The current EU Novel Food Regulation (EU NFR) is regarded as „one of the best known examples of non-tariff measure affecting the entry of biodiversity-based and traditional products into the EU market“ (UNCTAD 2014). A new proposal by the European Comission now seeks to amend the existing NFR.
Introduced in 1997 and meant to protect the EU consumer from harmful (e.g. modified) novel food products containing unknown or unresearched substances it still compasses also traditional plant-based products from third countries making their market introduction into the EU market a lengthy and expensive process.
What is the EU Novel Food Regulation?
Basically, novel foods according to the EU NFR are those, that „have not been used for human consumption to a significant degree in the EU before 15 May 1997“ (European Comission). In order to be able to market these novel foods, companies must apply to a EU country authority for authorisation. It acts as a regulatory framework to protect consumers in Europe from harmful foods or substances.
However, the regulation until now failed to differentiate between completely new foods that have not been consumed before because they are maybe artificially created, and those that are just new to Europe. These latter foods might have been consumed by societies in other parts of the world for centuries or even thousands of years. (Read here what this has to do with Biodiversity)
What is the new EU NFR proposal about?
The major changes in a new EU NFR would be:
- a centralised EU procedure for the assessment and authorisation of novel foods (application to the EC instead of country authorities)
- a generic list of authorised novel foods for the EU (no need to re-apply for authorisation for already authorised products)
- a simplified assessment procedure („fastrack“) for „traditional foods“ from third countries (in comparison to other foods such as modified organisms etc.)
This document by UNCTAD provides a good overview about the current legislation, the proposed changes and the consequences.
The fact that „traditional foods“ from third countries might use a „fastrack“ approval process on the one hand looks promising. On the other hand, certain information has to be provided, that almost seem impossible to gather, or can be disputed easily. Traditional foods need to have „a history of safe use in a third country“ for at least 25 years and they need to have the „experience of continuous use for at least 25 years in the customary diet of a large part of the population of a third country“.
What are the upsides, what are the downsides of the new proposal to the EU Novel Food Regulation?
It seems, that the EU is heading in the right direction on this important topic. Although traditional products that have a safe history of consumption in their countries of origin are still included in the application scope of the EU NFR, the new proposal contains some significant improvements compared to the 1997 regulation.
First and foremost, an important point has been made by the EU by acknowledging, that ‚traditional foods‘ are different from the rest of the foods that the ’97 regulation seeks to regulate.
Secondly, the fact that once a certain product has passed the process, it might be considered as a generic approval, thus enabling other parties than the applicant to deal with the respective product.
However, some definitions/criteria still leave too much room for interpretation or are difficult to measure. E.g. the proof of a „history of safe use in a third country“ or the „experience for continuous use for at least 25 years“ or „large part of the population“. Particularly for foods from rural areas or remote regions, those criteria will be tough to substantiate. This might invite objectors and lead to discussions. These unclear and mushy criteria will open the doors for everybody wanting to object against an application/authorisation.
Moreover, these unclear definitions could lead to the fact that the ratio of approvals vs. objections might even decline as objections towards an application will be easily possible. Consequently, obtaining an approval under the EU NFR might even get more difficult.
It will also be interesting to see, how the new regulation will affect the costs that occur in the overall process. Only if costs really come down, the new EU NFR will be beneficial for the applying companies.
Altogether, it has to be proven that a revised EU NFR will lower the amount of time and costs for an approval and at the same time increases the ratio of approved applications.
One thing, that the new EU NFR still doesn’t consider is to check if the cultivation and production of a certain product contributes to the conservation of biodiversity and to sustainability goals, plus takinf fair and equitable benefit sharing in the third countries into account. But maybe this would be a bit too much to ask for.
European Comission: Proposal for a Regulation of the Europan Parliament and of the Europan Council on Novel Foods (2013)
UNCTAD: New European Union Comissio’s Proposal on Novel Food Regulation (2014)