Transgenic Res (2019) 28:169–174

https://doi.org/10.1007/s11248-019-00149-y (0123456789().,-volV)
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PROCEEDINGS PAPER

The EU regulatory framework on genetically modified

organisms (GMOs)
Chantal Bruetschy

Published online: 18 July 2019

Ó Springer Nature Switzerland AG 2019

Abstract The European Union (EU) legislation on
genetically modified organisms (GMOs) aims to
ensure a high level of protection for human, animal
and environmental health and a well-functioning EU
internal market. The framework regulates the release
of GMOs into the environment and their use as, or in,
food and feed. It has three main pillars: pre-market
authorisation based on a prior risk assessment, trace-
ability and labelling. Within this legal framework, the
EU has authorised the placing on the market of 118
GMOs so far. These have been obtained through long-
standing techniques of genetic modification, namely
transgenesis. Following the adoption of the GMO
legislation, new techniques of genetic modification,
including new mutagenesis techniques, have been
developed, which have raised questions regarding the
applicability of the GMO legislation and attracted a lot
of attention from stakeholders and the general public.
This article provides an overview of EU GMO
legislation and implementation of the EU Court of
Justice ruling on organisms obtained by mutagenesis
techniques, issued in July 2018. It also updates on the
Disclaimer: The opinions expressed and arguments employed
in this paper are the sole responsibility of the author and do not
necessarily reflect those of the OECD or of the governments of
its Member countries.
C. Bruetschy (&)
Directorate General Health and Food Safety, European
Commission, 1049 Brussels, Belgium
e-mail: chantal.bruetschy@ec.europa.eu
recent initiatives by the European Commission and
EU Member States on new developments in biotech-
nology. The manuscript is based on the author’s
contribution at the OECD Conference on Genome
Editing, Applications in Agriculture, Implications for
Health, Environment and Regulation held in Paris on
28–29 June 2018. It is complemented with updated
information.
Keywords Genetically modified organisms

European Union
Regulatory framework

Mutagenesis
Synthetic biology
Gene drive
Brief description
The European Union’s regulatory framework for the
release and placing on the market of GMOs aims to
ensure a high level of protection for human, animal
and environmental health and a well-functioning EU
internal market. The framework is based on three basic
principles: pre-market authorisation based on a prior
risk assessment, traceability and labelling.
The authorisation of deliberate releases (including
experimental releases) and the placing on the market
of GMOs is regulated by Directive 2001/18/EC. In the
case of GM food and feed, a specific authorisation
procedure is laid down by Regulation (EC) No 1829/
2003. In all cases, an authorisation can only be granted
if no risk for health or the environment has been

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identified on the basis of a risk assessment carried out
by an independent risk assessment body. At EU level,
the assessment of risks is the responsibility of the
European Food Safety Authority (EFSA). A GMO
authorisation can only be granted where, based on the
outcome of such risk assessment, no adverse health or
environmental effects are identified. In addition, the
EU regulatory framework ensures a high level of
transparency of the authorisation procedure. Informa-
tion on the applications for authorisation, supplemen-
tary information provided by applicants, opinions
from the risk assessment authorities and monitoring
reports of authorised products are made available to
the public, with exclusion of confidential commercial
information. The public can comment on the opinions
published by the national risk assessment authorities
and EFSA.1
Traceability and labelling requirements ensure that
relevant information on GMOs is available for oper-
ators and consumers. Regulation (EC) No 1830/2003
addresses labelling of GMOs and traceability of
GMOs and GM food and feed, while Regulation
(EC) No 1829/2003 lays down requirements on
labelling for GM food and feed specifically. Autho-
rised GMOs need to be labelled, except if their
presence in conventional product is not more than
0.9% per ingredient and it is unavoidable or adven-
titious. The labelling rules clearly aim to provide the
market (consumers, farmers, etc.) with the freedom of
choice. The thresholds have been established to take
account of operators confronted with situations of
unwanted and unexpected presence of authorised
GMOs, despite their efforts to avoid such presence.
While the EU framework establishes a labelling and
traceability threshold for authorised GMOs, there is a
policy of ‘‘zero tolerance’’ on the presence of unau-
thorised GMOs. This implies that GMOs not autho-
rised in the EU cannot be placed on the market
(Directive 2001/18/EC and Regulation (EC) No 1829/
2003).
In addition, a number of Member States have
adopted national rules on voluntary labelling of
1 2
A proposal aimed at strengthening the transparency of the risk
assessment process of products assessed by EFSA has been
adopted by the European Commission [COM (2018) 179 final].
The proposal provides for the proactive disclosure by EFSA of
scientific data, studies and other information supporting appli-
cations for authorisation under EU law, with exclusion of
information which may be considered confidential.
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Transgenic Res (2019) 28:169–174
‘‘GMO-free food or feed’’ or of ‘‘food derived from
animals not fed with GM feed’’.2 These rules are not
subject to EU harmonised mandatory labelling but
reflect societal demands and reservation at national
level regarding GMOs.
The EU GMO legislation has also introduced the
necessary requirements to allow appropriate enforce-
ment. Applicants intending to place GMOs on the EU
market must develop and provide in their applications
a suitable detection method and positive and negative
control samples as well as certified reference material
to enable validation and application of the method.
The reference to this method in the EU authorisation
decision shows its importance for enforcement pur-
poses at national level: those methods are part of the
control and inspection systems of the national author-
ities to ensure GMOs placed on the market—whether
imported or produced in the EU—are duly approved
and duly labelled in line with legislation.
Scientific developments: brief overview
GMOs currently authorised for placing on the market
in the EU have been obtained through long-standing
techniques of genetic modification, namely transgen-
esis. At the time the GMO legislation was adopted,
new techniques of genetic modification were at an
initial stage of development or did not even exist. The
use of such techniques, notably in the development of
agricultural products, has raised questions on the
applicability of the GMO legislation and attracted
considerable attention from stakeholders and the
general public.
For example, targeted mutagenesis techniques are
among these new promising techniques. The French
Conseil d’Etat requested the Court of Justice of the
European Union (CJEU) to give legal clarification on
their legal status. In particular, this was to clarify
whether organisms obtained using such techniques
were subject to the requirements of Directive 2001/18/
EC or were covered by the exemption provided in that
National rules have to be notified to the Commission pursuant
to Directive (EU) 2015/1535 laying down a procedure for the
provision of information in the field of technical regulations and
of rules on Information Society services; the Commission
checks compliance of such national rules with the relevant EU
legislation and verify that such rules are nor misleading neither
they restrict the trade within the EU.
Transgenic Res (2019) 28:169–174
Directive (Case C-528/16, Confédération paysanne
and Others).
In July 2018, the CJEU published a judgment
clarifying that organisms obtained by mutagenesis
techniques are exempted from the GMO legislation
only if they have conventionally been used in a
number of applications and have a long safety record.
Therefore, the CJEU concluded that the authorisation,
traceability and labelling requirements of the GMO
legislation are applicable to organisms obtained by
mutagenesis techniques which have appeared or have
been developed since its adoption. They therefore
include ‘‘targeted’’ or ‘‘new’’ mutagenesis.
Synthetic biology (SynBio) and gene drives mod-
ified organisms are other fast developing domains in
biotechnology. Available EU Scientific opinions
(SCENIHR, SCCS, SCHER 2014, 2015a, b)3 on
synthetic biology consider that these new technolo-
gies, methods and principles enable faster and easier
design and manufacturing of GMOs. They also
consider that the first new SynBio developments could
be assessed under the current methodology used for
GMO risk assessment. However, further rapid devel-
opments may require existing methodologies to be
revisited and improved regularly to continue to ensure
their safety. GMOs engineered with gene drives (gene
drive modified organisms) are covered by the existing
framework but they raise specific questions regarding
the potential impact on the environment: whereas for
conventional (transgenic) GMOs the impact on the
environment is risk assessed and risk managed with a
view to limit the dissemination, the primary objective
of gene drives is precisely to be disseminated in the
environment to fulfil their objective.4
Follow up by the Commission to the Court ruling
on mutagenesis
To ensure a high level of safety the European
Commission has mandated EFSA to deliver opinions
3
The Scientific Committee on Emerging and Newly Identified
Health Risks (SCENIHR), the Scientific Committee on Health
and Environmental Risks (SCHER) and the Scientific Commit-
tee on Consumer Safety (SCCS) delivered three opinions on
SynBio in 2014 and 2015.
4 5
For example to suppress or replace populations of disease
vectors such as mosquitos (Scientific Advice Mechanism, High
Level Group of Scientific Advisors 2017).
171
on gene drive modified organisms and on GMOs
developed through Synbio. In particular, the Com-
mission asked EFSA to identify potential risks on the
impact on humans, animals and the environment that
current and near future SynBio developments and
gene drive modified organisms could pose, and then
importantly to determine whether existing guidelines
for risk assessment are adequate.
EFSA will take into account available literature,
previous analyses carried out by EU Member States or
at international level and will consider the products
most likely to be placed on the market in the next
10 years. Final opinions will be adopted following
public consultations and should be available by end
2020. Furthermore, to be fully in line with the latest
interpretation of the legislation, the Commission will
soon mandate EFSA to assess whether present risk
assessment methodologies are fully adapted to prod-
ucts produced with new mutagenesis techniques.
Follow up by the EU Member States to the Court
ruling on mutagenesis
The responsibility to enforce Union agri-food chain
legislation lies with Member States, whose competent
authorities monitor and verify, through the organisa-
tion of official controls, that relevant Union require-
ments are effectively complied with and enforced. The
Commission is responsible for making sure that all EU
countries properly apply EU law. In this role, the
Commission is referred to as the ‘guardian of the
Treaties’.
As mentioned above, operators are controlled by
Member States’ authorities and they remain respon-
sible for ensuring that products placed on the market—
whether imported from outside Europe or produced
within the EU—are safe and comply with all relevant
regulatory requirements.
In this context, Member States raised difficulties5
linked to identification and quantification of products
produced with new mutagenesis techniques. In certain
cases these products cannot be distinguished from
conventionally produced ones. To help Member States
in their enforcement activities, the Commission
In the Standing Committee of September 2018 (European
Commission 2018b) and Regulatory Committee of October
2018 (European Commission 2018c).
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suggested that the European Union Reference Labo-
ratory for GMOs (EURL), in close collaboration with
GMO laboratories established in each of the Member
States (ENGL), assess together the analytical chal-
lenges to identify and quantify products produced with
new mutagenesis techniques.6
This joint work is important. The EURL formally
validates the detection methods as part of the EU
GMO approval process and national GMO laborato-
ries perform GMO testing as part of the Member
States’ enforcement responsibilities.
The joint work was launched at the regular bi-
annual meeting of the ENGL in early October 2018. It
will result in a EURL/ENGL report in early 2019
identifying current and future means for Member
States to detect food or feed obtained by new
mutagenesis techniques. The report will highlight
any limitations where these arise. It will also help
business operators—both those based in the EU and
those in third countries exporting to the EU (European
Commission 2016).
Field trials are carried out for research purposes or
with a view to submitting the outcome in an applica-
tion for authorisation of placing on the market under
Directive 2001/18/EC. They fall under the responsi-
bility of the Member States and are subject to key
principles defined in the Directive. Importantly the
Decision by a Member State to authorise or reject a
field trial must be based on an evaluation of the risk for
health and environment and is valid only in the
territory of the Member State concerned, where the
field is situated. In the light of this, the Commission
underlined in recent discussions with Member States
their obligation to ensure that experimental cultivation
of crops obtained through new mutagenesis techniques
is carried out in line with the Directive 2001/18/EC.
Further, Member States are obliged to notify their
trials to the Commission so that they can be published
in an open register (European Commission 2018a).
All stakeholders concerned
As developments in biotechnology raise a number of
questions, relating inter alia to science, innovation
6
Hosted by the Joint Research Centre of the European
Commission—see website http://gmo-crl.jrc.ec.europa.eu/
default.htm.
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Transgenic Res (2019) 28:169–174
potential or ethical concerns, stakeholder involvement
is key to devise and implement GM policy. At a
European Commission high level conference on
modern biotechnologies in September 2017, attended
by a wide range of stakeholders,7 the new develop-
ments were discussed. The Scientific Advice Mecha-
nism (SAM)8 presented the state of play of the new
techniques in agricultural biotechnologies and out-
lined the agricultural uses of new techniques in the
fields of synthetic biology and gene drive.
The conference key messages were that new
techniques, while fostering innovation in the EU,
should not compromise the EU’s high level of safety.
Further, different types of farming do and should co-
exist, and should allow for innovation. However
innovation alone, particularly in biotechnology, is
not sufficient: it needs to take account civil society’s
needs, acceptance and trust. This latter point is of
utmost importance in the European Union: whereas
around 118 GMOs (European Commission 2018d)
have been authorised so far in the European Union,
most of them are used to feed animals and very few are
for human consumption. There has been almost no
market for GM food in Europe so far, primarily as
consumers do not see any benefits in GMOs and,
therefore, attach a lot of importance to the freedom of
choice.
At the same time, a high number of universities and
research institutes in Europe have highlighted the
potential of new breeding techniques and the benefits
for society as a whole (Public position 2018). The
seeds, food or feed produced with such new biotech-
nology need to be safe; importantly, their character-
istics need to be clearly explained to all those
concerned, in particular if and how they are different
7
Conference ‘‘Modern Biotechnologies in Agriculture - Paving
the way for responsible innovation’’ Attendance of 350 partic-
ipants including the Estonian Minister of Rural Affairs, Tarmo
Tamm, Members of the European Parliament, policy makers,
industry stakeholders, representatives of civil society, scientists,
and experts from Member States and web streaming by several
hundred people.
8
The overall objective of SAM is to provide scientific advice to
the Commission that i) is transparent and independent of
institutional or political interests; ii) brings together evidence
and insights from different disciplines and approaches; iii) takes
into consideration the specificities of EU policy making (e.g.
different national perspectives and principles of subsidiarity)
(Scientific Advice Mechanism, High Level Group of Scientific
Advisors 2017).
Transgenic Res (2019) 28:169–174
and possibly better than the transgenic GMOs autho-
rised so far and conventionally bred products. If new
mutagenesis techniques or other new biotechnology
developments can address global challenges such as
environmental and climate change challenges, sus-
tainable agriculture, food insecurity, antimicrobial
resistance, animal and plant health outbreaks and
animal welfare issues, while remaining fully safe for
humans, animals and the environment, then innova-
tion in those sectors should be fostered in Europe. As
the costs to develop products with new techniques are
considered overall to be much lower than for conven-
tional GMOs (Scientific Advice Mechanism, High
Level Group of Scientific Advisors 2017), support for
this sector should in principle allow the entry of a
higher number of operators, including European
SMEs.
Constructive dialogue needed
To date, the debate on conventional GMOs has been
polarised—either very resistant or very enthusiastic. It
has not allowed a consensus despite a solid EU
framework, a thorough authorisation process and a
high number of GMOs approved on the basis of
comprehensive risk assessment. Communication in
the area of new biotechnology needs to be carried out
with much responsibility by all those concerned:
companies, academics, NGOs and indeed policy-
makers at national, EU and international level. Past
experience on the absence of consensus shows that
constructive dialogue between all the key stakeholders
has become an essential tool to enable Europe to
benefit from biotechnology where such development
is safe and beneficial to society.
As mentioned by Commissioner Andrukaitis on the
occasion of the SAM’s statement of 13 November
2018 (Scientific Advice Mechanism, Group of Chief
Scientific Advisors 2018), it is important to hold a
‘‘broad reflection and discussion on how we, as a
society, want to go forward with such issues as gene
editing’’ (European Commission 2018e). The Com-
mission will foster such dialogues with all relevant
stakeholders.
173
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