Plants produced using new genomic techniques

BRIEFING

EU Legislation in Progress

EPRS | European Parliamentary Research Service

Author: Ivana Katsarova

Members' Research Service

PE 754.549 – May 2024

Plants produced using new

genomic techniques

OVERVIEW

On 5 July 2023, the Commission tabled a proposal for a regulation on certain new genomic

techniques (NGTs). It establishes two categories of plants obtained by NGTs: plants comparable to

naturally occurring or conventional plants, and plants with modifications that are more complex.

The two categories will be subject to different requirements to reach the market, taking into account

their different characteristics and risk profiles.

Feedback from stakeholders is mixed. While industry interest groups hailed the 'game-changing

proposals' bringing innovation in plant breeding, the organic food and farming movement criticised

the Commission's plan to take NGTs out of the existing legal framework, as it could leave organic

food systems unprotected.

In a vote on 7 February 2024, the Parliament adopted its first-reading position with 307 votes for to

263 against and 41 abstentions. MEPs agreed to support a simplified registration for plant varieties

produced using NGTs that are deemed to be equivalent to conventional varieties, while retaining

stricter controls for others that are not (plants resulting from targeted mutagenesis and cisgenesis).

The Council is yet to reach a general approach.

Proposal for a regulation of the European Parliament and of the Council on plants obtained by

certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625

Committee responsible:

Rapporteur:

Shadow rapporteurs:

Environment, Public Health and Food

Safety (ENVI)

Jessica Polfjärd (EPP, Sweden)

Christophe Clergeau (S&D, France)

Jan Huitema (Renew, the Netherlands)

Martin Häusling (Greens/EFA, Germany)

Pietro Fiocchi (ECR, Italy)

Silvia Sardone (ID, Italy)

Anja Hazekamp, (The Left, the Netherlands)

COM(2023) 411 final

5.7.2023

2023/0226(COD)

Ordinary legislative

procedure (COD)

(Parliament and Council

on equal footing –

formerly 'co-decision')

Next steps expected:

Trilogue negotiations

EPRS | European Parliamentary Research Service

Context

Plant breeding is an ancient activity, dating back to the very beginnings of agriculture. In the

mid-1800s, Gregor Mendel

outlined the principles of heredity using pea plants and thus provided

the necessary framework for scientific plant breeding. The further development of genetic

inheritance laws in the early 20th century sped up their application in plant breeding. Advances in

biotechnology in the late 1970s allowed conventional breeding techniques – used to hybridise

plants – to evolve, with the use of novel techniques able to introduce genetic changes. The term

'established genomic techniques' refers to those techniques developed before 2001. A variety of

new techniques have been developed over the past 20 years based on advances in biotechnology

and for which the term 'new genomic techniques' (NGTs) is now widely used. Whereas established

genomic techniques generate random sequence alterations in the genome, NGTs allow changes to

be directed to a selected genomic location, thus enabling more precise editing of the genome.

What are new genomic techniques?

Defined as 'techniques capable of changing the genetic

material of an organism and that have emerged or have

been developed since 2001',

NGTs are based on gene

transfer (mutagenesis/cisgenesis/intragenesis

) or rely

on the accuracy of genome (or gene) editing.

The most prominent gene-editing tool is based on

Clustered Regularly Interspaced Short Palindromic

Repeats (CRISPR

) technology. CRISPR uses artificially

engineered enzymes called nucleases that act as

molecular scissors to split open the DNA double-

stranded helix, allowing the cell's own machinery to

repair the break (see Figure 1). This technique is quick,

precise and cheap, and has been used as a platform for

many other NGTs.

CRISPR's developers, French microbiologist Emmanuelle

Charpentier and US biochemist Jennifer Doudna, were

awarded the 2020 Nobel Prize in Chemistry

. Expected

benefits of gene-edited crops include enhanced

nutrition, improved food safety, greater resistance to

disease, weeds and pests, and better climate resilience, including drought tolerance.

Mutagenesis, cisgenesis and intragenesis

These genetic engineering techniques allow the genetic structure of an organism to be altered by adding,

deleting or altering Deoxyribonucleic acid (DNA) – the molecule inside cells that contains the genetic information

responsible for the development and function of an organism – with the aim of enhancing its genetic properties.

 Mutagenesis is a set of techniques, allowing modifications of the genome without the insertion

of foreign DNA. Prior to 1990, only conventional or random methods of mutagenesis were applied

in vivo to entire plants. Later on, technical progress led to the emergence of in vitro mutage nesis,

which made it possible to target the mutations (targeted mutagenesis) in order to create

organisms with specific traits, or investigate the effects of genetic changes.

 Cisgenesis is a modification of the genetic material of an organism with a sequence from the same

species or one closely related. The new sequence is an exact copy of the sequence already present

in the breeders' gene pool, which is the set of all genetic information for a given species.

 Intragenesis is a modification of the genetic material of an organism with a combination of

different sequences from the same species or one closely related. The new sequence is a re-

arranged copy of sequences already present in the breeders' gene pool.

Figure 1 – CRISPR-Cas9 in gene editing

Source: Cambridge Core, 2016.

Plants produced using new genomic techniques

Currently, over 500 products are being developed worldwide using CRISPR and are at different

stages of development, ranging from basic research to advanced R&D and near-commercialisation.

In 2021, a Japanese company commercialised the first

CRISPR-edited food – a gene-edited tomato,

containing high levels of gamma-aminobutyric acid, an amino acid expected to help lower blood

pressure. It was followed the same year by two species of fish gene edited to grow bigger. The green

leafy vegetable range

Conscious™ Greens, modified to enhance its flavour and colours, is expected

to enter the US market in 2023. Data show that the global genome-edited product market was worth

over US$5 billion in 2021 and is projected to be worth nearly US$12 billion by 2026.

On 3 October 2023, the Commission presented a Recommendation on critical technology areas for

the EU's economic security, for further risk assessment with EU countries. Out of the 10 critical

technology areas, four are considered highly likely to present the most sensitive and immediate risks

related to technology security and technology leakage, among which are biotechnologies.

Existing situation

EU legal framework on genetically modified organisms

The EU legislation on genetically modified organisms (GMOs) is one of the strictest in the world. It

has two main objectives: protecting human and animal health and the environment in accordance

with the

precautionary principle,

and ensuring the functioning of the internal market. Stringent

procedures exist for the safety assessment, risk assessment and authorisation of GMOs before they

can be placed on the market. To enable consumers as well as professionals to make informed

decisions,

labelling and traceability are also ensured.

The EU's GMO legislation stems from 1990, when the first two directives regulating the use of GMOs

came into force. These main pieces of legislation are supplemented by a number of

implementing

rules or by recommendations and guidelines on more specific aspects. Both original directives have

since been updated,

but the definition of a GMO has remained unchanged, which makes the

continuum between genetic engineering and conventional breeding difficult to accommodate.

Whether an organism obtained through NGTs is considered a GMO depends on the interpretation

of the current GMO definition. Article 2(2) of Directive 2001/18/EC defines a GMO as 'a n organism,

with the exception of human beings, in which the genetic material has been altered in a way that

does not occur naturally by mating and/or natural recombination'. In a process-based

interpretation of this definition, the mere use of a technique of genetic modification suffices for a

resulting organism to be considered a GMO. In a product-based interpretation, the resulting

organism must contain a new combination of genetic material in order to qualify as a GMO. A third

possible interpretation combines both criteria. However, the definition is commonly interpreted as

process-based and currently does not reflect the progress made in NGTs.

Authorisation and cultivation of GMOs in the EU

The only GMO authorised for cultivation in the EU is maize MON 810, grown in Spain and Portugal, but 18 out

of 27 EU countries have restricted or prohibited its cultivation in all or part of their territories. Directive (EU)

2015/412 gives EU countries more flexibility to decide on the cultivation of genetically modified crops on their

territory, under certain conditions, at two distinct points in time:

 during the authorisation procedure: an EU country can ask to amend the geographical scope

of the application to ensure that its territory will not be covered by the EU authorisation;

 after a GMO has been authorised: an EU country may prohibit or restrict the cultivation of the

crop based on grounds related, among other things, to environmental or agricultural policy

objectives, or other compelling grounds such as town and country planning, land use, socio-

economic impacts, co-existence and public policy.

While the market for genetically modified food in the EU is small, the EU makes use of a substantial amount of

genetically modified feed, being a major importer of high protein agricultural goods from countries where

GMOs dominate production, such as Brazil.

EPRS | European Parliamentary Research Service

The annexes to the directive further define the techniques that:

 result in genetic modification (listed in Annex I A, Part 1);

 are not considered to result in genetic modification (Annex I A, Part 2);

 result in genetic modification but yield organisms that are excluded from the scope

of the directive (Article 3 and Annex I B). These techniques are mutagenesis and cell

fusion (a technique where live cells with new combinations of heritable genetic

material are formed through the fusion of two or more cells by means of methods that

do not occur naturally).

In addition, recital 17 states that the directive 'should not apply to organisms obtained through

certain techniques of genetic modification which have conventionally been used in a number of

applications and have a long safety record'.

In replies to parliamentary questions, the Commission has stressed

that the decision to include or

exclude a technique from the scope of Directives 2001/18/EC and 2009/41/EC (on the contained use

of GMOs) depends on the interpretation of the definition of GMOs and of the conditions for

exemption provided for in the two directives. The Commission has also

noted that the evaluation is

complex, because the definition of a GMO under EU legislation refers both to the characteristics of

the organism obtained and to the techniques used.

Is gene editing comparable to conventional breeding?

The legal status of NGTs has raised questions in the EU as well as worldwide.

In 2018, the Court of Justice of the European Union delivered a judgment in which it held that

organisms obtained by targeted mutagenesis are GMOs – since mutagenesis alters the genetic

material of an organism in a way that does not occur naturally – and therefore such organisms come

within the scope of EU-wide

authorisation, traceability and labelling rules. On the question of

whether the EU GMO legislation applies to organisms obtained by NGTs, the Court considered that

the risks linked to the use of these techniques are similar to those of transgenesis – the introduction

of a foreign gene into an organism – since the direct modification of the genetic material of an

organism through mutagenesis makes it possible to obtain the same effects.

The precautionary principle has thus been the most influential argument for placing techniques

of targeted mutagenesis under the EU legislation governing GMOs. The Court's ruling also

reaffirmed the EU's doctrine of regulating the process used to create GMOs rather than focusing on

the characteristics of the final product(s), as is typically the case in the US, for example (see Table 1).

However, the Court exempted the varieties that were created through 'mutagenesis techniques

which have conventionally been used in a number of applications and have a long safety record'.

In 2019, the Council asked

the Commission to submit a study on the status of NGTs under EU law in

light of the Court's ruling. The study, published in 2021, concluded that organisms obtained through

NGTs, notably targeted mutagenesis, cisgenesis and intragenesis, are GMOs.

International legal instruments

The Convention on Biological Diversity – an international legal instrument ratified by 196 nations and in force for

the past 30 years – covers biodiversity at all levels (ecosystems, species and genetic resources, including

biotechnology) through its

Cartagena Protocol on biosafety. The Protocol seeks to protect biological

diversity from the potential risks posed by GMOs and is grounded in the precautionary principle. It notably allows

countries to ban GMO imports and requires exporters to label shipments containing genetically altered

commodities such as corn or cotton. The EU signed and ratified the Protocol in 2002 and its current definition of

a GMO is in line with it. However, leading producers of GMO, such as the US, Argentina and Canada, have not

signed the treaty. International discussions in the framework of the more recent Nagoya Protocol

– in force since

2014 – include, inter alia, the regulatory status of genome-editing techniques.

Plants produced using new genomic techniques

Comparative elements

Regulation of NGTs among main non-EU producers of GMO crops

In the United States, food and agricultural products are regulated by three governmental agencies –

the US Department of Agriculture, the Food and Drug Administration and the Environmental

Protection Agency (USDA, FDA and EPA) – under the 1986 US Coordinated Framework for

Biotechnology that ensures these products are safe for the environment and human health. The

three agencies regulate the characteristics of the products themselves rather than the process used

to develop them. Even though the

precautionary principle forms part of the US law on

biotechnology, the process during which a GMO is produced is not considered to be dangerous per

se and neither is the transfer of genetic material between organisms.

In 2018, the USDA issued a statement on plant-breeding innovation, clarifying that the Agency did

not have plans to regulate plants 'produced through innovative new breeding techniques which

include techniques called genome editing'. In 2020, the USDA enacted the

SECURE rule focusing on

the properties of the plant rather than its method of production. The FDA, for its part, offers a

voluntary premarket

consultation programme for developers of new plant varieties to obtain early

feedback on potential food safety considerations. In 2020, the EPA stated its intention to modify its

oversight of plant-incorporated pesticides in order to exempt products made with newer

biotechnologies,

such as gene editing.

In Brazil, safety standards for GMOs are set by the National Technical Commission for Biosafety

(CTNBio). The risk level of each newly developed plant or food is evaluated on a case-by-case-basis.

As in the US, the assessment focuses on the characteristics of the final product rather than the

process used to create it. Gene-edited crops obtained through NGTs which do not contain foreign

DNA are thus regulated

as conventional plants and are exempt from the GMO regulatory framework.

In 2015, Argentina became the first country in the world to develop regulatory criteria establishing

whether a crop obtained through NGTs is or is not a GMO. The 'Argentina model' consists of only

regulating genome-edited plants with permanent insertion of foreign DNA. All gene-edited

products are examined on a case-by-case basis by the Argentine Biosafety Commission.

The regulation of plants in Canada is based on the 1990 Plant Protection Act and solely considers

the novel trait of a plant, regardless of which technology was used to produce it. A novel trait is

defined by the

Canadian Food Inspection Agency as 'a trait which is both new to the Canadian

environment and has the potential to affect the specific use and safety of the plant with respect to

the environment and human health. These traits can be introduced using biotechnology,

mutagenesis, or conventional breeding techniques.' The Agency provides

pre-market assessments

for novel foods, novel feeds, and plants with novel traits, offering early feedback on potential issues.

Table 1 – Top five global producers of GMO crops

Country

Commercial cultivation

2019 (million hectares)

Regulatory

concept

Ratification of Cartagena

Protocol

USA

71.5

Product

Brazil 52.8 Product Yes

Argentina

Product

Canada

12.5

Product

Yes

India

11.9

Product

Source: ISAAA Brief 55, Biotech crops, 2019.

EPRS | European Parliamentary Research Service

In India, GMOs are regulated under the 1989 'Rules for the manufacture, use, import, export and

storage of hazardous microorganisms, genetically engineered organisms or cells'. The Rules are

supported by a series of guidelines on contained research, biologics, confined field trials, food safety

assessment, and environmental risk assessment. In 2022, India's Ministry of Environment, Forest and

Climate Change announced the exemption of genome-edited plants without foreign genes from

biosafety assessment.

Parliament's starting position

In a 2014 resolution on 'Plant breeding: what options to increase quality and yields', Parliament noted

that it was important to develop and use new plant-breeding techniques that respond to societal

and agricultural demands and to be open to the technologies available. In addition, MEPs expressed

concern at the Commission's delay in assessing new breeding techniques, and called on the

Commission to clarify their regulatory status. The same year, in another

resolution on 'The future of

Europe's horticulture sector – strategies for growth', Parliament urged the Commission to differ entiate

between cisgenic and transgenic plants and to create a different approval process for cisgenic plants.

Conversely, during the 2014-2019 term, Parliament systematically objected to every authorisation

of 'traditional' genetically modified food and feed, demanding the suspension of all GMO approvals

until their authorisation process has been revised. Similarly, in a 2020

resolution on COP15 to the

Convention on Biological Diversity and in a 2021 resolution on the EU biodiversity strategy for 2030,

Parliament called for a global moratorium on releases of gene drive organisms into nature.

In October 2021, Parliament outlined its initial views on NGTs in an own-initiative report on the EU's

farm to fork strategy. While noting the potential benefits from science and innovation in terms of

NGTs, Parliament underscored the precautionary principle and the need to ensure transparency and

freedom of choice for farmers and consumers. Similarly, the resolution stressed the importance of

risk assessments and a comprehensive overview of options for traceability and labelling to ensure proper

oversight and provide consumers with relevant information, including for products from third countries.

Council starting position

Given that the 2018 ruling by the Court of Justice brought legal clarity as to the status of NGTs, but

also raised practical questions for both national authorities and the plant-breeding sector, the Co uncil

requested the Commission to prepare a study (see box below). The Commission study was published

in April 2021 and the Agriculture and Fisheries Ministers held a debate on its conclusions in May 2021.

The ministers

responded positively to the study and appreciated the need to modernise the current

legislation, while also recognising the particular challenges presented by such modernisation. They

discussed the importance of reflecting the latest scientific developments when conducting risk

assessments on NGTs, and the need to raise awareness and provide education on these issues. In

March 2023, at the EU Environment Council meeting, Austria, supported by Cyprus and Hungary,

voiced its

concerns about the safety of plants derived from NGTs. The three delegations called for

the application of the precautionary principle, as previously requested by the Environment Ministers

December 2021.

Commission study on NGTs

While the study clarified that organisms obtained through NGTs are subject to the EU GMO legislation, it

concluded that recent developments in biotechnology, combined with the ambiguity of definitions, still impede

the interpretation of some concepts, thus leading to regulatory uncertainty. Importantly, as NGTs constitute a

highly heterogeneous group, safety considerations depend on the particular technique, its use and the

characteristics of the resulting product. The study also confirmed that the current regulatory system involves

implementation and enforcement challenges, relating in particular to the detection of NGT products that contain

no foreign genetic material. This is an issue both for enforcement authorities and for applicants. Indeed, the

availability of reliable detection methods is a prerequisite for a GMO market authorisation. Complementary

traceability tools do not appear to offer a solution to this particular challenge and present a number of limitations.

Plants produced using new genomic techniques

Preparation of the proposal

Various studies were conducted to support the impact assessment, including case studies and

reports by the Commission's Joint Research Centre and the European Food Safety Authority

(EFSA).

The proposal was accompanied by an impact assessment (IA), which received a positive opinion

with reservations from the Regulatory Scrutiny Board on 26 May 2023.In line with the conclusions

drawn in the 2021 Commission study on NGTs, the IA concluded that the current EU GMO legislation

is not fit for purpose for plants obtained by NGTs. The

initial appraisal conducted by the EPRS on the

Commission IA confirms that the legislative proposal corresponds to the preferred option and to the

monitoring and reporting provisions identified in the IA.

The changes the proposal would bring

On 5 July 2023, the European Commission tabled a proposal for a regulation on plants obtained by

certain NGTs aiming at maintaining a high level of protection of human health, while encouraging

the development of varieties that help to fight climate change and reduce use of pesticides.

Categories of plants and definitions

The regulation follows a lex specialis – lex generalis approach. In other words, where there are no

specific rules envisaged, NGT plants and their products would be subject to the rules that apply to

GMOs. The Commission's proposal is structured around a distinction between two categories of

plants. The aim is to distinguish varieties 'considered equivalent to conventional plants' – 'category

1 NGT plants' – from all other plants obtained through NGTs (category 2 NGT plants), namely,

targeted mutagenesis, cisgenesis and intragenesis.

This fundamental distinction permeates the

text as a whole and determines the different provisions envisaged by the Commission.

Annex I to the Commission proposal indicates that a 'NGT plant is considered equivalent to

conventional plants when it differs from the parent plant by no more than 20 genetic modifications'.

These 'genetic modifications' are listed exhaustively. They include, for example, nucleotide deletion,

targeted reversal of a DNA sequence, but also 'any other targeted modification, regardless of size, provided

that the resulting DNA sequences already exist [...] in a species of the breeder's genetic heritage'.

According to Article 29 of the proposal, the Commission reserves the right to use delegated acts to

'adapt this list [of genetic modifications] to scientific and technological progress' up to five years

after the entry into force of the text. Beyond these criteria, the Commission states that plants whose

characteristic trait obtained through NGTs is 'herbicide tolerance' are excluded from 'category 1 NGT

plants'. 'Category 2 NGT plants' are defined by default: they include all other varieties obtained

through these new breeding techniques.

Notification, verification, authorisation and placing on the market

The deliberate release and placing on the market of NGT plants would be subject to one of two

procedures: verification to establish equivalence with conventional products (Chapter II), or

authorisation in accordance with Directive 2001/18

on the deliberate release into the environment

of GMOs or Regulation 1829/2003 (Chapter III) on genetically modified food and feed.

Criteria for the risk assessment of plants obtained by mutagenesis or cis-genesis

In October 2022, following a request by the European Commission, the EFSA published a statement on the criteria

for the risk assessment of plants obtained by mutagenesis or cisgenesis. The core of these criteria is the concept

of 'history of safe use', which was originally developed for food risk assessment and has always been heavily

debated regarding its use in environmental risk assessment. The EFSA stated in the document that, before the

proposed risk assessment criteria could be applied, many aspects required further development and definition,

including the concept of 'history of safe use'. Particularly with regard to environmental risk assessment, many

questions remain open, as the EFSA considers them to be overly vague.

EPRS | European Parliamentary Research Service

Since 'category 1 NGT plants' are considered 'equivalent' to conventional plants, the deliberate

release and placing on the market of this type of variety would be conditional on a simple

verification procedure. To do so, the applicant would have to apply to the competent authority in

the EU country concerned and provide it with information on the genetic modifications carried out.

The verification procedure would rely on science-based criteria covering the type and extent of

plant genetic modifications that can be observed in nature or with conventional breeding

techniques. However, 'category 1 NGT plants' remain prohibited in organic production (Article 5).

To guarantee uniform application and legal certainty to operators, the Commission proposal

complements the criteria by thresholds for both size and number of modifications, ensuring that

plants featuring complex sets of modifications remain under the regulatory oversight of the GMO

legislation. The criteria would be subject to possible revision in view of scientific and technical

progress. Once this procedure is validated, the variety would be considered a NGT similar to a

conventional variety.

The Commission intends to create a principle of free movement for 'category 1 NGT plants'.

Consequently, this category is excluded from the scope of the 'safeguard clauses' that EU countries may

adopt to prohibit the use of a GMO in their territories. Prior to the placing on the market of NGT plants

which have not yet been classified as category 1 by way of a verification procedure, the procedure would

be conducted at EU level from the outset to ensure the smooth functioning of the internal market.

For 'category 2 NGT plants', the notification procedure referred to in Article 6(1) of Directive

2001/18/EC would apply for any introduction into the environment other than placing on the market.

It would include an 'environmental risk assessment' concerning, among other things, potential

effects on human and animal health. When placing category 2 NGT plant products intended for

human consumption on the market, the applicant must go through an authorisation procedure, i.e.

a risk assessment of the product. EU countries are also required to adopt coexistence measures to

avoid the unintended presence of such NGT plants in organic and conventional crops (Article 24).

Traceability and labelling

As regards traceability, the Commission chose a hybrid solution. For 'category 1 NGT plants', it

abandons the mandatory labelling that applies to GMOs. At consumer level, traceability is deemed

to be guaranteed through the labelling of seeds and the creation of a new, publicly accessible

database listing all 'category 1 NGT plants' (Articles 10-11) and through the variety catalogues of the

plant reproductive material/forest reproductive material legislation

(Articles 36-39). It introduces

mandatory labelling, only for products intended for plant reproduction. The Commission proposes

to maintain mandatory labelling for all 'category 2 NGT plants', to indicate that they are GMOs.

The Commission leaves the possibility of specifying the characteristics brought about by the genetic

modification by adding a factual statement on the intended purpose of the genetic modification

(Article 26). To enable operators to use this complementary labelling in a harmonised manner and

avoid misleading or confusing indications, a proposal for such labelling would be provided in the

application for authorisation and would be specified in the authorisation decision.

Monitoring and oversight

Category 1 NGT plants would remain subject to any regulatory oversight that applies to

conventionally bred plants. As is the case for conventional plants and products, those NGT plants

and related products would be subject to the applicable sectoral legislation on seed and other plant

reproductive material, food, feed and other products, and horizontal frameworks, such as the nature

conservation legislation and environmental liability. In this regard, NGT food falling out of the scope

of Regulation 1829/2003

on genetically modified food as a consequence of the equivalence

determination but featuring a significantly changed composition or structure that affects the

nutritional value of the food will fall within the scope of

Regulation (EU) 2015/2283 on novel foods.

Plants produced using new genomic techniques

Regulatory incentives

Regulatory incentives (Article 22) would be offered to applicants for 'category 2 NGT plants'

containing traits with the potential to contribute to a sustainable agri-food system, in order to steer

the development towards such traits. Such incentives would consist of an accelerated procedure for

risk assessment and enhanced pre-submission advice. Additional incentives would be offered to

applicants from small or medium-sized enterprises (SMEs), to promote access by small players and

to support diversification of the food system.

Issues relating to patents and intellectual property rights

The proposal does not regulate issues of intellectual property. The Commission intends to assess, as

part of a broader market analysis, the impact that the patenting of plants and related licensing and

transparency practices may have on innovation in plant breeding. It will also assess their impact on

breeders' access to genetic material and techniques, on availability of seeds to farmers and on the

overall competitiveness of the EU biotech industry. The Commission will report on its findings by 2026.

Advisory committees

Consultation of the European Economic and Social Committee (EESC) and the European Committee

of the Regions (CoR) is mandatory for this legislative file.

The EESC adopted its opinion

in October 2023 (rapporteur Arnaud Schwartz, Diversity Europe –

Group III, France). While it welcomes the principle of an environmental and health risk assessment

corresponding to the type of modification applied, the opinion urges the Commission to consider

implementing systematic ex post monitoring and labelling of 'category 1 NGT plants'. It also proposes

the creation of a European traditional seed bank, which could help guarantee the availability of

endemic plants in the future, through a collaboration with the

Global Seed Vault in Norway.

The CoR adopted its opinion on 17 April 2024 (rapporteur Erik Konczer, PES, Hungary). CoR argued

that NGT regulations could increase farmers' dependency on large seed companies, thereby

reducing the resilience of the EU food system, and could undermine the EU targets to reach 25 % of

organic farming by 2030. CoR also insisted on amending the rules to include traceability and

labelling of NGTs.

National parliaments

Two reasoned opinions were sent within the deadline. The House of Representatives of Cyprus

considers that the proposal is in conflict with the principle of subsidiarity. It has doubts that the need

for legislative action at the EU level is based on sufficient quantitative and qualitative indicators and

that an alternative course of action has been adequately and thoroughly explored. Similarly, the

Hungarian National Assembly objects to the adequacy of the legal basis employed, as well as the

fact that contrary to current legislation on GMOs, the proposal does not grant the possibility for EU

countries to choose whether they wish to cultivate plants obtained by NGTs.

Stakeholder views

The EU's largest farm lobby, COPA-COGECA, welcomed the Commission's proposal, arguing that

NGTs are 'part of the toolbox that enables breeders to speed up their breeding programmes and

bring faster and better plant varieties to the market, which must be accessible in all sectors and all

regions helping European farmers, who face many challenges including the acceleration of climate

change'. The umbrella body underlines that new plant varieties 'must offer additional benefits

compared to existing ones', while 'knowing that these varieties have been tested and evaluated

according to an already established criteria is a form of assurance for farmers'.

EPRS | European Parliamentary Research Service

Commenting on the proposal, Euroseeds Secretary-General Garlich von Essen welcomed the

'differentiation of conventional-like NGTs from the outdated and practically unworkable approval

requirements of transgenic GMOs', which is a 'prerequisite for a proportionate framework adapted

to different profiles of these plants'. This notification process 'needs to be efficient and based on

clear scientific criteria' to avoid a situation whereby 'a simple administrative process becomes

politicised and inconclusive.' Euroseeds supports the distinction made on the market but raises

concerns about 'inconsistencies and restrictions, such as the prohibition of NGT-derived plants in

organic farming'.

IFOAM Organics Europe, the umbrella body representing the organic movement, is on a

completely different page, arguing

that the proposal is 'misguided, dangerous for European seed

autonomy, and a distraction from the agro-ecological solutions needed to move agriculture towards

sustainability'. The body urges MEPs and governments to 'act to protect the freedom of farmers and

consumers not to use or buy products from genetic engineering, and to prevent the monopolisation

of genetic resources through patents'. It welcomes the prohibition of NGTs from organic production,

which is 'in line with the position of the organic food and farming sector', but voices misgivings as

the proposal 'does not provide a clear basis to protect GMO-free and organic production with co-

existence measures, nor to ensure a fair distribution of risks and burdens'.

Friends of the Earth Europe echoes this view, arguing that the proposal 'sacrifices consumer rights

and puts nature at risk', as it 'abolishes labelling requirements, safety checks and any type of liability

processes for new GMOs'. The NGO says that the 'deregulation proposal' will, inter alia, allow the

release of untested new GMOs into nature, and that 'no research has been conducted on how new

GMOs interact with bees and other pollinators, nor on how GMO cropping can speed biodiversity

loss'. Claiming the proposal is 'based on promises made by the industry about products that are

currently still in the pipeline, without baseline or independent assessment on the actual

sustainability of new GMOs,' the NGO urges EU environment and health ministers and MEPs to reject

the proposal.

Pesticide Action Network (PAN) Europe also joined the chorus of opponents, describing the

'solutions' proposed by industry as 'merely wishful thinking', likening it to the 'same kind of

deception that we observed earlier with conventional GMOs'. PAN Europe believes that the proposal

'violates the precautionary principle' and is 'not in line with the European Green Deal's promises', as

the new techniques 'will only benefit the seed industry, leaving farmers, citizens and the

environment unprotected'.

Legislative process

European Parliament

The rapporteur – Jessica Polfjärd (EPP, Sweden) – presented her draft report to the Committee on

the Environment, Public Health and Food Safety (ENVI) on 7 November 2023. The file was su bject to

the

urgent procedure under the Parliament's Rules of Procedure (RoP). Nearly 1 200 amendments

were tabled (24-233, 234-538, 539-863 and 864-1193). The Committee on Agriculture and Rural

Development (AGRI), which has shared competencies under Rule 57 of the RoP, voted on its opinion

on 11 December 2023, after tabling nearly 600 amendments.

Several amendments in Polfjärd's draft report presented to ENVI sought to relax the provisions

applying to 'category 1 NGT plants' by eliminating the additional requirements placed on them

compared to conventional plants. Amendment 10 proposed removing the term 'genetically

modified' from the definition of NGT plants. Arguing that 'Conventional-like NGT plants should be

treated conventionally...', Polfjärd suggested deleting the requirement for mandatory labelling of

seeds from 'category 1 NGT plants' (amendment 5), in contrast to the Commission's proposal. The

justification statement reads that 'transparency and consumer choice can be fully ensured' by

making information on NGT use available in public databases. Similarly, amendment 4 would allow

use of 'category 1 NGT plants' in organic farming.

Plants produced using new genomic techniques

Polfjärd's amendments 22 and 23 concerning the criteria set out in Annex I to determine NGT plants

falling under 'category 1', maintain that the threshold of 20 genetic modifications must be relative to the

ploidy status

of the plant, that is, the number of sets of chromosomes that are found within the nucleus.

Several amendments clarify that the competent authority of the EU country in which the application

is submitted should be entrusted with the verification process for the marketing of NGT-derived

seeds. The remaining EU countries would be able to challenge an approval decision only with a

reasoned objection. Finally, concerning patents of plants obtained through NGTs, Polfjärd

acknowledges the concerns of breeders and farmers but suggests that the issue should be

addressed in a separate piece of legislation to prevent the proposal from exceeding its scope.

On 24 January 2024, ENVI adopted its position

with 47 votes for to 31 against and 4 abstentions.

ENVI Members agreed with the proposed two different categories and sets of rules for NGT plants.

Specifically, NGT plants similar to those bred with conventional methods (category 1 NGT plants)

would be exempt from the EU's market requirements for GMOs (on risk assessment and labelling),

whereas category 2 NGT plants would still need to comply with these requirements. However, MEPs

amended the size and number of modifications required for a plant to come under category 1.

ENVI Members maintained the ban on using NGT plants in organic farming as proposed by the

Commission. Similarly, MEPs amended the proposal to introduce a full ban on patents for all NGT

plants, to 'avoid legal uncertainties, increased costs and new dependencies for farmers and

breeders'. The lawmakers also want the Commission to incorporate this patenting ban into the EU's

rules on intellectual property rights, and to present a report by June 2025 on the impact of patents

on plant breeders' and farmers' access to seeds.

Furthermore, MEPs agreed with the Commission's proposal to label NGT seeds, but did not back

mandatory labelling requirements at the consumer level for category 1 NGT plants. MEPs also

accepted the idea of an accelerated risk assessment procedure to facilitate the use of category 2

NGT plants, but stressed that this should respect the EU's precautionary principle.

On 7 February 2024, Parliament adopted its first-reading position

with 307 votes for to 263 against

and 41 abstentions. ENVI's position was endorsed without major changes. MEPs agreed to support

a simplified registration for plant varieties produced using NGTs that are deemed to be equivalent

to conventional types, while retaining stricter controls for others that are not (plants resulting from

targeted mutagenesis and cisgenesis). Since interinstitutional negotiations failed to begin (see next

section) Parliament closed the first reading and confirmed its position in a

vote on 24 April 2024.

Council

In the Council, the proposal was presented to delegations in the Working Party on Genetic resources

and innovation in agriculture on 10 July 2023. Ministers exchanged views on it at the Agriculture and

Fisheries Council on 25 July, 20 November, 11 December 2023 and 26 March 2024. The Working Party

examined the NGT proposal during its meetings of 26-27 July, 11-12 and 25-26 September, 5-6 and

30-31 October, 14 and 27-28 November 2023, and at those of 11-12 January and 7-8 February 2024.

At the Agriculture and Fisheries Council meeting of 26 March, the Belgian Presidency tried in vain to

obtain a negotiating mandate. EU countries remain split on a number of controversial issues. These

include the patenting of NGTs (currently excluded from the proposal), which some countries argue

should be banned to ensure farmers' access to seeds. Other controversial issues include the proposed

division of NGT plants into two categories and the labelling requirements for each of these.

Many delegations reportedly stressed their support for the Belgian compromise text and the work

done to address the patent issue. In addition, some EU countries would have wished to see emphasis

placed on the importance and potential of NGTs for the environment, but also for EU

competitiveness. Spain, supported by the Czech, Danish, Dutch, Estonian, Finnish, Italian,

Portuguese and Swedish delegations, requested

that the EU Council finalise discussions on NGTs,

given their importance for the agri-food sector.

EPRS | European Parliamentary Research Service

However, the compromise text presented by the Belgian Presidency did not receive sufficient

support to obtain a qualified majority at this stage. Given the time remaining before the European

elections, it would in any case not be possible to complete the procedure during the current

European Parliament term. The Belgian Presidency would nevertheless continue to work towards

reaching a common position among EU countries until the end of its term in June 2024.

EUROPEAN PARLIAMENT SUPPORTING ANALYSIS

Rakstelyte A., Legislation for plants produced by certain new genomic techniques, EPRS, European

Parliament, September 2023.

OTHER SOURCES

European Parliament, Plants obtained by certain new genomic techniques and their food and feed,

Legislative Observatory (OEIL).

ENDNOTES

That is, after the existing EU legislation on genetically modified organisms was adopted.

At EU level, the precautionary principle was enshrined in the Maastricht Treaty in 1992. It is now included in Article 191

of the Treaty on the Functioning of the European Union among the principles underpinning EU environmental policy.

Directive 90/220/EEC on the deliberate release of GMOs into the environment and Directive 90/219/EEC on the

contained use of genetically modified micro-organisms.

Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and

Directive 2009/41/EC on the contained use of genetically modified micro-organisms. Regulation (EC) No 1829/2003,

concerning genetically modified food and feed, was added in 2003.

NGTs are indeed capable of altering the genetic material in a target organism. However, these alterations in some

cases merely result in genetic combinations that also occur in nature or through conventional breeding, while other

alterations are more unlikely to occur naturally.

In the US, the term 'bioengineered crops' is used for GMO crops.

The use of NGTs introducing genetic material from a non-crossable species (transgenesis) should remain subject to

the current GMO legislation, since the resulting plants might bear specific hazards associated with the transgene and

there is no indication that current GMO legislative requirements need adaptation in the same way as for NGT plants.

This section aims to provide a flavour of the debate and is not intended to be an exhaustive account of all different

views on the proposal. Additional information can be found in related publications listed under 'European Parliament

supporting analysis'.

Haploid organisms only contain one complete chromosome set, unlike diploids, which contain two. Polyploids –

organisms with more than two complete sets of chromosomes – are common among plants. In the case of a diploid

plant, one modification would account for two changes.

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background material to assist them in their parliamentary work. The content of the document is the sole

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position of the Parliament.

Reproduction and translation for non-

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Third

edition. The 'EU Legislation in Progress' briefings are updated at key stages in the legislative procedure.