Novel food waiting may reduce to one year
waiting time for approval down from around three years to just one,
according to the European Advisory Service.
The European Commission's revision of the rule is aimed at simplifying the process and fostering industry innovation. In the EU, a food is judged to be novel if it was not eaten in a significant quantity in Europe before May 1997. According to the EU Novel Foods Regulation (EC) 258/97, new food ingredients must be shown to meet three criteria before they can be authorised for sale: they must not be unsafe, their labelling must not be misleading and their nutritional quality must not be inferior to other similar foods that they could replace. Novel food qualification covers food groups such as plant algae, fungi microorganisms and animal derived foods, but also foods that have altered compositional structure. EAS regulatory adviser Pieter Lagae said that the revision could significantly reduce the waiting time for approval. It is feared that the novel food regulation as it stands stifles innovation as companies wishing to use a new ingredient in a supplement or fortified food have a long wait on their hands for approval. He said: "It is well known that a three year novel food procedure is very common. First you have the member state assessment followed by the commission sending it to the other member states, then they have 60 days to comment. After which the commission will consult with the European Food Safety Authority (EFSA) which will then issue an opinion. It can be a year after then before a decision is reached." The draft of the revision, which is being prepared by the Commission, would reduce the amount of assessment an application has to go through. Instead, EFSA will immediately assess the application and not the member state. "It, however, remains to be seen if this shall be the case. It is mainly due to the fact that EFSA has 180 days for its risk assessment, there is no member state assessment in advance," he said. While this would reduce the timing of assessment, it might not make the novel food rules any clearer. Lagae added: "On the other hand the revision may not necessarily or immediately result in more clarity for company that is asking whether or not they have a novel food." The current legislation means that authorisation is linked to an individual applicant, which means only the applicant can benefit for the approval and other firms should put through their own applications before they can market similar products. Under the draft proposals, companies will not have their application protected from others using it unless they apply for exclusivity. Lagae believes this wouldn't necessarily hamper innovation, as the draft currently includes a data-protection clause. "This can be granted only in special cases for newly developed scientific evidence and appropriate data with a 5-year exclusivity period," he said. There has so far been no indication when the revision may be finalised.
