Safety of foods containing estragole

Background: 

Mandated by the European Commission, the European Food Safety Authority (EFSA) is currently preparing a scientific opinion on the safety of fennel tea for sensitive consumer groups, such as infants, children, pregnant women and breastfeeding mothers. As stated in the call for data of 4 August 2023, EFSA considers the levels of estragole, methyl eugenol and safrole in such foods as herbal teas, spices or dietary supplements to be decisive when it comes to an evaluation of safety.

Strategic evaluation

The evaluation in accordance with Article 8 of Regulation (EC) 1925/2006 is being conducted as a consequence of the genotoxic properties of estragole, methyl eugenol and safrole. The addition of these substances to foods in isolated form has therefore been prohibited since 2011 by Regulation (EC) No 1334/2008 on flavourings, which also defines maximum levels for foods flavoured with preparations that naturally contain these substances. The EFSA will be finalised by May 2025. As estragole and related substances are found in a vast number of herbs and spices, such as anise, basil, tarragon, fennel, star anise, nutmeg, pepper and many others, the possibility of further restrictions that go beyond those already laid down in the flavourings regulation cannot be ruled out in the medium term.

Analysis

PhytoLab has a method for determination of estragole, methyl eugenol, safrole and other toxicologically relevant phenylpropanoids, such as ß-asarone, apiole, dillapiole, elemicin and myristicin, in raw plant materials, extracts, flavourings, essential oils or finished products at its disposal, which has been accredited in accordance with Article 64 of the German Food and Feed Code (LFGB) with code number L 47.08-2.

Toxicological issues

Even if a regulatory limit has not been specified, the question of what constitutes a safe level of estragole or another phenylpropanoid within the meaning of Article 14 of Regulation (EC) 178/2002 may arise in individual cases (e.g., baby food). PhytoLab experts with many years of experience are at your service when it comes to questions of this nature.

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

Medical Affairs:

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

Analysis:

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

Regulatory Affairs:

ANKE STEUBER
Phone +49 9163 88-446
anke.steuber@phytolab.de