Live from Probiotech and Microbiota 2013

Ciao ciao? Italy’s rogue probiotic health claim stance may have limited shelf life

By Shane Starling in Brussels

- Last updated on GMT

Related tags European union

Ciao ciao? Italy’s rogue probiotic health claim stance may have limited shelf life
Italian food supplement manufacturers continue to make probiotic health claims under a “soft law” governmental decree, although the country’s stance could be challenged by EU organs, a lawyer said this morning at congress.

Italy is in fact permitting one single claim around the idea of ‘gut flora balance’ as condition of use information rather than a health claim, but Sebastian Romero Melchor from K&L Gates said the European Commission and member states had already formed the opinion that the Italian position contravened EU law.

“[The Italian Ministry of Health] decree is an instrument of soft law,”​ Romero Melchor said of the Italian government’s action to protect what may be the EU’s largest probiotic supplements market.

“Under article 23 of the nutrition and health claims regulation (NHCR) a member state wishing to enact its own laws needs to inform the European Commission and member states. There is a six-month period where opposition can be expressed.”

“But Italy hasn’t done that. They didn’t adopt the guidance as hard law. They kept it as an administrative guidance which avoids the necessity of going through article 23 and facing opposition.”

“It doesn’t fly legally.”

“enhances the balance of gut flora”?

The Italian decree said that since the European Food Safety Authority had deemed that increasing healthy gut flora was not of itself a health benefit, “supports the balance of gut flora” ​could be employed as a mandatory condition of use statement and not a health claim.

“The EC and member states were not convinced – they saw it is as a way of deharmonisation," ​Romero Melchor observed. "If you make it mandatory you are circumventing the NHCR.”

But no member state or the EC is known to have taken direct action against Italy.

Jean Savigny, from Keller and Heckman, in a later discussion at Probiotech and Microbiota 2013 today said the EC's silence on Italy was, "mysterious".

Article 1.4 offers hope?

Interested parties in other EU member states who had looked to Italy as a claims oasis that could have been replicated in their own jurisdictions will be disappointed by the assessment, but Romero Melchor pointed to another legal avenue: Article 1.4 of the NHCR.

The Brussels-based partner said there is a strong case for the term ‘probiotic’ to be considered a ‘product descriptor’ under that article, even if another section of the same law explicitly states that probiotics, prebiotics, antioxidants and other nutrients are unauthorised implied health claims.

“Already the term probiotic can stay on market where it is a sales name as is the case with some food supplements,” ​he said.

“Similarly with article 1.4 – the general descriptor article – there is strong legal ground to say the term probiotic can be used like this.”

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Don't misread the law, Italy's right

Posted by Luca Bucchini,

Health claims are clearly defined in the Nutrition and Health Claims Regulations, along with essential features. EFSA has said that the statement “Increasing the number of any group of bacteria" does not correspond to a benefit; hence it is not a health claim, implied or not. As a consequence the NHCR does not apply. There is plenty of legislation under which the statement may be evaluated, and possibly found misleading by competent authorities. However, the relevant legislation does not include the NHCR, and Italy is right so say so.

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When you look carefully, Italy's case is not weak

Posted by Luca Bucchini,

Italy seems to have taken EFSA at its word. My understanding of Italy's reasoning is the following. If we trust that EFSA, beyond evaluating scientific evidence, also had the mandate to say what statement is a claim, and what statement is not a health claim (as it did, most say), then when it says a statement is not a health claim, then it is not, and the regulation does not apply.
That's what it said on the statement: "Increasing the number of any groups of bacteria". Of course the claim may be regarded as an implied health claim; if so, however, EFSA should have established whether it was backed by science, or not. Instead it clearly said that it is not a health claim, as it is not health benefit related. As such a statement which is not a health claim may still be misleading under other food information laws, but not under the NHCR.
In any case, it is clearly up to the national authorities who enforce the regulation as well as other food information laws to make the call. Enforcement has to be case-by-case, as context may turn an innocent statement into an implied a health claim. Should the EC get involved? In principle enforcement should not vary across the EU. Yet, in this field, a reasonable approach, which takes into account supporting evidence from each business, in terms of consumer understanding and context, is needed. Reasonable enforcement should be left to Member States, at least for now, as authorities build up experience in their markets. If the regulation is stretched too far, aren't we also testing the boundaries of the "high level of health protection for consumers" principle that, according to the Court of Justice, warrants the prohibition of certain health claims? Is the no-flexibility approach also to conflict with the principle of proportionality and the established freedom to conduct businesses?

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Efsa/food supplements

Posted by Christian Sanchez,

If the supplment is safe, the EFSA position deprives the consumers of potential benefits like the improvement of immune system and a lot of other ones... why? because EFSA has not the absolute evidence of efficacy and theoretically will not have it never. please, leave the consumers, medical doctors.. to decide what is efficient or not and focus on safety. Thanks.

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