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 539

Pascal Canfin, Max Orville

Proposal for a regulation

Article 6 – paragraph 3 – point d – point ii

Text proposed by the Commission

Amendment

(ii) the NGT plant meets the criteria set out in Annex I;

(ii) the NGT plant meets the criteria set out in Annex I, at least one of the traits in Annex III part 1 and the criteria of Annex III part 2;

Or. en

Amendment 540

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 6 – paragraph 3 – point d – point ii

Text proposed by the Commission

Amendment

(ii) the NGT plant meets the criteria set out in Annex I;

(ii) the NGT plant is equivalent to plants derived from conventional breeding methods or natural processes based on the data collected from in-door risk assessment;

Or. en

Amendment 541

Christophe Clergeau

Proposal for a regulation

Article 6 – paragraph 3 – point d – point ii a (new)

Text proposed by the Commission

Amendment

(iia) the results of the in-door safety assessment set out in Annex IV.

Or. en

Amendment 542

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 3 – point d a (new)

Text proposed by the Commission

Amendment

(da) a declaration from the applicant that there are:

(i) no patents or exclusive rights covering the process used to develop the plant,

(ii) no patents or exclusive rights covering the plant or parts thereof, and

(iii) no application has been tabled for such patents or exclusive rights to be granted;

Or. en

Justification

The Commission proposal aims to facilitate the commercialisation of NGT plants in Europe. In the absence of specific safeguards, this could lead to an increased number of patented seeds in the EU.

As a result, breeders and farmers could find themselves at a heightened risk of legal action from NGT developers if they inadvertently use their patented genetic sequences.

Specifically with regards to CRISPRC/Cas products, researchers have warned of a "patent thicket" that could be extremely hard to navigate for the majority of plant breeders and farmers.

In September 2019, the European Parliament called for “free access to plant material (including plant traits)” saying this was “absolutely essential for the innovative capacity of the European plant-breeding and farming sectors, their competitiveness and the development of new plant varieties in order to guarantee global food security, tackle climate change and prevent monopolies within the breeding sector” and warning that “any restriction or attempt to hamper access to genetic resources may lead to an excessive market concentration in the field of plant breeding, to the detriment of market competition, consumers and the European internal market and food security”(https://www.europarl.europa.eu/doceo/document/TA-9-2019-0020_EN.html)

This amendment, in line with the Parliament’s position, aims to ensure that the NGT Regulation will not hamper free access to plant material for farmers and plant breeders.

Amendment 543

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 3 – point d b (new)

Text proposed by the Commission

Amendment

(db) whether the NGT plant fits the criteria of a novel food and is therefore subject to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, and if so, that the requirements of Regulation (EU) 2015/2283 have been fulfilled;

Or. en

Amendment 544

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 3 – point d c (new)

Text proposed by the Commission

Amendment

(dc) a declaration that the deliberate release would not be in breach of the Cartegena Protocol on biosafety under the UN convention on biological diversity, and a description of how the requirements are fulfilled;

Or. en

Amendment 545

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 3 – point d d (new)

Text proposed by the Commission

Amendment

(dd) submission of a reference material and a validated detection method;

Or. en

Amendment 546

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 3 – point e

Text proposed by the Commission

Amendment

(e) in the cases referred to in paragraph 2, an indication of the Member States in which the requester intends to undertake the deliberate release;

deleted

Or. en

Justification

There should not be the possibility that applicants target the least strict or most over-burdened Member State competent authorities.

Amendment 547

Christophe Clergeau

Proposal for a regulation

Article 6 – paragraph 3 – point e

Text proposed by the Commission

Amendment

(e) in the cases referred to in paragraph 2, an indication of the Member States in which the requester intends to undertake the deliberate release;

deleted

Or. en

Amendment 548

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 6 – paragraph 3 – point e

Text proposed by the Commission

Amendment

(e) in the cases referred to in paragraph 2, an indication of the Member States in which the requester intends to undertake the deliberate release;

deleted

Or. en

Amendment 549

Christophe Clergeau

Proposal for a regulation

Article 6 – paragraph 3 – point e a (new)

Text proposed by the Commission

Amendment

(ea) an environmental risk assessment carried out in accordance with the principles and criteria set out in Parts 1 and 2 of Annex II and with the implementing act adopted in accordance with Article 27, point (c);

Or. en

Amendment 550

Christophe Clergeau

Proposal for a regulation

Article 6 – paragraph 3 – point e b (new)

Text proposed by the Commission

Amendment

(eb) a monitoring plan for environmental effects as mentioned in Parts 1 and 2 of Annex II;

Or. en

Amendment 551

Christophe Clergeau

Proposal for a regulation

Article 6 – paragraph 3 – point e c (new)

Text proposed by the Commission

Amendment

(ec) methods for sampling (including references to existing official or standardised sampling methods, e.g. genetic markers or PCR primers), detection, identification and quantification of the NGT plant. 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;

Or. en

Amendment 552

Christophe Clergeau

Proposal for a regulation

Article 6 – paragraph 3 – point e d (new)

Text proposed by the Commission

Amendment

(ed) samples of the category 1 NGT plant and their control samples, and information as to the place where the reference material can be accessed;

Or. en

Amendment 553

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 3 – point f

Text proposed by the Commission

Amendment

(f) an identification of the parts of the verification request and any other supplementary information that the requester demands to be treated as confidential, accompanied by verifiable justification, pursuant to Article 11 of this Regulation and Article 39 of Regulation (EC) No 178/2002.

deleted

Or. en

Amendment 554

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 3 – point f

Text proposed by the Commission

Amendment

(f) an identification of the parts of the authorisation request and any other supplementary information that the requester demands to be treated as confidential, accompanied by verifiable justification, pursuant to Article 39 of Regulation (EC) No 178/2002.

Or. en

Amendment 555

Christophe Clergeau

Proposal for a regulation

Article 6 – paragraph 3 – point f a (new)

Text proposed by the Commission

Amendment

(fa) a declaration on the non-applicability of Regulation (EU) 2015/2283 of 25 November 2015 on novel foods, or on the correct application of possible obligations arising from this Regulation;

Or. en

Amendment 556

Christophe Clergeau

Proposal for a regulation

Article 6 – paragraph 3 – point f b (new)

Text proposed by the Commission

Amendment

(fb) any other relevant information relating to the file, including possible refusal, withdrawal or acceptance of previous requests or national or European decisions;

Or. en

Amendment 557

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 5

Text proposed by the Commission

Amendment

5. If the verification request does not contain all the necessary information, it shall be declared inadmissible by the competent authority within 30 working days within the date of receipt of a verification request. The competent authority shall inform the requester, the other Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.

5. Within 60 working days from the date of receipt of an authorisation request, the competent authority shall declare whether the authorisation request is admissible, or whether in the absence of the necessary information required pursuant to paragraph 3, it is inadmissible. The competent authority shall inform the requester, the other Member States and the Commission of its decision without undue delay of the inadmissibility of the authorisation request and shall provide the reasons of its decision.

Or. en

Amendment 558

Christophe Clergeau

Proposal for a regulation

Article 6 – paragraph 5

Text proposed by the Commission

Amendment

5. If the verification request does not contain all the necessary information, it shall be declared inadmissible by the competent authority within 2 months within the date of receipt of a verification request. The competent authority shall inform the requester, the other Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.

Or. en

Amendment 559

Christophe Clergeau

Proposal for a regulation

Article 6 – paragraph 6

Text proposed by the Commission

Amendment

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

6. If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and Annex IV. For that purpose, the competent authority shall forward the request to the European Food Safety Authority (“The Authority”) without undue delay. Within 6 months, the Authority shall make a statement on whether the plant is a NGT plant fulfilling the criteria set out in Annex I, including whether it contains any genetic material originating from outside the breeders’ gene pool. The statement shall be forwarded to all Member States, to the Commission, and shall be made public. After receiving this statement, the competent authority shall prepare a verification report within 3 months from the date of receipt of the verification request. The competent authority shall make available the verification report to the other Member States and to the Commission without undue delay.

Or. en

Amendment 560

Ondřej Knotek

Proposal for a regulation

Article 6 – paragraph 6

Text proposed by the Commission

Amendment

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

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

Or. en

Amendment 561

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Article 6 – paragraph 6

Text proposed by the Commission

Amendment

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

6. If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and prepare a verification report within 30 working days from the date of receipt of a verification request. The competent authority asks the European Food Safety Authority (‘the Authority’) for scientific opinion on the verification report and shall make it available to the other Member States and to the Commission without undue delay.

Or. en

Amendment 562

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 6

Text proposed by the Commission

Amendment

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

6. If the verification request is not deemed admissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in paragraph 3 and prepare a authorisation report within 60 working days from the date on which it has informed the Member States and Commission of its decision pursuant to paragraph 5. The competent authority shall make available the verification report to the other Member States and to the Commission without undue delay.

Or. en

Justification

leak

Amendment 563

Stanislav Polčák

Proposal for a regulation

Article 6 – paragraph 6

Text proposed by the Commission

Amendment

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

6. If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and prepare a verification report within 60 working days from the date of receipt of a verification request. The competent authority shall make available the verification report to the other Member States and to the Commission without undue delay.

Or. cs

Amendment 564

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 6 – paragraph 6

Text proposed by the Commission

Amendment

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

6. If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and prepare a verification report within 60 working days from the date of receipt of a verification request. The competent authority shall make available the verification report to the other Member States and to the Commission without undue delay.

Or. en

Amendment 565

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

Proposal for a regulation

Article 6 – paragraph 7

Text proposed by the Commission

Amendment

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

7. The other Member States and the Commission may make reasoned objections to the verification report with regard to the fulfilment of the criteria set out in Annex I, within 20 days from the date of receipt of that report. A reasoned objection by a Member State shall be science-based and shall directly refer to the criteria as set out in Annex I.

Or. en

Justification

The verification process should be based on fulfilling the science-based criteria as laid down in Annex I of this Regulation and should be assessed by the competent authority in the Member State to which the verification request was made. Allowing other Member States to make 'comments' without further specifications on the content thereof risks undermining a streamlined process of verification. Any intervention by the Commission in the verification process should be scientifically justified and should only and directly relate to the criteria as laid down in Annex I.

Amendment 566

Ondřej Knotek

Proposal for a regulation

Article 6 – paragraph 7

Text proposed by the Commission

Amendment

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

7. The other Member States and the Commission may make reasoned comments together with scientific justification as regards the fulfilment of the criteria set out in Annex I, to the verification report within 20 days from the date of receipt of that report.

Or. en

Amendment 567

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

Proposal for a regulation

Article 6 – paragraph 7

Text proposed by the Commission

Amendment

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

7. The other Member States and the Commission may make reasoned objections to the verification report with regard to whether the criteria set out in Annex I have been met within 20 days from the date of receipt of that report.

Or. it

Amendment 568

Francesca Peppucci

Proposal for a regulation

Article 6 – paragraph 7

Text proposed by the Commission

Amendment

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

7. The other Member States and the Commission may make reasoned objections to the verification report with regard to compliance with the criteria in the Annex I within 20 days from the date of receipt of that report.

Or. en

Amendment 569

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 7

Text proposed by the Commission

Amendment

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

7. The other Member States and the Commission may make comments to the authorisation report within 45 days from the date of receipt of that report.

Or. en

Amendment 570

Christophe Clergeau

Proposal for a regulation

Article 6 – paragraph 7

Text proposed by the Commission

Amendment

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

7. The other Member States and the Commission may make comments to the verification report within 3 months from the date of receipt of that report.

Or. en

Amendment 571

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

Proposal for a regulation

Article 6 – paragraph 7

Text proposed by the Commission

Amendment

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

7. The other Member States and the Commission may make reasoned scientific opinion to the verification report within 20 days from the date of receipt of that report.

Or. en

Justification

The verification procedure of category 1 NBT plants by national competent authorities which must be science-based.

Amendment 572

Norbert Lins

Proposal for a regulation

Article 6 – paragraph 7

Text proposed by the Commission

Amendment

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

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

Or. de

Amendment 573

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Article 6 – paragraph 7

Text proposed by the Commission

Amendment

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

7. The Authority shall issue its scientific opinion to the verification report within 30 days from the date of receipt of that report.

Or. en

Amendment 574

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 6 – paragraph 7

Text proposed by the Commission

Amendment

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

7. The other Member States and the Commission may make comments to the verification report within 40 days from the date of receipt of that report.

Or. en

Amendment 575

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Article 6 – paragraph 8

Text proposed by the Commission

Amendment

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

deleted

Or. en

Amendment 576

Ondřej Knotek

Proposal for a regulation

Article 6 – paragraph 8

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 577

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 8

Text proposed by the Commission

Amendment

8. In cases where comments are raised by another Member State or the Commission, within the deadline referred to in paragraph 7, the competent authority that prepared the authorisation report shall forward the comment(s) to the MS and the Commission. The competent authorities and the Commission may discuss any outstanding issues within 60 days.

Or. en

Amendment 578

Francesca Peppucci

Proposal for a regulation

Article 6 – paragraph 8

Text proposed by the Commission

Amendment

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

Or. en

Amendment 579

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

Proposal for a regulation

Article 6 – paragraph 8

Text proposed by the Commission

Amendment

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

Or. en

Justification

Amendment 580

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

Proposal for a regulation

Article 6 – paragraph 8

Text proposed by the Commission

Amendment

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

Or. it

Amendment 581

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

Proposal for a regulation

Article 6 – paragraph 8

Text proposed by the Commission

Amendment

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

Or. en

Amendment 582

Stanislav Polčák

Proposal for a regulation

Article 6 – paragraph 8

Text proposed by the Commission

Amendment

8. In the absence of any comments from a Member State or the Commission, within 20 working days from the expiry of the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall adopt a decision declaring whether the NGT plant is a category 1 NGT plant. It shall transmit the decision without undue delay to the requester, the other Member States and to the Commission.

Or. cs

Amendment 583

Christophe Clergeau

Proposal for a regulation

Article 6 – paragraph 8

Text proposed by the Commission

Amendment

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

Or. en

Amendment 584

Ondřej Knotek

Proposal for a regulation

Article 6 – paragraph 9

Text proposed by the Commission

Amendment

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

deleted

Or. en

Amendment 585

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Article 6 – paragraph 9

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 586

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 9

Text proposed by the Commission

Amendment

9. In the absence of any comments from a Member State or the Commission or if outstanding issues are resolved within the period referred to in para 8, the competent authority that prepared the report shall, within 10 working days from the deadline referred to in para 7 or, in the case outstanding issues are resolved in para 8, adopt a decision establishing whether the NGT plant fulfils the conditions set out in article 5(1) and this article. It shall transmit the decision without delay to the notifier, the other Member States and the Commission.

Or. en

Amendment 587

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

Proposal for a regulation

Article 6 – paragraph 9

Text proposed by the Commission

Amendment

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

Or. en

Amendment 588

Francesca Peppucci

Proposal for a regulation

Article 6 – paragraph 9

Text proposed by the Commission

Amendment

9. In cases where a reasoned objections is made by another Member State or by the Commission by the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall forward the objections and their justifications to Member States to the Commission without undue delay.

Or. en

Amendment 589

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

Proposal for a regulation

Article 6 – paragraph 9

Text proposed by the Commission

Amendment

9. In cases where a reasoned objection is made by another Member State or by the Commission by the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall forward the objections and their justifications to the Member States and the Commission without undue delay.

Or. it

Amendment 590

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

Proposal for a regulation

Article 6 – paragraph 9

Text proposed by the Commission

Amendment

9. In cases where a reasoned objection is made by another Member State by the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall forward the reasoned objection to the Commission and the other Member States without undue delay.

Or. en

Justification

Amendment 591

Christophe Clergeau

Proposal for a regulation

Article 6 – paragraph 9

Text proposed by the Commission

Amendment

Or. en

Amendment 592

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 9 a (new)

Text proposed by the Commission

Amendment

9a. In cases where comments are raised and maintained by another Member State or the Commission, the competent authority that prepared the report shall forward the authorisation report, and the comments to the European Food Safety Authority (‘the Authority’) without undue delay. The Authority shall deliver a statement on whether the notified NGT plant fulfils the conditions set out in Article 5(1) and under this article no later than 45 working days from the date of the referral. The Authority shall make available the statement to the Commission and the Member States.

Or. en

Amendment 593

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 9 b (new)

Text proposed by the Commission

Amendment

9b. Where the Authority is consulted in accordance with paragraph 9a of this Article, it shall, in accordance with Article 38(1) of Regulation (EC) No 178/2002, make public without delay the notification, relevant supporting information and any supplementary information supplied by the applicant, as well as its statement.

Or. en

Amendment 594

Ondřej Knotek

Proposal for a regulation

Article 6 – paragraph 10

Text proposed by the Commission

Amendment

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

10. The competent authority shall adopts its decision based on EFSA's opinion within 20 working days from the date of receipt of the EFSA's opinion. The competent authority shall transmit the decision without undue delay to the requested, to other Member States and to the Commission.

Or. en

Amendment 595

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Article 6 – paragraph 10

Text proposed by the Commission

Amendment

10. The competent authority shall adopt its decision based on the EFSA´s opinion within 20 working days from the date of receipt of the EFSA´s opinion. The competent authority shall transmit the decision without undue delay to the requester, the other Member States and to the Commission.

Or. en

Amendment 596

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

Proposal for a regulation

Article 6 – paragraph 10

Text proposed by the Commission

Amendment

10. The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 45 working days from the date of receipt of the reasoned objections and their justifications, taking that information into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

Or. it

Amendment 597

Francesca Peppucci

Proposal for a regulation

Article 6 – paragraph 10

Text proposed by the Commission

Amendment

10. The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 45 working days from the date of receipt of reasoned objections and their justifications, taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

Or. en

Amendment 598

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

Proposal for a regulation

Article 6 – paragraph 10

Text proposed by the Commission

Amendment

10. The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 45 working days from the date of receipt of the reasoned objection(s), taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

Or. en

Justification

Amendment 599

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

Proposal for a regulation

Article 6 – paragraph 10

Text proposed by the Commission

Amendment

10. The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 45 working days from the date of receipt of the reasoned objections, taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

Or. en

Amendment 600

Christophe Clergeau

Proposal for a regulation

Article 6 – paragraph 10

Text proposed by the Commission

Amendment

10. The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 3 months from the date of receipt of the comment(s), taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

Or. en

Amendment 601

Stanislav Polčák

Proposal for a regulation

Article 6 – paragraph 10

Text proposed by the Commission

Amendment

10. The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 60 working days from the date of receipt of the comment(s), taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

Or. cs

Amendment 602

Ulrike Müller

Proposal for a regulation

Article 6 – paragraph 10

Text proposed by the Commission

Amendment

10. The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 20 working days from the date of receipt of the comment(s), taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

Or. en

Justification

As stated in recital 20 of the proposal, the verification of category 1 NGT plant status is of technical nature and does not involve any risk assessment or risk management considerations and the decision on the status is only declaratory. Hence, it should be ensured that comments by Member States do not trigger an unduly long procedure. As the Commission considers 20 days a sufficient period for Member States to prepare comments, the same period should be adequate for their assessment.

Amendment 603

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 10

Text proposed by the Commission

Amendment

10. On fulfilment of the conditions set out in Article 5(1) and in this article, the Commission shall prepare a draft decision authorising the NGT plant within 60 working days from the date of receipt of the statement of the Authority, taking the latter into account. The decision shall be adopted in accordance with the procedure laid down in Article 28(3).

Or. en

Amendment 604

Christophe Clergeau

Proposal for a regulation

Article 6 – paragraph 11

Text proposed by the Commission

Amendment

11. The Commission shall publish a summary of the decisions referred to in paragraphs 8 and 10 in the Official Journal of the European Union.

11. Within 15 days following their submission or issuance, the competent authority of the Member State where the verification request was submitted to and, where relevant, the Commission shall make public the verification request, the verification report referred to in paragraph 6, the comments referred to in paragraph 7 and the decisions referred to in paragraphs 8 and 10.

Or. en

Amendment 605

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 11

Text proposed by the Commission

Amendment

11. The Commission shall publish a summary of the decisions referred to in paragraphs 8 and 10 in the Official Journal of the European Union.

11. The Commission shall publish a summary of the decisions referred to in paragraphs 9, 9b new and 10 in the Official Journal of the European Union.

Or. en

Amendment 606

João Pimenta Lopes

Proposal for a regulation

Article 7

Text proposed by the Commission

Amendment

[...]

deleted

Or. pt

Amendment 607

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Article 7

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Justification

Merged with Article 6. Moreover: (i) We prefer a simple, effective, and harmonized verification procedure of NGT plant status at the national level in order to reduce the administrative burden and increase available access for SMEs. (ii) The outcome of the procedure should be strictly based on scientific opinion. (iii) The verification of NGT plant status resulting in the classification of NGT 1 or NGT 2 should be carried out in a uniform procedure regardless the use of these plants (for deliberate release into the environment or placing on the market). (iv) It can be achieved by merging Articles 6 and 7 and proposed amendments.

Amendment 608

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

Proposal for a regulation

Article 7

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Amendment 609

Marie Toussaint

Proposal for a regulation

Article 7

Text proposed by the Commission

Amendment

[...]

deleted

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 610

Lydie Massard

Proposal for a regulation

Article 7

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Amendment 611

Günther Sidl

Proposal for a regulation

Article 7

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Amendment 612

Martin Häusling

Proposal for a regulation

Article 7 – title

Text proposed by the Commission

Amendment

Verification procedure of category 1 NGT plant status prior to the placing on the market of NGT products

Authorisation procedure of category 1 NGT plant status prior to the placing on the market of NGT products

Or. en

Amendment 613

Martin Häusling

Proposal for a regulation

Article 7 – title

Text proposed by the Commission

Amendment

Verification procedure of category 1 NGT plant status prior to the placing on the market of NGT products

Authorisation procedure of category 1 NGT plant status prior to the placing on the market of NGT products

Or. en

Amendment 614

Christophe Clergeau

Proposal for a regulation

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

1. Where a declaration of category 1 NGT plant status referred to in Article 4(1), point (a), has not already been made in accordance with Article 6, to obtain such a declaration before placing on the market a NGT product, the person intending to place the product on the market shall submit a verification request to the Authority in accordance with paragraph 2 and the implementing act adopted in accordance with Article 27, point (b).

1. Before placing on the market a NGT product, the person intending to place the product on the market shall submit a verification request to the Authority in accordance with paragraph 2 and the implementing act adopted in accordance with Article 27, point (b).

Or. en

Justification

Going through Article 6 procedure should not allow to skip Article 7 procedure

Amendment 615

Martin Häusling

Proposal for a regulation

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

1. In order to obtain an authorisation for placing on the market of a category 1 NGT product, the applicant shall submit an authorisation request to the Authority for determination that the NGT plant fulfils the conditions set out in Article 5(1), in paragraph 2 of this Article as well as the implementing act adopted in accordance with Article 27, point (b).

Or. en

Amendment 616

Christophe Clergeau

Proposal for a regulation

Article 7 – paragraph 2 – point b a (new)

Text proposed by the Commission

Amendment

(ba) the denomination of the variety;

Or. en

Amendment 617

Erik Poulsen, Asger Christensen, Jan Huitema, Emma Wiesner

Proposal for a regulation

Article 7 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) a description of the trait(s) and characteristics which have been introduced or modified including information on the technique(s) used to obtain the trait(s);

Or. en

Amendment 618

Christophe Clergeau

Proposal for a regulation

Article 7 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) a description of the trait(s) and characteristics which have been introduced or modified, including disclosure of the sequence of genetic modification ;

Or. en

Amendment 619

Stanislav Polčák

Proposal for a regulation

Article 7 – paragraph 2 – point c

Text proposed by the Commission

Amendment

Or. cs

Amendment 620

Christophe Clergeau

Proposal for a regulation

Article 7 – paragraph 2 – point c a (new)

Text proposed by the Commission

Amendment

(ca) a declaration on possible properties for treating or preventing disease in human beings or possible use or administration to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, within the meaning of Article 1-2. (a) and (b) of Directive 2001/83/EC on the Community code relating to medicinal products for human use;

Or. en

Amendment 621

Christophe Clergeau

Proposal for a regulation

Article 7 – paragraph 2 – point c b (new)

Text proposed by the Commission

Amendment

(cb) any granted patent or pending application for patent covering the whole Cat.1 NGT plant or part of it;

Or. en

Amendment 622

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 7 – paragraph 2 – point d – point i

Text proposed by the Commission

Amendment

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

(i) the plant is a NGT plant, including that it does not contain any genetic material originating from outside cell, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

Or. en

Amendment 623

Stanislav Polčák

Proposal for a regulation

Article 7 – paragraph 2 – point d – point i

Text proposed by the Commission

Amendment

(i) the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

Or. cs

Amendment 624

Martin Häusling

Proposal for a regulation

Article 7 – paragraph 2 – point d – point i

Text proposed by the Commission

Amendment

(i) the entire genome sequence, performed via an unbiased long-read sequencing with the most accurate and up to date techniques to show that, among other things, the plant does not contain any transgenic material or transgenes, such as those which may have been inserted as part of the development of the plant;

Or. en

Amendment 625

Martin Häusling

Proposal for a regulation

Article 7 – paragraph 2 – point d – point i a (new)

Text proposed by the Commission

Amendment

(ia) information in accordance with the requirements specified in the implementing act adopted in accordance with Article 27, point (a);

Or. en

Amendment 626

Martin Häusling

Proposal for a regulation

Article 7 – paragraph 2 – point d – point ii

Text proposed by the Commission

Amendment

(ii) the NGT plant meets the criteria set out in Annex I;

(ii) the NGT plant meets the criteria set out in Annex I, including through the submission of independent studies verifying the safety of the modifications outlined in annex I, paragraph 1, points 1 and 2;

Or. en

Amendment 627

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 7 – paragraph 2 – point d – point ii

Text proposed by the Commission

Amendment

(ii) the NGT plant meets the criteria set out in Annex I;

(ii) the NGT plant is equivalent to plants derived from conventional breeding methods or natural processes based on the data collected from in-door risk assessment;

Or. en

Amendment 628

Martin Häusling

Proposal for a regulation

Article 7 – paragraph 2 – point d – point ii a (new)

Text proposed by the Commission

Amendment

(iia) an environmental risk assessment, carried out in accordance with Directive 2001/18

Or. en

Amendment 629

Christophe Clergeau

Proposal for a regulation

Article 7 – paragraph 2 – point d – point ii a (new)

Text proposed by the Commission

Amendment

(iia) the results of the in-door safety assessment set out in Annex IV

Or. en

Amendment 630

Martin Häusling

Proposal for a regulation

Article 7 – paragraph 2 – point d a (new)

Text proposed by the Commission

Amendment

(da) a declaration from the applicant that there are:

(i) no patents or exclusive rights covering the process used to develop the plant,(

(ii) no patents or exclusive rights covering the plant or parts thereof, and

(iii) no application has been tabled for such patents or exclusive rights to be granted;

Or. en

Justification

The Commission proposal aims to facilitate the commercialisation of NGT plants in Europe. In the absence of specific safeguards, this could lead to an increased number of patented seeds in the EU.

As a result, breeders and farmers could find themselves at a heightened risk of legal action from NGT developers if they inadvertently use their patented genetic sequences.

Specifically with regards to CRISPRC/Cas products, researchers have warned of a "patent thicket" that could be extremely hard to navigate for the majority of plant breeders and farmers.

This amendment, in line with the Parliament’s position, aims to ensure that the NGT Regulation will not hamper free access to plant material for farmers and plant breeders.

Amendment 631

Christophe Clergeau

Proposal for a regulation

Article 7 – paragraph 2 – point d a (new)

Text proposed by the Commission

Amendment

(da) an environmental risk assessment carried out in accordance with the principles and criteria set out in Parts 1 and 2 of Annex II and with the implementing act adopted in accordance with Article 27, point (c);

Or. en

Amendment 632

Martin Häusling

Proposal for a regulation

Article 7 – paragraph 2 – point d b (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 633

Christophe Clergeau

Proposal for a regulation

Article 7 – paragraph 2 – point d b (new)

Text proposed by the Commission

Amendment

(db) a monitoring plan for environmental effects as mentioned in Parts 1 and 2 of Annex II;

Or. en

Amendment 634

Christophe Clergeau

Proposal for a regulation

Article 7 – paragraph 2 – point d c (new)

Text proposed by the Commission

Amendment

(dc) methods for sampling (including references to existing official or standardised sampling methods, e.g. genetic markers or PCR primers), detection, identification and quantification of the NGT plant. 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;

Or. en

Amendment 635

Martin Häusling

Proposal for a regulation

Article 7 – paragraph 2 – point d c (new)

Text proposed by the Commission

Amendment

(dc) a declaration that the placing on the market would not be in breach of the Cartegena Protocol on biosafety under the UN convention on biological diversity, and a description of how the protocol's requirements are fulfilled;

Or. en

Amendment 636

Martin Häusling

Proposal for a regulation

Article 7 – paragraph 2 – point d d (new)

Text proposed by the Commission

Amendment

(dd) a declaration that the placing on the market is in conformity with the Regulation on food information to consumers, as well as legislation on nutrition and health claims made on food, and a description on how the relevant provisions are fulfilled;

Or. en

Justification

For example, the food information to consumers regulation lays down requirements relating to the labelling of the level of gluten in products.

Amendment 637

Christophe Clergeau

Proposal for a regulation

Article 7 – paragraph 2 – point d d (new)

Text proposed by the Commission

Amendment

(dd) samples of the category 1 NGT plant and their control samples, and information as to the place where the reference material can be accessed;

Or. en

Amendment 638

Martin Häusling

Proposal for a regulation

Article 7 – paragraph 2 – point d e (new)

Text proposed by the Commission

Amendment

(de) reference material and a validated sampling and detection method;

Or. en

Amendment 639

Martin Häusling

Proposal for a regulation

Article 7 – paragraph 2 – point e

Text proposed by the Commission

Amendment

(e) an identification of the parts of the verification request and any other supplementary information that the requester demands to be treated as confidential, accompanied by verifiable justification, pursuant to Article 11 of this Regulation and Article 39 of Regulation (EC) No 178/2002.

deleted

Or. en

Amendment 640

Martin Häusling

Proposal for a regulation

Article 7 – paragraph 2 – point e

Text proposed by the Commission

Amendment

(e) an identification of the parts of the authorisation request and any other supplementary information that the requester demands to be treated as confidential, accompanied by verifiable justification, pursuant to Article 39 of Regulation (EC) No 178/2002.

Or. en

Amendment 641

Christophe Clergeau

Proposal for a regulation

Article 7 – paragraph 2 – point e a (new)

Text proposed by the Commission

Amendment

(ea) a declaration on the non-applicability of Regulation (EU) 2015/2283 of 25 November 2015 on novel foods, or on the correct application of possible obligations arising from this Regulation;

Or. en

Amendment 642

Christophe Clergeau

Proposal for a regulation

Article 7 – paragraph 2 – point e b (new)

Text proposed by the Commission

Amendment

(eb) any other relevant information relating to the file, including possible refusal, withdrawal or acceptance of previous requests or national or European decisions.

Or. en

Amendment 643

Martin Häusling

Proposal for a regulation

Article 7 – paragraph 3

Text proposed by the Commission

Amendment

3. The Authority shall acknowledge receipt of the verification request to the requester without delay, stating the date of receipt. It shall make available the verification request to the Member States and to the Commission without undue delay and make public the verification request, relevant supporting information and any supplementary information supplied by the requester, in accordance with article 38(1) of Regulation (EC) No 178/2002, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation.

3. The Authority shall acknowledge receipt of the authorisation request to the applicant without delay, stating the date of receipt. It shall make available the authorisation request to the Member States and to the Commission without undue delay and make public the authorisation request, all relevant supporting information and any supplementary information supplied by the applicant, in accordance with article 38(1) of Regulation (EC) No 178/2002, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002.

Or. en

Amendment 644

Martin Häusling

Proposal for a regulation

Article 7 – paragraph 4

Text proposed by the Commission

Amendment

4. If the verification request does not contain all the necessary information, it shall be declared inadmissible by the Authority within 30 working days within the date of receipt of a verification request. The Authority shall inform the requester, the Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.

4. If the authorisation request does not contain all the necessary information, it shall be declared inadmissible by the Authority within 60 working days within the date of receipt of an authorisation request. The Authority shall inform the applicant, the Member States and the Commission without undue delay of the inadmissibility of the authorisation request and shall provide the reasons of its decision.

Or. en

Amendment 645

Christophe Clergeau

Proposal for a regulation

Article 7 – paragraph 4

Text proposed by the Commission

Amendment

4. If the verification request does not contain all the necessary information, it shall be declared inadmissible by the Authority within 60 working days within the date of receipt of a verification request. The Authority shall inform the requester, the Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.

Or. en

Amendment 646

Christophe Clergeau

Proposal for a regulation

Article 7 – paragraph 5

Text proposed by the Commission

Amendment

5. If the verification request is not deemed inadmissible in accordance with paragraph 4, the Authority shall deliver its statement on whether the NGT plant fulfils the criteria set out in Annex I within 30 working days from the date of receipt of a verification request. The Authority shall make available the statement to the Commission and the Member States. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its statement public, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation.

5. If the verification request is not deemed inadmissible in accordance with paragraph 4, the Authority shall deliver its statement on whether the NGT plant fulfils the criteria set out in Annex I within 6 months from the date of receipt of a verification request. The Authority shall make available the statement to the Commission and the Member States without undue delay. Member States may make comments on the statement within 2 months from the date of receipt of that statement. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its statement, and where relevant, comments made by Member States, public, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation.

Or. en

Amendment 647

Martin Häusling

Proposal for a regulation

Article 7 – paragraph 5

Text proposed by the Commission

Amendment

5. If the authorisation request is not deemed inadmissible in accordance with paragraph 4, the Authority shall deliver its assessment on whether the NGT plant fulfils the criteria set out in Annex I and set out in this Article within 60 working days from the date of receipt of an authorisation request. The Authority shall make available the draft assessment to the Commission and the Member States. The Authority shall also make its draft assessment public.

Or. en

Amendment 648

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 7 – paragraph 5

Text proposed by the Commission

Amendment

5. If the verification request is not deemed inadmissible in accordance with paragraph 4, the Authority shall deliver its statement on whether the NGT plant fulfils the criteria set out in Annex I within 60 working days from the date of receipt of a verification request. The Authority shall make available the statement to the Commission and the Member States. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its statement public, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation.

Or. en

Amendment 649

Martin Häusling

Proposal for a regulation

Article 7 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5a. Member States, the Commission and the public may make comments on the draft assessment of the Authority within 45 days.

Or. en

Amendment 650

Martin Häusling

Proposal for a regulation

Article 7 – paragraph 5 b (new)

Text proposed by the Commission

Amendment

5b. The Authority shall deliver its assessment on whether the notified NGT plant fulfils the conditions set out in Article 5(1), annex I and in this Article, taking into account the comments received from Member States, the public and the Commission, within 30 days from the deadline referred to in paragraph 5a new. The Authority shall make available the assessment to the Commission and the Member States. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its assessment public.

Or. en

Amendment 651

Christophe Clergeau

Proposal for a regulation

Article 7 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 30 working days from the date of receipt of the statement of the Authority, taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

6. The Commission shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 3 months from the date of receipt of the statement of the Authority, taking the latter into account. Member States may make comments on the draft decision within 2 months from the date of receipt of that draft decision. The decision shall be adopted within the 3 following months, in accordance with the procedure referred to in Article 28(2).

Or. en

Amendment 652

Martin Häusling

Proposal for a regulation

Article 7 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 45 working days from the date of receipt of the assessment of the Authority, taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(3).

Or. en

Amendment 653

Catherine Griset, Aurélia Beigneux

Proposal for a regulation

Article 7 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6a. Category 1 NGT plants shall be subject to a systematic ex-post health and environmental risk assessment through the implementation of regular reviews in order to adapt the authorisations in line with scientific developments and the effects observed by the biovigilance and sociovigilance networks. In the event of a negative assessment, the authorisation for release shall be suspended pending further analysis.

Or. fr

Amendment 654

Christophe Clergeau

Proposal for a regulation

Article 7 – paragraph 7

Text proposed by the Commission

Amendment

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

7. The Commission shall make public its draft decision, the comments referred to in paragraph 6, and its decision.

Or. en

Amendment 655

Francesca Peppucci

Proposal for a regulation

Article 7 a (new)

Text proposed by the Commission

Amendment

Article 7a

Freedom of movement

Member States do not prohibit or restrict the intentional release or placing on the market of Category 1 NGT plants and Category 1 NGT products.

Or. en

Amendment 656

Günther Sidl

Proposal for a regulation

Article 8

Text proposed by the Commission

Amendment

Article 8

deleted

System of exchange of information between Member States, the Commission and the Authority

The Commission shall set up and maintain an electronic system for the submission of verification requests in accordance with Articles 6 and 7 and the exchange of the information under this Title.

Or. en

Amendment 657

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

Proposal for a regulation

Article 8

Text proposed by the Commission

Amendment

Article 8

deleted

System of exchange of information between Member States, the Commission and the Authority

The Commission shall set up and maintain an electronic system for the submission of verification requests in accordance with Articles 6 and 7 and the exchange of the information under this Title.

Or. en

Amendment 658

Marie Toussaint

Proposal for a regulation

Article 8

Text proposed by the Commission

Amendment

Article 8

deleted

System of exchange of information between Member States, the Commission and the Authority

The Commission shall set up and maintain an electronic system for the submission of verification requests in accordance with Articles 6 and 7 and the exchange of the information under this Title.

Or. en

Justification

Amendment 659

Lydie Massard

Proposal for a regulation

Article 8 – paragraph 1

Text proposed by the Commission

Amendment

The Commission shall set up and maintain an electronic system for the submission of verification requests in accordance with Articles 6 and 7 and the exchange of the information under this Title.

The Commission shall set up and maintain an electronic system for the submission of applications for registration and all necessary data and studies for the exchange of information pursuant to this title and shall maintain that system. All data shall be promptly displayed to the public in a publicly viewable register and shall be sent immediately upon request without charge.

Or. en

Amendment 660

Martin Häusling

Proposal for a regulation

Article 8 – paragraph 1

Text proposed by the Commission

Amendment

The Commission shall set up and maintain an electronic system for the submission of verification requests in accordance with Articles 6 and 7 and the exchange of the information under this Title.

The Commission shall set up and maintain an electronic system for the submission of authorisation requests in accordance with Articles 6 and 7 and the exchange of the information under this Title.

Or. en

Amendment 661

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Article 8 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

Free movement Member States shall not prohibit, restrict or impede the deliberate release or the placing on the market of category 1 NGT plants and related products, which comply with the requirements of this Regulation.

Or. en

Amendment 662

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

Proposal for a regulation

Article 8 a (new)

Text proposed by the Commission

Amendment

Article 8a

Free movement

Member States shall not prohibit, restrict, or impede the deliberate release or the placing on the market of category 1 NGT plants and related products, which comply with the requirements of this Regulation.

Or. en

Justification

It is essential for the good functioning of the internal market and the free movement of NGT plant products across the EU, that the deliberate release of NGT plants and placing on the market of NGT products are based on the harmonized requirements and procedures laid down in this Regulation, leading to the adoption of a decision uniformly applicable to all Member States. It is important that Member States do not unilaterally derogate from the provisions set out in this Regulation in a way that would restrict, prohibit or hinder the free movement, placing on the market and deliberate release of NGT plants or related products within the territory of the Union.

Amendment 663

Lydie Massard

Proposal for a regulation

Article 8 a (new)

Text proposed by the Commission

Amendment

Article 8a

The Commission shall publish the detection method and make reference material of the NGT plant available to the European GMO reference laboratories.

Or. en

Amendment 664

João Pimenta Lopes

Proposal for a regulation

Article 9

Text proposed by the Commission

Amendment

Article 9

deleted

Database of decisions declaring the category 1 NGT plant status

The Commission shall establish and maintain a database listing the decisions declaring the category 1 NGT plant status adopted in accordance with Article 6(8) and (10) and Article 7(6).

The database shall contain the following information:

(a) name and the address of the requester;

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

(d) a description of the trait(s) and characteristics which have been introduced or modified;

(e) an identification number, and

(f) the decision referred to in Article 6(8) or (10), and Article 7(6), as appropriate.

2. The database shall be publicly available.

Or. pt

Amendment 665

Marie Toussaint

Proposal for a regulation

Article 9

Text proposed by the Commission

Amendment

Article 9

deleted

Database of decisions declaring the category 1 NGT plant status

The Commission shall establish and maintain a database listing the decisions declaring the category 1 NGT plant status adopted in accordance with Article 6(8) and (10) and Article 7(6).

The database shall contain the following information:

(a) name and the address of the requester;

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

(d) a description of the trait(s) and characteristics which have been introduced or modified;

(e) an identification number, and

(f) the decision referred to in Article 6(8) or (10), and Article 7(6), as appropriate.

2. The database shall be publicly available.

Or. en

Justification

Amendment 666

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

Proposal for a regulation

Article 9

Text proposed by the Commission

Amendment

Article 9

deleted

Database of decisions declaring the category 1 NGT plant status

The Commission shall establish and maintain a database listing the decisions declaring the category 1 NGT plant status adopted in accordance with Article 6(8) and (10) and Article 7(6).

The database shall contain the following information:

(a) name and the address of the requester;

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

(d) a description of the trait(s) and characteristics which have been introduced or modified;

(e) an identification number, and

(f) the decision referred to in Article 6(8) or (10), and Article 7(6), as appropriate.

2. The database shall be publicly available.

Or. en

Amendment 667

Günther Sidl

Proposal for a regulation

Article 9

Text proposed by the Commission

Amendment

Article 9

deleted

Database of decisions declaring the category 1 NGT plant status

The Commission shall establish and maintain a database listing the decisions declaring the category 1 NGT plant status adopted in accordance with Article 6(8) and (10) and Article 7(6).

The database shall contain the following information:

(a) name and the address of the requester;

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

(d) a description of the trait(s) and characteristics which have been introduced or modified;

(e) an identification number, and

(f) the decision referred to in Article 6(8) or (10), and Article 7(6), as appropriate.

2. The database shall be publicly available.

Or. en

Amendment 668

Christophe Clergeau

Proposal for a regulation

Article 9 – title

Text proposed by the Commission

Amendment

Database of decisions declaring the category 1 NGT plant status

Information and public access

Or. en

Amendment 669

Lydie Massard

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The Commission shall establish and maintain a database listing the decisions declaring the category 1 NGT plant status adopted in accordance with Article 6(8) and (10) and Article 7(6).

The Commission shall establish and maintain a public database listing the decisions declaring the category 1 NGT plant status adopted in accordance with Article 6(8) and (10) and Article 7(6).

Or. en

Amendment 670

Christophe Clergeau

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The Commission shall establish and maintain a database listing the decisions declaring the category 1 NGT plant status adopted in accordance with Article 6(8) and (10) and Article 7(6).

The Commission shall establish and maintain a register for the purpose of recording the information related to all products consisting of, made of, or containing Cat.1 NGT plant.

Or. en

Amendment 671

Christophe Clergeau

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – introductory part

Text proposed by the Commission

Amendment

The database shall contain the following information:

The register shall contain the following information:

Or. en

Amendment 672

Christophe Clergeau

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point b

Text proposed by the Commission

Amendment

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

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

Or. en

Amendment 673

Christophe Clergeau

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point b a (new)

Text proposed by the Commission

Amendment

(ba) the denomination of the variety ;

Or. en

Amendment 674

Christophe Clergeau

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point d

Text proposed by the Commission

Amendment

(d) a description of the trait(s) and characteristics which have been introduced or modified;

(d) a description of the trait(s) and characteristics which have been introduced or modified, including possible properties for treating or preventing disease in human beings or possible use or administration to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action;

Or. en

Amendment 675

Stanislav Polčák

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point d

Text proposed by the Commission

Amendment

(d) a description of the trait(s) and characteristics which have been introduced or modified;

(d) a description of the trait(s) and characteristics which have been introduced, removed or modified;

Or. cs

Amendment 676

Christophe Clergeau

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point d a (new)

Text proposed by the Commission

Amendment

(da) a copy of the studies, which have been carried out and any other available material to demonstrate that:

(i) the plant is a NGT plant;

(ii) the NGT plant meets the criteria set out in Annex I;

(iii) the results of the in-door safety assessment set out in Annex IV;

Or. en

Amendment 677

Martin Häusling

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point d a (new)

Text proposed by the Commission

Amendment

(da) information about the genetic modification and the site(s) at which both intended and unintended modifications occur;

Or. en

Amendment 678

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point d a (new)

Text proposed by the Commission

Amendment

(da) relevant data from in-door risk assessment;

Or. en

Amendment 679

Martin Häusling

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point d b (new)

Text proposed by the Commission

Amendment

(db) the stage at which the NGT plant is at (deliberate release and/or placing on the market);

Or. en

Amendment 680

Christophe Clergeau

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point d b (new)

Text proposed by the Commission

Amendment

(db) the sequence of the genetic modification;

Or. en

Amendment 681

Martin Häusling

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point d c (new)

Text proposed by the Commission

Amendment

(dc) all risk assessment data and studies, including those pointing to potential adverse or unintended effects;

Or. en

Amendment 682

Christophe Clergeau

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point d c (new)

Text proposed by the Commission

Amendment

(dc) any granted patent or pending application for patent covering the whole Cat.1 NGT plant or part of it;

Or. en

Amendment 683

Christophe Clergeau

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point d d (new)

Text proposed by the Commission

Amendment

(dd) methods for sampling (including references to existing official or standardised sampling methods, e.g. genetic markers or PCR primers), detection, identification and quantification of the NGT plant;

Or. en

Amendment 684

Martin Häusling

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point d d (new)

Text proposed by the Commission

Amendment

(dd) all techniques used in the development of the NGT plant;

Or. en

Amendment 685

Christophe Clergeau

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point e a (new)

Text proposed by the Commission

Amendment

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

Or. en

Amendment 686

Martin Häusling

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point e a (new)

Text proposed by the Commission

Amendment

(ea) the risk assessment, carried out in accordance with Directive 2001/18;

Or. en

Justification

In the Treaty on the Functioning of the EU (TFEU), Article 114 § 3 states: “The Commission, in its proposals envisaged in paragraph 1 concerning health, safety, environmental protection and consumer protection, will take as a base a high level of protection, taking account in particular of any new development based on scientific facts. Already, many problems, including unintended effects, have been documented for NGTs. For example, CRISPR applications have turned out to cause toxicity (Álvarez et al., 2022), mosaicism (Mehravar et al., 2019) and other unintended genomic abnormalities (Höijer et al., 2022; Chu and Agapito-Tenfen, 2022). Whereas these effects have been observed in organisms intentionally exposed to CRISPR/Cas, its impact and adverse effects on non-target and unintentionally exposed organisms are yet unknown (Schenke and Cai, 2020). Such knowledge is only generated when risk assessments are required and in place and both the impact and the uncertainties are estimated and acknowledged.

Amendment 687

Lydie Massard

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point e a (new)

Text proposed by the Commission

Amendment

(ea) information about the genetic modification and the site;

Or. en

Amendment 688

Lydie Massard

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point f

Text proposed by the Commission

Amendment

(f) the decision referred to in Article 6(8) or (10), and Article 7(6), as appropriate.

(f) confirmation that the NGT plant is not subject to any patent.

Or. en

Amendment 689

María Soraya Rodríguez Ramos, Michal Wiezik

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point f a (new)

Text proposed by the Commission

Amendment

(fa) information on whether a given NGT plant or part of its genetic material is covered by a granted patent or by a patent application in the EU.

Or. en

Justification

Information on pending or approved patent claims are important for breeders and farmers to be able to avoid using such seeds

Amendment 690

Martin Häusling

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point f a (new)

Text proposed by the Commission

Amendment

(fa) full details of the detection and sampling method.

Or. en

Justification

Detection and sampling methods of NGT plants are necessary for the traceability along the food chain.

Amendment 691

Lydie Massard

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point f a (new)

Text proposed by the Commission

Amendment

(fa) risk assessment according to Directive 2001/18.

Or. en

Amendment 692

Martin Häusling

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point f b (new)

Text proposed by the Commission

Amendment

(fb) the name of the variety.

Or. en

Amendment 693

Lydie Massard

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point f b (new)

Text proposed by the Commission

Amendment

(fb) detection methods.

Or. en

Amendment 694

Martin Häusling

Proposal for a regulation

Article 9 – paragraph 2

Text proposed by the Commission

Amendment

2. The database shall be publicly available.

2. The database, including all information required under paragraph 1, shall be made publicly available and kept up to date, clearly accessible on the Commission website, as well as on dedicated webpages of each of the Member State's competent authorities.

Or. en

Amendment 695

Lydie Massard

Proposal for a regulation

Article 9 – paragraph 2

Text proposed by the Commission

Amendment

2. The database shall be publicly available.

2. The database and all information contained in it shall be publicly available.

Or. en

Amendment 696

Stanislav Polčák

Proposal for a regulation

Article 9 – paragraph 2

Text proposed by the Commission

Amendment

2. The database shall be publicly available.

2. The database shall be publicly available free of charge online.

Or. cs

Amendment 697

Christophe Clergeau

Proposal for a regulation

Article 9 – paragraph 2

Text proposed by the Commission

Amendment

2. The database shall be publicly available.

2. The register shall be publicly available.

Or. en

Amendment 698

Marie Toussaint

Proposal for a regulation

Article 10

Text proposed by the Commission

Amendment

Article 10

deleted

Labelling of category 1 NGT plant reproductive material, including breeding material

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

Or. en

Justification

Amendment 699

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

Proposal for a regulation

Article 10

Text proposed by the Commission

Amendment

Article 10

deleted

Labelling of category 1 NGT plant reproductive material, including breeding material

Or. en

Amendment 700

Günther Sidl

Proposal for a regulation

Article 10

Text proposed by the Commission

Amendment

Article 10

deleted

Labelling of category 1 NGT plant reproductive material, including breeding material

Or. en

Amendment 701

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 10 – title

Text proposed by the Commission

Amendment

Labelling of category 1 NGT plant reproductive material, including breeding material

Traceability and labelling of category 1 NGT plant reproductive material, including breeding material and of category 1 NGT plants, plant material, its progeny and products derived from it

Or. en

Amendment 702

Stanislav Polčák

Proposal for a regulation

Article 10 – title

Text proposed by the Commission

Amendment

Labelling of category 1 NGT plant reproductive material, including breeding material

Labelling of category 1 NGT plant reproductive material, including breeding material, and labelling of NGT products

Or. cs

Amendment 703

Martin Häusling

Proposal for a regulation

Article 10 – title

Text proposed by the Commission

Amendment

Labelling of category 1 NGT plant reproductive material, including breeding material

Labelling of NGT category 1

Or. en

Amendment 704

Christophe Clergeau

Proposal for a regulation

Article 10 – title

Text proposed by the Commission

Amendment

Labelling of category 1 NGT plant reproductive material, including breeding material

Traceability and labelling requirement for products consisting of or containing category 1 NGT products

Or. en

Amendment 705

María Soraya Rodríguez Ramos, Michal Wiezik

Proposal for a regulation

Article 10 – title

Text proposed by the Commission

Amendment

Labelling of category 1 NGT plant reproductive material, including breeding material

Traceability and labelling requirements for products consisting of or containing category 1 NGT products

Or. en

Amendment 706

João Pimenta Lopes

Proposal for a regulation

Article 10.º – title

Text proposed by the Commission

Amendment

Labelling of category 1 NGT plant reproductive material, including breeding material

Labelling of NGT plant reproductive material

Or. pt

Amendment 707

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

Proposal for a regulation

Article 10 – title

Text proposed by the Commission

Amendment

Labelling of category 1 NGT plant reproductive material, including breeding material

Transparency of category 1 NGT plant reproductive material, including breeding material

Or. en

Amendment 708

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Article 10 – title

Text proposed by the Commission

Amendment

Labelling of category 1 NGT plant reproductive material, including breeding material

Transparency of category 1 NGT plant reproductive material, including breeding material

Or. en

Amendment 709

María Soraya Rodríguez Ramos, Michal Wiezik

Proposal for a regulation

Article 10 – paragraph 1

Text proposed by the Commission

Amendment

A.TRACEABILITY

1. From the the first stage to all subsequent stages of the placing on the market of a category 1 NGT plant or a product consisting of or containing category 1 NGT plants or products, including bulk quantities, operators shall ensure that the following information is transmitted in writing to the operator receiving the product:

(a) that it contains or consists of category 1 NGT plants or products;

(b) the identification number in accordance with Article 9.

2. For products consisting of or containing mixtures of category 1 NGT plants or products to be used only and directly as food or feed or for processing, the information referred to in paragraph 1(b) may be replaced by a declaration of use by the operator, accompanied by a list of the identification number for all those category 1 NGT plants or products that have been used to constitute the mixture.

3. Paragraphs 1 to 3 shall be without prejudice to other specific requirements in Community legislation.

B. LABELLING

4. For category 1 NGT plants and for products consisting of or containing category 1 NGT plants and products, operators shall ensure that:

(a) for category 1 NGT plants, including plant reproductive material, the words 'category 1 NGT plant' or ‘cat 1 NGT’ appear on a label;

(b) for pre-packaged products consisting of, or containing category 1 NGT plants or products, the words ‘this product contains category 1 NGT products’ or ‘cat 1 NGT’ appear on a label;

(c) for non-pre-packaged products offered to the final consumer the words ‘this product contains category 1 NGT products’ or ‘cat 1 NGT’ shall appear on, or in connection with, the display of the product.

C. EXEMPTIONS

5. Paragraphs 1 to 4 shall not apply to traces of category 1 NGTs in products in a proportion no higher than the thresholds established in accordance with Articles 21(2) or (3) of Directive 2001/18/EC, in accordance with Articles 12, 24 or 47 of Directive 2001/18/EC and in other specific Community legislation, provided that these traces of category 1 NGT products are adventitious or technically unavoidable.

Or. en

Justification

Traceability measures are needed throughout the whole supply chain to enable food processors and operators to avoid the accidental or unavoidable presence of NGTs in their production process. Labelling requirements facilitate traceability and ensure consumer and operators' right of choice.

Amendment 710

Martin Häusling

Proposal for a regulation

Article 10 – paragraph 1

Text proposed by the Commission

Amendment

Plant reproductive material, including for breeding and scientific purposes, as well as food, feed and other products that contain or consist of category 1 NGT plant(s), as well as their progeny, which are placed on the market or made available to third parties, whether in return for payment or free of charge, shall bear a label indicating the words ‘genetically modified organism’, in accordance with the requirements laid down in Directive 2001/18 and regulation (EC) No 1830/2003, followed by the identification number of the NGT plant(s) it has been derived from.

Or. en

Amendment 711

Christophe Clergeau

Proposal for a regulation

Article 10 – paragraph 1

Text proposed by the Commission

Amendment

Traceability and labelling requirements defined in Directive 2001/18, Regulation 1829/2003 and Regulation 1830/2003 should apply for all plants and products consisting of or containing Category 1 NGT.

For products consisting of category 1 NGT, the words "This product consists of [name of the product] obtained by new genetic technique " shall appear on the label of the product.

For products containing category 1 NGT, the words "This product contains [name of the product] obtained by new genetic technique" shall appear on the label of the product.

Or. en

Justification

Plants and products of category 1 NGT are covered by patents. In order to respect consumers' freedom of choice, to enforce patent rights but also to clearly inform other breeders, farmers and any other third parties that the use of the plants or the products could lead to the payments of royalties to patent owners, the full traceability and labelling requirements defined in Directive 2001/18, Regulation 1829/2003 and Regulation 1830/2003 should apply.

Amendment 712

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Article 10 – paragraph 1

Text proposed by the Commission

Amendment

Plant reproductive material, including for breeding and scientific purposes, that contains or consists of category 1 NGT plant(s) and is made available to third parties, whether in return for payment or free of charge, shall bear a mention in national variety register automatically transmitted in the EU common register provided for in PRM/FRM indicating the words ‘cat 1 NGT’, followed by the identification number of the NGT plant(s) it has been derived from.

Or. en

Amendment 713

Stanislav Polčák

Proposal for a regulation

Article 10 – paragraph 1

Text proposed by the Commission

Amendment

Or. cs

Amendment 714

Lydie Massard

Proposal for a regulation

Article 10 – paragraph 1

Text proposed by the Commission

Amendment

Plant reproductive material, including for breeding and scientific purposes, NGT plant for food and feed use, NGT product and produced from an NGT plant shall fulfil the labelling requirements as set out in Directive 2001/18 and Regulation (EC) No 1830/2003.

Or. en

Amendment 715

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 10 – paragraph 1

Text proposed by the Commission

Amendment

Category 1 NGT plants, including plant material, progeny and products derived from it that contain or consists of category 1 NGT plant(s) shall bear a front-of-pack label indicating the words ‘GMO cat 1 NGT’, followed by the identification number of the NGT plant(s) it has been derived from.

Or. en

Amendment 716

João Pimenta Lopes

Proposal for a regulation

Article 10 – paragraph 1

Text proposed by the Commission

Amendment

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

Or. pt

Amendment 717

Catherine Griset, Aurélia Beigneux

Proposal for a regulation

Article 10 – 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 718

Erik Poulsen, Asger Christensen, Emma Wiesner

Proposal for a regulation

Article 10 – paragraph 1 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

It shall be prohibited to label consumer products as containing NGT products or having been developed using NGT. It shall furthermore be prohibited to use ‘negative labelling’ by labelling products as not containing NGT products (non-NGT, free of NGT etc)

Or. en

Justification

It is important to ensure that there will not be any labelling on consumer products - also ‘negative labelling’ as described. Such labelling is discriminatory and misleading towards consumers as the knowledge of plant breeding techniques is not widespread and is never labelled when it comes to other methods.

Amendment 719

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 10 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

Category 1 NGT plants and products shall be subject to the rules and requirements of the Union GMO legislation with regard to traceability and labelling and to provisions in other Union legislation that apply to GMOs.

Or. en

Amendment 720

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 10 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

Member States shall take appropriate measures to avoid the unintended presence of category 1 NGT plants in products not subject to this Regulation, Directive 2001/18 or Regulation 1829/2003, including by the possibility of opt-out.

Or. en

Amendment 721

Martin Häusling

Proposal for a regulation

Article 10 a (new)

Text proposed by the Commission

Amendment

Article 10a

Traceability of NGT category 1

1. When placing products produced from category 1 NGT plants and products on the market, operators shall ensure that the following information is transmitted in writing to the operator receiving the product:

(a) an indication of each of the food ingredients which is produced from category 1 NGT plants and products;

(b) an indication of each of the feed materials or additives which is produced from category 1 NGT plants and products;

(c) in the case of products for which no list of ingredients exists, an indication that the product is produced from category 1 NGT plants and products.

2. Without prejudice to Article 6 of EC Directive 1830/2003, operators shall have in place systems and standardised procedures to allow the holding of the information specified in paragraph 1 and the identification, for a period of five years from each transaction, of the operator by whom and to whom the products referred to in paragraph 1 have been made available.

3. Paragraphs 1 and 2 shall be without prejudice to other specific requirements in Community legislation.

4. Paragraphs 1, 2 and 3 shall not apply to traces of category 1 NGT plants and products in products for food and feed produced from category 1 NGT plants and products in a proportion no higher than the thresholds established for those GMOs in accordance with Articles 12, 24 or 47 of Regulation (EC) No 1829/2003, provided that these traces of category 1 NGT plants and products are adventitious or technically unavoidable.

Or. en

Justification

Traceability measures are needed throughout the whole supply chain to enable food processors and operators to avoid the accidental or unavoidable adventitious presence of NGTs in their production process. The absence of a traceability system would amount to imposing the entry of NGTs into the production stream to all food production systems, including organic operators. The freedom to choose whether to use NGTs or not is an essential right of farmers and food producers, both conventional and organic, across Europe, which can only be enforced through a thorough traceability system all along the production chain.

Amendment 722

Pascal Canfin, Max Orville

Proposal for a regulation

Article 10 a (new)

Text proposed by the Commission

Amendment

Article 10a

Article 12 Measures to avoid the unintended presence of category 1 NGT plants

Member States may take appropriate measures to avoid the unintended presence category 1 NGTs. Member States shall develop crop-specific and adjusted measures, based on updated scientific knowledge, to avoid the unintended presence of category 1 NGTs.

Or. en

Amendment 723

Martin Häusling

Proposal for a regulation

Article 10 b (new)

Text proposed by the Commission

Amendment

Article 10b

Cultivation opt-out possibility for Member States

During the authorisation procedure of a given category 1 NGT or during the renewal of authorisation, a Member State may demand that the geographical scope of the written consent or authorisation be adjusted to the effect that all or part of the territory of that Member State is to be excluded from cultivation, according to Article 26b of Directive 2001/18/EC.

Or. en

Amendment 724

Martin Häusling

Proposal for a regulation

Article 10 c (new)

Text proposed by the Commission

Amendment

Article 10c

Measures to avoid the unintended presence of category 1 NGT plants

Member States shall take appropriate measures to avoid the unintended presence of category 1 NGTs, including the possibility of applying the opt-out. Member States shall develop crop specific and adapted measures, based on the latest scientific knowledge and independent science, in order to avoid the unintended presence of category 1 NGTs. Member States shall instate a strict liability system and a compensation fund to compensate operators in the event of contamination.

Or. en

Amendment 725

João Pimenta Lopes

Proposal for a regulation

Article 11

Text proposed by the Commission

Amendment

Article 11

deleted

Confidentiality

1. The requester referred to in Articles 6 and 7 may submit a request to the Member State competent authority or to the Authority, as appropriate, to treat certain parts of the information submitted under this Title as confidential, accompanied by verifiable justification, in accordance with paragraphs 3 and 6.

2. The competent authority or the Authority, as appropriate, shall assess the confidentiality request referred to in paragraph 1.

3. The competent authority or the Authority, as appropriate, may grant confidential treatment only with respect to the following items of information, upon verifiable justification, where the disclosure of such information is demonstrated by the requester to potentially harm its interests to a significant degree:

(a) items of information referred to in points (a), (b) and (c) of Article 39(2) of Regulation (EC) No 178/2002;

(b) DNA sequence information; and

4. The competent authority or the Authority, as appropriate, shall, after consultation with the requester, decide which information is to be treated as confidential and shall inform the requester of its decision.

5. Member States, the Commission and the Authority shall take the necessary measures to ensure that confidential information notified or exchanged under this Chapter is not made public.

6. The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis.

7. In the event of a withdrawal of the verification request by the requester, Member States, the Commission and the Authority shall respect the confidentiality as granted by the competent authority or the Authority in accordance with this Article. Where the withdrawal of the verification request takes place before the competent authority or the Authority has decided on the relevant confidentiality request, Member States, the Commission and the Authority shall not make public the information for which confidentiality has been requested.

Or. pt

Amendment 726

Martin Häusling

Proposal for a regulation

Article 11

Text proposed by the Commission

Amendment

Article 11

deleted

Confidentiality

2. The competent authority or the Authority, as appropriate, shall assess the confidentiality request referred to in paragraph 1.

(a) items of information referred to in points (a), (b) and (c) of Article 39(2) of Regulation (EC) No 178/2002;

(b) DNA sequence information; and

5. Member States, the Commission and the Authority shall take the necessary measures to ensure that confidential information notified or exchanged under this Chapter is not made public.

6. The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis.

Or. en

Amendment 727

Marie Toussaint

Proposal for a regulation

Article 11

Text proposed by the Commission

Amendment

Article 11

deleted

Confidentiality

2. The competent authority or the Authority, as appropriate, shall assess the confidentiality request referred to in paragraph 1.

(a) items of information referred to in points (a), (b) and (c) of Article 39(2) of Regulation (EC) No 178/2002;

(b) DNA sequence information; and

5. Member States, the Commission and the Authority shall take the necessary measures to ensure that confidential information notified or exchanged under this Chapter is not made public.

6. The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis.

Or. en

Justification

Amendment 728

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

Proposal for a regulation

Article 11

Text proposed by the Commission

Amendment

Article 11

deleted

Confidentiality

2. The competent authority or the Authority, as appropriate, shall assess the confidentiality request referred to in paragraph 1.

(a) items of information referred to in points (a), (b) and (c) of Article 39(2) of Regulation (EC) No 178/2002;

(b) DNA sequence information; and

5. Member States, the Commission and the Authority shall take the necessary measures to ensure that confidential information notified or exchanged under this Chapter is not made public.

6. The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis.

Or. en

Amendment 729

Günther Sidl

Proposal for a regulation

Article 11

Text proposed by the Commission

Amendment

Article 11

deleted

Confidentiality

2. The competent authority or the Authority, as appropriate, shall assess the confidentiality request referred to in paragraph 1.

(a) items of information referred to in points (a), (b) and (c) of Article 39(2) of Regulation (EC) No 178/2002;

(b) DNA sequence information; and

5. Member States, the Commission and the Authority shall take the necessary measures to ensure that confidential information notified or exchanged under this Chapter is not made public.

6. The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis.

Or. en

Amendment 730

Martin Häusling

Proposal for a regulation

Article 11 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) DNA sequence information; and

deleted

Or. en

Justification

DNA sequence information should not fall under the scope of confidentiality provisions, as it is of particular importance for the development of detection methods as well as for the assessment of, inter alia, unintended effects

Amendment 731

Christophe Clergeau

Proposal for a regulation

Article 11 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) DNA sequence information; and

(b) DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the genetic modification ; and

Or. en

Amendment 732

Martin Häusling

Proposal for a regulation

Article 11 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Information related to the development of detection methods, the name of the category 1 NGT plant variety, the classification of an NGT plant or products as a category 1 NGT plant or product, and the name of the requester company shall not fall under the information which may be treated as confidential.

Or. en

Amendment 733

Martin Häusling

Proposal for a regulation

Article 11 – paragraph 5 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

Notwithstanding paragraph 4, information which directly or indirectly relates to effects on human health, animal health or the environment, shall be made public by the Authority.

Or. en

Amendment 734

Martin Häusling

Proposal for a regulation

Article 11 – paragraph 6

Text proposed by the Commission

Amendment

6. The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis.

6. The relevant provisions of Articles 39e, 39 and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis.

Or. en

Amendment 735

Christophe Clergeau

Proposal for a regulation

Article 11 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6 a. Notwithstanding paragraphs 3, 5 and 6 of this Article:

(a) where urgent action is essential to protect human health, animal health or the environment, such as in emergency situations, the competent authority may disclose the information referred to in paragraph 3; and

(b) information which forms part of the opinions or statements of the Authority or the conclusions of the assessment reports and which relate to foreseeable effects on human health, animal health or the environment shall nevertheless be made public. In that case, Article 39c of Regulation (EC) No 178/2002 shall apply.

Or. en

Amendment 736

Christophe Clergeau

Proposal for a regulation

Article 11 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7 a. Third parties may submit request to the National competent authority, to the Commission or to the Authority to access confidential information with substantiated argumentation, such as significant concerns about the environment, animal or human health.

Or. en

Amendment 737

Christophe Clergeau

Proposal for a regulation

Article 11 a (new)

Text proposed by the Commission

Amendment

Article11a

Measures to avoid the unintended presence of category 1 NGT plants

1. Member States shall take appropriate measures to avoid the unintended presence of category 1 NGT plants in other 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 1 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 738

Lydie Massard

Proposal for a regulation

Article 11 a (new)

Text proposed by the Commission

Amendment

Article 11a

Member States shall take the appropriate measures to avoid the unintended presence of category 1 plants not subject to Directive 2001/18 or Regulation 1829/2003, based on an implementing regulation to be presented by the EU Commission.

Or. en

Amendment 739

Christophe Clergeau

Proposal for a regulation

Article 11 b (new)

Text proposed by the Commission

Amendment

Article 11b

Duration of the validity of the declaration

If the monitoring results show that there is a risk to health or the environment, or if new scientific data supports this hypothesis, the competent authority may withdraw its decision.

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 740

Lydie Massard

Proposal for a regulation

Article 11 b (new)

Text proposed by the Commission

Amendment

Article 11b

During the authorisation procedure of a given category 1 NGT or during the renewal of consent/authorisation, a Member State may demand that the geographical scope of the written consent or authorisation be adjusted to the effect that all or part of the territory of that Member State is to be excluded from cultivation, according to article 26b of Directive 2001/18/EC.

Or. en

Amendment 741

João Pimenta Lopes

Proposal for a regulation

Chapter III – title

Text proposed by the Commission

Amendment

III Category 2 NGT plants and category 2 NGT products

III NGT Plants and NGT products

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout).

Or. pt

Justification

The risks associated with NGT plants are very diverse, ranging from plants with risk profiles similar to those of conventionally bred plants, to plants with different types and degrees of hazards and risks that may be similar to those of plants obtained through established genetic modification techniques. The levels of regulatory oversight depending on the range of potential risks posed by NGT plants and products is not adequate to protect the environment and health. The risk assessment of all NGT plants should therefore be carried out in the same way as for any GMO.

Amendment 742

Lydie Massard

Proposal for a regulation

Chapter III – title

Text proposed by the Commission

Amendment

III Category 2 NGT plants and category 2 NGT products

III NGT plants and NGT products

Or. en

Amendment 743

Günther Sidl

Proposal for a regulation

Chapter III – title

Text proposed by the Commission

Amendment

III Category 2 NGT plants and category 2 NGT products

III NGT plants and NGT products

Or. en

Amendment 744

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

Proposal for a regulation

Chapter III – title

Text proposed by the Commission

Amendment

III Category 2 NGT plants and category 2 NGT products

III NGT plants and NGT products

Or. en

Amendment 745

Lydie Massard

Proposal for a regulation

Article 12 – title

Text proposed by the Commission

Amendment

Status of Category 2 NGT plants and category 2 NGT products

Status of NGT plants and NGT products

Or. en

Amendment 746

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

Proposal for a regulation

Article 12 – title

Text proposed by the Commission

Amendment

Status of Category 2 NGT plants and category 2 NGT products

Status of NGT plants and NGT products

Or. en

Amendment 747

Günther Sidl

Proposal for a regulation

Article 12 – title

Text proposed by the Commission

Amendment

Status of Category 2 NGT plants and category 2 NGT products

Status of NGT plants and NGT products

Or. en

Amendment 748

Martin Häusling

Proposal for a regulation

Article 12 – paragraph 1

Text proposed by the Commission

Amendment

The rules which apply to GMOs in Union legislation in so far as they are not derogated from by this Regulation, shall apply to category 2 NGT plants and category 2 NGT products.

The rules which apply to GMOs in Union legislation, as well as food safety and environmental legislation, in so far as they are not derogated from by this Regulation, shall apply to category 2 NGT plants and category 2 NGT products.

Or. en

Amendment 749

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

Proposal for a regulation

Article 12 – paragraph 1

Text proposed by the Commission

Amendment

The rules which apply to GMOs in Union legislation in so far as they are not derogated from by this Regulation, shall apply to category 2 NGT plants and category 2 NGT products.

The rules which apply to GMOs in Union legislation shall apply to NGT plants and NGT products.

Or. en

Amendment 750

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 12 – paragraph 1

Text proposed by the Commission

Amendment

The rules which apply to GMOs in Union legislation in so far as they are not derogated from by this Regulation, shall apply to category 2 NGT plants and category 2 NGT products.

The rules which apply to GMOs in Union legislation shall apply to category 2 NGT plants and category 2 NGT products.

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

Amendment 751

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

Proposal for a regulation

Chapter III – Section 1 – title

Text proposed by the Commission

Amendment

1 Deliberate release of category 2 NGT plants for any other purpose than for placing on the market

1 Deliberate release of NGT plants for any other purpose than for placing on the market

Or. en

Amendment 752

Günther Sidl

Proposal for a regulation

Chapter III – Section 1 – title

Text proposed by the Commission

Amendment

1 Deliberate release of category 2 NGT plants for any other purpose than for placing on the market

1 Deliberate release of NGT plants for any other purpose than for placing on the market

Or. en

Amendment 753

Günther Sidl

Proposal for a regulation

Article 13 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

As regards the deliberate release of a category 2 NGT plant for any other purpose than placing on the market, the notification referred to in Article 6(1) of Directive 2001/18/EC shall include:

As regards the deliberate release of an NGT plant for any other purpose than placing on the market, the notification referred to in Article 6(1) of Directive 2001/18/EC shall include:

Or. en

Amendment 754

Lydie Massard

Proposal for a regulation

Article 13 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

As regards the deliberate release of a category 2 NGT plant for any other purpose than placing on the market, the notification referred to in Article 6(1) of Directive 2001/18/EC shall include:

As regards the deliberate release of a NGT plant for any other purpose than placing on the market, the notification referred to in Article 6(1) of Directive 2001/18/EC shall include:

Or. en

Amendment 755

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

Proposal for a regulation

Article 13 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

As regards the deliberate release of a category 2 NGT plant for any other purpose than placing on the market, the notification referred to in Article 6(1) of Directive 2001/18/EC shall include:

As regards the deliberate release of a NGT plant for any other purpose than placing on the market, the notification referred to in Article 6(1) of Directive 2001/18/EC shall include:

Or. en

Amendment 756

Martin Häusling

Proposal for a regulation

Article 13 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) a copy of the studies, which have been carried out and any other available material to demonstrate that the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

(b) a copy of the studies, which have been carried out and any other available material to demonstrate that the plant is a NGT plant and falls within the scope of this Regulation, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

Or. en

Amendment 757

Stanislav Polčák

Proposal for a regulation

Article 13 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) a copy of the studies, which have been carried out and any other available material to demonstrate that the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

Or. cs

Amendment 758

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

Proposal for a regulation

Article 13 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) a copy of the studies, which have been carried out and any other available material to demonstrate that the plant is a NGT plant, including that it does not contain any genetic material originating from outside the cell where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

Or. en

Amendment 759

Günther Sidl

Proposal for a regulation

Article 13 – paragraph 1 – point c – point ii

Text proposed by the Commission

Amendment

(ii) information relating to the category 2 NGT plant(s);

(ii) information relating to the NGT plant(s);

Or. en

Amendment 760

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

Proposal for a regulation

Article 13 – paragraph 1 – point c – point ii

Text proposed by the Commission

Amendment

(ii) information relating to the category 2 NGT plant(s);

(ii) information relating to the NGT plant(s);

Or. en

Amendment 761

Günther Sidl

Proposal for a regulation

Article 13 – paragraph 1 – point c – point iv

Text proposed by the Commission

Amendment

(iv) information on the interactions between the category 2 NGT plant(s) and the environment;

(iv) information on the interactions between the NGT plant(s) and the environment;

Or. en

Amendment 762

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

Proposal for a regulation

Article 13 – paragraph 1 – point c – point iv

Text proposed by the Commission

Amendment

(iv) information on the interactions between the category 2 NGT plant(s) and the environment;

(iv) information on the interactions between the NGT plant(s) and the environment;

Or. en

Amendment 763

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

Proposal for a regulation

Article 13 – paragraph 1 – point c – point v

Text proposed by the Commission

Amendment

(v) a plan for monitoring in order to identify effects of the category 2 NGT plant(s) on human health or the environment;

(v) a plan for monitoring in order to identify effects of the NGT plant(s) on human health or the environment;

Or. en

Amendment 764

Günther Sidl

Proposal for a regulation

Article 13 – paragraph 1 – point c – point v

Text proposed by the Commission

Amendment

(v) a plan for monitoring in order to identify effects of the category 2 NGT plant(s) on human health or the environment;

(v) a plan for monitoring in order to identify effects of the NGT plant(s) on human health or the environment;

Or. en

Amendment 765

Martin Häusling

Proposal for a regulation

Article 13 – paragraph 1 – point c – point vi

Text proposed by the Commission

Amendment

(vi) where relevant, information on control, remediation methods, waste treatment and emergency response plans;

(vi) information on control, remediation methods, waste treatment and emergency response plans;

Or. en

Amendment 766

Catherine Griset, Aurélia Beigneux

Proposal for a regulation

Article 13 – paragraph 1 – point d – point i (new)

Text proposed by the Commission

Amendment

(i) Category 2 NGT plants shall be subject to a systematic health and environmental risk assessment, including ‘off-target’ or unintended modifications and those related to the adventitious and persistent presence of residual DNA from the transformation vector.

Or. fr

Amendment 767

Catherine Griset, Aurélia Beigneux

Proposal for a regulation

Article 13 – paragraph 1 – point d – point ii (new)

Text proposed by the Commission

Amendment

(ii) Category 2 NGT plants shall be subject to a systematic ex-post health and environmental risk assessment through the implementation of regular reviews in order to adapt the authorisations in line with scientific developments and the effects observed by the biovigilance and sociovigilance networks. In the event of a negative assessment, the authorisation for release shall be suspended pending further analysis.

Or. fr

Amendment 768

Martin Häusling

Proposal for a regulation

Article 13 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

(da) a declaration stating that:

(i) there are no patents or exclusive rights covering the process used to develop the plant;

(ii) there are no patents or exclusive rights covering the plant or parts thereof;

(iii) no application has been tabled for such patents or exclusive rights to be granted;

Or. en

Amendment 769

Lydie Massard

Proposal for a regulation

Article 13 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

(da) the proof that:

(i) there are no patents or exclusive rights covering the process used to develop the plant;

(ii) there are no patents or exclusive rights covering the plant or parts thereof;

(iii) no application has been tabled for such patents or exclusive rights to be granted;

Or. en

Amendment 770

Christophe Clergeau

Proposal for a regulation

Article 13 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

(da) a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC;

Or. en

Amendment 771

Günther Sidl

Proposal for a regulation

Chapter III – Section 2 – title

Text proposed by the Commission

Amendment

2 Placing on the market of category 2 NGT products other than food or feed

2 Placing on the market of NGT products other than food or feed

Or. en

Amendment 772

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

Proposal for a regulation

Chapter III – Section 2 – title

Text proposed by the Commission

Amendment

2 Placing on the market of category 2 NGT products other than food or feed

2 Placing on the market of NGT products other than food or feed

Or. en

Amendment 773

Lydie Massard

Proposal for a regulation

Chapter III – Section 2 – title

Text proposed by the Commission

Amendment

2 Placing on the market of category 2 NGT products other than food or feed

2 Placing on the market of NGT products other than food or feed

Or. en

Amendment 774

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

Proposal for a regulation

Article 14 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. As regards the placing on the market of category 2 NGT products other than food and feed, the notification referred to in Article 13(2) of Directive 2001/18/EC, without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002, shall contain:

1. As regards the placing on the market of NGT products other than food and feed, the notification referred to in Article 13(2) of Directive 2001/18/EC, without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002, shall contain:

Or. en

Amendment 775

Günther Sidl

Proposal for a regulation

Article 14 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Or. en

Amendment 776

Günther Sidl

Proposal for a regulation

Article 14 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) designation and specification of the category 2 NGT plant;

(b) designation and specification of the NGT plant;

Or. en

Amendment 777

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

Proposal for a regulation

Article 14 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) designation and specification of the category 2 NGT plant;

(b) designation and specification of the NGT plant;

Or. en

Amendment 778

Martin Häusling

Proposal for a regulation

Article 14 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) a copy of the studies, which have been carried out and any other available material to demonstrate that the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

(d) a copy of the studies, which have been carried out and any other available material to demonstrate that the plant is a NGT plant, and that it falls within the scope of this Regulation, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

Or. en

Amendment 779

Stanislav Polčák

Proposal for a regulation

Article 14 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) a copy of the studies, which have been carried out and any other available material to demonstrate that the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

Or. cs

Amendment 780

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

Proposal for a regulation

Article 14 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) a copy of the studies, which have been carried out and any other available material to demonstrate that the plant is a NGT plant, including that it does not contain any genetic material originating from outside the cell where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

Or. en

Amendment 781

Martin Häusling

Proposal for a regulation

Article 14 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

(da) the entire genome sequence, performed via an unbiased long-read sequencing with the most accurate and up to date techniques to show that, among other things, the plant does not contain any transgenic material or transgenes, such as those which may have been inserted as part of the development of the plant;

Or. en

Amendment 782

João Pimenta Lopes

Proposal for a regulation

Article 14 – paragraph 1 – point h

Text proposed by the Commission

Amendment

(h) where appropriate, a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the time-period of the monitoring plan; this time-period may be different from the proposed period for the consent. If, based on the results of any release notified in accordance with Section 1, the findings of the environmental risk assessment, the characteristics of the NGT plant, the characteristics and scale of its expected use and the characteristics of the receiving environment, in accordance with the implementing act adopted in accordance with Article 27, point (d), the notifier considers that the NGT plant does not need a monitoring plan, the notifier may propose not to submit a monitoring plan;

deleted

Or. pt

Amendment 783

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 14 – paragraph 1 – point h

Text proposed by the Commission

Amendment

(h) a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC;

Or. en

Amendment 784

Günther Sidl

Proposal for a regulation

Article 14 – paragraph 1 – point h

Text proposed by the Commission

Amendment

Or. en

Justification

There is no sufficient justification to exempt some NGT plants completely from any monitoring. The monitoring is meant to identify unexpected effects and thus is essential in order to uphold the precautionary principle.

Amendment 785

Martin Häusling

Proposal for a regulation

Article 14 – paragraph 1 – point h

Text proposed by the Commission

Amendment

Or. en

Justification

The monitoring is meant to identify unexpected effects and thus is essential in order to uphold the precautionary principle. We do not see a sufficient justification to exempt some NGT plants completely from any monitoring.

Amendment 786

Christophe Clergeau

Proposal for a regulation

Article 14 – paragraph 1 – point h

Text proposed by the Commission

Amendment

(h) a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the time-period of the monitoring plan; this time-period may be different from the proposed period for the consent. If, based on the results of any release notified in accordance with Section 1, the findings of the environmental risk assessment, the characteristics of the NGT plant, the characteristics and scale of its expected use and the characteristics of the receiving environment, in accordance with the implementing act adopted in accordance with Article 27, point (d), the competent authority considers if the NGT plant should require a lighter monitoring plan;

Or. en

Amendment 787

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

Proposal for a regulation

Article 14 – paragraph 1 – point h

Text proposed by the Commission

Amendment

(h) a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the time-period of the monitoring plan; this time-period may be different from the proposed period for the consent. If, based on the results of any release notified in accordance with Section 1, the findings of the environmental risk assessment, the characteristics of the NGT plant, the characteristics and scale of its expected use and the characteristics of the receiving environment, in accordance with the implementing act adopted in accordance with Article 27, point (d), the notifier considers that the NGT plant only needs a limited monitoring plan, the notifier may propose a limited monitoring plan;

Or. en

Amendment 788

Günther Sidl

Proposal for a regulation

Article 14 – paragraph 1 – point j

Text proposed by the Commission

Amendment

(j) proposed commercial names of the products and names of category 2 NGT plants contained therein, and a proposal for a unique identifier for the category 2 NGT plant, developed in accordance with Commission Regulation (EC) No 65/2004 (60 ). After the consent any new commercial names should be provided to the competent authority;

(j) proposed commercial names of the products and names of NGT plants contained therein, and a proposal for a unique identifier for the NGT plant, developed in accordance with Commission Regulation (EC) No 65/2004 (60 ). After the consent any new commercial names should be provided to the competent authority;

_________________

60 Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (OJ L 10, 16.1.2004, p. 5).

Or. en

Amendment 789

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

Proposal for a regulation

Article 14 – paragraph 1 – point j

Text proposed by the Commission

Amendment

_________________

Or. en

Amendment 790

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

Proposal for a regulation

Article 14 – paragraph 1 – point l

Text proposed by the Commission

Amendment

(l) methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifier, the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2);

(l) methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant;

Or. en

Amendment 791

Pietro Fiocchi

Proposal for a regulation

Article 14 – paragraph 1 – point l

Text proposed by the Commission

Amendment

(l) methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant. If the specificities of the modification do not allow for the identification or quantification, methods for detection, identification and quantification do not need to be provided this is duly justified;

Or. en

Amendment 792

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

Proposal for a regulation

Article 14 – paragraph 1 – point l

Text proposed by the Commission

Amendment

(l) methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifier, the plant should be considered as category 1 NGT plant in accordance with Article 3(7)(c) of this Regulation;

Or. en

Justification

The proposal suggests that for certain category 2 NGT plants no or only an adapted identification method can be developed (yet). While these plants will consequently be regulated as GMOs, they are in fact not distinguishable from conventional plants. This is a specific challenge for imports. If for imports it is not possible to identify unauthorized NGTs with category 2 changes, it is discriminatory to require traceability and labelling of such products within the EU. Consequently, category 2 NGT plants for which no identification method can be developed should logically be treated as category 1 NGT plants.

Amendment 793

Jessica Polfjärd

Proposal for a regulation

Article 14 – paragraph 1 – point l

Text proposed by the Commission

Amendment

(l) methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant. If duly justified by the notifier, the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2);

Or. en

Amendment 794

Martin Häusling

Proposal for a regulation

Article 14 – paragraph 1 – point l

Text proposed by the Commission

Amendment

(l) methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if concluded by the Union Reference Laboratory, the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2);

Or. en

Justification

The Reference Laboratory should have the responsibility, not the applicant, to check and decide whether adapting the modalities to comply with analytical method requirements is justified, based on data provided by the applicant and any other available information.

Amendment 795

Günther Sidl

Proposal for a regulation

Article 14 – paragraph 1 – point l

Text proposed by the Commission

Amendment

(l) methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if concluded by the Union Reference Laboratory, the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2);

Or. en

Justification

The Reference Laboratory has the responsibility to check and decide independently and autonomously whether adapting the modalities to comply with analytical method requirements is justified, based on data provided by the applicant and any other available information.

Amendment 796

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

Proposal for a regulation

Article 14 – paragraph 1 – point m

Text proposed by the Commission

Amendment

(m) samples of the category 2 NGT plant and their control samples, and information as to the place where the reference material can be accessed;

(m) samples of the NGT plant and their control samples, and information as to the place where the reference material can be accessed;

Or. en

Amendment 797

Günther Sidl

Proposal for a regulation

Article 14 – paragraph 1 – point m

Text proposed by the Commission

Amendment

(m) samples of the category 2 NGT plant and their control samples, and information as to the place where the reference material can be accessed;

(m) samples of the NGT plant and their control samples, and information as to the place where the reference material can be accessed;

Or. en

Amendment 798

Martin Häusling

Proposal for a regulation

Article 14 – paragraph 1 – point n

Text proposed by the Commission

Amendment

(n) where applicable, the information to be provided for the purpose of complying with Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity;

(n) the information to be provided for the purpose of complying with Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity;

Or. en

Amendment 799

Günther Sidl

Proposal for a regulation

Article 14 – paragraph 2

Text proposed by the Commission

Amendment

2. The notifier shall include in this notification information on data or results from releases of the same category 2 NGT plant or the same combination of category 2 NGT plants previously or currently notified and/or carried out by the notifier either inside or outside the Union.

2. The notifier shall include in this notification information on data or results from releases of the same NGT plant or the same combination of NGT plants previously or currently notified and/or carried out by the notifier either inside or outside the Union.

Or. en

Amendment 800

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

Proposal for a regulation

Article 14 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 801

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

Proposal for a regulation

Article 14 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The assessment report as well as all information provided by the applicant shall be made publicly available on a website without undue delay.

Or. en

Amendment 802

Lydie Massard

Proposal for a regulation

Article 15

Text proposed by the Commission

Amendment

Article 15

deleted

Specific provisions on monitoring

The written consent referred to in Article 19 of Directive 2001/18/EC shall either specify monitoring requirements, as described in Article 19(3) point (f) or state that monitoring is not required. Article 17(2), point (b), of Directive 2001/18/EC shall not apply if monitoring is not required by the consent.

Or. en

Amendment 803

Martin Häusling

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

There is no justification for exempting some NGT 2 plants from monitoring, since the monitoring is intended to identify unexpected results and is therefore important from a precautionary perspective.

Amendment 804

Stanislav Polčák

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

The written consent referred to in Article 19 of Directive 2001/18/EC shall specify monitoring requirements, as described in Article 19(3) point (f). The requirement for monitoring can only be waived upon the renewal of consent, provided that it has been demonstrated that the category 2 NGT plant does not pose risks that need monitoring, such as indirect, delayed or unforeseen effects on human health or on the environment.

Or. cs

Amendment 805

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

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

The written consent referred to in Article 19 of Directive 2001/18/EC shall specify monitoring requirements, as described in Article 19(3) point (f).

Or. en

Amendment 806

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

The written consent referred to in Article 19 of Directive 2001/18/EC shall specify monitoring requirements, as described in Article 19(3) point (f).

Or. en

Amendment 807

Christophe Clergeau

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

The written consent referred to in Article 19 of Directive 2001/18/EC shall either specify monitoring requirements, as described in Article 19(3) point (f) or state that monitoring could be lighter. The written consent shall provide the adequate grounds that justifies that a monitoring plan is lighter. Article 17(2), point (b), of Directive 2001/18/EC shall not apply if monitoring is not required by the consent.

Or. en

Amendment 808

Günther Sidl

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

The written consent referred to in Article 19 of Directive 2001/18/EC shall either specify monitoring requirements, as described in Article 19(3) point (f) of this regulation. Seeds and other reproductive material has to be subjected to monitoring. Exemption from monitoring may be granted, if duly justified, for the release of non-reproductive material.

Or. en

Justification

Amendment 809

Francesca Peppucci

Proposal for a regulation

Article 16

Text proposed by the Commission

Amendment

Article 16

deleted

Labelling in accordance with Article 23

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

Or. en

Amendment 810

Martin Häusling

Proposal for a regulation

Article 16

Text proposed by the Commission

Amendment

Article 16

deleted

Labelling in accordance with Article 23

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

Or. en

Amendment 811

Pietro Fiocchi

Proposal for a regulation

Article 16 – paragraph 1

Text proposed by the Commission

Amendment

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

deleted

Or. it

Amendment 812

Günther Sidl

Proposal for a regulation

Article 16 – paragraph 1

Text proposed by the Commission

Amendment

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

deleted

Or. en

Amendment 813

Pietro Fiocchi

Proposal for a regulation

Article 16 – paragraph 1

Text proposed by the Commission

Amendment

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

In addition to Article 19(3) of Directive 2001/18/EC, to be adapted to include the designation ‘new genomic techniques’ or ‘NGT’, the written consent shall specify the labelling in accordance with Article 23 of this Regulation.

Or. it

Amendment 814

João Pimenta Lopes

Proposal for a regulation

Article 17

Text proposed by the Commission

Amendment

Article 17

deleted

Duration of the validity of the consent after renewal

1. The consent granted under Part C of Directive 2001/18/EC shall, after the first renewal in accordance with Article 17 of Directive 2001/18/EC, be valid for an unlimited period, unless the decision referred to in Article 17(6) or (8) provides that the renewal is 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 consent.

2. The last sentence in Article 17(6) and (8) of Directive 2001/18/EC shall not apply.

Or. pt

Amendment 815

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

Proposal for a regulation

Article 17

Text proposed by the Commission

Amendment

Article 17

deleted

Duration of the validity of the consent after renewal

2. The last sentence in Article 17(6) and (8) of Directive 2001/18/EC shall not apply.

Or. en

Amendment 816

Martin Häusling

Proposal for a regulation

Article 17 – paragraph 1

Text proposed by the Commission

Amendment

1. The consent granted under Part C of Directive 2001/18/EC shall, after each renewal in accordance with Article 17 of Directive 2001/18/EC, be valid for 10 years.

Or. en

Justification

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

Amendment 817

Günther Sidl

Proposal for a regulation

Article 17 – paragraph 1

Text proposed by the Commission

Amendment

1. The consent granted under Part C of Directive 2001/18/EC shall, after each renewal in accordance with Article 17 of Directive 2001/18/EC, be valid for 10 years.

Or. en

Amendment 818

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 17 – paragraph 1

Text proposed by the Commission

Amendment

1. The consent granted under Part C of Directive 2001/18/EC shall, after the first renewal in accordance with Article 17 of Directive 2001/18/EC, 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 819

María Soraya Rodríguez Ramos, Michal Wiezik

Proposal for a regulation

Article 17 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 820

Christophe Clergeau

Proposal for a regulation

Article 17 – paragraph 1

Text proposed by the Commission

Amendment

1. The consent granted under Part C of Directive 2001/18/EC shall, after each renewal in accordance with Article 17 of Directive 2001/18/EC, be valid for 10 years, unless after three renewal rounds the decision referred to in Article 17(6) or (8) provides that the renewal is 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 consent.

Or. en

Amendment 821

Lydie Massard

Proposal for a regulation

Article 17 – paragraph 1

Text proposed by the Commission

Amendment

1. The consent granted under Part C of Directive 2001/18/EC shall, after the first renewal in accordance with Article 17 of Directive 2001/18/EC, be valid for 10 years, unless the decision referred to in Article 17(6) or (8) provides that the renewal is 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 consent.

Or. en

Amendment 822

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 17 – paragraph 2

Text proposed by the Commission

Amendment

2. The last sentence in Article 17(6) and (8) of Directive 2001/18/EC shall not apply.

deleted

Or. en

Amendment 823

Martin Häusling

Proposal for a regulation

Article 17 – paragraph 2

Text proposed by the Commission

Amendment

2. The last sentence in Article 17(6) and (8) of Directive 2001/18/EC shall not apply.

deleted

Or. en

Justification

Article 17 of Directive 2001/18/EC relates to renewal of consent. the last sentence of Article 17(6) states that 'The validity of the consent should not, as a general rule, exceed ten years and may be limited or extended as appropriate for specific reasons'. the last sentence of 17(8) states that 'The validity of the consent may be limited as appropriate.' Both of these provisions should apply.

Amendment 824

Christophe Clergeau

Proposal for a regulation

Article 17 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. If the monitoring results show that there is a risk to health or the environment, or if new scientific data supports this hypothesis, the competent authority may withdraw its decision.

Or. en

Amendment 825

Günther Sidl

Proposal for a regulation

Chapter III – Section 3 – title

Text proposed by the Commission

Amendment

3 Placing on the market of category 2 NGT plants for food or feed use and of category 2 NGT food and feed

3 Placing on the market of NGT plants for food or feed use and of NGT food and feed

Or. en

Amendment 826

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

Proposal for a regulation

Chapter III – Section 3 – title

Text proposed by the Commission

Amendment

3 Placing on the market of category 2 NGT plants for food or feed use and of category 2 NGT food and feed

3 Placing on the market of NGT plants for food or feed use and of NGT food and feed

Or. en

Amendment 827

Günther Sidl

Proposal for a regulation

Article 18 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) category 2 NGT plants for food use or for feed use;

(a) NGT plants for food use or for feed use;

Or. en

Amendment 828

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

Proposal for a regulation

Article 18 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) category 2 NGT plants for food use or for feed use;

(a) NGT plants for food use or for feed use;

Or. en

Amendment 829

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

Proposal for a regulation

Article 18 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) food containing, consisting or produced from category 2 NGT plants or containing ingredients produced from category 2 NGT plants (‘category 2 NGT food’);

(b) food containing, consisting or produced from NGT plants or containing ingredients produced from NGT plants (‘NGT food’);

Or. en

Amendment 830

Günther Sidl

Proposal for a regulation

Article 18 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) food containing, consisting or produced from category 2 NGT plants or containing ingredients produced from category 2 NGT plants (‘category 2 NGT food’);

(b) food containing, consisting or produced from NGT plants or containing ingredients produced from NGT plants (‘ NGT food’);

Or. en

Amendment 831

Günther Sidl

Proposal for a regulation

Article 18 – paragraph 1 – point c

Text proposed by the Commission

Amendment

Or. en

Amendment 832

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

Proposal for a regulation

Article 18 – paragraph 1 – point c

Text proposed by the Commission

Amendment

Or. en

Amendment 833

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

Proposal for a regulation

Article 19 – title

Text proposed by the Commission

Amendment

Specific provisions on the application for authorisation referred to in Articles 5 and 17 of Regulation (EC) No 1829/2003

Specific provisions on the application for authorisation

Or. en

Amendment 834

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

Proposal for a regulation

Article 19 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. By way of derogation from Articles 5(3), point (e), and 17(3), point (e), of Regulation (EC) No 1829/2003, and without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002, an application for authorisation of a category 2 NGT plant for food or feed use, or category 2 NGT food or feed shall be accompanied by a copy of the studies, including, where available, independent, peer-reviewed studies, which have been carried out and any other available material to demonstrate that:

1. Without prejudice to Articles 5(3), point (e), and 17(3), point (e), of Regulation (EC) No 1829/2003 and to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002, an application for authorisation of a NGT plant for food or feed use, or NGT food or feed shall be accompanied by a copy of the studies, including independent, peer-reviewed studies, which have been carried out and any other available material to demonstrate that:

Or. en

Amendment 835

Günther Sidl

Proposal for a regulation

Article 19 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. By way of derogation from Articles 5(3), point (e), and 17(3), point (e), of Regulation (EC) No 1829/2003, and without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002, an application for authorisation of a NGT plant for food or feed use, or NGT food or feed shall be accompanied by a copy of the studies, including, where available, independent, peer-reviewed studies, which have been carried out and any other available material to demonstrate that:

Or. en

Amendment 836

Stanislav Polčák

Proposal for a regulation

Article 19 – paragraph 1 – point a

Text proposed by the Commission

Amendment

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

(a) the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

Or. cs

Amendment 837

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

Proposal for a regulation

Article 19 – paragraph 1 – point a

Text proposed by the Commission

Amendment

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

Or. en

Amendment 838

João Pimenta Lopes

Proposal for a regulation

Article 19 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the food or the feed complies with the criteria referred to in Article 4(1) or Article 16(1) of Regulation (EC) No 1829/2003, respectively, based on a safety assessment of the food or feed carried out in accordance with the principles and criteria laid down in Parts 1 and 3 of Annex II to this Regulation and with the implementing act adopted in accordance with Article 27, point (c).

(b) the food or the feed complies with the criteria referred to in Article 4(1) or Article 16(1) of Regulation (EC) No 1829/2003, respectively, based on an assessment of the risk to biodiversity and on a safety assessment of the food or feed carried out in accordance with the principles and criteria laid down in Parts 1 and 3 of Annex II to this Regulation and with the implementing act adopted in accordance with Article 27, point (c).

Or. pt

Amendment 839

João Pimenta Lopes

Proposal for a regulation

Article 19 – paragraph 2

Text proposed by the Commission

Amendment

2. By way of derogation from Articles 5(3), point (i), and 17(3), point (i), of Regulation (EC) No 1829/2003, an application for authorisation shall be accompanied by methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant and, where applicable, for the detection and identification of the NGT plant in the NGT food or feed.

deleted

In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the applicant or concluded by the European Union Reference Laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 during the procedure referred to in Article 20(4), the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2);

Or. pt

Amendment 840

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

Proposal for a regulation

Article 19 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

By way of derogation from Articles 5(3), point (i), and 17(3), point (i), of Regulation (EC) No 1829/2003, an application for authorisation shall be accompanied by methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant and, where applicable, for the detection and identification of the NGT plant in the NGT food or feed.

Without prejudice to Articles 5(3), point (i), and 17(3), point (i), of Regulation (EC) No 1829/2003, an application for authorisation shall be accompanied by methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant and, where applicable, for the detection and identification of the NGT plant in the NGT food or feed.

Or. en

Amendment 841

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

Proposal for a regulation

Article 19 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 842

Günther Sidl

Proposal for a regulation

Article 19 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Detection methods must be provided for all NGT plants. This is the only way to provide proof of organic farming and GMO-free agriculture in order to guarantee the GMO-free agriculture that consumers expect. As consumers have to pay higher prices for these quality products, GMO-free farming has to be guaranteed for these products.

Amendment 843

Pietro Fiocchi

Proposal for a regulation

Article 19 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the applicant or concluded by the European Union Reference Laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 during the procedure referred to in Article 20(4), the application for authorisation shall be accompanied by that justification;

Or. it

Amendment 844

Francesca Peppucci

Proposal for a regulation

Article 19 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the applicant or concluded by the European Union Reference Laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 during the procedure referred to in Article 20(4), the application for authorisation is accompanied by such justification;

Or. en

Amendment 845

Jessica Polfjärd

Proposal for a regulation

Article 19 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

If duly justified by the applicant or concluded by the European Union Reference Laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 during the procedure referred to in Article 20(4), the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2);

Or. en

Amendment 846

Christophe Clergeau

Proposal for a regulation

Article 19 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the applicant and concluded by the European Union Reference Laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 during the procedure referred to in Article 20(4), the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2);

Or. en

Amendment 847

Martin Häusling

Proposal for a regulation

Article 19 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if concluded by the European Union Reference Laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 during the procedure referred to in Article 20(4), the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2);

Or. en

Amendment 848

Martin Häusling

Proposal for a regulation

Article 19 – paragraph 3

Text proposed by the Commission

Amendment

3. By way of derogation from Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, in the case of category 2 NGT plants or food or feed containing or consisting of category 2 NGT plants, the application shall also be accompanied by:

deleted

(a) the environmental risk assessment carried out in accordance with the principles and criteria set out in Parts 1 and 2 of Annex II and with the implementing act adopted in accordance with Article 27, point (c);

(b) where appropriate, a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan. This duration may be different from the duration of the authorisation. If, based on the results of any release notified in accordance with Section 1, the findings of the environmental risk assessment, the characteristics of the NGT plant, the characteristics and scale of its expected use and the characteristics of the receiving environment, in accordance with the implementing act adopted in accordance with Article 27, point (d), the applicant considers that the NGT plant does need a monitoring plan, the applicant may propose not to submit a monitoring plan.

Or. en

Amendment 849

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

Proposal for a regulation

Article 19 – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

3. Without prejudice to Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, in the case of NGT plants or food or feed containing or consisting of NGT plants, the application shall also be accompanied by:

Or. en

Amendment 850

Günther Sidl

Proposal for a regulation

Article 19 – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

3. By way of derogation from Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, in the case of NGT plants or food or feed containing or consisting of NGT plants, the application shall also be accompanied by:

Or. en

Amendment 851

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 19 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC.

Or. en

Amendment 852

João Pimenta Lopes

Proposal for a regulation

Article 19 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan.

Or. pt

Amendment 853

Martin Häusling

Proposal for a regulation

Article 19 – paragraph 3 – point b

Text proposed by the Commission

Amendment

Or. en

Justification

Exemption from monitoring may be granted, if duly justified, in cases where no material capable of reproduction is released (see former Article 15).

Amendment 854

Christophe Clergeau

Proposal for a regulation

Article 19 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan. In case the application is a request for renewal and if based on the results of the monitoring report or regarding the findings of the environmental risk assessment of any released Cat 2 NGT plant or food or feed containing or consisting of Cat 2 NGT plant, the characteristics of the NGT plant, the characteristics and scale of its expected use and the characteristics of the receiving environment, in accordance with the implementing act adopted in accordance with Article 27, point (d), the competent authority may propose not require the continuation of the monitoring plan.

Or. en

Amendment 855

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

Proposal for a regulation

Article 19 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan. This duration may be different from the duration of the authorisation. If, based on the results of any release notified in accordance with Section 1, the findings of the environmental risk assessment, the characteristics of the NGT plant, the characteristics and scale of its expected use and the characteristics of the receiving environment, in accordance with the implementing act adopted in accordance with Article 27, point (d), the applicant considers that the NGT plant only needs a limited monitoring plan, the applicant may propose to submit a limited monitoring plan.

Or. en

Amendment 856

Martin Häusling

Proposal for a regulation

Article 19 – paragraph 4

Text proposed by the Commission

Amendment

4. The application shall also contain a proposal for labelling in accordance with Article 23.

deleted

Or. en

Amendment 857

Günther Sidl

Proposal for a regulation

Article 19 – paragraph 4

Text proposed by the Commission

Amendment

4. The application shall also contain a proposal for labelling in accordance with Article 23.

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. Article 19 (4) is connected to Article 23 and is therefore not needed as this article should be deleted.

Amendment 858

Martin Häusling

Proposal for a regulation

Article 20 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

By way of derogation from Article 6(1) and (2) and Article 18(1) and (2) of Regulation (EC) No 1829/2003, the Authority shall deliver an opinion on the application for authorisation referred to in Article 19 of this Regulation within six months as from the receipt of a valid application.

deleted

Or. en

Amendment 859

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 20 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

By way of derogation from Article 6(1) and (2) and Article 18(1) and (2) of Regulation (EC) No 1829/2003, the Authority shall deliver an opinion on the application for authorisation referred to in Article 19 of this Regulation within nine months as from the receipt of a valid application.

Or. en

Amendment 860

Christophe Clergeau

Proposal for a regulation

Article 20 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

By way of derogation from Article 6(1) and (2) and Article 18(1) and (2) of Regulation (EC) No 1829/2003, the Authority shall assent the application for authorisation referred to in Article 19 of this Regulation within six months as from the receipt of a valid application.

Or. en

Amendment 861

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 20 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

Where the Authority or the competent authority of the Member State carrying out the environmental risk assessment or the safety assessment of the food or feed pursuant to Article 6(3), points (b) and (c) and Article 18(3), points (b) and (c) of Regulation (EC) No 1829/2003 considers that additional information is necessary, the Authority, or the national competent authority through the Authority, shall ask the applicant to submit that information within a specified time limit. In that case, the six months period shall be extended by that additional period. The extension shall not exceed six months unless it is justified by the nature of the data requested or by exceptional circumstances.

Where the Authority or the competent authority of the Member State carrying out the environmental risk assessment or the safety assessment of the food or feed pursuant to Article 6(3), points (b) and (c) and Article 18(3), points (b) and (c) of Regulation (EC) No 1829/2003 considers that additional information is necessary, the Authority, or the national competent authority through the Authority, shall ask the applicant to submit that information within a specified time limit. In that case, the period shall be extended by that additional period. The extension shall not exceed six months unless it is justified by the nature of the data requested or by exceptional circumstances.

Or. en

Amendment 862

Martin Häusling

Proposal for a regulation

Article 20 – paragraph 3

Text proposed by the Commission

Amendment

3. By way of derogation from Article 6(3), point (d), and Article 18(3), point (d), of Regulation (EC) No 1829/2003, the Authority shall forward to the Union reference laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 the particulars referred to in Article 19(2) of this Regulation and in Article 5(3), point (j), and Article 17(3), point (j), of Regulation (EC) No 1829/2003.

deleted

Or. en

Amendment 863

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

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).

Or. en