European legal framework

Probiotic Foods in the EU

In the EU, Probiotic foods, mainly fermented milks and supplements, fall within the scope of the General Food Law. Communication on the nutritional & health effects of probiotics is regulated by the Nutrition & Health Claims Regulation 1924/2006 (NHCR):

Food business operators have to obtain a prior-authorization from the EU Commission to be entitled to communicate on the beneficial effects of their products on the product label or in advertising, ie Health claim approval.
NHCR applies to nutrition claims (such as “low fat”, “high fibre”) and to health claims.

Probiotic Foods in the EU: the regulatory framework

Almost 400 health claim applications with probiotics have been submitted for authorization. Only one was authorized – an article 13.1 claim on live yoghurt and improved lactose digestion for the microorganisms L. delbrueckii subsp. bulgaricus and Streptococcus thermophilus (minimum 10⁸CFU/g ).

Scientific Opinion on the substantiation of health claims related to live yoghurt cultures and improved lactose digestion (ID 1143, 2976) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 (Link).

All other probiotic health claims applications have been either rejected or withdrawn due to the uncertainty of the assessment of EFSA. The most common reason for rejection was the insufficient characterization, but in some cases, application on well-characterized microorganisms were also rejected. As there is no health claim authorized for individual strains (excep. the yoghurt microorganisms), probiotic is considered by the European Commission as a health claim.

However, in recent years different approaches have been developed by EU Member States.

Probiotic Foods in the EU: the EC Guidance of 2007

EC Guidance on the Regulation N° 1924/2006 on nutrition and health claims made on foods

A claim is a nutrition claim if in the naming of the substance or category of substances, there is only factual information (Nutrition claims examples: Contains lycopene; Contains lutein)
A claim is a health claim if in the naming of the substance, or category of substances, there is a description or indication of a functionality or an implied effect on health.

Enabling consumers to make a responsible choice

The EU Regulation on the provision of food information to consumers (FIC, EU 1169/2011), in whereas 17 states that:
‘The prime consideration for requiring mandatory food information should be to enable consumers to identify and make appropriate use of a food and to make choices that suit their individual dietary needs.’

The lack of a clear communication for the probiotic category is not helping consumers in making responsible choices.

Probiotics in the EU: Different approaches in European countries

Portugal (update February 2024)

In order to market probiotic food supplements in Portugal that are not yet on the Portuguese market, and that are already marketed in at least one European Union (EU) Member State (MS), the economic operator must notify the DGAV that it complies with the requirements for mutual recognition DGAV notification procedure

France (update January 2023)

On 24th January the Directorate General for Competition policy, Consumer Affairs and Fraud Control (DGCCRF) updated the Q&A about the implementation of the nutrition and health claims (Regulation (CE) n°1924/2006), with Q29 and Q30 on probiotic food and food supplements: DGCCRF LINK

The term probiotic is understood to refer to live microorganisms that, when consumed in adequate quantities, have a beneficial effect on the health of the host by contributing to the balance of the intestinal flora. It is therefore clarified that ‘probiotic’ is considered as a “non-specific health claim” which is allowed if accompanied by a specific authorized claim related to the probiotic action (e.g. on yoghurt the specific authorized health claim: “Live cultures of yoghurt or fermented milk improve the digestion of lactose – contained in these products – in individuals with difficulties in digesting it”).

In the case of food supplements, the term ‘probiotic’ can also be used as a category name to characterize the nature of the substances used in the product, as required by Article 6(3). Point (a) of the supplement Directive 2002/46/EC, providing that specific conditions are met (English translation here).

Denmark (update May 2021)

Denmark has published on May 11 2021 a new guideline on labelling which authorises the use of the term ‘probiotic’ on food supplements labels. The term can be used as a mandatory category designation on food supplements. The term “probiotics” can therefore currently be applied to food supplements, but not to other foods or food ingredients. The DK rule is available on the Danish Veterinary and Food Administration website.

Italy

The Italian Guidelines on Probiotics and Prebiotics are a comprehensive guideline for probiotics in food, allowing the use of the term “probiotic” if specific conditions are fulfilled.

Italian Ministry of Health: indication for use in food and food supplements of probiotic microorganisms traditionally used for intestinal microflora balance – English Version (www.salute.gov.it).

Czech Republic

The Czech Republic has issued National Guidelines allowing the use of the term “contains probiotics” as a nutrition claim, subject to the fulfilment of the conditions of use for nutrition claims defined in the nutrition and health claims (Regulation (CE) n°1924/2006) NHCR.

The Netherlands

In March 2021 the “Nutrition and Health Claims Handbook” was released, providing clear indication on the use of the term Probiotic in the Netherlands. The term “probiotic” can now be used in mandatory information, to identify the categories of micronutrients or substances that characterize the product in food supplements. The Nutrition and Health Claims Handbook is available on the website of the NVWA.

Spain (update November 2020)

In October 2020 the Spanish Agency for Food Safety and Nutrition (AESAN) issued National Q&A indicating that Spain will accept the use of the term “probiotic” on the labels of food and food supplements produced and commercialized in the country. Read more

Use of the term probiotic as “non- specific health”

Some Countries issued National Q&A indicating that the term probiotic can be used as non- specific health claim when accompanied by with the authorised health claim “live cultures of yoghurt improve lactose digestion” (Reg (EC) N. 1924/2006, Article 10.3 applies). This is the case for example of the UK.

UK Q&A Section 10: questions and answers, Q7