Dutch probiotics supplier, Winclove Bio Industries, has pulled its entire range of 30 health claim submissions from the European Union health claims process, in fear of the business impact of negative opinions from the claims assessor, EFSA.
The company cited inadequate communication from the European Food Safety Authority and unclear probiotic characterization criteria as it withdrew, saying it had become “impossible to participate in the process”.
“We are in favour of this regulation in principle but at the moment we cannot work with it because it is not clear to us what is being asked and the potential damage of negative opinions is too great,” president Peter Pekelharing told NutraIngredients.com this morning.
He said the company would not resubmit its dossiers until characterisation issues were clarified, and called on the European Commission to step in and take control of a regulation that had spun out of control as EFSA tried to deal with, “12 truckloads of work when only 10 boxes were expected”.
“EFSA has the best food scientists in Europe working for it, but they are overloaded and it is affecting the quality of their work,” he said.
Pekelharing said the company had been backed into a corner by the regulation after communication with EFSA broke down in the lead-up to one of its strains being among the 181 handed a negative opinion in the first batch of article 13.1 claims in October last year.
There were no positive opinions in that selection, nor have there been any before or after, and 171 of 181 were rejected on the grounds of poor characterisation, including Winclove’s. Some of Winclove's withdrawals were also drawn form the article 14 disease reduction list.
Pekelharing said probiotic companies were being left in the dark because EFSA guidance on characterisation had come too late, and at any rate, was insufficient.
He said Winclove strains were deposited at the Dutch Dairy Institute, NIZO, where they had been genetically characterised, “in conformity with current scientific standards” but despite formal requests, EFSA had not clarified whether this was sufficient in dialogue with Winclove.
Winclove became aware its actions were insufficient when EFSA issued the October 1 batch of opinions.
In its EC/EFSA letter dated February 3, Pekelharing wrote: “We were informed that deposition in a culture collection was not mandatory but desirable, but there was no answer concerning the absence of a system of recognized culture collection.”
“On the issue of the characterisation and a possibility to redress this problem we did not get an answer at all. Moreover, EFSA did not create any possibility to supplement the requested information, not even during the update procedure in summer, 2009.”
“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.”
He concluded: “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.”
EFSA on characterisation
EFSA issued characterisation advice in an October, 2009, Q&A that stated:
“For microorganisms (e.g. bacteria, yeast), as well as species identification, there should be sufficient characterisation (genetic typing) at strain level by internationally accepted molecular methods and strains should be named according to the International Code of Nomenclature."
“Although not required for substantiation of a claim, it is in the interests of the applicant that strains are deposited in an internationally recognized culture collection (with access number) for control purposes.”
Criticism about the manner in which EFSA communicates with applicants has been building with French dairy, Danone, last week criticizing the agency for failing to engage in “direct scientific dialogue” after it was handed a negative opinion for a prebiotic infant immunity health claim.