FIAP (Food Improvement Agents Package) first came into force in 2009 covering food additives, flavourings and enzymes, but it is not expected to be fully implemented until 2021. Enzyme manufacturers have until March 11, 2015 to submit dossiers for European approval of their products – including for enzymes used in the production of imported food – and approved dossiers will contribute to a European list of enzymes permitted for food use.
Novozymes says it has submitted nearly a third the expected list total, about 50 of 160. For those included on the initial list, sales will continue as usual, but after that, newly submitted enzymes will be subject to a two-year assessment procedure.
“We have seen it coming for a long time now and we are fully committed to providing the right information to ensure our products are safe,” the company’s vice president of toxicology and regulatory affairs, Signe Munk, told FoodNavigator.
Waiting for innovation
However, when it comes to adding new enzymes to the list after it is published, Munk said the authorities needed to take into account the possible impact of a two-year approval timeline.
“It will add time to the development of new innovation and that is somewhat concerning, but in the end it’s about safety and ensuring that all products have the right documentation,” she said.
Until now, enzymes have not had to be approved for food use in most European countries, except in France and Denmark. Generally, they are used as processing aids but are not functional in finished foods and drinks, so they have not been covered by regulations governing the safety of food additives.
Under the Danish system, approval of a food enzyme takes around six months, so a two-year approval process would represent a significant slow-down, even in a market that has such regulations in place. Munk also pointed out that the two-year timeline for approval under FIAP comes to a halt every time a question is raised, meaning the process could take even longer.
“Probably food companies will prioritise harder what kinds of products they want to develop,” she said. “From an industry perspective, we are very interested in keeping our innovation pipeline open…I would hate to see that this could slow down or see innovation down-prioritised.”
Overall, she said having a list of approved enzymes would be a big change from the current situation, but added: “It’s all about safety and having the assurance for the consumer.”
According to the European Food Safety Authority: “Historically enzymes are considered to be non-toxic and not of safety concern for consumers since they are naturally present in ingredients used to make food. However the development of more efficient production methods and use of new sources such as genetically-modified micro-organisms used by the food industry have resulted in more complex enzymes.”
To assess the safety of food enzymes for inclusion on the approved list, a dossier requires information on the identity of the source materials, the manufacturing process, an assessment of dietary exposure, and toxicological data. Further guidance is available here.