EU health claims system may be illegal, say trade groups

By Shane Starling

- Last updated on GMT

Related tags: Health claims, European union, European food safety authority

EU health claims system may be illegal, say trade groups
Several influential pan-European industry groups will consider mounting a legal challenge against the European Union nutrition and health claims regulation if, as expected, thousands of article 13.1 generic ‘health maintenance’ claims are forbidden across the bloc.

At a recent meeting in Brussels, members of the European Federation of Associations of Health Product Manufacturers (EHPM), the European Botanical Forum (EBF) and the European Responsible Nutrition Alliance (ERNA) discussed the possibility of challenging the controversial law in the European Court of Justice (ECJ), for breaching free trade principles written into the European Union Treaty.

See you in court?

“There are elements in that legislation that are challengeable in court,”​ said Patrick Coppens, secretary general of EBF and ERNA. “A lot will depend on the economic impact on companies issued with negative opinions by the European Food Safety Authority (EFSA).”

He said challenging the regulation in court would be a “last resort” ​but an approach to the European Ombudsman, who investigates and advises on EU maladministration, may be a first step if swathes of nutrition and health claims already in use across the 27-member state bloc are binned by EFSA and the European Commission.

A complaint made to the Ombudsman, who is independent, must be responded to in six months, although his recommendations are not legally binding.

“Going to court is a costly and time-consuming process,”​ Coppens told “It may take 2-3 years for a decision and the damage may have already been done. It is not an option we want to pursue but if notions of proportionality are not taken into account and this regulation is not applied properly then it may be something we pursue.”

In the meantime, EBF, ERNA, EHPM and others were focused on building a “constructive dialogue with the Commission” ​to ensure industry concerns are heard.

EFSA, which has been criticised for not engaging enough with industry, has invited industry stakeholders to its Parma, Italy, headquarters for discussions in June.

Coppens said the agenda of this meeting had not been made clear and said more telling would be the first batch of article 13.1 claim opinions, due imminently.

If a majority were negative, a member state campaign emphasising the fact the regulation “was not working”​ may be intensified.


Although EFSA is yet to pass opinion on any of the roughly 4000 article 13.1 claims it has in its possession, indications are that it will employ the same “gold standard” ​approach it has applied to the article 14 children’s and disease reduction and claims article 13.5 proprietary claims since issuing its first opinions in August last year.

The trade groups feel this approach places a disproportionate weighting on clinical, human, intervention trials, which do not reflect the intention of the regulation as it was written in 2006.

The Brussels meeting was attended by Lars Kolsholm from the European Commission health directorate (DG Sanco), who said the EC had given direction to EFSA to give an assessment on the quality of the evidence it had received, consider totality of that evidence and “take account of proportionality”. ​This​direction was welcomed by Coppens.

But at the meeting Kolshom said EFSA’s approach to article 13.1 claims was in line with the regulation’s terms of reference.

It was also suggested that an impact assessment was required and it was noted that many UK businesses would go out of business if the present course continued.

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