{"id":460,"date":"2025-03-25T15:35:34","date_gmt":"2025-03-25T14:35:34","guid":{"rendered":"https:\/\/www.nutrimedia.info\/?post_type=news&p=460"},"modified":"2025-04-07T19:53:43","modified_gmt":"2025-04-07T17:53:43","slug":"probiotics-and-efsa-marketing-strategies-in-the-face-of-regulatory-challenges","status":"publish","type":"news","link":"https:\/\/www.nutrimedia.info\/en\/news\/probiotiques-et-efsa-strategies-marketing-face-aux-defis-reglementaires\/","title":{"rendered":"Probiotics: Navigating the regulatory maze and deploying effective communication strategies"},"content":{"rendered":"

As marketing professionals in the food ingredients sector, we have often had to develop special expertise to overcome the regulatory hurdles associated with probiotics. This article takes an in-depth look at the restrictions still imposed by EFSA and suggests strategic approaches for communicating effectively while complying with the European legal framework.<\/strong><\/p>\n\n\n\n

The reasons behind EFSA's regulatory blockages<\/strong> about probiotics<\/h2>\n\n\n\n

European Regulation (EC) No 1924\/2006 on nutrition and health claims has profoundly transformed the landscape of communication on probiotics. EFSA, which is responsible for the scientific evaluation of these claims, has systematically rejected applications concerning probiotics for three fundamental reasons:<\/p>\n\n\n\n

1. Inadequate characterisation of micro-organisms<\/strong><\/h3>\n\n\n\n

EFSA requires precise and exhaustive identification of probiotic strains. Dossiers simply mentioning \u00abprobiotics\u00bb or \u00ablactic ferments\u00bb without detailed genomic characterisation are automatically rejected. This taxonomic rigour is justified by the principle that thehe beneficial effects are specific to each strain and cannot be generalised.<\/strong><\/p>\n\n\n\n

2. Insufficient scientific evidence<\/strong><\/h3>\n\n\n\n

EFSA's assessment criteria are among the strictest in the world. The studies submitted must :<\/strong><\/p>\n\n\n\n

    \n
  • Be randomised controlled clinical trials on human populations<\/li>\n\n\n\n
  • Demonstrate a direct causal link rather than a simple correlation<\/li>\n\n\n\n
  • Use scientifically recognised biomarkers<\/li>\n\n\n\n
  • Present an irreproachable and reproducible methodology<\/li>\n\n\n\n
  • Be published in peer-reviewed scientific journals<\/li>\n<\/ul>\n\n\n\n

    The majority of cases fail to meet all of these cumulative criteria.<\/p>\n\n\n\n

    3. Imprecise wording of allegations<\/strong><\/h3>\n\n\n\n

    EFSA systematically rejects claims considered too general or ambiguous<\/strong>. Terms such as \u00absupports immunity\u00bb or \u00abpromotes intestinal balance\u00bb are deemed insufficiently precise to be scientifically verifiable.<\/p>\n\n\n\n

    Europe's regulatory mosaic<\/strong> on probiotics<\/h2>\n\n\n\n

    Application of the European regulation varies considerably between Member States, creating a fragmented commercial environment:<\/p>\n\n\n\n

    Country<\/strong><\/td>Status of the term \u00abprobiotic\u00bb<\/strong><\/td>Regulatory approach<\/strong><\/td><\/tr>
    Italy<\/td>Authorised<\/td>Considered as nutritional information<\/td><\/tr>
    Spain<\/td>Authorised<\/td>Tolerated under certain conditions<\/td><\/tr>
    Denmark<\/td>Authorised with restrictions<\/td>Requires scientific documentation<\/td><\/tr>
    France<\/td>Not permitted<\/td>Considered an unauthorised health claim<\/td><\/tr>
    Germany<\/td>Generally prohibited<\/td>Tolerated in certain specific contexts<\/td><\/tr>
    United Kingdom (post-Brexit)<\/td>Under development<\/td>Trend towards greater flexibility<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    This disparity poses considerable challenges for pan-European marketing strategies and requires approaches tailored to each market.<\/p>\n\n\n\n

    Communication strategies to meet regulatory constraints<\/strong><\/h2>\n\n\n\n

    What can you do about it? Certainly, you can't give up! You can always communicate effectively about probiotics by adopting certain tactics: <\/p>\n\n\n\n

    1. Factual, science-based communication<\/strong><\/h3>\n\n\n\n

    Communication should focus on verifiable factual information:<\/p>\n\n\n\n