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Dr Schroeter: Concerning the first question my answer is clearly no. Even if you talk about guidelines in the framework of the Codex, it is an old experience that guidelines are the first step and legislation is inevitably the second because all Codex Alimentarius standards have legal impact since the World Trade Organization Agreement. I do not know what the outcome of such legislation would be, but it will neither be coherent nor transparent. The relevant aspects of single probiotics are too different to be dealt with in detailed claim legislation. These things can adequately be dealt with applying the general food principles to each single case and these principles need not be newly established. Article 8 of our food law forbids the marketing of food that can be a hazard for health. Article 17, saying "You may not mislead the consumer" and also "You may not raise claims which are not based on a sufficient scientific evidence," is also part of the food legislation all over the world. If probiotics or functional foods would be intended for a special dietary use, there are regulations on food for special dietary uses. If it would be a novel food, it would fall in the framework of the novel food regulation. We need no new legislation, but what we need to do is to apply strictly and adequately the present food law. There may be one special problem, the problem where we have the borderline between health claims and disease claims. But this is a general problem not related only to probiotics.
Dr Mogensen: Being an industrial person, I think that we could do with some harmonization and softening of the law. Today, it is impossible to say something on preventing, curing, or relieving diseases. I agree that we should not mislead the consumers, but there is an increasing understanding of the importance of the relation between food and health and this has also been recognized by the European Community. They are putting 5 billion dollars in the next 4 y into research in this area and they do expect the industry to come up with a similar sum. I have difficulties seeing why industry should invest 5–6 billion dollars in 4 y if they are even not allowed to promote this process. I think that they should have the option to at least make claims—for which I would prefer the word ‘information.’
Dr Schrezenmeir: I was quite astonished that a German judicial person would feel that everything is OK except for one minor point. But I think the impossibility to inform the consumer on preventive effects from a disease is the major point. If we leave the situation as it is, we have a continuing problem.
Dr Collins: I think that we are engaging in semantics here. I am really confused about the fact that disease-related advertising is prohibited, but health-related advertising is not. The consumer is going to be very confused, because lack of health is disease. By now many groups in Europe are working on either treating or preventing specific diseases with probiotic . Should they be applying for approval as medicines, not as foods? Is that realistic? What the consumer wants is something to prevent disease or treat disease. The consumer is obsessed with disease. What is health if it is "not disease"? Talking about "balance," "promoting health," and all that kind of stuff is masquerading because it means being dishonest to the consumer.
Dr Przyrembel: A group of foods intended for the treatment of diseases has been already defined, the foods for special dietary uses. There is no need to define another group. I think what everybody finds a little bit difficult is to accept food that is put on the market as conventional food, while at the same time a claim is made that it is suited for treatment. No legislative system can allow these 2 things to go together.
Dr Collins: I would argue that the specified foods are offered for deficiencies, for example a vitamin deficiency, but are not actually treating active disease conditions. There is no food I know of that is certified as a food to treat a disease.
Dr Przyrembel: Our law, for instance, considers a product that is primarily intended for treatment no longer a food. If the primary intention is not the treatment then you can market it as food. I agree with Dr Schroeter that one should clearly differentiate between the regulation for probiotics and for health claims in general, concerning all kinds of foods.
Dr Collins: It seems to me that we should have different levels of scientifically validated claims and different food categories. The general food for the population, a specifically claimed food for certain applications, and food that would be almost a medicine.
Dr Huis in't Veld: I agree with Professor Mogensen that it is very important to have international guidelines for functional foods, to which pre- and probiotics also belong. In Japan and the United States, for example, this has already been accepted by legislation, but not in Europe at the moment. There are guidelines in Sweden. Last month, guidelines for health claims were issued in the Netherlands and in the United Kingdom guidelines will very soon be available. In the Netherlands we are now able to go to an independent organization to deliver our scientific evidence for health effects. This will be evaluated by 3 experts and then get a "yes" or "no" for the use of certain health claims. But the claims may not be related to a disease. All these guidelines agree that the industry is responsible for providing scientific information for the health effects to come to some health claims. This information is to be given to the consumer. But medical claims on foods are not allowed in any of the EU [European Union] countries. So you can say something on the intestinal flora. But if you say it "prevents cancer" you come to a medical claim. Then you have a probiotic drug, which you can't get in the supermarket. To get it you have to go to a doctor for example. There are approved claims and nonapproved claims. I hope that guidelines will become introduced for the whole of Europe and actually all over the world.
Mr Kützemeier: There is consensus that there should be adequate consumer information. How to do that is another issue. However, there is one barrier in my view, which is Article 18 of the German national food law, prohibiting disease-related advertising. That should not to be removed, but modified on sound scientific evidence.
Dr Reid: I think we have to broaden definitions and should get away from health food. Probiotics is much more than food. Probiotics is health maintenance and risk reduction. We have not talked about nasopharyngeal or skin probiotics. There was only one talk about urogenital infection, but there are many other forms of applications. I think we have to be careful on how we are defining these things and we should broaden it to "health maintenance products."
Dr Huis in't Veld: In countries like Japan and the United States the distinctions between foods and pharmaceuticals are different from those in Europe. That is the point we have to discuss as well for international acceptance.
Dr Schrezenmeir: I think when we talk about whether a food should remain a food or not, we have to really think about why it should no longer be allowed to be named a food anymore if there is a proven effect of prevention of disease. Why should we have a barrier for telling the consumer that there is a proven effect?
Mr Kützemeier: This is a terminology that will be discussed within Codex in September this year [1998]. I would like to move on to point 2: Should the word probiotic be defined for the strains in the food or for the food?
Dr Denariaz: I think we saw several presentations yesterday and today that demonstrated that it is not only the strain that will give the effect but also some constituents and maybe also the other bacteria that are present in a product. So I think that when we talk about a claim on the packaging it has to be a claim that has to be validated for the product.
Mr Kützemeier: This is obviously consensus. Another question is: is there a need for defining a minimum requirement of probiotic bacteria in a product?
Dr Mogensen: Most of the researchers think that there should be certain numbers and certain efficiencies. I am often asked by a customer, what is the difference between your product and others? Why not buy another one? Therefore, I think it is important to have a documentation of the effects but we also must try to quantify. We need research in the future to clarify both the mechanisms and the requirements.
Dr Stanton: It is important to consider the minimum levels of probiotics in a food in order to consider it as a probiotic one. The most recent consensus that I can see suggests [1 x] 107 CFU [colony-forming units] per g or mL of product in order to be a probiotic product. But there is no actual consensus on that I believe.
Mr Kützemeier: [1 x] 107 CFU per g would mean [1 x] 109 CFU for a package containing 100 mL. This is a rather high number. This is more or less a suggestion, not an international consensus.
Dr Heller: I think we don't have to deal with absolute numbers at this point. We all know from experiments that one needs a certain number of organisms in a certain environment to produce a probiotic effect. So there are different numbers for different probiotic strains [and different foods]. If we call a food probiotic, this means also that a definite number of the probiotic organisms are included, derived from the scientific studies on this food.
Dr Denariaz: I totally agree with that. Another point that is important: it is not enough to define that having [1 x] 107 CFU is sufficient for an effect. This number needs to be present in the product until the end of shelf life.
Dr Mogensen: [1x] 107 CFU is enough per g if you eat 100 g. I think most investigators say that the daily dose should be about [1 x] 108 .
Dr Schrezenmeir: I think this can't be generally defined because different probiotic germs will have a different proliferative and adhesive potential as we have heard. So it is the question, which was the number with which this effect was shown the number present in the consumers' product.
Dr Driessen: Well, I think that what counts is the significant effect, not the microbial number. When we restrict ourselves to a certain number of bacteria now, then we limit ourselves for the future.
Mr Beltoft: Does the definition that the food and not only the ingredient is the probiotic mean that if you use the same ingredient in 2 different foods you would have to do the same clinical studies with both foods?
Dr Huis in't Veld: According to the guidelines in the Netherlands you have to do that. If you have a plain yogurt with a strain and prove it and add fruit then you have to do another clinical study in humans as well. That is very difficult.
Mr Kützemeier: Now, the final issue is: what would be the best approach in terms of demonstrating health benefits?
Dr Schiffrin: I think that with respect to the level of demonstration we have seen during these 2 d there is some consensus that we need clinical studies. We have seen different levels of biological organization—cellular, molecular—and we have seen a lot of in vitro systems these days but we know that for making a claim, we need some clinical evidence and hopefully in the future we will also have epidemiologic evidence when we have some time to go with these probiotics.
Mr Kützemeier: What do you mean by "some" clinical trials?
Dr Schiffrin: The clinical trials should be clearly designed, double-blind, placebo-controlled, maybe cross-over.
Dr Bhaskarabhatla: I think all of you would agree with my proposal that there should be an international body of probiotics and prebiotics. The industry, the judicial system, and the legislature all would welcome such a body. This international body would be a resource center and support the research, too. When a particular strain of probiotic bacteria is identified to be safe, effective, and successful, that information should be disseminated. Researchers or clinicians could seek that information from the resource center.
Mr Kützemeier: An interesting view, but I have some doubts about the practical chances for this proposal.
Dr Collins: In the European Union programs you cannot get funds for doing a clinical trial. If you call it a clinical trial, it excludes you from funding because probiotics are considered as food. So we have to apply for feeding trials or food trials, although what we are actually doing are clinical trials.
Dr Denariaz: We should call it then human trials. We don't have to call them clinical trials.
Dr Collins: Yes, but at the same time locally they are clinical trials, because we have to go through an ethics committee's approval for clinical trials. So I think that it is important that we comply with the European Union restrictions or the legal restrictions imposed on us. I agree that it is time now to do extensive human trials. The animal trials were of relevance up to now. Today we are in the position to proceed with extensive human trials in a safe way because we have documented safety.
Dr Heller: I think we learned from this discussion that probiotics are certainly something that is worth continued study but there is obviously a lot to do to be able to promote probiotics in the correct way and communicate it to the consumer. Thank you very much.