Amen­de­menten Hazekamp over planten verkregen met bepaalde nieuwe geno­mi­ca­tech­nieken en de levens­mid­delen en dier­voeders daarvan, 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 Environment, Public Health and Food.

Amendment 1
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda, Sandra Pereira, João Pimenta Lopes

Proposal for a regulation
Recital -1

Amendment

(-1) The European Parliament rejects the Commission proposal.

Amendment 2
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

Proposal for a regulation
Recital -1 a (new)

Amendment

(-1 a) A sustainable food system is at the heart of the European Green Deal. Agroecology can provide healthy food while maintaining productivity, increase soil fertility and biodiversity, and reduce the footprint of food production. Organic farming in particular holds great potential for farmers and consumers alike. The sector creates jobs and attracts young farmers. Organic farming also provides 10-20 % more jobs per hectare than conventional farms, and creates added value for agricultural products. To make the most of this potential, under the Green Deal’s Farm to Fork and Biodiversity Strategies, the European Commission has set a target of ‘at least 25% of the EU’s agricultural land under organic farming and a significant increase in organic
aquaculture by 2030’.

Amendment 3
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

Proposal for a regulation
Recital 1

Text proposed by the Commission

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

32 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).

Amendment

(1) Since 2001, when Directive 2001/18/EC of the European Parliament and of the Council ( 32 ), on the deliberate release of genetically modified organisms (GMOs) into the environment was adopted, significant progress in biotechnology has led to the development of new genomic techniques (NGTs), most prominently genome editing techniques that enable changes to be made to the genome at precise locations. However, also these newer techniques may lead to unexpected risks and outcomes that cannot be fully predicted and that may be different compared to plants obtained by conventional breeding.

32 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).

Amendment 4
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

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^1a, 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;

^1a European Parliament resolution of 20 October 2021 on a farm to fork strategy for a fair, healthy and environmentally-friendly food system (2020/2260(INI)), P9_TA(2021)0425

Amendment 5
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

Proposal for a regulation
Recital 7 a (new)

Amendment

(7 a) Currently, the debate on using NGTs in plant breeding is held almost exclusively among scientists, scientific and industry organisations, and companies in the agri-food field, as well as a small number of NGOs. However, in shaping a new policy on NGTs, it is important to include the voice of citizens, not only because biotechnologies have the power to redesign life, but also because they offer the potential to reshape the practice of agriculture and the future of our food (system). The way we produce food involves questions of how we want to live on this planet and how we want to relate to other species. For purposes of democracy, citizens need to have a say on which public values are incorporated in a new policy for NGTs.

Amendment 6
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

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 7
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

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 8
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

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 9
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

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 10
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

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 and should remain banned in organic production. It is necessary to ensure that the organic sector as a whole has the means to remain GMO-free. Member States should lay down rules to ensure and enforce sufficiently wide buffer zones between
organic, conventional and NGT crops. Labelling and traceability shall remain in place on all NGT plants and products containing them to ensure cross-contamination to organic plants and products is not taking place.

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

Amendment 11
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

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 consumers, food producers, farmers and other operators, plant reproductive material, plants, food and feed and products of NGT plants should be labelled as GMO and NGT.

Amendment 12
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

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 13
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

Proposal for a regulation
Recital 36

Text proposed by the Commission

(36) Herbicide tolerant plants are bred to be intentionally tolerant to herbicides, in order to be cultivated in combination with the use of those herbicides. If such cultivation is not done under appropriate conditions, it may lead to development of weeds resistant to those herbicides or to the need to increase of quantities of herbicides applied, regardless of the breeding technique. For this reason, NGT plants featuring herbicide-tolerant traits should not be eligible for incentives under this framework. However, this Regulation should not take other specific measures on herbicide tolerant NGT plants, because such measures are taken horizontally in [the Commission’s Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union].

Amendment

(36) Herbicide tolerant plants are bred to be intentionally tolerant to herbicides, in order to be cultivated in combination with the use of those herbicides. Practice shows that such cultivation leads to development of weeds resistant to those herbicides and to the need to increase of quantities of herbicides applied, regardless of the breeding technique. For this reason, plants featuring herbicide-tolerant traits should not be regarded as NGT plants and their cultivation should not be allowed in the Union.

Amendment 14
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

Proposal for a regulation
Chapter II

Text proposed by the Commission

[...]

Amendment

deleted

Amendment 15
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

Proposal for a regulation
Article 12 - paragraph 1

Text proposed by the Commission

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.

Amendment

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

Amendment 16
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

Proposal for a regulation
Article 23 - title

Text proposed by the Commission

Labelling of authorised category 2 NGT products

Amendment

Traceability and labelling requirements for NGT plants, NGT plant reproductive material, including breeding material and NGT products

Amendment 17
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

Proposal for a regulation
Article 23 - paragraph 1

Text proposed by the Commission

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

Amendment

NGT plants, products containing or consisting of NGT plant(s) and 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 comply with the labelling requirements referred to in Article 21 of Directive 2001/18/EC, Articles 12, 13, 24 and 25 of Regulation (EC) No 1829/2003, and Article 4(6) to (7) of Regulation (EC) No 1830/2003, followed by the identification number of the NGT plant(s) it has been derived from.

Amendment 18
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

Proposal for a regulation
Article 25 - paragraph 1

Text proposed by the Commission

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

Amendment

deleted

Amendment 19
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

Proposal for a regulation
Article 30 - paragraph 2 a (new)

Amendment

2 a. The report shall address the impact on the organic value chain;

Amendment 20
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

Proposal for a regulation
Article 30 - paragraph 2 b (new)

Amendment

2 b. The report shall address the effects on the trust and freedom of choice of citizens.

Amendment 21
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

Proposal for a regulation
Article 32 - paragraph 1

Text proposed by the Commission

Any decision taken under, or failure to exercise, the powers vested in the Authority by this Regulation may be reviewed by the Commission on its own initiative or in response to a request from a Member State or from any person directly and individually concerned.

Amendment

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

Amendment 22
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

Proposal for a regulation
Article 32 a (new)

Present text

2. Inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety.

Amendment

Article 32 a (new)

Amendments to Directive 98/44/EC on patents

Article 4, paragraph 2

"deleted"

Amendment 23
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

Proposal for a regulation
Article 32 b (new)

Amendment

Article 32b

Amendment to Directive 98/44/EC on patents

In article 6, paragraph 1, point (e) is added:

(e) NGT plants, plant material, parts thereof, genetic information and process features they contain, as defined in Regulation (EU) .../... [OP: please insert reference to this Regulation];

Amendment 24
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

Proposal for a regulation
Article 32 c (new)

Amendment

Article 32c

Amendments to Directive 98/44/EC on patents

In article 8, the following paragraphs are added:

By way of derogation from paragraph 1, the protection conferred by a patent on a biological material possessing specific characteristics shall not extend to plant material in which that biological material is incorporated and which is not distinguishable from plant material obtained or which can be obtained by an essentially biological process.

By way of derogation from paragraph 2, the protection conferred by a patent on a process that enables the production of a biological material possessing specific characteristics as a result of the invention shall not extend to plant material in which that biological material is incorporated and which is not distinguishable from plant material obtained or which can be obtained by an essentially biological process.

Amendment 25
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

Proposal for a regulation
Article 32 d (new)

Amendment

Article 32d

Amendment to Directive 98/44/EC on patents

In article 9, the following paragraph is added:

By way of derogation from paragraph 1, the protection conferred by a patent on a product containing or consisting of genetic information shall not extend to plant material in which the product is incorporated and in which the genetic information is contained and performs its function, but which is not distinguishable from plant material obtained or which can be obtained by an essentially biological process

Amendment 26
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

Proposal for a regulation
Article 32 e (new)

Amendment

Article 32e

Amendment to Directive 98/44/EC on patents

In article 15, the following paragraph is added:

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this amended Directive not later than 30 December 2024. They shall forthwith inform the Commission thereof.

Amendment 27
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

Proposal for a regulation
Article 34 - paragraph 2 - subparagraph 1

Text proposed by the Commission

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

Amendment

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

Amendment 28
Anja Hazekamp, Marina Mesure, Mick Wallace, Manon Aubry, Leila Chaibi, Clare Daly, Manu Pineda

Proposal for a regulation
Annex I

Text proposed by the Commission

Criteria of equivalence of NGT plants to conventional plants

A NGT plant is considered equivalent to conventional plants when it differs from the recipient/parental plant by no more than 20 genetic modifications of the types referred to in points 1 to 5, in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic tools.

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

(2) deletion of any number of nucleotides;

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

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

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

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

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

Amendment

deleted