Enzymes may be used as processing aids under the Australia New Zealand Food Standards Code, and lipase from a number of different sources has already been approved.
However DSM applied at the end of last year for approval of lipase derived from Aspergillus niger thatwas modified using recombinant DNA techniques to contain multiple copies of the gene for an engineered form of lipase from Fusarium culmorum.
The enzyme is intended to be used in the bakery sector to improve the ability of dough to retain gas. This makes the dough more stable during proofing.
The likely approval of this enzyme by FSANZ was announced today follows a favourable pre-market safety assessment. The food safety body is inviting comments from interested parties.
Factors which swung the positive view include the long history of use of Aspergillus niger as an expression system for enzymes, as well as enzymes from other Fusarium species generally agreed to be safe.
Moreover, the recombinant lipase is likely to be proteolytically degraded in the human gastrointestinal tract, the agency found. No evidence of toxicity or genotoxicity was seen at high doses, and since no hazard was identified FSANZ deemed there to be no need to set an acceptable daily intake.
For its intended use in bread-making, the lipase was judged to be “technologically justified and achieves its stated purpose”.
Enzymes in Europe
A spokesperson for DSM told FoodNavigator.com that the enzyme is already available to bakers in Europe and the US, where it is marketed as Panamore Golden.
FSANZ notes that JECFA has considered a number of Aspergillus niger enzymes, all of which have received an ADI of “not specified”. JECFA has not considered recombinant enzymes, however.
In Europe, new legislation that requires new enzymes for use as processing aids to go through an EU approvals process for the first time is currently being introduced. Until now no pre-market approval has been required in most EU countries, with the exception of France and Denmark.
More information on DSM’s lipase application is available at this link.