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EU NHCR in the dock

German professors sue EC over ‘void’ EU health claims regulation

2 commentsBy Shane Starling , 12-Mar-2012
Last updated on 13-Mar-2012 at 10:56 GMT2012-03-13T10:56:45Z

The NHCR is being challenged on many grounds. One is the core idea of disease risk factor reduction

The NHCR is being challenged on many grounds. One is the core idea of disease risk factor reduction

The two German professors of law and nutrition that were rebutted by EFSA and the European Commission over a water-hydration health claim have made good their threat, and dragged the controversial EU regulation into court.

The action, lodged by professors Moritz Hagenmeyer and Andreas Hahn, asserts the EU nutrition and health claims regulation (NHCR) should be “declared void” on nine separate grounds including:

  • Arbitrary and unnecessary reliance on ‘reduction in disease risk factors’ (“legally unjustified”)
  • The existence of a disease risk factor in their own article 14 submission rejected last year
  • Non-proportionality
  • Breach of “essential procedural requirements”
  • Breach of time limits

The case will be heard in the European Court of Justice and is the first time the NHCR has been challenged in European courts. The action is published in the latest edition of European Food and Feed Law Review.

The professors had submitted the claim: “Regular consumption of significant amounts of water can reduce the risk of development of dehydration and of concomitant decrease of performance.”

The European Food Safety Authority (EFSA)’s Panel on Dietetic Products, Nutrition and Allergies (NDA) rejected the claim, saying these were, “measures of water depletion and thus are measures of the disease (dehydration).”

It therefore concluded: “…the proposed claim does not comply with the requirements for a disease risk reduction claim pursuant to [the NHCR].”

Subsequent EC and member state deliberations brought no revision, prompting the professors to ponder legal action.

Risk factors

The court action makes the case that the concept of ‘reduction of disease risk’ that is so fundamental to the NDA claims assessment process, is not written into the regulation itself, and therefore invalid.

“[EU regulation No. 1170/2011 – where the rejection is written into law] has to be declared void, because the defendant has declared the mentioning of a ‘risk factor’ compulsory for an application for authorisation although such an obligation does not follow from the Regulation [NHCR – 1924/2006].”

They highlight what they see as an inconsistency between the ruling handed them and that for a xylitol-dental carries claim, which was positive.

In that instance they noted that the NDA changed the proposed wording to make it fit the disease risk factor reduction model, but their application was given no such treatment.

“That is legally unjustified.”

After publication professor Hahn sent an email stating: "We think that our arguments are convincing. Nevertheless nobody knows whether this will be a political decision."

2 comments (Comments are now closed)


hhhmm. I understand that an Art 14 disease risk reduction has to refer to a "risk factor" (this to have a clear regulatory distinction to a medicinal claim).

If a claims refers directly to a disease, symptom, dysfunction, syndrome etc - then we have a medicinal claim.

If this case was sucessful at the ECoJ, then it is not necessary anymore for applicants to provide any risk factor for an Art 14 Claim. Then we can directly refer to a disease.

I don't think this was the intention of the legislators, and therefore I think this case will not result in anything from which food industry could profit.

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Posted by Norbert Sedlacek
13 March 2012 | 18h082012-03-13T18:08:38Z


Finally some men stand up against this dictatorship!

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Posted by Hansa
12 March 2012 | 20h382012-03-12T20:38:57Z

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