EFFCA Guidelines for Probiotics in Food and Dietary Supplements

 

Premises

The following "EFFCA guidelines for probiotics used in food and dietary supplements" is a professional position paper, shared by all the members of the Association. These guidelines are the steps to be followed in order to define, as "probiotics" only strains of microorganisms complying with the listed requirements.

The EFFCA members shall have a period of 3 years to conform with the content of these guidelines.

It is agreed that this document represents the official "position paper" of EFFCA (European Food and Feed Culture Association) toward Institutional Organisations e.g. the European Union, the National Authorities etc, with reference to the use of probiotics food and dietary supplements

The EFFCA members should neither use nor make any reference to the present document for promotion and/or commercial support for their own strains and/or products, until the completion of the 3- year period established for the compliance.

EFFCA guidelines for Probiotics in Food and Dietary supplements

Introduction

Microorganisms have a long history of use to produce foods, ingredients or food supplements. In recent years the term "probiotic" has been introduced to specifically highlight the beneficial health effects of certain microorganisms. Not only the meaning of the word "probiotic" but also the individual interpretation of this word has evolved over time and led to a wide range of so called "probiotic" products.

EFFCA decided to set up guidelines for "probiotics" to have a more consistent interpretation of the word "probiotic", and a clearer interpretation of the requirements to have in place, before the microorganism should be considered a "probiotic". This document describes first of all a definition of a "probiotic", followed by a recommendation of characterizations and evaluations EFFCA believes form the minimal requirements to call a microorganism a "probiotic".

EFFCA believes that these guidelines will not only lead to more transparency for all parties in the business chain, but also will increase the intrinsic value and trustworthiness of the "probiotic" products.

Definition of Probiotics :

There are many published definitions for probiotics. EFFCA subscribes the following definition :

"Pro biotic" means "For life". Probiotics are living microorganisms (bacteria or yeasts), which, when ingested or locally applied in sufficient numbers confer one or more specified demonstrated health benefits for the consumer.

Guidelines and requirements for a probiotic

In order to claim that a microorganism or a defined mixture of specific microorganisms has a probiotic effect, EFFCA recommends the guidelines below. The general scheme outlining these quality standards for the evaluation of a probiotic is shown in figure 1. The details are specified in the following sections.

Quality standards of a probiotic should be characterized in terms of:

    1. Strain identification,
    2. Safety assessment,
    3. Biological characterization,
    4. Demonstration of beneficial effects through efficacy studies in humans,
    5. Confirmation to specification.

Figure 1

 

Ad 1: Strain identification

With respect to strain identification EFFCA refers to the recommendation by the WHO/FAO expert consultation report entitled "Guidelines for the evaluation of probiotics in Food" (ftp://ftp.fao.org/es/esn/food/wgreport2.pdf), paragraph 3.1. page 2-4, which can be summarized as follows :

It was recognized that it is necessary to know the genus and species of the probiotic strain. The current state of evidence suggests that probiotic effects are strain specific. Strain identity is important to link a strain to a specific health effect as well as to enable accurate surveillance and epidemiological studies. In case where there is suitable scientific substantiation of health benefits, which are not strain specific, but species specific, individual strain identity might not be critical for these specific health benefits.

Strain typing has to be performed with a reproducible genetic method or using a unique phenotypic trait. It is recommended that all strains be deposited in an internationally recognized culture collection.

Probiotic strains must be identified by methods including internationally accepted molecular techniques to establish the phenotype and genotype and named according to the International Code of Nomenclature (approved lists are available at http://www.bacterio.cict.fr/), and strains should preferably be deposited in a reputable internationally recognized culture collection.

Ad 2: Safety assessment

Historically, lactic acid bacteria and bifidobacteria associated with food have been considered to be safe (Adams & Marteau, 1995). EFFCA and IDF have made an Inventory of microorganisms with a documented history of use in food (Inventory is available http--www.effca.com-anglais-pages-statique-11_list_of_microorg.htm).

Potential probiotic species not included in the list made by EFFCA/IDF require more studies to demonstrate its safety. In case a documented history of safe use is not available on the probiotic species, safety studies as laid forward by Novell Food Regulations are applicable within the EU. Outside the EU, EFFCA recognizes as a bases for safety studies the recommendation by the WHO/FAO expert consultation report entitled "Guidelines for the evaluation of probiotics in Food" (ftp://ftp.fao.org/es/esn/food/wgreport2.pdf), chapter 3.3. page 6.

Despite these considerations, any possible future adverse aspect of both food and non-food associated lactic acid bacteria and bifidobacteria strains have to be investigated.

Ad 3: Biological characterization involving probiotic aspects (not obligatory*)

EFFCA recognizes that it is important to have clear evidence to support the health effects of a probiotic. The first stage of building this evidence might be done through in vitro tests. In vitro tests are useful for screening purposes and to gain knowledge of strains and the physiological mechanisms of potential probiotic strains. Examples of the main currently used in vitro tests for the study of potential probiotic strains are :

In a second stage of building the evidence to support the health effects of probiotics in vivo tests in animals play an important role. In some cases, animal models exist to provide substantiation of in vitro effects and determination of strains mechanism. *Where appropriate, EFFCA encourages, to use these in vivo test prior to human trials, as often as possible.

Ad 4: Demonstration of beneficial effects in humans

The principal outcome of efficacy studies on probiotics should be proven benefits in human trials, such as statistically and biologically significant improvement in condition, the reduction of symptoms, improved well-being or quality of life; reduced risk of disease or prolonged time for a relapse or faster recovery from illness. The definite evidence for efficacy should be proven by in vivo tests in humans.

For the minimal requirements of "demonstration of a health benefit" EFFCA adopts the LABIP recommendations outlined in a LABIP workshop document (G. Guarner and G.J. Schaafsma. 1998. Probiotics. International Journal of Food Microbiology. 30, p. 237-238) sponsored by the European Community (supported by EFFCA) and the recommendation by the WHO/FAO expert consultation report entitled "Guidelines for the evaluation of probiotics in Food" (ftp://ftp.fao.org/es/esn/food/wgreport2.pdf), which can be summarized as follows :

"For the demonstration of a specified health benefit of a specific strain or a defined mixture of specific strains, a well designed human study (like: double blinded, placebo controlled, sufficient representative numbers of probiotics etc) is required, and the proof of efficacy in humans should be granted by at least one well-designed human study".

With respect to what is a "well-designed human study" EFFCA should stipulate that such studies must be designed and performed according to good clinical practices and approved by ethics committees, which control the conduct of studies using human subjects.

Ad 5: Specifications and labelling

EFFCA recognizes that all products should meet the specifications outlined by the supplier. It is up to the manufacturer to define the details of specifications of its products. Information provided to the customers should be not misleading. EFFCA recommends supplying customers with detailed information, which should at least contain :

EFFCA recommends that specific beneficial health effects should also be mentioned in the documentation and/ or on the label.

Currently in most countries, only general functional claims are allowed on foods and foods supplements containing probiotics. A specific claim on the label and in promotion should comply with Codex General Guidelines on Claims (CAC/GL 1-1979 (Rev. 1-1991) and/ or locally accepted recommendations to avoid misleading information

EFFCA has the position that specific health claims on foods should be allowed relating to the use of probiotics, where sufficient scientific evidence is available.

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