Food testing under GMP - food and pharmaceuticals

By Dr. Helga Neumann-Hensel, Eurofins Fintelmann und Meyer GMP GmbH, and Frank Kareth, Eurofins DILU – Deutsches Institut für Lebensmitteluntersuchung GmbH, Germany

The new unit Eurofins Fintelmann und Meyer GMP covers the area of products that lie between food and pharmaceuticals. The market of food, pharmaceuticals, over the counter (OTC) products and food supplements is very large. Many products are borderline in nature and can be a pharmaceutical as well as a food depending on how they are marketed. For example pumpkin seeds can be a roasted snack or a salad topping, garlic capsules can be a food supplement with benefits for the cardio-vascular system and peppermint oil can be a food-flavouring. However, they might all be pharmaceuticals if the labelling indicates that they are to be used to cure a disease.

In many cases the products have to be analysed according to Pharmacopoeia methods to the high pharma quality standard GMP (Good Manufacturing Practice). GMP is regulated by national and international agencies. Regulatory inspections are performed by the national agencies to ensure the quality of the service.

Eurofins Fintelmann und Meyer GMP performs the analysis under such quality standards and has GMP certification and as well accreditation to DIN EN ISO/IEC 17025. Chemical and microbiological analyses are performed according to the current Pharmacopoeia (e.g. EP, USP, BP, JP) and ISO methods. Eurofins Fintelmann und Meyer GMP can prove the microbial status of the products, identify active ingredients and impurities, and measure their content.

In cooperation with Eurofins DILU (Deutsches Institut für Lebensmitteluntersuchung), Eurofins Fintelmann und Meyer GMP offers customer support in respect of the formulation of food supplements and functional food. Eurofins DILU recommends test schemes, checks the legal status and labelling requirements of health food and is the specialist on matters such as food additives, active ingredients and health claim labelling and advertising. A health claim is any claim that states that there is a relationship between food and health, or that a food product significantly reduces a risk factor for a particular disease (like “calcium is good for your bones” or risk reduction claims like “calcium intake might reduce the risk of osteoporosis”).

For food to bear a health claim, the claim must be approved by the European Commission and the food has to contain a significant quantity of the nutrient or active ingredient in the amount of the product that can reasonably be expected to be consumed. Compliance can be tested by Eurofins.

Contacts: helganeumannhensel@eurofins.de (Eurofins Fintelmann und Meyer GMP) and frankkareth@eurofins.de (Eurofins DILU)