Fears have emerged that the decision by the European Food Safety Authority (EFSA) to publish Article 13.1 health-claims opinions in batches could result in a distortion of the EU market for functional foods and supplements.
EFSA released its first 523 judgments on the 4,000-plus Article 13.1 claims in October, and is expected to publish opinions for the rest over the next 18 months in a series of three further batches.
But according to Patrick Coppens, secretary general of the European Responsible Nutrition Alliance, a trade group, this approach could put companies whose claims are assessed and rejected early on at a disadvantage in relation to rival firms whose claims are assessed and rejected later in the process, which is not now expected to end until summer 2011 at the soonest.
"Obviously, the publication in batches is going to advantage some companies and disadvantage others," he said. "You might have a substance for which aclaim has already been rejected, while a claim for another substance with the same health effect is still in the process. The difference may be two to three years."
The situation would be similar where claims were approved, said Coppens. Companies that are marketing substances using claims approved early on in the process could gain a head start over companies whose claims are approved later. "It's a massive distortion of the market," said Coppens.
Coppens, who was speaking at a conference on the EU Nutrition & Health Claims Regulation organised by NutraIngredients.com, said the European Commission had actually asked EFSA not to publish opinions in batches for this very reason. The plea was rejected.
Also speaking at the conference, functional dairy company Danone complained about the need for greater data protection for companies that have invested in research and development behind ingredients in order to satisfy the health claims regulation.
Under Article 13.5 of the regulation, companies are able to apply for claims for their ingredients on the basis of proprietary science. But the French company, which makes the highly successful probiotic yoghurt brands Activia and Actimel, said this wasn't as clear-cut as it sounds.
"Companies are faced with a dilemma: how to reconcile the need for data protection with the need to prove the efficacy of their products," said Patrick O'Quin, Danone's vice president of external affairs. "This is an open question that has not been answered by the European regulation. From a scientific point of view, papers need to be published in peer-reviewed scientific journals to confirm the quality of the research. Nevertheless, some of the data contained in our applications are proprietary and must remain so.
"For us, if published data cannot be treated as proprietary, then what use does this Article in the regulation serve if the only data which can be treated as proprietary must be either confidential, or patented or copyrighted and thus already protected by other legal articles?"
One concern relating to the final wording of claims was addressed. In May, UK-based Provexis obtained a positive opinion from EFSA for its tomato extract FruitFlow, an antithrombotic ingredient. But EFSA significantly changed the wording proposed by Provexis.
Provexis had applied for the claim: "Helps to maintain a healthy blood flow and benefits circulation". But EFSA said the evidence did not reflect this wording and instead approved the claim: "Helps maintain normal platelet aggregation." Provexis and others were uneasy about using such technical language on labels.
The commission appears to have listened to these concerns and in December adopted the claim into law as: "Helps maintain normal platelet aggregation, which contributes to healthy blood flow." Provexis CEO Stephen Moon said the company was "delighted," adding: "It affirms FruitFlow as a scientifically and commercially credible product."
The outcome of this episode is positive for the whole industry, not just Provexis, as many others may eventually find themselves in a similar position. It is a rare happy ending in a saga chequered with tales of woe.