Food business operators introducing special categories of food into the market, such as food supplements or food for special medical purposes, have for years encountered controversial practices by sanitary inspection authorities regarding the verification of food classification. Although the provisions and principles of administrative procedure are clear, a worrying automatism can actually be observed among local stations. A negative letter from the Chief Sanitary Inspector (GIS) issued in the course of explanatory proceedings, or even the mere initiation of explanatory proceedings, often de facto becomes a categorical sentence for a product, mindlessly enforced by State County Sanitary Inspectors in decisions prohibiting marketing issued under Article 8 of the Act of 25 August 2006 on Food Safety and Nutrition (u.b.\u017c.\u017c.). The latest judgments of the Voivodeship Administrative Court in \u0141\u00f3d\u017a, however, shed new light on this practice, defending the fundamental procedural rights of entrepreneurs and the decision-making independence of local sanepid authorities. These judgments will allow for the defense of the fundamental procedural rights of entrepreneurs and their products.<\/p>\n\n\n\n
In the case in question, the authorities of both instances completely ignored expert evidence submitted by the party \u2013 including an opinion from a scientific institution authorized to verify food classification under Article 31(1)(2) of the Act on Food Safety and Nutrition and entered into the relevant list of the Ministry of Health \u2013 deeming that since the assessment of product classification belongs to GIS, the opinions of experts or scientific institutions on this matter are irrelevant.<\/p>\n\n\n\n
The Voivodeship Administrative Court in \u0141\u00f3d\u017a thus addressed a practical issue of extreme importance for the food industry: can local sanitary inspection authorities base their decision to prohibit marketing solely on the position of GIS, while ignoring scientific evidence submitted by the party? The court’s answer is categorical and constitutes an important signal for the entire market.<\/p>\n\n\n\n
The recommendation for the authority re-examining the case is now to conduct the proceedings thoroughly, taking into account the specialized evidence submitted by the party. Time will tell whether the sanitary inspection authorities can handle the substantive burden placed on them by the administrative courts, but for participants in the food market, this is undoubtedly a step toward the rule of law and business stability.<\/p>\n\n\n\n Food business operators introducing special categories of food into the market, such as food supplements or food for special medical purposes, have for years encountered controversial practices by sanitary inspection authorities regarding the verification of food classification. The latest judgments of the Voivodeship Administrative Court in \u0141\u00f3d\u017a, however, shed new light on this practice, defending the fundamental procedural rights of entrepreneurs and the decision-making independence of local sanepid authorities.<\/p>\n","protected":false},"author":5,"featured_media":1611,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[42],"tags":[312,371,101,216,370],"class_list":["post-1614","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-food-law-en","tag-food-law","tag-food-market","tag-gis-en","tag-law","tag-sanitary"],"acf":[],"_links":{"self":[{"href":"https:\/\/ajlaw.pl\/en\/wp-json\/wp\/v2\/posts\/1614","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ajlaw.pl\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ajlaw.pl\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ajlaw.pl\/en\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/ajlaw.pl\/en\/wp-json\/wp\/v2\/comments?post=1614"}],"version-history":[{"count":3,"href":"https:\/\/ajlaw.pl\/en\/wp-json\/wp\/v2\/posts\/1614\/revisions"}],"predecessor-version":[{"id":1617,"href":"https:\/\/ajlaw.pl\/en\/wp-json\/wp\/v2\/posts\/1614\/revisions\/1617"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ajlaw.pl\/en\/wp-json\/wp\/v2\/media\/1611"}],"wp:attachment":[{"href":"https:\/\/ajlaw.pl\/en\/wp-json\/wp\/v2\/media?parent=1614"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ajlaw.pl\/en\/wp-json\/wp\/v2\/categories?post=1614"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ajlaw.pl\/en\/wp-json\/wp\/v2\/tags?post=1614"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
From notification to GIS to prohibition of marketing<\/strong><\/p>\n\n\n\n
The case concerned an entrepreneur who notified GIS of the intention to place a product on the territory of the Republic of Poland for the first time as a dietary food for special medical purposes. The notification was made under Article 29(1) of the Act on Food Safety and Nutrition, which is an obligation for any entity intending to market food supplements, FSMP, fortified foods, or infant formulas.<\/p>\n\n\n\n
The Chief Sanitary Inspector initiated explanatory proceedings under Article 30(1) of the Act on Food Safety and Nutrition, culminating in a letter informing the company that, in its assessment, the notified product did not meet the definition of FSMP set out in Regulation (EU) No 609\/2013 of the European Parliament and of the Council of 12 June 2013 and the requirements of Commission Delegated Regulation (EU) 2016\/128 of 25 September 2015.<\/p>\n\n\n\n
GIS conveyed its position to the local authorities, for whom it became the direct impulse to initiate proceedings under Article 8 of the Act on Food Safety and Nutrition. Despite the scientific explanations provided by the party, the State County Sanitary Inspector issued a decision prohibiting the marketing of the product as food for special medical purposes, fully sharing the position of GIS expressed in the letter concluding the explanatory proceedings. The appellate authority (PWIS) upheld it, arguing, among other things, that the PPIS was actually entitled and obliged to take into account the position of GIS in its ruling.<\/p>\n\n\n\n
The authorities, in line with GIS, reiterated that the entrepreneur had not demonstrated that in the disease conditions indicated on the labeling there was a special requirement for specific ingredients of the product and that the product met those needs. In their view, the product could at most function on the market as a food supplement for healthy and sick individuals, but not as FSMP.<\/p>\n\n\n\n
Parallel issues regarding GIS proceedings and the nature of its act<\/strong><\/p>\n\n\n\n
The significance of the judgment of the WSA in \u0141\u00f3d\u017a is best seen against the background of the earlier dispute over the legal nature of the GIS letter itself. Initially, the WSA in Warsaw ruled that this document was merely informative in nature and was not subject to review by administrative courts. It was only the Supreme Administrative Court (NSA) that changed this assessment, indicating that the GIS letter is an act in the field of public administration that can be challenged in court. This paved the way for judicial verification of the authority’s position.<\/p>\n\n\n\n
The dispute over the product’s classification lasted for several years and returned to the docket multiple times. Crucial significance was attached to the position of the NSA, which emphasized that GIS cannot resolve a case solely on the basis of its own assessment if there are doubts requiring specialized knowledge. In such situations, the authority should use expert opinions. As a result, the WSA in Warsaw set aside the GIS position, holding that the evidentiary material had not been sufficiently clarified. However, the case remains ongoing.<\/p>\n\n\n\n
The development of the parallel case was of great importance to the optics of the WSA in \u0141\u00f3d\u017a. The entrepreneur repeatedly applied for suspension of the proceedings until the final judgment on the GIS act. The WSA in \u0141\u00f3d\u017a ultimately refused to suspend, arguing that the decision under Article 8 of the Act on Food Safety and Nutrition is entirely independent, and its legality is not directly conditional on the outcome of the case concerning the GIS letter. It was precisely this thesis that became the foundation of the breakthrough ruling.<\/p>\n\n\n\n
A decision under Article 8 of the Act on Food Safety and Nutrition is an independent ruling<\/strong><\/p>\n\n\n\n
A key element of the considerations of the WSA in \u0141\u00f3d\u017a was the interpretation of the legal nature of the proceedings conducted under Article 8 of the Act on Food Safety and Nutrition. According to this provision, the competent PPIS, by way of a decision, prohibits the marketing or orders the withdrawal from the market of a product that does not meet the requirements specified in Chapter II of the Act.<\/p>\n\n\n\n
The WSA unequivocally stated that the decision under Article 8 of the Act on Food Safety and Nutrition ‘is not in the nature of a secondary enforcement act relative to the position of GIS’. It is an independent administrative decision that authoritatively determines the rights of a party. Since the legislator entrusted this competence to the County Sanitary Inspector, it is that authority that has an absolute duty to independently establish and prove that the grounds for prohibiting marketing have occurred.<\/p>\n\n\n\n
The court strongly emphasized that a general statement by the authority is not enough. Non-compliance of a product with legal requirements cannot be assumed in advance by the authorities, nor presumed based on the position of another authority. It must be precisely demonstrated during fair evidentiary proceedings, with absolute respect for the principles of administrative procedure.<\/p>\n\n\n\n
Although the court acknowledged that the duty of proper product classification rests on the entrepreneur, this responsibility does not relieve the authority of its own procedural obligations. When issuing a prohibiting decision, the authority must independently prove why the classification made by the entrepreneur is incorrect. The result of the explanatory proceedings before GIS can, of course, be an important element of the case file; however, it does not relieve the PPIS and PWIS of the duty to evaluate evidence. The authority may share the position of GIS, but it must substantiate why it does so, based on what findings of its own and in relation to what specific evidence.<\/p>\n\n\n\n
An interesting argument raised by the Court was also the inconsistency of the sanitary authorities themselves. The authorities refused to suspend the proceedings claiming that the GIS act did not constitute a preliminary question, but at the same time, in the substantive ruling, they treated that very same GIS act as decisive and determinative for the entire case. The WSA in \u0141\u00f3d\u017a called out this action: since the GIS letter did not condition the issuance of the decision, it could only be one of many pieces of evidence subject to objective evaluation.<\/p>\n\n\n\n
The role of scientific evidence submitted by the entrepreneur<\/strong><\/p>\n\n\n\n
Another extremely important thread from the practical perspective of food industry companies is the approach of authorities to external expert opinions. In the case in question, the company submitted an extensive scientific and medical study as well as an opinion from a scientific institution. The authorities ignored this evidence, explaining that since competence for assessing classification lies with GIS, expert opinions are irrelevant in this matter.<\/p>\n\n\n\n
The WSA in \u0141\u00f3d\u017a considered such action to be a gross violation of administrative procedure. The court indicated that an authority cannot rule out the significance of specialized evidence in advance. The sanitary authority had every right to subject this evidence to substantive criticism \u2013 it could have found that the opinion did not address all the criteria of the FSMP definition, that it did not demonstrate a special nutritional need of patients, or that it referred only to general physiological benefits. However, it had to do so by way of an analytical evaluation of the evidence, reasoned in the decision. Dismissing a scientific opinion with a one-sentence statement that ‘classification belongs to GIS’ was directly termed by the court as evading the evaluation of evidence, which constitutes a drastic violation of the rules. The party’s documents should have been thoroughly confronted with the substantive legal criteria.<\/p>\n\n\n\n
A five-step test for the classification of food for special medical purposes<\/strong><\/p>\n\n\n\n
In order to structure the method of substantive processing in FSMP cases, the Voivodeship Administrative Court formulated a five-step classification test on which authorities ruling under Article 8 of the Act on Food Safety and Nutrition should rely. This test stems directly from the analysis of Article 2(2)(g) of Regulation No 609\/2013 and the provisions of Commission Delegated Regulation (EU) 2016\/128.<\/p>\n\n\n\n
According to the court’s guidelines, for an authority in proceedings under Article 8 of the Act on Food Safety and Nutrition to effectively challenge an FSMP classification, it must jointly examine five key elements:<\/p>\n\n\n\n\n
The court also noted that the mere reference by an entrepreneur to the beneficial or physiological effect of ingredients does not determine that we are dealing with food for special medical purposes. At the same time, however, a mere statement by the sanepid that a given product could be consumed by healthy individuals, or that similar ingredients occur in ordinary food supplements, is not sufficient to issue a prohibition on marketing. The authority’s assertions must in each case refer to the specific product, its exact composition, designed labeling, and the intended use declared by the manufacturer, supported by appropriate documentation.<\/p>\n\n\n\n
A fundamental flaw of the set-aside decisions of the PPIS and PWIS was that the justifications for these acts did not show that the full classification test described above had been conducted. The authorities treated the central headquarters’ position as decisive, denying any significance to the party’s evidentiary material. Such action by the authorities violated procedural provisions in a manner that could have had a significant impact on the final outcome of the administrative case \u2013 in the view of the WSA, it cannot be ruled out that after a thorough analysis of the opinion of the competent scientific unit, the PPIS ruling would have been completely different.<\/p>\n\n\n\n
Significance of the judgment for the food business<\/strong><\/p>\n\n\n\n
The judgment of the WSA in \u0141\u00f3d\u017a (along with its comprehensive guidelines for further proceedings) is a ruling of fundamental importance for the entire Life Science sector. Entrepreneurs operating in the market for food for special medical purposes and food supplements have thus gained a powerful weapon in combating often arbitrary decisions by local sanitary inspectorates.<\/p>\n\n\n\n
Several universal conclusions flow from the ruling:<\/p>\n\n\n\n\n
<\/li>\n<\/ul>\n\n\n\n
If you have a problem with a prohibition on marketing products or an order for their withdrawal, please contact us: ajlaw.pl eoleszczuk-romanska@ajlaw.pl office@ajlaw.pl<\/p>\n","protected":false},"excerpt":{"rendered":"