The dynamic development of the computer games market has led to a significant change in the monetization models used by game producers and publishers. The traditional sales model, based on a one-time purchase of a product by the consumer, has been largely replaced by solutions based on long-term user engagement and generating revenue through micropayments (microtransactions). Mechanisms known as loot boxes, consisting in the paid purchase of virtual packages with random content.

Although initially perceived as a means of enhancing gameplay, this mechanism is currently the subject of intense legal, economic, and social debate. It is increasingly being pointed out that the design of loot boxes utilizes psychological mechanisms similar to those that have been present in traditional gambling games for many years. The random nature of the reward, the uncertainty of the outcome, the “near miss” effect, the limited availability of certain items, and the use of dynamic animations intended to enhance the user’s emotional engagement all contribute to the blurring of the line between entertainment and gambling mechanisms.

Additional controversy stems from the fact that the vast majority of modern games using loot boxes are also aimed at minors. Unlike traditional gambling games, participation in these mechanisms does not require a specific age or meeting specific formal requirements. In practice, this means that random monetization mechanisms are also used by children and adolescents, who, due to their stage of psychological development, are particularly susceptible to the influence of behavioral design techniques and so-called dark patterns).

In recent years, the issue of loot boxes has ceased to be analyzed solely through the prism of gambling law. Regulations concerning consumer protection, digital services, and child safety in the online environment are gaining increasing importance. Discussions at the European Union level indicate that the future legal framework may be based not only on classic definitions of games of chance but also on instruments to combat manipulative practices and ensure a high level of protection for consumers using digital services.

At the national level, the problem remains equally relevant. Polish lawmakers have not yet decided to introduce a separate definition of loot boxes into the Gambling Act of 19 November 2009. This does not mean, however, that these mechanisms remain entirely outside the scope of existing regulations. In practice, administrative bodies assess each specific business model on a case-by-case basis, analyzing whether its design meets the statutory definition of gambling. At the same time, the development of the secondary market for trading in virtual items, particularly so-called skin gambling , is creating new interpretative challenges that the legislature did not anticipate when enacting the current regulations.

The changes introduced by the PEGI rating system in 2026 provided an additional impetus for reassessing the current regulations. The revised rules for classifying games with paid random mechanisms confirm the growing awareness of the risks associated with the use of loot boxes, especially for underage users. Although the PEGI rating is not a source of generally applicable law, its practical importance for the European market remains significant and may influence both the distribution of games and the future direction of legislative changes.

The purpose of this article is to analyze the current legal status of loot boxes under Polish and European Union law, taking into account recent regulatory changes, the practices of administrative bodies, and the experiences of selected European countries. Particular attention will be paid to whether the current regulations effectively protect consumers from mechanisms based on randomness and whether the current regulatory model meets the challenges of the modern digital economy.

The essence of loot boxes and their functioning models

The concept of a lootbox has not yet been defined in either Polish or European Union law. However, in the literature and by public institutions, it is generally accepted that a lootbox is a mechanism whereby the user obtains, for a fee or free of charge, a virtual package containing items whose contents remain unknown until opened. A characteristic element of this solution is randomness – the user has no influence on the item they receive, and the probability of obtaining individual rewards is determined by the game developer or platform operator.

At the definitional level, however, it should be emphasized that the term “lootbox” encompasses a wide variety of business models, the legal assessment of which cannot be uniform. Public debate often equates all mechanisms based on randomness with gambling, while from a legal perspective, individual solutions differ in both their economic structure and the degree of risk to the consumer. It is precisely this diversity that means that assessing the compliance of lootboxes with applicable regulations requires an analysis of the specific operational model, not just the presence of a random element.

The most classic model occurs in games where lootbox content is limited solely to cosmetic items, such as skins , animations, character outfits, or visual effects. These items do not affect gameplay or increase the player’s chances of success. They are intended solely for aesthetic purposes, allowing the user to personalize the appearance of their character or equipment. Such solutions were long considered relatively safe from a consumer protection perspective, but the development of secondary markets for trading virtual items has significantly changed their economic significance.

A good example is the Counter-Strike series, where weapon skins initially served only a visual purpose. Over time, however, a robust secondary market developed around these items, allowing them to be sold for real money. Consequently, the value of some virtual items began to reach several thousand, or even several dozen thousand, and in exceptional cases, several hundred thousand euros. In practice, this means that a randomly acquired item can have a tangible financial value, even though the game developer itself does not officially allow for its sale. The existence of an external market is one of the main arguments raised in the discussion on the classification of such mechanisms as potentially akin to gambling.

Loot boxes used in sports games, such as EA SPORTS FC Ultimate Team, are of a different nature. In this model, users purchase virtual packs containing player cards, coaches, or other team items. Unlike skins in games like Counter-Strike, acquired items directly impact gameplay. Acquiring rare players can increase a team’s competitiveness and improve player performance. Although the developer publishes information regarding the probability of receiving rewards in a given category, the user still doesn’t know the contents of a specific pack at the time of purchase, and the decision to purchase is based on a random mechanism.

Yet another model is found in so-called gacha games, extremely popular, especially in Asian markets and in the mobile gaming segment. This mechanism is based on randomization of characters, equipment, or other items necessary for further progression in the game. A characteristic feature of gacha systems is their close connection to long-term user monetization. Players are encouraged to repeatedly make micropayments to obtain exceptionally rare characters or items, the probability of obtaining which can be extremely low. The literature indicates that these solutions most fully utilize the mechanisms of behavioral economics and the psychology of addiction.

However, the most controversial are third-party platforms that enable the trading of virtual items and participation in games of chance that use items from video games as a form of currency. These services operate independently of game developers, leveraging the existing market for skins or other digital goods to organize mechanisms reminiscent of classic casino games. Users deposit funds or use their virtual items to participate in lotteries, roulette, duels, or other games based on chance. Unlike traditional loot boxes offered by game producers, the participant’s goal is not only to obtain a specific item but often to achieve a tangible economic benefit resulting from the possibility of reselling it.

From a legal perspective, the differences between the presented models are crucial. Not every mechanism employing an element of randomness automatically leads to its classification as gambling. Factors that should be assessed include, first and foremost, the potential for financial gain, the existence of a secondary market, the method of financing participation, the possibility of withdrawing funds, and the actual impact of randomness on achieving a specific outcome. In practice, this means a case-by-case analysis of the specific business model, rather than adopting a uniform classification for all types of loot boxes .

This approach is also reflected in the practice of many European countries. Both administrative bodies and courts are increasingly moving away from abstract assessments of the lootbox mechanism itself, focusing instead on analyzing their actual operation and impact on consumer interests. Consequently, the current legal debate no longer revolves around the question of whether lootboxes as a category should be considered gambling, but rather which monetization models justify their inclusion in a specific regulatory regime.

Loot boxes and the definition of gambling in Polish law

Assessing the compliance of lootbox mechanisms with Polish law requires, above all, an analysis of the provisions of the Gambling Act of 19 November 2009. Although the legislature has not yet decided to introduce a separate definition of lootboxes, this does not mean that these mechanisms remain outside the scope of applicable regulations. On the contrary, in practice, their legal classification depends on whether the specific operating model meets the criteria for one of the games specified in the Act.

The basic premise of the Gambling Act is to subject activities in which the outcome depends on chance to a specific regime, and the participant gains the opportunity to obtain a specific financial or material benefit. The Act does not use the term “lootbox” because it was enacted at a time when modern computer game monetization models were practically nonexistent. This necessitates a functional interpretation, taking into account the economic nature of the mechanism in question, not just its name or the technical solutions adopted by the game developer.

A key element of most loot boxes is undoubtedly randomness. The user making the purchase neither knows the contents of the package nor has the ability to influence the outcome of the drawing. However, the mere presence of a random element is not sufficient to classify a given mechanism as gambling. In practice, the nature of the prize received by the participant and the ability to assign it a real economic value are equally important.

This is where a fundamental difference between classic loot boxes offered by game developers and the mechanisms used by third-party platforms for trading virtual items becomes apparent. If the item obtained through a draw has a purely aesthetic function and cannot be legally exchanged for cash or used outside of the game environment, the arguments for classifying such a mechanism as gambling are significantly weaker. The situation is different when the item is de facto a property that can be freely traded on the secondary market, yielding a real financial benefit.

In practice, the greatest controversy surrounds so-called skin gambling. In this model, users use items obtained in-game as a means of participating in subsequent games of chance organized by third parties. Skins, which were originally purely cosmetic, are beginning to function as a kind of digital currency with measurable economic value. This mechanism leads to a situation in which participants risk losing items of real-world value in exchange for the opportunity to win an even more valuable reward. This structure bears a much greater resemblance to classic gambling games than the traditional micropayment systems used by game developers.

At the same time, caution should be exercised before drawing too far-reaching conclusions. The mere existence of a secondary market does not automatically mean that every loot box should be classified as gambling. From a legal perspective, a case-by-case analysis of the entire business model is necessary, including, among other things, the method of acquiring virtual items, the possibility of their resale, the role of the game producer, the scope of control over the trade in digital assets, and the actual economic significance of the rewards. Consequently, two mechanisms utilizing an identical element of randomness may be subject to entirely different legal assessments.

This position is also reflected in the practice of Polish administrative bodies. To date, there has been no established practice of automatically classifying all loot boxes as gambling. Authorities focus instead on analyzing specific business models and assessing whether they meet the requirements of applicable regulations. This approach reflects the nature of the Gambling Act, which uses functional definitions, leaving authorities considerable scope for assessing individual factual circumstances.

In this context, the practice of entering certain online platforms into the Register of Domains Used to Offer Gambling Games in Contravention of the Act has become particularly significant. However, such an entry does not mean that all platforms utilizing the element of randomness conduct illegal activities. Each decision is preceded by an assessment of the specific operational model of the given service. Consequently, it cannot be assumed that the lootbox mechanism itself has been deemed illegal in Poland. It is not the abstract technical structure that is being assessed, but rather its practical application.

Under current law, it seems more appropriate to ask not whether loot boxes per se constitute gambling, but which of their numerous operating models demonstrate characteristics that justify the application of the provisions of the Gambling Act. This approach avoids oversimplification and better reflects the reality of the digital market, where solutions with widely varying levels of risk to consumers coexist.

At the same time, it should be noted that even if a given mechanism does not meet the criteria for gambling within the meaning of the Act, this does not mean there is a lack of legal oversight. Modern regulations increasingly refer to consumer protection instruments, counteracting manipulative practices, and ensuring the safety of children using digital services. Therefore, analysis of loot boxes cannot be limited solely to gambling law. Regulations regarding consumer protection, digital services, and designing interfaces in accordance with fair trading principles are gaining increasing importance, and in many cases, they may prove to be a more effective tool for protecting users than traditional gambling law instruments.

Loot boxes as a challenge to consumer protection law and the regulation of digital services

Although the debate surrounding loot boxes has for many years focused primarily on gambling law, a shift in regulatory direction is now becoming increasingly apparent, both at the national and European Union levels. Contemporary challenges related to random mechanisms in computer games concern not only the classification of specific models as gambling, but also the compliance of the practices employed with the principles of consumer protection, the protection of minors, and the fair design of digital services.

This change is primarily due to the development of the digital economy. The mechanisms used by game producers are increasingly based not on traditional product sales, but on long-term user engagement and gradual increase in spending through appropriately designed psychological solutions. This phenomenon is referred to in the literature as behavioral monetization, or monetization that leverages knowledge from cognitive psychology and behavioral economics. The goal of such mechanisms is not simply to facilitate a purchase, but to create an environment that encourages users to make subsequent purchasing decisions impulsively or emotionally.

Of particular importance in this regard are so-called dark patterns, referred to in Polish literature as manipulative or deceptive design patterns. These design solutions exploit the workings of human perception and decision-making processes to induce behaviors that are beneficial to the entrepreneur, but not necessarily aligned with the consumer’s true interests. In the case of loot boxes, these can take a variety of forms – from counters counting down the time until the end of a promotion, through messages about the limited availability of specific rewards, to elaborate animations that enhance the emotional experience of opening the packages.

These mechanisms are not coincidental. Psychological research indicates that a reward system based on a variable ratio reinforcement schedule is one of the most effective ways to maintain long-term user engagement. This same mechanism has been used for many years in classic gambling games, where the unpredictability of rewards maintains a high level of motivation for subsequent attempts. In the case of loot boxes, this mechanism is transferred to the computer gaming environment and combined with an attractive audiovisual setting and the ability to immediately make another purchase.

From the perspective of consumer protection law, a crucial question is whether the use of such solutions could lead to a violation of traders’ obligations arising from provisions on fair market practices. It should be noted that contemporary EU regulations increasingly place greater emphasis not only on the content of information provided to consumers, but also on the design of digital interfaces. Therefore, the subject of assessment is increasingly not the product or service itself, but rather the architecture of the purchasing process and the impact of the interface on the user’s freedom of decision-making.

Underage users are particularly important here. Both the European Commission and the European Parliament have repeatedly stated that children using digital services require a higher level of protection than the average consumer. This stems from their limited ability to assess economic risk and their greater susceptibility to persuasive techniques used by businesses. In practice, this means that solutions acceptable to adult users may be deemed disproportionate or unfair if they are primarily targeted at children and adolescents.

The importance of this issue has increased following the entry into force of Regulation (EU) 2022/2065 on the Digital Single Market (Digital Services Act – DSA). Although this act does not explicitly regulate lootbox mechanisms, it establishes a number of obligations regarding the design of digital services and the protection of users from practices that may negatively impact their decision-making autonomy. In particular, the DSA emphasizes the need to ensure a high level of protection for minors and limit the use of solutions that exploit the vulnerabilities of specific user groups. This trend indicates that future assessments of the legality of lootboxes will increasingly be conducted not only through the lens of gambling law but also taking into account consumer protection standards applicable in the digital environment.

In parallel, the European Commission is working on a legislative package known as Digital Fairness, which aims to adapt EU consumer protection regulations to the realities of the digital economy. Issues under review include manipulative design patterns, interface design that exploits user vulnerability, and mechanisms that exert excessive psychological pressure during purchasing decisions. Although the legislative work has not yet been completed, the direction of the proposed changes clearly indicates that future regulations may also cover monetization mechanisms used in video games.

The European Parliament also highlighted the need to enhance the protection of minors in its resolution of 26 November 2025 on the protection of children online. The document indicated that mechanisms such as loot boxes, in-game currencies, and other systems based on chance should be subject to special scrutiny from the perspective of protecting children from addictive and manipulative digital practices. While the resolution is non-binding, it provides an important political signal indicating the direction of future legislative action at the European Union level.

A separate but crucial element of the modern user protection system is the PEGI age rating. Starting in 2026, this system will adopt a more stringent approach to games featuring paid random mechanisms, recognizing them as solutions requiring a higher age rating. While the PEGI rating is not a source of law and does not in itself determine the legality of specific monetization models, it reflects a growing consensus on the need to provide greater protection for minors from mechanisms that utilize randomness and behavioral design techniques.

The above circumstances lead to the conclusion that the future of loot box regulation will likely be shaped primarily by regulations concerning consumer protection and digital services, rather than solely by traditional gambling law instruments. While the Gambling Act focuses on the qualification of specific business models, contemporary EU regulations increasingly assess the design of digital services and their impact on the autonomy of user decisions. Consequently, assessing the legality of loot boxes in the future will require comprehensive consideration of both gambling law and regulations concerning consumer protection, digital services, and children’s rights.

Approach of selected European countries to regulating loot boxes – a comparative analysis

The lack of a uniform definition of loot boxes in European Union law has led individual member states to develop different models for regulating this phenomenon. These differences concern not only the legal classification of random-based mechanisms but, above all, the assessment of the risks loot boxes pose to consumers, especially minors. As a result, the European Union currently boasts both countries adopting a very restrictive approach and jurisdictions that prefer to analyze individual business models rather than create separate statutory regulations.

Belgium has taken the most stringent stance for many years. The Belgian Gaming Commission has determined that certain lootbox mechanisms meet the criteria for gambling if the participant pays a fee, the outcome depends on chance, and the reward represents a specific economic value. Consequently, some game producers have decided to remove paid lootboxes from the Belgian market or significantly limit their functionality. This solution was primarily preventative in nature and aimed at limiting children and adolescents’ exposure to mechanisms that utilize randomness as a monetization tool .

The Dutch experience was different. For many years, the Dutch supervisory authority took a similar stance to the Belgian one, deeming certain lootbox models to be in violation of gambling regulations. The dispute concerned one of the most popular monetization models used by Electronic Arts became the subject of years of administrative and court proceedings. However, the final rulings demonstrated that the classification of loot boxes cannot be based solely on the presence of an element of randomness, but requires consideration of the overall economic structure of the game, the method of trading virtual goods, and the actual potential for financial gain for the user. The Dutch experience thus highlighted the difficulties associated with applying traditional definitions of gambling law to new business models operating in the digital economy.

At the opposite extreme is the approach adopted in Poland. To date, Polish lawmakers have not decided to create separate regulations regarding loot boxes or introduce a statutory definition. This means that the assessment of individual models is based on applicable gambling regulations and an analysis of the specific factual circumstances. This approach provides administrative bodies with significant interpretative flexibility, but also limits predictability for businesses operating in the digital market.

The practice of Polish authorities indicates that a functional assessment of the specific business model is crucial. In the case of platforms enabling the use of virtual items as a means of participating in games of chance, authorities may apply the instruments provided for in the Gambling Act, including entry into the Register of Domains Used to Offer Gambling Games Contrary to the Act. However, this does not automatically mean that all loot boxes used in computer games are illegal. The Polish model is therefore based on an analysis of the economic impact of a given solution, not on an abstract assessment of the randomness mechanism itself.

An analysis of the solutions adopted in individual countries leads to the conclusion that what is becoming increasingly important is not simply classifying loot boxes as gambling, but rather protecting consumers from the psychological mechanisms that lead to excessive spending or compulsive behavior. Therefore, many countries are beginning to perceive the loot box problem as an issue that goes beyond traditional gambling law and requires the use of instruments appropriate to consumer law and digital market regulation.

This approach also aligns with actions undertaken at the European Union level. The European Commission and the European Parliament increasingly point out that the fragmentation of national regulatory models can lead to uneven levels of user protection in the digital single market. The global nature of game producers’ operations means that businesses operate simultaneously in multiple markets, adapting their business models to the most stringent requirements in force in individual countries. In practice, this means that future legal solutions will likely aim for greater harmonization of consumer protection standards at the EU level.

However, this doesn’t mean a complete ban on loot boxes is necessary. A much more likely approach would be to introduce requirements regarding the transparency of random mechanisms, the publication of actual reward probabilities, more effective age verification of users, and restrictions on the use of solutions that exploit the vulnerability of children and adolescents to persuasive techniques. Such a regulatory model would preserve the possibility of using micropayments as a legal method of financing computer games while simultaneously strengthening consumer protection.

From the perspective of Polish law, the experiences of other European countries have significant interpretative significance. They demonstrate that mechanisms operating at the intersection of gambling and digital services cannot be assessed solely through the lens of classic legal constructs developed for traditional casinos or lotteries. The development of the digital economy requires a more comprehensive approach, taking into account both the economic significance of virtual goods and the impact of interface design on consumer decisions. Consequently, the future model for regulating loot boxes will likely be based on a combination of instruments from gambling law, consumer protection law, and regulations governing digital services, rather than the exclusive application of one of these legal regimes.

Conclusions de lege lata and postulates de lege ferenda

The analysis leads to the conclusion that current Polish law does not allow for a uniform legal classification of all lootbox mechanisms. Despite the growing number of voices calling for the recognition of lootboxes as a form of gambling, the current legal status does not provide a basis for automatically subjecting this entire product category to the provisions of the Gambling Act of 19 November 2009. Each assessment requires consideration of the actual operation of the specific business model, the nature of the prize, the potential for further turnover, and the economic impact of user participation in the random mechanism.

This doesn’t mean, however, that the current regulations remain entirely insufficient. With respect to some models operating on the market – particularly platforms that use virtual items as a means of participating in games of chance or enabling their exchange for cash – current regulations may be applicable. The practice of administrative bodies to date demonstrates that the Gambling Act remains an instrument that helps counteract the riskiest forms of activity, especially when virtual goods begin to function as an equivalent of money or property.

At the same time, it’s important to note that the vast majority of modern loot boxes don’t pose a classic gambling law problem. Their primary purpose isn’t to organize games of chance in the traditional sense, but to create a monetization model that leverages psychological mechanisms that increase user propensity to make subsequent purchases. For this reason, the current regulatory debate is increasingly shifting from gambling law toward consumer protection law and the regulation of digital services.

It seems that this is precisely the direction that Polish lawmakers should also adopt. Attempting to classify all loot boxes as gambling would oversimplify the extremely diverse digital market. A much more rational solution seems to be creating separate regulatory obligations for mechanisms that utilize randomness, without the need for automatic application of the entire gambling law regime.

First and foremost, it seems reasonable to introduce full transparency into random mechanisms. Before making a purchase, users should be able to familiarize themselves with the actual probability of winning individual prizes, how the randomization algorithm works, and whether this probability remains constant for all participants. Such solutions already exist in some computer games, but currently they are primarily driven by voluntary decisions by businesses or requirements in specific foreign markets.

The second direction of change should be to strengthen the protection of underage users. In light of current psychological knowledge and the positions of EU institutions, there is little doubt that children are particularly susceptible to the influence of mechanisms based on a variable reward system. Therefore, it seems reasonable to consider limiting the ability of people under a certain age to purchase paid loot boxes or introducing mandatory parental control mechanisms to effectively manage minors’ expenses.

Regardless of the above, legislators should consider introducing more detailed regulations regarding third-party platforms enabling the trading of virtual items. It is this market segment that currently raises the greatest concerns from the perspective of consumer protection and compliance with the Gambling Act. In particular, situations in which items obtained in-game become a means of participation in subsequent games of chance or can be directly converted into cash require analysis. In such cases, the line between a digital service and gambling activity becomes significantly blurred, justifying the application of more restrictive oversight measures.

Obligations regarding marketing activities should also be a crucial element of future regulations. In practice, loot boxes are primarily promoted through influencers and online creators, whose audiences often include minors. While advertising collaborations in and of themselves cannot be deemed unacceptable, situations in which marketing messages exclusively emphasize the possibility of winning exceptionally valuable prizes, disregarding the actual probability of winning them, or employing techniques that could create unreasonable expectations among recipients regarding potential benefits, require special consideration. In this regard, both consumer protection regulations and regulations regarding the integrity of advertising messages may apply.

The issues presented demonstrate that the issue of loot boxes is not limited to gambling law. In fact, it exemplifies a much broader phenomenon involving the use of advanced digital design techniques to influence users’ economic decisions. Technological advancements increasingly render traditional private and public law frameworks inadequate for assessing new business models based on user behavior analysis and interface design that maximizes consumer engagement and spending.

Consequently, the future of loot box regulation will likely depend less on further expansion of the definition of gambling than on the development of European consumer protection standards in the digital environment. Regulations on the transparency of digital services, countering manipulative design patterns, and ensuring a high level of protection for children using the internet are becoming increasingly important . These instruments may become the primary tool for mitigating the risks associated with loot box operations in the coming years.

It should therefore be assumed that effective regulation of this phenomenon requires a multifaceted approach, combining instruments of gambling law, consumer protection law, and digital market regulation. Only such a comprehensive solution will achieve the right balance between the freedom of game producers to conduct business and the need to ensure a high level of protection for users, particularly children and adolescents, who remain most vulnerable to the negative effects of random-based mechanisms.

Artykuł Lootboxes in Computer Games – Between Gambling Law and Consumer Protection. Regulatory Analysis Against the Background of Polish and European Union Law. pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

You see a video, a product catches your eye, and an “add to cart” button is already blinking in the corner of the screen. A few seconds later the order is placed, paid for, and on its way — all without leaving the app. That’s how TikTok Shop works: a closed-loop model in which the path from watching a piece of content to completing a purchase has been cut to the bare minimum. That very immediacy is its greatest strength and, at the same time, the source of its most serious concerns.

A platform that in 2017 drew around 72 million monthly users now attracts more than 1.5 billion — and between 11 and 15 million in Poland alone. TikTok has stopped being merely a place for entertainment and has turned into a powerful advertising and sales engine, combining influencer marketing, algorithmic personalization, and the emotional purchasing impulse. For businesses, it is a new and remarkably effective retail space. For consumers, it is an environment in which it grows ever harder to tell an authentic recommendation from an ad, or a fleeting enthusiasm from a considered decision.

That is precisely why TikTok Shop has landed at the center of lawmakers’ attention. While its model is not unlawful, the platform’s operation intersects with an entire web of regulation: from consumer law and the ban on “dark patterns,” through the EU’s DSA and DMA, data protection and safeguards for minors, all the way to advertising, media, and electronic communications law. This article shows where the convenience of one-tap shopping ends and the protection of the buyer’s free will begins.

What makes the TikTok Shop platform innovative?

Today, an effective marketing strategy is becoming an increasingly important priority for sellers. In Poland, monopolies in sales are relatively rare. Many competing companies operate in most industries. When purchasing products, consumers must choose from hundreds, or even thousands, of options offered by different brands. The scale of this phenomenon is evidenced by the fact that in the fourth quarter of 2025, over 2.9 million active businesses operated in Poland alone, the largest group of which were those associated with the retail sector. Meanwhile, buyers generally do not want to spend much time thoroughly analyzing goods available on the market. They are often guided by the opinions of other users, brand recognition, or media coverage. Therefore, in an information society based on the dynamic development of social media, tailoring advertising to current consumer needs and behaviors becomes crucial for running a business. Authentic and credible recommendations from trusted creators are becoming more important, and for many buyers, they are more persuasive than formulaic television commercials.

Considering the above arguments, many companies are making changes to their advertising strategies, for example, opting for influencer marketing. Online creators typically publish aesthetically and thematically consistent content that captures the interest of users with similar preferences and tastes. A business partnering with an influencer who shares similar values gains the opportunity to reach a large group of potential consumers, made up of the influencer’s followers. TikTok has become the dominant platform enabling the implementation of the marketing model described above. In 2017, the application had approximately 72 million monthly active users, and according to data from 2026, this number has increased to approximately 1.54 billion. In Europe alone, TikTok has already reached over 200 million users, and in Poland, the number ranged from 11 to 15 million. The average time spent on the platform is 70 minutes per day, which translates to approximately 35 hours per month. These statistics also indicate the continued growth of TikTok’s popularity, confirming the future of using social media for advertising and promotional purposes.

The development of influencer marketing significantly changed existing marketing practices, and its increasing prevalence led to the transformation of the TikTok app from a social media platform into an advertising system. The effective and profitable collaboration between media and advertising prompted the platform to take the next step in its development, combining these two sectors. Users were offered the opportunity to completely simplify the purchasing process. Previously, consumers only saw product advertisements, which attracted their attention and prompted them to search for sales offers. However, this pattern left them time to consider whether a purchase was truly necessary or necessary. It was also likely that, despite their interest in the product, they would eventually forget about the advertised product, and therefore their desire to purchase it.

The solution to the marketing strategy described above turned out to be a new feature presented by TikTok: TikTok Shop. The innovative nature of this tool is based on a closed-loop model, meaning the purchasing process takes place within a single app. Users first encounter content promoting a specific item. They then have the option to immediately purchase it by adding the advertised item to their shopping cart in the bottom corner of the app. TikTok acts as an intermediary for payment, shipping, and the entire order process. In this way, the app has evolved not only into a profitable advertising system but also an online store, becoming a marketplace platform that mediates payment, logistics, and order fulfillment.

The origins of TikTok Shop

Initially, the online shopping phenomenon developed through e-commerce. Its popularity contributed to the diversification of online sales into several business models: B2C, B2B, and C2C. The former involves a relationship between a business and an individual customer (examples include online stores such as Zalando, Zara, and IKEA). B2B refers to transactions between businesses, while C2C refers to sales between individuals, such as on platforms like Vinted, OLX, and Allegro.

These e-commerce models typically control the sales process independently. Their profits largely come from consumers who shop by searching for specific products they need. Entrepreneurs compete with each other through marketing activities aimed at convincing consumers of the quality of their products and building brand recognition.

In the next stage, the development of social media, and consequently influencer marketing, contributed to the emergence of a completely new type of buyer, one driven by impulse. Online creators present a specific lifestyle on their profiles in a significantly idealized form, which attracts the attention of their followers and becomes a role model. The desire to emulate the creator they follow can manifest itself both in their behavior and in the possessions they possess. The influencer thus becomes a person who inspires and encourages the purchase of a given product. Even if, from a rational perspective, the buyer doesn’t need the product, they often decide to purchase it under the influence of influencer marketing.

Additionally, a new branch of e-commerce has emerged, known as discovery commerce . This model relies on the discovery and purchase of new items while actively browsing social media. Highly advanced algorithms select content for users that aligns with their tastes or interests, in order to evoke certain emotions that then transform into a strong purchasing impulse. Social media platforms, recognizing this profitable sector, have contributed to the development of social commerce, including TikTok Shop. This solution capitalizes on users’ fleeting enthusiasm and allows them to complete their order without leaving the app. The entire process, from advertising content to payment and shipping, is handled by TikTok, which can limit the time available for rational purchase consideration.

What exactly does the purchasing process look like on TikTok Shop?

TikTok Shop is not a separate app, but a new feature added to the TikTok platform. There’s no need to create a new account or install a new app. This solution provides access to a wide group of potential consumers, as every existing TikTok user over the age of 18 can familiarize themselves with the new feature. This solution gives businesses multiple ways to reach consumers. The platform offers a separate tab, “Shop,” where users can search for specific products using filters and categories, or browse recommended items based on their activity on the platform.

Products offered by sellers using the TikTok Shop service can also be viewed on the “For You Page” tab. This is the subpage most frequently visited by users. This option is especially useful when a company decides to use influencer marketing. A creator posts a video promoting a selected product, and buyers are immediately presented with a purchase button at the bottom of the page. Consumers can also directly access the profiles of brands and creators to find the products they offer or promote.

The latest feature, TikTok Live, is gaining popularity. Before the live stream begins, the seller or influencer adds products available in the TikTok Shop. During the live stream, the host can showcase products, communicate with users, and answer their questions via chat. This can increase the credibility of the product and the seller, as well as encourage consumers to make a purchase, which they can do without interrupting the stream.

The very process of posting ads on TikTok Shop helps build consumer trust. Becoming a seller requires thorough verification, which the TikTok platform conducts to protect users from unreliable and fictitious businesses.

The first step to becoming a seller is to log in to your TikTok Seller Center account using your email address, phone number, or existing TikTok account. You’ll also need to fill out an application form with information that proves your seller credentials, such as your company name, address, and contact information.

After successful verification, the seller completes their store profile, adding a description, name, logo, seller details, addresses, customer service information, and tax information. It’s also necessary to configure payment and delivery methods, including the shipping address, available delivery methods, order processing time, and return policy. Connecting the store dashboard to a regular TikTok account is also crucial. This allows for tagging offered products in live videos, etc. The seller then has the option to publish their product, including the title, description, price, available models, and inventory. The platform also allows businesses to add listings by importing a product catalog from another sales platform.

After a consumer makes a purchase, the seller receives a sale notification in the TikTok Seller Center. The seller is then responsible for packaging and shipping the item to the user, which can be done manually or using external order processing systems.

Distance selling and consumer rights

The TikTok Shop platform offers the option of concluding a sale via a distance contract. This does not require the parties to be physically present at the same time, but rather requires at least one means of distance communication (Act of 30 May 2014 on consumer rights, Article 2). Therefore, when making a purchase through the TikTok Shop, consumer rights are governed by national and European Union law.

In Poland, the primary legal act regulating these activities is the Act of May 30, 2014, on Consumer Rights. Article 12 requires businesses to clearly inform consumers in distance contracts, including the method and deadline for contract execution, the total price including taxes, the right to withdraw from the contract, the complaint procedure, and the seller’s identifying information. The TikTok Shop platform is therefore obligated to provide the required information to the user before finalizing the order via the app. An important regulation is also included in Article 17 of the aforementioned Act and concerns the requirement to design the interface in a way that confirms the consumer’s awareness of the obligation to pay. In the case of platforms that allow order completion via a “button,” it must be clearly marked, e.g., “I buy with an obligation to pay” or “I buy and pay.” Otherwise, the contract is not concluded. The requirements described above are referred to as ” button ” solution ” and are intended to protect consumers from accidentally concluding paid contracts. Alternative obligations also arise from the Directive of the European Parliament and of the Council of 25 October 2011 on consumer rights.

The Consumer Rights Act also implements the EU Commodity Directive (2019/771), introducing uniform standards for the conformity of goods with the contract. A trader is liable for any lack of conformity of goods with the contract upon delivery and for two years from the date the discrepancy is discovered. The Act also governs basic consumer claims in the event of non-conformity, including repair or replacement of the goods, and if this is not possible, a price reduction or withdrawal from the contract.

Given that the sales strategy on the TikTok Shop platform relies on recommendation algorithms and influencer marketing, the Omnibus Directive (EU) 2019/2161 of November 27, 2019, plays a significant role in consumer empowerment. Its regulations introduce the obligation to provide information about the lowest price, disclose whether reviews were published by verified consumers, and indicate whether the seller is a business or an individual. The Omnibus Directive therefore increases consumer awareness and allows consumers to make more rational and manipulation-free purchasing decisions.

Digital Services Act Regulation

Due to their global nature, online platforms reach hundreds of millions of users. Content published through them can reach a very wide audience, thus influencing social, political, and economic relations. Massive social networking sites, therefore, go beyond simply providing entertainment or communication services and digital space, and are beginning to shape the reality around us.

The strong influence of individual platforms on current international relations has initiated more stringent oversight, including through the provisions of Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on the single market for digital services and amending Directive 2000/31/EC (Digital Services Act – DSA). Based on this regulation, TikTok was recognized by the European Commission as a Very Large Online Platform (VLOP). This status is granted to portals with monthly active users exceeding 10% of the EU population. TikTok exceeded the threshold and was classified as a VLOP in 2023.

Platforms deemed globally influential are not solely responsible for removing illegal content. They are also required to counteract the negative consequences that may arise from their operation. Among the most important responsibilities of very large online platforms (VLOPs) is the identification and assessment of systemic risks and the potential implementation of proportionate mitigation measures. Impacts on fundamental rights, democratic processes, the protection of minors, public safety, and the dissemination of illegal content are particularly scrutinized. Once a specific risk is identified, measures are planned to counteract its escalation, such as modifying the user interface or changing certain advertising practices. In emergency situations, the European Commission has the authority to require VLOP providers to assess the platform’s impact on the development of the crisis, implement specific mitigation measures, and submit periodic reports on the effectiveness of these actions. Very large online platforms are also required to undergo an annual independent audit of compliance with the Digital Services Act (DSA) and regularly publish comprehensive reports on their activities. The aim of this action is to ensure transparency of the platform’s operation towards users and supervisory authorities.

The DSA also regulates advertising by introducing the requirement to maintain a public ad repository. This repository should include, among other things, the ad’s content, advertiser, funding entity, broadcast time, and the number of recipients. This solution is intended to ensure transparency in advertising messages and enable social and scientific analysis of platforms’ promotional activities. Restrictions have also been imposed on recommendation systems. This means that VLOPs are required to provide users with at least one way to display content that is not based on profiling, meaning it does not use user activity history or data. To monitor platforms’ compliance with the EU regulation, it is also possible to impose a requirement to share data on, for example, the performance of recommendation algorithms with the European Commission, national digital service coordinators, or verified researchers.

TikTok, however, is not subject only to the obligations of very large online platforms. It is subject to all regulations provided for in the Digital Services Act. According to Article 26, each advertisement must be clearly identified as promotional material and indicate the advertiser, the funding entity, and the mechanism by which it was tailored to the user. This restriction is particularly useful for the TikTok Shop platform, where sponsored content is commonly created in the manner of regular content published by creators. Limiting the phenomenon of so-called hidden advertising through the provisions described above aims to increase user awareness.

One of the DSA’s key goals is also the protection of minors. When designing their services, platforms are required to consider a high level of protection for minors and their privacy. It is prohibited to display advertisements based on the profiling of minors when the platform has knowledge of the user’s minor status. The goal is to limit the use of children’s data for marketing purposes and reduce the risk of addictive use of the app.

The European Commission has also become concerned about potential negative consumer behavior resulting from the increasing transformation of large social media platforms into e-commerce portals. Complex profiling algorithms, influencer marketing, and instant purchases can encourage users to make impulsive decisions or even become dependent on purchasing processes. Articles 25 and 27 of the Consumer Protection Act (DSA) mitigate this risk. Designing web interfaces that manipulate or complicate consumer decision-making – so-called dark patterns – is prohibited. Examples of unacceptable solutions include hiding options that are less favorable to the business, making it difficult to unsubscribe from services, or designing buttons that encourage a specific choice. Users should also be fully aware of how the recommendation system works; therefore, platforms are required to clearly present its main parameters and the possibility of changing the content suggestion method.

Tamper protection and dark patterns

A key premise of the TikTok Shop platform is the immediacy of purchases. While this solution is very beneficial for businesses and, typically, consumers, it can lead to abuse. Sales without leaving the app, a simplified order completion process, and algorithmic personalization of recommended products seem to provide greater convenience when shopping online. However, some activities can be classified as ” dark patterns”, manipulations used to mislead users and influence their decisions. Because the practices described above can lead to impulsive behavior and distort consumer will, they may be treated as unfair market practices and subject to criminal penalties.

The Act of 23 August 2007 on Counteracting Unfair Market Practices defines an unfair market practice as a sale that is contrary to good practice and significantly distorts or may distort the market behavior of the average consumer before, during or after the conclusion of a product agreement , in particular a misleading market practice and an aggressive market practice (Act of 23 August 2007 on Counteracting Unfair Market Practices, Article 4). The main grounds for considering a market practice misleading include the dissemination of false information or truthful information in a potentially misleading manner. Such misleading information typically concerns the existence of a product, its type or availability, price, the method of price calculation, or the existence of a special price advantage.

To encourage immediate purchases, sellers pressure buyers with messages suggesting limited availability or a limited-time promotion for a specific product. Examples of such messages include phrases like “100 people are viewing the product,” “offer ends in 2 hours,” or “only 4 items left.” This practice is not illegal and is one of the most common marketing mechanisms. Problems arise when the website or portal is programmed to continually extend promotions, the offer doesn’t actually expire after the specified date, or the counter restarts upon page refresh.

Misleading practices, such as suggesting the limited nature of a permanently available offer, and aggressive practices, such as exerting time pressure, may result in legal consequences. In addition to the aforementioned Act of 23 August 2007 on Combating Unfair Commercial Practices, this issue is also regulated by Directive 2005/29/EC concerning unfair business-to-consumer commercial practices in the internal market. This directive distinguishes between misleading commercial practices and aggressive commercial practices. Together, they constitute unfair commercial practices, which include, in particular, actions that are contrary to the requirements of professional diligence and that significantly distort or are likely to significantly distort the economic behavior of the average consumer who reaches or is targeted by the practice, or the average member of a group of consumers if the commercial practice is targeted at a specific group of consumers (Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (“Unfair Commercial Practices Directive”), Chapter 2, Article 5, paragraph 2).

Directive (EU) 2019/2161 of the European Parliament and of the Council of 27 November 2019 (Omnibus Directive) is also intended to combat various manifestations of the “dark patterns” phenomenon. It requires sellers to disclose the lowest price for a product within the last 30 days. This is intended to prevent the practice of artificially inflating prices and then announcing sales. The practice of fake reviews has also been curbed by introducing an obligation to disclose whether and how reviews posted on sales websites are verified. The Omnibus Directive also introduced the requirement to indicate on marketplace platforms whether the seller is a private individual or a professional entrepreneur, so that consumers are aware of who they are buying from.

The European Union has also introduced restrictions related to the design of digital services, contained in Regulation 2022/2065 on the Digital Single Market (DSA). As a result, online platform providers cannot design, organize, or operate their online interfaces in a way that misleads, manipulates, or otherwise interferes with or limits the ability of service users to make free and informed decisions. The regulation therefore directly addresses the fight against “dark patterns,” i.e., website design practices that deliberately use deceptive techniques, such as pre-selected consents or difficult unsubscribes.

The President of the Office of Competition and Consumer Protection (UOKiK) has broad authority to protect consumers from the unfair commercial practices mentioned above. Under the Act of 16 February 2007 on Competition and Consumer Protection, one of his powers is to protect the collective interests of consumers, including through provisions counteracting unfair market practices. If necessary, the UOKiK President may initiate proceedings against a business, ordering it to cease the unfair practice, or requiring the seller to remedy the effects of the violation. Should a business fail to comply with the guidelines, he may impose a fine of up to 10% of the business’s turnover in the previous year.

The number of legal acts, including EU documents, regulating unfair commercial practices reflects the considerable interest in this issue among both legislators and consumer protection authorities. TikTok Shop, as a social commerce model, is not illegal. It utilizes mechanisms combining influencer marketing, personalization, and emotional impact on the recipient, but the design of the user interface is crucial for this platform. The popularity of mass sales portals has contributed to the increasing use of “dark patterns” by businesses over the past few years. For this reason, the European Union and the Office of Competition and Consumer Protection (UOKiK) are increasingly rigorously monitoring sales tactics and issuing new legal acts to protect consumers and their free will when making purchases.

Influencer Marketing and Advertising Law

The effectiveness of influencer marketing stems from combining advertising with the ability to make an immediate purchase. Affiliate links, product tags, or direct purchase buttons, such as those on the TikTok Shop platform, are displayed beneath posts, videos, or other promotional materials. This purchasing model has proven effective by significantly simplifying the ordering process, thus reducing the time consumers spend considering the rationale behind the transaction.

The popularity of the marketing strategy described above stems from its perception by users, who perceive it as authentic and credible. Influencers present promoted products in a natural way, integrating them into their daily routine. However, if the material does not solely reflect the creator’s personal opinion but is created after receiving a benefit in return, it is considered commercial communication. This means it is subject to legal regulations on advertising and consumer protection. In Poland, influencers should clearly label advertising content in accordance with the Recommendations of the President of the Office of Competition and Consumer Protection. These regulations are intended to prevent misleading users.

Only content regarding a product that the influencer purchased independently and for which they did not receive remuneration or other benefits can be marked as a private opinion. Such material contains genuine feelings and opinions and therefore does not constitute advertising under the law and is not subject to advertising law. This is the most credible and reliable form of review for potential consumers, as it was created by a person not under any obligation to the manufacturer.

A manufacturer may enter into an agreement with an influencer to promote a product in exchange for a free product, financial benefit, or other form of remuneration. This creates legally regulated advertising. It may take the form of a post, report, or live broadcast in which the creator demonstrates how they use the product and its positive properties. Due to the natural presentation of the product as an everyday element, the recipient may have difficulty distinguishing a genuine recommendation from commercial content. The Act of August 23, 2007, on Counteracting Unfair Market Practices, classifies the act of concealing a promotional message as a misleading omission. Failure to clearly indicate the commercial nature of the material may hinder consumers’ proper assessment of the message and directly influence their purchasing decisions.

Another common advertising strategy is to feature a product integrated into published content without directly promoting it, for example, by placing it in the background of the material. This phenomenon is called product placement. Activities covered by advertising and consumer protection law also include, among others, affiliate and partner links, ambassador programs, and partner competitions. In Poland, these practices must contain clear, understandable to the average recipient, and visible advertising labels from the very beginning, such as “advertisement,” “paid collaboration,” or “sponsored content.” The Office of Competition and Consumer Protection (UOKiK) also recommends the use of two-level labeling, meaning that, in addition to the information contained in the content, the platform’s functionality must also be used to announce the paid collaboration. Detailed guidelines can be found in the Recommendations of the President of the UOKiK regarding the labeling of advertising content by influencers. Material is considered advertising content not only when the influencer receives monetary compensation in exchange for its creation. The same obligation applies when promoting your own business, receiving a free product or service, or obtaining a sales commission via an affiliate link or discount code (Recommendations of the President of the Office of Competition and Consumer Protection regarding the marking of advertising content by influencers).

In the event of non-compliance with the Recommendations of the President of the Office of Competition and Consumer Protection regarding the labeling of advertising content by influencers, pursuant to the Act of 16 February 2007 on Competition and Consumer Protection, the Office of Competition and Consumer Protection (UOKiK) conducts proceedings against entrepreneurs using practices that violate the collective interests of consumers. Actions may be taken against advertisers, influencers, and marketing agencies. Therefore, responsibility for incorrect labeling of advertising content rests not only with the creator publishing the material but also with all entities participating in organizing the promotional campaign. One of the sanctions that the President of the UOKiK has the right to impose is a financial penalty. Incorrectly labeled promotional material can also be considered surreptitious advertising. Due to the dynamic development of influencer marketing, the proper creation of marketing content is currently widely subject to UOKiK scrutiny. Therefore, it is worth clearly and understandably labeling sponsored publications, among other things, to avoid significant financial penalties.

Personal data protection

TikTok Shop, as a hybrid social network and e-commerce platform, processes a significant amount of data related to both user activity and purchasing processes. The app’s operation is based on audience profiling and matching the most relevant content. Therefore, the platform’s operations are subject to the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (GDPR).

In addition to user data such as name, surname, contact details, shipping addresses, and payment information, media platforms also collect information that allows for behavioral analysis. Time spent browsing specific products, interactions with ads, and the history of items added to carts or wish lists allow the TikTok Shop platform to create a personalized recommendation system based on past activity. This phenomenon creates so-called behavioral advertising, a marketing strategy based on user profiling using advanced algorithms to predict future purchasing decisions. The concept of profiling refers to the automated processing of personal data, particularly for the purpose of predicting a user’s economic situation, personal preferences, interests, health, and location.

According to the GDPR, profiling is permissible, but it also comes with a number of obligations. Platforms are obligated to transparently inform users about, among other things, the purposes of profiling, the legal basis for data processing, the consequences of the actions taken, and their rights, including the right to object to profiling. Data of minors is particularly protected. Due to the growing popularity of the TikTok app among young users, it was necessary to subject it to special regulations in this regard. In the area of information society services, the processing of data of children over 16 years of age is lawful. An exception is made for situations in which a person with parental authority or guardianship provides prior consent. However, EU member states may introduce a lower age limit in their laws, but it must be at least 13 years old, as is the case in Poland, for example. To ensure that platforms enforce their obligations related to the protection of minors, they should use appropriate age verification mechanisms. In practice, however, this solution requires further improvement due to the common practice of users providing false data during registration.

The President of the Office of Competition and Consumer Protection (UOKiK) plays a crucial role in protecting users, especially the collective interests of consumers. He is authorized to take action against entrepreneurs who engage in unfair market practices, design manipulative interfaces, and so on. Personal data protection, however, falls primarily within the remit of the Office for Personal Data Protection (UODO), which oversees compliance with the GDPR and the secure processing of information by companies and institutions. Due to its global influence, TikTok has attracted increasing attention from EU authorities in recent years and is becoming the subject of more frequent inspections. Due to the platform’s European headquarters being located in Ireland, the relevant supervisory authority is the Irish Data Protection Commission (DPC). For example, in 2025, this institution imposed a fine of €530 million on ByteDance, the app’s owner. The fine was imposed on the transfer of user data from the European Economic Area to China in violation of the GDPR and the failure to demonstrate data protection at the level guaranteed in the EU.

The GDPR is supplemented by Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications), which regulates, in addition to the processing of personal data, the confidentiality of electronic communications, also known as ePrivacy. Due to the scope of its regulations, the provisions of this directive have particular relevance to the TikTok Shop application. The platform uses numerous tracking technologies, such as cookies and mobile device advertising identifiers, to monitor user activity. Information may be stored on a user’s device or accessed only after obtaining prior consent. Exceptions are made only for technologies strictly necessary to provide the service requested by the user, such as remembering a shopping cart. An additional ePrivacy regulation was also envisaged, the purpose of which was to replace the current directive and harmonize the personal data protection rules applicable in all EU Member States. The changes were to include, among other things, simplifying the rules regarding cookies. However, the project encountered legislative difficulties and was not adopted by decision of the European Commission.

Abuse of Market Power and the Digital Markets Plan

The dynamic expansion of the largest digital platforms’ influence has led to the need to adapt competition law to the new situation, particularly in the digital market. To this end, the European Union adopted Regulation (EU) 2022/1925 of the European Parliament and of the Council of 14 September 2022 on contestable and fair markets in the digital sector and amending Directives (EU) 2019/1937 and (EU) 2020/1828 (Digital Markets Act – DMA). The Act introduces the concept of a gatekeeper. This term refers to an entrepreneur with an influential position in the internal market, through which business users reach end users. A gatekeeper provides a core platform service and maintains an established market position.

The dominant position of a gatekeeper is also associated with a number of obligations. Among other things, the practice of self-preferencing, which involves favoring one’s own products or services over the offers of other businesses using the platform, is prohibited. In the case of TikTok Shop, this could involve using recommendation algorithms to increase the visibility of products promoted by individual sellers, without applying objective and fair advertising criteria. This type of favoritism and limiting the reach of individual entities could lead to a distortion of fair competition between businesses using TikTok Shop for sales purposes.

By decision of the European Commission, BytaDance Ltd. was granted gatekeeper status solely for the operation of the TikTok application as a social media platform. The DMA regulations governing the gatekeeper position do not apply directly to TikTok Shop, but they may impact the rules for recommending products and using entrepreneurs’ data.

Media law and audiovisual regulations

Audiovisual materials are the primary tool for promoting and selling products on the TikTok Shop marketplace. Therefore, the app’s operations are also subject to scrutiny for compliance with media law and regulations governing audiovisual media services. The dominant role in this regard is played by Directive 2010/13/U of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation, or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive – AVMSD) and the Broadcasting Act of 29 December 1992, which implements it into Polish law. As a result of the amendment to the Act of 11 August 2021, the regulations have been extended to video-sharing platforms, including the TikTok app.

Video-sharing platforms are primarily obligated to implement appropriate measures to protect minors from harmful content that could negatively impact their moral, mental, or physical development. These provisions have been implemented into Polish law through Article 47e of the Broadcasting Act, which mandates, among other things, the marking of potentially inappropriate content with special graphics for young viewers. These regulations are particularly important for the TikTok Shop platform due to the constantly growing number of underage users. Posting content that spreads hatred and discrimination is also prohibited.

TikTok Shop, a hybrid social media platform and e-commerce platform, is often used to publish so-called audiovisual commercial communications—images used to directly or indirectly promote goods, services, or individuals (Directive 2010/13/U of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services, Article 1). Article 9 of the AVMSD requires member states to ensure that such communications are easily recognizable, thus prohibiting hidden audiovisual commercial communications. The use of subliminal techniques or the inclusion of discriminatory content would also be illegal. The National Broadcasting Council (KRRiT) is responsible for ensuring compliance with audiovisual law. Its remit includes, among other things, overseeing the activities of video-sharing platform providers.

The sales method used by TikTok Shop may seem analogous to teleshopping, offerings directly to consumers to deliver goods or services in exchange for payment. This modern form of interactive audiovisual commerce (live shopping) bears numerous similarities to traditional teleshopping. The mechanisms of both aforementioned sales methods involve presenting the product, its specific features, available options, and generally encouraging the recipient to purchase. However, teleshopping is targeted at a general, anonymous audience who may only be interested in the recommended product. Meanwhile, TikTok Shop relies on advanced algorithms that target promotional content to users who, based on their previous activity, have shown interest in similar content.

Platform liability under e-commerce regulations

The original act regulating the legal liability of online platforms in the European Union was Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce). Its foundation was the so-called safe harbor principle, i.e., the principle of limited liability of online intermediaries. According to this principle, hosting service providers and online platforms were not liable for content or goods published by users, provided they had no actual knowledge of the illegal nature of the content or goods or services or, upon obtaining such knowledge, promptly removed any infringements. Furthermore, the directive did not impose a general obligation on platforms to monitor content published by users.

However, the ongoing development of digital platforms has made it necessary to amend the current liability model. Regulation (EU) 2022/2065 – Digital Services Act (DSA) – came into effect on February 17, 2024. This regulation does not eliminate the principle of limited liability but significantly expands monitoring obligations, especially for very large online platforms (VLOPs). One of the key obligations introduced under the new regulations is the Know Your Business Customer (KYBC) principle. This regulation aims to increase the safety of consumers shopping online by limiting sales conducted by dishonest or anonymous traders. Before enabling sales through its platform, an online platform must collect and verify basic data identifying the seller. The required information includes, among others, the trader’s name, registered office address, contact details, registration number in the relevant register of traders, and the trader’s payment account details. In the event of refusal to provide the specified data or providing it falsely, the platform should prevent the trader from conducting sales until the situation is resolved.

A problematic issue related to the TikTok Shop app is defining the platform’s responsibility for transactions conducted by sellers using it. Although TikTok Shop formally acts as an online intermediary, it can be argued that its operating mechanism goes beyond passive hosting. A recommendation system using algorithms, promoting offers, and providing marketing and analytical tools to sellers are the mechanisms TikTok Shop uses to shape consumer behavior and purchasing decisions. The platform’s influence on the visibility of offers and the order fulfillment process may support assigning it broader responsibilities in overseeing the online sales process.

Regulations on electronic communications, including the European Electronic Communications Code and the Polish Electronic Communications Law

The TikTok Shop platform does not constitute an electronic communications service under European Union law, but its operations provide for various forms of electronic communication. TikTok Shop’s use of push notifications, in-app messages, and marketing communications requires the platform to comply with regulations governing electronic marketing and the protection of user privacy in electronic communications. The primary legal acts regulating these aspects are Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing the European Electronic Communications Code (EECC) and the Act of 12 July 2024 – Electronic Communications Law.

The primary function of TikTok Shop is to enable entities to sell goods through the social media platform. Article 2 of the European Electronic Communications Code defines an electronic communications service as the transmission of signal transmissions or the provision of interpersonal communications services. The mere ability to exchange messages between users or with sellers does not automatically qualify the TikTok Shop platform as a provider of electronic communications services, as this is not its core competency and does not constitute its core business. However, because electronic communications are primarily used for marketing purposes, it is obligated to comply with regulations governing direct marketing and the protection of user privacy.

Push notifications, messages sent directly to users’ mobile devices, are an increasingly popular marketing solution. TikTok Shop uses them to provide information about order status, discounts, time-limited campaigns, or the launch of live shopping. Transactional notifications regarding order fulfillment, shipping, or payment status are typically part of the contract and do not require marketing consent. However, notifications encouraging potential consumers to make a purchase are classified as direct marketing and, in accordance with electronic communications law, require prior user consent.

The practice of using automated calling systems and electronic means of communication for advertising purposes without the user’s prior consent is also prohibited. Users should be clearly informed about the purpose of receiving marketing communications, the data controller, and the possibility of withdrawing consent, which should not result in any negative consequences. With respect to the TikTok Shop platform, the above position means that it is unlawful to send promotional content to users solely based on the fact that they have an account on the app.

TikTok Shop is the clearest example of how thin the line between entertainment, advertising, and commerce has become – a one-tap purchase woven into a stream of content is now as effortless as liking a video. Yet that convenience comes at a price: the closed-loop model and algorithmic personalization shrink the time left for rational reflection, while responsibility for protecting the consumer shifts increasingly away from the buyer and onto the platform and the legislator. EU and national regulations – from consumer law, through the DSA and DMA, data protection and safeguards for minors, all the way to media and electronic communications law – form a web meant to counterbalance the platform’s power and restore the buyer’s awareness of their own choices. TikTok Shop thus remains a dual phenomenon: on one hand a groundbreaking innovation in digital commerce, on the other a test of whether the law can keep pace with a technology that sells faster than we can think.

Artykuł A Store in Your Pocket, the Law in the Background: TikTok Shop Under the Regulators’ Lens pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Biostimulants in aesthetic medicine – current regulatory challenges for manufacturers, distributors and clinics

The aesthetic medicine market is currently one of the fastest-growing healthcare segments in Europe. Particularly dynamic growth is observed in so-called tissue biostimulants, preparations used to stimulate the body’s natural regenerative processes. While traditional fillers dominated just a few years ago, today both manufacturers and physicians are increasingly turning to preparations containing poly-L-lactic acid (PLLA), calcium hydroxyapatite, polynucleotides, and collagen preparations, whose mechanism of action is based on the stimulation of tissue regeneration processes rather than solely on mechanical effects.

The growing popularity of these products, however, raises a number of legal questions. These concern not only their qualification as medical devices, but primarily the manner of communicating their properties and permissible forms of promotion. In practice, manufacturers, importers, distributors, and aesthetic medicine clinics increasingly face the dilemma of drawing the line between providing reliable product information and advertising, which is subject to stringent legal restrictions.

This issue has become particularly important following the entry into force of the Act of April 7, 2022, on Medical Devices and the issuance of the Regulation of the Minister of Health on the Advertising of Medical Devices. Polish legislators have decided to introduce some of the most detailed regulations regarding the advertising of medical devices in Europe. These restrictions directly impact the activities of manufacturers, distributors, importers, healthcare providers, and marketing agencies serving the aesthetic medicine industry.

At the same time, it’s important to remember that advertising medical devices does not operate in isolation from other legal regulations. Businesses must consider not only the provisions of Regulation (EU) 2017/745 on medical devices (MDR) and the Medical Devices Act, but also regulations on consumer protection, combating unfair market practices, combating unfair competition, personal data protection, and sometimes regulations governing the practice of medical professions and healthcare activities. Consequently, a single marketing campaign may be subject to simultaneous assessment under several different legal regimes.

Particular difficulties arise with products used exclusively by individuals with appropriate professional qualifications. In practice, most biostimulants are administered via injection by a physician or other qualified medical professional. This raises the question of whether products intended exclusively for professional use can be advertised at all, and if not, how can businesses legally present information about their offerings on websites, social media, or at industry conferences.

The purpose of this study is to present practical aspects of applying regulations regarding the advertising of medical devices, using tissue biostimulants as an example. Particular attention will be paid to the boundary between advertising and information, the obligations of manufacturers and distributors, the most common marketing errors, and compliance solutions that can reduce the risk of violating applicable regulations.

Biostimulants – why do they raise so much legal controversy?

From a legal perspective, biostimulants constitute one of the most interesting categories of medical devices. Their specificity lies in the fact that, although formally subject to regulations specific to medical devices, their method of use, risk profile, and patient perception often resemble medicinal products more than traditional medical devices.

In market practice, patients often fail to recognize the difference between a medicinal product and a biostimulant. Both types of products are administered in a doctor’s office, require medical qualifications, involve intervention in the body, and may cause adverse reactions. Therefore, for the average consumer, the difference between a medicinal product and a medical device remains almost invisible.

From the perspective of EU law, however, what matters most is not the method of administration or the site of use, but the mechanism by which the principal intended action is achieved. The MDR is based on a fundamental distinction between medicinal products and medical devices. If the principal action is achieved by pharmacological, immunological, or metabolic means, the product will generally be classified as a medicinal product. However, if the mechanism of action is based on other properties – for example, physical or mechanical – the product may be classified as a medical device, even if its use leads to long-term biological effects.

This very boundary has been the subject of numerous interpretational disputes for years. In the case of biostimulants, the preparation does not replace natural processes occurring in the body nor does it produce a therapeutic effect through a pharmacological mechanism. Its purpose is to create conditions enabling the activation of natural regenerative processes, such as stimulating fibroblasts to produce collagen or rebuilding the extracellular matrix. It is this mechanism that causes most currently available biostimulants to be classified as medical devices.

This does not mean, however, that all products marketed as “biostimulants” automatically fall into the same regulatory category. Legal classification is determined by a case-by-case analysis of the specific product, its intended use, and the mechanism of action specified by the manufacturer. In practice, there are also products that, despite similar aesthetic applications, may be subject to different legal regimes, including regulations concerning medicinal products, cosmetics, and medical devices.

This is fundamental for subsequent marketing communications. Already at the product qualification stage, the manufacturer should consider the target audience, the information that can be conveyed to recipients, and the advertising restrictions that will apply. Mistakes made at this stage often result in the need to redesign the entire marketing strategy after the product has been launched.

Can biostimulants be advertised? Limitations under the Medical Devices Act and the MDR Regulation

One of the most frequently asked questions by manufacturers, importers, and healthcare providers is whether biostimulants can be advertised to a broad audience. The answer to this question is ambiguous and requires consideration of both the provisions of the EU MDR Regulation, the Polish Medical Devices Act, and implementing regulations governing advertising.

In practice, a certain pattern can be observed. Many entrepreneurs equate the fact that a product has been legally introduced to the market with the ability to freely promote it. However, this assumption is incorrect. Approval of a medical device for marketing does not automatically mean that the manufacturer or distributor can use any marketing tools. On the contrary, the more specialized the product and the greater the risk associated with its use, the greater the restrictions on its communication.

In the case of biostimulants, it is particularly important that the vast majority of these products are intended for use only by individuals with appropriate professional qualifications. Treatments using them require medical qualification, maintaining appropriate aseptic conditions, and injections performed in accordance with medical knowledge. Therefore, the recipient of the product is not the patient, but a medical professional who then uses the product while providing healthcare services or aesthetic medicine treatments.

This circumstance is of fundamental importance from the perspective of advertising law.

Advertising of medical devices is not advertising of consumer products.

The Medical Devices Act adopts different assumptions than the regulations governing the advertising of ordinary consumer goods. The legislator’s goal was not to create freedom in marketing activities, but to ensure that decisions regarding the use of medical devices are made primarily based on medical knowledge, not advertising messages.

For this reason, the legislator decided to introduce numerous restrictions on both the content of advertising and its target audience. In practice, this means that, already at the design stage of a marketing campaign, entrepreneurs should answer three fundamental questions:

• who is the actual user of the product,
• to whom the message is addressed,
• whether the information provided is of a promotional nature or purely informational.

Only a combined analysis of these elements allows us to assess the compliance of the planned communication with applicable regulations.

The intended use of the product is crucial.

In practice, there’s a common misconception that advertising opportunities are determined solely by how a product is sold. This isn’t the correct approach.

The manufacturer’s intended use of the product and the user group specified in the technical documentation and instructions for use are of much greater importance. If the manufacturer has specified that the product should only be used by professionals, this also influences the assessment of the admissibility of directing marketing messages to individuals without medical qualifications.

This is precisely the situation with most biostimulants. These products are intended for procedures requiring appropriate professional training, knowledge of anatomy, aseptic techniques, and the ability to recognize contraindications. From a regulatory perspective, it would be difficult to justify extensive advertising campaigns aimed at the general public when the product itself cannot be used independently by the average consumer.

This doesn’t mean, however, that businesses cannot provide any information regarding such products. On the contrary, the law permits the provision of information about medical devices, but the line between information and advertising requires individual assessment.

Advertising and information – why is the distinction so important?

In practice, the vast majority of disputes concerning medical device advertising do not focus on obvious promotional campaigns. Much more often, the problem arises with materials that businesses define as “informational,” while from the perspective of regulatory authorities, they may be considered advertising.

Importantly, neither the MDR nor the Medical Devices Act provide a legal definition of medical device advertising. However, the lack of a statutory definition does not imply any freedom of interpretation. Case law and doctrine assume that the nature of a message is primarily determined by its actual purpose, not the name given to it by the trader.

If the primary purpose of the message is to increase interest in the product, build a positive image of the product or encourage its purchase or use, there is a high probability that the message will be classified as advertising, regardless of whether it contains a direct call to purchase.

In practice, this means that even seemingly neutral materials may be considered advertising if they are prepared in a way that highlights only the advantages of the product, ignores its limitations or uses characteristic marketing techniques.

Is the manufacturer’s website itself an advertisement?

This is one of the most frequently asked questions in the practice of law firms advising manufacturers of medical devices.

There is no single universal answer to this question.

The mere presence of product information on a website does not constitute advertising. A website can function as a product catalog, a database of technical documentation, or a platform for communicating with medical professionals. However, if the product’s presentation goes beyond providing objective information and begins to utilize typical marketing mechanisms, the risk of such communication being classified as advertising significantly increases.

For example, posting instructions for use, declarations of conformity, technical data, or information on how to use a product on a website will generally be informative. However, a situation in which the same website includes slogans such as “revolutionary rejuvenation method,” “the most effective biostimulator available on the market,” “instant lifting effect,” or “spectacular results guaranteed” should be assessed differently. In such cases, the message goes beyond neutral information and begins to serve a promotional purpose.

Therefore, designing websites for medical device manufacturers requires close collaboration between marketing departments and legal and regulatory affairs departments . In practice, even seemingly minor changes in product presentation can result in a different legal classification for the entire message.

The boundary between advertising and information – practical problems of producers and aesthetic medicine clinics

While the distinction between advertising and information seems intuitive, in practice it is one of the most problematic issues related to the functioning of the medical device market. This stems primarily from the fact that contemporary marketing communication rarely takes the form of classic television or print advertising. Businesses much more frequently utilize websites, social media, newsletters, podcasts, webinars , expert blogs, and educational materials. Each of these forms can—depending on how it is prepared—be considered both neutral information and advertising.

In practice, there is no single element that automatically determines the classification of a given message. Supervisory authorities and courts analyze all the circumstances, taking into account the content of the message, its form, presentation, audience, and the actual purpose of the publication. This means that even a message containing only truthful information may be considered advertising if its primary purpose is to encourage the purchase or use of a product.

For this reason, businesses should move away from the simple question: “Are we allowed to publish this information?” and instead ask themselves: “How will the average recipient perceive this message?” It is the recipient’s perspective, not the business’s intention, that will in many cases determine the legality of the message.

Website – an entrepreneur’s business card or an advertising tool?

The first place where doubts arise is almost always the manufacturer’s, distributor’s, or clinic’s website. For many businesses, it is their primary channel of communication with the market, yet it is also one of the most frequently scrutinized elements during inspections conducted by regulatory authorities.

The mere presence of information about a medical device on a website is not prohibited. Businesses have the right to present information about the products offered, their properties, methods of use, technical documentation, and instructions for use. However, problems arise when the presentation method goes beyond providing objective information.

A good example is comparing two descriptions of the same product.

The first one could be as follows:

“A preparation intended for the reconstruction of tissue volume in accordance with the instructions for use. The product is intended for use by qualified medical professionals.”

This description is for informational purposes only. It is limited to presenting the product’s intended use and user group.

The following message should be assessed differently:

“The most innovative biostimulator on the market. It instantly rejuvenates the skin and provides a spectacular lifting effect after just one treatment.”

Although both messages refer to the same product, the second employs typical marketing tactics. It uses evaluative terms (“the most innovative,” “spectacular effect”), promises of effectiveness, and suggests a competitive advantage. This type of message is difficult to consider as neutral technical information.

In practice, this means that entrepreneurs should analyze not only the content of the information, but also the way it is expressed. Often, it is individual marketing terms that determine the overall nature of the message.

Newsletters and mailings to customers

Another tool increasingly used by manufacturers and distributors is newsletters and emails directed to customers. Again, not every message can be considered advertising.

If a newsletter contains information about changes in regulations, new regulatory requirements, announcements from supervisory authorities, or changes to product instructions, it will generally serve an informative purpose. However, messages whose primary purpose is to increase sales of a specific product should be assessed differently.

For example, a message titled “Changes to MDR requirements for technical documentation” would be educational in nature. An email with the slogan “Discover the most effective biostimulant available on the market – order today” would undoubtedly serve an advertising function.

This does not, of course, prohibit commercial communication. However, entrepreneurs should remember that such communication is subject to all restrictions applicable to advertising medical devices.

Webinars and training – education or product promotion?

The significant increase in the popularity of webinars organized by medical device manufacturers has also led to this form of communication starting to attract the attention of supervisory authorities.

Organizing training for doctors and other medical professionals is nothing unusual. On the contrary, in many cases, proper user training is an essential element in ensuring the safe use of a device.

The problem arises, however, when a webinar described as a “scientific training” actually focuses almost exclusively on promoting one product, highlighting its advantages while omitting limitations, contraindications, and alternative methods of treatment.

In practice, it is worth adopting the principle that the more educational the material is, the greater the emphasis should be on presenting objective medical knowledge, and not only information beneficial to the manufacturer.

Scientific conferences

Similar problems apply to industry conferences. Sponsorship of scientific events by medical device manufacturers is common practice and raises no objections in itself. However, risks arise when the scientific component is subordinated to marketing objectives.

In practice, particular caution should be exercised when presenting research results for a specific product. Results should be presented honestly, taking into account methodological limitations and the full clinical context. Selectively presenting only favorable data may be viewed as misleading.

LinkedIn – professional communication can also be advertising

Many content creators assume that since LinkedIn is primarily a professional platform, the content published there is strictly business-related. However, this assumption is far-fetched.

If a LinkedIn entry is limited to information about participation in a conference, obtaining a certificate, a scientific publication or organizational changes in the company, it is generally difficult to attribute an advertising nature to it.

However, if a publication contains incentives to use a specific product, comparisons with competitive products, promises of specific clinical effects or highlights the advantages of a product in order to increase sales, it may be considered advertising, regardless of the fact that it was published on a professional website.

LinkedIn is increasingly being used as a marketing platform for the healthcare market. Therefore, communications conducted via this platform should also be subject to the company’s internal compliance procedures.

Social media – the biggest challenge for the biostimulant market

Social media has completely transformed the way patients make decisions. Just a dozen or so years ago, the primary source of information was a doctor’s consultation and manufacturer-provided materials. Today, many patients primarily seek information on Instagram, TikTok, Facebook, and YouTube, guided by the opinions of influencers , physicians with educational profiles, and other users’ testimonials.

For entrepreneurs, this represents a huge marketing opportunity, but also significant regulatory risk. Traditional regulations regarding medical device advertising were designed with press, radio, and television advertising in mind. Modern online communication is much more dynamic and often combines elements of education, personal branding, and product promotion. As a result, assessing the legality of a specific message requires a case-by-case analysis of its actual purpose and context.

Instagram – where does education end and advertising begin?

Instagram remains the most important communication channel used by aesthetic medicine clinics and physicians performing biostimulant treatments. This platform relies primarily on visual communication, which inherently has a stronger impact on audiences than traditional product descriptions.

From a legal perspective, however, it cannot be assumed that every post about a procedure constitutes advertising. Physicians have the right to conduct educational activities, explain the mechanisms of individual procedures, discuss indications and contraindications, and comment on scientific publications. Such activities contribute to increasing patient awareness and should not, in and of themselves, be equated with advertising.

The line is crossed when communication begins to focus on promoting a specific medical device or building its commercial appeal. This applies particularly to publications containing marketing slogans, incentives for procedures, information about price promotions, comparisons with competing products, or emphasizing the exceptional effectiveness of a specific product without providing the full medical context.

In practice, it is worth adopting the rule that the more a post resembles advertising material prepared by a marketing agency, the greater the risk of it being classified as an advertisement for a medical device.

TikTok – short form does not exempt from responsibility

Just a few years ago, few medical device manufacturers considered TikTok a business communication tool. Today, the situation is completely different. More and more clinics are publishing short videos demonstrating treatment procedures, patient reactions, and the aesthetic effects achieved after using specific products.

The specific nature of this platform, however, means that the message is necessarily simplified. A video lasting several dozen seconds rarely allows for the presentation of contraindications, possible side effects, or limitations of the product’s use. As a result, there is an increased risk of creating a one-sided image of the product, highlighting only its benefits.

From a compliance perspective , businesses should therefore exercise particular caution when preparing materials published on platforms based on short audiovisual forms. Merely shortening the message does not exempt them from ensuring its compliance with regulations on advertising medical devices.

Influencer Marketing – New Regulatory Risk

influencers remains one of the most dynamically developing areas of marketing. This phenomenon has also impacted the aesthetic medicine market. Increasingly, individuals with significant social media followings are publishing treatment reports, presenting their recovery processes, and describing their own experiences using specific products.

From a legal perspective, such collaboration requires special caution. Even if the influencer doesn’t mention a specific product, the way the treatment is presented can lead to increased interest in a specific technology or manufacturer. If the publication is created as part of a commercial collaboration, additional obligations arise under regulations regarding labeling advertising content and consumer protection.

In practice, the producer should remember that responsibility for the legality of the message is not always limited solely to the influencer. Depending on the cooperation model, the entrepreneur initiating the campaign may also be responsible for the manner in which marketing communications are conducted.

Doctor as a product ambassador

The use of physicians’ authority to promote medical products remains a particularly sensitive issue. Public trust in medical professionals means their statements have a much greater impact than traditional advertising messages.

This doesn’t mean, however, that doctors cannot publicly comment on the technologies they use. On the contrary, sharing medical knowledge, clinical experience, and research results is a crucial element in the development of medical science and practice. The problem arises only when a doctor’s statement ceases to be expert-based and begins to serve a marketing function.

The risk increases especially when a physician appears in manufacturer-produced materials, uses promotional language, or explicitly encourages consumers to choose a specific product. In such cases, the regulatory authority may determine that the use of the medical profession’s authority serves to increase the product’s commercial appeal, which requires assessment from the perspective of regulations governing the advertising of medical devices.

Before – after photos – an effective marketing tool or a source of risk?

One of the most distinctive elements of communication in aesthetic medicine is photographs depicting the patient’s appearance before and after the procedure. From a marketing perspective, this is an extremely effective tool for influencing potential clients. However, from a legal perspective, its use raises a number of concerns.

Firstly, such materials often lead the recipient to believe that the treatment will provide a guaranteed result. However, the results of medical procedures depend on numerous individual factors, such as the patient’s health, age, biological predispositions, and adherence to post-treatment recommendations . Presenting single, spectacular results can lead to unrealistic expectations.

Secondly, publishing patient photos requires compliance with regulations on personal data protection and the protection of personal rights. Consent to perform a procedure does not constitute consent to the dissemination of the image. The provider should obtain separate, informed, and voluntary consent covering the publication of photographs in specific communication channels.

Third, it’s important to remember that even properly obtained patient consent doesn’t eliminate the risk of a publication being considered an advertisement for a medical device. If a photo is used to promote a specific product or increase interest in a specific procedure, the entire message should be assessed in light of advertising regulations.

In practice, this means that the use of ” before – after ” photography requires simultaneous analysis from the perspective of medical device law, personal data protection, civil law, and consumer protection regulations. Failure to consider even one of these aspects can lead to significant legal risk.

Misleading advertising – why can a truthful message also violate the law?

One of the most common mistakes made by businesses operating in the medical device market is the belief that because all information contained in an advertisement is truthful, the message is automatically legal. However, this assumption is far-fetched and is not supported by either the EU MDR or national regulations regarding medical device advertising.

Assessing the legality of advertising is not limited to verifying the veracity of individual claims. Equally important are the manner in which they are presented, the context of the overall message, and the potential impact on the recipient’s decisions. Advertising can be misleading not only by providing false information, but also by selectively presenting facts, omitting important limitations, or emphasizing only the positive aspects of a product’s use.

This is why Article 7 of the MDR should be considered one of the key regulations governing the marketing communications of medical device manufacturers. This provision prohibits the use of texts, names, trademarks, images, symbols, or other markings that could mislead the user or patient regarding the intended purpose, safety, or performance of the device. This prohibition applies not only to labels and instructions for use but also to advertising materials and other forms of market communication.

In practice, this means that an entrepreneur should analyze each message not only in terms of compliance with the product’s technical documentation, but also from the perspective of how the average recipient might interpret the information presented.

Not only falsehood, but also silence

One of the most frequently underestimated aspects of advertising is the responsibility for omitting information that is important to the recipient. Businesses typically focus on avoiding false claims, much less on analyzing the consequences of omitting specific information.

Imagine an advertisement for a biostimulator in which the manufacturer presents excellent aesthetic results achieved after the treatment. All photographs are authentic, and the description of the effects reflects the actual experiences of selected patients. At the same time, the advertisement contains no information about the need for medical qualification, possible contraindications, the risk of side effects, or the body’s varied response to treatment.

Formally, none of the claims presented are false. Nevertheless, the recipient may be misled into thinking that achieving the presented effect is typical, predictable, and practically guaranteed. Consequently, the message may be considered misleading because it creates unrealistic expectations regarding the product’s performance.

A similar risk arises when using terms such as “safe,” “non-invasive,” “natural,” or “side-effect-free.” Even if a product has a high safety profile, using such phrases can imply an absence of risk, which is difficult to reconcile with clinical reality.

Can we use the terms “best”, “most effective” or “revolutionary”?

Marketing language often relies on the use of evaluative terms. Advertisements feature phrases such as “market leader,” “the most innovative product,” “the best rejuvenation technology,” or “a breakthrough in aesthetic medicine.” In the consumer goods sector, this type of communication is common. However, when it comes to medical devices, much greater caution is required.

First, an entrepreneur should have objective evidence to support any comparative or evaluative claim. Second, even the existence of scientific research does not always justify the use of terms suggesting absolute superiority over all competing solutions. In medical practice, the effectiveness of therapy depends on many factors, including the patient’s qualifications, the physician’s experience, and individual biological conditions.

From a compliance perspective, a much safer solution is to use a description based on clinical trial results and technical parameters of the product, instead of using general marketing slogans.

Practice of supervisory authorities – the growing importance of digital communication

Recent years have seen a significant increase in supervisory authorities’ interest in online communications. While previously, oversight activities focused primarily on traditional advertising materials, they now also analyze websites, social media profiles, newsletters, videos published on streaming platforms , and collaborations with influencers.

This trend is consistent with a broader trend observed at the EU level, where increasing emphasis is being placed on countering manipulative marketing practices and ensuring a high level of protection for consumers using healthcare services. Consequently, businesses should assume that online communications are subject to the same scrutiny as traditional forms of advertising.

The Polish Office of Competition and Consumer Protection and consumer protection – the second pillar of responsibility

Although the primary legislation regulating the advertising of medical devices remains the Medical Devices Act, businesses cannot limit their analysis solely to this legal regime. Consumer protection regulations also apply, in particular the Act on Combating Unfair Market Practices and the Act on Competition and Consumer Protection.

From the perspective of the President of the Office of Competition and Consumer Protection (UOKiK), the impact of a message on the average consumer is of particular importance. If a communication exploits emotions, raises unjustified expectations, or suggests characteristics that the recipient is unable to independently verify, it may be considered a practice that violates the collective interests of consumers.

In practice, this means that a single marketing campaign may be assessed simultaneously by different authorities under different legal frameworks. Manufacturers should therefore design their marketing activities to ensure compliance not only with medical device regulations but also with consumer protection and fair competition regulations.

Compliance instead of reaction after inspection

Experience in recent years shows that a significant number of violations are not the result of deliberate actions by businesses, but rather a lack of appropriate internal procedures. Marketing materials are often prepared by external advertising agencies that are intimately familiar with the mechanisms of selling consumer products but lack experience in the regulated sector.

compliance systems that encompass the entire marketing communications process is becoming increasingly important . Every piece of content – whether it’s an Instagram post, a product brochure, a webinar , or a YouTube video – should be reviewed not only by the marketing department but also by those responsible for regulatory and legal matters.

This approach allows for the identification of risks before the material is published, reducing the likelihood of initiating administrative proceedings, disputes with supervisory authorities and negative image consequences.

The most common mistakes of manufacturers, importers, distributors and clinics – what to avoid in practice?

Recent experience shows that most violations of regulations regarding medical device advertising do not result from deliberate disregard for applicable regulations. Quite the opposite – entrepreneurs operating in the aesthetic medicine market typically strive to conduct their business in compliance with the law, but they encounter difficulties resulting from ambiguous regulations and the dynamic development of modern communication channels. Marketing of medical products is increasingly conducted via social media, educational platforms, and industry events, whereas existing regulations were primarily designed with traditional forms of advertising in mind.

In practice, however, there are several recurring mistakes that occur regardless of the size of the company and which should be taken into account when designing a marketing strategy.

Mistake No. 1 – Equating commercial information with neutral information

One of the most common misconceptions is that material doesn’t constitute advertising solely because a business owner has designated it as “information.” This approach is unsupported by applicable law.

The nature of a message is assessed based on its actual function, not the name given by the author. If the material highlights the benefits of a specific product, builds its market appeal, or is intended to encourage the recipient to choose a specific product, there is a high probability that it will be classified as an advertisement, even if it does not contain a classic call to purchase.

An example would be an article published on the manufacturer’s website titled “Modern Skin Regeneration Possibilities.” If the majority of the text is devoted to a single product, highlights its advantages over the competition, and leads to a contact form allowing purchase of the product or registration for training, it’s difficult to consider such material solely educational.

In practice, entrepreneurs should remember that supervisory authorities analyze not only the content of the publication, but also its location, method of presentation and connection with the entrepreneur’s business activity.

Mistake #2 – Copying Cosmetic Product Marketing

The aesthetic medicine market is developing in parallel with the cosmetics market, resulting in many marketing activities being mutually inspired. However, from a regulatory perspective, this approach can lead to serious problems.

Cosmetics marketing relies primarily on building emotions, visual appeal, and creating a specific lifestyle. Meanwhile, communication regarding medical devices is subject to much more stringent requirements. Using identical marketing techniques for products covered by the MDR may lead to violations of advertising regulations, especially if the message ignores the limitations imposed by the product’s intended use or its method of use.

In practice, this means that the marketing department of a medical device manufacturer should not automatically use solutions used in cosmetic campaigns, even if they seem effective from a business point of view.

Mistake No. 3 – overexposing the effects of the treatment

Marketing materials for biostimulants often focus almost exclusively on aesthetic effects. Images depicting wrinkle smoothing, facial contour improvement, or increased skin firmness undoubtedly attract audiences and enhance the message’s appeal.

The problem, however, is that the results of aesthetic medicine treatments are individual. They depend on the patient’s age, health, skin condition, previous medical procedures, lifestyle, and the experience of the practitioner. Presenting individual, exceptionally positive results without proper context can lead to unrealistic expectations on the part of potential patients.

From a compliance perspective , it is much safer to present information about the mechanism of action of the product and its intended use than to focus all communication on spectacular visual effects.

Mistake No. 4 – Ignoring contraindications and limitations of use

Another common mistake is presenting a product solely through the lens of its benefits. Marketing materials often emphasize the product’s effectiveness, innovation, and safety, while failing to mention situations in which its use may be inadvisable.

Meanwhile, reliable communication regarding medical devices should also include information about contraindications, limitations of use, and the need for medical qualification. This doesn’t mean, of course, that every advertisement must include full instructions for use, but omitting all information regarding potential risks could lead to accusations of misleading consumers.

Mistake #5 – Lack of cooperation between marketing and legal departments

In many companies, marketing materials are prepared by external creative agencies or marketing departments that lack specialized knowledge of medical device regulations. Only then does the completed material reach the legal department, often just prior to publication.

affairs specialists and lawyers at the marketing campaign design stage. This avoids the need for later material withdrawal or costly modification.

Mistake #6 – Lack of social media procedures

Many companies have extensive procedures for approving product catalogs and printed materials, yet they don’t regulate the rules for publishing content on social media. Yet, it’s short posts on Instagram, Facebook, and LinkedIn that are currently published most frequently and have the greatest impact on a company’s image.

The lack of internal guidelines leads individual employees to publish content at their own discretion, often unaware of the legal consequences of using specific phrases or photographs. In practice, it’s worth developing separate policies for online communication, covering topics such as product presentation, use of photographic materials, publishing coverage of industry events, and collaborating with physicians and influencers.

Compliance practices – how to organize legal marketing communications?

Compliance system shouldn’t be limited to merely responding to emerging issues. Its primary goal is to prevent violations by establishing transparent rules for preparing and approving marketing materials.

In practice, a growing number of medical device manufacturers are implementing multi-stage approval procedures involving marketing departments, regulatory affairs specialists, quality control departments, and lawyers. This model allows for the assessment of a material not only in terms of its marketing appeal but also its compliance with the product’s technical documentation, instructions for use, and applicable regulations.

Maintaining documentation of the approval process is also particularly important. In the event of an audit, the company should be able to demonstrate that the materials were prepared in accordance with internal procedures and reviewed by appropriately qualified individuals. Archiving subsequent versions of materials, legal opinions, and publication decisions can be of significant evidentiary value.

In practice, a well-functioning compliance system shouldn’t be perceived as an obstacle to marketing activities. On the contrary, properly designed procedures enable legally secure communication, reducing the risk of administrative sanctions and disputes with supervisory authorities, while building trust with customers and business partners.

European perspective – why will the importance of compliance systematically grow?

Polish regulations on medical device advertising are currently among the most detailed in the European Union. However, this does not mean that businesses operating in the domestic market can limit themselves solely to knowledge of the provisions of the Medical Devices Act and the Regulation of the Minister of Health. The functioning of the medical devices market is increasingly determined by the practice of applying the MDR, the positions of EU bodies, and the actions of national regulatory authorities in individual member states.

The MDR does not contain comprehensive regulations on the advertising of medical devices. It focuses primarily on product safety, manufacturers’ obligations, conformity assessment, and the rules for placing devices on the market. At the same time, Article 7 of the MDR establishes the general principle that all communication about a device – regardless of its form – must not mislead users or patients about the product’s intended purpose, properties, safety, or efficacy.

In practice, this provision serves a much broader purpose than the classic ban on misleading advertising. It constitutes a specific interpretative principle that should be considered when assessing every form of communication conducted by a manufacturer or distributor. Increasingly, supervisory authorities are moving away from formalistic analysis of individual advertising slogans and focusing on the overall perception of the message by the average user.

At the same time, the activities of Medical Device Coordination Group (MDCG) highlights the growing importance of transparent information provided to users of medical devices. Although MDCG documents are not legally binding, in practice they guide the interpretation of MDR provisions by national authorities and notified bodies. Increasing emphasis is being placed on ensuring consistency between a device’s technical documentation, instructions for use, and market communications.

It can be predicted that in the coming years, marketing control will encompass not only traditional advertising but also recommendation algorithms of online platforms, message personalization, the use of artificial intelligence in marketing, and automated advertising profiles. The development of new technologies is blurring the lines between information, advertising, and educational content.

For manufacturers, this means moving away from a one-time approach to assessing marketing materials. Implementing ongoing compliance procedures that enable ongoing assessment of communications’ compliance with rapidly evolving regulatory requirements will be much more effective.

Practical checklist compliance before publishing marketing materials

In practice, most violations can be avoided by implementing simple verification procedures. Before publishing material regarding a medical device, it’s important to answer the following questions:

First, is the product intended for use by laypeople or exclusively by professionals? The answer to this question determines the acceptable scope of communication and the target audience.

Secondly, is the planned material truly informative, or is its primary purpose to increase interest in the product? When in doubt, it’s worth adopting a more cautious approach and evaluating the message according to advertising principles.

Third, are all claims regarding product properties supported by technical documentation, instructions for use, and conformity assessment results? Marketing departments should not independently make new claims regarding product effectiveness or safety.

Fourthly, does the material use evaluative terms such as “best”, “most effective”, “revolutionary” or “guaranteed effect”, the validity of which could be questioned by the supervisory authority?

Fifth, does the message include product use restrictions, the need for medical qualification, and other information relevant to user safety?

Sixth, does the publication contain photographs or recordings of patients? If so, it is necessary to verify not only compliance with regulations on advertising medical devices, but also the basis for processing personal data, the scope of consent granted, and the protection of personal rights.

Seventh, was the material reviewed by those responsible for regulatory and legal matters? In practice, even minor linguistic changes can significantly alter the legal assessment of the entire message.

Eighth, does the entrepreneur have documentation confirming the material approval process? In the event of an audit, the ability to demonstrate organizational diligence can be crucial to assessing the entrepreneur’s actions.

Summary

The development of the biostimulator market is one of the most dynamic areas in contemporary aesthetic medicine. These products respond to growing patient expectations for natural tissue regeneration methods, while simultaneously posing entirely new regulatory challenges for manufacturers, importers, distributors, and healthcare providers.

Contrary to popular belief, the biggest problem today isn’t the mere ability to advertise. The key challenge remains the ability to communicate effectively, while simultaneously providing accurate product information and complying with stringent legal requirements. The line between information and advertising is becoming increasingly blurred, especially in the digital environment, where communication occurs via social media, educational platforms, and artificial intelligence tools.

From the perspective of entrepreneurs, this means a shift in thinking about medical device marketing. Instead of treating compliance as a final stage of reviewing advertising materials, it’s worth viewing them as an integral element of the process of designing market communication. Early involvement of legal, regulatory, and quality specialists not only reduces the risk of administrative sanctions but also builds brand credibility and audience trust.

It can be expected that the requirements for communication transparency will systematically increase in the coming years. The development of artificial intelligence, data-driven marketing, and message personalization will force supervisory authorities to increasingly scrutinize not only the content of advertisements but also their distribution and impact on audience decisions. In this environment, competitive advantage will be achieved not by those businesses that conduct the most aggressive marketing communications, but by those that manage to combine innovation with regulatory responsibility.

Artykuł Biostimulants under the microscope of the law – where does information end and prohibited advertising of medical devices begin? pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

The phenomenon of fake reviews in the digital space has evolved from a marginal image issue to a central focus of market supervision authorities and EU legislators. The contemporary ontology of this phenomenon extends beyond primitive content fabrication to encompass any form of communication that, by distorting the actual consumer experience, misleads the recipient, directly influencing their decision-making process. Legally, a fake review is considered not only a completely false message, but also one that, by omitting important facts or manipulating context, creates a false impression of the quality of a product or the reliability of a seller. This practice is classified as unfair commercial activity if its nature causes or is likely to cause the average consumer to make a transactional decision they would not otherwise make, thus violating the fundamental principles of fair dealing.

The typology of activities considered unfair rests on several fundamental pillars, the most blatant of which is direct fabrication. This involves posting or commissioning the creation of false recommendations from specialized external entities, such as marketing agencies, which directly violates regulations on combating unfair market practices. Another mechanism is selective manipulation, in which a business intentionally manages the visibility of reviews by removing, concealing, or delaying the publication of negative reviews while favoring positive ones. Such action distorts the image of actual customer satisfaction and is considered misleading regarding the essential characteristics of a product or service. An equally significant aspect is feigned verification, i.e., declaring that reviews come from real buyers without implementing proportionate and reasonable steps to verify their authenticity, which constitutes a direct violation of the disclosure obligations imposed by the Omnibus Directive.

Contemporary market practices have also evolved more subtle forms of manipulation, such as astroturfing, which involves creating artificial social support through employees or store owners posing as independent consumers. These activities often involve the manipulation of user profiles, where images generated by artificial intelligence algorithms are used to authenticate fictitious accounts, creating false social proof. Each of these practices, regardless of their technological sophistication, is subject to strict scrutiny by competition and consumer protection authorities.

The role of the President of the Office of Competition and Consumer Protection and the responsibility of management boards

The President of the Polish Office of Competition and Consumer Protection (UOKiK) serves as a central regulator in the legal system, endowed with rigorous powers to counteract violations of collective consumer interests. The main disciplinary instrument at the authority’s disposal is an administrative fine, which can be imposed in the amount of 10% of the turnover achieved by the entrepreneur in the financial year preceding the year of issuance of the decision. The amount of the fine is not determined arbitrarily, but rather results from precisely defined criteria, which include, above all, the scale of the violation, its duration, and the degree of intentionality of the perpetrator. Importantly, this fine is intended to serve not only a repressive function but, above all, a preventive and deterrent one, discouraging other market participants from engaging in similar unfair practices involving the manipulation of reviews or misleading as to the authenticity of reviews.

The enforcement procedure in consumer matters is designed to ensure high effectiveness of supervisory activities. A business subject to a sanction is obligated to settle the fine within 14 days of the decision becoming final, which directly contributes to the state budget. A crucial procedural element is the prejudicial nature of the decisions of the President of the Office of Competition and Consumer Protection (UOKiK), which means that the authority’s findings regarding violations of the law are binding on common courts in compensation cases brought by injured customers. This legal structure significantly facilitates consumers in pursuing civil claims, as they do not have to prove the illegality of the store’s actions, focusing solely on demonstrating the damage suffered. The office’s activity in recent years, reflected in numerous proceedings against e-commerce leaders, confirms that protecting the transparency of reviews has become a regulatory priority, translating into real and severe financial consequences for violators.

The contemporary model of liability in consumer protection law departs from a concept focused solely on the business entity, shifting the burden of sanctions also to individuals who actually manage the enterprise. The President of the Office of Competition and Consumer Protection (UOKiK) has the authority to impose a personal fine of up to PLN 2,000,000 on a manager. This liability is triggered by demonstrating that the manager has intentionally allowed – through their actions or conscious omissions – the company to violate collective consumer interests. In case law, the degree of management involvement in decision-making processes regarding marketing and communications is crucial. This liability may therefore affect a management board member who approves a budget for obtaining reviews from external opinion farms or ignores the lack of implementation of verification procedures under the Omnibus Directive, despite being aware of such deficiencies.

It should be emphasized that the responsibility of managers is autonomous and independent of any penalty imposed directly on the entrepreneur. This is intended to provide a strong incentive for management to build internal compliance structures and actively oversee the entity’s operational ethics. In the era of digitalization of trade, where algorithms and automation of marketing processes can generate violations on a massive scale, the personal financial risk of managers is intended to compel prioritizing compliance as the foundation of business strategy. Therefore, the systemic fight against false reviews is implemented not only through sanctions against corporate structures but also by disciplining those who actually shape companies’ market policies. This, according to the legislature, is intended to ensure long-term improvement in integrity standards in electronic trading.

The Omnibus Directive and the blacklist of market practices

The implementation of the Omnibus Directive into the Polish legal system significantly redefined transparency standards in e-commerce, introducing mechanisms that directly address the systemic manipulation of consumer reviews. A key instrument in this regard is the so-called blacklist of market practices, which constitutes a catalog of behaviors considered unfair in all circumstances, eliminating the need for supervisory authorities to conduct a case-by-case analysis of the consequences of a given action. Classifying these market torts as unfair practices aims to eliminate evidentiary difficulties, as their mere existence exaggerates the entrepreneur’s wrongdoing. This legal framework not only strengthens the consumer’s position but, above all, simplifies the evidentiary process, making the fight against e-commerce abuse more effective and predictable for market participants. The foundation of the new regulations is an absolute prohibition on manipulating the verification and authenticity of product recommendations, which imposes an active obligation on sellers to implement procedures to verify the origin of reviews.

Under the current wording of the regulations, it is considered an unfair market practice for a trader to claim that product reviews were posted by consumers who actually used or purchased the product, in situations where reasonable and proportionate steps were not taken to verify their authenticity. This practice violates the consumer’s right to reliable information, which is essential for making an informed decision about purchasing the product, and violating it constitutes conduct contrary to good practice. The law prohibits not only posting completely false reviews, but also commissioning third parties to create them, or transferring recommendations between products with different parameters, which is referred to as review hijacking. Other offenses listed in the catalog are treated equally severely, such as using false quality certificates without appropriate authorization or using surreptitious advertising, which involves using editorial content to promote a product without clearly identifying the paid nature of the communication. Aggressive techniques are also considered particularly burdensome, including mass spamming and forced selling, which involves demanding payment for products delivered to the consumer without their prior order.

The blacklist also eliminates techniques such as bait advertising and direct persuasion of children to purchase, which aims to protect the integrity of the consumer decision-making process from manipulation. This protection of minors stems from their particular vulnerability to advertising messages and their inability to critically assess the persuasive nature of commercial offers. Expanding the list to include a ban on posting or commissioning another person to post false reviews for the purpose of promoting products significantly complements the system, preventing brands from using agencies that fabricate social evidence. It is emphasized that any form of distortion of the actual image of a product’s popularity constitutes a violation of the collective interests of consumers, which entitles the President of the Office of Competition and Consumer Protection (UOKiK) to intervene under public law as soon as a threat to the interests of all market users arises.

A particularly significant and painful consequence of these unfair techniques for entrepreneurs is a specific civil law sanction in the form of an extended right of withdrawal from the contract. If an e-store engages in practices listed in the prohibited catalog or fails to comply with information obligations regarding review verification, the statutory return period granted to the buyers is extended from 14 days to a full 12 months. This mechanism is a direct consequence of the assumption that, in the absence of reliable information, the consumer could not have expressed a fully informed intention to purchase, which suspends the running of standard mandatory deadlines. Systematic combating of review fraud and the use of black market practices is therefore becoming not only a matter of business ethics but the foundation of legal security and stability for every entity operating in the e-commerce sector. Neglect in transparency can lead to mass claims for refunds, posing a real threat to the operational liquidity of the company.

Manipulation Architecture and Platform Obligations under the Digital Services Act (DSA)

The phenomenon known as dark patterns constitutes a sophisticated form of interference in the user’s decision-making process, based on the deliberate use of interface architecture to distort their autonomy of will. Manipulative design patterns are not merely a manifestation of aggressive marketing, but a systematic designer’s action aimed at inducing a specific cognitive bias in the consumer, which ultimately leads to a purchase decision they would not have made in conditions of full transparency. The psychological foundation of these actions is the use of heuristics, i.e., simplified rules of reasoning and automatic thinking, which in the fast-paced environment of e-commerce transactions make the user susceptible to subliminal suggestions. This phenomenon has evolved from simple forms of persuasion to advanced interface manipulation, where the line between inducement and fraud is deliberately blurred to maximize conversion at the expense of the interests of the weaker party in the legal relationship.

A particularly significant area of application of these practices is the system for presenting reviews and suggesting their authenticity, where manipulation takes the form of so-called interface interference. Businesses often employ patterns involving selective content display, which in practice means deliberately hiding negative reviews on subsequent pages of the website while simultaneously highlighting only enthusiastic reviews on the product’s home page. This practice violates the model of the average consumer, who has the right to expect that the image presented of a product’s popularity and quality is reliable and has not been subjected to arbitrary filtering. Manipulation in the sphere of social evidence also includes fabricating popularity indicators, such as false messages about the number of people viewing a given product at a given time or false offer duration counters, which create an artificial sense of scarcity in the user and pressure them to immediately close the transaction. Under the Polish Act on Combating Unfair Market Practices, these activities may be classified as misleading because they distort the actual market conditions, preventing a rational comparison of offers.

Another dimension of manipulation is the technique known as confirmation shaming, which in the sphere of opinion writing involves the use of evaluative and emotional language to coerce users into specific behaviors, for example, through unsubscribe buttons suggesting a lack of consumer awareness. These practices are closely related to the “roach motel model”, where the process of issuing a favorable review is simplified to the maximum extent, while editing, reporting an error, or deleting content requires navigating a complex subpage structure, which is intended to discourage users from correcting false information. In the legal context, such procedural barriers are considered burdensome impediments that violate good practice and the principle of commercial fairness. An analysis of case law and the positions of supervisory authorities indicates that an interface that deliberately hinders users from exercising their rights or changing their minds loses its neutrality and becomes a tool for harming consumer interests.

A fundamental change in the regulatory sphere was brought about by the entry into force of the EU Digital Services Act (DSA), which, in Article 25, explicitly prohibits online platform providers from designing, organizing, and operating interfaces in a way that misleads or manipulates service users. This regulation is overarching and complements the existing consumer protection framework by introducing a direct obligation to maintain neutrality in choice architecture and prohibiting structures that significantly impede users’ ability to make free and informed decisions. Violation of this prohibition entails not only civil law risks but also severe administrative sanctions, which can amount to a significant percentage of the business’s global turnover.

In the sphere of law enforcement, the key role is played by the model design of the average consumer, who is observant and cautious but lacks specialized knowledge of the psychological mechanisms used in interface design. This protection is preventative and abstract in nature, meaning the President of the Office of Competition and Consumer Protection (UOKiK) can intervene in situations where the mere existence of a manipulative pattern poses a real risk of distorting market behavior, without having to wait for measurable financial damage to a specific individual. Effectively combating dark patterns requires businesses not only to comply with the law but, above all, to shift to a design model focused on reliability, where all product information, including opinions, is presented free from coercive mechanisms. Ultimately, interface transparency is becoming a prerequisite for maintaining trust in the digital economy, and the use of sophisticated forms of manipulation is perceived as highly harmful to society, subject to strict assessment in light of the principles of social coexistence.

New obligations for marketplaces regarding moderation and transparency

The entry into force of Regulation 2022/2065, known as the Digital Services Act (DSA), represents a fundamental shift in the liability paradigm for intermediary service providers, particularly marketplaces. This regulation shifts the emphasis from passive content hosting to active oversight of the transparency and security of the digital system, introducing rigorous operational standards aimed at eliminating illegal content while respecting users’ fundamental rights. A key pillar of this reform is the formalization of moderation processes, which until now were often subject to arbitrary internal platform decisions and are now subject to strict procedural rigors contained in the notice-and-action mechanism. Under the DSA, each platform is required to provide easily accessible and user-friendly tools for identifying potentially illegal content, including fake reviews or infringing offers. The mere receipt of a report obliges the provider to promptly and objectively address it.

The evolution of moderation obligations is inextricably linked to the requirement for transparency in decisions, which is achieved through the justification mechanism provided for in the EU regulation. When a marketplace decides to remove content, limit its visibility, or suspend a user’s account, the user is absolutely obligated to provide clear and specific reasons for such action, which is intended to prevent abuse by blocking reliable reviews that are unfavorable to the seller. This system is complemented by a mandatory internal complaint handling system, which allows users to appeal moderation decisions free of charge within a period of at least six months. This constitutes an important procedural guarantee and allows for the correction of potential algorithmic errors. It is indicated that such a legal framework is necessary to counteract the fragmentation of consumer protection, which previously relied primarily on general national clauses that were unsuitable for the scale of operations of global digital entities.

A significant innovation introduced specifically for trading platforms is the “Know Your Business Customer” (KYBC) principle, regulated in the chapter on marketplace transparency. These entities are charged with collecting and verifying information about traders offering their products through their interfaces, including registration data, payment account numbers, and declarations of commitment to offer goods in compliance with EU law. This mechanism aims to eliminate the phenomenon of anonymous sellers, who often promote defective products using fabricated reviews and, after raising capital, disappear from the market, avoiding legal liability. The platform is obligated to suspend services for sellers who fail to submit the required documents, making the marketplace an active guardian of the legality of trade, rather than merely a passive intermediary in trade.

The scope of transparency obligations extends beyond relationships with individual users to include public reporting through the periodic publication of transparency reports. These documents must include detailed data on the number of orders received from national authorities, statistics on content moderation initiated by the platform itself, and information on the use of automated tools in verification processes. For very large online platforms, these rigors are even stricter, including the obligation to conduct annual audits and systemic risk assessments, including analysis of the interface’s vulnerability to manipulation that could negatively impact public safety or consumer protection. The systemic fight against disinformation and unfair market practices is therefore anchored in the full transparency of operational processes, which allows supervisory authorities to continuously monitor the effectiveness of implemented security measures.

Supervision of compliance with these obligations is based on a new institutional architecture, in which national digital services coordinators, working closely with the European Commission, play a central role. The enforcement system for the adopted regulations is based on fines of up to 6% of a provider’s global turnover, which compels compliance with specific cybersecurity standards. This control system is designed to ensure that marketplaces not only implement the required procedures but also apply them reliably and uniformly across the European Union, which is crucial for building consumer confidence in cross-border trade. The introduction of these standards ends the phase of full regulatory freedom for platforms, imposing on them real responsibility for shaping the environment in which the modern exchange of goods and services takes place.

Technological verification mechanisms and modern operating models

Authenticity Suggestion and Pressure Mechanisms

The evolution of digital market oversight has led to the development of mechanisms in which traditional legal instruments are increasingly being replaced by algorithmic jurisdictions based on advanced artificial intelligence systems. The phenomenon known as AI exclusion is a modern form of sanction that, for e-commerce entities, can prove more severe than traditional financial penalties imposed by administrative bodies. The foundation of this process is the integration of data on the credibility of reviews directly with positioning parameters in ranking systems, which means that transparency is no longer merely an ethical obligation but a condition for the technical visibility of an offer. Recommendation algorithms operating within platforms such as Google and Amazon constantly analyze behavioral and linguistic patterns to identify anomalies suggesting manipulation of social evidence. These systems are currently capable of recognizing the structure of texts generated by LLM language models, which are characterized by a specific repetition of phrases and a lack of emotional details typical of authentic consumer experiences. An additional risk factor subject to automatic verification is the so-called review growth rate, where a sudden jump in the number of positive ratings without correlation with actual website traffic or sales volume is interpreted by AI as a warning signal initiating restrictive procedures.

The consequences of an online store being classified by AI systems as posing a high risk of manipulation are immediate and often irreversible in the short term. This mechanism, known in market practice as shadow banning or de-indexing, leads to a drastic decline in visibility in search results and the blocking of offers in advertising systems, effectively cutting the entrepreneur off from key customer acquisition channels. Under the provisions of the Digital Services Act, providers of very large online platforms are required to maintain particular transparency regarding the parameters used in recommendation systems. Article 27 of the aforementioned regulation requires platforms to clearly define in their regulations the key parameters determining information ranking, which aims to limit algorithmic arbitrage and enable entrepreneurs to understand the reasons for a potential decline in their market exposure. It is worth noting that modern risk assessment systems may be classified as high-risk systems within the meaning of the Artificial Intelligence Regulation, which imposes strict requirements on their creators regarding human oversight and the prevention of algorithmic discrimination.

In parallel to restrictive systems, a paradigm known as agentic commerce is developing, in which purchasing processes are carried out by autonomous AI assistants acting directly on behalf of the consumer. In this model, traditional product reviews cease to serve as persuasive texts for humans and become raw input data for machines that filter the market in search of offers with the highest level of verified trust. A key element of this new commerce architecture is the so-called trust layer, built on protocols such as the Universal Commerce Protocol promoted by Google or the Agentic Commerce Protocol developed by OpenAI. These systems are guided not only by price or availability of goods but above all by the certified credibility of the seller’s data, automatically rejecting offers from entities that lack a clear digital traceability of their recommendations. The collaboration of AI assistants with secure payment systems, such as the Agent Payments Protocol, creates a closed ecosystem in which offers at risk of manipulation are excluded at the initial algorithmic selection stage, before they are even presented to the user.

In the era of agent-based commerce, the role of modern shopping assistants is becoming dominant, forcing businesses to redefine their credibility-building strategies. The Context Protocol model and other open-source solutions enable the exchange of context between various AI models and commerce systems, allowing information about unfair practices by a single store to be instantly shared across the entire assistant network. The doctrine suggests that this systematic approach to eliminating abuse is a natural response to the technological ease of fabricating content online. For an e-commerce store, losing its trustworthy status in the eyes of Google or OpenAI algorithms means the modern equivalent of server shutdown, as AI assistants, protecting the interests of their users, will systematically bypass offers that generate manipulative signals. Thus, the fight for authenticity is no longer a mere compliance issue but an existential foundation in the new, automated e-commerce environment, where barriers to entry into the trust layer are becoming increasingly difficult for entities employing pressure mechanisms and suggesting false authenticity.

Compliance as a Service and the Digital Feedback Path

The rapid evolution of the e-commerce market and the increasing professionalization of unfair market practices have forced entrepreneurs to abandon a reactive reputation management model in favor of proactively building a digital immune system. The scale of the challenge facing modern e-commerce is illustrated by analyses of the systematic erosion of trust in the digital sector, pointing to the prevalence of fake reviews and consumer concerns about the mass implementation of generative artificial intelligence for opinion fabrication. This state of affairs creates decision paralysis, where an overabundance of unreliable information, instead of supporting the purchasing process, becomes an insurmountable barrier.

The economic impact of the lack of reliable content verification is directly measurable and translates into tangible operational losses for businesses. The literature emphasizes that exposure to manipulated reviews drastically reduces purchase intentions and brand trust, generating measurable financial losses. The information vacuum filled with false enthusiasm also leads to a phenomenon known as post-purchase dissonance, in which a product that fails to meet expectations is returned to the seller as a complaint or contract withdrawal. Consequently, the lack of investment in transparent review processes generates hidden logistical and operational costs that, in the long run, may outweigh the gains achieved through the temporary increase in conversions driven by manipulation.

In response to increasing regulatory rigor, including the Omnibus Directive, the Digital Services Act (DSA), and the AI Act framework, an operational model known as Compliance as a Service (CaaS) has emerged in market practice. It involves fully outsourcing compliance processes to specialized technology providers who take over the burden of monitoring and verifying content in accordance with current regulations. CaaS allows for the automation of data oversight, which is essential in an environment where the volume of incoming reviews precludes manual oversight without risking accusations of disproportionality. In this approach, compliance ceases to be merely an administrative cost and becomes a component of a strategy for building brand value by guaranteeing the authenticity of every customer touchpoint.

The foundation of the Compliance as a Service model is the maintenance of clean data and the generation of an indisputable digital trace of the review’s provenance. Every published review should be accompanied by a log containing metadata regarding the specific transaction, a unique order number, and delivery status, creating auditable proof of authenticity that can be presented during inspections by supervisory authorities such as the President of the Office of Competition and Consumer Protection. This digital reconstruction of the review process provides the most effective legal shield for businesses, eliminating the risk of allegations of unfair market practices. In the era of algorithmic jurisdiction, where ranking systems favor content supported by digital evidence, having a certified trace of data provenance is becoming a prerequisite for maintaining the market visibility of an offer.

Parallel to technical verification, modern review management systems integrate mediation mechanisms that allow for the amicable resolution of disputes before they are publicly expressed. Market experience suggests that implementing structured review processes allows for the amicable resolution of a significant portion of consumer disputes, effectively preventing the publication of negative reviews resulting from logistical errors. This approach aligns with the principles of reliability and good market practices, building customer relationships based on dialogue rather than solely on the one-way transmission of ratings.

Transaction verification is now becoming the market standard, replacing open, abuse-prone review sections with a system of unique invitations sent only after a purchase is completed. The literature emphasizes that restricting the review process to those who actually purchased the product is the simplest and most effective way to comply with the obligations imposed by the Omnibus Directive. This not only minimizes the risk of severe financial penalties, but above all, provides AI shopping assistants with reliable input data, which, in the new agent-based commerce paradigm, will determine the viability of each entity in the e-commerce ecosystem.

Artykuł Faking reviews in e-commerce – analysis of new legal regulations, algorithmic mechanisms and market practices in the e-commerce sector pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

1. Reports only via e-Sanepid

Every dietary supplement introduced to the market for the first time must be reported to the Chief Sanitary Inspector (GIS). Until now, various forms were acceptable – paper or electronic, with a handwritten or electronic signature. After the amendment comes into effect, the only acceptable method will be the e-Sanepid platform.

What does this mean in practice?

• It is necessary for each person submitting notifications to have a qualified electronic signature or a trusted profile.
• All communication with sanitary inspection bodies – letters, decisions, and confirmations – will be handled through the platform account. The moment of notification submission will be clearly confirmed with an official receipt, eliminating disputes over the deadline.
• Companies that have previously used paper forms or traditional correspondence must immediately switch to the new channel and ensure appropriate employee training.

The change also concerns the timing of the notification obligation: the previous option to notify the Chief Sanitary Inspectorate (GIS) at the stage of intended product introduction is no longer available. The obligation now arises at the time of actual introduction to the market.

2. Strict deadlines and automatic presumption of irregularities

The amendment introduces a completely new mechanism for conducting investigations. This change has the greatest potential to surprise companies without effective internal compliance procedures.

How does the new mechanism work?

If the Chief Sanitary Inspectorate initiates an investigation and requests the entity to submit a scientific opinion, the company has exactly 14 days to submit an application to an accredited scientific unit – at the same time forwarding a copy of it to the Chief Sanitary Inspectorate.

The mechanism for presuming irregularities is a significant innovation. Previously, a company’s inaction during the proceedings did not automatically result in any legal consequences – the proceedings could drag on for years. Following the amendment, any failure to meet the 14-day deadline will lead to direct negative consequences, regardless of whether the product is safe.

3. Advertising without reporting? A fine of nearly one million zlotys

This change directly impacts brands engaging in active digital marketing. Previously, advertising or presenting a dietary supplement without prior notification to the Chief Sanitary Inspectorate (GIS) was punishable by a fine (a misdemeanor). Following the amendment, this becomes grounds for imposing an administrative fine – with new, significantly higher penalties.

What exactly is prohibited?

The amendment penalizes not only the sale of a supplement without reporting it to the Chief Sanitary Inspectorate (GIS), but also the mere advertising or presentation of it if the notification has not been effectively submitted. In other words:

• Sponsored post on Instagram or Facebook promoting a new supplement before notification = grounds for an administrative penalty.
• Product page in the online store visible to the public before successful reporting to GIS = risk of infringement.
• Promotional materials sent to wholesalers or distributors before GIS is notified = potential infringement.
• Influencer marketing initiated before the date of effective notification = liability on the part of the entity commissioning the campaign.

Prohibition on suggesting medicinal properties – wider scope

The amendment expands liability for violations of advertising requirements from labeling to the entire marketing message. Previously, sanctions primarily covered incorrect packaging labeling. Following the amendment, a company is responsible for every communication channel – online advertising, point-of-sale materials, newsletters, or YouTube videos – if the message suggests that a varied diet does not provide sufficient nutrients, or if a supplement is presented as a medicinal product.

4. Public register – the company’s reputation under public scrutiny

The Chief Sanitary Inspectorate (GIS) has maintained a register of dietary supplements before, but the amendment will significantly expand its scope and availability. The data will be published on the e-Sanepid platform and will include:

• the name of the product and its qualitative composition (without quantitative data – the recipe remains protected),
• product qualification proposed by the entity,
• information about the initiation or ongoing investigation,
• data on the detection of a prohibited ingredient.

5. Fines – increase by over 330%

The maximum administrative fine for violating food safety regulations is increasing from 30 to 100 times the average monthly salary. At the current salary level, this means:

The new penalties are imposed administratively (not as fiscal or misdemeanor offenses), which means faster proceedings and no need to prove intentional guilt. A mere finding of a violation is sufficient. The increased level of sanctions has a real deterrent effect, especially for companies with turnover in the tens of millions of zlotys.

The biggest risks – a practical overview

Artykuł CLIENT ALERT Dietary supplements market in Poland Amendments to food safety regulations | May 2026 pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

We are delighted to share an important milestone in the continued development of KG Legal’s Data, AI & Cybersecurity Desk.

It has been a great honour to serve as the exclusive expert contributors for Poland to the OneTrust DataGuidance Privacy Overview – Poland, one of the world’s leading professional legal compliance resources relied upon by in-house counsel, privacy professionals, compliance officers, multinational organisations and technology companies operating across multiple jurisdictions.

Preparing this contribution was a long-term project that required several months of intensive legal analysis, research and editorial work. Our objective was not simply to describe the application of the GDPR in Poland. Instead, we sought to create a practical and comprehensive guide reflecting the significant transformation of the Polish regulatory landscape that has taken place in recent years as a result of new European legislation and its implementation into Polish law.

The publication therefore extends far beyond a traditional overview of Polish data protection law. It examines the interaction between privacy, digital regulation, cybersecurity and artificial intelligence, providing readers with practical guidance on the most important legal developments affecting organisations operating in Poland.

Our contribution discusses, among other things:

• the practical application of the GDPR within the Polish legal system;
• the powers and regulatory practice of the Polish supervisory authority for personal data protection;
• employee monitoring and workplace privacy;
• cookies, consent mechanisms and online tracking technologies;
• electronic communications and direct marketing requirements;
• international data transfers;
• personal data breaches and notification obligations;
• practical compliance with Polish privacy legislation;
• cybersecurity-related regulatory developments;
• the growing interaction between data protection and artificial intelligence governance.

A particularly important aspect of this work was addressing the rapidly evolving legislative environment. During the last few years, Poland has experienced substantial regulatory changes resulting from the implementation of numerous European legal instruments and the entry into force of directly applicable EU regulations that significantly affect organisations processing personal data.

Accordingly, the publication takes into account the practical implications of the evolving European digital regulatory framework, including the interaction between the GDPR and newer legal instruments governing digital services, artificial intelligence, cybersecurity and data governance. The analysis also reflects the impact of the AI regulatory framework, developments concerning data governance and electronic communications, as well as the increasingly interconnected compliance obligations facing businesses operating in today’s digital economy.

Rather than presenting legislation in isolation, the publication adopts a practical, compliance-oriented perspective. It combines:

• the GDPR and Polish implementing legislation;
• guidance issued by the European Data Protection Board (EDPB);
• the jurisprudence of the Court of Justice of the European Union;
• decisions and regulatory guidance published by the Polish Personal Data Protection Office (UODO);
• recent Polish legislative developments and market practice.

Our ambition was to create a resource that would assist both international and domestic organisations in navigating one of the fastest-changing areas of European regulation, where privacy law increasingly intersects with cybersecurity, AI governance, digital platforms, online communications and emerging technologies.

The contribution was prepared by Małgorzata Kiełtyka and Jakub Gładkowski, whose combined experience covers complex cross-border advisory work in data protection, artificial intelligence, life sciences, healthcare, technology law, cybersecurity, intellectual property and regulatory compliance.

https://www.dataguidance.com/experts-directory/Jakub_G%C5%82adkowski

https://www.dataguidance.com/experts-directory/Malgorzata_Kieltyka

For many years, Małgorzata Kiełtyka has advised international companies on GDPR compliance, healthcare regulation, AI governance, technology transactions and cross-border regulatory matters. Her practice combines strategic legal advice with practical implementation of compliance frameworks for multinational businesses operating in highly regulated sectors.

Jakub Gładkowski focuses on data protection, digital regulation, cybersecurity, intellectual property, IT law and emerging technologies. His practice includes advising innovative businesses on regulatory compliance, digital transformation projects and the implementation of European technology legislation affecting both public and private sector organisations.

Being entrusted with preparing Poland’s national contribution to OneTrust DataGuidance represents an important recognition of our team’s expertise and international standing. We are particularly proud that this publication reflects not only our experience in privacy law, but also our broader interdisciplinary approach, integrating data protection with AI regulation, cybersecurity, digital compliance and technology law.

We sincerely thank the editorial team at OneTrust DataGuidance for their confidence in our expertise and for the opportunity to contribute to a publication that supports legal and compliance professionals around the world.

For KG Legal, this publication marks another significant milestone in the continued growth of our Data, AI & Cybersecurity Desk and reinforces our commitment to delivering practical, business-oriented legal advice at the intersection of privacy, technology and innovation.

Artykuł A Major Milestone for KG Legal’s Data, AI & Cybersecurity Practice: Exclusive Poland Contribution to OneTrust DataGuidance pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

The Act amending the Act on the National Cybersecurity System aims to implement Directive (EU) 2022/2555 of the European Parliament and of the Council of 14 December 2022 (NIS Directive 2) and the partial application of Commission Delegated Regulation (EU) 2024/1366 of 11 March 2024 supplementing Regulation (EU) 2019/943 of the European Parliament and of the Council.

The amendment to the KSC Act significantly expands the scope of the regulations and introduces new obligations in the field of cybersecurity management. The changes include, among other things, the implementation of risk management systems and expanded incident reporting requirements. The new regulations also strengthen the powers of supervisory authorities and significantly increase the maximum amount of financial penalties. It also introduces liability for the management staff (manager) of an entity. In practice, this requires certain entities to take steps to comply with the new regulations.

The first experiences of entrepreneurs after the amendment came into force – practical conclusions

The few months that the amended Act on the National Cybersecurity System has been in effect demonstrate that the biggest challenge for businesses is no longer the analysis of the new regulations, but their practical implementation. For many organizations, the adaptation process began with a seemingly simple task: determining whether a given entity is even subject to the new regulations. In practice, this step proves to be one of the most problematic.

Under the previous legal framework, many businesses awaited a formal administrative decision confirming their status as an essential service operator. This approach is no longer appropriate. The status of a key or important entity stems directly from the Act, and obligations arise regardless of whether the business has already been entered on the register. This means that the responsibility for properly assessing their own situation rests primarily with the business itself.

Practice also shows that many companies focus solely on the issue of being entered into the register of key and important entities. However, entry itself is not the purpose of the regulation. The greatest challenges remain the actual implementation of an information security management system, conducting a risk analysis, developing incident response procedures, and adequately documenting the actions taken. In the future, supervisory authorities will primarily assess an organization’s actual level of compliance with the Act, not merely the formal fulfillment of registration obligations.

Another significant change is the significant increase in management responsibility. Management can no longer treat cybersecurity as a matter solely within the purview of IT departments. The Act requires active management involvement in the organization of the cybersecurity management system, oversight of its operation, and provision of adequate organizational and financial resources. In practice, this requires regular reporting on cybersecurity issues at the management level and documentation of decisions made.

Supply chain security is also becoming increasingly important. Businesses are required not only to secure their own IT systems but also to consider the risks arising from collaboration with IT service providers, cloud computing operators, software vendors, and outsourcing providers. In practice, this means reviewing supplier contracts, verifying the security measures in place, and implementing appropriate provisions for incident management and crisis cooperation.

It’s also noticeable that a growing number of businesses are choosing to conduct internal compliance audits before the statutory deadlines expire. This approach allows for early identification of organizational and technical gaps, reducing the risk of subsequent violations and costly remedial actions.

In practice, the best solution is to treat the implementation of the Act’s requirements not as a one-time project, but rather as a process encompassing regular risk analysis, procedure updates, employee training, and ongoing oversight of the organization’s security. This approach not only increases compliance but also significantly reduces the risk of cybersecurity incidents.

It’s worth emphasizing that the current transition period should be used to calmly prepare organizations for the full application of the new regulations. Postponing implementation until the final months before the statutory deadlines expire can be risky, especially for large organizations where implementing information security management systems requires the involvement of multiple departments and adequate time to prepare procedures and documentation.

Change in the circle of entities to which the Act applies.

Under the previous wording of the Act, an administrative decision was required to recognize an entity as an essential service operator (Article 5 of the Act before the amendment). Currently, the group of key and important entities is determined automatically (ex lege). The criteria for qualifying an entity as essential are found in Article 5, Section 1, and as an important entity in Article 5, Section 2 of the Act. It is possible that an entity meets the criteria for both key and important entities; such an entity is considered a key entity under Article 5, Section 4. When attempting to qualify entities, the Act also refers to EU regulations, particularly Regulation 651/2014/EU, which defines SMEs. Therefore, the primary criteria taken into account will be the number of employees and annual turnover. It is also necessary to refer to Annexes 1 and 2 of the Act, which precisely define the categories of entrepreneurs in specific sectors and subsectors.

The added Article 5a in paragraph 1 provides that key and important entities are subject to the obligations arising from the Act if they reside in the territory of the Republic of Poland or conduct their business in the territory of the Republic of Poland.

Articles 7 et seq. regulate matters related to the list of key and important entities. Before the amendment, the list contained only operators of essential services; now it includes key and important entities. Unlike the previous legal status, in which entry was made at the request of the authority responsible for cybersecurity (former wording of Article 7, paragraph 3 of the Act), entry is now made at the request of a key or important entity within six months of the occurrence of the conditions (Article 7c, paragraph 1 of the Act). Ex officio entry will generally only apply to existing operators of essential services, trust service providers, telecommunications companies, and public entities. This means that for entities meeting the conditions on the date the amendment comes into force, the deadline for submitting an application is October 3, 2026. Pursuant to the Announcement of the Minister of Digitization of April 8, 2026, regarding the schedule for submitting applications for entry in the register of key and important entities and for key or important entities to commence using the ICT system , self-registration on the list is possible from May 7, 2026, to October 3, 2026. The platform operating in the S46 system is available at https://wykaz-ksc.gov.pl/ . By April 3, 2027, key and important entities are required to commence using the ICT system specified in Art. 46 sec. 1 of the Act. This deadline begins depending on whether the entities were parties to agreements regarding the use of the ICT system referred to in Art. 46 sec. 1 of the Act concluded before April 3, 2026. For the former, the possibility of using the system was opened on April 8, 2026, and for the latter, this possibility will be available from June 12, 2026 (point 2 of the Communication of the Minister of Digital Affairs).

If an entity that meets the criteria for being considered a key or important entity fails to submit an application for entry, the authority responsible for cybersecurity may enter the entity on the list ex officio (Article 7j, paragraph 1 of the Act). Failure to comply with certain obligations related to the list (failure to timely complete missing data on the list or failure to correct data despite a request or failure to submit an application for entry) may result in the imposition of a substantial fine (Article 73, paragraph 1, point 1 and Article 73, paragraph 1a, point 1 of the Act). The catalogue of data to be included on the list has also been changed (expanded) (Article 7, paragraph 2).

In practice: The expansion of the scope of entities and the shift from administrative decision-making to automatic regulation mean that many entities may be subject to the Act without formal confirmation of this status. In practice, independent qualification analysis and continuous monitoring of compliance with statutory criteria become crucial. An incorrect assessment (or failure to comply) may result in exposure to sanctions (severe fines).

New responsibilities for cybersecurity management.

Duties

Chapter 3, which governs the obligations of key and important entities, has been expanded, and Chapters 3a and 3b have been added, addressing domain name registration service providers and public entities. Article 8 of the Act governs obligations related to the implementation of an information security management system. Compared to the previous legal framework, numerous obligations have been added. The responsibility of the manager of a key or important entity for the performance of its cybersecurity obligations has been introduced (Article 8c of the Act), and the manager’s responsibilities have also been defined (Articles 8d–8f of the Act).

The regulations regarding incident reporting have also changed. A key or important entity classifies a given incident as serious (after meeting the requirements of Article 2, Section 7 of the Act), then issues an early warning, reports the incident, and finally submits a final report on the handling of the serious incident to the CSIRT (a three-step reporting model instead of the previous one-step model – Article 11 of the Act).

Deadlines

Pursuant to Article 15 of the Act, key entities must conduct a security audit of the information system used in the service provision process at least once every three years. For key entities that were not previously classified as key service operators, the first audit should be conducted within 24 months of the date the conditions are met (Article 16, point 2, therefore, for these entities, the deadline for conducting the audit is April 3, 2028).

The Act amending the KSC Act establishes a 12-month transition period during which key and important entities have time to fulfill the obligations specified in Chapter 3 of the Act (except for the obligation to conduct the first audit, which entities have 24 months to conduct). Therefore, with respect to obligations such as implementing an information security management system, risk assessment, implementing technical and organizational measures, reporting and managing incidents, and verifying personnel’s criminal records, the deadline for compliance with these regulations expires on April 3, 2027.

In practice: The imposed obligations require the implementation of an information security management system. Furthermore, the single-tier incident reporting system has been changed, replaced by a more complex three-tier system. Essential entities will be required to conduct audits. Importantly, entities that were not previously considered essential service operators will be required to conduct an audit within two years of the amendment’s entry into force. However, most of the new obligations will have to be implemented by April 3, 2027. Failure to comply with these obligations will result in the manager of the relevant entity being held liable.

Change in the amount and grounds for imposing fines.

Until April 2, 2026, the maximum amount of the fine imposed on entities (only for the most serious violations) was PLN 1 million (former wording of Article 73, paragraph 5 in fine). Currently, the maximum amount of the fine is, as a rule, EUR 10 million (Article 73, paragraph 3 of the Act), and for the most serious violations, up to PLN 100 million (Article 73, paragraph 5 in fine of the Act).

With the imposition of a large number of obligations on key and important entities, the list of violations for which a fine may be imposed has also been expanded (Article 73 of the Act).

The new provisions on fines come into force only two years after the entry into force of the Act (i.e. from April 3, 2028).

In practice: Increasing the amount of fines disciplines key entities and important entities to take their cybersecurity obligations very seriously. It is worth emphasizing, however, that the amended regulations on fines will not enter into force until April 3, 2028.

Changes in the supervision and control of key and important entities.

Chapter 11 of the Act, which deals with the supervision and control of key and important entities, has been significantly expanded. Some provisions remain unchanged (the requirement to apply the provisions of the Entrepreneurs’ Law or the Act on Audit in Government Administration, the powers of the person conducting the audit, most of the obligations of audited entities, and provisions regarding audit protocols and post-audit recommendations).

Important changes

The most important changes in the scope of supervision include a significant expansion of Article 53, which describes the powers of the authority responsible for cybersecurity regarding supervision and oversight of key entities. It empowers the competent authority to issue various types of administrative decisions aimed at enforcing the provisions of the Act. This article also contains a number of procedural provisions defining the nature of the proceedings. Generally, the regulations contained in this article apply only to key entities, but as stated in Article 53, paragraph 17, certain provisions also apply to inspections of important entities. Article 53, paragraph 3 states that supervision of key entities is both post-empty and preventive, while for important entities, supervision is only post-empty.

A new obligation for both key and important entities is the information obligation specified in Article 53c, which requires a key or important entity to provide certain data at the request of the authority responsible for cybersecurity.

A new institution is the ad hoc review added in Article 59c, which may be carried out only if the conditions specified in the cited Article are met.

In practice: Strengthening the powers of supervisory authorities and introducing ad hoc inspections means increased risk of inspections and the need to maintain constant readiness to demonstrate compliance with regulations. Entities should also prepare for more frequent requests for information from authorized bodies.

Minor changes

Chapter 10 has been amended and Chapters 10a – 10c have been added, but they do not contain any standards addressed to entities and are therefore not relevant from a practical point of view.

Several changes concern Chapter 12 concerning the Government Plenipotentiary for Cybersecurity and the Cybersecurity Board, but these changes do not have any significant impact on the entities.

Article 12a has been added, addressing specific measures to ensure cybersecurity at the national level. It primarily contains provisions on recommendations from the Government Plenipotentiary for Cybersecurity (Article 67a), the procedure for designating a supplier as a high-risk supplier (Articles 67b–67f), and a safeguarding order in the event of a critical incident (Articles 67g–67i).

Minor changes also apply to the Cybersecurity Strategy of the Republic of Poland (Articles 68–72). The changes primarily concern the content and method of developing the strategy, as well as the frequency of strategy reviews (2.5 years instead of the previous 2 years).

The amendment to the Act on the National Emergency Response Plan creates the basis for the adoption of the National Emergency Response Plan (Articles 72a – 72f of the Act).

Recommended actions.

In light of the amendments to the Commercial Companies Code, entities subject to the new regulations should take steps to ensure their operations are in compliance with the law. It is recommended that:

1)      Self-identification in order to determine whether a given entity qualifies as a key or important entity within the meaning of the Act.

2)      Implementation or update of an information security management system.

3)      Development of procedures for identifying and reporting incidents, taking into account the new procedure.

4)      Ensuring the involvement of management staff, e.g. the manager’s implementation of the obligations under Article 8d or 8e.

5)      Preparing the organization for potential supervisory activities, e.g. inspections.

• Action:

ex officio entries carried out by the Minister of Digital Affairs (current key service operators, trust service providers, telecommunications companies and public entities)

• Deadline:

April 13 – May 6, 2026

• Action:

self-registration in the list of key and important entities

• Deadline:

May 7 – October 3, 2026

• Action:

launching the possibility of using the S46 system for new entities

• Deadline:

June 12, 2026

• Action:

end of the deadline for starting to use the S46 system and implementing obligations (end of the adjustment period)

• Deadline:

April 3, 2027

• Action:

the first ISMS audit (for key entities that were not key service operators) and the beginning of the application of the provisions on penalties

• Deadline:

April 3, 2028

Artykuł NIS2 in Poland: Practical Implications of the New Cybersecurity Framework for Businesses pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Just a few years ago, online store owners primarily had to ensure terms and conditions, privacy policies, and efficient order processing. Today, this is clearly not enough. EU regulations such as the Omnibus Directive and the Digital Services Act (DSA), as well as the increasing role of artificial intelligence in assessing store credibility, force businesses to consider their platforms much more broadly. It is no longer just about regulatory compliance, but also about building digital trust, which influences a store’s visibility, legal security, and customer purchasing decisions. Below, we present a practical checklist of the most important actions to implement to reduce the risk of sanctions and increase the credibility of an online store.

Practical guidelines for online store owners

I.            Avoiding UOKiK fines and compliance with the Omnibus Directive

a. Implement transactional verification: You should configure your feedback system so that each review you post is technically linked to the unique order number and email address of the customer who actually completed the purchase.

b. Updating the content of the regulations: In the “Rules for publishing opinions” section, the verification procedure should be described in detail, whether all opinions (including critical ones) are published and how the average product rating is calculated.

c. Transparent labeling: Each review should have a clear status indication (e.g., “Purchase confirmed”). If a benefit is provided in exchange for reviews (e.g., a discount code), this information must be clearly and prominently displayed within the review text.

d. Lowest price mechanism: In accordance with the requirements of price transparency, each discount must display the lowest price of the product that was valid in the 30 days prior to the introduction of the discount.

Legal basis: Act of 30 May 2014 on consumer rights ( Journal of Laws of 2024, item 1796, as amended); Directive (EU) 2019/2161 of the European Parliament and of the Council of 27 November 2019 amending Council Directive 93/13/EEC and Directives 98/6/EC, 2005/29/EC and 2011/83/EU of the European Parliament and of the Council as regards the better enforcement and modernisation of Union consumer protection rules (OJ EU L 328 of 2019, No. 328, p. 7, as amended); Act of 23 August 2007 on counteracting unfair market practices ( i.e. Journal of Laws of 2023, item 845).

II.            Ensuring compliance with the Digital Services Act (DSA)

a. Implementing a “report content” mechanism: Every review or user-generated content must have an easily accessible button to report suspected illegality or manipulation of the content.

b. Procedure for justifying decisions: In the event of deletion of an opinion or blocking of a user account, the platform is obliged to send the author a detailed justification indicating a specific violation of the regulations or legal provisions.

c. Internal Complaints Process: Users must be able to appeal moderation decisions for a period of at least 6 months from the date the platform takes action.

d. Designation of a contact point: The entrepreneur must designate an electronic contact point for supervisory authorities and users, enabling efficient communication on matters relating to digital security.

Legal basis: Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on the single market for digital services and amending Directive 2000/31/EC (Digital Services Act) (OJ EU L 277, 2022, No. 277, p. 1, as amended), in particular Articles 16, 17 and 20.

III.            Reducing the risk of “algorithmic exclusion”

a. Design Patterns (UX) Audit: Eliminate so-called dark patterns, such as asymmetric selector buttons, hard-to-close pop-ups, or mechanisms that make it difficult to unsubscribe. Supervisory algorithms treat such practices as signals of poor interface quality.

b. Data Certification for AI: Ensure structured review data is provided, allowing shopping assistants and crawlers to properly verify the “digital provenance” of the data.

c. Filtering synthetically generated content: It is worth implementing tools that monitor review language for bot-like patterns (unnatural correctness, lack of detail) to avoid indexing false enthusiasm that results in lower trust rankings.

Legal basis: REGULATION (EU) 2022/2065 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 19 October 2022 on the single market for digital services and amending Directive 2000/31/EC (Digital Services Act) (OJ EU L 277, 2022, p. 1, as amended) – Article 25 (prohibition of deceptive interfaces)

IV.            Proper management of data and opinions (CaaS model)

a. Digital Audit Trail: It is recommended to store logs containing transaction metadata related to opinions for a period enabling verification of data reliability (e.g. 12-24 months).

b. Active mediation systems: Instead of deleting negative feedback, use complaint management systems that document the process of resolving customer disputes. Resolving a problem is treated by ranking systems as evidence of high-quality service.

c.       “Know Your Business Customer” principle: When running a marketplace model, it is essential to verify the identity of sellers before allowing them to offer goods, collecting registration numbers and contact details.

Legal basis: REGULATION (EU) 2022/2065 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 19 October 2022 on the single market for digital services and amending Directive 2000/31/EC (Digital Services Act) (OJ EU L of 2022, No. 277, p. 1, as amended) – Article 30; Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ EU L of 2016, No. 119, p. 1, as amended).

Artykuł Is Your Online Store Ready for the New Era of Control? A Practical Guide to E-Commerce Responsibilities in 2026 pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

The Polish dietary supplements market is facing the most significant regulatory overhaul in years. The draft amendment to the Act on Food and Nutrition Safety and the Act on the State Sanitary Inspectorate introduces a series of far-reaching changes that will substantially alter the way supplements are notified, monitored, advertised, and supervised in Poland. While the reform does not formally introduce a pre-market authorization system, it undeniably strengthens the position of regulatory authorities and increases the compliance burden imposed on businesses operating in the sector.

The amendment, expected to enter into force six months after publication, reflects both domestic concerns regarding the rapid expansion of the supplements market and the broader European trend toward stricter food safety oversight. For manufacturers, importers, distributors, and marketing agencies, the proposed changes may require a complete reassessment of internal procedures, legal risk management, and commercial strategy.

The reform arrives at a time when the Polish dietary supplements market continues to expand at an exceptional pace. Poland has become one of the largest supplement consumers in the European Union, both in terms of total market value and per capita spending. According to market estimates, the sector exceeded PLN 7 billion in value in 2024 and is expected to continue growing steadily over the coming years. The scale of the market alone has become a challenge for regulators. Between 2017 and 2020, more than 62,000 supplement notifications were submitted to the Chief Sanitary Inspectorate (GIS), while the number of products listed in official registers exceeded 29,000.

At the same time, authorities increasingly pointed to systemic weaknesses in the existing framework. Under the current rules, a business may place a dietary supplement on the market immediately after submitting a notification to GIS, even if doubts exist regarding the product’s composition or classification. The authorities may initiate explanatory proceedings, but the product can still remain commercially available during the investigation. In practice, this system has often been criticized for providing insufficient preventive control and allowing potentially problematic products to circulate before any meaningful assessment takes place.

Another major concern involved the widespread use of aggressive advertising strategies. For years, the dietary supplements industry has been accused of blurring the line between supplements and medicinal products. Many advertisements indirectly suggested therapeutic effects or implied that supplements could substitute proper medical treatment or balanced nutrition. Regulators and pharmaceutical companies repeatedly argued that existing penalties were too low to deter large market participants from engaging in questionable promotional practices.

The lack of a centralized digital supervision system also contributed to inefficiencies. The notification process relied partly on outdated administrative mechanisms, resulting in difficulties with document verification, inconsistent communication, and lengthy proceedings. The new amendment seeks to address these concerns through digitalization, stricter procedural obligations, and substantially higher financial sanctions.

One of the most visible changes introduced by the reform is the mandatory use of the e-Sanepid platform for all supplement notifications. Until now, notifications could be submitted either electronically or in paper form, and businesses had some flexibility regarding the form and timing of submission. Under the new rules, however, the process becomes fully digitized. Notifications will only be accepted through the e-Sanepid system and will require either a qualified electronic signature or a trusted electronic profile.

This change may appear largely technical at first glance, but in reality it significantly increases the formalization of the entire notification process. For large companies with developed compliance departments, adapting to electronic communication systems is unlikely to create serious difficulties. Smaller businesses, however, may face operational and financial challenges connected with digital authentication tools, procedural monitoring, and document management requirements.

The amendment also changes the moment at which the notification obligation arises. Previously, the law referred both to products already introduced to the market and those merely intended for future introduction. The new wording removes the reference to “intended introduction,” meaning that the obligation will arise only once the product is actually being placed on the market. Although this clarification simplifies the legal interpretation of the obligation, it also narrows the flexibility businesses previously enjoyed when planning product launches.

Perhaps the most consequential aspect of the reform concerns explanatory proceedings and scientific opinions. Under the current framework, businesses could effectively delay proceedings indefinitely by postponing the submission of required scientific documentation. While the law imposed certain deadlines on the authorities themselves, it did not establish sufficiently strict obligations for the notifying entity. This created situations where proceedings remained unresolved for years, significantly limiting the effectiveness of supervision.

The amendment introduces a much stricter procedural regime. Once GIS requests a scientific opinion regarding a product’s classification or compliance, the business will have only 14 days to submit an application to a scientific institution or to the President of the Office for Registration of Medicinal Products. Furthermore, the scientific opinion itself must generally be issued within six months, with an absolute maximum period of twelve months in exceptional cases.

The most significant innovation is the introduction of a legal presumption against the entrepreneur. If the entity fails to submit the application for an opinion within the required 14-day period, the law will automatically presume that the proposed classification of the product is incorrect and that the product does not meet the requirements applicable to its category. In practical terms, procedural inactivity itself may lead to negative legal consequences.

This fundamentally changes the balance between businesses and regulatory authorities. Previously, delaying the process often worked in favor of companies by allowing products to remain on the market while proceedings continued. Under the new rules, inaction may immediately weaken the entrepreneur’s legal position. Businesses will therefore need to implement much stricter internal monitoring systems to ensure compliance with procedural deadlines.

The amendment additionally prohibits businesses from circumventing the procedure by repeatedly submitting notifications for identical products. Once proceedings are initiated, companies will no longer be able to submit another notification concerning a product with the same qualitative and quantitative composition. Similarly, withdrawing a notification will not allow the entrepreneur to restart the process with the same formula at a later stage. These restrictions are intended to eliminate procedural abuse and prevent companies from avoiding regulatory scrutiny through repeated filings.

Another major reform concerns transparency and the expansion of the public product register maintained within the SEPIS system. The current register already contains certain information regarding notified products, but the scope of publicly available data remains relatively limited. The new system significantly broadens the amount of information accessible to consumers and competitors alike.

Under the amendment, the register will include the product name, form of the product, qualitative composition, information regarding active substances, details concerning explanatory proceedings, and information about prohibited ingredients. Although quantitative composition data and certain identifying information regarding the reporting entity will remain confidential, the reform nevertheless represents a substantial increase in market transparency.

From the consumer protection perspective, this may be viewed as a positive development. Consumers will gain easier access to information about supplement composition and regulatory status, potentially allowing for more informed purchasing decisions. However, from the business perspective, the new transparency rules create considerable reputational risks. Information regarding ongoing explanatory proceedings may become publicly visible long before any final administrative decision is issued. As a result, companies may face reputational damage even in situations where no violation is ultimately confirmed.

The reform also updates the broader inspection framework to align Polish law with Regulation (EU) 2017/625 on official controls. Although the regulation has already been directly applicable across the European Union since 2019, several references in Polish legislation still pointed to repealed EU acts. The amendment therefore modernizes the legal terminology and adapts national provisions to the currently binding European framework.

Importantly, however, the changes do not significantly expand the substantive powers of sanitary authorities. The amendment primarily introduces terminological adjustments, extending references from “official food controls” to “official controls and other official activities.” Sanitary authorities will continue to possess extensive powers during inspections, including access to facilities, examination of production processes and documentation, and collection of samples for laboratory testing.

The reform does, however, expand the situations in which businesses must bear the costs of inspections and administrative activities. In addition to existing obligations related to violations, follow-up inspections, and border sanitary controls, businesses will now also be required to cover costs associated with official activities performed at their own request, such as the issuance of certain documents. While this change may appear relatively modest compared to other parts of the reform, it nevertheless contributes to the overall increase in operational costs for market participants.

One of the most controversial elements of the amendment concerns advertising and marketing practices. The reform significantly broadens the scope of administrative liability related to the promotion and presentation of dietary supplements. Previously, penalties focused primarily on incorrect product labeling. Under the new rules, liability will explicitly extend to advertising, online promotion, social media activities, and the overall presentation of products.

Most importantly, the amendment introduces severe sanctions for advertising or presenting a supplement before notifying GIS. This is likely to have a major impact on digital marketing strategies commonly used in the supplements industry. Influencer campaigns, online pre-launch promotions, teaser advertisements, and social media product announcements may all potentially fall within the scope of the new sanctions if conducted before formal notification.

The amendment also reinforces existing prohibitions against suggesting that a balanced diet cannot provide sufficient nutrients or implying medicinal properties of supplements. Although these prohibitions already existed under current law, the reform significantly strengthens enforcement mechanisms by attaching much higher financial penalties to violations.

Indeed, the increase in administrative penalties represents one of the most dramatic aspects of the reform. Under the current framework, the maximum administrative fine generally amounts to thirty times the average monthly salary. The amendment raises this threshold to one hundred times the average salary, increasing potential penalties by more than 330 percent.

Based on current economic indicators, maximum fines could exceed PLN 800,000. Such amounts are clearly intended to function as genuinely deterrent sanctions rather than symbolic administrative measures. For large corporations with extensive marketing operations, these penalties may significantly alter risk calculations related to aggressive advertising or borderline compliance practices.

For businesses operating in the supplements sector, the cumulative impact of these changes may be substantial. Compliance costs are likely to increase considerably. Companies may need to invest in legal advisory services, digital infrastructure, scientific assessments, employee training, and enhanced compliance monitoring systems. Marketing departments in particular will face increased scrutiny and will need to carefully verify advertising content before publication.

The reform may also contribute to market consolidation. Large, well-established companies are generally better positioned to absorb increased compliance costs and adapt to stricter regulatory requirements. Smaller businesses, startups, and niche supplement brands may struggle with the financial and administrative burden created by the new framework. As a result, the amendment could unintentionally reduce market diversity and strengthen the competitive position of major industry players.

From the perspective of public authorities, the reform aims to improve the efficiency and credibility of food safety supervision. Digitalization through e-Sanepid and SEPIS is expected to accelerate administrative processes, improve data analysis capabilities, and strengthen market oversight. The introduction of strict procedural deadlines should also reduce the risk of excessively lengthy proceedings and administrative disputes.

At the same time, the implementation of these systems will require significant investments in technological infrastructure and administrative capacity. The effectiveness of the reform will therefore depend not only on the wording of the legislation itself, but also on the practical ability of GIS and related institutions to manage the new digital environment efficiently.

Ultimately, the amendment does not formally transform dietary supplements into products requiring prior authorization before market entry. Businesses will still be able to introduce supplements through a notification-based system rather than a licensing procedure. Nevertheless, the practical reality of operating in the sector is likely to change considerably.

The reform substantially increases the procedural obligations imposed on businesses, strengthens enforcement tools available to authorities, raises financial exposure connected with non-compliance, and introduces far greater transparency into the market. While these changes may improve consumer protection and market oversight, they also create new operational and reputational risks for entrepreneurs.

For companies active in the supplements industry, the coming months may therefore become a critical period of preparation. Businesses that fail to adapt quickly to the new regulatory environment may face not only financial penalties, but also significant disruptions to their commercial operations and marketing strategies.

Artykuł Dietary Supplements Under Tightened Scrutiny: How the 2026 Reform Could Reshape the Polish Market pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

At the outset, it should be emphasized that the regulation relating to witnesses in the Act of 29 August 1997, the Tax Ordinance, is laconic.

If a decision is made to take evidence by questioning a witness, the party must be notified of the place and time of the hearing at least seven days in advance. The parties may participate and ask questions during the hearing (Article 190 of the Code of Criminal Procedure).

The doctrine defines a witness as someone possessing knowledge of facts relevant to the case that the tax authority is attempting to reconstruct for the purposes of the proceedings. According to the commentary on the Tax Ordinance, a witness in tax proceedings can be either a person present at an event and thus relying on their personal observations, or one who obtained information indirectly, most often from other people.

Only a natural person can be a witness, regardless of age or legal capacity. The ability to perceive reality and articulate one’s observations is crucial. Therefore, it is impossible for another entity, such as an organizational unit without legal personality or a legal person, to attempt to act as a witness.

Under applicable law, witness testimony is one of the admissible forms of evidence in tax proceedings. If this evidence is used, a concise transcript of the witness’s testimony is mandatory. However, there is one step that cannot be taken spontaneously during the proceedings. If a decision is made to hear evidence from a witness, the party must be notified of the location and time of the hearing at least seven days in advance. Parties may participate in the hearing and ask questions during it.

Witness rights and obligations (including the right to refuse to testify or answer questions)

However, the provisions of the Tax Ordinance specify groups of individuals who cannot be questioned as witnesses. This primarily applies to individuals who, due to health conditions or other circumstances, are unable to properly perceive reality or communicate their observations. This exclusion also applies to individuals obligated to maintain the confidentiality of classified information, unless they have been released from this obligation in a legally prescribed manner. The final category includes clergy of legally recognized denominations, but only with respect to information covered by the seal of confession.

This category primarily includes individuals who, due to illness or disability, are unable to properly perceive their surroundings or communicate their observations to others. However, this does not mean that every person suffering from a mental disorder is automatically excluded from testifying. Their condition at the time of questioning is crucial – if they are capable of consciously perceiving and reporting facts, they may be questioned. In situations raising doubts, the tax authority may consult an expert, such as a psychologist or doctor. It is also worth remembering that communicating observations does not have to be exclusively verbal. Other forms of communication are also permissible, including non-verbal signals and behaviors.

Another group includes individuals obligated to maintain the confidentiality of classified information under circumstances covered by confidentiality, unless they have been released from this obligation in accordance with applicable regulations. This applies to classified information classified as top secret, secret, confidential, and restricted. As the regulation itself indicates, it is possible to release such a person from the obligation of confidentiality, however, this is an exceptional situation, not specifically addressed by the Tax Ordinance. With this in mind, legal scholars refer to the provisions of Articles 179 and 180 of the Code of Criminal Procedure.

The final group excluded from witnessing are clergy of legally recognized denominations – regarding facts covered by the seal of confession. The key issue is the religion and church to which the clergy belongs, as this exclusion applies only to denominations recognized by the Polish legal system.

Apart from the exceptions mentioned above, the obligation to fulfill public obligations imposed on individuals by the state is the rule. Witnessing is generally considered one of these obligations, so serving as a witness is generally unavoidable. Failure to comply with the authorities’ orders may result in disciplinary action.

Public administration bodies, including tax authorities, are obligated to act on the basis and within the limits of the law. Therefore, if for any reason it proves impossible to obtain evidence in the form of witness testimony, this cannot have negative consequences for the taxpayer.

The obligation to testify, however, is not absolute. The legislature has granted the right to refuse to testify to immediate family members of a party to the proceedings. This right is available to spouses, ascendants (e.g., parents and grandparents), descendants (children and grandchildren), siblings, first-degree relatives, as well as persons in a relationship of adoption, guardianship, or wardship. Importantly, the right to refuse to testify does not expire upon the termination of the marriage, adoption, guardianship, or wardship. Exercising this right must also not result in any negative consequences for the parties to the proceedings.

Other witnesses generally cannot refuse to testify, but in certain situations they have the right to refuse to answer a specific question. This applies to cases where answering could expose the witness or their immediate family to criminal or fiscal liability. This protection extends to the same group of individuals who are entitled to refuse to testify: spouses, ascendants, descendants, siblings, first-degree relatives, and persons related by adoption, guardianship, or wardship.

Refusing to answer a question does not constitute an admission of guilt, nor can it constitute grounds for imposing penalties on the parties. At the same time, neither legal provisions nor legal doctrine provide any guidance on the possibility of using this mechanism upon termination of a marriage, guardianship, care, or adoption. In practice, this may depend on the individual authority or court, should the decision be appealed.

Special protection is also provided to individuals bound by professional secrecy. They may refuse to answer a question if doing so would reveal legally protected information. This applies primarily to tax advisors, individuals employed by tax advisors or entities providing tax advisory services, as well as attorneys and legal counselors. The purpose of this measure is to protect the confidentiality of information entrusted to members of professions of public trust.

Before the hearing begins, the tax authority is obligated to inform the witness of their rights. This obligation is a manifestation of the principle of building public trust in the tax authorities and is intended to ensure that the witness is aware of their rights. At the same time, the authority should advise the witness of the legal liability for making false statements and the consequences that may result from providing false information.

Rules for taking evidence from witness statements.

The Act lacks any rules governing witness questioning. The regulations and legal doctrine suggest that the form may be either oral or written, but doubts arise regarding the latter. There is also no information on the procedure for conducting questioning. This leaves the authorities with considerable discretion. In addition to the authorities, the parties may also ask questions of witnesses. The regulations do not specify the extent to which a party may ask questions and provide explanations, hence the legal doctrine’s position that this is permissible at any stage of the questioning.

The Tax Ordinance does not specifically regulate the manner of conducting witness interviews. In practice, this means that tax authorities and courts often resort to solutions developed in other procedures. For example, as in civil proceedings, it is permissible to interview witnesses whose accounts contradict each other. Furthermore, case law has also accepted the possibility of confronting witnesses to clarify discrepancies in their testimony. However, if a witness resides outside of Poland, their interview may be conducted through a consul.

However, it’s important to remember that witness testimony is supplementary in tax proceedings. Tax authorities primarily use this evidence when the collected documentation – particularly tax records, accounting records, or other documents – does not allow for a clear determination of the facts and resolution of the case.

Fiscal secrecy

Fiscal secrecy is the exclusion of individual taxpayer, payer, and collector data contained in documentation submitted to the tax authority. It also covers the confidentiality of such data contained in documents held by the authority or information obtained by the authority about this data. The statutory prohibition on disclosing this type of information is intended to provide additional protection for fiscal secrecy, which is one of several secrets protected by law. The purpose of such measures is to protect individual privacy and safeguard the state’s interest. Only in special cases, for reasons of public interest, is it permissible to disclose this data to tax audits and tax authorities. Such measures are intended to protect the private interests of the person or organizational unit being audited. Expanding interpretations of provisions allowing for exceptions to the rule are also prohibited.

The scope of fiscal secrecy is very broad. It covers not only data contained in tax returns and other documents submitted by taxpayers, payers, and collectors, but also all information obtained by tax authorities in the course of performing their statutory duties.

Protection covers, among other things, information collected during inspections, tax proceedings, tax and customs audits, as well as proceedings concerning fiscal crimes and misdemeanors. Fiscal secrecy also covers data contained in tax authority documentation and information obtained from banks, other institutions, and entities cooperating with the tax administration.

The scope of protection also extends to data obtained through international exchange of tax information, double taxation procedures, risk analyses conducted by the National Revenue Administration, taxpayer cooperation programs, and investment agreements. This means that fiscal secrecy covers not only information provided directly by taxpayers, but also data collected by authorities from other sources and documentation created during ongoing proceedings.

In summary, fiscal secrecy covers not only information collected by tax authorities but also data regarding the sources of this information and how it is stored. The scope of this protection is very broad and is intended to ensure the security and confidentiality of taxpayers’ information provided to the tax administration.

This does not mean, however, that all data is strictly confidential. The legislator has provided exceptions that allow for the disclosure of certain information to a business’s contractors. This applies in particular to information about whether the taxpayer has submitted the required tax returns and documents, whether they have correctly reported the events subject to disclosure, and whether they have any tax arrears. In practice, this means that a contractor can obtain basic information that allows them to assess the business’s tax reliability and credibility.

Subjective scope

In addition to defining what information is covered by fiscal confidentiality, the legislator also specified the group of individuals obligated to maintain it. This obligation primarily rests with employees and officers of the National Revenue Administration, employees of the National Revenue Information Service, and other individuals involved in performing the duties of tax authorities.

Representatives of local government and government administration, members of local government appeal boards, persons undergoing internships and apprenticeships in tax authorities, as well as persons participating in specific tax proceedings or procedures for exchanging information with other countries are also obliged to maintain fiscal secrecy.

The list of entities covered by this obligation is broad and includes all individuals who, in connection with the performance of their duties or participation in proceedings, gain access to information protected by fiscal secrecy. The purpose of this solution is to ensure the security of taxpayer data and reduce the risk of unauthorized disclosure.

Individuals who have access to information covered by fiscal secrecy are required to sign a written confidentiality agreement. Importantly, this obligation does not expire upon termination of employment, internship, apprenticeship, or performance of a specific function. This means that information protected by fiscal secrecy cannot be disclosed even after the termination of these relationships.

The obligation of confidentiality also applies to any person to whom such information has been lawfully disclosed. Disclosure is only permissible when permitted by law. Data subjects are an exception – they are not bound by the obligation to maintain the confidentiality of information relating to them.

The attitude of the tax authorities towards the witness’s representative

In practice, tax authorities do not allow the appointment of a proxy for a witness. They justify this by citing the lack of a clear legal basis in the Tax Ordinance. This position was also confirmed by the Commissioner for Human Rights.

This approach is supported by both case law and prevailing doctrine. It has been pointed out that the participation of a witness’s attorney could be contrary to the principle that tax proceedings are open only to the parties thereto.

Although there are some opinions in the literature supporting a witness’s right to be assisted by an attorney, this view remains decidedly minority. Consequently, it is difficult to expect the tax authority to grant such a request, and the chances of an administrative court changing this position also seem slim.

Artykuł Witness in Polish tax proceedings – obligation, right or risk? pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.