Risk Triggers as Innovation Triggers? Risk Analysis and Innovation's Promotion under the Novel Food Regulation
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EFFL 312022
I 219
Risk Triggers as Innovation Triggers? Risk
analysis and innovation's promotion under the
Novel Food Regulation
Alessandro Monaco and Kai P. Purnhagen*
Regulation (EU) No. 2283/2015 on novel foods (NFR) defines the legal framework applica-
ble to the majority of food innovations in the European Union. Following a risk analysis ap-
proach, the NFR requires pre-market authorization for foods not available on the European
market before 1997, to assess the potential threats to human health and consumers' inter-
ests. The NFR's regulatory scope requires identification of certain factors which constitute
a presumption of risk in innovative products and processes. We refer to such factors as risk
triggers This paper shows that 'Legal Novelty' and 'Unnaturalness' are the main risk trig-
gers associated with novel foods, even though the link between 'Legal Novelty' and 'Unnatu-
ralness' and a clear risk for consumers' interests, human health or the environment is not ev-
ident per se. Novel foods, compared to non-novel food products, are thus subject to addition-
al regulatory requirements investigating their safety. Benefits derived from their market en-
try and adoption are therefore delayed, or even lost. As a consequence, the innovation process
in the food sector, which we identify as an implicit objective of the NFR, is potentially hin-
dered.
I. Introduction
Non-sustainable agricultural practices, intensive
breeding and long supply chains have been identi-
fied as critical aspects contributing to environmen-
tal degradation and climate change.' The develop-
ment of innovative products and processes in the
form of alternative proteins, gene-edited crops and
making use of the promises of digitalization may
remedy these shortfalls and contribute to the future
of our society.2 Designing a regulatory environment
which facilitates the innovation process in the food
Alessandro Monaco, Lecturer, Junior Researcher and Ph.D. Candi-
date, University of Bayreuth Faculty VII. For Correspondence:
<alessandro.monaco@uni-bayreuth.de>. Kai P. Purnhagen, Profes-
sor and Director at Research Centre for German and European
Food Law, University of Bayreuth. For Correspondence: <kai.purn-
hagen@uni-bayreuth.de>. This research is funded by the Deutsche
Forschungsgemeinschaft (DFG), grant agreement PU424/2-1 and
by the Oberfrankenstiftung, grant agreement No. FP00535.
1 European Commission, 'Farm to Fork Strategy' (2021) <https://ec
.europa.eu/food/system/files/2020-05/f2faction-plan_2020
_strategy-infoen.pdf>. 10.
2 Maria Carmela Annosi and others, 'Digitalization within Food
Supply Chains to Prevent Food Waste. Drivers, Barriers and
Collaboration Practices' (2021) 93 Industrial Marketing Manage-
sector should arguably be a critical policy objective
of the European Union's (EU) legislation.
Several scattered provisions govern the develop-
ment and adoption of food innovations. These pro-
visions range from the pre-market approval of cer-
tain categories of food innovations to labelling law
and the rules governing the Common Agricultural
Policy.3 In this article we will concentrate on the role
of Regulation (EU) No. 2283/2015 on novel foods
(NFR), which regulates the market entrance of those
food innovations classified as novel food products
and processes.4
ment 208; Ademola A Adenle and others, 'Two Decades of
GMOs: - How Can Modern Biotechnology Help Meet SDGs'
[2020] Science, Technology and Innovation for Sustainable
Development Goals: Insights from Agriculture, Health, Environ-
ment and Energy 401; Alejandro Parodi and others, 'The Potential
of Future Foods for Sustainable and Healthy Diets' (2018) 1
Nature Sustainability 782.
3 C-422/16 - Verband Sozialer Wettbewerb eV v TofuTown.com
GmbH [2017] Court of Justice of the European Union
ECLI:EU:C:2017:458, at para. 39; Kai P Purnhagen, 'The Increas-
ing Overlap of Agricultural, Free Movement and Competition Law
in the EU' (2021) 46 European Law Review 20.
4 Regulation (EU) 2015/2283 on novel foods, OJ L 327,
11.12.2015, 1-22. (hereafter: NFR) Article 3(2).](ViewImageLocal?handle=hein.journals/effl2022&div=41&collection=&method=preview&ext=.png&size=3)
Risk Triggers as Innovation Triggers? Risk Analysis and Innovation's Promotion under the Novel Food Regulation
Risk Triggers as Innovation Triggers? Risk Analysis and Innovation's Promotion under the Novel Food Regulation