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 PolandAmendments 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 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.