Currently, no consensus exists on the term “probiotic,” which has long troubled the probiotic industry.
European and many national authorities classify the term as an implied health claim due to its health benefits. However, in recent years, several Member States (Denmark, Netherlands, Poland, Spain, Italy, Czech Republic, Greece, Bulgaria) have chosen not to adhere to this opinion.
More countries are approving probiotic claims
France is now the next European country to authorize the term “probiotic.”
In early January, the French authority, General Directorate for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF), declared the term “probiotic” legally admissible on food supplement labels. Additionally, the term can accompany the phrase “contributes to the balance of the intestinal flora,” provided the product meets specified conditions such as a minimum number of live cells per daily dose. This stance aligns with the Italian perspective. Consequently, the French authority’s decision puts pressure on EU authorities for uniform regulation and harmonization within the EU.
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As experts in probiotic research, a&r can help companies navigate the complex regulatory landscape for probiotic products. With over 20 years of experience in probiotics, we offer a wide range of services, including clinical trial design, data analysis, and regulatory compliance support. Our expert team can assist companies in demonstrating the safety and efficacy of their probiotic products, ensuring they meet regulatory requirements for market approval. Moreover, we provide expert guidance on probiotic labeling and marketing claims to ensure compliance with the latest regulations and guidelines.
Contact us today to explore your probiotic claim possibilities!