“The costs involved in gaining EU market access for individual players are high and quite often with those generic products, the returns are insufficient,” said Reinder Sijtsma, government relations and regulatory affairs director, Nutreco.
He was talking about the challenges for the feed sector linked to ongoing revisions in EU feed legislation during the Akademie Fresenius feed event, being run online over two days, 27-28 October.
The tightening supply of ‘generic’ feed additives in the EU was already observed under the feed additive reauthorization process, he said. Industry is fearful that as the REFIT process pertaining to EU feed additive legislation starts to be fully implemented, the trend will accelerate.
“On top of the costs involved, many generic feed additive manufacturers say the EU feed additive legislation process is quite unpredictable and that it can take a long time; moreover, with those generic feed additives you cannot get exclusivity,” said the regulatory affairs expert.
Those concerns apply to technological, sensory and nutritional additives, there is not an issue for zootechnical, coccidiostats or strain specific additives, which can be awarded holder specific feed additive authorizations.
A post from Pen & Tec Consulting, published in September 2019, would support Sijtsma’s statements:
“All authorizations for nutritional, technological and sensory feed additive are generic, meaning once one of these products are approved, any other company can sell the same product as long as they meet the specification outlined in the authorization. We believe that this disincentivizes companies to invest in new and novel products that fall within these ‘generic’ feed additive categories because of the financial burden of generating data and then getting no market protection once authorized.
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October 27, 2020 at 11:18PM
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Industry flags challenges for 'generic' feed additives linked to limits of EU regulation - FeedNavigator.com
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