Probiotics, the chaos of labels in the European single market

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Probiotics-label

The manifesto published by the International Probiotics Association (IPA) on 9 December 2023 offers an opportunity to highlight the chaos of the labels of foods and food supplements that contain probiotics, in the single market of the Old Continent. (1) The status-quo and the essential solutions, in summary below.

1) Probiotics, concept

The definition of ‘probiotics’ as ‘live microorganisms that, when administered in adequate amounts, confer a health benefit on the host‘ (FAO, WHO, 2014) can be broken down into four simple criteria that allow us to establish whether certain strains of microorganisms can be qualified as probiotics, for the purposes of their use in foods and food supplements (Binda et al., 2020). (2)

Probiotic strains can be designated as such – in scientific literature, regulatory dossiers and communications with the authorities, information to consumers – provided they are:

– sufficiently characterized (genus, species, sub-species, according to international nomenclature, followed by the indication of the strain which may correspond to the catalog number of a recognized ‘cell collection’ or a commercial strain designation);

– safe for intended use. For this purpose, consideration may also be given to the QPS (Qualified Presumptions of Safety) developed by EFSA;

– supported by at least one positive clinical study in humans, conducted according to generally accepted scientific standards or the provisions and recommendations of the competent authorities, where applicable;

– live in the product, until the end of its shelf-life, at a dose effective for the purposes. (2)

2) Popularity and benefits

Foods and food supplements containing probiotics have achieved considerable popularity in the Old Continent in the last two decades. In fact, European consumers tend to associate the term ‘probiotic’ with microorganisms beneficial to health, thanks to their favorable interaction with the intestinal microbiota.

Scientific literature has in fact already confirmed the correlations between the intake of probiotics and a wide series of health benefits, of particular importance among other things in the modulation of the immune system (3,4,5). While research continues, with a view to tackling various disorders and diseases by working on the microbiota. (6)

3) References to ‘probiotics’ on the label, the inconsistencies in the European single market

References to ‘probiotics’ – on the labels of food products and food supplements – are still without uniform regulation in the single market of the Old Continent. This situation brings to:

– serious asymmetries in information and consumer protection in the 27 member countries,

– brake on research and innovation in a sector with high potential compared to Sustainable Development Goal No 3 (#sdg3, Ensure Health and Well-being),

– alteration of competition between operators in the different national markets.

3.1) European Union, uniform rules

The European legislator has standardized the discipline of:

– nutrition and health claims to be made on foods (EC Reg. 1924/06 and following);

– addition of nutrients and other substances (Reg. CE 1925/06);

– food information to consumers (EU Reg. 1169/11).

The application of the aforementioned regulations, logically, means that:

– the probiotic ingredients, as qualified and characterized above (see the previous paragraph 1), must be included in the ingredient list of the foods that contain them; (7)

– the simple reference to the presence of probiotics on the label (outside the list of ingredients) and advertising of commonly used foods entails the application of the QUID (Quantity of Ingredients Declaration); (8)

– the specification of the probiotic content and the minimum number of live microorganisms present in the product today falls within the scope of voluntary information and better expresses, compared to QUID alone, the fairness of the commercial information, (9)

– the indication of the presence and content of probiotics does not qualify as a ‘nutrition claim’, to the extent that it is not suggested that these substances in foods have ‘particular nutritional beneficial properties‘; (10)

– the use of voluntary health claims relating to the presence of probiotics in commonly used foods is subject to the prior authorization procedure established in Nutrition and Health Claims Regulation (EC) No 1924/06. (11)

3.2) Opinions of the European Commission and EFSA

The European Commission guidelines on the application of the Nutrition and Health Claims Regulation (2007) – however devoid of any legal value (12) – incorrectly indicated the expression ‘contains probiotics’ as an example of a ‘health claim’. (13)

The scope of the NHCR is, however, limited to voluntary information in commercial communication, while the mere mention of an ingredient (with its usual name) is mandatory information. (14) The above example is therefore incorrect.

EFSA (2016) in turn confirmed that the term ‘probiotic’ cannot be understood in itself as a ‘health claim’, in the absence of even implicit indications or suggestions of specific benefits for nutrition and health which in fact integrate the respective definitions of ‘nutrition claims’ and ‘health claims’. (15)

3.3) Member States, the fragmentation of the rules

The fragmentation of the rules on the use of the term ‘probiotics’ on the labels of foods and food supplements in the single market has reached the paradox. To the point that:

– some Member States admit to referring to this category of ingredients (e.g. Italy. See note 16),

– other States limit the recall to food supplements only,

– several States even prohibit the use of the word ‘probiotics’ on any label.

Different interpretations on the labeling of food supplements are due to the Food Supplements Directive 2002/46/EC. Which should be repealed and replaced by a Regulation, to put an end to the asymmetries of protection and obstacles to the free movement of goods, in line with the principles stated in the ‘White paper on food safety’ (2000). However, the chaos on the labels of commonly used foods is completely unjustified.

4) Necessary solutions

The European Commission has the primary responsibility for ensuring the free movement of goods within the single market. Food Information Regulation , moreover, provided for the mandatory notification to DG Sante of the European Commission of any regulatory project of the Member States that affects consumer information relating to food.

Reasons of procedural economy suggest that DG Sante:

– collect data on the rules and/or interpretations in force in the 27 Member States, regarding:
the indication of the term ‘probiotics’ on the label of foods and food supplements, and the related conditions of use;

– clarify the EU rules to be applied (see above, paragraph 3.1), involving DG Internal Market to clarify the illegitimacy of national bans on the use of the term ‘probiotics’ in consumer information,

– propose to the PAFF (Plants, Animals, Food and Feed) Standing Committee to adopt theCriteria to Qualify Microorganisms as “Probiotic” in Foods and Dietary Supplements, (2) as a criterion to be followed in official controls to evaluate the ‘loyalty of information’ relating to probiotics.

The alternative solution – submitting to the Court of Justice of the European Union one of the various unacceptable national bans on the use of the usual name ‘probiotics’ to designate the relevant ingredients on the labels of food and food supplements – would indeed lead to the same results, within a couple of years late and a few more bad impressions.

Dario Dongo

Footnotes

(1) IPA Europe. Call for a responsible use of the term ‘probiotic’ in Europe. 4.12.23 http://tinyurl.com/2nkkut7v

(2) Binda Sylvie, Hill Colin, Johansen Eric, Obis David, Pot Bruno, Sanders Mary Ellen, Tremblay Annie, Ouwehand Arthur C. Criteria to Qualify Microorganisms as “Probiotic” in Foods and Dietary Supplements. Frontiers in Microbiology, Volume 11, 2020. https://doi.org/10.3389/fmicb.2020.01662

(3) Dario Dongo, Carlotta Suardi. More probiotics, less antibiotics. GIFT (Great Italian Food Trade).

(4) Dario Dongo, Carlotta Suardi. Prebiotics and probiotics, microbiome and immune system, GIFT (Great Italian Food Trade). 28.4.20

(5) Dario Dongo, Gabriele Sapienza, Probiotics, potential anti-inflammatory activity of Lactobacillus spp. and Rhodopseudomonas palustris. GIFT (Great Italian Food Trade).

(6) Gabriele Sapienza. Bifidobacterium infantis and HMO oligosaccharides to modulate the intestinal microbiota, study. GIFT (Great Italian Food Trade).

(7) Food Information Regulation (EU) No 1169/11, Article 18

(8) Regulation (EU) No 1169/11, Article 22

(9) Reg. (EU) No 1169/11, article 36

(10) Nutrition and Health Claims Regulation (EC) No 1924/06, Article 2.1.4

(11) Nutrition and Health Claims Regulation (EC) No 1924/06, articles 13,14

(12) The only institution with the power to express official and legally binding interpretations of EU law, please note, is the Court of Justice of the European Union (CJEU)

(13) Guidance on the Implementation of Regulation (EC) No 1924/2006 on Nutrition and Health Claims made on Foods. Conclusions of the Standing Committee on the Food Chain and Animal Health http://tinyurl.com/3m3ksae5

(14) ‘claim’ means any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics’ (Reg. EC 1924/06, article 2.1.2.1)

(15) EFSA Guidance on the scientific requirements for health claims related to the immune system, the gastrointestinal tract and defense against pathogenic microorganisms EFSA Journal 2016;14(1):4369 https://doi.org/10.2903/j.efsa.2016.4369

(16) Dario Dongo. Probiotics and prebiotics, green light from the Ministry. GIFT (Great Italian Food Trade).

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Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.

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