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05.10.20, 13)24Op-Ed: "The limits of legal metamorphosis – the Novel Food Status o…cts” by Dr Sabrina Röttger-Wirtz and Dr Alie de Boer - EU Law Live
Page 1 of 6https://eulawlive.com/op-ed-the-limits-of-legal-metamorphosis-the-no…-status-of-insects-by-dr-sabrina-rottger-wirtz-and-dr-alie-de-boer/
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5TH OCTOBER 2020 CONSUMER, HEALTH & ENVIRONMENT
Op-Ed: “The limits of legalOp-Ed: “The limits of legal
metamorphosis – the Novel Foodmetamorphosis – the Novel Food
Status of insects” by Dr SabrinaStatus of insects” by Dr Sabrina
Röttger-Wirtz and Dr Alie de BoerRöttger-Wirtz and Dr Alie de Boer
Metamorphosis – an abrupt striking change in form, structure or substance –
is generally a phenomenon witnessed in biology or common motif in prose.
However, as the
Entoma
case shows, law also encounters this phenomenon:
the novel food status of insects was subject to a potential metamorphosis
under the – by now replaced – Novel Food Regulation 258/97. The Court of
Justice had to examine how far legal interpretation can stretch, before it
amounts to completely transforming (and essentially rewriting) a legislative
provision.
In 1997, very much in the wake of the BSE crisis, food safety was high on the
agenda in EU Law. It was also a time of radical scientific and technological
advancement with the rise of nanotechnologies, cloning and genetic
modification. Against this backdrop the 1997 Novel Food Regulation was
adopted to ensure the safety of all foods, while only introducing a pre-market
procedure for those products that were significantly changed.
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05.10.20, 13)24Op-Ed: "The limits of legal metamorphosis – the Novel Food Status o…cts” by Dr Sabrina Röttger-Wirtz and Dr Alie de Boer - EU Law Live
Page 2 of 6https://eulawlive.com/op-ed-the-limits-of-legal-metamorphosis-the-no…-status-of-insects-by-dr-sabrina-rottger-wirtz-and-dr-alie-de-boer/
What was apparently not on the table when drafting the food legislation was
the consumption of insects in the average European’s diet outside of TV
show challenges. However, in the search for alternative protein sources and
the integration of more exotic foods in European diets, insects slowly crawled
on the European market. However, the Member States adopted diverging and
disputed interpretations of the Novel Food Regulation, and some classified
whole insects as novel foods, which made their marketing illegal before
having obtained a marketing authorisation. Other Member States believed
that whole insects were not considered novel under the Regulation.
Ultimately, the seller of whole insects – Entoma – took legal action against a
French order to withdraw its products from the market due to a lack of
authorisation. This led to the
Entoma
preliminary ruling discussed here, in
which the Court of Justice was asked to settle questions on whether insects
are novel foods under the 1997 Regulation or not.
The Novel Food Regulation 258/97 defined novel foods on the basis of a two
cumulative criteria: (i) the lack of a significant degree of human consumption
of food and food ingredients in the EU before the Regulation entered into
force (15 of May 1997) and (ii) if it falls into one of the six categories of foods
listed in Article 1. The relevant category in question was: ‘(e) foods and food
ingredients consisting of or isolated from plants and food ingredients
isolated from animals, except for foods and food ingredients obtained by
traditional propagating or breeding practices and having a history of safe
food use’.
For context, it should be said that Novel Food Regulation 258/97 was
replaced by the new Novel Food Regulation 2015/2283 which was adopted
due to the need to revise, clarify and update the legal framework. In the new
Novel Food Regulation the fact that whole insects are covered by the novel
food definition is absolutely clear, as the relevant category now reads ‘(v)
food consisting of, isolated from, or produced from animal or their parts (…)’
and Recital 8 confirms that whole insects and their parts are covered by the
Regulation.
However, the Court of Justice – and the Advocate General – had to disregard
the recent clarification and only examine the scope as applicable at the time.
The Opinion of AG Bobek is a textbook-worthy (and highly entertaining)
exercise in applying different legal interpretation methods. AG Bobek by now
certainly is an expert in the judicial interpretation of EU food law in the face
of changing circumstances, given that he also carried out a similar exercise in
case C-528/16, arguing that the new gene-editing techniques are not
covered by the GMO Deliberate Release Directive (although the Court did not
follow his interpretation). In
Entoma
, AG Bobek concludes that neither a
05.10.20, 13)24Op-Ed: "The limits of legal metamorphosis – the Novel Food Status o…cts” by Dr Sabrina Röttger-Wirtz and Dr Alie de Boer - EU Law Live
Page 3 of 6https://eulawlive.com/op-ed-the-limits-of-legal-metamorphosis-the-no…-status-of-insects-by-dr-sabrina-rottger-wirtz-and-dr-alie-de-boer/
textual interpretation, nor systematic or historical interpretation would bring
whole insects into the remit of the provision ‘food ingredients isolated from
animals’. France also argued for a teleological expansion of the scope of the
regulation – based on the idea that if isolates from insects are regulated due
to their risk to human health, then whole insects should be too as they
present the same or an even greater risk. This dynamic interpretation of the
provision in question was outright denied by AG Bobek – he called it a
euphemism for legislating via ‘
ex post
interpretative readjustments’, and
made clear that an ‘interpretation cannot
be contra legem
’.
In its judgment, leaning on the Opinion of the AG, the Court also engaged in a
literal interpretation of the provision. It examined the usual meaning of the
words and came to the conclusion that ingredients are not consumed by
themselves but added substances to create food, and that ‘isolated from’
refers to an extraction process which excludes the whole animal from its
scope. According to the Court this also holds true when examining the
context and objectives of the Regulation. Thus, the Court concluded that
whole insects were not covered by the 1997 Novel Food Regulation. This
finding not only has historical value under the 1997 Novel Foods Regulation,
but also means that whole insects can benefit from the transitional provision
introduced in Article 35(2) of Regulation 2015/2283, which allows producers
that marketed insects before 1 January 2018 to keep them on the market
until a decision is taken on their authorisation requests that needed to be
submitted until 2 January 2020.
What is the moral of this denied metamorphosis story? An often-repeated
narrative is the EU’s cautious regulation of novel products and its alleged
negative effects on innovation. Nevertheless, as the case of insects shows,
legal uncertainty can be equally damaging to an industry in the making,
especially where high R&D investments are required. The costs of legal
uncertainty are even more difficult to bear in an industry mostly composed of
SMEs like the insects-food and feed industry. If Member States were
concerned about risks to the food and feed use of whole insects, they would
have had the means to address the problem without (artificially) extending
the scope of the Regulation. As noted by the Court and the AG, where the
Novel Food Regulation would have been deemed not to cover whole insects,
the Member States had been free to adopt national measures to protect
human health under the regular free movement of goods exception scheme
(Articles 34 and 36 TFEU). To this we would like to add that the EU has a very
detailed food safety system in place beyond the Novel Food Regulation,
providing rules on chemical and biological safety and response mechanisms
to emerging risks (like the safeguard clause in the GFL as well as the RASFF).
05.10.20, 13)24Op-Ed: "The limits of legal metamorphosis – the Novel Food Status o…cts” by Dr Sabrina Röttger-Wirtz and Dr Alie de Boer - EU Law Live
Page 4 of 6https://eulawlive.com/op-ed-the-limits-of-legal-metamorphosis-the-no…-status-of-insects-by-dr-sabrina-rottger-wirtz-and-dr-alie-de-boer/
If some Member States were concerned about the risks of whole insects
before, calling for EU harmonisation would also have been an option – as the
following revision of the Novel Food Regulation has shown. So what are the
potential health risks of consuming insects? In 2015, EFSA published a first
risk profile concerning insects for food and feed use, in which it was clarified
that the main safety concerns arise from microbiological hazards (due to the
microbiota in the intestinal tract and on the surface of insects), chemical
hazards (when the substrate on which insects are reared is contaminated),
and allergenicity of insect proteins. And even though some scientific
uncertainties were highlighted, five years later no new hazards have been
linked to insect consumption. However, it is questionable whether there is a
difference in risks from consuming whole insects or isolates from insects. In
general, the microbiological and chemical hazards can be controlled by
hygienic production, regardless of consumption of the whole animal or its
use as a food ingredient isolated from the animal. This only changes where
the consumption concerns an extract that is concentrated, as this would
naturally also increase the exposure to potential hazardous substances. So
scientifically speaking, the extended scope of the 2015 Novel Food
Regulation is reasonable, as there is no obvious difference between the risks
of whole or isolated insect foods.
However, the concerns regarding the whole insect consumption should have
been explicitly addressed in unambiguous regulatory measures. Conversely,
by strictly (over-)interpreting the scope instead of actually taking regulatory
measures on a national or EU-level, time was lost on the road to alternative
proteins. The 2015 EFSA Opinion stipulates that a lack of information on how
the animals will be farmed and which forms of preparation and consumption
will be proposed significantly influence the risks. Often the concrete scientific
requirements for authorising a food can only be shaped with actual
authorisation applications reaching the EFSA. Had the legal status been
clarified earlier, then the application of the industry might have already
clarified some of these data gaps. It should also be mentioned that the
industry is not opposed to regulation: the relevant industry association IPFF
actually provides recommendations on hygiene rules and welcomed the
2015 Novel Food Regulation as providing harmonised rules. Currently it is
crunch time for insect regulation, as the first EFSA Opinions on submitted
Novel Foods applications are anticipated to be released soon, this will also
shed more light on the potential different risk profiles of insect products
depending on species and forms of consumption.
Dr Sabrina Röttger-Wirtz is an Assistant Professor of EU Law at the
05.10.20, 13)24Op-Ed: "The limits of legal metamorphosis – the Novel Food Status o…cts” by Dr Sabrina Röttger-Wirtz and Dr Alie de Boer - EU Law Live
Page 5 of 6https://eulawlive.com/op-ed-the-limits-of-legal-metamorphosis-the-no…-status-of-insects-by-dr-sabrina-rottger-wirtz-and-dr-alie-de-boer/
Maastricht Centre for European Law (Maastricht University), working on EU
risk regulation in the fields of pharmaceuticals, foods and pesticides.
Dr Alie de Boer is Assistant Professor Nutrition & Food Law at Maastricht
University, where she studies the use of scientific evidence in legislative
procedures for food safety (such as novel foods) and health effects. Together
they recently published the article ‘Personalised Nutrition: The EU’s
Fragmented Legal Landscape and the Overlooked Implications of EU Food
Law’ in the European Journal of Risk Regulation
(https://doi.org/10.1017/err.2020.79).
05.10.20, 13)24Op-Ed: "The limits of legal metamorphosis – the Novel Food Status o…cts” by Dr Sabrina Röttger-Wirtz and Dr Alie de Boer - EU Law Live
Page 6 of 6https://eulawlive.com/op-ed-the-limits-of-legal-metamorphosis-the-no…-status-of-insects-by-dr-sabrina-rottger-wirtz-and-dr-alie-de-boer/
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