Novel food regulation

Novel food is defined by the Novel Food Regulation (EC) No 258/97 as foods or food ingredients which have not been used to a significant degree for human consumption in the EU before 15 May 1997, when the first regulation on novel food came into force. Currently, the commercialization of insects is governed by the Novel Foods Regulation (EU) No 2015/2283, which came into force on 1 January 2018. Following the regulation, insect products must be authorized as Novel Food by European Food Safety Authority (EFSA) and approved by European Commission (EC) before being legally put on the EU market for safe consumption as food products. Yellow mealworm (Tenebrio molitor) is the first insect species authorized in Europe as safe for human consumption.

Licensing agreement with Protix
To accelerate the authorization of our mealworm ingredients for food products, we have signed a Novel Food licensing agreement with insect industry pioneers Protix. This license covers frozen or dried yellow mealworms and dried yellow mealworm powder.

Where do we stand
The acquired licensing agreement from Protix allows us to produce and sell our currently developed whole insect powder for food applications. According to the statement of European Commission services (DG SANTE), the contractual Novel Food licensing agreement enables the business operator to market authorized products. A separate Novel food application is not required if the terms of the concluded commercial contract with the authorized applicant are followed.

Further steps
The R&D team is actively preparing to submit an additional Novel Food Dossier. Our further purpose is to get Novel Food authorization for our other specialist ingredients, including defatted insect protein, insect oil and soluble insect protein concentrate.

Divaks UAB
V. Kudirkos str. 22
LT-01113 Vilnius

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