Food supplements

Background: 

The European Food Safety Authority (EFSA) will soon be receiving European Commission mandates to evaluate the safety of other substances in accordance with Article 8 of Regulation (EC) No 1925/2006. The “candidates” for safety evaluations include individual substances (such as melatonin and tryptophan), plant compounds (e.g. curcumin, piperin and coumarin) and plants (including Ashwagandha, Cimicifuga, Hypericum and Maca). EFSA evaluations of hydroxycitric acid (rel. to Schisandra and Hibiscus), berberine and fennel fruits (estragole and other compounds) are currently in progress and are expected by May 2025.

Strategic evaluation

As far as developers, producers and distributors of food supplements and enriched foodstuffs, as well as herbal teas and spices, are concerned, quality requirements are being tightened up considerably as a result of the escalation of safety requirements based on Article 8 procedures. Compliance with these requirements can only be assured by using valid analytical procedures to determine the content of safety-relevant constituents, with particular focus on herbal ingredients. Foresightful consideration of the current state of scientific and regulatory knowledge is therefore crucial for sustainable marketing.

PhytoLab methods for Art. 8 substances

PhytoLab already has validated methods at its disposal for determination of important substances regulated/potentially covered by Article 8 of Regulation (EC) No. 1925/2006 in food supplements:

• Hydroxyanthracene derivatives: aloe emodin, emodin, danthron, physcion, rhein – (Regulation (EU) 2021/468)
• Green tea catechins ((-)-epigallocatechin-3-gallate (EGCG)) – (Regulation (EU) 2022/2340))
• Monacolin A (Regulation – (EU) 2024/2041)
• Estragole, methyl eugenol, safrole, ß-asarone, apiol, dillapiol, elemicin, myristicin – (EFSA-Q-2022-00804)
• Berberine – (EFSA-Q-2022-00803)
• Hydroxycitric acid – (EFSA-Q-2022-00805)
• Coumarin, curcumin, melatonin, piperine, synephrine –
(EFSA Working Group meeting on substances other than vitamins and minerals on 27 and 28 January 2025

We also offer analytical methods and expertise for many other safety-relevant plant constituents that are governed by legal stipulations (e.g. regulations on flavourings, cosmetics and contaminants).

Toxicological issues

Even if regulatory limits have not been specified, the question of what constitutes a safe level or intake of a plant/plant compound within the meaning of Article 14 of Regulation (EC) 178/2002 arises in individual cases (official complaints, baby food, etc.) and, to an increasing extent, as early as the product development stage. PhytoLab experts with many years of experience are also at your service when it comes to these questions as well as product labelling.

We would be delighted to give you customised advice. Your contacts at PhytoLab:

Analysis:

DR. KLAUS REIF
Phone +49 9163 88-337
klaus.reif@phytolab.de

Medical Affairs:

DR. HARTWIG SIEVERS
Phone +49 9163 88-154
hartwig.sievers@phytolab.de

Sales:

MARTIN MÜLLER
Phone +49 9163 88-5534
sales@phytolab.de