Analysis of the legal definition of a "dietary supplement" and its regulatory, procedural and market implications in the Polish and European legal systems

PART I: LEGAL DEFINITION AND LEGAL STATUS OF A DIETARY SUPPLEMENT

1.1. Legal Definition in the Polish Legal Order

In the Polish legal system, the fundamental legal act regulating the status of dietary supplements is the Act of 25 August 2006 on the safety of food and nutrition (hereinafter referred to as the Act on the Food and Nutrition Safety).1

Pursuant to Article 3, Section 3, Item 39 of this Act, a "dietary supplement" is precisely defined as:

"a food intended to supplement a normal diet and being a concentrated source of vitamins, minerals or other substances with a nutritional or other physiological effect."

This definition is supplemented with a key clarification regarding the product's form. A dietary supplement must be "marketed in a dosage form, such as capsules, tablets, dragees and other similar forms, powder sachets, liquid ampoules, dropper bottles and other similar forms of liquids and powders intended to be consumed in small, measured unit quantities."

Importantly, this definition contains a fundamental exclusion, stating that the concept applies "with the exception of products having the properties of a medicinal product within the meaning of the provisions of pharmaceutical law."

1.2. Legal Implications of the "Food" (Food) Status

A key element of the above definition, determining further implications, is the legal classification of a dietary supplement as a "foodstuff," meaning food. This classification is fundamental and determines the entire regulatory regime.

Firstly, the status of a "foodstuff" excludes dietary supplements from the Pharmaceutical Law regime2 and brings them entirely under the jurisdiction of food law.1 Legal The food industry, unlike the pharmaceutical industry, is based on the paradigm of the entrepreneur's responsibility for the product's safety and on post-marketing control (after being introduced to the market).5 This model is fundamentally different from the pre-market authorization required for medicinal products.6

Secondly, the definition specifies the purpose of a supplement: "supplementing a normal diet."7 This means that a supplement is generally intended for healthy individuals whose diet may not provide all the necessary nutrients in adequate amounts.7 This purpose is nutritional or physiological, but in no way therapeutic (curative).

1.3. Harmonization at EU Level: Directive 2002/46/EC

The Polish legal definition is not an autonomous creation; it is a precise transposition of the definition contained in Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements.8

Directive 2002/46/EC aimed to harmonize the EU internal market. However, it should be emphasized that the scope of this harmonization proved very limited in practice. This directive defined the concept of a dietary supplement and only harmonized the rules for the use of vitamins and minerals.9

A key element of this harmonisation are two annexes to the Directive:

1. Annex I: Establishes a closed list (so-called positive list) of vitamins and minerals permitted for use in the production of dietary supplements.9

2. Appendix II: Provides a closed list of the chemical forms of these vitamins and minerals that may be used (e.g., magnesium in the citrate form, and not necessarily in another form if it is not listed).8

However, an analysis of Directive 2002/46/EC reveals a fundamental problem with far-reaching consequences for the market. Although the definition of a supplement is broad (it includes "other substances"), the harmonization framework is very narrow (only vitamins and minerals). The preamble and Article 4(5) of the Directive10 envisage that specific rules would be established in the future for substances other than vitamins and minerals, including botanicals.11 However, this legislative "future" never materialized.

This has created a fundamental legal gap at the European Union level. This disparity between broad definition and narrow harmonization is a direct cause of regulatory chaos and market fragmentation, especially in the rapidly growing field of plant-based dietary supplements.11

PART II: THE KEY DICHOTOMY: DIETARY SUPPLEMENT VS. MEDICINAL PRODUCT

The legal status of a dietary supplement is defined per negationem – it is a food product, excluding medicinal products. Understanding this dichotomy is crucial for analyzing the entire market.

2.1. The Purpose-Based and Functional Distinction

• Dietary supplement: As indicated, its purpose is to supplement the diet.7 It is intended for healthy individuals.7 Its effect is nutritional (e.g., providing a missing vitamin) or physiological (e.g., supporting the proper functioning of the digestive system).

• Medicinal product (medicine): It is defined by a separate act – Pharmaceutical Law.2 Its purpose is to treat, diagnose, prevent diseases or modify the physiological functions of the body through pharmacological, immunological or metabolic action.14 Unlike a supplement, a medicine must have proven therapeutic effectiveness in clinical trials.6

2.2. Marking as a Consequence of Definition

The definition and status of "food" results in stringent requirements for the labeling of supplements, specified in the regulation of the Minister of Health implementing the EU directive.8 The label must include:

• The term "dietary supplement";

• The statement that "dietary supplements cannot be used as a substitute for a varied diet";

• Warning regarding "not exceeding the recommended daily dose."8

These labeling requirements serve as a regulatory defense mechanism. They are intended to actively prevent consumers from being misled about the nature of the product and consistently emphasize its status as food, not medicine. The statement "not a dietary substitute" directly reflects the definitional purpose of "dietary supplement." Medicinal product labeling is radically different—it must include, among other things, the marketing authorization number and, in many cases, Braille markings.14

2.3. The Borderline Product Problem

In market practice, the line between a supplement and a drug can be extremely fluid. The same ingredient (e.g., vitamin D, magnesium, or a plant extract) may, depending on the dosage and presentation, be classified as a dietary supplement or a medicinal product.

The classification of a product as a “supplement” or “medicine” depends on a number of factors: composition (in particular the dose of the active substance), declared purpose (health and marketing claims) and the overall presentation of the product.

The Chief Sanitary Inspectorate (GIS) actively monitors this limit, using the opinions of an advisory body. As Dr. Przemysław Rzodkiewicz from GIS points out, if the maximum dose of a given ingredient (established, for example, in resolutions of the Dietary Supplements Committee) is exceeded, the body initiates explanatory proceedings.15

The process is as follows:

1. The Dietary Supplements Team (GIS advisory body) establishes maximum safe doses for ingredients in dietary supplements (e.g. magnesium).15

2. The entrepreneur notifies the Chief Sanitary Inspectorate of the intention to introduce a product with a dose exceeding this established level.

3. For GIS, this is an alarm signal (a "red flag") that this product, due to the high dose, may cause a pharmacological effect, not only a physiological one.15

4. In such a situation, GIS initiates proceedings 15 to qualify the product – to determine whether it is still food or already a medicinal product.

5. If, during the proceedings, the Chief Sanitary Inspectorate (GIS) determines that the product is, in fact, a drug (and not a supplement), the product is deemed to be illegally marketed. This is because it does not have a marketing authorization required by the Pharmaceutical Law, which is issued by the President of the Office for Registration of Medicinal Products.6

The risk of reclassifying a product from a dietary supplement to a medicinal product is the most serious regulatory risk for the entity introducing the product to the market. Such an administrative decision leads to an immediate order to suspend marketing and withdraw the product from the market.5

PART III: MARKETING PROCEDURES – COMPARATIVE ANALYSIS

The legal definition (“food” vs. “drug”) is a fork in the road that directs an entrepreneur to one of two fundamentally different procedural, economic, and business paths.

3.1. Procedure for Dietary Supplements: Notification (Report) to the Chief Sanitary Inspectorate

The status of a "foodstuff" 1 determines the procedure. In the case of dietary supplements, this is not registration or authorization (as is often mistakenly believed), but notification of the first placing on the market.14

• Legal basis: Article 29, paragraph 1 of the Act on the BŻZ.17

• Authority: Chief Sanitary Inspector (GIS).14

• Process: From 2020, the procedure is carried out exclusively electronically17 through the e-Sanepid system.18 The entrepreneur submits a "Notification of the introduction or intention to introduce a food product for the first time to the market"20 together with a label template.20

The responsibility model underlying this procedure is crucial to understanding the market. Submitting a notification does not imply acceptance, verification, or approval of the product by GIS.14

This system is characterized by a speed vs. risk dichotomy:

1. Speed: As indicated by sources14, an entrepreneur can legally begin marketing a product immediately after successfully submitting a notification and receiving an Official Submission Certificate (UPP). There is no need to wait for any formal decision, permit, or other document from the Chief Sanitary Inspectorate.14

2. Risk: This minimal barrier to entry is offset by the full responsibility (for composition, safety, labelling and legal compliance) placed on the entrepreneur from the outset.5

This system is based on deferred control (ex-post). This model (low entry barrier) is the main reason for the dynamic growth in the number of dietary supplements on the Polish market.

However, if post-marketing verification (conducted by GIS after notification) reveals irregularities (e.g. inconsistent composition, exceeded doses, borderline product status), the authority may impose severe sanctions: a fine (up to PLN 50), issuing a decision to suspend trade or ordering the product to be withdrawn from the market.5

3.2. Medicinal Product Procedure: Marketing Authorisation (MA)

The procedure for a medicinal product is the complete opposite of the notification of a supplement.

• Authority: President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL).3

• Procedure: Marketing authorization is required.3 This is a rigorous, time-consuming and costly authorization procedure (pre-market approval).

• Requirements: The entrepreneur must submit extensive documentation (so-called "dossier"), which, as detailed in 6, includes the application and up to 23 types of attachments, including:

• Evidence of efficacy: Research results, including clinical trials, demonstrating the therapeutic efficacy of the product.6

• Evidence for quality: Detailed description of the manufacturing and control methods used in the process.6

• Evidence of safety: Adverse event reports, environmental hazard assessment, and Risk Management Plan (RMP).6

• Deadline: The permit is issued no later than 210 days from the date of submission of a complete application.6 In practice, due to the need to supplement the documentation, this process is often much longer.

The barriers to market entry (time, financial – especially the costs of clinical trials – and procedural) are fundamentally and incomparably higher than for dietary supplements. Choosing the wrong regulatory path (e.g., attempting to notify a drug as a supplement) or subsequent requalification by a regulatory authority is disastrous for the product's lifecycle.

3.3. Table 1: Dietary Supplement vs. Medicinal Product – Comparison of Regulatory Frameworks

PART IV: REGULATORY ANALYSIS OF THE COMPOSITION OF DIETARY SUPPLEMENTS

The legal definition defines a supplement as "a concentrated source of vitamins, minerals, or other substances." Regulatory analysis of these components reveals further variation in legal regimes.

4.1. Harmonized Ingredients: Vitamins and Minerals

As mentioned in Part I, this is the only area of ​​dietary supplement composition that has been fully harmonized at European Union level.9

The regulations (Directive 2002/46/EC and the national implementing regulation 8) precisely define:

• Appendix I (What?): A closed list of permitted vitamins and minerals.9

• Annex II (In what form?): A closed list of permitted chemical forms (sources) of these ingredients that may be used in production.8

These lists are positive in nature – only the substances and chemical forms listed on them may be used.

It's worth noting that these lists are not static and are subject to amendment. This process is illustrated by changes introduced in recent years, such as the addition of nicotinamide riboside chloride to Annex II as a new source of niacin, or magnesium citrate malate as a source of magnesium.9 Such changes are only possible after obtaining a positive scientific opinion from the European Food Safety Authority (EFSA) on the safety and bioavailability of the new form.10

4.2. The Problem of Maximum Doses (Lack of EU Harmonization)

Although Directive 2002/46/EC harmonised the lists of permitted vitamins and minerals, it did not establish uniform, pan-European maximum permissible doses of these ingredients in dietary supplements.

This significant regulatory gap in Poland is filled by the Dietary Supplements Team, which serves as an advisory and consultative body to the Chief Sanitary Inspector.15 This Team, pursuant to Article 9, Section 2a of the Act on the State Sanitary Inspection, is tasked, among other things, with determining the maximum doses of vitamins and minerals in the recommended daily dose, "above which they demonstrate a therapeutic effect."16

The team carries out this task by adopting resolutions.15 These resolutions (a list of which is available at 16) define maximum levels for, among others:

• Vitamin D (Resolution No. 1/2021)

• Vitamin B6 (Resolution No. 2/2024)

• Magnesium (Resolution No. 19/2019)

• Zinc (Resolution No. 10/2019)

• Iron (Resolution No. 20/2019)

• And many others.16

The legal status of these resolutions is specific. As GIS representative Dr. Rzodkiewicz clearly emphasizes, the Team's resolution "is an expert opinion, not a legal provision."15 However, he immediately adds that manufacturers "should take it into account."15 The reason for this state of affairs is crucial: this resolution specifies in what situations (i.e., at what doses) GIS will initiate explanatory proceedings to determine whether a given product is not, in fact, a medicinal product (as discussed in Part II).15

In market practice, the resolutions of the Dietary Supplements Committee, although formally non-binding soft law, act as de facto binding regulatory guidelines. Ignoring them by a manufacturer constitutes a direct invitation to a GIS inspection and the risk of product reclassification.

4.3. Non-Harmonized Ingredients: "Other Substances" with Physiological Effect

The legal definition of a dietary supplement includes a broad and vague category: "other substances with a nutritional or other physiological effect."4 This is a legal loophole through which thousands of ingredients that are not vitamins or minerals are introduced into the market. This category includes amino acids, fatty acids, fiber, caffeine, probiotics, and, most importantly, botanicals.

The regulation of these substances is highly inconsistent:

• Probiotics: As indicated by the literature24, food law lacks detailed, separate regulations regarding the production of probiotics, leading to calls for standards closer to the pharmaceutical regime. At the same time, EFSA applies separate assessment procedures to microorganisms, such as the QPS (Qualified Presumption of Safety), which further complicates their status.25

• Other substances (e.g. caffeine): As with vitamins and minerals, the Dietary Supplements Committee also regulates these ingredients through resolutions, specifying maximum permissible doses (e.g. Resolution No. 16/2019 on caffeine) or conditions of use (e.g. Resolution No. 3/2019 on beta-alanine).16

The category of “other substances” is the least regulated area at the EU level, which places the entire burden of assessing the safety and qualification of the product on national authorities (in Poland – GIS, substantively supported by the Team for Dietary Supplements).

PART V: LEGAL STATUS OF BOTANICALS – THE EUROPEAN HARMONISATION GAP

The most complex and regulatory unstable area of ​​the dietary supplement market are products containing plant ingredients, so-called botanicals.

5.1. The Original Sin of Directive 2002/46/EC

As indicated in Part I, Directive 2002/46/EC, although it introduced the concept of a food supplement, does not apply to the full regulation of herbal substances.11 Its recitals explicitly state that provisions for substances other than vitamins and minerals (including herbal substances) are to be defined in the future.11 This legislative promise was never fulfilled.

As a result, while botanical supplements are legally defined as food (they fall under the category of “other substances…”), the detailed rules for their use (positive/negative lists, maximum doses, purity requirements) are not and have never been harmonized at the European Union level.

5.2. The Problem of Health Claims: EFSA's "Pending" List

A direct consequence of the lack of harmonization of ingredients is chaos in the area of ​​health claims for botanicals. According to Regulation (EC) No. 1924/2006 (on nutrition and health claims), each health claim (e.g., "helps digestion") requires scientific evaluation and authorization by EFSA and the European Commission.

In the case of plant ingredients, an exceptional situation occurred:

1. EFSA has received thousands of applications for health claims for botanicals.

2. However, the Office suspended their assessment, citing the lack of sufficient data and the fundamental problem of distinguishing between traditional (herbal) use and the scientific evidence required for food.

3. These applications were placed on the so-called "pending list."12

Claims on the "pending list" are neither approved nor rejected. Under the transitional provisions of Regulation 27, traders may temporarily use these claims (under their own responsibility), provided they were used in accordance with national law before 2008 and notified to the Commission.27

This creates a state of enormous legal uncertainty. All marketing of botanical-based dietary supplements is based on a legal temporary solution that has been in place for over a decade. The rulings of the Court of Justice of the European Union in this regard are ambiguous.12 There is a real risk that a potential "suspension" of the EFSA assessment and rejection of these claims could render most marketing activities in this segment illegal overnight.12

5.3. Market Fragmentation: National Initiatives (BELFRIT and GIS Resolutions)

Due to legislative inaction at the EU level, member states began to create their own national regulations on botanicals, which led to deep fragmentation of the market.13

• BELFRIT Initiative (Belgium, France, Italy): As part of this project, the regulatory authorities of these three countries agreed to create a common list of plant substances and preparations permitted for use in dietary supplements. The BELFRIT list includes over 1000 plants,30 specifying their permitted parts (e.g., leaf, root, rhizome).31 Importantly, these lists (which these countries have implemented into their national law) also include maximum allowable doses and mandatory label warnings for many plants.29
  Even within this initiative, however, there is some consistency. Analysis 30 shows that Italy has adopted a more liberal approach (e.g., not setting limits for plants containing anthraquinones, such as Aloe), while Belgium has introduced tougher restrictions. 29

• Polish Solution (Dietary Supplement Team): Poland has not formally joined the BELFRIT project.32 Instead, Poland is creating its own, parallel "quasi-BELFRIT" system through the resolutions of the Dietary Supplement Team mentioned above.16
  This team publishes resolutions regarding specific botanicals, working in two ways:

1. Negative list: Publishes a list of plant substances and raw materials that cannot be used in dietary supplements (e.g. yohimbine hydrochloride, kava, mucuna).16

2. Restriction list: Specifies detailed conditions of use, maximum doses, and mandatory labeling for popular botanicals (e.g., Withania somnifera (Ashwagandha), Rhodiola rosea, Tribulus terrestris, and Bacopa monnieri).16

For market players, this means that the legal status of dietary supplements containing botanicals is not uniform across the EU. A product legally marketed in Poland (compliant with the resolutions of the Dietary Supplements Committee) may be deemed illegal in Belgium (e.g., because it exceeds the dose specified in the BELFRIT-BE list), while a product legal in Italy (compliant with the liberal BELFRIT-IT list) may be challenged in Poland (e.g., because it exceeds the dose specified in the Team's resolution).

PART VI: MARKET SUPERVISION AND CONTROL SYSTEM IN POLAND

The definition of a dietary supplement as “food” also determines the architecture of market supervision institutions.

6.1. The Central Role of the Chief Sanitary Inspector (GIS)

The Chief Sanitary Inspector (GIS), together with the State Sanitary Inspection (PIS, Sanepid), is the main supervisory authority over the dietary supplements market in Poland.1

Its role, resulting from the supplement's status as food, includes:

• Administering the notification process: Maintaining a publicly available register of notified products.14

• Post-marketing surveillance: Inspection of products already placed on the market in terms of composition (whether it is consistent with the declaration), labelling (whether it is not misleading) and general safety.5

• Conducting explanatory proceedings: Key competence in assessing borderline products and their possible reclassification as medicinal products.15

6.2. Substantive Authority: Dietary Supplements Team

As demonstrated in the previous sections of the report, the Dietary Supplements Team plays a key role in the system. Formally, it is merely an advisory and consultative body to the Chief Sanitary Inspector.16 Its members include specialists from various fields (physicians, pharmacists, toxicologists).15

In practice, however, due to numerous loopholes in the law (both national and EU), this Team has become the key substantive regulator of the market.15 Its resolutions 16, although formally non-binding 15, constitute the scientific and substantive basis for the GIS control activities.15 They act as a safeguard for the liberal notification system – they identify “red flags” (e.g. exceeded doses, dangerous botanicals) that trigger GIS explanatory proceedings.

6.3. Division of Competencies: The Role of the Office of Competition and Consumer Protection and the Supreme Audit Office

The dietary supplement market is not monitored solely by the Chief Sanitary Inspectorate (GIS). The definition of a supplement as a consumer product (food) also places it under the scrutiny of other bodies.

• Office of Competition and Consumer Protection (UOKiK): The UOKiK monitors the dietary supplement market for practices that violate the collective interests of consumers.33 In practice, this means that while the Chief Sanitary Inspectorate (GIS) controls product composition and safety (food law), the UOKiK controls advertising and marketing (consumer law). UOKiK's actions33 often concern misleading advertising that falsely suggests a product's medicinal properties—in other words, violates its definition as food. Both authorities (GIS and UOKiK) often conduct joint activities and information campaigns.33

• Supreme Audit Office (NIK): The NIK is a state audit body.1 It does not directly supervise producers, but rather oversees the supervisory system. The NIK has repeatedly1 conducted audits to assess whether the supervision system (executed by the Chief Sanitary Inspectorate) over dietary supplements is effective and ensures consumer health safety.

For entrepreneurs, this means the need to conduct compliance activities at three levels simultaneously:

1. Product compliance (supervised by GIS) – compliance of composition, doses and labels with the Team’s resolutions.

2. Marketing compliance (supervised by the Office of Competition and Consumer Protection) – compliance of advertisements and statements with consumer law and Regulation 1924/2006.

3. Systemic compliance – awareness that GIS activities are under constant pressure and audit by the Supreme Audit Office, which increases GIS’s motivation to rigorously enforce regulations.

6.4. Table 2: Map of Supervisory Institutions of the Dietary Supplements Market in Poland

PART VII: EXPERT CONCLUSIONS AND IMPLICATIONS FOR MARKET PARTICIPANTS

The analysis of the legal definition of a “dietary supplement” and its regulatory environment leads to the following conclusions of a strategic nature for entities operating in this market:

1. Definition as a Key Business Risk Factor: The definition of a "dietary supplement" as a food is a fundamental factor that determines the entire model businessIt provides a low barrier to entry (notification instead of authorization 14), allowing for a quick product launch. However, in return, it places full and exclusive responsibility for product safety on the entrepreneur 5 and exposes them to severe sanctions under ex-post controls. 5

2. Reclassification Risk (Borderline Product): The greatest operational risk for an entity introducing dietary supplements is not a labeling error, but rather the reclassification of the product by the Chief Sanitary Inspectorate (GIS) as a medicinal product.15 This risk materializes primarily when the maximum doses indicated in the resolutions of the Dietary Supplements Committee15 are exceeded or through the use of claims and advertising suggesting therapeutic effects. Such reclassification is equivalent to the regulatory "death" of the product, as it means an immediate order to withdraw it from the market due to the lack of a legally required marketing authorization from the Office for Registration of Medicinal Products.6

3. De Facto Binding Nature of "Soft Law": In the Polish legal system, due to loopholes in hard law (especially EU law), the Dietary Supplements Team has become the de facto regulator of the composition of supplements.16 Its resolutions16, although formally non-binding and constituting only an "expert position"15, are the only credible substantive guideline for GIS control activities.15 Conducting business activities in conflict with these resolutions is an extremely risky activity.

4. European Fragmentation (Botanicals): The definition of a dietary supplement is harmonized at the EU level, but the rules for the use of botanical ingredients are not.11 This has led to profound fragmentation of the European market.13 National initiatives, such as BELFRIT (Belgium, France, Italy) 28 or the Polish resolutions of Team 16, create separate national regulatory regimes. An entity planning to distribute a botanical product within the EU must conduct a separate compliance analysis for each Member State.

5. Marketing Uncertainty (Pending List): Marketing of supplements containing botanicals is subject to legal suspension (EFSA's "pending list").12 This is a fundamental strategic risk for the entire industry, entirely dependent on future EFSA decisions or CJEU judgments.27

6. Multi-Level Supervision: The definition of a “supplement” as a consumer product (food) subjects it to multi-level scrutiny – not only by GIS/PIS, but also by the Office of Competition and Consumer Protection (advertising) and the Supreme Audit Office (audit of the GIS system).1 Effective compliance requires monitoring the guidelines and actions of all these bodies.

Works Cited

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