At Probiota the conference held in Copenhagen from 28th-30th March, there was great debate about the use of the word "probiotic" on labels. While it is allowed in several European countries including Spain, Italy, The Netherlands, Denmark and the Czech Republic, it is still not allowed in the UK and several other European countries.
A lively panel discussion took place on the final morning of the conference chaired by Stephen Daniells, NutraIngredients Editor in Chief of NI North & South America, Tanne Severin Holm of the Danish Veterinary and Food Administration, Brian Kelly – a Lawyer and Partner at European Life Sciences Group and David Pineda Ereno of DPE International Consulting.
Tanne explained to the hundreds of delegates gathered at the conference that Denmark published a new guideline in May 2021 which allows the use of the term ‘probiotic’ on food supplement labels and that it can be used as a mandatory category designation for food supplements but not food.
She said: “We still do not allow use for food, but we do allow it for food supplements. We are working to try and find a harmonised approach. Member states have different approaches and the playing field has become disharmonised, but we feel an urgent need to find a unified approach.”
Denmark followed the interpretation of The Netherlands and Poland where they consider probiotics as a mandatory category term for dietary supplements. Food supplement products can now be labelled with ‘probiotics’ when the product contains live lactic acid bacteria or bifidobacteria and it is assumed that the term is used so as not to imply a claim of the product. It cannot be used with extra information such as ‘probiotic effect’ for example as this could suggest a health claim.
Tanne added: “The use of the term is still voluntary, and we are still within the rules of the Claims Regulation so the term can therefore only be used on food supplements but not on other foods or food ingredients. I think the situation has changed a lot for the consumer and there's been a surge of fake information circulating online about what's healthy and beneficial for your health including supplements that can prevent COVID infections – there’s all kinds of fake news out there. It's become really confusing for consumers to navigate.”
Brian, who co-chairs his firm’s Food Industry Group provides regulatory advice across all food and beverage categories including food classifications and labelling, said the law needs to be changed.
He said: “The EU Commission finds it difficult to stray from its historic position with pro and prebiotics and this is one of the most restricted regimes in the world and I think there's going to need to be a change like there was in Denmark from central level. There's so much history around the word probiotic, with this whole health change regime. We have our own adjudicator for this in the UK Advertising Standards Authority, which rules that probiotic is a health claim."
Brian explained that it is difficult to change the situation with changing the law or creating a framework that allows communication, like he says, they have in Denmark where there is a mandatory term.
He says:"This is a nice, easy way of just getting around the rules, because rules only apply where you voluntarily making a claim. So, if you if you make it a mandatory requirement, then the law doesn't apply and so I think we're going to need some creative thinking on that. There’s a lot of momentum behind this right across the industry, not just supplements but right across the food sector. I'm still scratching my head why it hasn't been done months if not years ago.”
David Pineda Ereño explained, many EU member states, including Italy and Spain, are starting to go their own way, adopting a more liberal approach.
He said: "Consumers are aware of the benefits of probiotics on their digestive health and immune system. During the pandemic sales have accelerated very significantly and this contibuted to a positive impact among a number of EU states concerning the use of the word probiotic.
"The EU Commission has come out with its own interpretation to consider the word probiotic an unauthorised health claim. This intrepretation has been followed since 2006 and was followed by many EU member states with the exception of Italy and the Czech Republic as they are allowing the use of the word probiotic on the label. Since 2020 the Spanish authorities changed their position and are allowing the word probiotic on the label by using the principal mutual recognition."
Brian said he was pleased to see the UK is recognising and talking about separate regulation for nutraceuticals in the UK and having a category that can involve probiotic supplements and a whole are for functional ingredients to be operating.
He said: “Having a category that may involve supplements, probiotics and a whole area for these functional ingredients to be operating, I think that's been the problem. From a classification perspective or an enforcement perspective, how do you really manage that to give legal certainty to that area? That's another lesson when thinking and talking about a nutraceutical framework.”
He says a US style framework could come into play, and it could be a way of creating a different approach for health claims.
He concluded: “Essentially, these claims are just not getting approved and companies aren't submitting. The really depressing point is that there's lots of excellent science out there.”