What should EFSA do to improve the NHCR?

The aims of health claims are to encourage fair competition, not to mislead the public and to promote innovation in the food and drink industry, but more and more companies are being put off by the application process. What needs to change?

The reduction of disease risk claims on food and drinks (Rediclaim) project conducted a webinar last week on Nutrition and Health Claim Regulations (NHCR), where they recommended what needs to change in order for the NHCR to be more successful.

Rediclaim recruited a number of experts to research all aspects of the European Food Safety Authority’s (EFSA) NHCRs and compiled the results in a comprehensive hour long webinar.

The webinar discussed the benefits and disadvantage of different articles of the regulation​​, do’s and don’ts for submitting an application dossier and what improvements should EFSA make to the regulation.

Rosalind Malcolm – professor of law and director of environmental regulatory research at University of Surrey, UK – spoke during the summit on the efficiency of regulation enforcement and what needs to change to make it more effective.

Low or nil enforcement

She interviewed National Authorities to gain further insight.

She said disparities were found in her research in enforcement of the regulations as it is left up to member states to decide what is suitable.

As a result, Spain’s highest fine for breaching the NHCR is €600, 000, whereas Estonia has a maximum fine of €600.

All other member states sit somewhere in between the two.

“The range was surprising; remember that the requirement is of course to have effective, proportionate and dissuasive measures. There is a great deal of disparity across the whole piece in relation to enforcement but enforcement nevertheless was very limited,” she said.

National Authorities felt that the best way to combat this issue would be to have a specialised enforcement system at national level.

On top of issues of enforcement, Malcolm also commented on the similarities between NHCRs and the medicines approval process.

“Everybody mentioned the overlap with the medicines approval process, many of them – as a matter of routine – would contact their medicines approval people within their own country and seek their view of the claim so there are clearly issues around borderline claims,​” she said.

On top of this, National Authorities also felt that the procedure was too complicated, demanding and lengthy.

So what needs to change?

Looking at the context and the legal work that Malcolm and her team undertook, some recommended reforms were put forward during the webinar.

Malcolm says EU guidelines and Codes of Practice at a national level giving clearer information on i) scientific evidence necessary for a successful claim and ii) appropriate wording of the claims should be implemented.

Also desirable, would be for scientific assessment needs to be controlled and expedited, as Malcolm says this is at the core of the issues.

The team’s reform suggests an ad hoc approach to link the two approaches of medicines evaluation and the health claims approval.

As Malcolm found in her research that there is good communication between National Authorities, she calls for this to be exploited in order to provide more information to the industry on the process of health claim applications.

Malcolm also commented that harmonisation of enforcement is potentially an issue for the future but is not a matter of immediate concern.

Malcolm concluded by saying that the European Union needs to improve the strength of its health policy, which would avoid the difficulties of the conflicts we are seeing now.

You can watch the full webinar here​​.