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Aflatoxins / Allergens

Customer issue
Our customers come to us these days with ever more questions relating to allergens. The frequency of allergies in the population at large is increasing. Many allergies are triggered by ingredients in medicines or food. The EU has passed legislation that defines 12 substances as allergens (e.g. gluten, lactose, nuts, etc.) and ensures they are labeled appropriately in foods. As a manufacturer, you need to be able to make a statement on the presence of known allergens so that your labeling is accurate, making it easier for those affected to avoid substances that provoke allergies.

Similarly, aflatoxins are part of a group of mycotoxins that are particularly harmful to humans; they are regarded as carcinogenic in small quantities. Pharmaceutical and food manufacturers may not use materials with aflatoxin contents higher than certain limits set by the regulations. Manufacturers of proprietary medicinal products are obliged to guarantee that these limits are not exceeded.

EMD’s solution
We at EMD perform well-founded risk assessments for substances with respect to both kinds of contaminants: allergens and alfatoxins. You receive a certificate confirming that it is highly unlikely that the substances are contained within the product purchased from EMD.

EMD’s certificates give our professional opinion on 38 substances that may trigger allergies. As a rule, EMD itself does not carry out analyses; instead, we perform a risk assessment by examining the raw materials and manufacturing processes deployed. We enquire of the raw material suppliers and examine manufacturing and processing processes to determine the potential danger of contamination with allergens.

EMD as a raw material supplier does not analyze mycotoxin contents. But we do perform a risk assessment for aflatoxins that certifies the origin of a specific product, and that the presence of mould or the contamination with aflatoxins is unlikely. EMD cannot, however, guarantee the absence of aflatoxins, given the nature of storage or further production beyond its premises.

Benefits for you
Voluntary labeling by food and pharmaceutical companies reduces the risk for allergy sufferers and improves consumer protection. We provide correct data on raw materials, enabling you to label your products in a legally compliant way.

You know you can rely on us for accurately researched responses to your enquiries. This helps you meet your end customers’ expectations – and fulfill your legal obligations.


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EMD Chemicals is Merck KGaA, Darmstadt, Germany, in the US and Canada.