“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.”