Amen­de­menten Hazekamp over planten verkregen met bepaalde nieuwe geno­mi­ca­tech­nieken en levens­mid­delen en dier­voeders daarvoor, en tot wijziging van Veror­dening (EU) 2017/625

Proposal for a regulation on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 of the Committee on Agriculture and Rural Development.

Amendment 1
Anja Hazekamp

Proposal for a regulation
Citation -1 (new)

Amendment

– The European Parliament rejects the Commission proposal.

Amendment 2
Anja Hazekamp

Proposal for a regulation
Recital 6 a (new)

Amendment

(6 a) The European Parliament, in its reaction to the Farm to Fork strategy for a fair, healthy and environmentally-friendly food system, highlighted the precautionary principle and the need to ensure transparency and freedom of choice to farmers, processors and consumers, and stressed that any policy action on NGTs should include risk assessments and a comprehensive overview and assessment of options for traceability and labelling with a view to achieving proper regulatory oversight and should provide consumers with relevant information, including for products from third countries in order to ensure a level playing field;

Amendment 3
Anja Hazekamp

Proposal for regulation
Recital 6 b (new)

Amendment

(6 b) The European Parliament has called^1a for a comprehensive analysis of the socioeconomic and environmental effects on the food system of patents on breeding processes, plant propagation material and parts thereof, including their potential to increase market concentration and monopolisation in the food chain, as well as their impact on the affordability and availability of food, and called for the EU and its Member States not to grant patents on biological material and to safeguard the freedom to operate and breeders’ exemption for varieties. It is therefore appropriate to ensure that patented plants are not subject to any exemptions of the Union GMO legislation.

^1a European Parliament resolution of 14 June 2023 on ensuring food security and long-term resilience of the EU agriculture (2022/2183(INI)) P9_TA(2023)0238

Amendment 4
Anja Hazekamp

Proposal for a regulation
Recital 7

Text proposed by the Commission

(7) The Commission’s study on new genomic techniques (⁴⁵ ) concluded that the Union GMO legislation is not fit for the purpose of regulating the deliberate release of plants obtained by certain NGTs and the placing on the market of related products including food and feed. In particular, the study concluded that the authorisation procedure and risk assessment requirements for GMOs under the Union GMO legislation are not adapted to the variety of potential organisms and products that can be obtained with some NGTs, namely targeted mutagenesis and cisgenesis (including intragenesis), and these requirements can be disproportionate or inadequate. The study showed that this is particularly the case for plants obtained by these techniques, given the amount of scientific evidence that is already available, in particular on their safety. Furthermore, the Union GMO legislation is difficult to implement and enforce for plants obtained by targeted mutagenesis and cisgenesis and related products. In certain cases, genetic modifications introduced by these techniques are indistinguishable with analytical methods from natural mutations or from genetic modifications introduced by conventional breeding techniques, whereas the distinction is generally possible for genetic modifications introduced by transgenesis. The Union GMO legislation is also not conducive to developing innovative and beneficial products that could contribute to sustainability, food security and resilience of the agri-food chain.

⁴⁵ Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in Case C-528/16, SWD(2021) 92 final.

Amendment

deleted

Amendment 5
Anja Hazekamp

Proposal for a regulation
Recital 8

Text proposed by the Commission

(8) It is therefore necessary to adopt a specific legal framework for GMOs obtained by targeted mutagenesis and cisgenesis and related products when deliberately released into the environment or placed on the market.

Amendment

deleted

Amendment 6
Anja Hazekamp

Proposal for a regulation
Recital 10

Text proposed by the Commission

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

Amendment

(10) The legal framework for NGT plants should share the objectives of the Union GMO legislation to ensure a high level of protection of human and animal health and of the environment, in line with the precautionary principle and the One Health principle, for the concerned plants and products, so as to contribute to the sustainability objectives of the European Green Deal and the Farm to Fork, Biodiversity, Zero Pollution and Climate Adaptation strategies.

Amendment 7
Anja Hazekamp

Proposal for a regulation
Recital 13

Text proposed by the Commission

(13) This Regulation should distinguish between two categories of NGT plants.

Amendment

deleted

Amendment 8
Anja Hazekamp

Proposal for a regulation
Recital 14

Text proposed by the Commission

(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny obtained by conventional breeding techniques (‘category 1 NGT plants’) should be treated as plants that have occurred naturally or have been produced by conventional breeding techniques, given that they are equivalent and that their risks are comparable, thereby derogating in full from the Union GMO legislation and GMO related requirements in sectoral legislation. In order to ensure legal certainty, this Regulation should set out the criteria to ascertain if a NGT plant is equivalent to naturally occurring or conventionally bred plants and lay down a procedure for competent authorities to verify and take a decision on the fulfillment of those criteria, prior to the release or placing on the market of NGT plants or NGT products. Those criteria should be objective and based on science. They should cover the type and extent of genetic modifications that can be observed in nature or in organisms obtained with conventional breeding techniques and should include thresholds for both size and number of genetic modifications to the genome of NGT plants. Since scientific and technical knowledge evolves rapidly in this area, the Commission should be empowered in accordance with Article 290 of the Treaty on the Functioning of the European Union to update these criteria in light of scientific and technical progress as regards the type and extent of genetic modifications that can occur in nature or through conventional breeding.

Amendment

deleted

Amendment 9
Anja Hazekamp

Proposal for a regulation
Recital 15

Text proposed by the Commission

(15) All NGT plants that are not category 1 (‘category 2 NGT plants’) should remain subject to the requirements of the Union GMO legislation because they feature more
complex sets of modifications to the genome.

Amendment

(15) All NGT plants should remain subject to the requirements of the Union GMO legislation because they feature complex sets of modifications to the genome.

Amendment 10
Anja Hazekamp

Proposal for a regulation
Recital 16

Text proposed by the Commission

(16) Category 1 NGT plants and products should not be subject to the rules and requirements of the Union GMO legislation and to provisions in other Union legislation that apply to GMOs. For legal certainty for operators and transparency, a declaration of the category 1 NGT plant status should be obtained prior to deliberate release, including the placing on the market.

Amendment

deleted

Amendment 11
Anja Hazekamp

Proposal for a regulation
Recital 17

Text proposed by the Commission

(17) This declaration should be obtained prior to any deliberate release of any category 1 NGT plants for any other purpose than placing on the market, such as for field trials that are to take place in the territory of the Union, since the criteria are based on data that is available before the field trials and does not depend on these field trials. When no field trials are to take place in the territory of the Union, operators should obtain that declaration before placing the category 1 NGT product on the market.

Amendment

deleted

Amendment 12
Anja Hazekamp

Proposal for a regulation
Recital 18

Text proposed by the Commission

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

Amendment

deleted

Amendment 13
Anja Hazekamp

Proposal for a regulation
Recital 19

Text proposed by the Commission

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

Amendment

deleted

Amendment 14
Anja Hazekamp

Proposal for a regulation
Recital 20

Text proposed by the Commission

(20) 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. Therefore, when the procedure is conducted at Union level, such implementing decisions should be adopted by the advisory procedure, supported by scientific and technical assistance by the Authority.

Amendment

deleted

Amendment 15
Anja Hazekamp

Proposal for a regulation
Recital 21

Text proposed by the Commission

(21) Decisions declaring the category 1 NGT plant status should assign an identification number to the NGT plant concerned in order to ensure transparency and traceability of such plants when they are listed in the database and for the purpose of labelling of plant reproductive material derived from them.

Amendment

deleted

Amendment 16
Anja Hazekamp

Proposal for a regulation
Recital 22

Text proposed by the Commission

(22) Category 1 NGT plants should remain subject to any regulatory framework that applies to conventionally bred plants. As is the case for conventional plants and products, those NGT plants and their products will be subject to the applicable sectoral legislation on seed and other plant reproductive material, food, feed and other products, and horizontal frameworks, such as the nature conservation legislation and environmental liability. In this regard, category 1 NGT food featuring a significantly changed composition or structure that affects the nutritional value, metabolism or level of undesirable substances of the food will be considered as novel food and thus fall into the scope of Regulation (EU) 2015/2283 of the European Parliament and of the Council (⁴⁶ ) and will be risk assessed in that context.

⁴⁶ Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1).

Amendment

deleted

Amendment 17
Anja Hazekamp

Proposal for a regulation
Recital 23

Text proposed by the Commission

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

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

Amendment

(23) Regulation (EU) 2018/848 of the European Parliament and the Council on organic production and labelling of organic products and repealing Council Regulation (EC) 834/2007(⁴⁷ ) prohibits the use of GMOs and products from and by GMOs in organic production. It defines GMOs for the purposes of that Regulation by reference to Directive 2001/18/EC, excluding from the prohibition GMOs which have been obtained through the techniques of genetic modification listed in Annex 1.B of Directive 2001/18/EC. As a result, NGT plants are banned in organic production.

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

Amendment 18
Anja Hazekamp

Proposal for a regulation
Recital 24

Text proposed by the Commission

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

Amendment

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

Amendment 19
Anja Hazekamp

Proposal for a regulation
Recital 25

Text proposed by the Commission

(25) Category 2 NGT plants should remain subject to the requirements of the Union GMO legislation given that on the basis of current scientific and technical knowledge, their risks need to be assessed. Special rules should be provided in order to adapt the procedures and certain other rules laid down in Directive 2001/18/EC and Regulation (EC) No 1829/2003 to the specific nature of category 2 NGT plants and the differing levels of risk that they may pose.

Amendment

(25) NGT plants should remain subject to the requirements of the Union GMO legislation given that on the basis of current scientific and technical knowledge, their risks need to be assessed.

Amendment 20
Anja Hazekamp

Proposal for a regulation
Article 3 - paragraph 1 - point 2

Text proposed by the Commission

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

Amendment

(2) ‘NGT plant’ means a genetically modified plant obtained by targeted mutagenesis, on the condition that it does not contain any genetic material prepared
outside the cell, and there is no intellectual property right of any kind attached to the plant, its properties or the technique used to create it;

Amendment 21
Anja Hazekamp

Proposal for a regulation
Article 3 - paragraph 1 - point 5

Text proposed by the Commission

(5) ‘cisgenesis’ means techniques of genetic modification resulting in the insertion, in the genome of an organism, of genetic material already present in the breeders’ gene pool;

Amendment

deleted

Amendment 22
Anja Hazekamp

Proposal for a regulation
Article 3 - paragraph 1 - point 6

Text proposed by the Commission

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

Amendment

deleted

Amendment 23
Anja Hazekamp

Proposal for a regulation
Article 3 - paragraph 1 - point 7

Text proposed by the Commission

(7) ‘category 1 NGT plant’ means a NGT plant that:

(a) fulfils the criteria of equivalence to conventional plants, set out in Annex I, or

(b) is progeny of the NGT plant(s) referred to in point (a), including progeny derived by crossing of such plants, on the condition that there are no further modifications that would make it subject to Directive 2001/18/EC or Regulation 1829/2003;

Amendment

deleted

Amendment 24
Anja Hazekamp

Proposal for a regulation
Article 3 - paragraph 1 - point 8

Text proposed by the Commission

(8) ‘category 2 NGT plant’ means a NGT plant other than a category 1 NGT plant;

Amendment

deleted

Amendment 25
Anja Hazekamp

Proposal for a regulation
Article 3 - paragraph 1 - point 13

Text proposed by the Commission

(13) ‘category 1 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 1 NGT plant;

Amendment

deleted

Amendment 26
Anja Hazekamp

Proposal for a regulation
Article 3 - paragraph 1 - point 14

Text proposed by the Commission

(14) ‘category 2 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 2 NGT plant;

Amendment

deleted

Amendment 27
Anja Hazekamp

Proposal for a regulation
Chapter II - title

Text proposed by the Commission

II Category 1 NGT plants and category 1 NGT products

Amendment

The European Parliament deletes this chapter

Amendment 28
Anja Hazekamp

Proposal for a regulation
Article 5

Text proposed by the Commission

Article 5

Status of category 1 NGT plants

1. The rules which apply to GMOs in Union legislation shall not apply to category 1 NGT plants.

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

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

Amendment

deleted

Amendment 29
Anja Hazekamp

Proposal for a regulation
Article 6

Text proposed by the Commission

[...]

Amendment

deleted

Amendment 30
Anja Hazekamp

Proposal for a regulation
Article 7

Text proposed by the Commission

[...]

Amendment

deleted

Amendment 31
Anja Hazekamp

Proposal for a regulation
Article 8 - paragraph 1

Text proposed by the Commission

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.

Amendment

deleted

Amendment 32
Anja Hazekamp

Proposal for a regulation
Article 9

Text proposed by the Commission

Article 9

Database of decisions declaring the category 1 NGT plant status

1. 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;

(c) a summarised description of the technique(s) used to obtain the genetic modification;

(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.

Amendment

deleted

Amendment 33
Anja Hazekamp

Proposal for a regulation
Article 10

Text proposed by the Commission

Article 10

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.

Amendment

deleted

Amendment 34
Anja Hazekamp

Proposal for a regulation
Article 11

Text proposed by the Commission

Article 11

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

(c) breeding patterns and strategies.

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.

Amendment

deleted