Supreme Administrative Court 2024 Judgments (II GSK 589/23, 627/23, 806/23): End of Automatic Supplement Blocking by Sanitary Inspectorate in Poland
Summary: Since April 2024, the Supreme Administrative Court has ended the long-standing practice of automatic suspension of dietary supplement marketing by District Sanitary Inspectors (PPIS). The local authority must independently prove a violation, applying Art. 32 of the Act on Food Safety and Nutrition in accordance with Art. 138 of Regulation 2017/625, rather than acting as a "postman" for GIS. Key judgments: II GSK 589/23, II GSK 627/23, II GSK 806/23.
The landmark judgments of the Supreme Administrative Court from April 2024 (case nos. II GSK 589/23, II GSK 627/23, II GSK 806/23) fundamentally changed the interpretation of Art. 32 of the Act on Food Safety and Nutrition.
The Supreme Administrative Court ended the long-standing practice in which District Sanitary Inspectors (PPIS) automatically suspended marketing of products (particularly dietary supplements) solely on the basis of information about the initiation of explanatory proceedings by the Chief Sanitary Inspectorate (GIS).
The new line of case law means the end of the "postman" role for district-level authorities. The PPIS can no longer base decisions solely on the fact that GIS initiated proceedings.
Key Concepts in the Art. 32 Dispute
Understanding the change requires explanation of several key provisions.
Art. 30(1) - Explanatory Proceedings by GIS
Art. 30(1) of the Act on Food Safety and Nutrition regulates explanatory proceedings conducted by the Chief Sanitary Inspectorate (GIS). Proceedings are initiated when GIS has doubts about product classification, for example whether it is a dietary supplement or a medicinal product.
Art. 32(1) - Suspension of Marketing by PPIS
Art. 32(1) of the Act on Food Safety and Nutrition specifies the basis for the District Sanitary Inspector (PPIS) to issue a decision temporarily suspending the placing of a product on the market. This decision applies "until the conclusion of proceedings referred to in Art. 30(1)".
In light of the latest Supreme Administrative Court case law, this provision cannot be applied automatically solely on the basis of information about the initiation of proceedings by GIS.
Art. 138 of Regulation 2017/625 - Pro-EU Perspective
Art. 138 of Regulation 2017/625 is the overriding provision of European Union law concerning official controls. Authorities may apply restrictive measures (such as marketing suspension) only where non-compliance has been established, not merely suspected, and only after conducting an appropriate assessment.
The "Old Line" of Case Law - Automatism from Art. 30 to Art. 32
For years, an interpretation became established in which automatism existed between Art. 30 and Art. 32. Authorities (PPIS) considered that the mere initiation of proceedings by GIS under Art. 30 was sufficient grounds for the immediate issuance of a marketing suspension decision under Art. 32.
In practice, the PPIS acted as a "postman" - performing an administrative act based on a signal from GIS, without conducting its own evidentiary proceedings.
The "New Line" of the Supreme Administrative Court 2024 - PPIS as an Assessing Authority
The new line of Supreme Administrative Court case law from 2024 is based on a pro-EU interpretation of provisions. The Court held that the PPIS cannot act automatically. This authority must independently assess the product, gather evidence and demonstrate "the existence of a state of non-compliance with requirements" before issuing a marketing suspension decision.
The mere initiation of proceedings by GIS under Art. 30(1) can no longer serve as the sole basis for suspending product marketing under Art. 32.
Art. 32 of the Act on Food Safety and Nutrition must be interpreted in accordance with Art. 138 of Regulation 2017/625, which requires "establishment of non-compliance" rather than mere "suspicion".
Three 2024 Supreme Administrative Court Judgments - Pillars of the New Interpretation
Supreme Administrative Court Judgment, II GSK 589/23 (10 April 2024)
Thesis: Proceedings conducted by the PPIS "are characterised by considerable decisional discretion". The obligation to "demonstrate the existence of a state of non-compliance with requirements" rests on the local authority.
Supreme Administrative Court Judgment, II GSK 627/23 (10 April 2024)
Thesis: "There is no direct link" (no automatism) between the initiation of proceedings by GIS (Art. 30) and the proceedings of the PPIS (Art. 32). These are two separate, although related, proceedings.
Supreme Administrative Court Judgment, II GSK 806/23 (16 April 2024)
Thesis: The PPIS proceedings, "despite the indicated binding and certain auxiliary role", still require an independent assessment. The authority must prove non-compliance, guided by the overriding Art. 138 of Regulation 2017/625.
This means that the local authority must actively conduct its own evidentiary proceedings rather than passively waiting for the GIS decision.
Comparison of Case Law Lines: PPIS as "Postman" vs. "Assessor"
| Feature | Old line ("postman") | New Supreme Administrative Court 2024 line ("assessor") | Your benefit |
|---|---|---|---|
| Role of PPIS | Passive executor of GIS decisions. | Independent assessing authority. | You can effectively challenge the PPIS decision on appeal and in a complaint to the Voivodeship Administrative Court (WSA). |
| Basis for decision | Mere "suspicion" and the fact of proceedings initiated by GIS (Art. 30). | Requirement to "establish non-compliance" (Art. 138 of Regulation 2017/625). | Lack of documented non-compliance = strong argument for overturning the decision. |
| Required standard | Low - a formal letter from GIS was sufficient. | High - the authority must actively prove a violation. | The authority has more work and higher risk of losing if it acts schematically. |
| Evidentiary proceedings | Usually none; PPIS ignored evidence, waiting for GIS. | Mandatory; PPIS must assess evidence (e.g., studies, EU status). | You can use studies and legal EU trade as a protective shield. |
| Legal interpretation | Mechanical, domestic (automatism Art. 30 to Art. 32). | Pro-EU (Art. 138 of Regulation 2017/625 takes precedence). | You have an additional argument in the supremacy of EU law. |
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What the New Case Law Means in Practice
The new Supreme Administrative Court judgments have a direct impact on the situation of entrepreneurs in the food and supplement industry.
- End of automatism: The authority (PPIS/PWIS) can no longer justify a marketing suspension decision solely by the fact that GIS has initiated proceedings.
- Obligation of independent assessment: The PPIS must independently conduct proceedings, gather evidence and demonstrate that the product currently "does not meet requirements".
- Greater weight of evidence: The entrepreneur can actively present evidence (scientific studies, expert opinions, legal trade status in other EU countries), and the authority must substantively address them.
- Basis in EU law: The authority must apply Art. 138 of Regulation 2017/625, which requires "establishment of non-compliance" rather than mere "suspicion".
- Possibility of overturning decisions: Decisions issued based on the old, automatic interpretation are defective and easier to overturn in appeal or judicial proceedings.
Art. 32 - Frequently Asked Questions (FAQ)
1. Can the PPIS block a product solely based on a letter from GIS?
No. According to the new Supreme Administrative Court line (April 2024), a letter from GIS about the initiation of proceedings under Art. 30 alone is not sufficient. The PPIS must conduct its own assessment and establish that the product does not meet requirements.
2. What must the PPIS prove to suspend marketing?
The PPIS must actively demonstrate "the existence of a state of non-compliance with requirements". This means proving that the product violates food law provisions, not merely that GIS has doubts about it.
3. Can the PPIS ignore scientific studies or the fact of sale within the EU?
No. Ignoring evidence presented by the party (e.g., studies, opinions, the fact of legal sale in other EU countries) is a violation of the Code of Administrative Procedure (particularly Art. 7, 77 and 80). The PPIS is obliged to collect and assess such evidence.
4. What if the authority still relies on old Voivodeship Administrative Court (WSA) judgments or former Supreme Administrative Court rulings?
Lower-level authorities may attempt to rely on old case law. However, the three 2024 Supreme Administrative Court judgments (II GSK 589/23, II GSK 627/23, II GSK 806/23) represent the most recent and authoritative position on this matter and should be applied by administrative courts.
5. Do these Supreme Administrative Court judgments have retroactive effect?
These judgments do not have retroactive effect in a technical sense, but they establish the correct interpretation of provisions that should be applied in all pending proceedings (appeal and judicial), even if first-instance decisions were issued earlier.
6. What role does EU law (Regulation 2017/625) play here?
EU law plays a crucial role. The Supreme Administrative Court based its reasoning on the supremacy of EU law. Art. 138 of Regulation 2017/625 sets higher requirements (finding of non-compliance) than the previous Polish practice (suspicion).
7. Why is the PPIS no longer a "postman"?
Because the Supreme Administrative Court confirmed that the PPIS is an independent administrative authority, not merely an executive unit of GIS. It has a duty to independently establish the factual and legal situation in its proceedings and bears responsibility for the content of its decisions.
8. How to appeal a PPIS decision issued after the 2024 Supreme Administrative Court judgments?
As a rule, an appeal against a PPIS decision lies to the Voivodeship Sanitary Inspector (PWIS) within 14 days of service. In the appeal, it is worth directly citing the 2024 Supreme Administrative Court judgments (II GSK 589/23, II GSK 627/23, II GSK 806/23) and Art. 138 of Regulation 2017/625.
9. The Sanitary Inspectorate suspended my supplement - what should I do in practice?
First, analyse the PPIS decision to determine whether the authority actually demonstrated the product's non-compliance with law, or merely relied on the initiation of proceedings by GIS. Then prepare an appeal, present evidence (e.g., studies, EU sales status) and cite the new 2024 Supreme Administrative Court line of case law.
Key Takeaways
- The PPIS can no longer automatically suspend marketing of a product solely on the basis of GIS initiating proceedings.
- Application of Art. 32 of the Act on Food Safety and Nutrition requires demonstrating "establishment of non-compliance" in accordance with Art. 138 of Regulation 2017/625.
- The entrepreneur has the right to expect full evidentiary proceedings and a fair assessment of the evidence presented.