Only a few hundred health claim applications will probably be approved out of thousands submitted to authorities under the EU Nutrition and Health Claims Regulation, a leading French lawyer has predicted.
Jean Savigny, senior partner at the Brussels office of legal firm Keller & Heckman, said: “It will be very difficult to see more than a few hundred claims out of 3,000 or so submitted getting through if EFSA [European Food Safety Authority] applies the same criteria and evidence to article 13 claims as it has to article 14 claims.”
There had been press reports of 43,000 applications being submitted to the European Commission via Member States. But this figure actually referred to proposed wordings and not health relationships between a particular ingredient and a health benefit, he said. “There were more like 3-4,000 applications if you are talking about ingredients. However, it looks like we will end up with considerably less than that in 2010.”
Article 13 claims must be supported by ‘generally accepted science’ and refer to an ingredient’s claimed benefits on health (eg. ‘plant sterols are good for your heart’). Article 14 claims are for ingredients purporting to reduce the risk of disease or boost children’s health and development (eg. ‘plant sterols have been shown to reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of coronary heart disease’).
Of the nine applications under article 14 published to date, eight have been rejected. Companies worried that their applications might be rejected should seriously consider withdrawing them, said Savigny. “You need to consider the economic damage of a rejection. If you think there’s a risk your application will be rejected, you should consider withdrawing it rather than being up there in a public list of ingredients that have been rejected.”
There is already some evidence that companies are considering this option. Ireland’s National Dairy Council recently withdrew an application about dairy and bone health after applications to make claims about dairy and weight management and dental health were both rejected by EFSA.
EFSA’s response to Unilever’s application about ALA (alpha linolenic acid) and LA (linoleic acid) and children’s growth and development should also set alarm bells ringing for some applicants, said Savigny.
While the science behind the claim was considered sound, it was nevertheless rejected on the grounds that children should consume sufficient ALA and LA “as part of the recommended balanced diet”, said EFSA.
This came as a “complete surprise”, and potentially put many other applications at risk, claimed Savigny. If EFSA was saying you couldn’t make a claim about a substance if eating a balanced diet negated any further need for it, justifying any health claim would be hard. “This argument always comes up in relation to fortification with vitamins and minerals, and has been completely rejected, so I find it quite bizarre that EFSA is applying it here.”
If the same logic was applied elsewhere, claims about protein and weight management could well be rejected on the grounds that most people already consumed enough protein, he said.
Perhaps the biggest area of concern for worried applicants, however, was botanicals. Many of these would not make the grade if EFSA was looking for human intervention studies as the primary source of evidence to support a claim, said Savigny. Indeed, if EFSA took a very hard line, as it had so far, it could potentially kill off large swathes of the dietary supplements industry, he predicted. “I don’t think that this is how the people that originally proposed this legislation thought it would develop.”