JHCI review aims to inform EFSA on health claims
review of its own guidance on health claims submissions, with the
aim of helping the European Food Safety Authority (EFSA) develop
processes for when the impending EU-wide health claims legislation
comes into force.
The JHCI was set up to offer pre-market advice and a Code of Practice for the food industry, enforcers and consumers, and the initial guidance was first published in February 2002. At that time health claims approvals were within the jurisdiction of individual member states, but after drawn out political wrangling and compromise the EU Health and Nutrition Claims Regulation looks likely to be introduced in 2007.
Under the new legislation, EFSA will be responsible for assessing dossiers submitted by the industry, meaning that the JHCI's role will undoubtedly change. But in commissioning the review in anticipation of this, the UK's Food Standards Agency hopes to help EFSA shape its own guidelines based on the experience to date.
The review took into account feedback from previous submitters. While the initial guidance was pretty well received, JHCI executive director Melanie Ruffell told NutraIngredients.com, there was found to be room for improvement.
Specific recommendations include splitting the guidelines into two documents, one on preparing dossiers and the other on application of health claims. This, it is hoped, would ease the reported tensions between desired flexibility in presenting the science and prescriptiveness in presentations.
It was also recommended that an upfront 'at-a-glance' flowchart of the overall claim submission process be provided, setting out the relationship between substantiation and application, what needs to be, done when and by whom, and any estimations of timelines, deadlines, dates and likely costs.
Previous submitters said they found verbal guidance from the JHCI to be useful - however it was recommended that a minimum knowledge base be established for submitters to work with and understand the requirements of the guidelines.
Ruffell said that she is very sure the JHCI can have an on-going role under the new legislation, although it is still too early to say what this will be.
"We are a piece of the puzzle, and a lot of the other pieces are still missing," she told NutraIngredients.com. "It is difficult to know at this stage what the real impact will be, as we don't know what companies will have to go through or what EFSA's basis for judgement will be."
On the shape of the EU legislation, Ruffell said: "The legal framework seems to be a good compromise, given the differences between the member states."
Since it was established the JHCI has approved several generic claims for the UK, which is seen as one of the most liberal markets: on omega-3 PUFA and heart health; wholegrain foods and heart health; oats and blood cholesterol; soya protein and blood cholesterol; and reduced saturated fat and blood cholesterol.
It is not currently a legal requirement that claims be assessed by the JHCI prior to market entry, however it is required that claims on product packaging and marketing materials should not mislead consumers; should be substantiated by good evidence; and they should not claim to treat or cure a disease.
