IPA explains rationale for harmonized probiotic guidelines at Codex

By Stephen Daniells

- Last updated on GMT

© Getty Images / ayo888
© Getty Images / ayo888
The development of guidelines and a harmonized framework for probiotics in Codex is necessary to ensure and sustain quality probiotic products on a global scale, says the International Probiotics Association (IPA).

In a wide-ranging statement from the association, IPA noted that it is “working to ensure that products everywhere in the world that are intended to be marketed as “probiotics” meet a harmonized, science-based definition, and meet basic minimum criteria.”​ 

Argentina leading proposed probiotic work at Codex

As reported by NutraIngredients-USA,​ the International Probiotics Association introduced a proposal at the 39th session of the of the CCNFSDU (Codex Committee on Nutrition and Foods for Special Dietary Uses) meeting in Berlin on December 6th, which was attended by government representatives, observers and experts from 66 Member States and 41 international organizations. The IPA proposal to work towards harmonizing probiotic guidelines for use in foods and dietary supplements received the support of Argentina, with the country committing to leading the work. 

“As a globally recognized reference for standards on food products, a guidance document or standard in Codex can facilitate the application of the FAO/WHO recommendations that are already a global reference,” ​stated the organization in a release. “IPA plans to build upon these existing recommendations, providing substantive guidance on aspects specific to probiotics, such as ingredient identification and manufacturing.”​ 

The need for harmonization

George Paraskevakos, IPA’s executive director, told us: “The establishment of global guidance will satisfy authorities, consumers and industry, and will certainly lead to better consumer satisfaction, health, well-being and ensure fair practices in food trade.”

The association noted that Codex guidelines on probiotics could address the existing recommendations (FAO/WHO, National frameworks) and provide substantive guidance on aspects specific to probiotics, such as:

-          A clear definition (which does not always exist across national regulations and is not provided at Codex level);
-          Criteria to be met;
-          Safety / characterization of probiotics;
-          Current manufacturing best practices ensuring quality;
-          Appropriate content labeling;

“These guidelines on the use of probiotics in food and food supplement could be used by the different countries as a reference for minimal standards for probiotics,” ​said IPA. “Communications regarding the beneficial effects and/or health claims, remain the competence of national / transnational authorities.”

Addressing confusion

Probiotics bacteria © Getty Images ClaudioVentrella
© Getty Images / ClaudioVentrella

The FAO/WHO defines probiotics as live microorganisms that when administered in adequate amounts, confer a health benefit on the host. IPA noted that, while this definition is dynamic, “it encompasses three main attributes that an increasing number of products labelled as “probiotics” do not meet”​. 

The marketplace is witnessing the launch of many products labeled as “probiotic” that do not adhere to the commonly referenced FAO/WHO definition, added the association. 

“There seems to exist a mix/confusion between the identification of probiotics (factual nature/what probiotics are) and the specific benefits of probiotics (what probiotics do).  This is mainly due to the fact that probiotics do not have clear status, being considered as nutrients or at least acknowledging their specific and inherent characteristics which are the physiological effect attached to probiotics and the health benefits associated to them,” ​said the IPA.

IPA’s Paraskevakos told NutraIngredients-USA: “We are all familiar with the FAO / WHO expert panel definition and subsequent work for probiotics, from 2001/2002​. This definition is good and has been respected from not only the probiotic community but also the scientific and regulatory communities since its inception. However it only provides a very general guidance for the recognition of the health benefit and consumer demand for probiotic foods, in a world where a global regulatory landscape is not harmonized.

“Due to the technological and scientific advances within the probiotic industry we are now at a crossroads and a broader scope is required to include these advancements into new guidelines. This initiative will address the growing consumer demand for probiotic products used in foods and dietary supplements with the goal of enhancing the overall safety and quality for consumers.”

What is out of scope for the Codex effort on probiotics?

IPA has also stressed that their approach does not seek to list specific requirements to demonstrate efficacy, or to introduce a strain-specific list claiming efficacy. In some cases, this is regulated at national level and Codex would not be the right forum as it could be in conflict with national lists and this is not the objective of the work, said the association. “Moreover, it would be difficult to manage updates of such a list, as this would imply initiating the lengthy procedures required for updating the Codex standard,”​ added IPA.

Stakeholder collaboration

IPA said it is enthusiastic and looking forward to supporting Argentina, which is leading the initiative at Codex. 

“Additionally this initiative is wholly supported by IPA EU and as you well know they are the ‘European voice of probiotics’ and are a chapter of IPA,” ​said ​Dr Amy Smith from DuPont Nutrition & Health, who is chairing the IPA Codex Task Force. “Subsequently we also received letters of support and discussed with other stakeholders about the process including Government agencies, NGO’s and industry.

“From all the feedback I truly believe the timing for this harmonization work to happen was ideal,” ​said Dr Smith.

To read the full IPA proposal that was presented to the CCNFSDU meeting, please click here.


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