Should food producers fear explanatory proceedings? The notification system for initial marketing of dietary supplements and other foodstuffs | In Principle

For some time, the initial marketing of certain types of foods in Poland has required notification of the Chief Sanitary Inspector. The notification system for dietary supplements and functional foods has been in place in Poland for more than 20 years, and a similar system is in place in most EU member states. The most questions arise from the initiation of explanatory proceedings involving the classification and compliance of the notified product. Further doubts began to arise at the beginning of 2023, when a long-expected bill amending the regulations governing the procedure for reporting and advertising dietary supplements was published.

First of all: What foods to notify to the Chief Sanitary Inspector?

To monitor products marketed in Poland, a food operator introducing or intending to introduce foodstuffs to the market for the first time is obliged to notify the Chief Sanitary Inspector (GIS). The Food Safety and Nutrition Act clearly specifies which products must be notified in the GIS register:

• Nutritional supplements
• Infant formula and foods for special nutritional use (e.g. dietary foods for special medical purposes)
• Enriched food—foodstuffs to which vitamins, minerals or substances referred to in Annex III, Parts B and C of Regulation 1925/2006 are added (i.e. substances whose use in food is banned, restricted or subject to control by the European Union).

What is the purpose of explanatory proceedings?

The Food Safety and Nutrition Act does not assume that explanatory proceedings are mandatory. Once a product is notified to the register of foodstuffs subject to mandatory notifications, the Chief Sanitary Inspector, who is the authority in charge of the register, decides whether to initiate explanatory proceedings. The proceedings serve to dispel any doubts the authority has about the proper classification of a foodstuff and whether the product meets the requirements appropriate for a particular type of food or other product intended for human use, e.g. a medicinal product or medical device, which are subject to separate and stricter regulations.

The nature of the proceedings

Explanatory proceedings are evidentiary. The authority may require the food operator to provide relevant documents to determine the correct classification of the notified product or confirm whether or not the requirements for product composition are met. In particular, the authority may:

• Request an opinion from the Dietary Supplements Team operating within the Sanitary and Epidemiological Council
• Require the entity to document that the product meets the requirements, in particular to submit opinions of national scientific units.

The Chief Sanitary Inspector must take into account opinions by both the Dietary Supplements Team and national scientific units, but the authority is not bound by the positions adopted by the reviewing bodies. The situation is different in the case of a suspicion that the notified product qualifies as a medicinal product, cosmetic or medical device, as then, under the act, the Chief Sanitary Inspector must require the entity to submit an opinion of the president of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) in this regard, and the authority conducting the explanatory proceedings is bound by the opinion. In turn, the food operator is not entitled to challenge unfavourable opinions from these bodies.

The course of explanatory proceedings

The Chief Sanitary Inspector is not bound by any time limit for initiation of explanatory proceedings as to classification and compliance of a notified product. The authority may decide that it is necessary to conduct the proceedings at any time, and must immediately notify the food operator of initiation of these proceedings.

The duration of the proceedings must not exceed 60 working days, but this does not include the time necessary to document fulfilment of specific requirements for a product, e.g. providing opinions of scientific units or the president of URPL. In practice, it takes many months to submit the requested documentation to the authority, stretching explanatory proceedings out more than a year due to the long period necessary for issuance of opinions of the relevant bodies (even up to a year), and, above all, due to the passivity of notifiers, which, when ordered by the Chef Sanitary Inspector, may delay applying for such opinions.

It is also a matter of dispute whether, if the explanatory proceedings significantly exceed the 60-day period, the producer has a right to complain against the lengthiness of the proceedings. Under Art. 29–31 of the Food Safety and Nutrition Act, these are special proceedings for which no explicit reference is made to procedural provisions in the Administrative Procedure Code. Pursuant to the current case law of the administrative courts, only the general provisions of the code apply to explanatory proceedings involving notification of dietary supplements, and only to the extent necessary to bring the notification of the intention to market the product into effect. Explanatory proceedings should guarantee the fairness of acts taken by administrative authorities, while maintaining impartiality, proportionality and equal treatment (Province Administrative Court in Warsaw judgment of 17 February 2022, case no. V SA/Wa 5258/21). Thus, filing of a reminder to the Chief Sanitary Inspector due to protracted explanatory proceedings will not be binding on the authority.

How to challenge unfavourable findings of the Chief Sanitary Inspector?

The Chief Sanitary Inspector must inform the notifier in writing of the results of the explanatory proceedings. The letter should include the authority’s position and justification for GIS’s findings on classification or compliance of the foodstuff. Until recently, the possibility of challenging such a letter was disputed, but the latest line of case law allows it to be challenged by filing a complaint with the administrative court.

The Supreme Administrative Court recently held that such a letter from the Chief Sanitary Inspector is a form of public administrative act, and thus is subject to administrative court review pursuant to Art. 3 §2(4) of the Law on Procedure Before the Administrative Courts. The court noted that the GIS letter “leads to certain effects directly provided for in the law and directly affects the entity’s public-law rights,” as it prevents release of the product (Supreme Administrative Court order of 25 April 2023, case no. II GSK 151/23). Therefore, a complaint against the Chief Sanitary Inspector letter should be heard according to the relevant provisions on proceedings before the administrative courts, and the court should rule on the correctness of the letter within the meaning of the Food Safety and Nutrition Act.

If the administrative act is overturned, the Chief Sanitary Inspector must inform the entity again of the results of the proceedings by issuing a new letter meeting the relevant requirements and taking into account the court’s reasoning in the judgment.

Parliament plans to amend the Food Safety and Nutrition Act

On 2 January 2023, a bill was released which would amend the Food Safety and Nutrition Act, including key changes in notifying dietary supplements and functional foods to the GIS register. The drafters note the lack of a specific regulation and the need to guarantee greater safety for consumers of supplements and other notifiable foodstuffs. According to the explanatory memorandum to the bill, the purpose of the amendment is to make the notification system for products introduced for the first time on the Polish market tighter and more effective. Thus the bill provides for new deadlines in explanatory proceedings, which could result in serious consequences for the notifier if they are not met. These are:

• 14 days to submit a request for issuance of the opinion of scientific units or the president of URPL via the Chief Sanitary Inspector
• 14 days for the Chief Sanitary Inspector to submit the notifier’s request to reviewing bodies
• 6 months for issuance and service on the notifier of opinions from scientific units or the president of URPL
• Possible extension of the deadline for issuing an opinion to 12 months if the 6-month deadline cannot be met (special cases).

The plan to impose on notifiers of foodstuffs to the GIS register a 14-day deadline for submitting requests is significant, as failure to meet the deadline would result in a statutory presumption that the classification of the foodstuff proposed by the food operator is incorrect and that the product fails to comply with the requirements for the specific type of foodstuff. Then the authority would have to discontinue the explanatory proceedings. Information on completion of the explanatory proceedings and the results (e.g. improper classification or non-compliance) is crucial, as it appears in the public register of products covered by the initial marketing notification. Undoubtedly, proceedings concluded unfavourably for the producer may negatively affect the company’s image.

New duties—harsher fines

The bill would also tighten the sanctions for marketing products subject to notification without notifying the Chief Sanitary Inspector. For violation of this obligation, the county sanitary inspector could impose a fine of up to 100 times the average monthly wage in the national economy for the preceding year announced by Statistics Poland (under current law, the fine can be up to 30 times the average wage).

Summary

Although explanatory proceedings are not currently regulated in detail in the Polish legal system, food producers must expect a narrowing of procedural rights, mainly:

• No possibility to file a reminder to the Chief Sanitary Inspector due to protraction of the explanatory proceedings
• No possibility to challenge unfavourable opinions of national scientific units or the president of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• The right of the authority to initiate explanatory proceedings at any time.

The announced amendment to the provisions governing the notification system seems unfavourable to businesses, as it provides for a presumption of incorrect classification of a foodstuff proposed by a food operator and failure to meet the requirements for a given type of foodstuff in the event of failure to submit a timely request for opinions.

There may be some consolation in the fact that a business can assert its rights before the administrative court by filing a complaint against the conclusions reached by the Chief Sanitary Inspector in explanatory proceedings.

Joanna Krakowiak, attorney-at-law, Jolanta Prystupa, M&A and Corporate practice, Life Science & Healthcare practice, Wardyński & Partners