International Animal Health Journal: Products for shaping the gut microbiome

Regulatory opportunities and challenges

The gut microbiome is able to influence various organs and functions of the body. Feed & Feed Additives can optimize the landscape of microorganisms present in the gastrointestinal tract and even benefit diseased animals. Sabine Richter, Dr. Regina Wolf and Dr. Klaus Hellmann at Klifovet AG focus on the regulatory options available and the different opportunities for such products.

https://www.animalhealthmedia.com/products-for-shaping-the-gut-microbiome-regulatory-opportunities-and-challenges/

The gut microbiome is meant to influence various compartments, organs and functions of the body. At the same time, the microbiome may be influenced by many factors such as the physiological state and the diet, but also by substances such as medicines. In animals, feed and feed additives can influence the landscape of microorganisms present in the gastrointestinal tract. In diseased animals, specifically designed products may beneficially affect the gut flora. Any of these products have to meet different provisions and fit into regulatory requirements of the legislation in the territory before being placed on the target market. Depending on the product, its intended use and classification, different regulatory pathways for feed materials, feed additives or veterinary medicinal products are defined in the European Union, as described in more detail hereafter. These different regulatory pathways provide different opportunities, but also challenges for the product on the market. Other factors such as quality requirements, distribution channels and market opportunities also have to be taken into consideration for a successful development. This article focuses on the regulatory options available and the different opportunities for such products.