In January 2021, the European Food Safety Authority (EFSA) issued a scientific opinion confirming the safety of insects reared and manufactured by the company Agronutris, in this case tenebrio molitor (mealworms). It was an important step towards the sesame of the commercialization, but this opinion was not sufficient in itself since it had to be transcribed in an authorization regulation of the European Commission with the agreement of the Member States. It is now done.
What was Agronutris’ regulatory path to get there?
In Europe, food products that were not consumed significantly before 1997 must be authorized for sale. As the consumption of insects was not cultural, the regulation of this market was not clearly harmonized at Member State level. Since 2018, the new “Novel Food” regulation specifies that insects are indeed new foods that must be authorized after evaluation by EFSA.
The Agronutris company was the first to submit authorization request files in 2018. The constitution of these files represents a significant investment that can be evaluated over several years of work and a few hundred thousand euros. This is the case for all requests that occur in a pioneering field where EFSA’s scientific doctrine has not yet been established.
In addition, internal scientific expertise is needed to manage EFSA’s requests for additional information. The fact that the file is considered complete when it is submitted does not mean that EFSA will not have additional questions which must be answered precisely. During this time, the evaluation procedure is suspended. This is the reason why opinions are seldom delivered within the prescribed time limit of nine months. In the case of Agronutris, three years were necessary.
All companies that develop alternative proteins with novel characteristics (eg cellular meat) will have to go through this same process to access the European market.
Not just any insects
This authorization does not open up the market globally since only insects raised and processed by the company Agronutris are authorized for the moment. The company benefits from marketing exclusivity for 5 years because EFSA’s opinion was issued on the basis of proprietary scientific data. Other companies wishing to commercialize insects will have to obtain their own authorization or find an agreement with Agronutris to use its data.
The criteria for the composition of insects are strictly defined in the appendix to the authorization regulations and must be respected because they guarantee the safety of the product.
At this time, authorization is limited to two specific use cases. Either in the form of whole dehydrated insects, for example in snacking. Or in the form of powder incorporated up to a limit of 10% in protein products, cookies, pasta and ready meals. Any other use must be the subject of a request for extension of the authorization.
Finally, the products must include a statement intended for people with allergies to shellfish, appearing near the list of ingredients.
What to remember:
- This authorization is a first in Europe.
- Obtaining an authorization is a complex scientific and regulatory process which can be rewarded with exclusivity.
- Insects are a textbook case for other new alternative proteins wishing to enter the European market.
By Gilles Boin, lawyer specializing in product regulation
Expert opinions are published under the full responsibility of their authors and in no way commit the editorial staff of L’Usine Nouvelle.
Source: UsineNouvelle – Actualités A la une by www.usinenouvelle.com.
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