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Novel Food: Approval process to be simplified. Industry fears disadvantages through increased transparency of the authorisation process

The European regulation on Novel Food came into force in January 2018. A central assessment and authorisation procedure was also introduced at the same time. Since then, risk managers within the EU have been making decisions, for example, on approving food from new sources for the market and on products which are won through nanotechnology. How is this new regulation being handled by the food industry in practice? What do companies now have to be aware of? All these topics were discussed at the international Fresenius Conference "Novel Food" in Mainz on 5 and 6 July.

For their two-day convention, Akademie Fresenius was able to win the support of international experts from the authorities, the legal sector and companies, such as Ferrero and BASF. Apart from experience with implementing the Novel Food Regulation, the agenda also covered the positive list for novel foods – the so-called Union List. In addition, the experts also discussed the basics for assessing the risks of novel proteins. 

The Novel Food Regulation defines a foodstuff as being “novel”, if it had not been consumed to a significant degree by humans in the EU prior to 15 May 1997. This might include food made from plants, animals, microorganisms, algae or mushrooms for example as well as food derived through new production processes.

Since the new Regulation was introduced, the EU Commission in Brussels has been responsible for the authorisation of novel foodstuffs. A new registration process is now also in place for traditional food from countries outside the EU.

Novel Food Regulation accelerates authorisation process

Peter Loosen, Managing Director and Head of the Brussels office of the German Federation for Food Law and Food Science (BLL) welcomes the new European regulation. “The new regulation improves conditions so that food businesses can easily bring new and innovative foods to the EU market, while maintaining a high level of food safety for European consumers.” He assumes that the authorisation will now be considerably speeded up.

Industry fears that the Brussels initiative for more transparency will harm Europe’s role as a research centre

Peter Loosen views the proposals that the EU Commission made in April 2018 with respect to revising food legislation in general with a critical eye. The Commission’s proposals are aimed at making the authorisation process and the decisions made by the European Food Safety Authority more transparent to the general public. This would make it easier for the public to get information on the results of the risk assessment processes used in the industry which would increase consumer confidence and sensitise them for approaching novel foods with more awareness. On the other hand, increased transparency might also prove a hinderance to innovations within the food industry, Loosen went on to say: The danger that confidential data from risk assessment processes could end up in the hands of the general public might lead to companies transferring their research and development work to locations outside the EU. This would be a setback for Europe’s role as a research centre. 

Proposals for simplifying and improving the Union List of Novel Foods

With the introduction of the Novel Food Regulation, the Commission also published a list which includes details of the authorised novel foods and defines when these may be used and how they must be labelled. This “Union List” was the topic of numerous practical field reports and discussions at the Fresenius conference. Bernd Haber of BASF has already subjected this list to a critical review and is of the opinion that there is still a lot to be done. For example, it does still not contain all the approvals and registrations that have been authorised according to the old novel food legislation. He explained that the labelling provisions applying to approved novel foods varied considerably. Additionally, many of the entries dealt with foodstuffs that could not actually be classified as being “novel”. All in all, Haber could not identify a “systematic principle” behind the specifications of the list. He would like to see numerous changes made – for example, the removal of the need to quote patent numbers. It would also be possible to further simplify entries for similar ingredients.

Food made from insects: Risks to allergy sufferers

The new Novel Food Regulation makes it easier to approve whole insects and food made from insects within the EU. However, this also increases the risks to allergy sufferers as it has been proven that products made from insects may cause allergies. In this context, Kitty Verhoeckx, scientist from TNO and former member of the EFSA focus group on food allergies, reported that insects cause food allergic reactions in already allergic patients due to cross-reactivity (shrimp and possibly house dust mite) and is able to induce new allergies (de novo sensitisation). “For every new insect included in our diets, a new assessment is needed”, said Verhoeckx. In summary, Kitty Verhoeckx demanded that research efforts to develop methods to predict the development of new allergies by novel foods should be intensified and must be an EU broadly supported approach. 

Fresenius Allergen Management conference in November

Another Akademie Fresenius conference will be dealing with the challenges connected with both old and new food allergies: The seventh International Fresenius Conference “Food Allergens” will be taking place in Wiesbaden/Germany on 12 and 13 November 2018 and will be providing a broad overview of recent developments in the legal field, new analysis tools and approaches for installing a comprehensive allergen management system. The agenda not only includes clinical aspects but also practical field reports on the introduction of an integrated risk management system as well as the critical factors involved in risk communication. Please refer to for more information.

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