Aflatoxins in enzymes

Background: 

Aflatoxins are genotoxic, carcinogenic and teratogenic mould
toxins (mycotoxins). They are subject to stringent statutory regulations because of their high toxicity. Maximum levels in food are laid down in Commission Regulation (EU) 2023/915 and the German Ordinance on the Limitation of Contaminants in Food (KmV).

Statutory regulations

Section 2.8.18 of the European Pharmacopoeia lays down maximum
limits of 2 µg/kg for aflatoxin B1 and 4 µg/kg for the total content of aflatoxins B1, B2, G1 and G2 in herbal medicinal products, which correspond with the maximum levels specified in the ordinance prohibiting the use of substances contaminated with aflatoxins in the manufacture of medicinal products (Aflatoxin Prohibition Ordinance [Aflatoxin VerbotsV]) published by the German Federal Ministry for Health on 19 July 2000. A much stricter limit of 0.05 µg/kg has been imposed with respect to the total content of aflatoxins B1, B2, G1 and G2 in enzymes and enzyme preparations used in the manufacture of foodstuffs (KmV) and medicinal products (Aflatoxin VerbotsV). This means that the determination of aflatoxins in enzymes/enzyme preparations imposes the highest demands on the analysis method used.

Analysis

For this reason, PhytoLab has established a high-performance method for the determination of aflatoxins in enzymes and enzyme products. This is a fully validated method, which offers a means of quantitating aflatoxins B1, B2, G1 and G2 in raw materials, active ingredients and finished products with a quantitation limit (LoQ) of 0.01 µg/kg.

Our service for you

A comprehensive, CTD-compliant document package is available for the test method and validation process. PhytoLab checks and documents the suitability of the method for your product on the basis of a product-specific verification procedure, if required.

We would be delighted to help you find solutions. Your contacts at PhytoLab:

Analysis:

DR. MICHAEL SCHWARZ
Phone +49 9163 88-327
michael.schwarz@phytolab.de

Sales:

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