Lead in a Food Supplement

Do maximum levels for contaminants in food govern how much of a substance the human body absorbs — or simply how much is present? The Regional Administrative Court of Lower Austria (LVwG NÖ) dismissed, by ruling of 3 December 2024,^[i] an appeal by a food business against an officially ordered ban on placing a food supplement on the market. The ruling confirmed that the authority in this case had no alternative course of action.

Background

During a food inspection, a sample of the product in question was taken. Analysis by the AGES revealed a lead content of 4.25 mg/kg, while EU Regulation 2023/915 sets a maximum level of 3.0 mg/kg for food supplements.

The competent authority accordingly prohibited the further placing on the market of the affected batch and required the appellant to report on the measures taken.

Arguments of the Appellant

In its appeal, the appellant submitted, among other things, that:

• a bioavailability study it had commissioned using artificial gastric juice had returned lower lead values,
• the product had already been dispatched and consumed since April 2024, making a recall no longer feasible,
• a blanket ban on placing the product on the market was disproportionate.

Decision of the Court

The LVwG NÖ rejected these arguments and upheld the official ban. The court found that:

• the official analytical method (ICP-OES/ICP-MS) measures the actual lead content of a product,
• EU Regulation 2023/915^[ii] is based exclusively on the absolute content of a contaminant, not on its bioavailability,
• the authority was obliged under § 39 LMSVG to issue a ban on placing the product on the market,
• labelling alone or a voluntary recall recommendation was insufficient, since the product was not fit to be placed on the market.

Since units of the affected batch were already in circulation, the court supplemented the authority's decision with an obligation to notify downstream purchasers and consumers.

Conclusion

The ruling demonstrates that businesses cannot invoke alternative analytical methods when assessing contaminant limits where the applicable EU Regulation prescribes an absolute measurement.

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More Food Law:

Some of the following articles are in German.

• Supreme Administrative Court: CBD Oils Are Food
• Penalty for Compliant Food?
• Food Labelling under the FIR: LVwG Tyrol on 'Saure Lunge'
• Detox Tea and the Health Claims Regulation
• Food Supplements – Recommended Daily Intake: Zero
• Menu vs. Manufacturer's Information
• Who Is a Food Business Operator II
• Raspberry-Free Raspberry Dessert
• Fake Frankfurters?
• Defective Muesli Bars?
• Who Is a Food Business Operator?
• Double Jeopardy for Multi-Batch Contamination?
• No Criminal Liability for Incorrect Labelling?

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About Sabadello Legal

Sabadello Legal advises and represents manufacturers of food products and food supplements, among other areas. Our clients include food law start-ups as well as established SMEs and international corporations. If you have questions about food law, we would be happy to assist. We advise on food law (LMSVG), labelling and compliance, and product controls — from risk analysis and regulatory communication through to defending against official measures and administrative penalties.

Contact

RA Mag. Andreas Sabadello
Sabadello Legal
+43 1 9971037
office@sabadello.legal

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Disclaimer

This article is for general information purposes only. It does not constitute individual legal advice.

Footnotes

^[i] LVwG Lower Austria, LVwG-AV-1260/001-2024, 9 December 2024. ↑

^[ii] Commission Regulation (EU) 2023/915 of 25 April 2023 on maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006. ↑