Regulation

Regulating the safety of probiotics - the European approach
Wright, A. von

This article reviews pertinent legislation regulating the safety of probiotics within the European Union (EU). Currently available probiotic organisms and known issues regarding their safety are briefly summarised. While most of the species and genera, particularly lactobacilli and bifidobacteria are apparently safe, certain micro-organisms may be problematic; particularly the enterococci, which are associated with nosocomial infections and harbour transmissible antibiotic resistance determinants. At present, probiotic human foods are not governed under specific EU regulatory frameworks, although the Novel Food Regulation EU 258/97, could be relevant in some specific cases. However, microbial feed additives (regulated by Council Directive 70/254/EEC and in accordance with guidelines of the Scientific Committee on Animal Nutrition (SCAN)) are subjected to detailed safety assessment with the intention of ensuring that they are innocuous to target animals, users and consumers. Particular attention is focused on the presence of transmissible antibiotic resistance markers, and to the potential for production of harmful metabolites. The guidelines do not differentiate between species and strains with long histories of safe use and other micro-organisms. This has caused some concern regarding overregulation, if the same principles are to be applied to probiotics or starter cultures intended for human food use. Accordingly, SCAN has launched an initiative towards a "Qualified Perception of Safety" (QPS) concept, which would allow strains with established safety status to enter the market without extensive testing requirements. It is likely that the European Food Safety Authority (EFSA) will play a central role in the regulation of both human and animal probiotics.
Curr Pharm Des. 2005;11(1):17-23

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The importance of guidelines in the development and application of probiotics
Reid G.

Probiotics, defined as "Live microorganisms which when administered in adequate amounts confer a health benefit on the host" have many attributes including the lack of adverse side effects associated with their use. While probiotics have proven benefits, the optimism associated with their use is counterbalanced by the fact that many so-called 'probiotic' products are unreliable in content and unproven clinically. Therefore much remains to be done to gain the acceptance of the broader medical community. Recognition of the obvious product inequality and the lack of any regulatory guidelines lead to the development of Operating Standards in 2002 (FAO/WHO), that would ensure product safety, reliability and a level playing field for all companies producing probiotic products. The guidelines constitute a set of parameters required for a product/strain to be termed 'probiotic' and also the clinically relevant steps to be followed to move probiotics closer to being embraced by the medical community. These include
i) implementation of Guidelines for use of probiotics;
ii) phase I, II and III clinical trials to prove health benefits that are as good as or better than standard prevention or treatments for a particular condition or disease;
iii) Good Manufacturing Practice and production of high quality products;
iv) studies to identify mechanism of action in vivo;
v) informative/ precise labelling;
vi) development of probiotic organisms that can carry vaccines to hosts and/or anti- viral probiotics;
vii) expansion of proven strains to benefit the oral cavity, nasopharynx, respiratory tract, stomach, vagina, bladder and skin as well as for cancer, allergies and recovery from surgery/ injury.
Curr Pharm Des. 2005;11(1):11-6

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