{"id":5020,"date":"2026-06-09T13:45:45","date_gmt":"2026-06-09T11:45:45","guid":{"rendered":"https:\/\/igifoodlaw.com\/?p=5020"},"modified":"2026-06-09T14:00:53","modified_gmt":"2026-06-09T12:00:53","slug":"poland-proposes-major-reform-of-the-food-supplement-notification-system-a-new-regulatory-direction-for-food-supplements-fsmps-and-borderline-products","status":"publish","type":"post","link":"https:\/\/igifoodlaw.com\/en\/poland-proposes-major-reform-of-the-food-supplement-notification-system-a-new-regulatory-direction-for-food-supplements-fsmps-and-borderline-products\/","title":{"rendered":"Poland Proposes Major Reform of the Food Supplement Notification System: A New Regulatory Direction for Food Supplements, FSMPs and Borderline Products"},"content":{"rendered":"

Draft amendment signals a shift towards stricter supervision and stronger enforcement<\/strong><\/h3>\n

Poland is considering one of the most significant reforms of its food supplement regulatory framework in recent years. A draft amendment to the Food Safety and Nutrition Act<\/strong> and the State Sanitary Inspection Act<\/strong>, which has recently completed the public consultation stage, proposes a comprehensive revision of the notification system applicable to food supplements, foods for special medical purposes (FSMPs), and other notified food categories. Although the legislative process is still ongoing and the final text may change substantially before adoption, the proposal already provides valuable insight into the regulatory direction pursued by the Polish authorities. Rather than introducing isolated procedural amendments, the draft appears to reflect a broader policy objective: transforming the existing notification system into a more enforcement-oriented supervisory mechanism.<\/p>\n

For manufacturers, importers and distributors \u2014 particularly foreign operators using Poland as an entry point to the EU market \u2014 the proposal deserves close attention.<\/p>\n

Not merely an amendment, but another attempt to tighten the system<\/strong><\/h3>\n

The draft amends the Polish Food Safety and Nutrition Act, which implements, among\u00a0other things,\u00a0Directive 2002\/46\/EC on food supplements<\/strong>, and also introduces<\/span> extensive changes to the legal framework governing the State Sanitary Inspection. Importantly, this is not the first attempt to strengthen the Polish notification regime. Previous legislative initiatives have also sought to increase the supervisory powers of the authorities and reduce perceived abuses of the notification system. The current proposal continues this trend and confirms that Polish regulators increasingly view the notification procedure not merely as an administrative formality but as an instrument for active market surveillance and early regulatory intervention.<\/p>\n

Background: increasing number of notifications<\/strong><\/h3>\n

According to the explanatory memorandum accompanying the draft, the reform is largely driven by the rapid increase in the number of notifications submitted to the Chief Sanitary Inspectorate (GIS). The legislator points to tens of thousands of notified products and argues that the existing procedural framework no longer provides sufficient tools to supervise the market efficiently, particularly in cases involving products whose regulatory qualification is disputed. Against this background, the proposal introduces measures intended to accelerate proceedings, strengthen GIS powers, and discourage repeated notifications about products that raise classification concerns.<\/p>\n

Removal of notifications based on the intention to place products on the market<\/strong><\/h3>\n

One of the most visible practical changes concerns the notification procedure itself. <\/strong>Under the current legislation, operators may notify either the first placing of a product on the Polish market or merely their intention to do so. In practice, many businesses \u2014 especially international companies \u2014 have used this mechanism as a regulatory planning tool before launching products commercially. The draft removes this possibility entirely. If adopted, notifications would only concern products being placed on the market. According to the explanatory memorandum, the legislator considers the concept of notifying a mere intention to market a product incompatible with the definition of “placing on the market” under Regulation (EC) No 178\/2002.<\/p>\n

Although this may appear to be a technical amendment, it could have significant practical consequences. Companies may lose an important opportunity to identify potential regulatory concerns before investing in a full commercial launch.<\/p>\n

Full digitalisation of the notification process<\/strong><\/h3>\n

The proposal also introduces mandatory electronic notifications through the newly established e-Sanepid platform operating within the SEPIS system<\/a>. Paper submissions would no longer be accepted, and notifications would be considered filed only after being properly authenticated by a qualified electronic signature or a trusted profile. This change forms part of a broader digitalisation strategy but also places greater emphasis on procedural accuracy and electronic communication with the authorities. For foreign businesses without an established local administrative infrastructure, compliance with these technical requirements may require additional preparation.<\/p>\n

Borderline products become the central focus<\/strong><\/h3>\n

Perhaps the most important aspect of the proposal concerns products situated at the regulatory interface between food and medicinal products. Borderline classification has long represented one of the most complex issues in EU food law. Products containing botanicals, high-dose vitamins and minerals, innovative ingredients, or therapeutic-style communication frequently raise questions about whether they should be regulated as food supplements, FSMPs, or medicinal products. The draft suggests that Polish authorities intend to address these issues much more proactively.<\/p>\n

Exclusion of the Administrative Procedure Code<\/strong><\/h3>\n

One of the most controversial proposals is the exclusion of the Polish Administrative Procedure Code from explanatory proceedings initiated by GIS following a notification. According to the explanatory memorandum, these proceedings should not be regarded as classic administrative proceedings but rather as supervisory activities aimed at assessing the regulatory status of products. From a business perspective, however, this proposal raises important questions about procedural safeguards and legal certainty. The Administrative Procedure Code traditionally provides operators with procedural rights relating to participation in proceedings, access to evidence, access to files, and legal remedies. Excluding its application could fundamentally change the procedural balance between operators and the supervisory authority.<\/p>\n

This issue is likely to remain a key topic of discussion in further legislative work.<\/p>\n

New procedural deadlines and legal presumptions<\/strong><\/h3>\n

The proposal introduces a new procedural framework for cases in which GIS requires an opinion from a scientific institution or the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL). Operators would be required to submit the request for such an opinion within 14 days and inform GIS accordingly. Failure to comply would create a statutory presumption that the operator’s proposed product qualification is incorrect and that the product does not satisfy the legal requirements applicable to the relevant food category. Such a mechanism represents a significant shift in regulatory philosophy.<\/p>\n

Rather than placing the burden on the authority to demonstrate that the product has been incorrectly classified, the proposal effectively increases the operator’s procedural responsibility. For businesses operating internationally, where internal approval processes, scientific documentation, and translations often require coordination across multiple jurisdictions, meeting such deadlines may prove challenging.<\/p>\n

Restrictions on repeated notifications<\/strong><\/h3>\n

The proposal also seeks to prevent repeated notifications involving products with identical qualitative and quantitative compositions. Until the requested scientific opinion is submitted, operators would not be allowed to file another notification for the same formulation. Furthermore, if an operator withdraws a notified product during explanatory proceedings and subsequently fails to provide the requested opinion, a new notification for the same composition would no longer be possible. These provisions appear designed to discourage repeated attempts to introduce products that remain subject to unresolved classification concerns.<\/p>\n

Significantly higher financial penalties<\/strong><\/h3>\n

The draft also proposes a substantial increase in administrative sanctions. The maximum financial penalty for selected infringements would increase from 30 to 100 times the average monthly salary in Poland, potentially reaching approximately PLN 900,000 under current economic conditions. The explanatory memorandum expressly indicates that these higher penalties are intended particularly for large operators conducting extensive advertising campaigns through television, radio and online media.<\/p>\n

This reflects the increasing importance regulators attach to food communication and marketing practices. For international brands operating cross-border digital campaigns, the proposal reinforces the need to ensure that product presentation complies not only with EU legislation but also with national enforcement practices.<\/p>\n

Possible impact on existing notifications<\/strong><\/h3>\n

Another noteworthy aspect of the proposal is its potential application to notifications submitted before the amendment enters into force. If maintained during the legislative process, this approach could affect ongoing explanatory proceedings and create additional uncertainty for products already present on the Polish market. From the perspective of legal certainty and legitimate expectations, this issue may become one of the most closely scrutinised aspects of the reform.<\/p>\n

Implications for foreign operators<\/strong><\/h3>\n

The proposed amendments are likely to be particularly important for foreign companies marketing food supplements and FSMPs in Poland. Many international businesses manage regulatory affairs centrally while relying on local representatives or external advisers for notification procedures. The proposed framework suggests that this model may require adaptation. Earlier assessment of product qualification, stronger scientific substantiation, robust local regulatory support and careful review of marketing communications may become increasingly important components of market entry strategies. For products presenting any degree of borderline risk, regulatory planning may need to begin well before notification is submitted.<\/p>\n

A broader regulatory trend<\/strong><\/h3>\n

Although the draft legislation is still under parliamentary consideration and its provisions may change considerably before adoption, its overall direction is already evident. The proposal reflects a broader shift from a procedural notification model towards a supervisory framework characterised by earlier intervention, stronger enforcement powers, stricter procedural expectations and greater reliance on scientific substantiation. For the food supplement and FSMP industry, this development should not be viewed as an isolated national initiative but rather as part of a wider European trend towards enhanced scrutiny of product qualification, health-related communication and compliance documentation. Companies active in the Polish market should therefore closely monitor further legislative developments and consider whether their current notification strategies, scientific dossiers and marketing practices remain fit for an evolving regulatory environment.<\/p>\n

Expert Commentary: Dr Izabela Ta\u0144ska – Food Law & Sustainable Food Regulatory Expert | CEO of IGI FOOD LAW<\/em><\/h3>\n

“In my view, this draft amendment should be seen as much more than a revision of the Polish notification procedure. It represents another attempt to redefine the relationship between food business operators and the supervisory authorities by shifting the system towards earlier intervention, stronger enforcement powers, and greater procedural responsibility for businesses. This is a significant policy choice that may shape the future of the Polish food supplement market.<\/em><\/p>\n

One of the most important issues for the industry is undoubtedly the proposal to exclude the application of the Polish Administrative Procedure Code (KPA) from explanatory proceedings conducted by the Chief Sanitary Inspectorate. Borderline product cases frequently involve highly complex scientific and legal assessments and often determine whether a product may remain on the market at all. For this reason, preserving the procedural safeguards guaranteed by the KPA \u2014 including transparency, the right to be heard, access to evidence and active participation in the proceedings \u2014 should remain a priority. In my opinion, maintaining these guarantees is essential for ensuring legal certainty, proportionality and a fair balance between the public interest and the legitimate rights of food business operators.<\/em><\/p>\n

This issue is particularly relevant for international companies notifying products in Poland. Predictable procedural rules and effective legal safeguards are fundamental elements of investment certainty and of the proper functioning of the EU internal market. As Poland continues to attract foreign operators seeking access to Central and Eastern European markets, preserving confidence in the notification system should remain an important objective of the legislative process.<\/em><\/p>\n

Finally, while the draft will undoubtedly continue to evolve following public consultations and parliamentary debate, it already confirms a broader regulatory trend visible across Europe. Authorities increasingly expect businesses to resolve qualification issues, build robust scientific substantiation and ensure regulatory compliance before products reach the market. Companies should therefore use the current legislative process not only to monitor the proposed amendments but also to reassess their notification strategies, internal compliance procedures and scientific documentation in anticipation of a more demanding regulatory environment.”<\/em><\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Draft amendment signals a shift towards stricter supervision and stronger enforcement Poland is considering one of the most significant reforms of its food supplement regulatory framework in recent years. A draft amendment to the Food Safety and Nutrition Act and the State Sanitary Inspection Act, which has recently completed the public consultation stage, proposes a […]<\/p>\n","protected":false},"author":5,"featured_media":5022,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-5020","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"acf":[],"yoast_head":"\nPoland Proposes Major Reform of the Food Supplement Notification System: A New Regulatory Direction for Food Supplements, FSMPs and Borderline Products - IGI FOOD LAW<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/igifoodlaw.com\/en\/poland-proposes-major-reform-of-the-food-supplement-notification-system-a-new-regulatory-direction-for-food-supplements-fsmps-and-borderline-products\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Poland Proposes Major Reform of the Food Supplement Notification System: A New Regulatory Direction for Food Supplements, FSMPs and Borderline Products - IGI FOOD LAW\" \/>\n<meta property=\"og:description\" content=\"Draft amendment signals a shift towards stricter supervision and stronger enforcement Poland is considering one of the most significant reforms of its food supplement regulatory framework in recent years. 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