EFFL 4|2019 The Regulatory Environment of Plant-Based and Cultured Meat 323

Meat 2.0 – The Regulatory Environment of

Plant-Based and Cultured Meat
Astrid Seehafer and Marvin Bartels*

For “artificial meat products” based on plants or cultured animal cells, a huge global mar-
ket is anticipated. However, prior to placing on the market in the European Union, food busi-
ness operators must comply with a rather complex regulatory environment. For example,
some products may be subject to the authorisation requirements of Regulation (EU)
2015/2283 on novel foods or Regulation (EC) No 1829/2003 on genetically modified food and
feed. As European Union law does not prescribe a legal name for such products, the name
of the food that is customary in the individual Member States should be used. In Germany,
the new guidelines for vegan and vegetarian food that have a similarity to food of animal
origin have to be taken into consideration.

I. Introduction The advantage of such meat products is quite ob-

There are only a few product developments in the
food industry at present in which both traditional
food companies and also large tech companies are
investing huge sums – and which are, at the same
time, hailed by environmental and animal welfare
organisations, such as PETA, as the “food of the fu-
ture”. One of them is artificial meat: plant or cell-
based artificial meat products that – unlike classical
meat replacement products such as tofu, tempeh or
seitan – have a taste, texture and appearance that can
barely or no longer be distinguished from conven-
tional meat.
* Dr Astrid Seehafer, MSc, is a lawyer at Freshfields Bruckhaus
Deringer LLP and specialised in product compliance and product
liability disputes. Marvin Bartels is a trainee lawyer at Freshfields
Bruckhaus Deringer LLP.
This article was first published in German as: Dr Astrid Seehafer
and Marvin Bartels, “Fleisch 2.0 – Das regulatorische Umfeld von
pflanzenbasiertem und kultiviertem Fleisch”, 03 ZLR 2019, pp.
359-372.
1 A. Rorheim, A. Mannino, T. Baumann and L. Caviola, “Cultured
Meat: An Ethical Alternative To Industrial Animal Farming, Policy
Paper”, Sentience Politics 2016, (1):1-14 with further references.
2 According to Beyond Meat, for example, the production of their
burger patties requires 99% less water, 93% less area, 90% less
greenhouse gas emissions and 46% less energy than the produc-
tion of burger patties made from beef.
3 See Neil Stephens et al., “Bringing cultured meat to market:
Technical, socio-political, and regulatory challenges in cellular
agriculture”, 78 Trends in Food Science & Technology 2018, pp.
155 et seq.; Antony Froggatt and Laura Wellesley, “Meat Ana-
logues: Considerations for the EU”, Research paper of the Royal
Institute of International Affairs 2019, pp. 9 et seq.
vious: while the global demand for food continues
to increase, the manufacturing of conventional
meat products requires about 75% of the area used
worldwide for agriculture and causes about 15% of
global greenhouse gas emissions.1 In this respect,
the production of plant-based artificial meat offers
huge opportunities to save resources.2 Apart from
the reduction of the intensive livestock farming of
currently more than 60 billion animals per year
and the related advantages for animal welfare, ar-
tificial meat products also offer health benefits, be-
cause germs, antibiotics and other contaminants
can be avoided in the production process. Some (ar-
tificial) meat products are even free from choles-
terol.
Against this background, the development of the
global market for new artificial meat products is
currently snowballing: Analysts such as Allied Mar-
ket Research have been forecasting an annual
growth rate of over 7% and global sales of around
7.5 billion USD by 2025.3 In May 2019, a study con-
ducted by Barclays even found a global market size
of 140 billion USD by 2029 to be likely, given recent
trends. The leading producers and developers of ar-
tificial meat to date have largely been based in Cal-
ifornia (e.g. Beyond Meat, Impossible Foods, Mem-
phis Meats), the Netherlands (Mosa Meat), Israel
(e.g. SuperMeat, Future Meat) and Japan (e.g. Inte-
griculture). Since April 2019, Nestlé has also of-
fered its own artificial meat products in Germany,
which are sold both in retail stores and at McDon-
324 The Regulatory Environment of Plant-Based and Cultured Meat
ald’s.4 Many of the start-ups are funded by investors
such as Bill Gates, Li Ka-shing, Google, Merck,
Tyson Foods and Cargill. The value of Beyond Meat,
which went public at the beginning of May 2019,
has at times increased by 500% above its initial list-
ing.
But what is the regulatory environment which
plant-based and cultured artificial meat products
have to face in Europe? What rules have to be ob-
served by food business operators before placing
their products on the European market and with re-
gard to the naming of the products?
II. Product Categories and Technical
Background
Most artificial meat products that are currently com-
mercialised are based on plant ingredients such as
soy, pea or potato proteins. By adding beetroot juice
or similar vegetable ingredients some of these prod-
ucts can even “bleed”. Artificial meat burgers and
sausages are particularly popular. These include, for
example, the “Beyond Meat Burger” developed by Be-
yond Meat, which consists, among other things, of
pea protein5 as well as the “Incredible Burger” from
Nestlé and the “Big Vegan TS” from McDonald’s,
made from soy and wheat protein.6
The so-called “Impossible Burger” has been devel-
oped by Impossible Foods and contains wheat, pota-
to and soy proteins as well as leghaemoglobin, which
is produced by means of genetically modified yeast.
Like the blood pigment haemoglobin contained in
animal blood cells, leghaemoglobin contains trace el-
ements such as iron and, according to the producer,
is supposed to provide the desired taste and smell of
meat.7 According to Impossible Foods, the company
is also able to imitate other food, such as beef, pork,
chicken, fish, cheese, yoghurt, milk or cream, based
on vegetable ingredients. The “Impossible Burger” is
currently available in the US, Hong Kong and Singa-
pore; and since April 2019, Burger King uses Impos-
sible Food’s patties for its “Impossible Whopper” in
the US. The new system gastronomy company
Vedang has also advertised the burger as being on of-
fer in Berlin.
Artificial meat can, however, also be produced by
tissue engineering, such that the end product is even
molecularly identical to conventional meat (so-called
cell-based, in-vitro, or cultured meat).8 Although this
EFFL 4|2019
cell-based artificial meat is still at an early stage of
development compared to plant-based meat, large in-
vestments and research are currently being carried
out in this area as well.9 The starting point of tissue
cultivation are animal stem cells, which are obtained
by taking muscle cells from (living) animals by biop-
sy. Although it is expected that many tonnes of meat
can be produced based on one biopsy, several (non-
European) companies already use genetically modi-
fied stem cells as a starting material in order to avoid
the need to take cells from live animals as far as pos-
sible. The cells are first cultured and propagated in a
nutrient medium and then grown together to form
muscle fibre and the desired meat structure. Al-
though this already works well for less structured
minced meat (the first so-called “In-vitro Burger” was
introduced to the public in the Netherlands already
in 2013), it is still difficult for more complicated struc-
tures such as a steak.
III. Requirements for Placing Artificial
Meat on the Market
Like any other food, artificial meat products have to
meet the applicable food law provisions, so that they
can be placed on the European market. If they con-
tain novel and/or genetically modified ingredients,
prior authorisation has to be obtained. As the rele-
vant rules in the European Union are often very re-
strictive compared to other jurisdictions, such as the
4 Froggatt and Wellesley, “Meat Analogues”, supra note 4, at pp.
37 et seq. offer a summary of the participants relevant in the
market at that time as well as of their respective investors and
partners.
5 The “Beyond Meat Burger” has been available in German super-
markets since May 2019. In addition, Beyond Meat produces
different kinds of sausages from plant ingredients.
6 According to the producer, other ingredients of the “Incredible
Burgers” are: Water, vegetable oils, spirit vinegar, natural flavour-
ings, garlic powder, plant extracts (beetroot, carrots, pepper), salt,
stabiliser, barley malt extract, black pepper, and spirulina concen-
trate.
7 According to the producer, other ingredients of the “Impossible
Burgers” are: Coconut oil, water-soluble crude fibres, natural
flavours, vitamin B1, and water.
8 See also Froggatt and Wellesley, “Meat Analogues”, supra note 4,
at pp. 6 et seq.
9 Promising research is being conducted especially by start-ups
based in California and Israel as well as by the Dutch company
Mosa Meat, which is supported by Merck and the Bell Food
Group.
EFFL 4|2019 The Regulatory Environment of Plant-Based and Cultured Meat
USA and China, and are applied in a rather strict
manner,10 this is likely to continue to have an impact
on the scope of the availability of plant-based artifi-
cial meat with novel and/or genetically modified in-
gredients as well as of cell-based artificial meat on
the European market.
1. Novel Food
According to Regulation (EU) 2015/2283 on novel
foods (Novel Food Regulation), any novel food may
only be marketed in the European Union if it has
been authorised by the European Commission and
is included in the Union list of novel foods. Critical
for the denomination of a food product as “novel” is
whether the food falls into one of the categories of
article 3 para. 2 lit. a) Novel Food Regulation and
whether it was used for human consumption to a
significant degree within the Union before 15 May
1997.
Although the European Commission has com-
mented only rather reluctantly on the categorisation
of cultured meat (“Cultured meat may fall under [ar-
ticle 3 para. 2 lit. a) vi)”]),11 it can be assumed that it
is a novel food12 and that therefore the Novel Food
Regulation is applicable. The same also applies to
those plant-based meat products that contain novel
ingredients. In the event of uncertainties with regard
to the scope of the Novel Food Regulation, for exam-
ple regarding the designation of leghaemoglobin, 13
food business operators should consult the Member
State in which they first intend to place the novel
food on the market. In Germany, the Federal Office
10 See also Markus Streinz, “Grundlagen des Lebensmittelrechts”,
in: Dr Rudolf Streinz and Markus Kraus, Lebensmittelrechts-
Handbuch, 39th ed. Part II (Munich: C.H. Beck 2018), recital 504
et seq.
11 Answer of the Commission dated 8 October 2018 to the written
question E-004200/2018. Article 3 para. 2 lit. a) vi) Novel Food
Regulation refers to food consisting of, isolated from or produced
from cell cultures or tissue cultures derived from animals, plants,
micro-organisms, fungi or algae.
12 See also Ludivine Petetin, “Frankenburgers, Risks and Approval”,
5 (2) EJRR 2014, pp. 168, 177 et seq.
13 In this context it may be noted that leghaemoglobin should not
fall under article 3 para. 2 lit. a) ii) Novel Food Regulation if it is
not produced from microorganisms but only by means of mi-
croorganisms.
14 See also Streinz in: Streinz/Kraus, “Grundlagen des Lebensmittel-
rechts”, supra note 11, recital p. 514.
325
of Consumer Protection and Food Safety (BVL) is the
responsible body.
If the artificial meat product or one of its ingredi-
ents is a novel food, the food business operator should
first check whether it has already been authorised
and included in the Union list. This is because, gen-
erally, all food business operators may market novel
food that has been previously authorised, unless the
authorisation is based on protected scientific evi-
dence or data, and the data protection of five years
granted to the applicant has not yet expired. At the
time of writing, it is the authors’ understanding that
no authorisation has been granted, let alone applied
for, in relation to individual cultured meat products.
However, and largely due to the diversity of produc-
tion processes and ingredients used in different cul-
tured artificial meat products, any single novel food
authorisation might not necessarily encompass oth-
er cultured meat products.
If a novel food has not been authorised yet, it has
to undergo an authorisation procedure prior to its
placement on the market. The procedure is provided
for in article 10 et seq. of the Novel Food Regulation
and in the Implementing Regulation (EU) 2017/2469,
and is conducted by the European Commission with
the participation of the European Food Safety Au-
thority (EFSA), which gives a scientific opinion on
the effects on human health. While the Member
States are kept informed of procedures, they are, as
such, not involved. According to the provisions of
the Novel Food Regulation, only those novel foods
that do not pose a safety risk for human health shall
be authorised. Furthermore, novel foods must not
have an intended use which is misleading to con-
sumers, and, if the novel foods are intended to re-
place another food, they must not differ from that
food in such a way that their normal consumption
would be nutritionally disadvantageous for the con-
sumer. In addition to a product description, the ap-
plicant food business operator must therefore also
submit data on the compositional, nutritional, toxi-
cological and allergenic properties of the novel food.
For small or medium-sized companies, the costs re-
lated to the collection and/or procurement of data are
likely to be quite significant.14
The Novel Food Regulation itself provides dead-
lines for the procedure, based on which the proce-
dure for authorising a novel food should take be-
tween 18 and 24 months. Although this time period
is shorter than under the previous regulation on nov-
326 The Regulatory Environment of Plant-Based and Cultured Meat
el food, it is still a lengthy process by global standards
and is exacerbated by the fact that, prior to the au-
thorisation, products cannot be marketed in the Eu-
ropean Union.
On the other hand, the Novel Food Regulation al-
so offers the applying food business the advantage
that, at the applicant’s request, the Commission
grants data protection under the conditions set out
in article 26 para. 2 Novel Food Regulation. For a pe-
riod of five years, the authorisation may then only
be used by the applicant. This exclusive right of use
might help companies recoup their costs for the de-
velopment and the application.
2. Genetically Modified Food
If artificial meat products contain or consist of a ge-
netically modified organism (GMO) or if they them-
selves or their ingredients have been produced from
a GMO, Regulation (EC) No 1829/2003 on genetical-
ly modified food and feed (GMO Regulation) requires
that they not be placed on the market unless the or-
ganism or food is covered by an authorisation under
the GMO Regulation. If the food is considered to be
novel at the same time, only an authorisation under
the GMO Regulation is required, since the provisions
of the Novel Food Regulation are superseded by the
GMO Regulation.
a. Definition of GMO and Conditions of
Authorisation
According to the GMO Regulation read in conjunc-
tion with Directive 2001/18/EC on the deliberate re-
lease into the environment of genetically modified
organisms (Deliberate Release Directive), GMOs are
such organisms in which the genetic material has
been altered in a way that does not occur naturally
by mating and/or natural recombination. However,
some techniques are excluded by article 3 para. 1 in
conjunction with Annex I B Deliberate Release Direc-
tive.
According to a recent judgment by the European
Court of Justice (ECJ), the term GMO also covers or-
ganisms which have been obtained using genome
editing methods (such as CRISPR), i.e. organisms in
which foreign DNA might not have been inserted,
but merely individual genes specifically deleted.15
This judgment was heavily criticised mainly by sci-
EFFL 4|2019
entific organisations but also industrial associations
and some Member States16 while European Commis-
sioner Andriukaitis used the judgment as an oppor-
tunity to reiterate the need for legislative reform.17
Nevertheless, artificial meat products based on such
new and precise breeding techniques like CRISPR
are currently subject to authorisation under the GMO
Regulation irrespective of which genetic changes
have been made.
This authorisation procedure is carried out by the
European Commission in consultation with the
EFSA, which provides a safety assessment. The Mem-
ber States are also involved in the decision. Accord-
ing to the GMO Regulation, genetically modified food
will not be authorised if it has adverse effects on hu-
man or animal health or the environment, if it is mis-
leading to consumers or if it differs from the food
which it is intended to replace to such an extent that
its normal consumption would be nutritionally dis-
advantageous for the consumer. Although, at first
glance, these requirements seem to be similar to the
criteria of the Novel Food Regulation, the authorisa-
tion procedure outlined in article 5 et seq. GMO Reg-
ulation is more complex, time-consuming and, in the
end, often more expensive for the applicants, since
a large amount of additional information, analyses,
declarations and samples are usually required for the
application. In particular, consideration must be giv-
en to whether the genetic modification leads to un-
intentional modifications. If such differences are
identified, further testing will have to demonstrate
that products produced from GMOs are as safe as the
control group.
It should also be noted that a granted authorisa-
tion is not valid for an unlimited period but only for
ten years (with the possibility for renewal thereafter).
15 Case C-528/16, ECJ, Judgement of 25 July 2018,
ECLI:EU:C:2018:583.
16 See, inter alia, Jens Kahrmann and Georg Leggewie, “Gentech-
nikrechtliches Grundsatzurteil des EuGH und die Folgefragen für
das deutsche Recht”, 40 NuR (2018), p. 761; Editorial, “Gen-
edited plants cross European event horizon”, 36 Nature Biotech-
nology (2018), p. 776; Statement from the directors of the Max
Planck Institute for Plant Breeding Research dated 6 August 2018;
Regulating genome edited organisms as GMOs has negative
consequences for agriculture, society and economy, Position
paper from 93 European plant and life sciences research centres
and institutes dated 12 November 2018.
17 See also Martin Wasmer, “Roads Forward to European GMO
Policy – Uncertainties in Wake of ECJ Judgment Have to be
Mitigated by Regulatory Reform, 7 Front Bioeng Biotechnol.
(2019), article 132.
EFFL 4|2019 The Regulatory Environment of Plant-Based and Cultured Meat
In addition, the authorisation holder and the food
business operator have to comply with specific mon-
itoring and labelling obligations (article 9, article 12
et seq. GMO Regulation). In particular, the packaging
must state clearly that the food contains or consists
of or is produced from GMOs.
b. Plant-Based Meat
Prior to their marketing in the European Union,
plant-based artificial meat products have to be autho-
rised according to the GMO Regulation if they con-
tain plant ingredients extracted from genetically
modified plants. This could be the case with, for ex-
ample, artificial meat products based on soy proteins,
because, particularly in North and South America,
many cultivated soy varieties are nowadays geneti-
cally engineered. Plant-based protein sources, which
are produced by means of a genome editing method
– which might become increasingly common outside
Europe in the coming years18 – also need an autho-
risation pursuant to the aforementioned jurisdiction
of the ECJ.
There is also some discussion as to whether plant-
based artificial meat products that contain
leghaemoglobin (such as the so-called “Impossible
Burger”) or leghaemoglobin itself needs an authori-
sation according to the GMO Regulation.19 As
leghaemoglobin is simply an oxygen-transporting
protein found naturally, for example, in the root nod-
ules of soy plants, it is itself not a GMO. In order to
produce larger quantities of leghaemoglobin, genes
18 For this see, inter alia, Caixia Gao, “The future of CRISPR tech-
nologies in agriculture”, 19 Nature Reviews Molecular Cell
Biology (2018), pp. 275 et seq.
19 See Froggatt and Wellesley, “Meat Analogues”, supra note 4, at
pp. 29 et seq.
20 See also Walter Zipfel and Kurt-Dietrich Rathke, loc. cit., article 2
Regulation (EC) No 1829/2003, recital 23 ff.; ECJ, Judgment of 6
September 2011, case C-442/09, ECLI:EU:C:2011:541; COM
(2006) 626 final, pp. 26 et seq. Under article 3 para. 1 lit. c)
GMO Regulation fall, for example, rapeseed oil from genetically
modified rapeseed (food) and mayonnaise with oil from genetical-
ly modified rapeseed (food ingredient).
21 See Stephens et al., “Bringing cultured meat to market: Technical,
socio-political, and regulatory challenges in cellular agriculture”,
supra note 4, loc. cit., pp. 159 et seq.; Froggatt/Wellesley, “Meat
Analogues”, supra note 4, loc. cit., pp. 7 et seq. describe the
different processes.
22 Many observers are sceptical about this, see e.g. Stephens et al.,
“Bringing cultured meat to market: Technical, socio-political, and
regulatory challenges in cellular agriculture”, supra note 4, loc.
cit., p. 162; Lieven Thorrez and Herman Vandenburgh, “Chal-
lenges in the quest for ‘clean meat’”, 37 Nature Biotechnology
(2019), pp. 215 et seq.
327
of soy plants are inserted into yeast. Leghaemoglo-
bin is then produced by means of this genetically
modified yeast in fermenters. According to the
recitals 16 of the GMO Regulation, food which is
“manufactured with the help of a genetically modi-
fied processing aid included in the scope of this Reg-
ulation” is not “included in the scope of this regula-
tion”.20 Thus, there are good reasons to consider that
leghaemoglobin is not a food ingredient which is
“manufactured from GMO”. This requires, however,
that the produced leghaemoglobin can be separated
from individual DNA fragments of the genetically
modified yeast so that those are not present in the
food. The same applies to other substances, which
are manufactured by means of genetically modified
microorganisms.
Due to the long and expensive authorisation pro-
cedure – and possibly also due to the need to label
food as GMO – many producers might decide not to
market plant-based artificial meat products with ge-
netically modified protein sources or other organ-
isms in the European Union. In other jurisdictions,
such as the US, less stringent requirements apply.
c. Cultured Meat
Companies located outside the European Union,
such as the Californian company Memphis Meats, of-
ten use genetic engineering including modern
genome editing techniques in the manufacturing of
cultured meat in order to create induced pluripotent
stem cells (iPS cells) as initial cells and to reduce the
number of necessary biopsies.21 Moreover, with ge-
netic engineering, these companies aim to cultivate
cells more quickly and without having to use foetal
bovine serum as a nutrient medium during cell pro-
liferation. If such cell-based artificial meat products
are to be placed on the European market, they would
have to pass the authorisation procedure of the GMO
Regulation. Some non-European cultured meat de-
velopers have already suggested that, in the event of
a launch on the European market, and if technically
feasible in the future, they might forego the use of
genetic engineering.
European companies such as Mosa Meat are al-
ready working on the production of cultured meat
without the utilisation of genetic engineering. It re-
mains to be seen, however, whether cultured meat
can be produced competitively without modern ge-
netic engineering techniques.22 At any rate, it seems
328 The Regulatory Environment of Plant-Based and Cultured Meat
possible that cultured meat products might be mar-
keted in the European Union only with a significant
delay and at higher prices.
IV. Names for Artificial Meat
Another area of great practical relevance is which
names artificial meat products can be marketed with
in the European Union. After all, food business op-
erators want to market their artificial meat products
as attractively as possible and inform the consumers
as precisely as possible with regards to which con-
ventional meat product is being replaced.23
1. Provisions of Union Law
Under article 17 para. 1 of Regulation (EU) No
1169/2011 on the provision of food information to
consumers (Food Information Regulation), the name
of the food is a mandatory particular for pre-pack-
aged food and shall inform on the kind of food and
its special properties.
Generally, food must be designated with its legal
name. If there is no such legal name, the food busi-
ness operators can choose whether they want to mar-
ket the food under its customary name or under a de-
scriptive name.24
Whilst there are legal names, for example, for milk
and milk products, see article 78 para. 1 in conjunc-
tion with Annex VII Regulation (EU) No 1308/2013
establishing a common organisation of the markets
in agricultural products (COM Regulation) so that
names such as “milk”, “butter” and “cheese” must not
be used for plant-based products,25 no comparable
limitations exist for vegetarian and vegan meat alter-
native products.
Food business operations may therefore name ar-
tificial meat products by describing the kind of food
and its special properties on the packaging or on a
label attached to it. Alternatively, they may use a cus-
tomary name, i.e. a name of the food which is accept-
ed by consumers in the Member State in which that
food is sold, without that name needing further ex-
planation, article 2 para. 2 lit. o) Food Information
Regulation. The customary usage is therefore not de-
termined by means of a uniform European under-
standing but can be different in each Member State.
If in doubt, food business operators that want to in-
EFFL 4|2019
troduce artificial meat products on the European
market have to ascertain for each Member State
whether and which name is deemed to be custom-
ary.
In Germany, when determining what is custom-
ary, reference is mainly made to the guidelines of the
German Food Code (Deutsches Lebensmittelbuch).
The German Food Code is a collection of guiding prin-
ciples, in which the production, properties or other
qualities of food relevant for its marketability are de-
scribed. The guidelines are resolved by the German
Food Code Commission (Deutsche Lebensmittelbuch-
Kommission – DLMBK), which is affiliated with the
Federal Ministry of Food and Agriculture, taking in-
to consideration the international food standards
recognised by the Federal Government, sections 15
et seq. German Food and Feed Code (Lebensmittel-
und Futtermittelgesetzbuch — LFGB). As they are not
legal norms, these guidelines are not legally binding.
They are not considered to be administrative guide-
lines either but as an interpretative aid and/or as an
expert opinion.26 The guidelines aim to capture the
prevailing commercial usage and consumer expecta-
tion as to the composition and other characters of
food and, based on that, they establish a (rebuttable)
presumption as to what an appropriate customary
name might be. In practice, however, these guide-
lines are often treated as legal norms by supervisory
authorities and courts.27 If, therefore, food business
operators use customary names which do not corre-
spond to the provisions of the guidelines, they should
at least be aware of this risk.
23 See also Felix Domke, “Vegetarian and Vegan Products – La-
belling and Definitions”, 13 EFFL (2018), pp. 102, 104 et seq.;
Froggatt and Wellesley, “Meat Analogues”, supra note 4, loc. cit.,
at p. 26.
24 Walter Zipfel and Kurt-Dietrich Rathke, Lebensmittelrecht, 172nd
ed. (Munich: C.H. Beck Verlag 2018), article 17 Regulation (EU)
1169/2011, recital 19.
25 See also Case C-422/16, ECJ, Judgement of 14 June 2017,
ECLI:EU:C:2017: 567.
26 See also Walter Zipfel and Kurt-Dietrich Rathke, Lebensmittel-
recht, 171st ed. (Munich: C.H. Beck Verlag 2018), Sec. 15 LFGB
recital 17; Prof. Dr. Alfred Hagen Meyer in: Prof. Dr. Alfred Hagen
Meyer and Prof. Dr. Rudolf Streinz, LFGB – BasisVO, 2nd ed
(Munich: C.H. Beck Verlag 2012), Sec. 15 LFGB recital 1 et seq.;
Thomas Boch, Lebensmittel- und Futtermittelgesetzbuch, 7th
online-ed. (Baden-Baden: Nomos 2018), Sec. 15 recital 1 et seq.;
Hildegard Schöllmann, “Die neuen Leitsätze für vegane und
vegetarische Lebensmittel mit Ähnlichkeit zu Lebensmitteln
tierischen Ursprungs”, 2 ZLR (2019), pp. 301, 302 et seq.
27 Schöllmann, “Die neuen Leitsätze für vegane und vegetarische
Lebensmittel mit Ähnlichkeit zu Lebensmitteln tierischen Ur-
sprungs”, supra note 27, loc. cit, at p. 302 with further references.
EFFL 4|2019
2. Guidelines for Vegan and Vegetarian
Food With a Similarity to Food of
Animal Origin
In the guidelines for meat and meat products (Leit-
sätze für Fleisch und Fleischerzeugnisse), the DLMBK
defines the term “meat” as “all parts of slaughtered
or slain warm-blooded animals intended for human
consumption”. Based on this definition, these guid-
ing principles should not apply to artificial meat
products.
On request of the German Butchers Association,
on 4 December 2018, the DLMBK published guide-
lines for vegan and vegetarian food that have a sim-
ilarity to food of animal origin (Leitsätze für vegane
und vegetarische Lebensmittel mit Ähnlichkeit zu
Lebensmitteln tierischen Ursprungs; Guidelines),
which should at least apply to plant-based artificial
meat. As they are, however, not applicable to “prod-
ucts of animal origin”, there is some doubt as to
whether the Guidelines also cover cultured meat
whose initial cells were taken from animals by means
of a biopsy.
The Guidelines, amongst other things, try to ex-
plain which references to names for food of animal
origin are “customary” or “not customary”. For this,
they include a gradated concept of similarity by dif-
ferentiating between an “extensive” and a “sufficient”
sensory similarity (appearance, smell, taste, texture,
consistency, and mouth feel).
“Customary” are therefore, e.g., names based on
cut pieces of meat (“schnitzel” or “goulash”), for food
made from minced meat (“meat balls”) and for cate-
gories of sausages (“sausage spread” or “bratwurst”)
insofar as there is a sufficient sensory similarity to
the food of animal origin, to which reference is made.
This should also apply correspondingly to the artifi-
cial meat burgers predominantly marketed so far. In
this case, the Guidelines require, however, that it is
made clear in an easily readable font and clearly vis-
ible location which relevant ingredient is being re-
placed. Such products have then to be labelled as, for
28 See also the joint statement of ProVeg International and of pro-
ducers of vegetarian and vegan meat alternatives dated 6 June
2019.
29 Schöllmann, “Die neuen Leitsätze für vegane und vegetarische
Lebensmittel mit Ähnlichkeit zu Lebensmitteln tierischen Ur-
sprungs”, loc. cit, at p. 304 with further references pointing to a
possible violation of the principle of rule of law.
The Regulatory Environment of Plant-Based and Cultured Meat 329
example, “vegetarian burger made from soy and
wheat protein” or “vegetarian meat ball made from
pea proteins”.
The DLMBK deems names to be “non-customary”
when they refer to specially grown parts of meat such
as “fillet” and “steak”, offal (e.g. “liver”) or animal
species, unless there is an extensive sensory similar-
ity to the food of animal origin, to which reference
is made. Additionally, names for specific sausage
types such as “Lyoner” and “Salami,” or names for
specific delicatessen salads (such as “meat salad”), are
deemed to be “non-customary”. References to these
foods are, if at all, only used for a more detailed de-
scription of vegan and vegetarian foods, as far as
there is a sufficient sensory similarity to the food of
animal origin to which reference is made. In this case,
producers of artificial meat might have to market
such products with names such as “vegan soy sausage
salami-type” or “soy-based vegetarian salad in the
style of a meat salad”.
It remains doubtful whether these Guidelines will
actually lead to more clarity and transparency of food
names, particularly as names such as “seitan vegetar-
ian burger with soy filling type cordon bleu” are not
necessarily easily comprehensible.28 In the German
legal literature, it has also already been pointed out
that the principle of “customary usage” tries to cap-
ture a current state whereas the DLMBK, in parts, is
not only describing but also proactively defining.
This means that with some paragraphs in the Guide-
lines a customary usage is not necessarily deter-
mined. Instead the DLMBK is merely working to-
wards a prevailing public opinion because there is
no customary name or because the development of
the prevailing public opinion is going in a direction
that is not desired by the DLMBK.29 In any case, it
remains questionable whether the name “vegan
sausage” can be said to be customary, in principle,
while “vegan salami” cannot. Some companies such
as Taifun-Tofu, which is marketing “Tofu-Wiener”,
have already announced to not accept the Guidelines
and, if necessary, to seek a judicial review.
3. Prohibition of Misleading Statements
As with any information, the name and labelling of
artificial meat products shall not be misleading, arti-
cle 7 para. 1 lit. a) Food Information Regulation.
Therefore, based on the overall presentation of the
330 The Regulatory Environment of Plant-Based and Cultured Meat
product, the meat-free character of the artificial meat
products has to be recognisable to a reasonably well-
informed, observant and circumspect consumer –
which is likely already in the interest of the marketer
of artificial meat. According to the (legally not bind-
ing) Guidelines, the marketing of artificial meat
should therefore not include a visual representation
of animals, unless a misleading inference can be
ruled out by the existence of sufficient countervail-
ing information. This could, for example, be achieved
with clearly visible additional information such as
“meat-free”.30 In addition, the Guidelines require that
the terms “vegan” or “vegetarian” are indicated in an
easily visible place. For cultured meat, it could fur-
ther be useful to point to the manufacturing process
to prevent the accusation of possibly being mislead-
ing.
The designations “vegan” or “vegetarian” must al-
so not be used in a way that misleads consumers re-
garding the relevant properties of these foods. Al-
though the market for “vegetarian” and “vegan” prod-
ucts has grown quickly, the terms “vegan” and “veg-
etarian” are still not legally defined at a European lev-
el. However, the European Commission has an-
nounced that in 2019, it will initiate preparations for
the enactment of implementing acts for the defini-
tion of these terms stipulated in article 36 para. 3 sen-
tence 1 lit. b) Food Information Regulation.31 In Ger-
many, the Conference of Ministers for Consumer Pro-
tection of the Federal States (Länder) agreed on def-
initions of the terms “vegan” and “vegetarian” in 2016,
and the Guidelines also include corresponding defi-
nitions. According to these, foods are “vegan” when
they do not contain ingredients of animal origin.
They are, in contrast, “vegetarian” when they meet
the requirements for vegan foods, but also contain at
least one of certain exhaustively listed ingredients,
such as milk, eggs and honey. Based on these defini-
tions, most of the plant-based artificial meat prod-
ucts are likely to be called “vegan”.
Prior to the publishing of the Guidelines, describ-
ing names such as “veggie schnitzel” or “soy
bratwurst” had already been subject to legal proceed-
ings. For good reasons, courts deemed them as not
misleading despite the reference to known meat
names because such names are not only sufficiently
clear but have also been known to consumers for a
long time.32 Moreover, referring to well-known meat
names provides a point of orientation for properties
such as taste and smell.33 This view is also confirmed
EFFL 4|2019
by the Forsa Institute’s survey on opinions on food
labelling (Meinungen zur Kennzeichnung von Lebens-
mitteln) from June 2015: Only 4% of the 1,003 partic-
ipants stated that they had ever accidentally bought
a vegetarian or vegan product instead of one contain-
ing meat. Seventy-eight percent of the participants
considered names based on already known products,
such as “veggie liver sausage made from soy”, to be
adequate, also because, from their point of view, these
names precisely describe the plant-based alternative
product.
4. Ongoing Discussion
Due to the ongoing discussion on naming alternative
meat products, producers and suppliers of artificial
meat products should be vigilant regarding further
political and legal developments. Already in 2016,
then Federal Minister for Food and Agriculture,
Christian Schmidt, intended to prohibit meaty names
for vegetarian products by an extension of the COM
Regulation. The European Commission, however, de-
clined this initiative.34 As a result, the new Guide-
lines were passed in Germany. In France, a compara-
ble legislative proposal was discussed, which later
30 If food companies wish to label artificial meat products with the
“V-Label”, it must be noted that it is a protected trademark which
must be licensed.
31 See also Till Strecker, “Developments in European Food Law:
What is Vegetarian?”, 11 EFFL (2016), at p. 21; Neli Sochirca,
“The European Legal Framework on Vegan and Vegetarian
Claims”, 13 EFFL (2018), at p. 514; Froggatt and Wellesley, “Meat
Analogues”, supra note 4, loc. cit., p. 3; Schöllmann, “Die neuen
Leitsätze für vegane und vegetarische Lebensmittel mit Ähn-
lichkeit zu Lebensmitteln tierischen Ursprungs”, loc. cit., pp. 311
et seq.
32 VG Gelsenkirchen (administrative court), order dated 19 March
2012 – 19 L 145/12, ECLI:DE:VGGE:2012:0319.19L145.12.00 =
BeckRS 2016, 45468; OVG Münster (higher administrative court),
order dated 23 October 2012 – 13 B 986/12, ECLI:DE:OVGN-
RW:2012:1023.13B986.12.00 = LMRR 2012, 75.
33 See also Dr Markus Grube, in Wolfgang Voit and Dr Markus
Grube (eds.), Lebensmittelinformationsverordnung, 2nd ed. (Mu-
nich: C.H. Beck Verlag 2016), recital 84; Dr Antje Dau, “Veggie
und vegan – der neue Trend”, 3 recht-Die Zeitschrift für europäis-
ches Lebensmittelrecht (2016), pp. 116, 119; Prof Dr. Jörg
Fritzsche and Jonas Knapp, “Rechtliche Grenzen für Bezeichnun-
gen veganer Lebensmittel nach der EuGH-Entscheidung “Tofu-
Town”, WRP (2017), pp. 897, 900 et seq.; Dr. Andreas Kiontke,
“TofuTown-Urteil des EuGH: Geht es nun der `Veggie-Wurst´ an
die Pelle?”, GRUR-Prax (2017), at p. 320; Dr. Boris Riemer,
“Bezeichnungsschutz im Lebensmittelrecht”, NJW (2017), pp.
2795, 2797.
34 See also the answer to the parliamentary question E-003771-16,
dated 4 May 2016.
EFFL 4|2019 The Regulatory Environment of Plant-Based and Cultured Meat
failed, albeit only for formal reasons, at the French
constitutional court.35
More recently, on 1 April 2019, the European Par-
liament’s Committee on Agriculture, led by the
French socialist Éric Andrieu, decided to submit a
draft resolution to the European Parliament for a vote,
according to which the future common agricultural
policy after 2020 shall contain a particularly strict
protection of names. According to this proposal,
which was already controversially discussed within
the European public, even the term “burger”, which
is already widely used for artificial meat products,
shall be used for conventionally produced meat only.
Similar discussions are held on the other side of
the Atlantic: After Missouri introduced a protection
of names for meat products in early 2019, this ques-
tion was also discussed in other U.S. states. In March
2019, the competent federal authorities, the FDA and
the USDA, have formally agreed on regulating cul-
tured meat products, including naming issues, at the
federal level – and thus taking priority over any state
level regulations.
V. Patent Law
For producers of artificial meat products, the protec-
tion of their inventions under intellectual property
law should also be of high practical relevance. Espe-
cially in the area of cell-based artificial meat, which
is technologically particularly complex, companies
such as Memphis Meats already protect their devel-
opments with patents in order to secure their invest-
ments. However, as is also the case for plant-based
artificial meat, filing a patent application might reg-
35 Conseil constitutionnel, Décision n° 2018-771 DC du 25 octobre
2018. The French legislator had linked the provisions with a
proposed law, to which they had no sufficient relationship.
36 Impossible Foods, for example, already holds almost one dozen
patents.
37 Even if some criticise the patentability of artificial meat related
inventions (most recently, for example, Martin Häusling (MEP),
patent law’s function of encouraging innovation must not be
ignored, see also Marvin Bartels, “Ein Plädoyer für das utilitaristis-
che Patentrecht”, ZGE/IPJ (2019), pp. 1, 27 et seq.
331
ularly be advisable if the patentability requirements
are met.36 Innovators (and investors) should likewise
observe the growing patent landscape to assess their
freedom to operate.37
VI. Conclusion and Outlook
Plant-based and cultured meat offers tremendous op-
portunities not only for food business operators but
also for consumer and environmental protection as
well as animal welfare. Prior to the placement on the
European Union market, food business operators
must, however, consider an often complex regulato-
ry environment. In particular, some artificial meat
products or their ingredients require an authorisa-
tion according to the Novel Food Regulation or the
GMO Regulation. Moreover, naming of these prod-
ucts may not be carried out uniformly across Europe
as, in the European Union, no legal name for artifi-
cial meat products exists, and the “customary usage”
system is based on national prevailing public opin-
ion. In Germany, for example, the new Guidelines of
the DLMBK for vegan and vegetarian food that have
a similarity to food of animal origin have to be tak-
en into consideration.
At the same time, the demand and supply of plant-
based artificial meat products is growing rapidly in
Europe and elsewhere. Even fast-food chains are fol-
lowing the trend to offer alternatives to burgers made
from conventional meat, which are, at the same time,
in their texture, taste and appearance very similar to
meat. To what extent cultured meat will prevail re-
mains to be seen. Given the lengthy authorisation
procedures and that the GMO definition currently in-
cludes organisms obtained by genome editing meth-
ods, further delays are to be expected.
As for the naming of products, food business op-
erators should keep an eye on the ongoing political
discussions on a potential introduction of provisions
on the protection of names for the benefit of conven-
tional meat products. It will also be interesting to see
to what extent the Guidelines for vegan and vegetar-
ian foods can withstand foreseeable legal proceed-
ings.
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