Sittings · Document

Draft report (COM(2023)0411 – C9-0238/2023 – 2023/0226(COD)) 2023-11-19

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

Committee on the Environment, Public Health and Food Safety

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AM_Com_LegReport

Amendment 864

Christophe Clergeau

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.

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 proceed to his 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.

Or. en

Amendment 865

Martin Häusling

Proposal for a regulation

Article 20 – paragraph 5

Text proposed by the Commission

Amendment

5. By way of derogation from Article 6(5), point (f), and Article 18(5), point (f), of Regulation (EC) No 1829/2003, in the event of an opinion in favour of authorising the food or the feed, the opinion shall also include:

deleted

(a) the method, validated by the Union reference laboratory, for detection, including sampling, and, where applicable, identification and quantification of the NGT plant and detection and identification of the NGT plant in the NGT food or feed, and a justification of any adaptation of the method in the cases referred to in Article 19(2), subparagraph 2;

(b) an indication of where appropriate reference material can be accessed.

Or. en

Amendment 866

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 20 a (new)

Text proposed by the Commission

Amendment

Article20a

Specific provisions on refusing NGT plants, food, feed and products

Without prejudice to the criteria in Regulation (EC) No 1829/2003 and Directive 2001/18/EC, the deliberate release of NGT plants and the placing on the market of NGT food, feed and products shall be refused if a Member States deems it probable that it would jeopardise health, the environment or the sustainability of the food chain.

Or. en

Amendment 867

João Pimenta Lopes

Proposal for a regulation

Article 21

Text proposed by the Commission

Amendment

Article 21

deleted

Duration of the validity of the authorisation after renewal

By way of derogation from Article 11(1) and Article 23(1) of Regulation (EC) No 1829/2003, after the first renewal, the authorisation shall be valid for an unlimited period, unless the Commission decides to renew the authorisation for a limited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the authorisation.

Or. pt

Amendment 868

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 21

Text proposed by the Commission

Amendment

Article 21

deleted

Duration of the validity of the authorisation after renewal

Or. en

Amendment 869

Christophe Clergeau

Proposal for a regulation

Article 21 – paragraph 1

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 870

Günther Sidl

Proposal for a regulation

Article 21 – paragraph 1

Text proposed by the Commission

Amendment

The authorisation shall be valid for a period of 10 years.

Or. en

Amendment 871

Martin Häusling

Proposal for a regulation

Article 21 – paragraph 1

Text proposed by the Commission

Amendment

After the first renewal, the authorisation shall be valid for a limited period of 10 years.

Or. en

Justification

Considering there is no history of safe use for new genomic techniques, it is important to review the validity of the consent every ten years to take into account latest scientific evidence and market trends.

Amendment 872

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 21 – paragraph 1

Text proposed by the Commission

Amendment

By way of derogation from Article 11(1) and Article 23(1) of Regulation (EC) No 1829/2003, after the first renewal, the authorisation shall be valid for a limited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring.

Or. en

Amendment 873

María Soraya Rodríguez Ramos, Michal Wiezik

Proposal for a regulation

Article 21 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 874

Lydie Massard

Proposal for a regulation

Article 21 – paragraph 1

Text proposed by the Commission

Amendment

By way of derogation from Article 11(1) and Article 23(1) of Regulation (EC) No 1829/2003, after the first renewal, the authorisation shall be valid for 10 years, unless the Commission decides to renew the authorisation for a limited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the authorisation.

Or. en

Amendment 875

Christophe Clergeau

Proposal for a regulation

Article 21 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1. The authorisation shall be valid for a limited period of 10 years, unless the Commission decides after three renewal rounds by way of derogation from Article 11(1) and Article 23(1) of Regulation (EC) N° 1829/2003 to renew the authorisation for an unlimited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the authorisation.

Or. en

Amendment 876

Christophe Clergeau

Proposal for a regulation

Article 21 – paragraph 1 b (new)

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 , the competent authority may withdraw its decision.

The withdrawal decision must be sent by registered mail to the beneficiary of the decision, who has 15 days in which to make observations. In that case, the marketing of the NGT plant or product is prohibited from the day following the date of receipt of the registered letter.

Or. en

Amendment 877

Martin Häusling

Proposal for a regulation

Article 21 a (new)

Text proposed by the Commission

Amendment

Article 21a

Safeguard clause

The Member State shall ensure that in the event of a severe risk, emergency measures, such as suspension or termination of the placing on the market, shall be applied, including information to the public.

The Member State shall immediately inform the Commission and the other Member States of actions taken under this Article and give reasons for its decision, supplying its review of the environmental risk assessment, indicating whether and how the conditions of the consent should be amended or the consent should be terminated, and, where appropriate, the new or additional information on which its decision is based.

For the purpose of calculating the 60-day period, any period of time during which the Commission is awaiting further information which it may have requested from the notifier or is seeking the opinion of the Scientific Committee or Committees which has or have been consulted shall not be taken into account. The period of time during which the Commission is awaiting the opinion of the Scientific Committee or Committees consulted shall not exceed 60 days. Likewise, the period of time the Council takes to act in accordance with the regulatory procedure referred to in Article 30(2) shall not be taken into account.

Or. en

Justification

It is important to have a clear process in order to suspend or terminate the placing of NGTs on the market in case serious issues are detected. It is fundamental that the public authorities have that possibility for NGTs, as they already have for other GMOs.

Amendment 878

Lydie Massard

Proposal for a regulation

Article 21 a (new)

Text proposed by the Commission

Amendment

Article 21a

Safeguard clause

1. Where a Member State, as a result of new or additional information made available since the date of the consent and affecting the environmental risk assessment or reassessment of existing information on the basis of new or additional scientific knowledge, has detailed grounds for considering that a NGT as or in a product which has been properly notified and has received written consent under this Directive constitutes a risk to human health or the environment, that Member State may provisionally restrict or prohibit the use and/or sale of that GMO as or in a product on its territory. The Member State shall ensure that in the event of a severe risk, emergency measures, such as suspension or termination of the placing on the market, shall be applied, including information to the public. The Member State shall immediately inform the Commission and the other Member States of actions taken under this Article and give reasons for its decision, supplying its review of the environmental risk assessment, indicating whether and how the conditions of the consent should be amended or the consent should be terminated, and, where appropriate, the new or additional information on which its decision is based.

2. Within 60 days of the date of receipt of the information trans mitted by the Member State, a decision shall be taken on the measure taken by that Member State in accordance with the regulatory procedure referred to in Article 30(2). For the purpose of calculating the 60-day period, any period of time during which the Commission is awaiting further information which it may have requested from the notifier or is seeking the opinion of the Scientific Committee or Committees which has or have been consulted shall not be taken into account. The period of time during which the Commission is awaiting the opinion of the Scientific Committee or Committees consulted shall not exceed 60 days. Likewise, the period of time the Council takes to act in accordance with the regulatory procedure referred to in Article 30(2) shall not be taken into account.

Or. en

Amendment 879

Günther Sidl

Proposal for a regulation

Chapter III – Section 4 – title

Text proposed by the Commission

Amendment

4 Common provisions for category 2 NGT plants and category 2 NGT products

4 Common provisions for NGT plants and NGT products

Or. en

Amendment 880

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Chapter III – Section 4 – title

Text proposed by the Commission

Amendment

4 Common provisions for category 2 NGT plants and category 2 NGT products

4 Common provisions for NGT plants and NGT products

Or. en

Amendment 881

Martin Häusling

Proposal for a regulation

Article 22

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Justification

There is no justification to give certain category 2 NGTs incentives based on their assumed sustainability traits leading to fast-track procedures and unjustified advantages. In particular speeding up the process could lead to important information or steps in the process being overlooked. In any case, to claim that one particular plant is sustainable due to its intended trait is not possible. Genuine sustainability can only be concluded after an assessment of the agricultural system in which plants are grown, as well as their complex relationships with the environment and under the economic and social conditions in which they are used.

Amendment 882

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 22 – title

Text proposed by the Commission

Amendment

Incentives for category 2 NGT plants and category 2 NGT products containing traits relevant for sustainability

Incentives for NGT plants and NGT products containing traits relevant for sustainability

Or. en

Amendment 883

Günther Sidl

Proposal for a regulation

Article 22 – title

Text proposed by the Commission

Amendment

Incentives for category 2 NGT plants and category 2 NGT products containing traits relevant for sustainability

Incentives for NGT plants and NGT products containing traits relevant for sustainability

Or. en

Amendment 884

Christophe Clergeau

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.

deleted

Or. en

Amendment 885

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Emma Wiesner, Andreas Glueck, Ulrike Müller

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 Article 51(1) of Regulation (2023/0227) and it does not have any traits referred to in Part 2 of that Annex.

Or. en

Justification

For the sake of consistency and legal certainty, the sustainability assessment should be in line with Regulation of Plant Reproductive Material, which establishes the sustainability requirements for all types of plant reproductive material.

Amendment 886

Lydie Massard

Proposal for a regulation

Article 22 – paragraph 1

Text proposed by the Commission

Amendment

1. The incentives in this Article shall apply to 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.

Or. en

Amendment 887

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 22 – paragraph 1

Text proposed by the Commission

Amendment

1. The incentives in this Article shall apply to NGT plants and 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.

Or. en

Amendment 888

Günther Sidl

Proposal for a regulation

Article 22 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 889

Christophe Clergeau

Proposal for a regulation

Article 22 – paragraph 2

Text proposed by the Commission

Amendment

2. The following incentives shall apply to applications for authorisation submitted in accordance with Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 19:

deleted

(a) by way of derogation from Article 20(1), subsection (1) of this Regulation, the Authority shall deliver its opinion on the application within 4 months from the receipt of a valid application, unless the complexity of the product requires application of the time limit referred to in Article 20(1). The time limit shall be extendable under the conditions set out in Article 20(1), subsection (2);

(b) where the applicant is a SME, it shall be exempted from the payment of the financial contributions to the Union Reference Laboratory and to the European Network of GMO Laboratories referred to in Article 32 of Regulation (EC) No 1829/2003.

Or. en

Amendment 890

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 22 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) where the applicant is a SME, and by way of derogation from Article 20(1), subsection (1) of this Regulation, the Authority shall deliver its opinion on the application within 4 months from the receipt of a valid application, unless the complexity of the product requires application of the time limit referred to in Article 20(1). The time limit shall be extendable under the conditions set out in Article 20(1), subsection (2);

Or. en

Amendment 891

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 22 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) by way of derogation from Article 20(1), subsection (1) of this Regulation, the Authority shall deliver its opinion on the application within 6 months from the receipt of a valid application, unless the complexity of the product requires application of the time limit referred to in Article 20(1). The time limit shall be extendable under the conditions set out in Article 20(1), subsection (2);

Or. en

Amendment 892

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 22 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) where the applicant is a micro or small enterprise, it shall be exempted from the payment of the financial contributions to the Union Reference Laboratory and to the European Network of GMO Laboratories referred to in Article 32 of Regulation (EC) No 1829/2003.

Or. en

Amendment 893

Christophe Clergeau

Proposal for a regulation

Article 22 – paragraph 3

Text proposed by the Commission

Amendment

3. The following pre-submission advice for the purposes of the risk assessment conducted in accordance with Annex II shall, in addition to Article 32a of Regulation (EC) No 178/2002, apply prior to notifications submitted in accordance with Article 13 of Directive 2001/18/EC in conjunction with Article 14 and to applications for authorisation submitted in accordance with Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 19:

deleted

(a) the staff of the Authority shall, at the request of a potential applicant or notifier, provide advice on plausible risk hypotheses that the potential applicant or notifier has identified based on the properties of a plant, product or hypothetical plant or product, that need to be addressed by providing the information under Parts 2 and 3 of Annex II. The advice shall not, however, cover the design of studies to address the risk hypotheses;

(b) where the potential applicant or notifier is a SME, it may notify the Authority of how it intends to address the plausible risk hypotheses referred to in point (a) that it has identified based on the properties of a plant, product or hypothetical plant or product, including the design of the studies it intends to perform in accordance with the requirements laid down Parts 2 and 3 of Annex II. The Authority shall provide advice on the notified information, including on the design of the studies.

Or. en

Amendment 894

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 22 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) the staff of the Authority shall, at the request of a potential applicant or notifier where that is a SME, provide advice on plausible risk hypotheses that the potential applicant or notifier has identified based on the properties of a plant, product or hypothetical plant or product, that need to be addressed by providing the information under Parts 2 and 3 of Annex II. The advice shall not, however, cover the design of studies to address the risk hypotheses;

Or. en

Amendment 895

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 22 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) where the potential applicant or notifier is a micro or small enterprise, it may notify the Authority of how it intends to address the plausible risk hypotheses referred to in point (a) that it has identified based on the properties of a plant, product or hypothetical plant or product, including the design of the studies it intends to perform in accordance with the requirements laid down Parts 2 and 3 of Annex II. The Authority shall provide advice on the notified information, including on the design of the studies.

Or. en

Amendment 896

Christophe Clergeau

Proposal for a regulation

Article 22 – paragraph 4

Text proposed by the Commission

Amendment

4. The pre-submission advice referred to in paragraph 3 shall comply with the following requirements:

deleted

(a) it shall be without prejudice and non-committal as to any subsequent assessment of applications or notifications by the Panel on Genetically Modified Organisms of the Authority. The staff of the Authority providing the advice shall not be involved in any preparatory scientific or technical work that is directly or indirectly relevant to the application or notification that is the subject of the advice;

(b) for potential notifications in accordance with Article 13 of Directive 2001/18/EC in conjunction with Article 14 and for potential applications under Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 19 concerning a category 2 NGT plant to be used as seeds or other plant reproductive material, the pre-submission advice shall be provided by the Authority together, or in close collaboration with the competent authority of the Member State to which the notification or application is going to be submitted;

(c) the Authority shall make public without delay a summary of the pre-submission advice once an application or notification has been considered valid. Articles 38(1a) shall apply mutatis mutandis;

(d) potential applicants or notifiers demonstrating that they are a SME can request the pre-submission advice referred to in paragraph 3, point (a), at different points in time.

Or. en

Amendment 897

Günther Sidl

Proposal for a regulation

Article 22 – paragraph 4 – point b

Text proposed by the Commission

Amendment

(b) for potential notifications in accordance with Article 13 of Directive 2001/18/EC in conjunction with Article 14 and for potential applications under Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 19 concerning a NGT plant to be used as seeds or other plant reproductive material, the pre-submission advice shall be provided by the Authority together, or in close collaboration with the competent authority of the Member State to which the notification or application is going to be submitted;

Or. en

Amendment 898

Günther Sidl

Proposal for a regulation

Article 22 – paragraph 4 – point c

Text proposed by the Commission

Amendment

(c) the Authority shall make public without delay a summary of the pre-submission advice once an application or notification has been considered valid. Articles 38(1a) shall apply mutatis mutandis;

(c) the Authority shall make public without delay a summary of the pre-submission advice once an application or notification has been considered valid. Articles 38(1a) (enter regulation) shall apply mutatis mutandis;

Or. en

Justification

Clarification needed. It should be made clear, to which act the reference refers to.

Amendment 899

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 22 – paragraph 4 – point c

Text proposed by the Commission

Amendment

(c) the Authority shall make public without delay a summary of the pre-submission advice once an application or notification has been considered valid. Articles 38(1a) shall apply mutatis mutandis;

(c) the Authority shall make public without delay the pre-submission advice once an application or notification has been considered valid. Articles 38(1a) shall apply mutatis mutandis;

Or. en

Amendment 900

Christophe Clergeau

Proposal for a regulation

Article 22 – paragraph 5

Text proposed by the Commission

Amendment

5. Any request for the incentives shall be submitted to the Authority at the time of request of advice referred to in paragraph 3 or the application referred to in Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 19, and accompanied by the following information:

deleted

(a) the information necessary to establish that the intended trait(s) conveyed by the genetic modification of the category 2 NGT plant meet the conditions referred to in paragraph 1;

(b) where applicable, the information necessary to demonstrate the (potential) applicant or notifier is a SME;

(c) for the purpose of paragraph 3, information on the aspects listed in Part 1 of Annex II as far as it can already be provided and any other relevant information.

Or. en

Amendment 901

Günther Sidl

Proposal for a regulation

Article 22 – paragraph 5 – point a

Text proposed by the Commission

Amendment

(a) the information necessary to establish that the intended trait(s) conveyed by the genetic modification of the category 2 NGT plant meet the conditions referred to in paragraph 1;

(a) the information necessary to establish that the intended trait(s) conveyed by the genetic modification of the

NGT plant meet the conditions referred to in paragraph 1;

Or. en

Amendment 902

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 22 – paragraph 5 – point a

Text proposed by the Commission

Amendment

(a) the information necessary to establish that the intended trait(s) conveyed by the genetic modification of the category 2 NGT plant meet the conditions referred to in paragraph 1;

(a) the information necessary to establish that the intended trait(s) conveyed by the genetic modification of the NGT plant meet the conditions referred to in paragraph 1;

Or. en

Amendment 903

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 22 – paragraph 5 – point b

Text proposed by the Commission

Amendment

(b) where applicable, the information necessary to demonstrate the (potential) applicant or notifier is a SME;

(b) where applicable, the information necessary to demonstrate the (potential) applicant or notifier is a micro, small or medium enterprise;

Or. en

Amendment 904

Christophe Clergeau

Proposal for a regulation

Article 22 – paragraph 6

Text proposed by the Commission

Amendment

6. Article 26 of Directive 2001/18/EC and Article 30 of Regulation (EC) No 1829/2003 shall apply to information submitted under this article to the Authority, as appropriate.

deleted

Or. en

Amendment 905

Christophe Clergeau

Proposal for a regulation

Article 22 – paragraph 7

Text proposed by the Commission

Amendment

7. The Authority shall lay down the practical arrangements to implement paragraphs (3) to (6).

deleted

Or. en

Amendment 906

Martin Häusling

Proposal for a regulation

Article 22 – paragraph 8

Text proposed by the Commission

Amendment

8. The Commission is empowered to adopt delegated acts in accordance with Article 26 amending the lists of traits of NGT plants laid down in Annex III in order to adapt them to scientific and technological progress and to new evidence relating to the impact on sustainability of those traits, subject to the following conditions:

deleted

(a) the Commission shall take into account the monitoring of the impacts of this Regulation in accordance with Article 30(3);

(b) the Commission shall conduct an up-to-date scientific literature review of the impact on environmental, social and economic sustainability of the trait(s) it intends to add to or delete from the list in Annex III;

(c) where applicable, the Commission shall take into account the results of monitoring which was carried out in accordance with Article 14, point (h), or Article 19(3), of NGT plants harbouring the trait(s) conveyed by their genetic modification.

Or. en

Justification

Annex III is an essential part of the regulation that should not be amended by delegated acts.

Amendment 907

Günther Sidl

Proposal for a regulation

Article 22 – paragraph 8

Text proposed by the Commission

Amendment

deleted

(a) the Commission shall take into account the monitoring of the impacts of this Regulation in accordance with Article 30(3);

Or. en

Justification

Annex III as an essential part of the regulation that should not be amended by delegated acts.

Amendment 908

Christophe Clergeau

Proposal for a regulation

Article 22 – paragraph 8

Text proposed by the Commission

Amendment

deleted

(a) the Commission shall take into account the monitoring of the impacts of this Regulation in accordance with Article 30(3);

Or. en

Amendment 909

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 22 – paragraph 8 – introductory part

Text proposed by the Commission

Amendment

8. The Commission may adopt a legislative proposal amending the lists of traits of NGT plants laid down in Annex III in order to adapt them to scientific and technological progress and to new evidence relating to the impact on sustainability of those traits, subject to the following conditions:

Or. en

Amendment 910

João Pimenta Lopes

Proposal for a regulation

Article 22.º – paragraph 8 – point b

Text proposed by the Commission

Amendment

(b) the Commission shall conduct an up-to-date scientific literature review of the impact on environmental, social and economic sustainability and impact on health of the trait(s) it intends to add to or delete from the list in Annex III;

Or. pt

Amendment 911

Martin Häusling

Proposal for a regulation

Article 22 – paragraph 8 – point c

Text proposed by the Commission

Amendment

(c) the Commission shall take into account the results of monitoring which was carried out in accordance with Article 14, point (h), or Article 19(3), of NGT plants harbouring the trait(s) conveyed by their genetic modification.

Or. en

Amendment 912

Francesca Peppucci

Proposal for a regulation

Article 23

Text proposed by the Commission

Amendment

Article 23

deleted

Labelling of authorised category 2 NGT products

In addition to the labelling requirements referred to in Article 21 of Directive 2001/18/EC, Articles 12, 13, 24 and 25 of Regulation (EC) No 1829/2003, and Article 4(6) to (7) of Regulation (EC) No 1830/2003, and without prejudice to the requirements under other Union legislation, the labelling of authorised category 2 NGT products may also mention the trait(s) conveyed by the genetic modification, as specified in the consent or the authorisation pursuant to Sections 2 or 3 of Chapter III of this Regulation.

Or. en

Amendment 913

Lydie Massard

Proposal for a regulation

Article 23 – title

Text proposed by the Commission

Amendment

Labelling of authorised category 2 NGT products

Labelling of authorised NGT products

Or. en

Amendment 914

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 23 – title

Text proposed by the Commission

Amendment

Labelling of authorised category 2 NGT products

Labelling of authorised NGT products

Or. en

Amendment 915

Günther Sidl

Proposal for a regulation

Article 23 – title

Text proposed by the Commission

Amendment

Labelling of authorised category 2 NGT products

Labelling of authorised NGT products

Or. en

Amendment 916

Martin Häusling

Proposal for a regulation

Article 23 – paragraph 1

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Any additional food label should be based on clear methodologies and baselines, define who is assessing the claim and how the claims are verified and possibly challenged. This could article lead to greenwashing. Conventional seeds which are used in genuinely sustainable food systems will be at an unfair advantage if NGT category 2 can use this provision,

Amendment 917

Pietro Fiocchi

Proposal for a regulation

Article 23 – paragraph 1

Text proposed by the Commission

Amendment

deleted

Or. it

Amendment 918

Günther Sidl

Proposal for a regulation

Article 23 – paragraph 1

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

In the EU, no definition of sustainability exists. Specific regulations for "green claims" are currently being negotiated at EU level to avoid greenwashing. Information on the property conferred by the genetic modification under this regulation is therefore obsolete. Any additional food label should be based on clear methodology, baselines, define who is assessing the claims and how they can challenge.

Amendment 919

Lydie Massard

Proposal for a regulation

Article 23 – paragraph 1

Text proposed by the Commission

Amendment

The labelling requirements referred to in Article 21 of Directive 2001/18/EC, Articles 12, 13, 24 and 25 of Regulation (EC) No 1829/2003, and Article 4(6) to (7) of Regulation (EC) No 1830/2003 shall apply to NGT products .

Or. en

Amendment 920

Pietro Fiocchi

Proposal for a regulation

Article 23 – paragraph 1

Text proposed by the Commission

Amendment

In addition to the labelling requirements referred to in Article 21 of Directive 2001/18/EC, Articles 12, 13, 24 and 25 of Regulation (EC) No 1829/2003, and Article 4(6) to (7) of Regulation (EC) No 1830/2003, to be adapted to include the designation ‘new genomic techniques’ or ‘NGT’, and without prejudice to the requirements under other Union legislation, the labelling of authorised category 2 NGT products may also mention the trait(s) conveyed by the genetic modification, as specified in the consent or the authorisation pursuant to Sections 2 or 3 of Chapter III of this Regulation. The name and mention of the trait(s) conferred by the amendment may be indicated on the label using a QR code and/or link.

Or. it

Amendment 921

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 23 – paragraph 1

Text proposed by the Commission

Amendment

In addition to the labelling requirements referred to in Article 21 of Directive 2001/18/EC, Articles 12, 13, 24 and 25 of Regulation (EC) No 1829/2003, and Article 4(6) to (7) of Regulation (EC) No 1830/2003, and without prejudice to the requirements under other Union legislation, the labelling of authorised NGT products may also mention the trait(s) conveyed by the genetic modification, as specified in the consent or the authorisation pursuant to Sections 2 or 3 of Chapter III of this Regulation. This information needs to be evidence-based and needs to be accompanied by the statement that sustainable agriculture needs to be seen in a holistic manner and sustainability cannot be captured in a specific trait.

Or. en

Amendment 922

Catherine Griset, Aurélia Beigneux

Proposal for a regulation

Article 23 – paragraph 1 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

This label shall ensure that sufficient and understandable information is provided to users and consumers. In particular, it shall specify the production process used, the changes made and their expected food and environmental benefits. The introduction of a QR code may complement the physical labelling, which must remain the norm.

Or. fr

Amendment 923

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 24 – title

Text proposed by the Commission

Amendment

Measures to avoid the unintended presence of category 2 NGT plants

Measures to avoid the unintended presence of NGT plants

Or. en

Amendment 924

Günther Sidl

Proposal for a regulation

Article 24 – title

Text proposed by the Commission

Amendment

Measures to avoid the unintended presence of category 2 NGT plants

Measures to avoid the unintended presence of NGT plants

Or. en

Amendment 925

Lydie Massard

Proposal for a regulation

Article 24 – title

Text proposed by the Commission

Amendment

Measures to avoid the unintended presence of category 2 NGT plants

Measures to avoid the unintended presence of NGT plants

Or. en

Amendment 926

Christophe Clergeau

Proposal for a regulation

Article 24 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003.

1. Member States shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products on the basis of a delegated act proposed by Commission in accordance with Article 26 to define notably the size of the buffer strip for each sort of crops and the obligation of NGT growers to inform organic and certified non-GMO growers with field plots next to those where NGT plants are grown.

Member States shall develop the definition of crop specific and adapted measures as a matter of subsidiarity, based on the latest scientific and experimental knowledge, to avoid the unintended presence of category 2 NGT plants.

2. Member States shall instate a strict liability system and a compensation fund to compensate operators in the event of contamination in accordance with the principal of the extended producer responsibility.

3. The Commission shall gather and coordinate information based on the studies at EU and national level, observe the developments regarding coexistence in the Member States and, on the basis of the information and observations, develop guidelines on the coexistence of NGT, conventional and organic crops.

Or. en

Amendment 927

Pietro Fiocchi

Proposal for a regulation

Article 24 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003.

The Commission shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003 , only where NGT Category 2 plants can be detected, identified and quantified by analytical methods. 2(a). The burden of proof for the unintentional presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation (EC) No 1829/2003 should not be placed on the users of category 2 NGT plants.

Or. it

Amendment 928

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 24 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003.

Member States shall take appropriate measures to avoid the unintended presence of NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003. This shall include legally binding buffer zones of no less than 2 kilometre between NGT crops and conventional crops and of no less than 5 kilometre between NGT crops and organic crops. It shall also include detailed legally binding measure to avoid cross contamination further in the food chain, an enforcement plan and appropriately dissuasive penalties.

Or. en

Amendment 929

Lydie Massard

Proposal for a regulation

Article 24 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003.

Member States shall take appropriate measures to avoid the unintended presence of NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003. A public register about the location where NGT are grown plus detection methods for NGT are obligatory. Member states will introduce liability schemes that producers of NGT burden the costs for contamination in neighbour fields as well as contamination caused by joint use of machineries, storages and processing entities.

Or. en

Amendment 930

Günther Sidl

Proposal for a regulation

Article 24 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003.

Member States shall take appropriate measures to avoid the unintended presence of NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003. This includes an obligation of NGT growers to inform organic and certified non-gm growers with field plots in a distance were outcrossing is possible to those where NGT plants are grown, according to the details specified in implementing act XXX.

Or. en

Justification

accompanying measures are needed to support the MS in taking appropriate measures that effectively prevent mixing without causing unnecessary burdens; at least the development of guidelines is needed to support a level playing field within the EU. The distance for the obligation to inform neighbours depends on the biology of the plant.

Amendment 931

Francesca Peppucci

Proposal for a regulation

Article 24 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003.

The European Commission shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003, only where category 2 NGT plants can be detected, identified and quantified by analytical methods.

Or. en

Amendment 932

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 24 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003.

Member States shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003, including by the possibility of opt-out.

Or. en

Amendment 933

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Article 24 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003.

Member States and the European Commission shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003.

Or. en

Amendment 934

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 24 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

Member States shall set up a public register in which the all locations where NGT plants are bred or cultivated are shown, described by means of latitude and longitude coordinates corresponding to at least one latitude and one longitude point and using at least six decimal digits.

Or. en

Amendment 935

Francesca Peppucci

Proposal for a regulation

Article 24 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

The burden of proof of the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation (EC) No 1829/2003 should not be placed on the user of category 2 NGT plants.

Or. en

Amendment 936

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 24 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

Member States shall introduce liability schemes in order to ensure that the costs of cross-contamination of conventional and organic operators with NGTs are born by the operator that released the NGT into the environment. The latter shall also bear the burden of proof.

Or. en

Amendment 937

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 24 – paragraph 1 c (new)

Text proposed by the Commission

Amendment

Where operators cultivate NGT crops, they will make this visible to the public by putting up information signs in their field which should be clearly legible.

Or. en

Amendment 938

Ivan David

Proposal for a regulation

Article 24 a (new)

Text proposed by the Commission

Amendment

Article 24a

Protection of the intellectual property of breeders

1) Category 1 NGT plants, as well as plants and varieties that can be produced and occur in nature, or can be produced by conventional breeding, or are considered conventional plants, cannot be patented.

2) To protect the intellectual property of breeders of category 1 NGT plants, as well as plants and varieties that may be produced and occur naturally, or may be produced through conventional breeding, or are considered conventional plants, the procedure laid down in Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights, as amended, shall be applied.

Or. cs

Justification

NGT rostliny kategorie 1 , stejně jako rostliny a odrůdy, které mohou vzniknout a vyskytovat se přirozeně nebo mohou vzniknout konvenčním šlechtěním nebo jsou považovány za konvenční rostliny, neměly by být předmětem patentového nýbrž odrůdového práva, které umožňuje využívat tzv. šlechtitelskou výjimku, a tím podporuje inovace a vytváření nových odrůd.Odrůdové právo EU je vysoce účinným a široce využívaným systémem ochrany nových odrůd. Umožňuje ochranu duševního vlastnictví šlechtitele, licenční poplatky jsou významným zdroje refinancování nákladného šlechtitelského procesu. Na rozdíl od patentu umožňuje využití chráněné odrůdy pro výzkum a šlechtění dalších odrůd bez souhlasu držitele šlechtitelského osvědčení, a tím podporuje inovaci ve šlechtění.Odrůdové právo EU navíc zachovává farmářskou výjimku, která malým zemědělským podnikům a malým farmářům umožňuje použít část úrody jako osivo v dalším roce.Odrůdové právo EU znemožňuje držiteli patentu, aby při podpisu prodejní smlouvy na osivo zemědělce nutili se zavázat k prodeji veškeré úrody zpět držiteli patentů. Takové praktiky často zneužívané ve třetích zemích k vykořisťování zemědělců a způsobují monopolizaci trhu se zemědělskými komoditami.

Amendment 939

João Pimenta Lopes

Proposal for a regulation

Article 25

Text proposed by the Commission

Amendment

Article 25

deleted

Cultivation

Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.

Or. pt

Amendment 940

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 25

Text proposed by the Commission

Amendment

Article 25

deleted

Cultivation

Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.

Or. en

Amendment 941

Lydie Massard

Proposal for a regulation

Article 25

Text proposed by the Commission

Amendment

Article 25

deleted

Cultivation

Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.

Or. en

Amendment 942

Günther Sidl

Proposal for a regulation

Article 25

Text proposed by the Commission

Amendment

Article 25

deleted

Cultivation

Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.

Or. en

Justification

Article 26b of Directive 2001/18 allows the total or partial exclusion of the cultivation of genetic engineering on the territory of the respective member state. In the sense of subsidiarity of the member states, this possibility is also to be maintained extensively for NGT plants.

Amendment 943

Stanislav Polčák

Proposal for a regulation

Article 25

Text proposed by the Commission

Amendment

Article 25

deleted

Cultivation

Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.

Or. cs

Amendment 944

Günther Sidl

Proposal for a regulation

Article 25 – paragraph 1

Text proposed by the Commission

Amendment

Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.

deleted

Or. en

Justification

Amendment 945

Martin Häusling

Proposal for a regulation

Article 25 – paragraph 1

Text proposed by the Commission

Amendment

Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.

deleted

Or. en

Justification

Member States must have all legal means to ensure and implement adapted and crop-specific coexistence rules in their territory, including the right to ban the cultivation of NGTs in areas where coexistence is practically or economically not feasible or undesirable. A prohibition of national bans as foreseen in Article 25 of the Commission’s proposal would mean the loss of important national sovereignty and rights for Member States.

Amendment 946

Pascal Canfin, Max Orville

Proposal for a regulation

Article 25 – paragraph 1

Text proposed by the Commission

Amendment

Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.

deleted

Or. en

Amendment 947

Christophe Clergeau

Proposal for a regulation

Article 25 – paragraph 1

Text proposed by the Commission

Amendment

Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.

Article 26b of Directive 2001/18/EC shall apply to NGT plants. Article 23 of Directive 2001/18/EC shall apply for all NGT mutatis mutandis.

Or. en

Amendment 948

Jessica Polfjärd

Proposal for a regulation

Article 25 – paragraph 1

Text proposed by the Commission

Amendment

Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.

Article 26b of Directive 2001/18/EC shall not apply to category 1 NGT plants.

Or. en

Justification

Since NGT 1 plants are deemed to be conventional-like, there should be no opt-out from cultivation of these products.

Amendment 949

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 25 – paragraph 1

Text proposed by the Commission

Amendment

Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.

Article 26b of Directive 2001/18/EC shall apply to category 2 NGT plants.

Or. en

Amendment 950

Anna Zalewska, Krzysztof Jurgiel

Proposal for a regulation

Article 25 – paragraph 1

Text proposed by the Commission

Amendment

Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.

Article 26b of Directive 2001/18/EC shall apply to category 2 NGT plants.

Or. pl

Justification

Member States should retain the right to prohibit the cultivation of category 2 NGT plants in their territory, in accordance with Article 26b of Directive 2001/18.

Amendment 951

Martin Häusling

Proposal for a regulation

Article 25 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

The provisions for the risk assessment of stacked events of current GMO Regulation fully apply to category 2 NGT plants.

Or. en

Justification

It has to be discussed if this also applies to category 1 NGT plants. The specific provisions (such as Implementing Regulation 503/2013) may be listed in the text of this Article.

Amendment 952

Martin Häusling

Proposal for a regulation

Article 25 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

The Commission, after consulting the Authority, shall propose adequate processes, criteria and methodologies for the assessment of systemic effects, such as combinatorial, cumulative and long-term effects, to be adopted by an implementing regulation in accordance with Article 27 and Article 28(3) in order to supplement Annex II.

Or. en

Amendment 953

Pietro Fiocchi

Proposal for a regulation

Article 25 a (new)

Text proposed by the Commission

Amendment

Article 25a

Category 2 NGT plants for which a detection method, which can detect, identify and quantify, cannot be provided shall not be subject to the requirements laid down in Article 23 of Regulation (EU) 2017/625 , Article 21 of Directive 2001/18/EC, Articles 12, 13, 24 and 25 of Regulation (EC) No 1829/2003, and Article 4 and 5 of Regulation (EC) No 1830/2003.

Or. en

Amendment 954

Martin Häusling

Proposal for a regulation

Article 26

Text proposed by the Commission

Amendment

Article 26

deleted

Exercise of the delegation

1. The power to adopt the delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

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

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.

4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(61 ).

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

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.

_________________

61 OJ L 123, 12.5.2016, p. 1.

Or. en

Justification

We have deleted provisions subject to delegated acts in the EC proposal.

Amendment 955

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 26

Text proposed by the Commission

Amendment

Article 26

deleted

Exercise of the delegation

1. The power to adopt the delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

_________________

61 OJ L 123, 12.5.2016, p. 1.

Or. en

Amendment 956

Günther Sidl

Proposal for a regulation

Article 26 – paragraph 1

Text proposed by the Commission

Amendment

1. The power to adopt the delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

deleted

Or. en

Justification

The definitions of NGT are the core of the legislations and cannot not changed via delegated acts as defined in Art 290 TFEU only non-essential elements can be amended via delegated acts.

Amendment 957

Günther Sidl

Proposal for a regulation

Article 26 – paragraph 2

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 958

Christophe Clergeau

Proposal for a regulation

Article 26 – paragraph 2

Text proposed by the Commission

Amendment

2. The power to adopt the delegated acts referred to in Article 6(1), Article 6(3), Article 11a and Article 24 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 European Parliament or the Council opposes such extension not later than 3 months before the end of each period.

Or. en

Amendment 959

Sirpa Pietikäinen

Proposal for a regulation

Article 26 – paragraph 2

Text proposed by the Commission

Amendment

2. The power to adopt the delegated acts referred to in 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 European Parliament or the Council opposes such extension not later than 3 months before the end of each period.

Or. en

Amendment 960

Günther Sidl

Proposal for a regulation

Article 26 – paragraph 3

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 961

Pietro Fiocchi

Proposal for a regulation

Article 26 – paragraph 3

Text proposed by the Commission

Amendment

3. The delegations of power referred to in Article 5(3) and Article 22(8) may be exercised only for the purpose of adapting to scientific and technological progress, on the understanding that the non-regression clause must apply. The delegations of power 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.

Or. it

Amendment 962

Francesca Peppucci

Proposal for a regulation

Article 26 – paragraph 3

Text proposed by the Commission

Amendment

3. The delegations of power referred to in Article 5(3) and Article 22(8) may only be exercised to adapt to scientific and technological progress, and the non-regression clause must be applied. Delegations of power 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.

Or. en

Amendment 963

Christophe Clergeau

Proposal for a regulation

Article 26 – paragraph 3

Text proposed by the Commission

Amendment

3. The delegations of power referred to in Article 6(1), Article 6(3), Article 11a and Article 24 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.

Or. en

Amendment 964

Sirpa Pietikäinen

Proposal for a regulation

Article 26 – paragraph 3

Text proposed by the Commission

Amendment

3. The delegations of power referred to in 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.

Or. en

Amendment 965

Günther Sidl

Proposal for a regulation

Article 26 – paragraph 4

Text proposed by the Commission

Amendment

deleted

_________________

61 OJ L 123, 12.5.2016, p. 1.

Or. en

Amendment 966

Günther Sidl

Proposal for a regulation

Article 26 – paragraph 5

Text proposed by the Commission

Amendment

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

deleted

Or. en

Amendment 967

Günther Sidl

Proposal for a regulation

Article 26 – paragraph 6

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 968

Christophe Clergeau

Proposal for a regulation

Article 26 – paragraph 6

Text proposed by the Commission

Amendment

6. A delegated act adopted pursuant to Article 6(1), Article 6(3), Article 11a and Article 24 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.

Or. en

Amendment 969

Sirpa Pietikäinen

Proposal for a regulation

Article 26 – paragraph 6

Text proposed by the Commission

Amendment

6. A delegated act adopted pursuant to 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.

Or. en

Amendment 970

Martin Häusling

Proposal for a regulation

Article 27 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

The Commission shall adopt implementing acts concerning:

The Commission shall adopt implementing acts supplementing the provisions laid down in this Regulation concerning:

Or. en

Amendment 971

Martin Häusling

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;

deleted

Or. en

Justification

This is an essential provision and should not be decided via implementing acts. Essential provisions should be adopted by the Council and the Parliament in the ordinary legislative procedure.

Amendment 972

Christophe Clergeau

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;

deleted

Or. en

Justification

The importance of this act required a delegated act.

Amendment 973

Günther Sidl

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;

deleted

Or. en

Justification

It should be clear for all stakeholders what the regulation will look like before it enters into force in order to have clarity for them. With this delegated act, stakeholders are left in the dark about the extent to which changes will be made regarding categorization and labelling. However, as these points are crucial for the implementation of the proposal, these answers would need to be available before a vote by the Member States and the Parliament.

Amendment 974

Günther Sidl

Proposal for a regulation

Article 27 – paragraph 1 – point b

Text proposed by the Commission

Amendment

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

deleted

Or. en

Justification

As Article 6 and 7 is proposed to be deleted no reference is necessary.

Amendment 975

Christophe Clergeau

Proposal for a regulation

Article 27 – paragraph 1 – point b

Text proposed by the Commission

Amendment

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

deleted

Or. en

Justification

The importance od this act required a delegated act.

Amendment 976

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 27 – paragraph 1 – point b

Text proposed by the Commission

Amendment

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

deleted

Or. en

Amendment 977

Martin Häusling

Proposal for a regulation

Article 27 – paragraph 1 – point b

Text proposed by the Commission

Amendment

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

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

Or. en

Amendment 978

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 27 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(ba) methodology and information requirements for in-door risk assessment in accordance with the principles and criteria laid down in Annex I;

Or. en

Amendment 979

Günther Sidl

Proposal for a regulation

Article 27 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) the methodology and information requirements for the environmental risk assessment of category 2 NGT plants and the safety assessments of category 2 NGT food and feed, in accordance with the principles and criteria laid down in Annex II;

deleted

Or. en

Justification

As all NGT plants should follow the requirement regarding 2001/18 no delegated acts for the Commission are necessary for methodology and information requirements for the risk assessment of NGT plants or NGT products.

Amendment 980

Martin Häusling

Proposal for a regulation

Article 27 – paragraph 1 – point c

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

This is an essential provision and should not be decided via implementing act. Essential provisions should be adopted by the Council and the Parliament in the ordinary legislative procedure. If anything, this should be decided via a delegated regulation, not an implementing regulation.

Amendment 981

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 27 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) the methodology and information requirements for the environmental risk assessment of NGT plants and the safety assessments of NGT food and feed, in accordance with the principles and criteria laid down in Annex II;

Or. en

Amendment 982

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 27 – paragraph 1 – point c a (new)

Text proposed by the Commission

Amendment

(ca) methodology, processes and criteria for assessment of systemic effects on the environment, biodiversity and ecosystems, including combinatorial, cumulative and long-term effects, taking into account opinion of the Authority;

Or. en

Amendment 983

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 27 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) adapted modalities to comply with analytical method requirements referred to in Article 14(1), point (l), and Article 19(2).

deleted

Or. en

Amendment 984

Günther Sidl

Proposal for a regulation

Article 27 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(ea) the methodology and information requirements to demonstrate that a trait can be considered to be sustainable.

Or. en

Amendment 985

Günther Sidl

Proposal for a regulation

Article 27 – paragraph 1 – point e b (new)

Text proposed by the Commission

Amendment

(eb) the methodology and information on how to define the inclusion of genetic information in the breeders gene pool.

Or. en

Amendment 986

Günther Sidl

Proposal for a regulation

Article 27 – paragraph 1 – point e c (new)

Text proposed by the Commission

Amendment

(ec) Definitions of and methodology to define risk profiles necessary for Annex II.

Or. en

Amendment 987

Günther Sidl

Proposal for a regulation

Article 27 – paragraph 2

Text proposed by the Commission

Amendment

Before adopting the implementing acts referred to in points (a) to (d), the Commission shall consult the Authority. The implementing acts shall be adopted in accordance with the procedure referred to in Article 28(3).

Before adopting the implementing acts referred to in points (a) to (d), the Commission shall consult the Authority. Before adopting the implementing act(s) referred to in point (e), the Commission shall consult the Joint Research Centre with the European Union Reference Laboratory for Genetically Modified Food and Feed. The implementing acts shall be adopted in accordance with the procedure referred to in Article 28(3).

Or. en

Amendment 988

Martin Häusling

Proposal for a regulation

Article 27 – paragraph 2

Text proposed by the Commission

Amendment

Before adopting the implementing acts referred to in paragraph 1, the Commission shall consult the Authority. Before adopting the implementing act(s) referred to in point (e), the Commission shall consult the Joint Research Centre with the European Union Reference Laboratory for Genetically Modified Food and Feed. The implementing acts shall be adopted in accordance with the procedure referred to in Article 28(3).

Or. en

Amendment 989

Christophe Clergeau

Proposal for a regulation

Article 27 – paragraph 2

Text proposed by the Commission

Amendment

Before adopting the implementing acts, the Commission shall consult the Authority. The implementing acts shall be adopted in accordance with the procedure referred to in Article 28(3).

Or. en

Amendment 990

Martin Häusling

Proposal for a regulation

Article 28 – paragraph 2

Text proposed by the Commission

Amendment

2. Where reference is made to this paragraph, Article 4 of Regulation (EC) No 182/2011 shall apply.

deleted

Or. en

Justification

This is the advisory procedure. It should not be used. The examination procedure, which is more democratic, should be used instead.

Amendment 991

Günther Sidl

Proposal for a regulation

Article 28 – paragraph 2

Text proposed by the Commission

Amendment

2. Where reference is made to this paragraph, Article 4 of Regulation (EC) No 182/2011 shall apply.

deleted

Or. en

Amendment 992

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 28 – paragraph 2

Text proposed by the Commission

Amendment

2. Where reference is made to this paragraph, Article 4 of Regulation (EC) No 182/2011 shall apply.

deleted

Or. en

Amendment 993

Christophe Clergeau

Proposal for a regulation

Article 29 – title

Text proposed by the Commission

Amendment

Guidance

Guidance and ex ante evaluation

Or. en

Amendment 994

Christophe Clergeau

Proposal for a regulation

Article 29 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Before the date of application of this Regulation, the European Commission shall provide an evaluation of this Regulation on the strategic autonomy of the European Union, on the concentration of the breeding sector, on the future of the European Plant Variety Rights system, on the safety measures to preserve the genetic diversity currently maintain by little and medium breeders and on the rise of food costs for European consumers due to the patents on new genomic techniques controlled by a few multinational firms.

Or. en

Amendment 995

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 30 – paragraph -1 (new)

Text proposed by the Commission

Amendment

-1. By 31 December 2024, the Commission shall present a report on the issue of patents in the food chain, and their effects on food security, freedom of choice for farmers and consumers, increased corporate control in the plant breeding sector and monopolisation of our food. The Commission shall accompany this report with a legislative proposal to amend the intellectual property legislation to prohibit the use of patents on living organisms, genes, traits and breeding techniques.

Or. en

Amendment 996

Günther Sidl

Proposal for a regulation

Article 30 – paragraph 1

Text proposed by the Commission

Amendment

1. No sooner than three years after the first decision is adopted in accordance with Article 6(8) or (10) or Article 7(6) or in accordance with Sections 2 or 3 of Chapter III, whichever is the earliest, and thereafter every five years, the Commission shall forward to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of this Regulation.

1. No sooner than three years after the first decision is adopted in accordance with Sections 2 or 3 of Chapter III, whichever is the earliest, and thereafter every five years, the Commission shall forward to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of this Regulation.

Or. en

Amendment 997

Catherine Griset, Aurélia Beigneux

Proposal for a regulation

Article 30 – paragraph 1

Text proposed by the Commission

Amendment

1. No later than three years after the first decision is adopted in accordance with Article 6(8) or (10) or Article 7(6) or in accordance with Sections 2 or 3 of Chapter III, whichever is the earliest, and thereafter every five years, the Commission shall forward to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of this Regulation.

Or. fr

Amendment 998

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 30 – paragraph 1

Text proposed by the Commission

Amendment

1. No later than three years after the first decision is adopted in accordance with Article 6(8) or (10) or Article 7(6) or in accordance with Sections 2 or 3 of Chapter III, whichever is the earliest, and thereafter every three years, the Commission shall forward to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of this Regulation.

Or. en

Amendment 999

Martin Häusling

Proposal for a regulation

Article 30 – paragraph 2

Text proposed by the Commission

Amendment

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

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

Or. en

Amendment 1000

Günther Sidl

Proposal for a regulation

Article 30 – paragraph 2

Text proposed by the Commission

Amendment

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

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

Or. en

Amendment 1001

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Article 30 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. The report shall also address progress achieved regarding regulatory cooperation with trade partners and include information on the impact of divergent legislative approaches in third countries on EU international trade.

In that regard, the following elements should be included in the report:

- progress achieved in developing (private-public) Databases on NGT plants at global or third country level, in order to foster open dialogue with third countries.

- overview of outcome of risk assessment (including environmental) in main trade partners’ countries, and how this can feed into the EU regulatory framework.

Or. en

Amendment 1002

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 30 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. The report shall address the possible negative effects on biodiversity, environment and health, the impact on the organic value chain, the trust and freedom of choice of citizens.

Or. en

Amendment 1003

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 30 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

2b. The report shall address invasiveness, allergenic potential, impacts on non targeted organisms and the effects of NGTs in the use and risk of pesticides and fertilisers.

Or. en

Amendment 1004

Martin Häusling

Proposal for a regulation

Article 30 – paragraph 3

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 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.

3. For the purpose of the reporting referred to in paragraph 1, the Commission, by [24 months after the date 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 the impact of this Regulation, including data, studies and indicators relating to increased corporate control of the plant breeding sector and patents, allergenic potential of NGTs, invasiveness, levels of herbicide use and impacts on non-target organisms. The design of the programme shall specify the action to be taken by the Commission and by the Member States in collecting and analysing the data and other evidence.

Or. en

Amendment 1005

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 30 – paragraph 3

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 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.

Or. en

Amendment 1006

Catherine Griset, Aurélia Beigneux

Proposal for a regulation

Article 30 – paragraph 3 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

The competent authorities of the Member States shall set up biovigilance and sociovigilance networks to facilitate the collection of indicators and the measurement of environmental and health impacts.

Or. fr

Amendment 1007

Martin Häusling

Proposal for a regulation

Article 30 – paragraph 4

Text proposed by the Commission

Amendment

4. No sooner than two years after the publication of the first report referred to in paragraph 1 the Commission shall carry out an evaluation of the implementation of this Regulation and its impact on human and animal health, the environment, consumer information, the functioning of the internal market, and economic, environmental and social sustainability.

4. No later than one year after the publication of the first report referred to in paragraph 1 the Commission shall carry out an evaluation of the implementation of this Regulation with regard to respect for the precautionary principle, as well as its impact on human and animal health, biodiversity and the environment, consumer information and transparency, the functioning of the internal market, including concentration of the seed sector and impacts of patents, and economic, environmental and social sustainability.

Or. en

Amendment 1008

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Article 30 – paragraph 4

Text proposed by the Commission

Amendment

Or. en

Justification

As part of the evaluation of the Regulation, the Commission should also assess its bottlenecks in enabling the uptake of NGT 1 products. This will serve as basis for potential future reviews and adaptations of this legislation.

Amendment 1009

Erik Poulsen, Asger Christensen, Jan Huitema, Emma Wiesner

Proposal for a regulation

Article 30 – paragraph 4

Text proposed by the Commission

Amendment

4. No sooner than two years after the publication of the first report referred to in paragraph 1 the Commission shall carry out an evaluation of the implementation of this Regulation and its impact on human and animal health, the environment, consumer information, the functioning of the internal market herein the organic production, and economic, environmental and social sustainability.

Or. en

Amendment 1010

Martin Häusling

Proposal for a regulation

Article 30 – paragraph 5

Text proposed by the Commission

Amendment

5. The Commission shall present a report on the main findings of the evaluation referred to in paragraph 4 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.

5. The Commission shall present a report on the main findings of the evaluation referred to in paragraph 4 as well as on the findings of the monitoring programme referred to paragraph 3 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Where required to ensure a high level of protection of human and animal health and the environment, in line with precautionary principle, the report shall be accompanied by a legislative proposal for amendment of relevant provisions of this Regulation.

Or. en

Amendment 1011

Pernille Weiss

Proposal for a regulation

Article 30 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5a. By [one year after entry into force], the Commission shall present to the European Parliament and the Council a report reviewing available scientific and technical data on other organisms not encompassed by this Regulation, notably microorganisms, in view of including them in the scope of future legislative initiatives. Where appropriate, the report may be accompanied by a legislative proposal.

Or. en

Amendment 1012

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Nils Torvalds, Emma Wiesner, Andreas Glueck, Ulrike Müller

Proposal for a regulation

Article 30 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5a. Every three years, the Commission shall review the criteria listed in Annex I and Annex III of this Regulation and, where appropriate, amend them by means of a delegated act, in order to ensure adaptation to the latest scientific and technological progress.

Or. en

Justification

The field of plant biotechnology is generally characterized by a steady pace of scientific advancements. Regular revisions of the criteria listed in Annex I and III are therefore essential to keep the legislative framework for NGTs in the Union future-proof. The proposed timeframe for revisions of 3 years is based on the pace of technological advancements and is currently being considered by the UK government in relation to UK legislation on NGTs.

Amendment 1013

Erik Poulsen, Asger Christensen, Emma Wiesner

Proposal for a regulation

Article 30 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5a. By 2024, the Commission shall produce a report evaluating the specificities and needs for other sectors not covered in this legislation, such as microorganisms, including a proposal for further policy action.

Or. en

Amendment 1014

Jan Huitema, Karin Karlsbro, Nils Torvalds, Emma Wiesner, Andreas Glueck, Ulrike Müller

Proposal for a regulation

Article 30 – paragraph 5 b (new)

Text proposed by the Commission

Amendment

5b. No later than December 2026, the Commission shall present a study to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the effects of patenting plants on advancement in plant breeding, the influence of patents on breeders' accessibility to genetic resources and methods, the availability of seeds for farmers and the EU's competitiveness in the field of plant biotechnology. Where appropriate, the report shall be accompanied by a legislative proposal amending the framework for intellectual property rights for plants.

Or. en

Amendment 1015

Pernille Weiss

Proposal for a regulation

Article 30 – paragraph 5 b (new)

Text proposed by the Commission

Amendment

5b. By [two years after entry into force], the Commission shall present a report to the European Parliament and the Council examining existing Union GMO legislation and assessing the degree to which it is still fit for purpose. Specifically, the report shall consider whether current requirements under Union GMO legislations are sufficiently science-based, proportionate to the risks and harmonized with global requirements. Where relevant, the report may be accompanied by a legislative proposal.

Or. en

Amendment 1016

João Pimenta Lopes

Proposal for a regulation

Article 31

Text proposed by the Commission

Amendment

Article 31

deleted

References in other Union legislation

With regard to category 2 NGT plants, references in other Union legislation to Annex II or Annex III to Directive 2001/18/EC shall be construed as references to Parts 1 and 2 of Annex II to this Regulation.

Or. pt

Amendment 1017

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 31 – paragraph 1

Text proposed by the Commission

Amendment

With regard to NGT plants, references in other Union legislation to Annex II or Annex III to Directive 2001/18/EC shall be construed as references to Parts 1 and 2 of Annex II to this Regulation.

Or. en

Amendment 1018

Günther Sidl

Proposal for a regulation

Article 31 – paragraph 1

Text proposed by the Commission

Amendment

With regard to NGT plants, references in other Union legislation to Annex II or Annex III to Directive 2001/18/EC shall be construed as references to Part 2 of Annex II to this Regulation.

Or. en

Justification

According to the ruling of the European Court of Justice (ECJ) of July 25, 2018, organisms obtained by mutagenesis are in principle to be classified as genetically modified organisms (GMOs) and are therefore subject to the regulations of the Genetic Engineering Act (Directive 2001/18/EC). The reason given for this is that mutagenesis processes lead to a change in the genetic material of an organism that is not possible in a natural way. A distinction between category 1 and category 2 NGT plants is therefore not expedient. Therefore Annex 1 is also not needed.

Amendment 1019

Catherine Griset, Aurélia Beigneux

Proposal for a regulation

Article 31 a (new)

Text proposed by the Commission

Amendment

Article 31a

The Commission shall ensure that all NGT plants and products imported into the EU are subject to the same obligations as those originating in the Union and are systematically enshrined in trade agreements (‘mirror clause’). This shall concern, in particular, the inclusion of traceability and labelling clauses and the provision of all data and information required under this legislation.

Or. fr

Amendment 1020

Günther Sidl

Proposal for a regulation

Article 32

Text proposed by the Commission

Amendment

Article 32

deleted

Administrative review

To this effect a request shall be submitted to the Commission within two months from the day on which the party concerned became aware of the act or omission in question.

The Commission shall prepare a draft decision within two months requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to act.

Or. en

Justification

Article 32 introduces a comprehensive right of recourse for the Commission vis-à-vis Member State authorities. Any decision taken under the draft and any failure to exercise official powers can be reviewed on the Commission's own initiative or at the request of Member States or individuals concerned, and the Commission can then ask the authority to withdraw its decision or remedy the omission. Therefore, this article should be deleted to retain power for MS.

Amendment 1021

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 32 – paragraph 1

Text proposed by the Commission

Amendment

Any decision taken under, or failure to exercise, the powers vested in the Authority by this Regulation may be reviewed by the Commission on its own initiative or in response to a request from a Member State or from any natural or legal person with sufficient interest. Any non-governmental organisation promoting environmental protection and the protection of health, and meeting any requirements under national law shall be deemed to have sufficient interest.

Or. en

Amendment 1022

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 32 – paragraph 3

Text proposed by the Commission

Amendment

The Commission shall prepare a draft decision within two months requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to act.

The Commission shall prepare a draft decision within one months requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to act.

Or. en

Amendment 1023

Martin Häusling

Proposal for a regulation

Article 32 a (new)

Regulation (EU) 2015/2283

Article 2 – paragraph 2

Present text

Amendment

Article 32a (new)

Amendment to Regulation (EU)2015/2283

In Article 2, paragraph 2 is replaced by the following:

2. This Regulation does not apply to:

"2. This Regulation does not apply to:

(a) genetically modified foods falling within the scope of Regulation (EC) No 1829/2003;

(a) foods when and in so far as they are used as:

(b) foods when and in so far as they are used as:

(i) food enzymes falling within the scope of Regulation (EC) No 1332/2008;

(ii) food additives falling within the scope of Regulation (EC) No 1333/2008;

(ii) food additives falling within the scope of Regulation (EC) No 1333/2008; (iii) food flavourings falling within the scope of Regulation (EC) No 1334/2008;

(iii) food flavourings falling within the scope of Regulation (EC) No 1334/2008;

(iv) extraction solvents used or intended to be used in the production of foodstuffs or food ingredients and falling within the scope of Directive 2009/32/EC.

(iv) extraction solvents used or intended to be used in the production of foodstuffs or food ingredients and falling within the scope of Directive 2009/32/EC."

Or. en

(32015R2283)

Justification

The EC proposal refers to the novel food regulation, but article 2(2) of the novel food regulation excludes genetically modified food, so this AM makes sure that GM food is within the scope of the novel food regulation.

Amendment 1024

Martin Häusling

Proposal for a regulation

Article 32 d (new)

Directive 2002/55/EC

Article 9 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

Article 32d

Amendment to Directive 2002/55/EC

In Article 9, the following paragraph is inserted:

‘5a. Member States shall ensure that varieties containing or consisting of a category 1 or a category 2 NGT plant within the meaning of Regulation [please insert reference to this Regulation] are clearly indicated as varieties that have been genetically modified in the catalogue of varieties. They shall further ensure that any person marketing such a variety clearly indicates in his sales catalogue that the variety has been genetically modified.’

Or. en

Justification

The Commission proposal contains no obligation to ensure that varieties containing or consisting of a category 1 or 2 NGT plants are clearly indicated as varieties that are genetically modified in the catalogue of varieties. This amendment changes that.

Amendment 1025

Martin Häusling

Proposal for a regulation

Article 32 a (new)

Directive 2002/55/EC

Article 17 – subparagraph 3

Present text

Amendment

Article 32a (new)

Amendment to Directive 2002/55/EC

In Article 17, subparagraph 3 is replaced by the following:

The published notice shall clearly indicate those varieties which have been genetically modified.

"The published notice shall clearly indicate those varieties which have been genetically modified, including those which contain or consist of a category 1 NGT plant or 2 NGT plant within the meaning of Regulation [please insert reference to this Regulation]."

Or. en

(02002L0055)

Amendment 1026

Martin Häusling

Proposal for a regulation

Article 32 c (new)

Directive 2002/53/EC

Article 9 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

Article 32c

Amendment to Directive 2002/53/EC

In Article 9, the following paragraph is inserted:

‘5a. Member States shall ensure that varieties containing or consisting of a category 1 or category 2 NGT plant within the meaning of Regulation [please insert reference to this Regulation] are clearly indicated as varieties which have been genetically modified n the catalogue of varieties. They shall further ensure that any person marketing such a variety clearly indicates in his sales catalogue that the variety has been genetically modified.’

Or. en

Justification

Amendment 1027

Martin Häusling

Proposal for a regulation

Article 32 a (new)

Directive 2002/53/EC

Article 17 – subparagraph 3

Present text

Amendment

Article 32a (new)

Amendment to Directive 2002/53/EC

Article 17, subparagraph 3 is replaced by the following:

The published notice shall clearly indicate those varieties which have been genetically modified.

"The published notice shall clearly indicate those varieties which have been genetically modified, including those which contain or consist of a category 1 or category 2 NGT plant within the meaning of Regulation [please insert reference to this Regulation]."

Or. en

(02002L0053)

Amendment 1028

Martin Häusling

Proposal for a regulation

Article 32 b (new)

Directive 1999/105/EC

Article 10 – paragraph 2 – point j a (new)

Text proposed by the Commission

Amendment

Article 32b

Amendment to Directive 1999/105/EC

In Article 10(2) of Directive 1999/105/EC, the following point is inserted:

‘(ja) in the case of material of the ‘tested’ category, whether it contains or consists of a category 1 or category 2 NGT plant within the meaning of Regulation [please insert reference to this Regulation].’

Or. en

Justification

Amendment 1029

Martin Häusling

Proposal for a regulation

Article 32 a (new)

Directive 68/193/EEC

Article 5f

Present text

Amendment

Article 32a (new)

Amendment to Directive 68/193/EEC

Article 5f is replaced by the following:

Article 5f

"‘1. Member States shall ensure that genetically modified varieties which have been accepted are clearly indicated as such in the catalogue of varieties. They shall further ensure that any person marketing such a variety clearly indicates in their vine sales catalogue that the variety is genetically modified and states the purpose of the modification.

Member States shall ensure that genetically modified varieties which have been accepted are clearly indicated as such in the catalogue of varieties. They shall further ensure that any person marketing such a variety clearly indicates in their vine sales catalogue that the variety is genetically modified and states the purpose of the modification.

2. Member States shall ensure that varieties containing or consisting of a category 1 or category 2 NGT plant within the meaning of Regulation [please insert reference to this Regulation] are clearly indicated as varieties that are genetically modified in the catalogue of varieties. They shall further ensure that any person marketing such a variety clearly indicates in his sales catalogue that the variety is genetically modified.’"

Or. en

(31968L0193)

Justification

Amendment 1030

Christophe Clergeau

Proposal for a regulation

Article 32 a (new)

Text proposed by the Commission

Amendment

Article 32a

Penalties and withdrawal of the decision

Member States shall lay down the rules on penalties applicable in case of failure to disclose any information requested in the verification procedure or in the authorisation procedure. The competent authority may withdraw its decision.

The penalties provided for shall be effective, proportionate and dissuasive.

Member States shall without delay notify the Commission of those rules and any subsequent decision of penalties or withdrawal.

Or. en

Amendment 1031

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 32 a (new)

Text proposed by the Commission

Amendment

Article 32a

Access to justice

1. Any natural or legal person having sufficient interest shall have access to a court or other independent and impartial public body competent to review the procedural and substantive legality of the decisions, plans, permits, acts or failure to act of the competent authority under this Regulation. Any non-governmental organisation promoting environmental protection and the protection of human health, and meeting any requirements under national law shall be deemed to have sufficient interest.

2. Access to a court or other independent and impartial public body pursuant to paragraph 1 shall be fair, equitable, timely and not prohibitively expensive and provide adequate and effective remedies, including injunctive relief where appropriate. Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures.

Or. en

Amendment 1032

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 32 b (new)

Text proposed by the Commission

Amendment

Article 32b

Compensation

1. Member States shall ensure that, where damage to health, the environment or GMO-free food and feed chains has occurred as a result of a violation of the provisions of this Regulation, the individuals affected have the right to claim and obtain compensation for that damage from the relevant natural or legal persons and, where appropriate, from the relevant competent authorities responsible for the violation.

2. Member States shall ensure that, as part of the public concerned, non-governmental organisations promoting the protection of health or the environment and meeting any requirements under national law are allowed to represent the individuals affected and bring collective actions for compensation. Member States shall ensure that a claim for a violation leading to a damage cannot be pursued twice, by the individuals affected and by the non-governmental organisations referred to in this paragraph.

Or. en

Amendment 1033

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 33

Regulation (EU) 2017/625

Article 23

Text proposed by the Commission

Amendment

Article 33

deleted

Amendments to Regulation (EU) 2017/625

Article 23 of Regulation (EU) 2017/625 is amended as follows:

(1) in paragraph 2, point (a)(ii) is replaced by the following:

‘(ii) the cultivation of GMOs for food and feed production and the correct application of the plan for monitoring referred to in Article 13(2), point (e), of Directive 2001/18/EC, in Article 5(5), point (b), and Article 17(5), point (b), of Regulation (EC) No 1829/2003 and in Articles 14(1), point (h) and 19(3), point (b) of Regulation [reference to this Regulation];;

‘(b) the cultivation of GMOs for food and feed production and the correct application of the plan for monitoring referred to in Article 13(2), point (e), of Directive 2001/18/EC, in Article 5(5), point (b), and Article 17(5), point (b), of Regulation (EC) No 1829/2003 and in Articles 14(1), point (h) and 19(3), point (b) of Regulation [reference to this Regulation];.

Or. en

Amendment 1034

Günther Sidl

Proposal for a regulation

Article 33

EU 2017/625

Article 23

Text proposed by the Commission

Amendment

Article 33

deleted

Amendments to Regulation (EU) 2017/625

Article 23 of Regulation (EU) 2017/625 is amended as follows:

(1) in paragraph 2, point (a)(ii) is replaced by the following:

Or. en

Amendment 1035

Christophe Clergeau

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].

It shall apply when delegated acts referred to in Article 6(1), Article 6(3), Article 11a, Article 24 and all implementing acts required according to article 27 are adopted but no sooner than [36 months from the date of entry into force of this Regulation].

Or. en

Amendment 1036

Martin Häusling

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].

It shall apply from when all implementing acts required according to Article 27 are adopted, but no sooner than [36 months from the date of entry into force of this Regulation].

Or. en

Justification

See also former Art. 27

Amendment 1037

Günther Sidl

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].

It shall apply from [48 months from the date of entry into force of this Regulation].

Or. en

Amendment 1038

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

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].

It shall apply from [48 months from the date of entry into force of this Regulation].

Or. en

Amendment 1039

Marie Toussaint

Proposal for a regulation

Annex I

Text proposed by the Commission

Amendment

Criteria of equivalence of NGT plants to conventional plants

deleted

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 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.

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

(2) deletion of any number of nucleotides;

(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;

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

(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.

Or. en

Justification

This amendment forms part of a set of amendments deleting NGT category 1. By exempting category 1 NGTs, which will be make up the vast majority of NGTs, from GMO risk assessment, monitoring, traceability and consumer labelling, the Commission proposal fails to respect consumer rights as well as the precautionary principle, as laid down in the TFEU. Furthermore, there is no scientific basis underlying the criteria in Annex I which ‘determines’ if a NGT fulfils the criteria of ‘equivalence’ to conventional plants. The criteria have no bearing on safety, therefore there is no guarantee that GM plants meeting the criteria have a lower level of risk to human health and the environment.

Amendment 1040

Günther Sidl

Proposal for a regulation

Annex I

Text proposed by the Commission

Amendment

Criteria of equivalence of NGT plants to conventional plants

deleted

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

(2) deletion of any number of nucleotides;

(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;

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

Or. en

Justification

Amendment 1041

Lydie Massard

Proposal for a regulation

Annex I

Text proposed by the Commission

Amendment

Criteria of equivalence of NGT plants to conventional plants

deleted

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

(2) deletion of any number of nucleotides;

(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;

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

Or. en

Amendment 1042

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Annex I

Text proposed by the Commission

Amendment

Criteria of equivalence of NGT plants to conventional plants

deleted

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

(2) deletion of any number of nucleotides;

(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;

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

Or. en

Amendment 1043

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex I

Text proposed by the Commission

Amendment

Criteria of equivalence of NGT plants to conventional plants

deleted

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

(2) deletion of any number of nucleotides;

(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;

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

Or. en

Amendment 1044

Christophe Clergeau

Proposal for a regulation

Annex I – title

Text proposed by the Commission

Amendment

Criteria of equivalence of NGT plants to conventional plants 1. 1. A NGT plant is considered equivalent to conventional plants when it differs from the unedited parent plant by no more than 20 genetic modifications of the types referred to in points 1 to 2 within the whole genome of the host plant. (1) substitution or insertion of no more than 20 nucleotides for the purpose of disrupting or abolishing gene function ; any novel (intended or unintended) gene function shall be excluded ; (2) deletion of target inversion of any number of nucleotides for the purpose of disrupting or abolishing gene function ; any novel (intended or unintended) gene function shall be excluded ; 2. Alongside these process-based criteria, equivalence shall be verified on the basis of the results the genetic modifications produce on the plant. When compared to the unedited parent of the same species grown in the same conditions, result-based criteria shall be set out as follows : (1) the whole genome sequencing and profiling shows the desired genetic modifications have not modified the function of one or more genes other that the one or those specifically targeted; and (2) the whole transcriptome sequencing realized on the relevant part of the plant shows the desired genetic modifications have not modified other biochemical pathways than those specifically targeted; and (3) biochemical metabolite (metabolomics) and protein (proteomics) profiling realized on the relevant part of the plant shows the desired genetic modifications have not induced an increase in the levels of known toxins or allergens or the production by the plant of novel biochemicals or proteins other than those specifically desired.

Or. en

Justification

This amendment completes COM proposal by adding result-based criteria intended to screen possible unintended modifications of the plant.

Amendment 1045

Christophe Clergeau

Proposal for a regulation

Annex I – title

Text proposed by the Commission

Amendment

Criteria of equivalence of NGT plants to conventional plants A NGT plant is considered equivalent to conventional plants if, when compared to the unedited parent of the same species grown in the same conditions : - the whole genome sequencing and profiling shows the desired genetic modifications have not modified the function of one or more genes other that the one or those specifically targeted; and - the whole transcriptome sequencing realized on the relevant part of the plant shows the desired genetic modifications have not modified other biochemical pathways than those specifically targeted; provided any alteration of biochemical pathways, examined through gene ontology analysis, does not give rise to any adverse compositional consequences, and - biochemical metabolite (metabolomics) and protein (proteomics) profiling realized on the relevant part of the plant shows the desired genetic modifications have not induced an increase in the levels of known toxins or allergens or the production by the plant of novel biochemicals or proteins other than those specifically desired; provided any novel biochemicals or proteins produced by the plant does not present adverse effects on the plant itself, on any other forms of life it is known to interact with or bound to consume it.

Or. en

Justification

This amendment substitutes COM proposal by result-based criteria intended to screen possible unintended modifications of the plant + some implicit risk-assessment (no adverse compositional consequences and no adverse effects of novel biochemicals or proteins produced by the plant).

Amendment 1046

Christophe Clergeau

Proposal for a regulation

Annex I – title

Text proposed by the Commission

Amendment

Criteria of equivalence of NGT plants to conventional plants A NGT plant is considered equivalent to conventional plants if, when compared to the unedited parent of the same species grown in the same conditions : - the whole genome sequencing and profiling shows the desired genetic modifications have not modified the function of one or more genes other that the one or those specifically targeted; and - the whole transcriptome sequencing realized on the relevant part of the plant shows the desired genetic modifications have not modified other biochemical pathways than those specifically targeted; and - biochemical metabolite (metabolomics) and protein (proteomics) profiling realized on the relevant part of the plant shows the desired genetic modifications have not induced an increase in the levels of known toxins or allergens or the production by the plant of novel biochemicals or proteins other than those specifically desired.

Or. en

Justification

This amendment substitutes COM proposal by only result-based criteria intended to screen possible unintended modifications of the plant

Amendment 1047

Martin Häusling

Proposal for a regulation

Annex I – subheading 1

Text proposed by the Commission

Amendment

Criteria of equivalence of NGT plants to conventional plants

Classification of category 1 NGT plants

Or. en

Amendment 1048

Martin Häusling

Proposal for a regulation

Annex I – paragraph 1

Text proposed by the Commission

Amendment

A NGT plant may be classified as category 1 when it differs from the recipient/parental plant by no more than one set of intentional genetic modifications of the types referred to in points 1-3 and if no additional modification, intentional or unintentional , is present in any gene sequence or regulatory DNA sequence, or DNA sequences important in chromosomal activities and development, such as crossing over and speciation, that is not at the target site.

A plant can only be chosen as a parental plant if it is not already an NGT plant or an otherwise genetically modified plant.

Or. en

Justification

Given there is no history of safe use, these amendments to Annex I allow for better prediction of consequences and thus reduces the risks for human health and the environment whilst also allowing for gaining experience and data from/through placing on the market. (requiring that the specific crop or food/feed product is being monitored and data collected).

It also reduces the risks and increases predictability because it avoids the unpredictabilities arising from a) unintended genetic modifications (arising due to the processes used) and their individual or interactive consequences; and from b) the unpredictable nature of interactions, synergistic or cumulative effects arising from a multitude of changes within the same genome and organism.

By providing for accuracy and detailed molecular information (the required omic-tools are readily available) this is a more scienced-based approach as compared to the COM proposal. It provides better predictability and safeguards for the environment and human health.

Amendment 1049

Jan Huitema, Karin Karlsbro, Emma Wiesner, Andreas Glueck, Ulrike Müller

Proposal for a regulation

Annex I – paragraph 1

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 per haploid genome of the types referred to in points 1 to 5.

Or. en

Justification

To avoid a discriminatory approach for plant species with higher ploidy, it is essential that the total number of genetic modifications is based on the haploid genome. Not only 'targeted' insertion should be allowed. EFSA has argued that non-targeted insertion of genes is equally safe (EFSA Journal, 2012, 10(2), 2561). Removing 'targeted' is however essential: as 'targeted' insertion is still extremely complex, maintaining this criterion would be detrimental for breeders, in particular for SMEs. Instead, there should be a provision requiring that the inserted gene does not end up within an existing gene in a way that creates a chimeric protein (or 'combined' protein). In short, deleting the notion of 'targeted' will improve the practical feasibility of the requirements set, while adding a requirement preventing the creation of chimeric protein will ensure the same level of protection and safety.

Amendment 1050

Pietro Fiocchi

Proposal for a regulation

Annex I – paragraph 1

Text proposed by the Commission

Amendment

A NGT plant is considered equivalent to conventional plants when it contains only genetic modifications referred to in points 1 to 5 and when it differs from the recipient/parental plant by no more than 20 genetic modifications, excluded off target modifications, of the types referred to in points 1 to 4, in the targeted site or sites in the monoploid genome.

Or. en

Amendment 1051

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Annex I – paragraph 1

Text proposed by the Commission

Amendment

A NGT plant is considered equivalent to plants obtained by means of conventional selection methods when it contains only the genetic modifications referred to in points 1 to 5 and when it differs from the recipient/parental plant by no more than 20 genetic modifications, excluding off-target modifications, of the types referred to in points 1, 2 and 4, in the targeted site or sites in the monoploid genome.

Or. it

Amendment 1052

Ondřej Knotek

Proposal for a regulation

Annex I – paragraph 1

Text proposed by the Commission

Amendment

A plant prepared by new genomic techniques is considered equivalent to a conventional plant if it differs from the recipient/parental plant only by genetic modifications of the types referred to in points 1 to 4 which can be combined with each other.

Or. en

Amendment 1053

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Annex I – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Justification

The current wording of the Annex I disproportionately restricts breeders using NGT compared to conventional breeding practices. They are forced to work with only a maximum of 20 genetic modification which is not equivalent to conventional breeding. Therefore, we suggest not to limit the number of genetic modification or to refer this number per monoploid genome so that European breeders are not disadvantaged compared to breeders from third countries, who will not be restricted in any way.

Amendment 1054

Erik Poulsen, Asger Christensen, Emma Wiesner

Proposal for a regulation

Annex I – paragraph 1

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 30 genetic modifications per haploid genome of the types 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.

Or. en

Justification

As described in recital 14a, plants have a different number of haploid genomes, so in order not to discriminate the limit should apply to haploid genomes. Furthermore, the limitation should be raised from 20 to 30 as 20 limits the possibilities to use the technique in a beneficial way for our environment and increase food safety.

Amendment 1055

Pietro Fiocchi

Proposal for a regulation

Annex I – paragraph 1

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 per haploid of the types 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.

Or. it

Amendment 1056

Francesca Peppucci

Proposal for a regulation

Annex I – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1057

Anders Vistisen

on behalf of the ID Group

Proposal for a regulation

Annex I – paragraph 1

Text proposed by the Commission

Amendment

A NGT plant is considered equivalent to conventional plants when it contains only genetic modifications referred to in points 1 to 5 and when it differs from the recipient/parental plant by no more than 20 genetic modifications of the types referred to in points 1 to 4, in the targeted site or sites in the haploid genome.

Or. en

Amendment 1058

Christophe Clergeau

Proposal for a regulation

Annex I – paragraph 1

Text proposed by the Commission

Amendment

A NGT plant is considered equivalent to conventional plants when it differs from the unedited parent plant by no more than 20 genetic modifications of the types referred to in points 1 to 2 within the whole genome of the host plant.

Or. en

Amendment 1059

Martin Häusling

Proposal for a regulation

Annex I – point 1

Text proposed by the Commission

Amendment

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

(1) substitution or insertion of no more than 5 nucleotides (which is sufficient to cause the knockout or correction of a chosen gene or regulatory sequence) of or at a specific targeted sequence and if the resulting gene sequence does not give rise to a novel RNA or protein e.g. due to a frameshift mutation in or at the targeted sequence, and where the outcome of these substitutions or insertions were intended and have been shown to be safe for human health and the environment, and to be of no further or additional regulatory or metabolic or trait consequence.

Or. en

Justification

Amendment 1060

Christophe Clergeau

Proposal for a regulation

Annex I – point 1

Text proposed by the Commission

Amendment

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

(1) substitution or insertion of no more than 20 nucleotides for the purpose of disrupting or abolishing gene function ; any novel (intended or unintended) gene function shall be excluded;

Or. en

Amendment 1061

Norbert Lins

Proposal for a regulation

Annex I – point 1

Text proposed by the Commission

Amendment

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

(1) substitution or insertion of no more than 20 nucleotides; Multiple repeats of the same nucleotide sequences are counted singularly and as one genetic modification;

Or. en

Justification

Possibility of recognition of the concept of multiplex gene editing.

Amendment 1062

Francesca Peppucci

Proposal for a regulation

Annex I – point 1

Text proposed by the Commission

Amendment

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

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

Or. en

Amendment 1063

Pietro Fiocchi

Proposal for a regulation

Annex I – point 1

Text proposed by the Commission

Amendment

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

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

Or. it

Amendment 1064

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Annex I – point 1

Text proposed by the Commission

Amendment

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

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

Or. it

Amendment 1065

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Annex I – point 1 a (new)

Text proposed by the Commission

Amendment

(1a) Criteria specific for the use of targeted mutagenesis on the condition that the number of mutations events per any protein-coding sequence does not exceed 3:

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

(b) deletion of any number of nucleotides;

(2) Criteria specific for the use of cisgenesis on the condition that the genetic modification does not create a chimeric protein that is not already present in a species from the breeders’ gene pool:

(a) insertion of a continuous DNA sequence existing in the breeders’ gene pool;

(b) substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeders’ gene pool;

Or. en

Justification

In our opinion, the criteria for NGT category 1 are not uniform with regard to the permissibility of unplanned endogenous gene disruption. Moreover, the condition of targeted (intentional) modifications is not demonstrable and uniform as well. Hence, we propose simpler wording of the paragraph. We miss the presence of translocation in the annex, while it is mentioned in the Technical paper from the Commission that these translocations do occur in nature and conventional breeding. Therefore, it would be logical to include translocation under the requirement that it does not lead to creation of chimeric proteins.

Amendment 1066

Ondřej Knotek

Proposal for a regulation

Annex I – point 1 a (new)

Text proposed by the Commission

Amendment

(1a) Criteria specific for the use of targeted mutagenesis on the condition that the number of modifications per any gene cannot exceed 3;

Or. en

Amendment 1067

Ondřej Knotek

Proposal for a regulation

Annex I – point 1 b (new)

Text proposed by the Commission

Amendment

(1b) Criteria specific for the use of cisgenesis on the condition that only one modification can occur per one genome site;

Or. en

Amendment 1068

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Annex I – point 2

Text proposed by the Commission

Amendment

(2) deletion of any number of nucleotides;

deleted

Or. en

Amendment 1069

Martin Häusling

Proposal for a regulation

Annex I – point 2

Text proposed by the Commission

Amendment

(2) deletion of any number of nucleotides;

(2) deletion of any number of nucleotides at one particular targeted site or between two particular targeted sites and where no novel RNA or protein is produced, and where the outcome these deletions were intended and have been shown to be safe for human health and the environment and of no further or additional regulatory or metabolic or trait consequence.

Or. en

Justification

By providing for accuracy and detailed molecular information (the required omic-tools are readily available) this is a more science-based approach as compared to the COM proposal. It provides better predictability and safeguards for the environment and human health.

Amendment 1070

Christophe Clergeau

Proposal for a regulation

Annex I – point 2

Text proposed by the Commission

Amendment

(2) deletion of any number of nucleotides;

(2) deletion of target inversion of any number of nucleotides for the purpose of disrupting or abolishing gene function ; any novel (intended or unintended) gene function shall be excluded ;

Or. en

Amendment 1071

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Annex I – point 2

Text proposed by the Commission

Amendment

(2) deletion of any number of nucleotides;

(2) targeted deletion of any number of nucleotides;

Or. it

Amendment 1072

Christophe Clergeau

Proposal for a regulation

Annex I – point 3

Text proposed by the Commission

Amendment

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

deleted

(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;

Or. en

Justification

For a clear distinction between Category 1 and Category 2, NGT plants with DNA sequence existing in the breeder's gene pool should only be in Category 2

Amendment 1073

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Annex I – point 3

Text proposed by the Commission

Amendment

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

deleted

(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;

Or. en

Amendment 1074

Ondřej Knotek

Proposal for a regulation

Annex I – point 3 – introductory part

Text proposed by the Commission

Amendment

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

(3) on the condition that the genetic modification does not interrupt an endogenous gene or that the resulting DNA sequences context in the recipient plant already occurs in a species from the breeders’ gene pool :

Or. en

Amendment 1075

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Emma Wiesner, Ulrike Müller

Proposal for a regulation

Annex I – point 3 – introductory part

Text proposed by the Commission

Amendment

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

(3) on the condition that the genetic modification does not create a chimeric protein:

Or. en

Justification

Not only 'targeted' insertion should be allowed. EFSA has argued that non-targeted insertion of genes is equally safe (EFSA Journal, 2012, 10(2), 2561). Removing 'targeted' is however essential: as 'targeted' insertion is still extremely complex, maintaining this criterion would be detrimental for breeders, in particular for SMEs. Instead, there should be a provision requiring that the inserted gene does not end up within an existing gene in a way that creates a chimeric protein (or 'combined' protein). In short, deleting the notion of 'targeted' will improve the practical feasibility of the requirements set, while adding a requirement preventing the creation of chimeric protein will ensure the same level of protection and safety.

Amendment 1076

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Annex I – point 3 – point a

Text proposed by the Commission

Amendment

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

deleted

Or. en

Amendment 1077

Francesca Peppucci

Proposal for a regulation

Annex I – point 3 – point a

Text proposed by the Commission

Amendment

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

(a) targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool for reproductive purposes;

Or. en

Amendment 1078

Pietro Fiocchi

Proposal for a regulation

Annex I – point 3 – point a

Text proposed by the Commission

Amendment

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

(a) targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool; for reproductive purposes

Or. it

Amendment 1079

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Annex I – point 3 – point a

Text proposed by the Commission

Amendment

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

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

Or. it

Amendment 1080

Martin Häusling

Proposal for a regulation

Annex I – point 3 – point a

Text proposed by the Commission

Amendment

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

(a) targeted insertion of a contiguous DNA sequence existing within the species;

Or. en

Justification

Amendment 1081

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Annex I – point 3 – point a

Text proposed by the Commission

Amendment

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

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

Or. en

Amendment 1082

Pietro Fiocchi

Proposal for a regulation

Annex I – point 3 – point a

Text proposed by the Commission

Amendment

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

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

Or. en

Amendment 1083

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Emma Wiesner, Ondřej Knotek, Ulrike Müller

Proposal for a regulation

Annex I – point 3 – point a

Text proposed by the Commission

Amendment

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

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

Or. en

Justification

Not only 'targeted' insertion should be allowed. EFSA has argued that non-targeted insertion of genes is equally safe (EFSA Journal, 2012, 10(2), 2561). Removing 'targeted' is however essential: as 'targeted' insertion is still extremely complex, maintaining this criterium would be detrimental for breeders, in particular for SMEs. Instead, there should be a provision requiring that the inserted gene does not end up within an existing gene in a way that creates a chimeric protein (or 'combined' protein). In short, deleting the notion of 'targeted' will improve the practical feasibility of the requirements set, while adding a requirement preventing the creation of chimeric protein will ensure the same level of protection and safety.

Amendment 1084

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Annex I – point 3 – point b

Text proposed by the Commission

Amendment

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

deleted

Or. en

Amendment 1085

Martin Häusling

Proposal for a regulation

Annex I – point 3 – point b

Text proposed by the Commission

Amendment

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

(b) targeted substitution of an endogenous DNA sequence with a contiguous DNA sequence from the same species and where that sequence is derived from the same gene and where this sequence is not the result of a previous targeted or untargeted genetic modification.

Or. en

Justification

Given there is no history of safe use, these amendments to Annex I allow for better prediction of consequences and thus reduces the risks for human health and the environment whilst also allowing for gaining experience and data from/through placing on the market (requiring that the specific crop or food/feed product is being monitored and data collected).

Amendment 1086

Pietro Fiocchi

Proposal for a regulation

Annex I – point 3 – point b

Text proposed by the Commission

Amendment

(b) targeted substitution of an endogenous DNA sequence with 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 for reproductive purposes;

Or. it

Amendment 1087

Francesca Peppucci

Proposal for a regulation

Annex I – point 3 – point b

Text proposed by the Commission

Amendment

(b) targeted substitution of an endogenous DNA sequence with 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 for reproductive purposes;

Or. en

Amendment 1088

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Annex I – point 3 – point b

Text proposed by the Commission

Amendment

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

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

Or. en

Justification

There are multiple examples of cisgenesis being used to introduce beneficial traits. As long as the insertion does not result in the creation of an intragenic plant which would express a chimeric protein neither random introductions nor interruptions of endogenous genes by cisgenes should be excluded from Category 1. Excluding these applications from Annex I means less opportunities for developing beneficial traits by cisgene(s) in Category 1 (e.g. introduction of multiple disease resistant cisgenes to ensure durable resistance).

Amendment 1089

Ondřej Knotek

Proposal for a regulation

Annex I – point 3 – point b

Text proposed by the Commission

Amendment

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

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

Or. en

Amendment 1090

Pietro Fiocchi

Proposal for a regulation

Annex I – point 3 – point b

Text proposed by the Commission

Amendment

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

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

Or. en

Amendment 1091

Ondřej Knotek

Proposal for a regulation

Annex I – point 3 – point b a (new)

Text proposed by the Commission

Amendment

(ba) translocation of a continuous endogenous DNA sequence existing in the breeders’ gene pool;

Or. en

Amendment 1092

Erik Poulsen, Asger Christensen, Emma Wiesner

Proposal for a regulation

Annex I – point 3 a (new)

Text proposed by the Commission

Amendment

(3a) On the condition that NGTs are not used with the purpose of developing herbicide tolerant plants as described in recital 36;

Or. en

Amendment 1093

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Annex I – point 4

Text proposed by the Commission

Amendment

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

deleted

Or. en

Amendment 1094

Christophe Clergeau

Proposal for a regulation

Annex I – point 4

Text proposed by the Commission

Amendment

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

deleted

Or. en

Justification

For a clear distinction between Category 1 and Category 2, NGT plants with DNA sequence existing in the breeder's gene pool should only be in Category 2

Amendment 1095

Martin Häusling

Proposal for a regulation

Annex I – point 4

Text proposed by the Commission

Amendment

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

deleted

Or. en

Justification

Amendment 1096

Martin Häusling

Proposal for a regulation

Annex I – point 5

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Amendment 1097

Ondřej Knotek

Proposal for a regulation

Annex I – point 5

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1098

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Annex I – point 5

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

The point (5) was merged with point (3) for simplification. The wording/meaning of the point (5) is already covered in points (1) – (3).

Amendment 1099

Christophe Clergeau

Proposal for a regulation

Annex I – point 5

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

For a clear distinction between Category 1 and Category 2, NGT plants with DNA sequence existing in the breeder's gene pool should only be in Category 2

Amendment 1100

Pietro Fiocchi

Proposal for a regulation

Annex I – point 5

Text proposed by the Commission

Amendment

(5) any other 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 on the condition that the genetic modification does not interrupt an endogenous gene.

Or. en

Amendment 1101

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Annex I – point 5

Text proposed by the Commission

Amendment

Or. en

Amendment 1102

Francesca Peppucci

Proposal for a regulation

Annex I – point 5

Text proposed by the Commission

Amendment

Or. en

Amendment 1103

Pietro Fiocchi

Proposal for a regulation

Annex I – point 5

Text proposed by the Commission

Amendment

Or. it

Amendment 1104

Günther Sidl

Proposal for a regulation

Annex II – subheading 1

Text proposed by the Commission

Amendment

Risk assessment of category 2 NGT plants and category 2 NGT food and feed

Risk assessment of NGT plants and NGT food and feed

Or. en

Amendment 1105

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex II – subheading 1

Text proposed by the Commission

Amendment

Risk assessment of category 2 NGT plants and category 2 NGT food and feed

Risk assessment of NGT plants and NGT food and feed

Or. en

Amendment 1106

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex II – paragraph 1

Text proposed by the Commission

Amendment

Part 1 of this Annex describes the general principles to be followed to perform the environmental risk assessment of category 2 NGT plants referred to in Article 13, points (c) and (d), Article 14(1), point (e), and Article 19(3), point (a), and the safety assessment of category 2 NGT food and feed referred to in Article 19(1), point (b). Part 2 describes specific information for the environmental risk assessment of category 2 NGT plants and Part 3 describes specific information for the safety assessment of category 2 NGT food and feed.

Part 1 of this Annex describes the general principles to be followed to perform the environmental risk assessment of NGT plants referred to in Article 13, points (c) and (d), Article 14(1), point (e), and Article 19(3), point (a), and the safety assessment of NGT food and feed referred to in Article 19(1), point (b). Part 2 describes specific information for the environmental risk assessment of NGT plants and Part 3 describes specific information for the safety assessment of NGT food and feed.

Or. en

Amendment 1107

Günther Sidl

Proposal for a regulation

Annex II – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1108

Günther Sidl

Proposal for a regulation

Annex II – Part 1 – paragraph 1

Text proposed by the Commission

Amendment

The environmental risk assessment shall be carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC.

The environmental risk assessment shall be carried out in accordance with the precautionary principle and the principles set out in Annex II to Directive 2001/18/EC.

Or. en

Amendment 1109

Martin Häusling

Proposal for a regulation

Annex II – Part 1 – paragraph 1

Text proposed by the Commission

Amendment

The environmental risk assessment shall be carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC.

The environmental risk assessment shall be carried out in accordance with the precautionary principle and the principles set out in Annex II to Directive 2001/18/EC.

Or. en

Amendment 1110

Martin Häusling

Proposal for a regulation

Annex II – Part 1 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

The type and amount of information necessary for the environmental risk assessment of category 2 NGT plants laid down in Annex III of Directive 2001/18/EC and for the food and feed safety assessment of category 2 NGT food and feed shall be adapted to their risk profile. Factors to be considered include:

The type and amount of information necessary for the environmental risk assessment of category 2 NGT plants and for the food and feed safety assessment of category 2 NGT food is laid down in Annex III of Directive 2001/18/EC. Factors to be covered by the risk assessment include:

Or. en

Amendment 1111

Günther Sidl

Proposal for a regulation

Annex II – Part 1 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

The type and amount of information necessary for the environmental risk assessment of NGT plants laid down in Annex III of Directive 2001/18/EC and for the food and feed safety assessment of NGT food and feed shall be adapted to their risk profile. Factors to be considered include:

Or. en

Amendment 1112

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex II – Part 1 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

The type and amount of information necessary for the environmental risk assessment of NGT plants laid down in Annex III of Directive 2001/18/EC and for the food and feed safety assessment of NGT food and feed could be adapted to their risk profile. Factors to be considered include:

Or. en

Amendment 1113

Günther Sidl

Proposal for a regulation

Annex II – Part 1 – paragraph 2 – point a a (new)

Text proposed by the Commission

Amendment

(aa) characteristics of the recipient plant (i.a. allergenicity; potential for gene flow; weed potential; ecological function);

Or. en

Amendment 1114

Günther Sidl

Proposal for a regulation

Annex II – Part 1 – paragraph 2 – point a b (new)

Text proposed by the Commission

Amendment

(ab) long safety record of the recipient plant;

Or. en

Amendment 1115

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex II – Part 1 – paragraph 2 – point e a (new)

Text proposed by the Commission

Amendment

(ea) The cultivation in the European Union of similar non-GMO plants and the risks of cross-contamination;

Or. en

Amendment 1116

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex II – Part 1 – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

The environmental risk assessment of category 2 NGT plants and the risk assessment of category 2 NGT food and NGT feed shall consist of the following:

The environmental risk assessment of NGT plants and the risk assessment of NGT food and NGT feed shall consist of the following:

Or. en

Amendment 1117

Günther Sidl

Proposal for a regulation

Annex II – Part 1 – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

The environmental risk assessment of category 2 NGT plants and the risk assessment of category 2 NGT food and NGT feed shall consist of the following:

The environmental risk assessment of NGT plants and the risk assessment of NGT food and NGT feed shall consist of the following:

Or. en

Amendment 1118

Günther Sidl

Proposal for a regulation

Annex II – Part 1 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) hazard identification and characterisation;

(a) problem formulation including hazard identification and hazard characterisation;

Or. en

Amendment 1119

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex II – Part 1 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) hazard identification and characterisation;

(a) problem formulation including hazard identification and characterisation;

Or. en

Amendment 1120

Martin Häusling

Proposal for a regulation

Annex II – Part 1 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) hazard identification and characterisation;

(a) problem formulation including hazard identification and

Or. en

Justification

Taken from current EFSA guidance on ERA of GMO (EFSA 2010)

Amendment 1121

Günther Sidl

Proposal for a regulation

Annex II – Part 1 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) exposure assessment;

(b) exposure characterisation and assessment;

Or. en

Amendment 1122

Martin Häusling

Proposal for a regulation

Annex II – Part 1 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) exposure assessment;

(b) exposure characterisation and assessment;

Or. en

Amendment 1123

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex II – Part 1 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) exposure assessment;

(b) exposure characterisation and assessment

Or. en

Amendment 1124

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex II – Part 1 – paragraph 3 – point c a (new)

Text proposed by the Commission

Amendment

(ca) socio-economic assessment of the consequences of cross-contamination of the NGT plant to non-GMO plants and products thereof

Or. en

Amendment 1125

Günther Sidl

Proposal for a regulation

Annex II – Part 1 – paragraph 3 – point c a (new)

Text proposed by the Commission

Amendment

(ca) risk management strategies

Or. en

Amendment 1126

Martin Häusling

Proposal for a regulation

Annex II – Part 1 – paragraph 3 – point c a (new)

Text proposed by the Commission

Amendment

(ca) risk management strategies

Or. en

Amendment 1127

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex II – Part 1 – paragraph 3 – point c b (new)

Text proposed by the Commission

Amendment

(cb) risk management strategies

Or. en

Amendment 1128

Martin Häusling

Proposal for a regulation

Annex II – Part 1 – paragraph 3 – point c b (new)

Text proposed by the Commission

Amendment

(cb) overall risk evaluation

Or. en

Amendment 1129

Günther Sidl

Proposal for a regulation

Annex II – Part 1 – paragraph 3 – point c b (new)

Text proposed by the Commission

Amendment

(cb) overall evaluation

Or. en

Amendment 1130

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex II – Part 1 – paragraph 3 – point c c (new)

Text proposed by the Commission

Amendment

(cc) overall risk evaluation

Or. en

Amendment 1131

Martin Häusling

Proposal for a regulation

Annex II – Part 1 – paragraph 4 – point a – introductory part

Text proposed by the Commission

Amendment

(a) hazard identification and characterisation

(a) problem formulation, hazard identification and characterisation

Or. en

Amendment 1132

Günther Sidl

Proposal for a regulation

Annex II – Part 1 – paragraph 4 – point a – introductory part

Text proposed by the Commission

Amendment

(a) hazard identification and characterisation

(a) problem formulation, hazard identification and characterisation

Or. en

Amendment 1133

Martin Häusling

Proposal for a regulation

Annex II – Part 1 – paragraph 4 – point a – point i a (new)

Text proposed by the Commission

Amendment

(ia) information relating to the recipient plant or, where appropriate, to the parental plants;

Or. en

Amendment 1134

Martin Häusling

Proposal for a regulation

Annex II – Part 1 – paragraph 4 – point a – point i b (new)

Text proposed by the Commission

Amendment

(ib) information relating to the genetic modification and their intended effects

Or. en

Amendment 1135

Günther Sidl

Proposal for a regulation

Annex II – Part 1 – paragraph 4 – point a – point i a (new)

Text proposed by the Commission

Amendment

(ia) information relating to the genetic modification and their intended effects

Or. en

Amendment 1136

Günther Sidl

Proposal for a regulation

Annex II – Part 1 – paragraph 4 – point a – point ii

Text proposed by the Commission

Amendment

(ii) molecular characterisation.

(ii) molecular characterisation to check for intended and unintended effects.

The information shall be provided by collating already available data from scientific literature or from other sources or generating scientific data where necessary by performing appropriate experimental and bioinformatic studies.

Or. en

Amendment 1137

Martin Häusling

Proposal for a regulation

Annex II – Part 1 – paragraph 4 – point a – point ii

Text proposed by the Commission

Amendment

(ii) molecular characterisation.

(ii) molecular characterisation to check for intended and unintended effects. The information shall be provided by collating already available data from scientific literature or from other sources or generating scientific data where necessary by performing appropriate experimental and bioinformatic studies.

Or. en

Amendment 1138

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex II – Part 1 – paragraph 4 – point a – paragraph 1

Text proposed by the Commission

Amendment

The information shall be provided by collating already available data from scientific literature and from other sources, generating scientific data where necessary by performing appropriate experimental or bioinformatic studies.

Or. en

Amendment 1139

Martin Häusling

Proposal for a regulation

Annex II – Part 1 – paragraph 4 – point b – paragraph 1

Text proposed by the Commission

Amendment

Information shall be provided on the likelihood of each identified potential adverse effect. This shall be evaluated taking into consideration, as relevant, the characteristics of the receiving environment(s), the intended function, the dietary role, the expected level of use of the food and feed in the EU and the scope of the application for authorisation.

Information shall be provided to cover all relevant exposure routes to humans, livestock, and the environment. Exposure on the likelihood of each identified potential adverse effect. This shall be evaluated taking into consideration, as relevant, the characteristics of the receiving environment(s), the intended function, the dietary role, the expected level of use of the food and feed in the EU and the scope of the application for authorisation.

Or. en

Amendment 1140

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex II – Part 1 – paragraph 4 – point b – paragraph 1

Text proposed by the Commission

Amendment

Information shall be provided on the likelihood of each identified potential adverse effect, for all expose routes to humans, animals and the environment. This shall be evaluated taking into consideration the characteristics of the receiving environment(s), the intended function, the dietary role, the expected level of use of the food and feed in the EU and the scope of the application for authorisation.

Or. en

Amendment 1141

Günther Sidl

Proposal for a regulation

Annex II – Part 1 – paragraph 4 – point b – paragraph 1

Text proposed by the Commission

Amendment

Information shall be provided to cover all relevant exposure routes to humans, livestock, and the environment. Exposure shall be evaluated taking into consideration, the characteristics of the receiving environment(s), the intended function, the dietary role, the expected level of use of the food and feed in the EU and the scope of the application for authorisation.

Or. en

Amendment 1142

Günther Sidl

Proposal for a regulation

Annex II – Part 1 – paragraph 4 – point c – paragraph 1

Text proposed by the Commission

Amendment

The applicant shall base its risk characterisation of NGT plants and foods and feed on information from hazard identification, hazard characterisation and exposure assessment. The risk shall be characterised by combining, for each potential adverse effect, the magnitude with the likelihood of that adverse effect occurring to provide a quantitative or semi quantitative estimation of the risk. Where relevant, the uncertainty for each identified risk shall be described.

The applicant shall base its risk characterisation of NGT plants and foods and feed on information from hazard identification, hazard characterisation and exposure assessment. The risk shall for each protection goal (including specific protection goals) be characterised by combining, for each potential adverse effect, the magnitude with the likelihood of that adverse effect occurring to provide a quantitative or semi quantitative estimation of the risk and the uncertainties associated with this estimate.

Or. en

Justification

According to 2001/18/EC: It is important not to discount any potential adverse effect on the basis that it is unlikely to occur. According to EFSA uncertainties ALWAYS are part of the risk assessment (see EFSA 2018: Guidance on Uncertainty Analysis in Scientific Assessments https://doi.org/10.2903/j.efsa.2018.5123; EFSA 2019:Guidance on Communication of Uncertainty in Scientific Assessments, https://doi.org/10.2903/j.efsa.2019.5520)According to EFSA uncertainties ALWAYS are part of the risk assessment (see EFSA 2018: Guidance on Uncertainty Analysis in Scientific Assessments https://doi.org/10.2903/j.efsa.2018.5123; EFSA 2019:Guidance on Communication of Uncertainty in Scientific Assessments, https://doi.org/10.2903/j.efsa.2019.5520)

Amendment 1143

Martin Häusling

Proposal for a regulation

Annex II – Part 1 – paragraph 4 – point c – paragraph 1

Text proposed by the Commission

Amendment

The applicant shall base its risk characterisation of NGT plants and foods and feed on information from hazard identification, hazard characterisation and exposure assessment. The risk shall for each protection goal (including specific protection goals) be characterised by combining, for each potential adverse effect, the magnitude with the likelihood of that adverse effect occurring to provide a quantitative or semi quantitative estimation of the risk and the uncertainties associated with this estimate.

Or. en

Justification

According to 2001/18/EC: It is important not to discount any potential adverse effect on the basis that it is unlikely to occur. According to EFSA guidance, uncertainties are always part of the risk assessment (see EFSA 2018: Guidance on Uncertainty Analysis in Scientific Assessments https://doi.org/10.2903/j.efsa.2018.5123 and EFSA 2019:

Guidance on Communication of Uncertainty in Scientific Assessments, https://doi.org/10.2903/j.efsa.2019.5520)

Amendment 1144

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex II – Part 1 – paragraph 4 – point c – paragraph 1

Text proposed by the Commission

Amendment

The applicant shall base its risk characterisation of NGT plants and foods and feed on information from hazard identification, hazard characterisation and exposure assessment. The risk shall be characterised by combining, for each potential adverse effect and for each specific protection goal, the magnitude with the likelihood of that adverse effect occurring to provide a quantitative or semi quantitative estimation of the risk. The uncertainty for each identified risk shall be described.

Or. en

Amendment 1145

Christophe Clergeau

Proposal for a regulation

Annex II – Part 1 – paragraph 5

Text proposed by the Commission

Amendment

Any information on hazard identification and characterisation specified under Parts 2 and 3 shall only be required if the specific characteristics and the intended use of the category 2 NGT plant or category 2 NGT food or feed give rise to a plausible risk hypothesis that can be addressed utilising the specified information.

deleted

Or. en

Amendment 1146

Günther Sidl

Proposal for a regulation

Annex II – Part 1 – paragraph 5

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1147

Martin Häusling

Proposal for a regulation

Annex II – Part 1 – paragraph 5

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Comprehensive information on hazard identification and characterisation is essential in order to plan and perform a thorough risk assessment and thus to uphold the precautionary principle.

Amendment 1148

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex II – Part 1 – paragraph 5

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1149

Günther Sidl

Proposal for a regulation

Annex II – Part 2 – title

Text proposed by the Commission

Amendment

2 Specific information for the environmental risk assessment of category 2 NGT plants concerning hazard identification and characterisation

2 Specific information for the environmental risk assessment of NGT plants concerning hazard identification and characterisation

Or. en

Amendment 1150

Günther Sidl

Proposal for a regulation

Annex II – Part 2 – point 1

Text proposed by the Commission

Amendment

(1) Analysis of agronomic, phenotypic and compositional characteristics

(1) Analysis of agronomic, phenotypic and compositional characteristics according to Annex II of Directive 2001/18/EC

Or. en

Amendment 1151

Martin Häusling

Proposal for a regulation

Annex II – Part 2 – point 1

Text proposed by the Commission

Amendment

(1) Analysis of agronomic, phenotypic and compositional characteristics

(1) Analysis of agronomic, phenotypic and compositional characteristics according to Annex II of Directive 2001/18/EC

Or. en

Amendment 1152

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex II – Part 2 – point 6 a (new)

Text proposed by the Commission

Amendment

(6a) Impacts on organic cultivation

Or. en

Amendment 1153

Günther Sidl

Proposal for a regulation

Annex II – Part 2 – point 8

Text proposed by the Commission

Amendment

(8) Effects on human and animal health

(8) Effects on human, animal health and the food and feed chain

Or. en

Amendment 1154

Martin Häusling

Proposal for a regulation

Annex II – Part 2 – point 8

Text proposed by the Commission

Amendment

(8) Effects on human and animal health

(8) Effects on human, animal health and the food and feed chain

Or. en

Amendment 1155

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

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

Or. en

Amendment 1156

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex II – Part 2 – point 8 b (new)

Text proposed by the Commission

Amendment

(8b) Effects on protecting ecologically sensitive areas

Or. en

Amendment 1157

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex II – Part 2 – point 8 c (new)

Text proposed by the Commission

Amendment

(8c) Socio-economic effects on the food chain

Or. en

Amendment 1158

Günther Sidl

Proposal for a regulation

Annex II – Part 3 – title

Text proposed by the Commission

Amendment

3 Specific information for the environmental risk assessment of category 2 NGT plants concerning hazard identification and characterisation

3 Specific information for the safety assessment of NGT food and feed concerning hazard identification and characterisation

Or. en

Amendment 1159

Martin Häusling

Proposal for a regulation

Annex II – Part 3 – point 1 a (new)

Text proposed by the Commission

Amendment

(1a) Analysis of potential for persistence and invasiveness resulting from transport, loss, and spillage

Or. en

Amendment 1160

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex II – Part 3 – point 1 a (new)

Text proposed by the Commission

Amendment

(1a) Analysis of the potential for persistence and invasiveness resulting from transport, loss, and spillage

Or. en

Amendment 1161

Günther Sidl

Proposal for a regulation

Annex II – Part 3 – point 1 a (new)

Text proposed by the Commission

Amendment

(1a) Analysis of potential for persistence and invasiveness resulting from transport, loss, and spillage

Or. en

Amendment 1162

Martin Häusling

Proposal for a regulation

Annex II – Part 3 – point 2

Text proposed by the Commission

Amendment

(2) Toxicology

(2) Ecotoxicology and Toxicology

Or. en

Amendment 1163

Günther Sidl

Proposal for a regulation

Annex II – Part 3 – point 2

Text proposed by the Commission

Amendment

(2) Toxicology

(2) Ecotoxicology and Toxicology

Or. en

Amendment 1164

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex II – Part 3 – point 2

Text proposed by the Commission

Amendment

(2) Toxicology

(2) Toxicology and ecotoxicology

Or. en

Amendment 1165

Martin Häusling

Proposal for a regulation

Annex II – Part 3 – point 4

Text proposed by the Commission

Amendment

(4) Nutritional assessment

(4) Nutritional assessment, including impacts on human and animal microbiomes

Or. en

Amendment 1166

Pascal Canfin, Max Orville

Proposal for a regulation

Annex III – subheading 1

Text proposed by the Commission

Amendment

Traits referred to in Article 22

Traits referred to in Article 6 and Article 22

Or. en

Amendment 1167

Günther Sidl

Proposal for a regulation

Annex III – subheading 1

Text proposed by the Commission

Amendment

Traits referred to in Article 22

Traits referred to in Article 3 and 22

Or. en

Amendment 1168

Martin Häusling

Proposal for a regulation

Annex III – Part 1

Text proposed by the Commission

Amendment

1 Traits justifying the incentives referred to in Article 22:

deleted

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

(2) tolerance/resistance to biotic stresses, including plant diseases caused by nematodes, fungi, bacteria, viruses and other pests;

(3) tolerance/resistance to abiotic stresses, including those created or exacerbated by climate change;

(4) more efficient use of resources, such as water and nutrients;

(5) characteristics that enhance the sustainability of storage, processing and distribution;

(6) improved quality or nutritional characteristics;

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

Or. en

Amendment 1169

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Emma Wiesner, Andreas Glueck, Ulrike Müller

Proposal for a regulation

Annex III – Part 1 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Traits justifying the incentives referred to in Article 22:

Traits justifying the incentives referred to in Article 22 are listed in Article 52(1) of Regulation (EU) 2023/0227.

Or. en

Justification

For the sake of consistency, the sustainability assessment should be in line with Regulation of Plant Reproductive Material, which establishes the sustainability requirements for all types of Plant Reproductive Material.

Amendment 1170

María Soraya Rodríguez Ramos, Michal Wiezik

Proposal for a regulation

Annex III – Part 1 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Traits justifying the incentives referred to in Article 22:

Traits justifying the incentives referred to in Article 22, provided that such trait has been identified in the risk assessment:

Or. en

Amendment 1171

Pascal Canfin, Max Orville

Proposal for a regulation

Annex III – Part 1 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Traits justifying the incentives referred to in Article 22:

Traits justifying the qualification as category 1 NGT the incentives referred to in Article 22:

Or. en

Amendment 1172

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Emma Wiesner, Andreas Glueck, Ulrike Müller

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;

deleted

Or. en

Justification

Deletion in line with amendments aligning the sustainability assessment in this Regulation with the Regulation of Plant Reproductive Material.

Amendment 1173

Pascal Canfin, Max Orville

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 this traits also contributes to either point (2), (3) or (4) of this Annex;

Or. en

Amendment 1174

Günther Sidl

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 can justify incentives when combined with another trait or other traits under (2)-(7);

Or. en

Amendment 1175

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Emma Wiesner, Andreas Glueck, Ulrike Müller

Proposal for a regulation

Annex III – Part 1 – paragraph 1 – point 2

Text proposed by the Commission

Amendment

(2) tolerance/resistance to biotic stresses, including plant diseases caused by nematodes, fungi, bacteria, viruses and other pests;

deleted

Or. en

Justification

Deletion in line with amendments aligning the sustainability assessment in this Regulation with the Regulation of Plant Reproductive Material.

Amendment 1176

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Emma Wiesner, Andreas Glueck, Ulrike Müller

Proposal for a regulation

Annex III – Part 1 – paragraph 1 – point 3

Text proposed by the Commission

Amendment

(3) tolerance/resistance to abiotic stresses, including those created or exacerbated by climate change;

deleted

Or. en

Justification

Deletion in line with amendments aligning the sustainability assessment in this Regulation with the Regulation of Plant Reproductive Material.

Amendment 1177

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Annex III – Part 1 – paragraph 1 – point 3

Text proposed by the Commission

Amendment

(3) tolerance/resistance to abiotic stresses, including those created or exacerbated by climate change;

(3) tolerance/resistance to abiotic stresses, including those created or exacerbated by climate change conditions;

Or. en

Amendment 1178

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Annex III – Part 1 – paragraph 1 – point 3

Text proposed by the Commission

Amendment

(3) tolerance/resistance to abiotic stresses, including those created or exacerbated by climate change;

(3) tolerance/resistance to abiotic stresses, including those created or exacerbated by climate change conditions;

Or. en

Amendment 1179

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Emma Wiesner, Andreas Glueck, Ulrike Müller

Proposal for a regulation

Annex III – Part 1 – paragraph 1 – point 4

Text proposed by the Commission

Amendment

(4) more efficient use of resources, such as water and nutrients;

deleted

Or. en

Justification

Deletion in line with amendments aligning the sustainability assessment in this Regulation with the Regulation of Plant Reproductive Material.

Amendment 1180

Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex III – Part 1 – paragraph 1 – point 4

Text proposed by the Commission

Amendment

(4) more efficient use of resources, such as water and nutrients;

(4) evidence-based more efficient use of resources, such as water and nutrients;

Or. en

Amendment 1181

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Emma Wiesner, Andreas Glueck, Ulrike Müller

Proposal for a regulation

Annex III – Part 1 – paragraph 1 – point 5

Text proposed by the Commission

Amendment

(5) characteristics that enhance the sustainability of storage, processing and distribution;

deleted

Or. en

Justification

Deletion in line with amendments aligning the sustainability assessment in this Regulation with the Regulation of Plant Reproductive Material.

Amendment 1182

Pascal Canfin, Max Orville

Proposal for a regulation

Annex III – Part 1 – paragraph 1 – point 5

Text proposed by the Commission

Amendment

(5) characteristics that enhance the sustainability of storage, processing and distribution;

deleted

Or. en

Amendment 1183

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Emma Wiesner, Andreas Glueck, Ulrike Müller

Proposal for a regulation

Annex III – Part 1 – paragraph 1 – point 6

Text proposed by the Commission

Amendment

(6) improved quality or nutritional characteristics;

deleted

Or. en

Justification

Deletion in line with amendments aligning the sustainability assessment in this Regulation with the Regulation of Plant Reproductive Material.

Amendment 1184

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Emma Wiesner, Andreas Glueck, Ulrike Müller

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.

deleted

Or. en

Justification

Deletion in line with amendments aligning the sustainability assessment in this Regulation with the Regulation of Plant Reproductive Material.

Amendment 1185

Günther Sidl

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.

Or. en

Amendment 1186

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

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) a proven reduced need for external inputs, such as chemical pesticides and fertilisers.

Or. en

Amendment 1187

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Annex III – Part 2

Text proposed by the Commission

Amendment

2 Traits excluding the application of the incentives referred to in Article 22: tolerance to herbicides.

deleted

Or. en

Justification

Herbicide tolerant genes exist in nature. Herbicide tolerant plants intentionally bred to be tolerant to herbicides when used properly allow for a reduction in the use of herbicides. This trait should not be considered unsustainable. The sustainability criteria set in Annex III must be harmonised between NGT and PRM regulations.

Amendment 1188

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Annex III – Part 2 – paragraph 1

Text proposed by the Commission

Amendment

Traits excluding the application of the incentives referred to in Article 22: tolerance to herbicides.

Traits excluding the application of the incentives referred to in Article 22:

- tolerance to herbicides,

- tolerance to antimicrobials,

- plants containing the endospore (or crystal) toxins of the Bacillus thuringiensis (Bt) be resistant to certain insect pests

- patents on the plant, trait(s) or technique used,

Or. en

Amendment 1189

Martin Häusling

Proposal for a regulation

Annex III – Part 2 – paragraph 1

Text proposed by the Commission

Amendment

Traits excluding the application of the incentives referred to in Article 22: tolerance to herbicides.

Traits leading to exclusion from NGT category 1: tolerance to herbicides, higher use in pesticides, higher use in fertilizers, antimicrobial resistance (including through the use of antibiotic marker genes), higher greenhouse gas emissions, higher susceptibility to plant diseases, potential invasiveness, lack of spatio-temporal control.

Or. en

Amendment 1190

Christophe Clergeau

Proposal for a regulation

Annex III – Part 2 – paragraph 1

Text proposed by the Commission

Amendment

Traits excluding the application of the incentives referred to in Article 22: tolerance to herbicides.

Traits excluding the application of the incentives referred to in Article 22:

- tolerance to herbicides

- plants producing insecticides and pesticides

Or. en

Amendment 1191

Pascal Canfin, Max Orville

Proposal for a regulation

Annex III – Part 2 – paragraph 1

Text proposed by the Commission

Amendment

Traits excluding the application of the incentives referred to in Article 22: tolerance to herbicides.

Traits excluding the qualification as category 1 NGT referred in Article 6 and the application of the incentives referred to in Article 22: tolerance to plant protection products.

Or. en

Amendment 1192

Günther Sidl

Proposal for a regulation

Annex III – Part 2 – paragraph 1

Text proposed by the Commission

Amendment

Traits excluding the application of the incentives referred to in Article 22: tolerance to herbicides.

Traits excluding the application of the incentives referred to in Article 22: tolerance to herbicides, plants producing insecticides, pesticides.

Or. en

Amendment 1193

Christophe Clergeau

Proposal for a regulation

Annex III a (new)

Text proposed by the Commission

Amendment

ANNEX IIIa

In-door safety assessment

A Cat.1 NGT plant is considered safe, without having to go through field trials, if the following confined experiments have been undertaken and provide evidence that:

(1) the whole genome sequencing and profiling shows the intended and unintended genetic modifications have not adversely modified the function of one or more genes; and

(2) the whole transcriptome sequencing realized on the relevant part of the plant shows the intended and unintended genetic modifications have not adversely modified biochemical pathways, leading in particular to adverse compositional consequences, verified e.g. through gene ontology analysis; and

(3) biochemical metabolite (metabolomics) and protein (proteomics) profiling realized on the relevant part of the plant shows the intended and unintended genetic modifications have not induced an increase in the levels of known toxins or allergens or the production by the plant of toxic or allergenic novel biochemicals or proteins for the plant itself, any other forms of life it is known to interact with or bound to consume it.

Or. en

Justification

This amendment adds a proper “in-door safety assessment” to the Cat.1 NGT plants regime, by requiring safety data on the consequences of intended and unintended genetic modifications. These data may come from laboratory confined experiments only. These provisions are much lighter than the actual GMO regime insofar they allow for an exemption to perform field trials.