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.
DATE » 18.11.2020
AUTHORS » Sabine Richter; Dr. Klaus Hellmann; Dr. Regina Wolf