While reinforcing that methodological and ideological consensus between stakeholders and EU regulators remained a long way off, the European Federation of Associations of Health Product Manufacturers (EHPM), welcomed statements made by EFSA representatives at a conference last week in Berlin, Germany.
There the European Food Safety Authority (EFSA) hinted at a desire for greater dialogue as the EU nutrition and health claims regulation (NHCR) evolved.
Unknown is whether or not that will lead to an alteration in EFSA’s interpretation of the NHCR that has seen it to date employ the same ‘gold standard’, human clinical trial-weighted approach across all types of health claim applications (general (article 13.1); proprietary and emerging science (13.5); children’s development and disease risk factor reduction (14)).
Gold yes. Silver? Bronze?
To date, EFSA has unwaveringly adhered to the singular approach and with little momentum for methodological reform coming from the European Commission, it is difficult to see change coming in the short term, but even a signal of more open dialogue from EFSA is significant from the Italy-based agency that has been heavily criticized for its insularism.
EHPM would like to see a grading of claim-backing data, to reflect the non-linear nature of much nutrition science. Such an approach is employed by the likes of the World Health Organization and the World Cancer Research Fund, not to mention the US Food and Drug Administration.
Indeed the EU Ombudsman is considering an EHPM complaint along these very same lines – that EFSA’s interpretation of the NHCR is essentially too rigid.
“The regulation does not require a focus on conclusive evidence of cause and effect and this requirement is not proportionate legally or scientifically,” said EHPM Chairman Peter van Doorn.
“The legislation requires a scientific assessment of the highest possible standard but this standard cannot be automatically associated with the EFSA interpretation for conclusive proof of cause and effect and simple yes or no opinion.”
“This is an argument that we have brought to the table since the regulation’s terms of reference was published years ago.”
The elusiveness of conclusivity
The point was reinforced at the Berlin event by Professor David Richardson, scientific adviser to the UK Council for Responsible Nutrition, who told the congress why ‘yes or no’ health claim verdicts were not appropriate in nutrition science regulation.
“The reference to the ‘extent to which’ a cause and effect can be assessed is to me an assessment of whether it is strong, moderate or weak,” said professor Richardson.
“This type of assessment is helpful for regulators too, as it is a thorough basis upon which they can base their decisions. However, EFSA requires conclusive evidence. This is a challenge for the scientific community as a whole, because to get conclusive evidence of anything is very difficult.”