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.”