Speaking as part of a regulatory panel session at the recent congress held in Barcelona, Dr Elinor McCartney, President, Pen & Tec Consulting warned that innovation in the industry needs to be balanced with attempts to shift consumer sentiment to novel foods – in particular attitudes to genetically modified (GM) foods.
When asked about the potential for industry to innovate new strains using a variety mining and genetic modification techniques, McCartney said that while new strains must go through novel foods approval in Europe, the major issues relating to novel strains remains with consumer attitudes.
“Industry loves innovation. Regulators hate innovation. Anything that is new, is potentially dangerous,” she told delegates at the three day conference.
“Any probiotic strain that has not been used traditionally in food is considered a novel strain,” said the regulatory expert.
Regulatory approval
However, she noted that because of advances in modern molecular biology it is actually relatively simple to get a novel probiotic approved in the European Union.
Indeed, she noted that her company Pen & Tec were responsible for the first application and approval a few years ago for a novel probiotic strain from the clostridium family of bacteria.
“There are quite a few pathogens that are also present in that family,” she noted. “So you could imagine the reaction, first of all from the UK member state where that was put in and then the other member states after we finally convinced the UK that this strain was safe.”
Despite initial concerns based on the family of the bacteria, McCartney said the novel food application was ‘very successful’ and resulted in the first approval for a novel bacterial strain.
“To get a clostridium strain approved as a novel food is a giant step forward,” she said.
“Of course we see that there is a lot of innovation out here. People are digging out the most weird and wonderful strains from the gut microbiome and all of them in the EU will have to go through a novel foods regulation.”
Novel strains and GMs
McCartney told delegates that as a scientist she believes ‘the way forward’ is through the use of genetically modified microbes (GMMs).
“The food industry is its own worst enemy,” she said. “The food industry, driven my marketing, are convincing people that you need natural product with no preservatives, no chemicals, and for heaven’s sakes no GMOs!”
Despite this, she said that GM probiotics, would be ‘perfect’ scientifically – and would very likely have no problem at all with EFSA in terms of novel food approvals.
“But it’s a question of a paradigm shift in the European consumer relationship with GMOs and GMMs.”
Inspired by GM … but from the wild?
McCartney and other experts taking part in the regulatory debate also noted the potential for industry to use GM technologies to design idealised strains that perform specific functions for health, but to then use the vast – and every growing – libraries of existing ‘wild’ strains to find exact or similar matches.
Using this approach a company could potentially design a strain for specific purposes using GM technology, but then look to identify a naturally occurring strain that possesses the same functions using advanced profiling techniques.
While it would still mean obtaining novel food approval for a new strain, since the final strain would not be GM itself – but rather a naturally occurring strain that matches the profile of a GM-produced strain – there may be less backlash from consumers and the wider industry, the panellists said.