EU food lawyers spoken to by NutraIngredients said it was unlikely change could be effected in European Food Safety Authority (EFSA) claims assessment methods, because the nutrition and health claims regulation (NHCR) did not stipulate that different kinds of claims should be assessed to varied standards of scientific substantiation.
“For me, there is no hint in the NHCR that the scientific standard set for 13.1 claims should be relaxed vis-à-vis article 13.5 and 14 claims,” said Sebastián Romero Melchor, a Brussels-based food lawyer from Food Law Consultants.
Article 13.5 claims relate to proprietary and emerging science claims; article 14 claims to the reduction of disease risk and children’s development.
The European Federation of Associations of Health Product Manufacturers (EHPM) remained hopeful change can still occur, in welcoming the ombudsman’s decision to open an investigation.
“We hope that this process will clarify the need for the application of a different type of assessment,” said EHPM Chairman Peter van Doorn.
“We hope the outcome of this investigation will confirm that the article 13 claims evaluation should include an assessment of the totality of the evidence, the provision of clear indications on the extent or degree to which the food-health relationship is substantiated rather than the current yes/no opinions, and will lead to the use of accepted scientific methodologies for assessing strength, consistency and plausibility of the evidence.”
Although any investigation is unlikely to deliver conclusions until after the Q1 2012 EC deadline to make law the article 13 register of approved and rejected claims, EHPM director of European policy, Cynthia Rousselot, said her group was no less compelled to proceed with its course of action.
The EC has three months to submit comments on the matter to the ombudsman, then EHPM has a further month to submit further comments of its own. After that, the ombudsman will produce a report.
“The draft regulation may be law by then but we maintain our view the assessment should have been different and want reconsideration of the rejected list,” Rousselot said. “If the ombudsman finds in our favour I don’t think it will be positive for the EC to ignore that.”
Izabela Blaszkiewicz, a Brussels-based food lawyer at Hogan Lovells, said a pro-EHPM ombudsman verdict may act as a catalyst for regulatory change, but it would take time.
“Even if the Commission accepts the recommendations, any changes in the policy would be for the future, it will not cause a revision of the procedure of health claims evaluation now,” she reasoned.
“If the recommendations are issued quickly enough and are in line with the arguments of EHPM, maybe the Commission will be under pressure to review the process for botanicals but then again, it seems unlikely because it would disadvantage all other than botanicals claims that were rejected so far.”
Highest possible standard
EHPM has long-argued the pharma-style, intervention trial scientific preference that has been expressed by EFSA since publishing the first health claim assessments in 2008 is unfair, as it discriminates against other forms of nutrition science like cohort trials and history of use data.
But Melchor struggled to find in the regulation where it stipulates that different kinds of health associations should be assessed differently.
“Article 13.1 does not waive the general principle of scientific substantiation as per article 6 and recital 17,” he said. “Furthermore, recital 23 states that all health claims should only be authorised for use in the Community after a scientific assessment of the ‘highest possible standard’.”
But he added: “Having said that, and although the standard is the same, there is some merit in defending that the means to achieve that standard may be different depending on the type of claims, so the number of studies with a product in question, as well as the amount and nature of the supporting evidence, will depend on the type of claims.”
He noted the ombudsman could recommend the European Parliament, “take some political action, which it may or may not take up.”
The EU nutrition and health claims regulation can be found here.