Bill to amend the Food Safety and Nutrition Act: Higher penalties and sweeping changes in oversight
The Ministry of Health and the Chief Sanitary Inspector, Dr Paweł Grzesiowski, have drafted a bill to amend the Food Safety and Nutrition Act and the State Sanitary Inspectorate Act (item no. UD247). The bill would introduce a number of changes, including significantly raising fines for violating food regulations.
The bill was added to the Council of Ministers’ legislative agenda in June 2025. This is not the first attempt to comprehensively regulate the dietary supplements market in Poland—an area that has come under close scrutiny by the regulator for years. The Ministry of Health says that the aim of the proposed changes is to clarify and strengthen oversight of this sector. Although the dietary supplements market formally functions under the general rules of food law in the European Union, in practice it is a rapidly expanding field, and the existing oversight mechanisms have been found to be inadequate.
The scale of the challenges can be seen in the figures. The first dietary supplement was registered in Poland in 2007, and since then the rate of growth in sales and the number of products introduced onto the market have steadily risen. According to the Council of Ministers’ legislative agenda, in 2017–2020 over 62,000 notices of initial introduction of a dietary supplement onto the market, or intended introduction, were filed with the Chief Sanitary Inspector, and the total number of products entered in the register exceeded 29,000.
The industry has opted for self-regulation in the area of marketing, among other things via the Code of Best Practice for Advertising of Dietary Supplements adopted by the Polish Council for Supplements and Nutritional Foods (KRSIO) and later steps by the Polish Advertising Council, which in 2024 introduced specific rules for ethical advertising of such products.
The regulations governing the dietary supplements market are not uniform across all EU countries, because the member states have a degree of discretion in drafting their national regulations. As pointed out by the Ministry of Health, the current rules governing dietary supplements are generally harmonised with EU food law. However, in the proponents’ view, the existing solutions do not adequately protect consumers. Thus there is room for adoption of additional, more detailed requirements at the national level, and that is the direction chosen in the latest proposal.
Areas covered by the bill
The planned changes are not limited to dietary supplements. The bill also addresses issues of general food safety and organisation of the oversight system run by the State Sanitary Inspectorate (PIS).
The key changes include:
- Adjusting to EU law—ensuring application of Regulation (EU) 2017/625, which introduces a harmonised system of government oversight within the agri-food chain (e.g. inspections based on risk assessments and the duty to file annual reports with the European Commission), as well as implementation of Directive (EU) 2024/2839, which provides among other things for a duty to submit to the Commission the results of inspections of units engaged in irradiation of foods.
- Digitalisation of procedures—introduction of the SEPIS system, run on the e-Sanepid platform, for maintaining the register of dietary supplements and other foods covered by the notification obligation, as well as the register of establishments supervised by PIS. Another new feature will be transferring to SEPIS the process of registration and approval of establishments producing foods of non-animal origin as well as entities marketing materials and products that will come into contact with foods—this duty already exists, but so far the procedure has not been conducted digitally.
- Streamlining notification procedure—limiting the notification obligation to actual market launch (the proposal is to strike the term “or intended launch”), eliminating the duty to notify the Chief Sanitary Inspector of mandatorily enriched foods (such as iodised salt), and requiring notifications to be filed exclusively in electronic form, via the e-Sanepid platform.
- Elimination of inactive structures—closing down the Food and Nutrition Monitoring Council, which is no longer functioning (the Dietary Supplements Council will remain as an advisory body to the Chief Sanitary Inspector with respect to setting maximum permissible levels of vitamins and minerals in supplements).
- Stiffer fines—a significant increase in monetary penalties and expansion of the list of infringements that are subject to sanctions.
Increased monetary penalties
One of the most discussed proposals is to raise the maximum amount of fines to 100 times the average monthly salary in the national economy from the preceding year. Currently the limit is 30 times the average monthly salary. In practice this means that the maximum sanction would rise to as high as PLN 700,000.
The bill clarifies and extends the possibility of imposing fines on entities for infringement of the requirements for labelling of foods, including presentation, advertising and promotion. The bill makes it clear that the sanctions for failure to comply with labelling requirements in EU regulations (1333/2008 on food additives, 1334/2008 on flavourings, and 1169/2011 on food information for consumers) cover product presentation, advertising and promotion. The bill would also allow fines to be imposed for conducting activity inconsistent with the scope of registration.
According to the drafters, officials from the State Sanitary Inspectorate should be allowed to impose fines for violation of the act that are effective, proportionate and dissuasive.
Market context
The changes come in response to the rapid growth of the dietary supplements market and a steady increase in the number of notices of market launches. But some in the industry point out that while the bill would significantly increase the maximum sanctions, it does not provide for more frequent inspections or improved mechanisms for uncovering irregularities. In practice, this could mean that the increase in potential fines is primarily declarative, but will have little real impact on the functioning of the market.
The bill is currently being worked on within the government, and thus could still undergo significant revisions before becoming law.
Joanna Krakowiak, attorney-at-law, Karolina Hryckowian, Life Sciences & Healthcare practice, Wardyński & Partners
