Safety

Safety assessment is an essential phase in the development of any new food. Although few pro-biotic strains or prebiotic compounds have been specifically tested for safety, the long history of safe consumption of some probiotic strains could be considered the best proof of their safety. Although some lactobacilli and bifidobacteria have been associated with rare cases of bacteremia, usually in patients with severe underlying diseases, the safety of members of these genera is generally recognized due to their long history of safe use and their lack of toxicity. Furthermore, the low incidence of infections attributable to these microorganisms, together with a recent study showing that there is no increase in the incidence of bacteremia due to lactobacilli in Finland despite the increased consumption of probiotic lactobacilli, supports this hypothesis. With regard to other bacteria such as enterococci, S. boulardii, Clostridium butyricum, or some members of the genus Bacillus the situation is more complicated, even though they have been used as probiotics for some time.

In addition to the possibility of infection there are other risks that must be taken into account (Table 1). These include those risks associated with the metabolic properties of the strain (capacity for deconjugation/dehydroxylation of bile salts,

Table 1 Probiotic action: potential benefits and risks

Action mechanisms

Potential risks

Improvement of gut barrier

Proinflammatory effects

(immunologic, nonimmunologic)

Modulation of aberrant gut

Adverse effects on innate

microbiota

immunity

Modulation of inflammatory

Infection

response

Degradation of antigens

Production of harmful

substances

Binding/inhibition of carcinogens

Antibiotic resistance

(Specific risks related to

host, strain characteristics,

or interactions)

production of enzymes favoring the invasion/translocation through the epithelium, etc.), with the presence of active substances in the probiotic or product (immunoactive substances, toxic compounds, etc.), or with antibiotic resistance. It is clear that strains harboring transferable antibiotic resistance genes should not be used. In this context the specific risks related to each probiotic strain must be carefully identified.

Guidelines are needed to test the safety of probiotics. However, taking into account the great diversity of probiotic microorganisms, it is necessary to identify the specific risks associated with the respective strains, as well as the risk factors associated with the host and the possible interactions between probiotic-host-food components in order to assess the safety of these products. Additional epidemiolo-gical surveillance and follow-up of novel strains should be conducted. In this context, the specific risks related to each probiotic strain must be carefully identified. With regard to this, knowledge of mechanisms involved is a key factor not only for the assessment of health effects but also for the safety aspects of probiotics.

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