Key points
The probiotics industry suffered more than most from the arrival of Europe’s Nutrition and Health Claims Regulation (NHCR), but there are several developments in the pipeline that may offer a glimmer of hope.
First, the European Food Safety Authority (EFSA) is revising its guidance on how to prepare scientific dossiers supporting health claims relating to the gut and immune system. Second, the Italian industry is currently engaged in a bid to work around the ban on labelling food products as ‘probiotic’ by applying to have it classified as a ‘generic descriptor’, rather than an implied health claim.
Lastly, Beneo has succeeded in getting a positive verdict from EFSA for the ability of its inulin fibre to increase stool frequency. While inulin is a prebiotic fibre rather than a probiotic strain of bacteria, the lessons learned by Beneo in meeting EFSA’s standards for clinical research could point the way forward for other probiotics companies.
These snippets of potentially good news have been a long time coming, with virtually all previous claims relating to probiotics turned down by EFSA.
“As far as I am aware, the only exception was a claim on the effect of live yogurt cultures Lactobacillus delbrueckii subsp. Bulgaricus and Streptococcus thermophilus and increased lactose digestion,” says EFSA spokesman Jan Op Gen Oorth.
Why claims fail (Return to top)
There were three reasons why previous claims failed, he adds. Either the micro-organism was not sufficiently characterised; the claimed effect was not beneficial or was poorly defined; or no human trials were available with the specific micro-organism. “Health claims should be only authorised for use in the European Community after a scientific assessment of the highest standard,” says Op Gen Oorth.
In February, EFSA published new draft guidance on gut health and immune system claims. The draft is the result of a public consultation and was available for further comments until March 23, prior to being finalised. Before Food Ingredients, Health & Nutrition went to press, a technical report explaining the revisions was published and, with well over 100 pages to chew through, most observers were still trying to digest its contents. However, the general reaction was underwhelming.
According to Roberta Re, section manager for nutrition and health at Leatherhead Food Research (LFR), an initial reading throws up several key areas that are still unclear: “The bottom line is that everything is on a case-by-case basis, while everyone is desperately asking for a recipe telling them what they need to do.” She highlights pre-submission advice in particular as an area where industry is looking for much more support, so applicants can be sure any research they’re planning to invest in to build their case is on the right track.
“Several comments requested the possibility of consulting EFSA on study protocols in order to check whether the outcome measures and measurement tools planned may be appropriate for the scientific substantiation of health claims,” acknowledges EFSA's technical report.
However, the authority’s response provides no clear answer about how it plans to address this need in future: “EFSA would like to highlight that pre-submission meetings with individual applicants are not among the services that EFSA offers. EFSA aims, however, to develop new means and procedures to improve the interaction between EFSA and applicants. This aspect has not been addressed in the present guidance document.”
Meanwhile IPA Europe, which is the recently-formed united front of the International Probiotics Association, the Global Alliance for Probiotics and the Yoghurt and Live Fermented Milks Association (YLFA), “regrets that uncertainties remain, such as regarding study populations that are acceptable to substantiate a health claim on food”.
In contrast, LFR’s Re concedes that the right population size is probably too difficult for EFSA to pin down up front without looking at how each study is set up, but she thinks that EFSA’s call for studies to be conducted for “an extended period of time” is unnecessarily vague: “Does that mean two months or six months? What would be acceptable?”
Many hurdles to face (Return to top)
Of course, the hurdles faced by specific claims are only one aspect of the industry’s difficulties. The EU has deemed that the terms ‘probiotic’, ‘prebiotic’ and ‘antioxidants’ carry with them implied health claims. Since any claim for probiotics must be strain-specific, this amounts to a de facto ban on the use of ‘probiotic’ on food labels since the NHCR regime came into force in 2012.
“The expression ‘contains probiotics’ was interpreted by the European Commission and Member States as a health claim, based on an assumption that was never backed up by consumer data or risk assessment studies that the average European consumer perceives the term ‘probiotic’ as implying a health benefit,” says Carine Lambert, secretary general at YLFA. This situation has led to a fragmentation of the EU internal market.
In some countries, not only is the term ‘probiotic’ banned, but, in addition, neither the name of the microbial strain nor the term ‘live’ can be mentioned in any communication to consumers.
“Yet the term probiotic has been around since the 1950s. It’s used by scientists and consumers, so we argue that it’s a generic descriptor,” she says.
Regulation (Return to top)
Unfortunately, the regulation on generic descriptors (907/13) doesn’t contain a mechanism for establishing an EU-wide solution, so the industry will need to make its case one Member State at a time.
Italy was a natural first choice, since it previously regulated the labelling of foods containing probiotics to ensure they contained sufficient live bacteria. “Italy was the only country in Europe to have an existing framework for probiotic labelling,” says Lambert. “The Italian industry was very supportive so we prepared a dossier and submitted it to the Commission in June 2014.”
She says that the dossier was accepted without objection (although there are some outstanding questions about procedure). “The Commission should now draft a regulation accepting the dossier or not and pass it to Parliament by [this month],” urges Lambert. “If Italy succeeds, I hope it will be much quicker for the industry in other jurisdictions to do the same.”
Meanwhile, Beneo has succeeded in gaining a positive opinion from EFSA for the ability of its chicory-derived inulin fibres to increase stool frequency. So how did the company do it and does it look like it will be worth the effort?
“This is the first application we’ve made under Article 13.5 [which calls for new science],” explains Anke Sentko, vice president for regulatory affairs and nutrition communication. “We submitted data for an Article 13.1 claim [a general function claim] when the register was established but EFSA ruled at that time that the fibre was not sufficiently characterised.
“We combined inulin and its short chain form oligofructose we didn’t separate them out so maybe that is why. What we have learned is to be very specific.”
Demanding requirements (Return to top)
While Beneo was always going to be conducting research in this area, Sentko says that the EFSA requirements are very demanding: “To do it as the gold standard that EFSA described wasn’t routine in nutrition research in general.”
She says the decision has already attracted a lot of interest commercially: “No other fibre can make such a claim so there will be new product developments as manufacturers want to have that added value in their products.”
She also says that the industry as a whole is fascinated by Beneo's achievement: “Being successful in the hard world of EU health claims is something to be proud of, something to be acknowledged globally.”
Meanwhile, LFR’s Re believes Beneo’s success is a good demonstration of the need to keep claims very specific: “If the claim is too general, you can’t design the study effectively.
“You have to stay focused. ‘Stool frequency’ may not be as sexy as immunity, but how do you perceive better immunity? Keep it simple and to the point, then you can put the science together that's the real lesson here.”