if the product raises classification concerns.

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:

• Verify compliance with the new guidelines,
• Update labels and leaflets,
• Adjust quality and technological documentation.

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.