The last 12 months have been a difficult period for the probiotics industry. Four years after the EU announced it would introduce legislation to ensure all health claims were backed up by scientific evidence, not a single claim for a probiotic has yet been approved.
Danone conspicuously withdrew its application for approval of Activia and Actimel in April this year, after it became clear from the tranche of rejected probiotic claims that it was unlikely to gain approval.
Many of the claims were rejected by the European Food Safety Authority (EFSA) not on the basis that the science was flawed, but that the evidence did not characterise the strain in question clearly. But the rejected claims produced a raft of negative headlines, and concerns were voiced about how it would affect the £220M dairy shots industry, which relies on health claims for promotion.
But despite this hurdle, and the recession, the consumer probiotics market is in healthy growth. According to market researcher Frost & Sullivan, the EU market for digestive health ingredients which includes probiotics, prebiotics and digestive enzymes is likely to be worth $536M in 2015, up from $245M in 2008.
Manufacturers are also increasingly seeking out more targeted strains, expanding the market for probiotics even further. Danisco has developed a strain it claims will target obesity-related diabetes. The strain bifidobacterium lactis 420 counteracts the adverse effects of a high-fat diet, it claims, with tests on mice showing the strain is effective at allowing mice on a high fat diet to process glucose at the same rate as mice fed on a normal diet.
Weight loss probiotics are also being explored by fast-moving consumer goods giants, including Nestlé, according to Frost & Sullivan: "Nestlé's northern France-based Research Center and Imperial College London have recently entered an agreement to focus closely on gut microflora that affects metabolism to control weight," a report by the organisation claims. "Pioneering companies are trying to look for ingredients that have a more specified and targeted effect," says Kalle Leporanta of Valio. "In Japan you can buy products that are specifically targeted at pollen allergy caused by one specific type of cedar tree."
More common within Europe are immunity or gastrointestinal health products. Chr Hansen, for example, launched two new strains at the Vitafoods exhibition in May. Lactobacillus fermentum PCC and Lactobacillus F19 are the two most recent extensions to the company's Probio-Tec range of probiotic strains, both of which are designed to improve immunity.
Many more targeted strains of probiotics are being developed. According to Peter Rothschild, chief executive officer of BioGaia, BioGaia is developing a strain designed to combat helicobacter pylori, the bacteria that causes stomach ulcers. Other specific strains recently launched by BioGaia include one that tackles colic, and another for oral health problems such as tooth decay and gingivitis.
Fruit juices are set to become a more popular vehicle for probiotics, following the success of the Scandanavian brand ProViva. Sales more than doubled in the five years to 2008 to reach $83M [Euromonitor]. "One could easily imagine that natural beverages such as fruit juices or smoothies could become an accepted vehicle for probiotics and we are investing in that area to meet the future demands," says a Chr Hansen spokesman.
Healthy confectionery is a fast-growing area. Danisco also launched a probiotic 'yogurt bear' at the Vitafoods show containing its Howaru probiotic. The yogurt bears are a sugarless treat, similar in look to gummy bear sweets and are designed to make probiotics more appealing to both children and the elderly, says Audrey Bernard of Danisco. The firm is also set to launch a powdered probiotic sachet which can be added to cold drinks or mixed with cold foods, provisionally called Howaru Sprinkles. Probiotic cottage cheese, gum, mints, chews and snack bars are also likely to become more popular in the coming years, according to Euromonitor.
Technology is fast adapting and new techniques are being developed to get probiotics into different foodstuffs. "In order to achieve probiotic effect you have to guarantee a certain concentration of live probiotic bacteria in the product, also at the end of shelf-life," says Leporanta. "This is relatively easy in fresh dairy products that are refrigerated, as there is not normally much loss of the bacterial count. At best there is some increase of the bacterial count during manufacturing."
Chr Hansen says there are similar challenges: "One always has to ensure that the required amount of live probiotic bacteria are present at the end of shelf-life of the product, so that the consumer is certain that the health benefit is present. This can be a big challenge for some products, and not all probiotic strains have the same ability to survive in all foods."
Microencapsulation has long been touted as a way of making probiotics more stable. The method, which involves coating the bacteria in a protective shell, could protect probiotics from the heat that would normally kill them. Patricia Siuta-Cruce, vice president, technology, Balchem and Jacques Goulet, scientific director, Institut Rossell have researched this technique and, according to Frost & Sullivan: "Have developed an encapsulation process that offers good protection against short exposure to high temperatures."
Others, such as Wageningen University in the Netherlands, are looking at nanoencapsulation with a shell measuring between just two and 10 microns. This potentially opens to door to the wide availability of pasteurised foods and baked goods, although some in the industry, such as BioGaia, maintain the technology is not yet of a scale that would allow it to be used widely.
Probiotic straws, which contain the bacteria and are activated when used with a drink, and drinks with a blister pack on the lid were developed by BioGaia to address this problem, and are gaining in popularity, according to Rothschild, with companies such as Nestlé using them on drinks across the world. According to Euromonitor, the probiotics market in Europe is forecast to grow by 6% annually for the next five years, despite the recession and the negative publicity surrounding the EU health claims legislation. Chr Hansen says the reasons are clear: "The market for probiotics is still growing as consumers continue to buy products with health benefits they can feel."
Although the EFSA rulings are causing a lot of publicity, they are unlikely to heavily dent consumer demand, according to Sneha Pasricha, senior research analyst, Frost & Sullivan. She says: "There is a lot of buzz about the on-going EFSA issue but consumers seem to be still buying products with probiotics. This is because the health benefits of probiotics are well perceived in Europe and, until anything drastic happens with respect to regulatory scenario for probiotics, it is expected that the trend should continue."
Peggy Steele, global business director at Danisco, says the pressure is on manufacturers to prove effectiveness to sceptical retailers and consumers: "They seem to be very interested in getting probiotics that are clinically documented and at the higher levels that can deliver a true health benefit to their consumers. I think right now they are watching very cautiously to see what will happen and I don't see them walking away from this unless all the opinions are negative."
Nevertheless, there are concerns. "No doubt we are seeing reduced new product development (NPD) activity while food producers await more clarity regarding health claims," says a Chr Hansen spokesman. "The threat is not the legislation itself, but the uncertainty regarding the process."
Caroline Herody, regulatory affairs manager at Danisco, says EFSA needs to provide more guidance: "We support EFSA's work in ensuring that the claims are based on sufficient levels of science. I think the difficulty is related to the fact that there is a lack of clarity from EFSA on the requirements to actually compile a successful dossier, especially for ingredients such as probiotics, which are based on emerging science. They are clearly not generic ingredients. We hope that, in the coming months, EFSA will clarify the details it is expecting to actually substantiate officially the gut health and immune health claims. So it is just a matter of having better guidance from EFSA to be able to supply it with the data it wants."
Leporanta says that, until there is clearer guidance, NPD activity in Europe could be affected. "I do not believe that the health claims issue will kill the probiotic market, but it will certainly have an impact. Only the strong survive. We are confident that some probiotic products will get a health claim but this may still take quite a long time." Next year a full list of approved claims is expected to be published by EFSA. Whether any probiotics make it on to the list is another matter.