Special edition: Probiotic regulations and claims

Negotiating Europe's probiotic claim laws

By Shane Starling

- Last updated on GMT

Related tags Health claims European union

The third article in this series on probiotics looks at the
regulatory situation in the world's biggest and most developed
probiotic market - Europe.

The European market for probiotics has been booming for the best part of 10 years and has been one of the fastest growing sectors of the functional foods industry, let alone the mainstream food industry. Despite this, there are no established rules governing the way they are regulated in Europe - not in the European Union (EU) anyway - it is very much a country-by-country situation although that may be about to change in regard to health claims. Nutrition and health claims ​he European Union nutrition and health claims regulation - passed in January 2007 - will in the next 2-3 years drastically alter the European food marketing landscape, as thousands of claims are built into a centralized list. The claims-sensitive probiotics industry is watching keenly to see how this pans out. There are many probiotic dossiers that have been submitted to the European Commission, often relating to individual probiotic strains, and much value is attached to those that are approved. According to a presentation given by Kevin Gillies at the International Probiotics Association (IPA) World Congress held earlier this month, claims in the future will be strain-specific, placing greater weight on companies to get their regulatory house in order, especially if they want to compete in an increasingly claims-oriented market. At present, products can note the type of probiotic strain they may contain, but specific health claims are largely prohibited. January 2010 is the deadline for claims to be scientifically assessed by the European Food Safety Authority (EFSA) and passed back to the EC for final publication (or rejection). Interlinked with nutrition and health claim rules are nutrient profiling guidelines that are being debated and may affect which products can bear health claims. For instance a sugary probiotic yoghurt may be preventing from flagging its probiotic health potential to consumers because its sugar content may exceed thresholds being discussed within the EU and it may therefore be prohibited making any health claims. Again it is unclear which way this debate is likely to go although an EU working group has indicated it is favoring a pro-claims liberal approach but this aspect of the legislation has seen an excessive amount of flip-flopping. Another wait-and-see then. Other regulations ​ There is another EU working group considering a select bunch of nutrients for addition to the 2002 Food Supplements Directive positive list but there is little indication what the results of its work will be. Similar work is ongoing in relation to the fortified foods regulation. In the meantime, probiotics exist, like glucosamine and chondroitin and a few other nutrients, in a liminal space 'between regulations'. Gillies said probiotics are regulated by the rules pertaining to the products they are incorporated into and the health claims made about those products. He noted that probiotics, in regard to the EU's highly anachronistic Novel Foods laws, that only those strains that could demonstrate a history of safe use after May, 1997 were eligible to remain on the market without Novel Foods approval.

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