Food industry health claims legal challenge has “some force”: Lawyer


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Related tags Health claims regulation European union

Dutch and UK trade groups are hoping their NHCR challenge will be adjudicated by the end of the year
Dutch and UK trade groups are hoping their NHCR challenge will be adjudicated by the end of the year
European Union food law experts say the legal challenge to the EU nutrition and health claims regulation (NHCR) mounted yesterday by two trade groups and three companies had some merit, although its attack on the despised NHCR’s scientific criteria is weak.

“I think that there are certainly criticisms that can be made with some force of aspects of the implementation by the European Commission and the European Food Safety Authority (EFSA) of the regulation, particularly the lack of accurate and timely guidance,”​ said Owen Warnock, partner at UK law firm, Eversheds.

“Whether that will be enough for the Court to invalidate the regulation is quite another matter.” 

Same claim science?

Warnock said attacking the variability in the scientific criteria applied under various articles of the NHCR was less likely to win favour in the General Court of the European Union, where the groups have applied for a fast-track treatment of their case in the hope of a verdict before December 14, when the grace period for about 1500 rejected claims expires.

“As to the substantive rather than procedural issues, one of the challenges these bodies seem to be making is to say that the scientific test being applied before a health claim is regarded as valid is too demanding,”​ Warnock continued.

“I am far from convinced by this: It seems to me that if there is to be a Regulation on this issue at all it needs to be based on scientific evidence, and I do not think the Court will agree that the evidence can be less convincing for an Article 13.1 claim than for any other kind of health claim.”

The challenge has been mounted by the Dutch group Gezondheidsproducten Nederland (NPN) and the UK Health Food Manufacturers’ Association (HFMA), and seeks to annul the recently published article 13 register of 222 approved claims and about 1500 rejected claims.

The challenge is being mounted on several grounds including disproportionality and lack of guidance and legal certainty.

Independent action

NPN chair Mischa Strijder told us the challenge differed from one mounted earlier in the year by the German parties behind a rejected water-hydration claim in that it did not focus on the eligibility or otherwise of the controversial disease risk factor reduction principle that underpins article 14 (along with children’s claims).

“Our action is independent and comes because we are fed up with the scientific non-clarity of this regulation. We are very confident about the legal action and feel this was a good time before the article 13 transition period expires in December.”

The action is joined by three supplement companies, “so we can be specific about the damage this regulation is causing”​, Strijder said, but no other national trade bodies had been invited, nor the pan-European group they both belong to: The European Federation of Associations of Health Product Manufacturers (EHPM).

“We needed to take action quickly,” ​Strijder forwarded.

Waiting for the Ombudsman

EHPM director of European policy Cynthia Rousselot said the group was waiting on the EU Ombudsman to deliver his verdict on the proportionality of the regulation before deciding on further actions.

“The Ombudsman is about compromises so we are confident claims can be re-evaluated as there are already indications this can happen with the switch to validating all the article 13 claim batches at once, and putting botanical evaluations on hold.”

The Ombudsman could deliver a verdict in as little as a month.

Regulation maelstrom

Sebastián Romero Melchor, partner in the Brussels office of K&L Gates LLP observed the success of the NPN-HFMA challenge may lie in the way the court views the regulation itself, rather than its application.

Some aspects of its application by the Commission can be subject to criticism, but, in my view, it is the NHCR itself that is the origin of the maelstrom,”​ he said.

“For example, the ban on factual information relating to health in commercial communications unless supported by an authorised claim is disproportionate, but it results from the text of the regulation.”

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balance risk-benefit is the (missing) keystone

Posted by Luuk van Duijn,

The health claim system is basically a regulation protecting consumers against paying too much for food with unsubstantiated claims. It does not adress health issues though the name suggests this.
The EFSA approach is sadly enough based on the regulation system for farmaceuticals. However, since the health claim does not wheigh benefit against risk, EFSA has chosen to atribute to the benefit an absolute value. The benefit must be proven beyond any doubt.
With farmaceuticals however, there is allways a balance between risk and benefit and the system does not relies on absolute proof for whatever part of the dossier. Most of the cancer drugs would not be on the market if this would be the case. That is the reason the EFSA opinion are so harsh, harsher than for cancer drugs, where proof is often very thin. In the health claim system the opinions are (wrongfully) based on a method designed for a balanced opninion but, strictly in line with the regaulation, lack any balance in risk/benefit-analysis.
If the system is to be redesigned, I think it would be wise to design it in such a way that its opninions deliver a balanced view wheighing risk and benefit.

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The real problem with EFSA

Posted by Laszlo G Meszaros,

The EFSA people are not the best people of life sciences. From our experience, it seems that they are, in many instances, lacking knowledge, they do not follow the literature, etc... So it is going to be very difficult to deal with this agency in a constructive way... This of course might apply to other similar agencies all around Europe.

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