Source: EURLEX
Language: en
Format: md

**Council of the**
**European Union**

**Interinstitutional File:**

**2023/0226(COD)**

**INFORMATION NOTE**

From: General Secretariat of the Council

**Brussels, 2 July 2024**
**(OR. en)**

**10952/24**

**CODEC 1493**
**AGRI 481**
**AGRILEG 291**
**ENV 613**
**PE 181**

To: Permanent Representatives Committee/Council

Subject: 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

          - Outcome of the European Parliament's first reading

(Strasbourg, 22 to 25 April 2024)

**I.** **INTRODUCTION**

The rapporteur, Jessica POLFJÄRD (EPP, SE), presented a report on the above proposal for a

Regulation on behalf of the Committee on the Environment, Public Health and Food Safety (ENVI)

which contained 84 amendments (amendments 1 to 84) to the proposal.

In addition, The Left group tabled 130 amendments (amendments 85 to 107, 109 to 129, 131 to 136,

141 to 218, 315, 317), the ECR group tabled one amendment (amendment 108), the Greens/EFA

group tabled 25 amendments (amendment 137 to 140, 232 to 236, 238, 241 to 243, 246, 265, 275

and 276, 284 to 291), the S&D group tabled 13 amendments (amendments 219 to 231), the S&D

and Greens/EFA groups tabled 29 amendments (amendments 237, 250 to 264, 266 to 271, 277 to

283), the S&D, Greens/EFA and The Left groups tabled 10 amendments (amendments 239 and 240,

244 and 245, 247 to 249, 272 to 274), and the Committee on Agriculture and Rural Development

(AGRI) tabled 23 amendments (amendments 292 to 314).

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**II.** **VOTE**

When it voted on 24 April 2024, the plenary of the European Parliament adopted its position at first

reading on the proposal for a Regulation, which corresponds to the amendments it had adopted on 7

February 2024 **[1]** . No other amendments were adopted.

The Commission's proposal as thus amended is contained in the Parliament’s legislative resolution

as set out in the Annex hereto

**1** Amendments 1 to 3, 5 to 18, 20 to 43, 45, 46, 48 to 54, 56, 57, 59 to 83, 167, 228, 230, 239,
241, 243, 253, 260, 264 to 266, 268, 270, 291, 292, 311 to the proposal for a Regulation.

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**ANNEX**

**(24.4.2024)**

## **P9_TA(2024)0325** **Plants obtained by certain new genomic techniques and their food and feed**

**European Parliament legislative resolution of 24 April 2024 on the 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**
**(COM(2023)0411 – C9-0238/2023 – 2023/0226(COD))**

**(Ordinary legislative procedure: first reading)**

_The European Parliament_,

–
having regard to the Commission proposal to Parliament and the Council (COM(2023)0411),

–
having regard to Article 294(2), Article 43(2), Article 114 and Article 168(4)(b)of the Treaty
on the Functioning of the European Union, pursuant to which the Commission submitted the
proposal to Parliament (C9-0238/2023),

–
having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–
having regard to the reasoned opinions submitted, within the framework of Protocol No 2 on
the application of the principles of subsidiarity and proportionality, by the Cypriot Parliament
and the Hungarian Parliament, asserting that the draft legislative act does not comply with the
principle of subsidiarity,

–
having regard to the opinion of the European Economic and Social Committee of 26 October
2023 **[2]**,

– having regard to the opinion of the Committee of the Regions of 17 April 2024 **[3]**,

–
having regard to Rules 59 of its Rules of Procedure,

–
having regard to the opinion of the Committee on Agriculture and Rural Development,

–
having regard to the report of the Committee on the Environment, Public Health and Food
Safety (A9-0014/2024),

1. Adopts its position at first reading hereinafter set out **[4]** ;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially
amends or intends to substantially amend its proposal;

3. Instructs its President to forward its position to the Council, the Commission and the national

**2** [OJ C, C/2024/893, 6.2.2024, ELI: http://data.europa.eu/eli/C/2024/893/oj](http://data.europa.eu/eli/C/2024/893/oj)
**3** Not yet published in the Official Journal.
**4** This position corresponds to the amendments adopted on 7 February 2024 (Texts adopted,
P9_TA(2024)0067).

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parliaments.

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**Amendment 292**

**Proposal for a regulation**
**Title**

_Text proposed by the Commission_ _Amendment_

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 (Text with EEA relevance)

**Amendment 1**

**Proposal for a regulation**
**Recital 1**

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 _**and Directive 98/44/EC**_
(Text with EEA relevance)

_Text proposed by the Commission_ _Amendment_

(1) Since 2001, when Directive
2001/18/EC of the European Parliament
and of the Council ( [32] ), on the deliberate
release of genetically modified organisms
(GMOs) into the environment was adopted,
significant progress in biotechnology has
led to the development of new genomic
techniques (NGTs), most prominently
genome editing techniques that enable
changes to be made to the genome at
precise locations.

(1) Since 2001, when Directive
2001/18/EC of the European Parliament
and of the Council ( [32] ), on the deliberate
release of genetically modified organisms
(GMOs) into the environment was adopted,
significant progress in biotechnology has
led to the development of new genomic
techniques (NGTs), most prominently
genome editing techniques that enable
changes to be made to the genome at
precise locations. _**Major advances in**_
_**genetic engineering have already**_
_**contributed to the widespread use of**_
_**marker-assisted selection, which makes it**_
_**possible to identify and mobilise**_
_**interesting genes that are present in**_
_**biodiversity.**_

_**_________________**_ _**_________________**_

32 Directive 2001/18/EC of the European
Parliament and of the Council of 12 March

2001 on the deliberate release into the
environment of genetically modified
organisms and repealing Council Directive
90/220/EEC (OJ L 106, 17.4.2001, p. 1).

32 Directive 2001/18/EC of the European
Parliament and of the Council of 12 March

2001 on the deliberate release into the
environment of genetically modified
organisms and repealing Council Directive
90/220/EEC (OJ L 106, 17.4.2001, p. 1).

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**Amendment 167**

**Proposal for a regulation**
**Recital 1 a (new)**

_Text proposed by the Commission_ _Amendment_

_**(1a)**_ _**Allowing for new genomic**_
_**techniques and their results to be patented**_
_**risks giving multinational seed companies**_
_**even more power over farmers’ access to**_
_**seeds. In a context where large companies**_
_**already have a monopoly on seeds and**_
_**increasingly control natural resources,**_
_**this would deprive farmers of all freedom**_
_**of action by making them dependent on**_
_**private companies. For this reason,**_
_**patents on these products must be banned.**_

**Amendment 2**

**Proposal for a regulation**
**Recital 2**

_Text proposed by the Commission_ _Amendment_

(2) NGTs constitute a diverse group of
genomic techniques, and each of them can
be used in various ways to achieve
different results and products. They can
result in organisms with modifications
equivalent to what can be obtained by
conventional breeding methods or in
organisms with more complex
modifications. Among NGTs, targeted
mutagenesis and cisgenesis (including
intragenesis) introduce genetic
modifications without inserting genetic
material from non-crossable species
(transgenesis). They rely only on the
breeders’ gene pool, i.e. the total genetic
information that is available for
conventional breeding including from
distantly related plant species that can be
crossed by advanced breeding techniques.
Targeted mutagenesis techniques result in
modification(s) of the DNA sequence at
_**precise**_ locations in the genome of an
organism. Cisgenesis techniques result in

(2) NGTs constitute a diverse group of
genomic techniques, and each of them can
be used in various ways to achieve
different results and products. They can
result in organisms with modifications
equivalent to what can be obtained by
conventional breeding methods or in
organisms with more complex
modifications. Among NGTs, targeted
mutagenesis and cisgenesis (including
intragenesis) introduce genetic
modifications without inserting genetic
material from non-crossable species
(transgenesis). They rely only on the
breeders’ gene pool, i.e. the total genetic
information that is available for
conventional breeding including from
distantly related plant species that can be
crossed by advanced breeding techniques.
Targeted mutagenesis techniques result in
modification(s) of the DNA sequence at
_**targeted**_ locations in the genome of an
organism. Cisgenesis techniques result in

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the insertion, in the genome of an
organism, of genetic material already
present in the breeders’ gene pool.
Intragenesis is a subset of cisgenesis
resulting in the insertion in the genome of a
rearranged copy of genetic material
composed of two or more DNA sequences
already present in the breeders’ gene pool.

**Amendment 3**

**Proposal for a regulation**
**Recital 3**

the insertion, in the genome of an
organism, of genetic material already
present in the breeders’ gene pool.
Intragenesis is a subset of cisgenesis
resulting in the insertion in the genome of a
rearranged copy of genetic material
composed of two or more DNA sequences
already present in the breeders’ gene pool.

_Text proposed by the Commission_ _Amendment_

(3) There is ongoing public and private
research using NGTs on a wider variety of
crops and traits compared to those obtained
through transgenic techniques authorised in
the Union or globally( [33] ). This includes
plants with improved tolerance or
resistance to plant diseases and pests,
plants with improved tolerance or
resistance to climate change effects and
environmental stresses, improved nutrient
and water-use efficiency, plants with
higher yields and resilience and improved
quality characteristics. These types of new
plants, coupled with the fairly easy and
speedy applicability of those new
techniques, could deliver benefits to
farmers, consumers and to the
environment. Thus, NGTs have the
potential to contribute to the innovation
and sustainability goals of the European
Green Deal ( [34] ) and of the ‘Farm to Fork’
( [35] ), Biodiversity ( [36] ) and Adaptation to
Climate Change( [37] ) Strategies, to global
food security ( [38] ), the Bioeconomy
Strategy ( [39] ) and to the Union’s strategic
autonomy ( [40] ).

(3) There is ongoing public and private
research using NGTs on a wider variety of
crops and traits compared to those obtained
through transgenic techniques authorised in
the Union or globally( [33] ). This includes
plants with improved tolerance or
resistance to plant diseases and pests _**,**_
_**plants with tolerance to herbicides**_, plants
with improved tolerance or resistance to
climate change effects and environmental
stresses, improved nutrient and water-use
efficiency, plants with higher yields and
resilience and improved quality
characteristics. These types of new plants,
coupled with the fairly easy and speedy
applicability of those new techniques,
could deliver benefits to farmers,
consumers and to the environment. Thus,
NGTs have the potential to contribute to
the innovation and sustainability goals of
the European Green Deal ( [34] ) and of the
‘Farm to Fork’ ( [35] ), Biodiversity ( [36] ) and
Adaptation to Climate Change( [37] )
Strategies, to global food security ( [38] ), the
Bioeconomy Strategy ( [39] ) and to the
Union’s strategic autonomy ( [40] ).

_**_________________**_ _**_________________**_

33 Insights and solutions stemming from
EU-funded research and innovation
projects on plant breeding strategies may
contribute to address detection challenges,

33 Insights and solutions stemming from
EU-funded research and innovation
projects on plant breeding strategies may
contribute to address detection challenges,

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ensure traceability and authenticity, and
promote innovation in the area of new
genomic techniques. More than 1,000
projects were funded under the Seventh
Framework Programme and successor
Horizon 2020 programme with an
investment of over 3 billion Euros. Horizon
Europe support to new collaborative
research projects on plant breeding
strategies is also ongoing, SWD(2021) 92.

34 Communication from the Commission to
the European Parliament, the Council, the
European Economic and Social Committee
and the Committee of the Regions, The
European Green Deal, COM/2019/640
final.

35 Communication from the Commission to
the European Parliament, the Council, the
European Economic and Social Committee
and the Committee of the Regions, A Farm
to Fork Strategy for a fair, healthy and
environmentally friendly food system,
COM/2020/381 final.

36 Communication from the Commission to
the European Parliament, the Council, the
European Economic and Social Committee
and the Committee of the Regions, EU
Biodiversity Strategy for 2030: Bringing
nature back into our lives, COM/2020/380
final.

37 Communication from the Commission to
the European Parliament, the Council, the
European Economic and Social Committee
and the Committee of the Regions forging
a Climate-Resilient Europe - The New EU
Strategy on Adaptation to Climate Change,
COM(2021) 82 final

38 Communication from the Commission to
the European Parliament, the European
Council, the Council, the European
Economic and Social Committee and the
Committee of the Regions, Safeguarding
food security and reinforcing the resilience
of food systems, COM (2022) 133 final;
Food and Agriculture Organisation of the
United Nations (FAO), 2022, Gene editing
and agrifood systems, Rome, ISBN 97892-5-137417-7.

ensure traceability and authenticity, and
promote innovation in the area of new
genomic techniques. More than 1,000
projects were funded under the Seventh
Framework Programme and successor
Horizon 2020 programme with an
investment of over 3 billion Euros. Horizon
Europe support to new collaborative
research projects on plant breeding
strategies is also ongoing, SWD(2021) 92.

34 Communication from the Commission to
the European Parliament, the Council, the
European Economic and Social Committee
and the Committee of the Regions, The
European Green Deal, COM/2019/640
final.

35 Communication from the Commission to
the European Parliament, the Council, the
European Economic and Social Committee
and the Committee of the Regions, A Farm
to Fork Strategy for a fair, healthy and
environmentally friendly food system,
COM/2020/381 final.

36 Communication from the Commission to
the European Parliament, the Council, the
European Economic and Social Committee
and the Committee of the Regions, EU
Biodiversity Strategy for 2030: Bringing
nature back into our lives, COM/2020/380
final.

37 Communication from the Commission to
the European Parliament, the Council, the
European Economic and Social Committee
and the Committee of the Regions forging
a Climate-Resilient Europe - The New EU
Strategy on Adaptation to Climate Change,
COM(2021) 82 final

38 Communication from the Commission to
the European Parliament, the European
Council, the Council, the European
Economic and Social Committee and the
Committee of the Regions, Safeguarding
food security and reinforcing the resilience
of food systems, COM (2022) 133 final;
Food and Agriculture Organisation of the
United Nations (FAO), 2022, Gene editing
and agrifood systems, Rome, ISBN 97892-5-137417-7.

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39 European Commission, DirectorateGeneral for Research and Innovation, A

–
sustainable bioeconomy for Europe
Strengthening the connection between
economy, society and the environment:
updated bioeconomy strategy, Publications
Office, 2018,
https://data.europa.eu/doi/10.2777/792130.

40 Communication from the Commission to
the European Parliament, the Council, the
European Economic and Social Committee
and the Committee of the Regions, Trade
Policy Review - An Open, Sustainable and
Assertive Trade Policy, COM(2021)66
final.

**Amendment 5**

**Proposal for a regulation**
**Recital 9**

39 European Commission, DirectorateGeneral for Research and Innovation, A

–
sustainable bioeconomy for Europe
Strengthening the connection between
economy, society and the environment:
updated bioeconomy strategy, Publications
Office, 2018,
https://data.europa.eu/doi/10.2777/792130.

40 Communication from the Commission to
the European Parliament, the Council, the
European Economic and Social Committee
and the Committee of the Regions, Trade
Policy Review - An Open, Sustainable and
Assertive Trade Policy, COM(2021)66
final.

_Text proposed by the Commission_ _Amendment_

(9) Based on the current scientific and
technical knowledge in particular on safety
aspects, this Regulation should be limited
to GMOs that are plants, i.e. organisms in
the taxonomic groups Archaeplastida or
Phaeophyceae _**, excluding**_ microorganisms,
fungi and animals _**for which the available**_
_**knowledge is more limited**_ . For the same
reason, this Regulation should only cover
plants obtained by certain NGTs: targeted
mutagenesis and cisgenesis (including
intragenesis) (hereinafter ‘NGT plants’),
but not by other new genomic techniques.
Such NGT plants do not carry genetic
material from non-crossable species.
GMOs produced by other new genomic
techniques that introduce into an organism
genetic material from non-crossable
species (transgenesis) should remain
subject only to the Union GMO legislation,
given that the resulting plants might bear
specific risks associated to the transgene.
_**Moreover, there is no indication that**_
_**current requirements in the Union GMO**_
_**legislation for GMOs obtained by**_

(9) Based on the current scientific and
technical knowledge in particular on safety
aspects, this Regulation should be limited
to GMOs that are plants, i.e. organisms in
the taxonomic groups Archaeplastida or
Phaeophyceae _**. Available knowledge on**_
_**other organisms, such as**_ microorganisms,
fungi and animals _**, should be reviewed**_
_**with a view to future legislative initiatives**_
_**on them**_ . For the same reason, this
Regulation should only cover plants
obtained by certain NGTs: targeted
mutagenesis and cisgenesis (including
intragenesis) (hereinafter ‘NGT plants’),
but not by other new genomic techniques.
Such NGT plants do not carry genetic
material from non-crossable species.
GMOs produced by other new genomic
techniques that introduce into an organism
genetic material from non-crossable
species (transgenesis) should remain
subject only to the Union GMO legislation,
given that the resulting plants might bear
specific risks associated to the transgene.

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_**transgenesis need adaptation at the**_
_**present time.**_

**Amendment 6**

**Proposal for a regulation**
**Recital 10**

_Text proposed by the Commission_ _Amendment_

(10) The legal framework for NGT plants
should share the objectives of the Union
GMO legislation to ensure a high level of
protection of human and animal health and
of the environment and the good
functioning of the internal market for the
concerned plants and products, while
addressing the specificity of NGT plants.
This legal framework should enable the
development and placing on the market of
plants, food and feed containing, consisting
of or produced from NGT plants and other
products containing or consisting of NGT
plants (‘NGT products’) so as to contribute
to the innovation and sustainability
objectives of the European Green Deal and
the Farm to Fork, Biodiversity and Climate
Adaptation strategies and to enhance the
competitiveness of the Union agri-food
sector at Union and world level.

**Amendment 7**

**Proposal for a regulation**
**Recital 11**

(10) _**With full regard to the**_
_**precautionary principle,**_ the legal
framework for NGT plants should share
the objectives of the Union GMO
legislation to ensure a high level of
protection of human and animal health and
of the environment and the good
functioning of the internal market for the
concerned plants and products, while
addressing the specificity of NGT plants.
This legal framework should enable the
development and placing on the market of
plants, food and feed containing, consisting
of or produced from NGT plants and other
products containing or consisting of NGT
plants (‘NGT products’) so as to contribute
to the innovation and sustainability
objectives of the European Green Deal and
the Farm to Fork, Biodiversity and Climate
Adaptation strategies and to enhance the
competitiveness of the Union agri-food
sector at Union and world level.

_Text proposed by the Commission_ _Amendment_

(11) This Regulation constitutes lex
specialis with regard to the Union GMO
legislation. It introduces specific provisions
for NGT plants and NGT products. However,
where there are no specific rules in this

(11) This Regulation constitutes lex
specialis with regard to the Union GMO
legislation. It introduces specific provisions
for NGT plants and NGT products. However,
where there are no specific rules in this

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Regulation, NGT plants and products
_**(including food and feed)**_ obtained from
them should remain subject to the
requirements of the Union GMO legislation
and the rules on GMOs in sectoral
legislation, such as Regulation (EU)
2017/625 on official controls or the
legislation on certain products like plant and
forest reproductive material.

**Amendment 8**

**Proposal for a regulation**
**Recital 13 a (new)**

Regulation, NGT plants and products
obtained from them should remain subject to
the requirements of the Union GMO
legislation and the rules on GMOs in sectoral
legislation, such as Regulation (EU)
2017/625 on official controls or the
legislation on certain products like plant and
forest reproductive material.

_Text proposed by the Commission_ _Amendment_

_**(13a)**_ _**NGT plants with the potential to**_
_**persist, reproduce or spread in the**_
_**environment, within or beyond fields,**_
_**should be evaluated with the highest level**_
_**of scrutiny in respect of such plants’**_
_**impact on nature and the environment.**_

**Amendment 9**

**Proposal for a regulation**
**Recital 14**

_Text proposed by the Commission_ _Amendment_

(14) NGT plants that could also occur
naturally or be produced by conventional
breeding techniques and their progeny
_**obtained by conventional breeding**_
_**techniques**_ (‘category 1 NGT plants’)
should be treated as plants that have
occurred naturally or have been produced
by conventional breeding techniques, given
that they are equivalent and that their risks
are comparable, thereby derogating in full
from the Union GMO legislation and GMO
related requirements in sectoral legislation.
In order to ensure legal certainty, this
Regulation should set out the criteria to
ascertain if a NGT plant is equivalent to

(14) NGT plants that could also occur
naturally or be produced by conventional
breeding techniques and their progeny
(‘category 1 NGT plants’) should be
treated as plants that have occurred
naturally or have been produced by
conventional breeding techniques, given
that they are equivalent and that their risks
are comparable, thereby derogating in full
from the Union GMO legislation and GMO
related requirements in sectoral legislation.
In order to ensure legal certainty, this
Regulation should set out the criteria to
ascertain if a NGT plant is equivalent to
naturally occurring or conventionally bred

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naturally occurring or conventionally bred
plants and lay down a procedure for
competent authorities to verify and take a
decision on the fulfillment of those criteria,
prior to the release or placing on the
market of NGT plants or NGT products.
Those criteria should be objective and
based on science. They should cover the
type and extent of genetic modifications
that can be observed in nature or in
organisms obtained with conventional
breeding techniques and should include
thresholds for both size and number of
genetic modifications to the genome of
NGT plants. Since scientific and technical
knowledge evolves rapidly in this area, the
Commission should be empowered in
accordance with Article 290 of the Treaty
on the Functioning of the European Union
to update these criteria in light of scientific
and technical progress as regards the type
and extent of genetic modifications that
can occur in nature or through
conventional breeding.

**Amendment 10**

**Proposal for a regulation**
**Recital 14 a (new)**

plants and lay down a procedure for
competent authorities to verify and take a
decision on the fulfilment of those criteria,
prior to the release or placing on the
market of NGT plants or NGT products.
Those criteria should be objective and
based on science. They should cover the
type and extent of genetic modifications
that can be observed in nature or in
organisms obtained with conventional
breeding techniques and should include
thresholds for both size and number of
genetic modifications to the genome of
NGT plants. Since scientific and technical
knowledge evolves rapidly in this area, the
Commission should be empowered in
accordance with Article 290 of the Treaty
on the Functioning of the European Union
to update these criteria in light of scientific
and technical progress as regards the type
and extent of genetic modifications that
can occur in nature or through
conventional breeding.

_Text proposed by the Commission_ _Amendment_

_**(14a)**_ _**Taking into account the high**_
_**complexity of plant genomes, the criteria**_
_**for considering that a NGT plant is**_
_**equivalent to a naturally occurring or**_
_**conventionally bred plant should reflect**_
_**the diversity of plants genomic size and**_
_**their characteristics. Polyploid plants**_
_**contain more than two homologous**_
_**chromosomes. Within that category of**_
_**polyploid plants, tetraploid, hexaploid,**_
_**and octoploid have 4, 6 and 8 sets of**_
_**chromosomes respectively. Polyploid**_
_**plants tend to exhibit greater numbers of**_
_**genetic modifications compared to**_
_**monoploid plants. For those reasons, any**_
_**limit to the total number of individual**_

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_**modifications per plant should reflect the**_
_**number of chromosomes set in a plant**_
_**(“ploidy”).**_

**Amendment 11**

**Proposal for a regulation**
**Recital 18**

_Text proposed by the Commission_ _Amendment_

(18) Since the criteria for considering that
a NGT plant is equivalent to naturally
occurring or conventionally bred plants are
unrelated to the type of activity that
requires the deliberate release of the NGT
plant, a declaration of the category 1 NGT
plant status made prior to its deliberate
release for any other purpose than placing
on the market in the territory of the Union
should also be valid for the placing on the
market of related NGT products. In view of
the high uncertainty existing at the field
trial stage about the product reaching the
market and the likely involvement of
smaller operators in such releases, the
verification procedure of category 1 NGT
plant status prior to field trials should be
conducted by national competent
authorities as this would be less
administratively burdensome for operators,
and a decision should be taken at Union
level only in case there are comments to
the verification report by other national
competent authorities. Where the
verification request is submitted prior to
the placing on the market of NGT
products, the procedure should be
conducted _**at Union level**_ in order to ensure
effectiveness of the verification procedure
and consistency of the category 1 NGT
plant status declarations.

(18) Since the criteria for considering that
a NGT plant is equivalent to naturally
occurring or conventionally bred plants are
unrelated to the type of activity that
requires the deliberate release of the NGT
plant, a declaration of the category 1 NGT
plant status made prior to its deliberate
release for any other purpose than placing
on the market in the territory of the Union
should also be valid for the placing on the
market of related NGT products. In view of
the high uncertainty existing at the field
trial stage about the product reaching the
market and the likely involvement of
smaller operators in such releases, the
verification procedure of category 1 NGT
plant status prior to field trials should be
conducted by national competent
authorities as this would be less
administratively burdensome for operators,
and a decision should be taken at Union
level only in case there are comments to
the verification report by other national
competent authorities. Where verification
request is submitted prior to the placing on
the market of NGT products, _**and**_ _**if there**_
_**are reasoned objections by other Member**_
_**States,**_ the procedure should be conducted
_**in consultation with the Commission and**_

_**the European Food Safety Authority (‘the**_
_**Authority’)**_ in order to ensure effectiveness
of the verification procedure and
consistency of the category 1 NGT plant
status declarations.

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**Amendment 12**

**Proposal for a regulation**
**Recital 18 a (new)**

_Text proposed by the Commission_ _Amendment_

_**(18a)**_ _**In order to effectively select new**_
_**varieties that help the agricultural sector**_
_**increase food security, as well as**_
_**sustainability, adaptation and resilience in**_
_**relation to the consequences of climate**_
_**change, it is necessary to consider the**_
_**specificity of polyploid plants, which are**_
_**plants that contain more than two**_
_**genomes. For such plants, the maximum**_
_**number of genetic modifications allowed**_
_**for inclusion in category 1 NGT should be**_
_**proportionate to the number of genomes**_
_**they contain.**_

**Amendment 13**

**Proposal for a regulation**
**Recital 19**

_Text proposed by the Commission_ _Amendment_

(19) The competent authorities of the
Member States, the Commission and the
European Food Safety Authority (‘the
Authority’) should be subject to _**strict**_
deadlines to ensure that category 1 NGT
plant status declarations are made within a
reasonable time.

**Amendment 14**

**Proposal for a regulation**
**Recital 21**

(19) The competent authorities of the
Member States, the Commission and the
Authority should be subject to _**appropriate**_
deadlines to ensure that category 1 NGT
plant status declarations are made within a
reasonable time.

_Text proposed by the Commission_ _Amendment_

(21) Decisions declaring the category 1
NGT plant status should assign an
identification number to the NGT plant

(21) Decisions declaring the category 1
NGT plant status should assign an
identification number to the NGT plant

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concerned in order to ensure transparency
and traceability of such plants when they
are listed in the database _**and for the**_
_**purpose of labelling of plant reproductive**_
_**material derived from them**_ .

**Amendment 15**

**Proposal for a regulation**
**Recital 23**

concerned in order to ensure transparency
and traceability of such plants when they
are listed in the database _**. The information**_
_**listed should include information on the**_
_**technique or techniques used to obtain the**_
_**trait or traits**_ .

_Text proposed by the Commission_ _Amendment_

(23) Regulation (EU) 2018/848 of the
European Parliament and the Council on
organic production and labelling of organic
products and repealing Council Regulation
(EC) 834/2007( [47] ) prohibits the use of
GMOs and products from and by GMOs in
organic production. It defines GMOs for
the purposes of that Regulation by
reference to Directive 2001/18/EC,
excluding from the prohibition GMOs
which have been obtained through the
techniques of genetic modification listed in
Annex 1.B of Directive 2001/18/EC. As a
result, category 2 NGT plants will be
banned in organic production. However, it
is necessary to clarify the status of category
1 NGT plants for the purposes of organic
production. The use of new genomic
techniques _**is currently incompatible**_ with
the _**concept**_ of organic production _**in the**_
_**Regulation (EC) 2018/848 and with**_
_**consumers’ perception of organic**_
_**products**_ . The use of category 1 NGT
plants should therefore be _**also**_ prohibited
in organic production.

(23) Regulation (EU) 2018/848 of the
European Parliament and the Council on
organic production and labelling of organic
products and repealing Council Regulation
(EC) 834/2007( [47] ) prohibits the use of
GMOs and products from and by GMOs in
organic production. It defines GMOs for
the purposes of that Regulation by
reference to Directive 2001/18/EC,
excluding from the prohibition GMOs
which have been obtained through the
techniques of genetic modification listed in
Annex 1.B of Directive 2001/18/EC. As a
result, category 2 NGT plants will be
banned in organic production. However, it
is necessary to clarify the status of category
1 NGT plants for the purposes of organic
production. _**Currently, the compatibility of**_
the use of new genomic techniques with
the _**principles**_ of organic production
_**requires further consideration**_ . The use of
category 1 NGT plants should therefore be
prohibited in organic production _**, until**_
_**such further consideration takes place**_ .

_**_________________**_ _**_________________**_

47 Regulation (EU) 2018/848 of the
European Parliament and of the Council of
30 May 2018 on organic production and
labelling of organic products and repealing
Council Regulation (EC) No 834/2007 (OJ
L 150, 14.6.2018, p. 1).

47 Regulation (EU) 2018/848 of the
European Parliament and of the Council of
30 May 2018 on organic production and
labelling of organic products and repealing
Council Regulation (EC) No 834/2007 (OJ
L 150, 14.6.2018, p. 1).

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**Amendment 16**

**Proposal for a regulation**
**Recital 24**

_Text proposed by the Commission_ _Amendment_

(24) Provision should be made to ensure
transparency as regards the use of category
1 NGT plant varieties, to ensure that
production chains that wish to remain free
from NGTs can do so and thereby
safeguard consumer trust. NGT plants that
have obtained a category 1 NGT plant
status declaration should be listed in a
publicly available database. To ensure
traceability, transparency and choice for
operators, during research and plant
breeding, when selling seed to farmers or
making plant reproductive material
available to third parties in any other way,
plant reproductive material of category 1
NGT plants should be labelled as category
1 NGT.

**Amendment 17**

**Proposal for a regulation**
**Recital 29**

(24) Provision should be made to ensure
transparency as regards the use of category
1 NGT plant varieties, to ensure that
production chains that wish to remain free
from NGTs can do so and thereby
safeguard consumer trust. NGT plants that
have obtained a category 1 NGT plant
status declaration should be listed in a
publicly available database _**including**_
_**information on the technique or**_
_**techniques used to obtain the trait or**_
_**traits**_ . To ensure traceability, transparency
and choice for operators, during research
and plant breeding, when selling seed to
farmers or making plant reproductive
material available to third parties in any
other way, plant reproductive material of
category 1 NGT plants should be labelled
as category 1 NGT.

_Text proposed by the Commission_ _Amendment_

(29) Directive 2001/18/EC requires a
monitoring plan for environmental effects
of GMOs after their deliberate release or
placing on the market but provides for
flexibility as to the design of the plan
taking into account the environmental risk
assessment, the characteristics of the
GMO, of its expected use and of the
receiving environment. Genetic
modifications in category 2 NGT plants
may range from changes only needing a
limited risk assessment to complex
alterations requiring a more thorough
analysis of potential risks. Therefore, postmarket monitoring requirements for

(29) Directive 2001/18/EC requires a
monitoring plan for environmental effects
of GMOs after their deliberate release or
placing on the market but provides for
flexibility as to the design of the plan
taking into account the environmental risk
assessment, the characteristics of the
GMO, of its expected use and of the
receiving environment. Genetic
modifications in category 2 NGT plants
may range from changes only needing a
limited risk assessment to complex
alterations requiring a more thorough
analysis of potential risks. Therefore, postmarket monitoring requirements for

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environmental effects of category 2 NGT
plants should be adapted in the light of the
environmental risk assessment and the
experience in field trials, the characteristics
of the NGT plant concerned, the
characteristics and scale of its expected
use, in particular any history of safe use of
the plant and the characteristics of the
receiving environment. _**Therefore**_, a
monitoring plan for environmental effects
should _**not**_ be required _**if**_ the category 2
NGT plant _**is unlikely to**_ pose risks that
need monitoring, such as indirect, delayed
or unforeseen effects on human health or

on the environment.

**Amendment 18**

**Proposal for a regulation**
**Recital 36**

environmental effects of category 2 NGT
plants should be adapted in the light of the
environmental risk assessment and the
experience in field trials, the characteristics
of the NGT plant concerned, the
characteristics and scale of its expected
use, in particular any history of safe use of
the plant and the characteristics of the
receiving environment. _**In view of the**_
_**precautionary principle**_, a monitoring plan
for environmental effects should _**always**_ be
required _**when consent is first given. It**_
_**should only be possible to waive the**_
_**requirement for monitoring upon the**_
_**renewal of consent, provided that it has**_
_**been demonstrated that**_ the category 2
NGT plant _**does not**_ pose risks that need
monitoring, such as indirect, delayed or
unforeseen effects on human health or on

the environment.

_Text proposed by the Commission_ _Amendment_

(36) Herbicide tolerant plants are bred to
be intentionally tolerant to herbicides, in
order to be cultivated in combination with

the use of those herbicides. If such
cultivation is not done under appropriate
conditions, it may lead to development of
weeds resistant to those herbicides or to the
need to increase of quantities of herbicides
applied, regardless of the breeding
technique. For this reason, NGT plants
featuring herbicide-tolerant traits should
not _**be eligible for incentives under this**_
_**framework. However, this Regulation**_
_**should not take other specific measures**_
_**on herbicide tolerant NGT plants, because**_
_**such measures are taken horizontally in**_

_**[the Commission’s Proposal for a**_
_**Regulation**_ of the _**European Parliament**_
_**and of the Council on the production and**_
_**marketing of plant reproductive material**_
_**in the Union]**_ .

(36) Herbicide tolerant plants are bred to
be intentionally tolerant to herbicides, in
order to be cultivated in combination with

the use of those herbicides. If such
cultivation is not done under appropriate
conditions, it may lead to development of
weeds resistant to those herbicides or to the
need to increase of quantities of herbicides
applied, regardless of the breeding
technique. For this reason, NGT plants
featuring herbicide-tolerant traits should
not _**fall within the scope**_ of the _**category 1**_
_**NGT plants**_ .

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**Amendment 239**

**Proposal for a regulation**
**Recital 37**

_Text proposed by the Commission_ _Amendment_

_**(37)**_ _**In order to enable NGT plants to**_
_**contribute to the sustainability objectives**_
_**of the Green Deal and the Farm to Fork**_
_**and Biodiversity Strategies, cultivation of**_
_**NGT plants in the Union should be**_
_**facilitated. This requires predictability for**_
_**breeders and farmers as regards the**_
_**possibility to cultivate such plants in the**_
_**Union. Therefore, the possibility for**_
_**Member States to adopt measures**_
_**restricting or prohibiting the cultivation of**_
_**category 2 NGT plants in all or part of**_
_**their territory, set out in Article 26b of**_
_**Directive 2001/18/EC would undermine**_

_**those goals.**_

**Amendment 20**

**Proposal for a regulation**
**Recital 39**

_**deleted**_

_Text proposed by the Commission_ _Amendment_

(39) To achieve the goal of ensuring the
effective functioning of the internal
market _**, NGT plants and related products**_
_**should benefit from**_ the free movement of
_**goods, provided they comply with the**_
requirements _**of other**_ _**Union**_ _**law**_ .

**Amendment 21**

**Proposal for a regulation**
**Recital 40**

(39) To achieve the goal of ensuring the
effective functioning of the internal market
_**and**_ the free movement of _**NGT plant and**_
_**NGT products across the Union, the**_
_**deliberate release of NGT plants and**_
_**placing on the market of NGT products**_
_**should be based on the harmonised**_
requirements _**and procedures laid down in**_
_**this Regulation, leading to the adoption of**_
_**a decision uniformly applicable to all**_
_**Member States.**_

_Text proposed by the Commission_ _Amendment_

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(40) Given the _**novelty of the NGTs, it**_
_**will be important to monitor closely the**_
development _**and presence on the market**_
_**of NGT plants and products and evaluate**_
_**any accompanying impact on human and**_
_**animal health, the environment and**_
_**environmental, economic and social**_
_**sustainability. Information**_ should _**be**_
_**collected regularly and**_ within five years
after the adoption of the first decision
allowing the deliberate release or the
marketing of NGT plants or NGT products
in the Union _**, the Commission should**_
_**carry out an**_ evaluation _**of this Regulation**_
_**to**_ measure the progress made towards the
availability of NGT plants containing such
characteristics or properties on the EU
market.

**Amendment 22**

**Proposal for a regulation**
**Recital 43**

(40) Given the _**ongoing**_ development _**of**_
_**new genomic techniques, the Commission**_
should _**carry out an evaluation**_ within five
years after the adoption of the first decision
allowing the deliberate release or the
marketing of NGT plants or NGT products
in the Union _**. That**_ evaluation _**should**_
measure the progress made towards the
availability of NGT plants _**or NGT**_
_**products**_ containing such characteristics or
properties on the EU market _**, with the aim**_
_**of further improving this Regulation**_ .

_Text proposed by the Commission_ _Amendment_

(43) The types of NGT plants developed
and the impact of certain traits on
environmental, social and economic
sustainability are continuously evolving.
Therefore, based on the available evidence
of such developments and impacts, the
Commission should be empowered in
accordance with Article 290 of the Treaty
on the Functioning of the European Union
to adapt the list of traits that should be
incentivized or discouraged to achieve the
goals of the Green Deal and the Farm to
Fork, Biodiversity and Climate Adaptation
strategies.’

**Amendment 23**

**Proposal for a regulation**
**Recital 45 a (new)**

(43) The types of NGT plants developed
and the impact of certain traits on
environmental, social and economic
sustainability are continuously evolving.
Therefore, based on the available evidence
of such developments and impacts, _**fully**_
_**taking into account the precautionary**_
_**principle,**_ the Commission should be
empowered in accordance with Article 290
of the Treaty on the Functioning of the
European Union to adapt the list of traits
that should be incentivized or discouraged
to achieve the goals of the Green Deal and
the Farm to Fork, Biodiversity and Climate
Adaptation strategies.’

_Text proposed by the Commission_ _Amendment_

_**(45a)**_ _**The European Parliament has**_
_**called for the Union and its Member**_
_**States not to grant patents on biological**_

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_**material and to safeguard the freedom to**_
_**operate and the breeders’ exemption for**_
_**varieties. It should be ensured that**_

_**breeders have full access to the genetic**_
_**material of NGT plants, which by**_
_**definition are not transgenic plants.**_
_**Access to genetic materials can best be**_
_**secured when the right of patent holders**_
_**is exhausted in the hand of the breeder**_
_**(breeder’s exemption). As current**_
_**provisions in patent law do not provide for**_
_**a full breeder’s exemption, it should be**_
_**ensured that patents should not restrict**_
_**the use of NGT plants by breeders and**_
_**farmers. Hence, NGT plants should not**_
_**be subject to patent legislation, but should**_
_**for the protection of intellectual property**_
_**solely be subject to the Community Plant**_
_**Variety Rights (CPVR) system, as laid**_
_**down in Council Regulation (EC) No**_
_**2100/94, which allows the use of the**_
_**breeder’s exemption. NGT plants, their**_
_**derived seeds, their plant material,**_
_**associated genetic material such as genes**_
_**and gene sequences, and plant traits**_
_**should therefore be excluded from**_
_**patentability. The exclusion from**_
_**patentability should be applied in a**_
_**consistent manner across legislation.**_
_**Furthermore, in order to avoid patents**_
_**being granted or patent applications being**_
_**submitted between the date of the entry**_
_**into force of this Regulation and the**_
_**application of its provisions, it should be**_
_**ensured that plant material is excluded**_
_**from patentability from the day of entry**_
_**into force of this Regulation. For patents**_
_**already granted or pending patent**_
_**applications covering plant material, the**_
_**effects of patents should be further**_
_**limited. In addition, the Commission**_
_**should assess and address, in the**_
_**forthcoming study, how the broader**_
_**problem of patents being granted, directly**_
_**or indirectly, on plant material despite**_
_**previous efforts to close loopholes, should**_
_**be further addressed. The assessment**_
_**should address in particular the role and**_
_**impact of patents on breeders' and**_
_**farmers' access to plant reproductive**_
_**material, seed diversity and affordable**_

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_**prices, as well as on innovation and in**_
_**particular on opportunities for SMEs. The**_
_**report of the Commission should be**_
_**accompanied by the appropriate**_
_**legislative proposals in order to ensure**_
_**further necessary adjustments are made to**_
_**the intellectual property rights framework.**_

**Amendment 241**

**Proposal for a regulation**
**Recital 47 a (new)**

_Text proposed by the Commission_ _Amendment_

_**(47a)**_ _**The European Green Deal, the**_
_**‘Farm to Fork’, and the EU Biodiversity**_
_**Strategies put organic farming at the core**_
_**of a transition to sustainable food systems,**_
_**with a target to expand European**_
_**agricultural land under organic**_
_**production to 25 % by 2030. This is a**_
_**clear recognition of the environmental**_
_**benefits of organic farming, for less**_
_**dependency on inputs for farmers, and a**_
_**resilient food supply and food sovereignty.**_
_**This Regulation must not adversely**_
_**undermine the pathway to a transition of**_
_**European food systems to organic**_
_**farming to 25 % by 2030.**_

**Amendment 243**

**Proposal for a regulation**
**Recital 47 b (new)**

_Text proposed by the Commission_ _Amendment_

_**(47b)**_ _**Traceability requirements for food**_
_**and feed produced from NGTs should be**_
_**established to facilitate the accurate**_
_**labelling of such products, in accordance**_
_**with the requirements of Regulation (EC)**_
_**No 1829/2003 of the European**_
_**Parliament and of the Council of 22**_
_**September 2003 on genetically modified**_

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_**food and feed, so as to ensure that**_
_**accurate information is available to**_
_**operators and consumers to enable them**_
_**to exercise their freedom of choice in an**_
_**effective manner, as well as to enable**_
_**control and verification of labelling**_
_**claims. Requirements for food and feed**_
_**produced from NGTs should be similar in**_
_**order to avoid discontinuity of**_
_**information in cases of change in end**_

_**use.**_

**Amendment 24**

**Proposal for a regulation**
**Article 1 – paragraph 1**

_Text proposed by the Commission_ _Amendment_

This Regulation lays down specific rules
for the deliberate release into the
environment for any other purpose than
placing on the market of plants obtained by
certain new genomic techniques (‘NGT
plants’) and for the placing on the market
of food and feed containing, consisting of
or produced from such plants, and of
products, other than food or feed,
containing or consisting of such plants.

**Amendment 25**

**Proposal for a regulation**
**Article 3 – paragraph 1 – point 2**

This Regulation _**, in accordance with the**_
_**precautionary principle**_ lays down specific
rules for the deliberate release into the
environment for any other purpose than
placing on the market of plants obtained by
certain new genomic techniques (‘NGT
plants’) and for the placing on the market
of food and feed containing, consisting of
or produced from such plants, and of
products, other than food or feed,
containing or consisting of such plants _**,**_
_**ensuring a high level of protection of**_
_**human and animal health and the**_

_**environment**_ .

_Text proposed by the Commission_ _Amendment_

(2) ‘NGT plant’ means a genetically
modified plant obtained by targeted
mutagenesis or cisgenesis, or a
combination thereof, on the condition that
it does not contain any genetic material
originating from outside the _**breeders’**_ gene
pool that temporarily may have been

(2) ‘NGT plant’ means a genetically
modified plant obtained by targeted
mutagenesis or cisgenesis, or a
combination thereof, on the condition that
it does not contain any genetic material
originating from outside the gene pool _**for**_
_**conventional breeding purposes**_ that

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inserted during the development of the
NGT plant;

**Amendment 26**

**Proposal for a regulation**
**Article 3 – paragraph 1 – point 4**

temporarily may have been inserted during
the development of the NGT plant;

_Text proposed by the Commission_ _Amendment_

(4) ‘targeted mutagenesis’ means
mutagenesis techniques resulting in
modification(s) of the DNA sequence at
_**precise**_ locations in the genome of an
organism;

**Amendment 27**

**Proposal for a regulation**
**Article 3 – paragraph 1 – point 6**

(4) ‘targeted mutagenesis’ means
mutagenesis techniques resulting in
modification(s) of the DNA sequence at
_**targeted**_ locations in the genome of an
organism;

_Text proposed by the Commission_ _Amendment_

(6) _**‘breeders’**_ gene pool _**’**_ means the total
genetic information available in one
species and other taxonomic species with
which it can be cross-bred, _**including by**_
using advanced techniques such as embryo
rescue, induced polyploidy and bridge

crosses;

**Amendment 28**

**Proposal for a regulation**
**Article 3 – paragraph 1 – point 15 a (new)**

(6) _**‘**_ gene pool _**for conventional**_
_**breeding purposes’**_ means the total genetic
information available in one species and
other taxonomic species with which it can
be cross-bred, using advanced techniques
such as embryo rescue, induced polyploidy
and bridge crosses;

_Text proposed by the Commission_ _Amendment_

_**(15a)**_ _**‘One Health Approach’ means an**_
_**integrated, unifying approach that aims to**_
_**sustainably balance and optimise the**_
_**health of people, animals, plants and**_
_**ecosystems and recognises that the health**_
_**of humans, domestic and wild animals,**_
_**plants, and the wider environment**_
_**including ecosystems are closely**_
_**interlinked and inter-dependent;**_

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**Amendment 29**

**Proposal for a regulation**
**Article 3 – paragraph 1 – point 15 b (new)**

_Text proposed by the Commission_ _Amendment_

_**(15b)**_ _**“Chimeric protein” means proteins**_
_**created through the joining of two or**_
_**more genes or parts of genes that**_
_**originally coded for separate proteins.**_

**Amendment 30**

**Proposal for a regulation**
**Article 4 – paragraph 1 – point 1 – point b**

_Text proposed by the Commission_ _Amendment_

(b) is progeny of plant(s) referred to in
point (a); or

**Amendment 31**

**Proposal for a regulation**
**Article 4 – paragraph 1 – point 2**

(b) is progeny of plant (s) referred to in
point (a) _**on condition that the criteria of**_
_**equivalence set out in Annex I are still**_
_**satisfied**_ ; or

_Text proposed by the Commission_ _Amendment_

(2) the plant is a category 2 NGT plant
_**and**_ has been authorised in accordance
with Chapter III.

**Amendment 32**

**Proposal for a regulation**
**Article 4 – paragraph 1 a (new)**

(2) the plant is a category 2 NGT plant _**,**_
_**and has been granted consent or**_ has been
authorised in accordance with Chapter III.

_Text proposed by the Commission_ _Amendment_

_**1a.**_ _**The implementation, enforcement**_
_**and application of this Regulation shall**_
_**not have the object or effect of preventing**_
_**or impeding imports from third countries**_
_**of NGT plants and products that meet the**_
_**same standards as those laid down in this**_

_**Regulation.**_

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**Amendment 33**

**Proposal for a regulation**
**Article 4 a (new)**

_Text proposed by the Commission_ _Amendment_

_**Article 4a**_

_**Exclusion from patentability**_

_**NGT plants, plant material, parts thereof,**_
_**genetic information and the process**_
_**features they contain shall not be**_
_**patentable.**_

**Amendment 34**

**Proposal for a regulation**
**Article 5 – paragraph 2**

_Text proposed by the Commission_ _Amendment_

2. For the purposes of Regulation (EU)
2018/848, the rules set out in its _**Articles 5**_
_**(f) (iii) and**_ 11 shall apply to category 1
NGT plants and to products produced from
or by such plants.

**Amendment 35**

**Proposal for a regulation**
**Article 5 – paragraph 3**

2. For the purposes of Regulation (EU)
2018/848, the rules set out in its _**Article 5**_
_**(f), (iii), and Article**_ 11 shall apply to
category 1 NGT plants and to products
produced from or by such plants. _**[7 years**_
_**after the entry into force of this**_
_**Regulation], the Commission shall**_
_**present a report on the evolution of the**_
_**consumers' and producers' perception,**_
_**accompanied, where appropriate, by a**_
_**legislative proposal.**_

_Text proposed by the Commission_ _Amendment_

3. The Commission is empowered to
adopt delegated acts in accordance with
Article 26 amending the criteria of
equivalence of NGT plants to conventional
plants laid down in Annex I in order to
adapt them to scientific and technological
_**progress**_ as regards the types and extent of
modifications which can occur naturally or

3. The Commission is empowered to
adopt delegated acts in accordance with
Article 26 amending the criteria of
equivalence of NGT plants to conventional
plants laid down in Annex I _**, taking into**_
_**account potential associated risks and**_
_**functional consequences in the**_
_**verification procedure**_ in order to adapt

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through conventional breeding. those criteria to _**the latest**_ scientific and
technological _**developments**_ as regards the
types and extent of modifications which
can occur naturally or through
conventional breeding.

**Amendment 36**

**Proposal for a regulation**
**Article 5 – paragraph 3 a (new)**

_Text proposed by the Commission_ _Amendment_

_**3a.**_ _**The adventitious or technically**_
_**unavoidable presence of category 1 NGT**_
_**plants, reproductive material or parts**_
_**thereof in organic production, or in non-**_
_**organic products authorised in organic**_
_**production in accordance with Articles 24**_
_**and 25 of Regulation (EU) 2018/848,**_
_**shall not constitute non-compliance with**_
_**that Regulation.**_

**Amendment 37**

**Proposal for a regulation**
**Article 6 – paragraph 1**

_Text proposed by the Commission_ _Amendment_

1. To obtain the declaration of category
1 NGT plant status referred to in Article
4(1), point (a), before undertaking a
deliberate release of a NGT plant for any
other purpose than placing on the market,
the person intending to undertake the
deliberate release shall submit a request to
verify whether the criteria set out in Annex
I are met (‘verification request’) to the
competent authority designated in
accordance with Article 4(4) of Directive
2001/18/EC of the Member State within
whose territory the release is to take place
in accordance with paragraphs 2 and 3 and
the _**implementing**_ act adopted in
accordance with Article _**27**_, point (b).

1. To obtain the declaration of category
1 NGT plant status referred to in Article
4(1), point (a), before undertaking a
deliberate release of a NGT plant for any
other purpose than placing on the market,
the person intending to undertake the
deliberate release shall submit a request to
verify whether the criteria set out in Annex
I _**at least one of the traits referred to in**_
_**Annex III, Part 1, and the exclusion**_
_**criteria in Annex III, Part 2,**_ are met
(‘verification request’) _**. That verification**_
_**request shall be submitted**_ to the
competent authority designated in
accordance with Article 4(4) of Directive
2001/18/EC of the Member State within
whose territory the release is to take place
in accordance with paragraphs 2 and 3 and
the _**delegated**_ act adopted in accordance
with Article _**6(11a)**_, point (b).

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**Amendment 38**

**Proposal for a regulation**
**Article 6 – paragraph 3 – point c**

_Text proposed by the Commission_ _Amendment_

(c) a description of the trait(s) and
characteristics which have been introduced

or modified;

**Amendment 253**

**Proposal for a regulation**
**Article 6 – paragraph 3 – point c a (new)**

(c) a description of the trait or traits and
characteristics which have been introduced
or modified _**, including information on the**_
_**technique or techniques used to obtain the**_
_**trait or the traits and including disclosure**_
_**of the sequence of genetic modification**_ ;

_Text proposed by the Commission_ _Amendment_

_**(ca)**_ _**any patent or pending application**_
_**for a patent that covers the whole or part**_
_**of Cat.1 NGT plant;**_

**Amendment 39**

**Proposal for a regulation**
**Article 6 – paragraph 3 – point d – point i**

_Text proposed by the Commission_ _Amendment_

(i) the plant is a NGT plant, including
that it does not contain any genetic material
originating from outside the _**breeders’**_ gene
pool where such genetic material has been
temporarily inserted during the
development of the plant, in accordance
with the information requirements
specified in the _**implementing**_ act adopted
in accordance with Article _**27**_, point (a);

**Amendment 40**

**Proposal for a regulation**
**Article 6 – paragraph 3 – point d – point ii**

(i) the plant is a NGT plant, including
that it does not contain any genetic material
originating from outside the gene pool _**for**_
_**conventional breeding purposes**_ where
such genetic material has been temporarily
inserted during the development of the
plant, in accordance with the information
requirements specified in the _**delegated**_ act
adopted in accordance with Article _**6(11a)**_,
point (a);

_Text proposed by the Commission_ _Amendment_

(ii) the NGT plant meets the criteria set (ii) the NGT plant meets the criteria set
out in Annex I _**, at least one of the traits in**_

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out in Annex I; _**Annex III, Part 1, and the exclusion**_
_**criteria of Annex III, Part 2**_ ;

**Amendment 41**

**Proposal for a regulation**
**Article 6 – paragraph 3 – point d a (new)**

_Text proposed by the Commission_ _Amendment_

_**(da)**_ _**the denomination of the variety**_

**Amendment 42**

**Proposal for a regulation**
**Article 6 – paragraph 6**

_Text proposed by the Commission_ _Amendment_

6. If the verification request is not
deemed inadmissible in accordance with
paragraph 5, the competent authority shall
verify whether the NGT plant fulfils the
criteria set out in Annex I and prepare a
verification report within 30 working days
from the date of receipt of a verification
request. The competent authority shall
make available the verification report to
the other Member States and to the
Commission without undue delay.

**Amendment 43**

**Proposal for a regulation**
**Article 6 – paragraph 7**

6. If the verification request is not
deemed inadmissible in accordance with
paragraph 5, the competent authority shall
verify whether the NGT plant fulfils the
criteria set out in Annex I and prepare a
verification report within 30 working days
from the date of receipt of a verification
request. The competent authority _**may,**_
_**where appropriate, consult with the**_
_**European Food Safety Authority**_
_**('EFSA') while preparing the verification**_
_**report. The competent authority**_ shall
make available the verification report to
the other Member States and to the
Commission without undue delay.

_Text proposed by the Commission_ _Amendment_

7. The other Member States and the
Commission may make _**comments**_ to the
verification report within 20 days from the
date of receipt of that report.

7. The other Member States and the
Commission may make _**reasoned**_
_**objections**_ to the verification report _**, as**_
_**regards the fulfilment of the criteria set**_

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_**out in Annex I,**_ within 20 days from the
date of receipt of that report. _**Such**_
_**reasoned objections shall solely refer to**_
_**the criteria as set out in Annex I and**_

_**Annex III and shall include a scientific**_
_**justification.**_

**Amendment 311**

**Proposal for a regulation**
**Article 6 – paragraph 8**

_Text proposed by the Commission_ _Amendment_

8. In the absence of any _**comments**_ from
a Member State or the Commission, within
_**10 working days from the expiry of**_ the
deadline referred to in paragraph 7, the
competent authority that prepared the
verification report shall adopt a decision
declaring whether the NGT plant is a
category 1 NGT plant. _**It**_ shall transmit the
decision _**without undue delay**_ to the
requester, the other Member States and _**to**_
the Commission.

**Amendment 45**

**Proposal for a regulation**
**Article 6 – paragraph 9**

8. In the absence of any _**reasoned**_
_**scientific objections**_ from a Member State
or the Commission, within the deadline
referred to in paragraph 7, the _**national**_
competent authority that prepared the
verification report shall adopt a decision
declaring whether the NGT plant is a
category 1 NGT plant. _**The national**_
_**competent authority**_ shall transmit the
decision _**within 10 working days**_ to the
requester, the other Member States and the
Commission.

_Text proposed by the Commission_ _Amendment_

9. In cases where a _**comment**_ is made
by another Member State or by the
Commission by the deadline referred to in
paragraph 7, the competent authority that
prepared the verification report shall
_**forward the comment(s) to the**_
_**Commission**_ without undue delay.

**Amendment 46**

**Proposal for a regulation**
**Article 6 – paragraph 10**

9. In cases where a _**reasoned objection**_
is made by another Member State or by the
Commission by the deadline referred to in
paragraph 7, the competent authority that
prepared the verification report shall _**make**_
_**the reasoned objections publicly available**_
without undue delay.

_Text proposed by the Commission_ _Amendment_

10. The Commission, after having
consulted the _**European Food Safety**_

10. The Commission, after having
consulted the Authority, shall prepare a

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Authority _**(‘the Authority’)**_, shall prepare a
draft decision declaring whether the NGT
plant is a category 1 NGT plant within 45
working days from the date of receipt of
the _**comment(s)**_, taking the latter into
account. The decision shall be adopted in
accordance with the procedure referred to
in Article 28(2).

**Amendment 48**

**Proposal for a regulation**
**Article 7 – paragraph 2 – point b a (new)**

draft decision declaring whether the NGT
plant is a category 1 NGT plant within 45
working days from the date of receipt of
the _**reasoned objections**_, taking the latter
into account. The decision shall be adopted
in accordance with the procedure referred
to in Article 28(2).

_Text proposed by the Commission_ _Amendment_

_**(ba)**_ _**the denomination of the variety;**_

**Amendment 49**

**Proposal for a regulation**
**Article 7 – paragraph 2 – point c**

_Text proposed by the Commission_ _Amendment_

(c) a description of the trait(s) and
characteristics which have been introduced

or modified;

**Amendment 260**

**Proposal for a regulation**
**Article 7 – paragraph 2 – point d a (new)**

(c) a description of the trait(s) and
characteristics which have been introduced
or modified _**including information on the**_
_**technique or techniques used to obtain the**_
_**trait or the traits and on disclosure of the**_
_**sequence of genetic modification**_ ;

_Text proposed by the Commission_ _Amendment_

_**(da)**_ _**a monitoring plan for**_
_**environmental effects;**_

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**Amendment 50**

**Proposal for a regulation**
**Article 7 – paragraph 7**

_Text proposed by the Commission_ _Amendment_

7. The Commission shall publish _**a**_
_**summary of**_ the decision in the Official
Journal of the European Union.

7. The Commission shall publish the
_**final**_ decision in the Official Journal of the
European Union _**and shall publish, in a**_
_**dedicated and publicly available webpage,**_
_**its draft decision and the reasoned**_
_**objections referred to in Article 6**_ .

**Amendment 51**

**Proposal for a regulation**
**Article 9 – paragraph 1 – subparagraph 2 – point b**

_Text proposed by the Commission_ _Amendment_

(b) the designation of the category 1
NGT plant;

(b) the designation _**and specification**_ of
the category 1 NGT plant;

**Amendment 52**

**Proposal for a regulation**
**Article 9 – paragraph 1 – subparagraph 2 – point b a (new)**

_Text proposed by the Commission_ _Amendment_

_**(ba)**_ _**the denomination of the variety;**_

**Amendment 53**

**Proposal for a regulation**
**Article 9 – paragraph 1 – subparagraph 2 – point e a (new)**

_Text proposed by the Commission_ _Amendment_

_**(ea)**_ _**if provided, the opinion or statement**_
_**of EFSA, as referred to in Article 6 (10)**_
_**and Article 7(5); and**_

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**Amendment 54**

**Proposal for a regulation**
**Article 9 – paragraph 2**

_Text proposed by the Commission_ _Amendment_

2. The database shall be publicly
available.

**Amendment 264**

**Proposal for a regulation**
**Article 10 – paragraph 1**

2. The database shall be publicly
available _**, and in an online format**_ .

_Text proposed by the Commission_ _Amendment_

Plant reproductive material, including for
breeding and scientific purposes _**,**_ that
contains or consists of category 1 NGT
plant(s) and is made available to third
parties, whether in return for payment or
free of charge, shall bear a label indicating
the words ‘ _**cat 1 NGT**_ ’, followed by the
identification number of the NGT plant(s)
it has been derived from.

**Amendment 265**

**Proposal for a regulation**
**Article 10 – paragraph 1 a (new)**

_**Category 1 NGT plants, products**_
_**containing or consisting of category 1**_
_**NGT plant(s) and**_ plant reproductive
material, including for breeding and
scientific purposes that contains or consists
of category 1 NGT plant(s) and is made
available to third parties, whether in return
for payment or free of charge, shall bear a
label indicating the words ‘ _**New Genomic**_
_**Techniques**_ ’ _**. In the case of plant**_
_**reproductive material**_, _**it shall be**_ followed
by the identification number of the NGT
plant(s) it has been derived from.

_Text proposed by the Commission_ _Amendment_

_**Appropriate document-based traceability**_
_**for NGTs shall be provided by the**_
_**transmission and holding of information**_
_**that products contain or consist of NGT**_
_**plants and product, and the unique codes**_
_**for those NGTs, at each stage of their**_
_**placing on the market.**_

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**Amendment 266**

**Proposal for a regulation**
**Article 11 a (new)**

_Text proposed by the Commission_ _Amendment_

_**Article 11a**_

_**Withdrawal of the decision**_

_**If the monitoring results show that there**_
_**is a risk to health or the environment, or**_
_**if new scientific data supports this**_
_**hypothesis, the competent authority may**_
_**withdraw its decision referred to in Article**_
_**6(8) or statement referred to in Article**_
_**7(5). The withdrawal decision must be**_
_**sent by registered mail to the beneficiary**_
_**of the decision, who shall have 15 days in**_
_**which to make observations. In that case,**_
_**the marketing of the NGT plant or**_
_**product shall be prohibited from the day**_
_**following the date of receipt of the**_
_**registered letter.**_

**Amendment 56**

**Proposal for a regulation**
**Article 16**

_Text proposed by the Commission_ _Amendment_

_**Article 16**_ _**deleted**_

_**Labelling in accordance with Article 23**_

_**In addition to Article 19(3) of Directive**_
_**2001/18/EC, the written consent shall**_
_**specify the labelling in accordance with**_
_**Article 23 of this Regulation.**_

**Amendment 268**

**Proposal for a regulation**
**Article 17 – paragraph 2 a (new)**

_Text proposed by the Commission_ _Amendment_

_**2a.**_ _**If the monitoring results show that**_
_**there is a risk to health or the**_

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_**environment, or if new scientific data**_
_**supports this hypothesis, the competent**_
_**authority may withdraw its decision. The**_
_**withdrawal decision must be sent by**_
_**registered mail to the beneficiary of the**_
_**decision, who shall have 15 days in which**_
_**to make observations. In that case, the**_
_**marketing of the NGT plant or product**_
_**shall be prohibited from the day following**_
_**the date of receipt of the registered letter.**_

**Amendment 228**

**Proposal for a regulation**
**Article 20 – paragraph 4**

_Text proposed by the Commission_ _Amendment_

4. The Union reference laboratory shall
test and validate the method of detection,
identification and quantification proposed
by the applicant in accordance with Article
19(2) _**or assess whether the information**_
_**provided by**_ the applicant justifies the
application of adapted modalities to
comply with detection method
requirements _**referred to**_ in that _**paragraph**_ .

**Amendment 270**

**Proposal for a regulation**
**Article 21 – paragraph 1 a (new)**

4. The Union reference laboratory shall
test and validate the method of detection,
identification and quantification proposed
by the applicant in accordance with Article
19(2) _**. If**_ the applicant justifies the
application of adapted modalities to
comply with detection method
requirements _**, the Union reference**_
_**laboratory shall carry out its own**_
_**research and analyses to confirm the**_
_**claimed unfeasibility.**_ In that _**case, the**_
_**decision of the Union reference**_
_**laboratory shall be motivated and be made**_
_**public**_ .

_Text proposed by the Commission_ _Amendment_

_**If the monitoring results show that there**_
_**is a risk to health or the environment, or**_
_**if new scientific data supports this**_
_**hypothesis or if the competent authority**_
_**may withdraw its decision. The**_
_**withdrawal decision must be sent by**_

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_**registered mail to the beneficiary of the**_
_**decision, who shall have 15 days in which**_
_**to make observations. In that case, the**_
_**marketing of the NGT plant or product**_
_**shall be prohibited from the day following**_
_**the date of receipt of the registered letter.**_

**Amendment 57**

**Proposal for a regulation**
**Article 22 – paragraph 1**

_Text proposed by the Commission_ _Amendment_

1. The incentives in this Article shall
apply to category 2 NGT plants and
category 2 NGT products, where at least
one of the intended trait(s) of the NGT
plant conveyed by the genetic modification
is contained in _**Part 1 of Annex III**_ and it
does not have any traits referred to in Part
2 of that Annex.

**Amendment 59**

**Proposal for a regulation**
**Article 26 – paragraph 2**

1. The incentives in this Article shall
apply to category 2 NGT plants and
category 2 NGT products, where at least
one of the intended traits of the NGT plant
conveyed by the genetic modification is
contained in _**Article 51(1) of Regulation**_
_**(EU/…)***_ and it does not have any traits
referred to in Part 2 of that Annex.

__________________

_*** Commission proposal for a Regulation**_
_**on plant reproductive material**_
_**(COM/2023/414), (2023/0227(COD)).**_

_Text proposed by the Commission_ _Amendment_

2. The power to adopt the delegated
acts referred to in Article 5(3) and Article
22(8) shall be conferred on the
Commission for a period of 5 years from

[date of entry into force of this
Regulation]. The Commission shall draw
up a report in respect of the delegation of
power not later than 9 months before the
end of the 5-year period. The delegation of
power shall be tacitly extended for periods
of an identical duration, unless the

2. The power to adopt the delegated
acts referred to in Article 5(3) _**, Article**_
_**6(11a)**_ and Article 22(8) shall be conferred
on the Commission for a period of 5 years
from [date of entry into force of this
Regulation]. The Commission shall draw
up a report in respect of the delegation of
power not later than 9 months before the
end of the 5-year period. The delegation of
power shall be tacitly extended for periods
of an identical duration, unless the

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European Parliament or the Council
opposes such extension not later than 3
months before the end of each period.

**Amendment 60**

**Proposal for a regulation**
**Article 26 – paragraph 3**

European Parliament or the Council
opposes such extension not later than 3
months before the end of each period.

_Text proposed by the Commission_ _Amendment_

3. The delegations of power referred to
in Article 5(3) and Article 22(8) may be
revoked at any time by the European
Parliament or by the Council. A decision to
revoke shall put an end to the delegation of
the power specified in that decision. It shall
take effect the day following the
publication of the decision in the Official
Journal of the European Union or at a later
date specified therein. It shall not affect the
validity of any delegated acts already in
force.

**Amendment 61**

**Proposal for a regulation**
**Article 26 – paragraph 6**

3. The delegations of power referred to
in Article 5(3) _**, Article 6(11a)**_ and Article
22(8) may be revoked at any time by the
European Parliament or by the Council. A
decision to revoke shall put an end to the
delegation of the power specified in that
decision. It shall take effect the day
following the publication of the decision in
the Official Journal of the European Union
or at a later date specified therein. It shall
not affect the validity of any delegated acts
already in force.

_Text proposed by the Commission_ _Amendment_

6. A delegated act adopted pursuant to
Articles Article 5(3) and Article 22(8) shall
enter into force only if no objection has
been expressed either by the European
Parliament or by the Council within a
period of two months of notification of that
act to the European Parliament and the
Council or if, before the expiry of that
period, the European Parliament and the
Council have both informed the
Commission that they will not object. That
period shall be extended by 2 months at the
initiative of the European Parliament or of
the Council.

6. A delegated act adopted pursuant to
Articles Article 5(3) _**, Article 6(11a)**_ and
Article 22(8) shall enter into force only if
no objection has been expressed either by
the European Parliament or by the Council
within a period of two months of
notification of that act to the European
Parliament and the Council or if, before the
expiry of that period, the European
Parliament and the Council have both
informed the Commission that they will
not object. That period shall be extended
by 2 months at the initiative of the
European Parliament or of the Council.

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**Amendment 62**

**Proposal for a regulation**
**Article 27 – paragraph 1 – point a**

_Text proposed by the Commission_ _Amendment_

_**(a)**_ _**the information required to**_
_**demonstrate that a plant is a NGT plant;**_

**Amendment 63**

**Proposal for a regulation**
**Article 27 – paragraph 1 – point b**

_**deleted**_

_Text proposed by the Commission_ _Amendment_

_**(b)**_ _**the preparation and the presentation**_
_**of the verification requests referred to in**_
_**Articles 6 and 7;**_

**Amendment 64**

**Proposal for a regulation**
**Article 30 – paragraph 2**

_**deleted**_

_Text proposed by the Commission_ _Amendment_

2. The report shall also address any
ethical issues that have arisen with the
application of this Regulation.

**Amendment 65**

**Proposal for a regulation**
**Article 30 – paragraph 3**

2. The report shall also _**identify and**_
address any issues regarding _**biodiversity**_
_**and environmental, human and animal**_
_**health, changes to agronomic practices as**_
_**well as socio-economic and**_ ethical issues
that _**may**_ have arisen with the application
of this Regulation.

_Text proposed by the Commission_ _Amendment_

3. For the purpose of the reporting
referred to in paragraph 1, the
Commission, by [24 months after the date

3. For the purpose of the reporting
referred to in paragraph 1, the
Commission, by [24 months after the date

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of entry into force of this Regulation] at the
latest, shall establish, after consulting the
competent authorities of the Member States
in accordance with Directive 2001/18/EC
and Regulation (EC) No 1829/2003, a
detailed programme for monitoring, based
on indicators, the impact of this
Regulation. It shall specify the action to be
taken by the Commission and by the
Member States in collecting and analysing
the data and other evidence.

**Amendment 66**

**Proposal for a regulation**
**Article 30 – paragraph 5 a (new)**

of entry into force of this Regulation] at the
latest, shall establish, after consulting the
competent authorities of the Member States
in accordance with Directive 2001/18/EC
and Regulation (EC) No 1829/2003, a
detailed programme for monitoring, based
on indicators, the impact of this
Regulation _**, including the intended and**_
_**unintended effects and systematic effects**_
_**on the environment, biodiversity and**_
_**ecosystems**_ . It shall specify the action to be
taken by the Commission and by the
Member States in collecting and analysing
the data and other evidence.

_Text proposed by the Commission_ _Amendment_

_**5a.**_ _**By June 2025 the Commission shall**_
_**submit a report to the European**_
_**Parliament, the Council, the European**_
_**Economic and Social Committee and the**_

_**Committee of the Regions on the role and**_
_**impact of patents on breeders' and**_
_**farmers' access to varied plant**_
_**reproductive material, as well as on**_
_**innovation and, in particular, on**_
_**opportunities for SMEs. The report shall**_
_**assess whether further legal provisions**_
_**are necessary in addition to those**_
_**provided for in Article 4a and Article 33a**_
_**of this Regulation. Where appropriate to**_
_**ensure breeders' and farmers' access to**_
_**plant reproductive material, seed diversity**_
_**and affordable prices, the report shall be**_
_**accompanied by a legislative proposal to**_
_**address further necessary adjustments in**_
_**the intellectual property rights framework.**_

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**Amendment 67**

**Proposal for a regulation**
**Article 30 – paragraph 5 b (new)**

_Text proposed by the Commission_ _Amendment_

_**5b.**_ _**By 2024, the Commission shall**_
_**submit a report to the European**_
_**Parliament, the Council, the European**_
_**Economic and Social Committee and the**_

_**Committee of the Regions evaluating the**_
_**specificities of and needs for other sectors**_
_**not covered in this legislation, such as**_
_**microorganisms, including a proposal for**_
_**further policy actions.**_

**Amendment 68**

**Proposal for a regulation**
**Article 30 – paragraph 5 c (new)**

_Text proposed by the Commission_ _Amendment_

_**5c.**_ _**Every four years, the Commission**_
_**shall assess the criteria of equivalence**_
_**established in Annex I and, if necessary,**_
_**update them through a delegated act as**_
_**referred to in Article 5(3).**_

**Amendments 69, 291cp1, 230/rev1 and 291cp3**
**Proposal for a regulation**
**Article 33 a (new)**

Directive 98/44/EC

Article 4, Article 8 and Article 9

_Text proposed by the Commission_ _Amendment_

_**Article 33a**_

_**Amendments to Directive 98/44/EC**_ _**[1a]**_

_**1.**_ _**Article 4 of Directive 98/44/EC on**_
_**the legal protection of biotechnological**_
_**inventions is amended as follows:**_

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_**(a)**_ _**In paragraph 1, the following points**_
_**are added:**_

_**'(c)**_ _**NGT plants, plant material, parts**_
_**thereof, genetic information and process**_
_**features they contain, as defined in**_
_**Regulation (EU) .../... [O.J. please insert**_
_**the number of this Regulation];**_

_**(d)**_ _**plants, plant material, parts thereof,**_
_**genetic information and process features**_
_**they contain that can be yielded by**_
_**techniques excluded from the scope of**_
_**Directive 2001/18/EC as listed in Annex I**_

_**B to that directive.'**_

_**(b)**_ _**the following paragraph 4 is added:**_

_**‘4.**_ _**Paragraphs 2 and 3 shall be**_
_**without prejudice to the exclusions from**_
_**patentability covered in paragraph 1.’**_

_**2.**_ _**In Article 8, the following**_
_**paragraph is added:**_

_**‘3. By way of derogation from paragraphs**_
_**1 and 2, the protection conferred by a**_
_**patent on a biological material possessing**_
_**specific characteristics as a result of the**_
_**invention shall not extend to biological**_
_**material possessing the same**_
_**characteristics that is obtained**_

_**independently of the patented biological**_
_**material and from essentially biological**_
_**processes, or to biological material**_
_**obtained from such material through**_
_**propagation or multiplication.’**_

_**3.**_ _**In Article 9, the following**_
_**paragraphs are added:**_

_**'2. By way of derogation from paragraph**_
_**1, a plant product containing or**_
_**consisting of genetic information obtained**_
_**by a patentable technical process shall not**_
_**be patentable if it is not distinguishable**_
_**from plant products containing or**_
_**consisting of the same genetic**_
_**information obtained by an essentially**_
_**biological process.**_

_**3. By way of derogation from paragraph**_
_**1, the protection conferred by a patent on**_
_**a product containing or consisting of**_
_**genetic information shall not extend to**_
_**plant material in which the product is**_

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_**incorporated and in which the genetic**_
_**information is contained and performs its**_
_**function but which is not distinguishable**_
_**from plant material obtained or which**_
_**can be obtained by an essentially**_
_**biological process.**_

_**4. The protection conferred by a patent on**_
_**a technical process that enables the**_
_**production of a product containing or**_
_**consisting of genetic information shall not**_
_**extend to plant material in which the**_
_**product is incorporated and in which the**_
_**genetic information is contained and**_
_**performs its function but which is not**_
_**distinguishable from plant material**_
_**obtained or which can be obtained by an**_
_**essentially biological process.'.**_

_**_______________________________**_

_**1a**_ _**Directive 98/44/EC of the European**_
_**Parliament and of the Council of 6 July**_
_**1998 on the legal protection of**_
_**biotechnological inventions (OJ L 213,**_
_**30.7.1998, p. 13).**_

**Amendment 70**

**Proposal for a regulation**
**Article 34 – paragraph 2 – subparagraph 1**

_Text proposed by the Commission_ _Amendment_

It shall apply from [24 months from the
date of entry into force of this Regulation].

**Amendment 71**

**Proposal for a regulation**
**Annex I – paragraph 1**

It shall apply from [24 months from the
date of entry into force of this Regulation].
_**Article 4a and Article 33a shall apply**_
_**from the date of entry into force.**_

_Text proposed by the Commission_ _Amendment_

A NGT plant is considered equivalent to
conventional plants _**when it differs from**_
_**the recipient/parental plant by no more**_
_**than 20 genetic modifications of the types**_

A NGT plant is considered equivalent to
conventional plants _**if the following**_
_**conditions**_ referred to in points 1 _**and 1a**_

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referred to in points 1 _**to 5, in any DNA**_
_**sequence sharing sequence similarity with**_
_**the targeted site that can be predicted by**_
_**bioinformatic tools**_ .

**Amendment 72**

**Proposal for a regulation**
**Annex I – point 1**

_**are met**_ :

_Text proposed by the Commission_ _Amendment_

(1) substitution or insertion of no more
than 20 nucleotides;

**Amendment 73**

**Proposal for a regulation**
**Annex I – point 1 a (new)**

(1) _**The number of the following genetic**_
_**modifications, which can be combined**_
_**with each other, does not exceed 3 per any**_
_**protein-coding sequence taking into**_
_**account that mutations in introns and**_

_**regulatory sequences are excluded from**_
_**this limit:**_

_**(a)**_ substitution or insertion of no more
than 20 nucleotides;

_**(b)**_ _**deletion of any number of**_
_**nucleotides;**_

_Text proposed by the Commission_ _Amendment_

_**(1a)**_ _**The following genetic modifications,**_
_**which can be combined with each other,**_
_**do not create a chimeric protein that is**_
_**not present in species from the gene pool**_
_**for breeding purposes or does not**_
_**interrupt an endogenous gene;**_

_**(a) insertion of continuous DNA**_
_**sequences existing in the gene pool for**_
_**breeding purposes;**_

_**(b) substitution of endogenous DNA**_
_**sequences with continuous DNA**_
_**sequences existing in the gene pool for**_
_**breeding purposes;**_

_**(c) inversion or translocation of**_
_**continuous endogenous DNA sequences**_
_**existing in the gene pool for breeding**_

_**purposes.**_

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**Amendment 74**

**Proposal for a regulation**
**Annex I – point 2**

_Text proposed by the Commission_ _Amendment_

_**(2)**_ _**deletion of any number of**_
_**nucleotides;**_

**Amendment 75**

**Proposal for a regulation**
**Annex I – point 3**

_**deleted**_

_Text proposed by the Commission_ _Amendment_

_**(3)**_ _**on the condition that the genetic**_
_**modification does not interrupt an**_
_**endogenous gene:**_

_**(a) targeted insertion of a contiguous**_
_**DNA sequence existing in the breeder’s**_
_**gene pool;**_

_**(b) targeted substitution of an endogenous**_
_**DNA sequence with a contiguous DNA**_
_**sequence existing in the breeder’s gene**_
_**pool;**_

**Amendment 76**

**Proposal for a regulation**
**Annex I – point 4**

_**deleted**_

_Text proposed by the Commission_ _Amendment_

_**(4)**_ _**targeted inversion of a sequence of**_
_**any number of nucleotides;**_

**Amendment 77**

**Proposal for a regulation**
**Annex I – point 5**

_**deleted**_

_Text proposed by the Commission_ _Amendment_

_**(5)**_ _**any other targeted modification of**_
_**any size, on the condition that the**_
_**resulting DNA sequences already occur**_
_**(possibly with modifications as accepted**_
_**under points (1) and/or (2)) in a species**_
_**from the breeders’ gene pool.**_

_**deleted**_

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# ANNEX GIP.INST EN

**Amendment 78**

**Proposal for a regulation**
**Annex II – Part 1 – paragraph 2 – point a a (new)**

_Text proposed by the Commission_ _Amendment_

_**(aa)**_ _**the characteristics of the recipient**_
_**plant like allergenicity, potential for gene**_
_**flow, weed potential, ecological function;**_

**Amendment 79**

**Proposal for a regulation**
**Annex II – Part 2 – point 6 a (new)**

_Text proposed by the Commission_ _Amendment_

_**(6a)**_ _**Impacts on organic cultivation**_

**Amendment 80**

**Proposal for a regulation**
**Annex II – Part 2 – point 8 a (new)**

_Text proposed by the Commission_ _Amendment_

_**(8a)**_ _**Effects on protecting and**_
_**conserving biodiversity**_

**Amendment 81**

**Proposal for a regulation**
**Annex III – title 1**

_Text proposed by the Commission_ _Amendment_

Traits referred to in Article 22 Traits referred to in Article _**6 and Article**_

22

**Amendment 82**

**Proposal for a regulation**
**Annex III – Part 1 – paragraph 1 – point 1**

_Text proposed by the Commission_ _Amendment_

(1) yield, including yield stability and
yield under low-input conditions;

(1) yield, including yield stability and
yield under low-input conditions _**, provided**_
_**that those traits also contribute to either**_
_**point (2), (3) or (4) of this Annex**_ ;

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# ANNEX GIP.INST EN

**Amendment 83**

**Proposal for a regulation**
**Annex III – Part 1 – paragraph 1 – point 7**

_Text proposed by the Commission_ _Amendment_

(7) reduced need for external inputs,
such as _**plant protection products and**_
fertilisers.

(7) reduced need for external inputs,
such as fertilisers _**, if it does not contradict**_
_**with Annex III, part 2**_ .

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# ANNEX GIP.INST EN