A Dutch probiotics supplier has withdrawn its ingredients from the European Union's health claims approval process claiming it has caused harm to its business.
Winclove Bio Industries, which is based in Amsterdam, received a negative opinion from the European Food Safety Authority for a probiotic strain in October 2009. EFSA rejected the claim, which had been submitted in 2007 through the Article 13.1 channel, on the basis that the micro-organism in question had not been sufficiently 'characterised' — a fate that has also befallen scores of other probiotic strains.
But Winclove has cried foul, arguing that guidelines for industry were inadequate at the time the application was made, and has accused EFSA of poor communication later on in the process.
In a statement, the company said: "At the time of application, in 2007, the procedure and the requirements on requested information were very unclear. In 2008, EFSA requested additional information, without further clarifying of the procedure and requirements. It was only in 2009, after the rejection of several health claims, that it slowly became clear what requirements were demanded by EFSA. In the meantime EFSA did not react to the letters that we've sent them for clarification, and we had to find one of our applications rejected by EFSA."
It continued: "The one claim being put down had considerable negative impact on our image in the market. As some applications have been made on the trade names of our customers, we feel obliged to protect them by withdrawing all our applications. We will consider re-launching our applications as soon as the procedure has become transparent."
Winclove notified EFSA of its intention to withdraw its applications in a letter to EFSA dated 3 February. In it, Winclove president Peter Pekelharing argued that there existed no recognised system for collecting cultures — despite advice from EFSA that one should be used when characterising micro-organisms.
"Our strains are deposited in the collection of the Dutch Dairy Institute NIZO, but it is unclear whether this fulfils EFSA requirements," he wrote. Attempts to clarify this point, and others, had been rebuffed by EFSA, Pekelharing claimed.
He continued: "The procedure followed by EFSA differs strongly from accepted procedures in the field of feed, medical devices and medicines in its complete lack of transparency and absence of any communication between applicant and the EFSA.
"This, added to the fact that EFSA did not publish its guidelines before the application deadline, makes it for our company impossible to participate in the process on an even basically acceptable level. We have noted the impact of EFSA´s negative decisions on our position in the market and must conclude that with the procedure as it is now, our risks of damage in the market by a rejection cannot be managed in an acceptable way.
"Therefore we have to inform you that we withdraw all our applications and inform you that any further action on your side which will damage our reputation will be held liable to you. We will reconsider our position as soon as the rules of the procedure have been clarified."