Food firms must adapt to toughest regulation
Pragmatism appears to have set in when it comes to doing business under the world’s toughest health and nutrition claims legislation. The way Danone adjusted its approach to marketing Actimel + yogurt drinks is a great example, brought about by the failure of probiotic health claims to clear the bar set by the European Food Safety Authority (EFSA). The new Actimel products can still sport an immunity claim, but only thanks to the recent addition of vitamin C to the ‘little bottle with a lot inside’.
The required level of vitamin C is now present in fruit versions of the yogurt drink, and the focus on vitamin C and other components such as calcium and vitamins B6 and D effectively relegates Danone’s proprietary L. casei cultures way down the pecking order in terms of generating interest among health-conscious consumers.
This sort of adjustment so far appears to be the norm under the new regime, rather than the Nutrition and Health Claims Regulation (NHCR) leading to a raft of prosecutions. For instance, Trading Standards services are responsible for local enforcement in the UK, and say they aim to encourage co-operation. “Trading Standards services have been working with businesses to get compliance – this could be through dealing with complaints [often from competitors], or picked up on a routine/project basis, or [through] advice being sought by the business,” says David Pickering, Trading Standards Institute joint lead officer for food and nutrition.
New health claims (Return to top)
The NHCR began to bite in December 2012, following the arrival of the list of generic health claims under Article 13.1. Subsequent claims have been examined on a case-by-case basis under Articles 13.5 (claims invoking new evidence) or 14 (claims referring to the reduction of a risk factor in the development of a disease or children’s development and health). For both, a dossier of scientific evidence must be submitted to EFSA.
EFSA has taken a firm line through the process, but its most common reasons for submissions to stumble have evolved. Initially, there were a lot of submissions for substances that EFSA deemed had been insufficiently characterised, while more recent submissions are increasingly rejected for failing to provide enough evidence to demonstrate a causal link between consuming a substance and the claimed health effect.
A spokeswoman for the European Commission (EC) says one reason for the shift is a growing understanding among applicants: “Food business operators have a better understanding of what is required by EFSA in terms of the characterisation of a food in the context of its scientific evaluation.”
“At the beginning the process was not very clear,” confirms Dr Roberta Re, nutrition research manager at Leatherhead Food Research. “Lots of submissions were very generic, not specific and lacked information. However, since then, we have all learned a lot about the process.”
With the quality of the scientific dossiers under increasing scrutiny, some have questioned whether the standard of evidence required to show a ‘cause and effect’ relationship is more suited to pharmaceuticals than food products. Re is broadly supportive of EFSA’s approach, but acknowledges that it can be hard to tease out the relationship between a specific food and health.
More complex than medicine (Return to top)
“Food is much more complex than medicine,” she says. “When you test a drug you have one active compound in a capsule acting against a clear biomarker (of a disease). In food you have a mixture of compounds and a matrix and the need to show an effect in a healthy subject That is often much harder to prove. In my opinion, it is not EFSA demanding too much and it is not the industry failing, but the process has highlighted that this is a very complex matter.”
Danone and other claimants dealing in probiotics are not the only ones to fall foul of the NHCR. Firms hoping to tell consumers about the abilities of krill to combat menstrual discomfort, of potato extracts to promote weight loss or of fizzy water to impact on glycaemic index have all failed to impress EFSA’s Panel on Dietetic Products, Nutrition and Allergies. But firms promoting probiotics face a particularly interesting problem, because EFSA has deemed that the term ‘probiotic’ is an implied health claim, so even the word itself can no longer be used.
This was highlighted recently when UK-based Probiotics International was forced to replace all references to ‘probiotics’ with ‘live bacteria’ in its marketing materials on its Bio-Kult brand by the Advertising Standards Authority because the former was judged to be an implied health claim.
Some of the national guidance on this issue goes further, effectively shifting the focus from explicit claims (‘our probiotic bacterium aids digestion/boosts immunity’ or whatever) to second-guessing what consumers might infer. So the advice from the Food Safety Authority of Ireland (FSAI) warns that even terms such as ‘live’ or ‘active’ are a problem. “… where terms like ‘live’ or ‘active’ are used to describe bacteria, these imply a probiotic function and therefore are considered to be health claims. No health claims have been approved for ‘probiotic’ and therefore terms that imply a probiotic function are not permitted,” advises the authority on its website.
Enforcement bodies (Return to top)
In contrast, enforcement bodies in the UK are more relaxed. “I am not aware of this difference in interpretation," says Pickering. “I thought you couldn’t use ‘probiotic’." Meanwhile, the Department of Health said the crucial thing was whether a term “implies a health benefit for the food, rather than being simply a description of one of its constituents (eg a micro-organism)”.
Luke Murphy, regulatory manager with Leatherhead Food Research, tries to clear up the confusion: “The FSAI guidance on probiotic claims is non-statutory. Whilst other Member States, including the UK, may have their own guidance on this aspect, this is not, I’m afraid, a harmonised area at the moment. The key is if the term ‘live’ implies probiotic or not. It could potentially be used to differentiate a ‘live’ yogurt from a pasteurised one.”
While Article 13.5 and 14 claims make their way through the process, the outcomes of other aspects of the NHCR also remain uncertain. For instance, the Regulation envisages the establishment of nutrition profiles that foods must conform to to make any health claim. “The adoption of the nutrient profiles is foreseen in Regulation (EC) No 1924/2006, however this subject became controversial and politically sensitive,” says the EC spokeswoman. “[For] the time being, there is no timeline for the adoption of nutrient profiles.”
Nutrient restrictions (Return to top)
“Some approved health claims now have restrictions on certain nutrients included as part of the conditions of use, though this is separate to the proposed ‘nutrient profiles’, which are still delayed,” says Murphy.
Botanical extracts also present a thorny issue with no resolution in sight. NHCR raises the possibility of requiring substantial evidence for their benefits to make a health claim when they’re used in food, but this contrasts with their use in traditional herbal medicinal products, where they only need to demonstrate ‘traditional use’ to make a claim.
“Two options have been proposed to Member States, either to ask EFSA to continue its assessment of ‘botanicals’ in the same way as for all other claims or to harmonise the EU legislation on ‘botanical’ substances, and to tackle consumer information together with safety and quality of these substances," says the EC spokeswoman. “No decision has been taken with this regard yet.”
“Companies who have had claims rejected and prohibited by law may be looking jealously at firms using certain botanical claims as they still sit in an albeit uncertain transition period,” says Murphy.
