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Regulation of EU probiotics
Legislative approaches to live micro-organisms used in foods


Pen & Tec Consulting, Pl. Ausias March 1, 4th Floor, D01 08195 Sant Cugat del Vallès, Barcelona, Spain


Probiotics in foods or food supplements are legally classed as ingredients in the EU and not subject to a pre-market safety assessment, unless novel. Nevertheless, food business operators must meet legal obligations in relation to safety, quality and the claims made on their products. This article summarises current legislation in relation to food probiotics, explains the background to EU (European Union) probiotic regulatory procedures, and highlights areas likely to change in the next decade. The influence of EFSA (European Food Safety Authority) opinions and guidance documents is discussed, particularly in relation to probiotic strain characterisation, antimicrobial resistance, QPS (qualified presumption of safety), interpretation of bacterial genomes and data required to support claims in relation to gut and immune function.


Surprisingly, probiotics are not defined in EU legislation, though most regulators tacitly accept the World Health Organisation definition of “live micro-organisms, which, when administered in adequate amounts, confer a health benefit on the host” (1). Despite the fact that probiotics have been used for millennia in fermentation processes to produce foods, well before the science of microbiology was able to isolate, identify, or even visualise the micro-organisms responsible for the fermented food, it is the area of feed micro-organisms that has pioneered most current EU approaches to probiotic strain characterisation and safety. This is because feed scandals such as the “mad cow” epidemic (bovine spongiform encephalopathy) helped drive a radical overhaul of EU food chain legislation, and spearheaded a range of EU legislative acts, starting with a White Paper on Food Safety, published in 2000 (2). EFSA was established in 2002, as a new, independent legal entity emanating from this White Paper on Food Safety. In the early 2000s, both EFSA and the EU Commission dealt with feed-related issues as a high priority. So, for example, althoug ...