Irish MEP: “We have opened a can of worms that EFSA and the Commission would have much preferred remained closed”

By Shane Starling

- Last updated on GMT

Related tags Efsa Health claims European union European commission

Irish MEP: “We have opened a can of worms that EFSA and the Commission would have much preferred remained closed”
Irish MEP Marian Harkin has become one of the most vocal European parliamentary opponents of the interpretation and application of the EU nutrition and health claims regulation (NHCR), and she was not appeased by EC and EFSA statements at a specially convened parliamentary meeting in Brussels yesterday.

There Harkin pointed to a clause in the NHCR she said indicated different types of claims (article 14 disease risk factor reduction versus article 13 general function claims for example) should be treated with differing scientific criteria, as UK nutritionist professor David Richardson indicated in his presentation at the event.

But the European Commission’s Health and Consumers Directorate (DG Sanco) representative, Basil Mathioudakis, flatly rejected Harkin’s implication, reaffirming the EC guidance that the European Food Safety Authority (EFSA) treat all health claim submissions equally in a scientific sense.

Speaking afterwards, Harkin expressed her frustration at the perceived stonewalling of what she said is clearly written in ‘recital 26’ of the 2006 regulation.

“No I was not happy with the answers I received because I voted for this regulation and as a legislator I expect the intent of the legislation to be carried through by the Commission and EFSA,"​ she said.

“If you look at recital 26 the intent of the parliament is very clear. Recital 26 says that health claims other than those referring to the reduction of disease risk and children’s development and health based on generally accepted scientific evidence should undergo a different type of assessment and authorisation.”


Harkin reasoned a unified application of scientific criteria may have simplified dossier assessment for EFSA’s NDA health claims panel.

“I understand EFSA have a big problem,”​ she said. “I understand they were absolutely snowed under with the number of claims. It was like a tsunami hitting them so therefore they left the same level of assessment for all claims yet that was never intended by the legislator.”

“We have opened a can of worms that EFSA and the Commission would have much preferred remained closed.”

Harkin added that the day had delivered another “bombshell”​ when Mathioudakis admitted retail staff may be liable to prosecution if they give nutritional advice to customers on banned claims, but that enforcement was the responsibility of individual member state authorities.


The Irish MEP, who is a member of the Alliance of Liberals and Democrats for Europe, was unimpressed by Mathioudakis’s suggestion that retailers could employ certain “tricks”​ to convey nutrient-health messaging such as the use of newspaper articles in-store.

“Is that we are asking food operators to resort to? This is a minefield,”​ she warned. “It will be impossible to implement and it is only by turning a blind eye that many of those shops can continue to operate. We cannot let a piece of legislation like this emerge with the parliament’s consent because we are the last line – right now – that can say yes or no to this.”

The NHCR text containing recital 26 can be found here.

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Its not EFSA's fault

Posted by Dr. Christiane Alexander,

EFSA had to follow the instructions given by the EC. Therefore, the type of assessment of 13.1 claims was not chosen by EFSA and they cannot be blamed for harsh evaluation criteria of 13.1 claims.

Secondly, the unfair part, in my view, was the "applying of two different kinds of measures" for 13.1 claims: the vitamins/minerals claims were accepted based on text book knowledge, whereas other nutrients were evaluated based on intervention studies, although text book knowledge exists for them.

Many vitamins and minerals would have not won claims based on gold standard clinical trial evidence. To a great extent, the evidence for vit/mins resulted from deficiency epidemics. Ethically, such conditions cannot be used in todays clinical trial settings.

Hence, many 13.1 claims were evaluated as described in Art 15-18 and others were not.

In conclusion, I do not think that the evaluation of the 13.1 claims was consistent.

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Different assessment for Art.13 of botanicals HC now needed

Posted by Dr Vaclav Bazata,

I believe that in the prism of this denunciation of such misbehavior by EFSA EC will finally instruct them to adopt the different scientific criteria for the assessment of remaining more than 1500 botanicals claims that were "put on hold", comprising also the traditions of use.

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can of worms

Posted by Frank Comhaire,

health claims MUST be scientifically proven. Perhaps the methods to obtain proof may be less stringent (e.g. proof of principle, consensus based) but general statements based on "that is what I heared" or "that is what "they" say", is insufficient.

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