Plants obtained by certain new genomic techniques and their food and feed

Amendments tabled for the plenary sitting on this text, in their own numbering series. This is a different set from the committee amendments tracked elsewhere on AmendEU, and is not counted in any of the site’s amendment totals.

1. Amendment 1S&DCouncil position · Recital 34
   Current text

   (34) Provision should be made to ensure transparency as regards the use of category 1 NGT plant varieties in order to ensure that production chains that wish to remain free from NGT plants and NGT products can do so, and thereby safeguard consumer trust. NGT plants that have obtained a declaration of category 1 NGT plant status should be listed in a publicly available database. That database should contain, inter alia, information on the techniques used to obtain the traits. For transparency reasons, the patent information and the licence declarations provided by the requester should also be included in the database and be kept up to date, without any responsibility on the part of the Commis…

   Amendment

   (34) 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 NGT plants and NGT products can do so and thereby safeguard consumer trust. NGT plants that have obtained a declaration of category 1 NGT plant status should be listed in a publicly available database. That database should contain, inter alia, information on the techniques used to obtain the traits as well as detection methods. For transparency reasons, the patent information and the licence declarations provided by the requester should also be included in the database and be kept up to date, without any responsibility on th…

   Excerpt — full text in the official PDF.
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2. Amendment 2S&DCouncil position · Recital 60
   Current text

   (60) The Commission, in cooperation with the Member States, should oversee the drawing-up of a Union-level code of conduct to support transparency on patents on plant biological material, breeders’ access to such material and legal certainty for breeders and farmers. The Commission should aim that the code of conduct include commitments by patent owners to provide clear and publicly accessible information on patents, to license patents under fair and reasonable conditions, and to seek the amicable settlement of patent disputes with breeders that are SMEs and with farmers in the case of unintentional minor presence of patented biological material in their fields. In the latter case, patent ow…

   Amendment

   (60) The Commission, in cooperation with the Member States, should draw-up a Union-level code of conduct to support transparency on patents on plant biological material, breeders’ access to such material and legal certainty for breeders and farmers. The code of conduct should include commitments by patent owners to provide clear and publicly accessible information on patents, to license patents under fair and reasonable conditions, and to seek the amicable settlement of patent disputes with breeders that are SMEs and with farmers in the case of unintentional presence of patented biological material in their fields. In the latter case, patent owners could consider refraining from enforcing th…

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3. Amendment 3S&DCouncil position · Recital 65
   Current text

   (65) In accordance with Directive 98/44/EC, the holder of the patent is to be entitled to prohibit the use of patented self-reproducing material in situations analogous to those where it would be permitted to prohibit the use of patented, non-self-reproducing products. However, situations where the unintentional or accidental presence of patented biological material of NGT plants occurs during agricultural activity by farmers, as a result of natural self-replication through cross-pollination, are not comparable to the situations that could arise for non-self-reproducing products. This is one of the relevant factors when determining whether a patent on an NGT plant has been infringed in such…

   Amendment

   (65) In accordance with Directive 98/44/EC, the holder of the patent is to be entitled to prohibit the use of patented self-reproducing material in situations analogous to those where it would be permitted to prohibit the use of patented, non-self-reproducing products. However, situations where the unintentional or accidental presence of patented biological material of NGT plants occurs during agricultural activity by farmers, as a result of natural self-replication through cross-pollination, are not comparable to the situations that could arise for non-self-reproducing products. Therefore, farmers should not be exposed to legal liability or bear the burden of proof in cases where patented N…

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4. Amendment 4S&DCouncil position · Recital 65 a (new)
   Amendment

   (65a) Patent protection should not extend to plant traits, genetic characteristics or biological material that occur in nature or that can be obtained through essentially biological processes, including conventional breeding methods such as crossing and selection. Granting exclusive rights over such naturally occurring traits would unduly restrict access to genetic resources, hamper innovation and undermine the breeders’ exemption.

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5. Amendment 5S&DCouncil position · Article 4 a (new)
   Amendment

   Article4a Incidental and accidental presence of patented NGT material 1. The protection conferred by a patent on NGT biological material shall not apply in the case of the incidental or accidental presence of patented genetic information in seeds, plant propagation materials, plants and parts of plants. 2. In any proceedings concerning alleged patent infringement involving NGT biological material, the patent holder shall bear the full burden of proof to demonstrate intentional use or deliberate incorporation of the patented material by the farmer, and the mere presence of patented biological material shall not in itself constitute evidence of infringement.

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6. Amendment 6S&DCouncil position · Article 6 – paragraph 3 – point d a (new)
   Amendment

   (da) methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the category 1 NGT plant. In cases where it is not feasible to provide an analytical method that identifies and quantifies, if duly justified by the person intending to undertake such a deliberate release, the modalities to comply with analytical method performance requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (c);

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7. Amendment 7S&DCouncil position · Article 7 – paragraph 2 – point d a (new)
   Amendment

   (da) methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the category 1 NGT plant. In cases where it is not feasible to provide an analytical method that identifies and quantifies, if duly justified by the person intending to undertake such a deliberate release, the modalities to comply with analytical method performance requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (c);

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8. Amendment 8S&DCouncil position · Article 9 – paragraph 1 – subparagraph 2 – point d a (new)
   Amendment

   (da) methods for sampling, detection, identification and quantification as referred to in Article 6(3) and Article 7(2);

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9. Amendment 9S&DCouncil position · Article 27 – paragraph 1 – point c
   Current text

   (c) adapted arrangements for complying with analytical method performance requirements referred to in Article 14(1), point (l), and Article 20(2).

   Amendment

   (c) adapted arrangements for complying with analytical method performance requirements referred to in Article 6(3), point (da), Article 7(2), point (da), Article 14(1), point (l), and Article 20(2).

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10. Amendment 10S&DCouncil position · Article 30 – paragraph 1
    Current text

    1. The Commission, in cooperation with the Member States, shall oversee the drawing-up of a code of conduct at Union level to enhance the transparency of information relating to patents on plant biological material, to facilitate breeders’ access to such material and to enhance legal certainty for breeders and farmers (‘code of conduct’).

    Amendment

    1. The Commission, in cooperation with the Member States, shall draw-up of a code of conduct at Union level to enhance the transparency of information relating to patents on plant biological material, to facilitate breeders’ access to such material and to enhance legal certainty for breeders and farmers (‘code of conduct’).

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11. Amendment 11S&DCouncil position · Article 30 – paragraph 3 – introductory part
    Current text

    3. The Commission shall aim that the code of conduct include the following commitments by patent owners:

    Amendment

    3. The code of conduct shall include the following commitments by patent owners:

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12. Amendment 12S&DCouncil position · Article 30 – paragraph 3 – point b
    Current text

    (b) arrangements for the licensing of patents under fair and reasonable conditions, including through the voluntary platforms referred to in paragraph 2;

    Amendment

    (b) arrangements for the licensing of patents under fair and reasonable conditions;

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13. Amendment 13S&DCouncil position · Article 30 – paragraph 4 – introductory part
    Current text

    4. The Commission shall aim that the code of conduct include the following commitments by voluntary platforms for the licensing of plant biological material:

    Amendment

    4. The code of conduct shall include the following commitments by platforms for the licensing of plant biological material:

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14. Amendment 14S&DCouncil position · Article 30 a (new)
    Amendment

    Article30a Obligations for licencing platforms and NGT patent holders 1. Platforms for the licensing of plant biological material operating in the Union shall abide by the code of conduct referred to in Article 30(1). 2. Platforms referred to in paragraph 1 shall notify the Commission of measures adopted in their internal rules of procedures to ensure the code of conduct is effectively applied. 3. The Commission shall establish a list of the platforms referred to in paragraph 1 and make it available to the public online. 4. Holders of a patent on an NGT plant biological material covered by a decision declaring the category 1 NGT plant status adopted in accordance with Article 6(12) or (14) o…

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15. Amendment 15S&DCouncil position · Article 37 a (new)
    Amendment

    Article37a Amendments to Directive 98/44/EC 1. Article 4 of Directive 98/44/EC on the legal protection of biotechnological inventions is amended as follows: (a) In paragraph 1, the following points are added: ‘(ba) NGT plants, plant material, parts thereof, genetic information and process features they contain, as defined in Regulation (EU) .../... [O.J. please insert the number of this Regulation]; (bb) plants, plant material, parts thereof, genetic information and process features they contain that can be yielded by techniques excluded from the scope of Directive 2001/18/EC as listed in Annex I B to that directive.’ (b) the following paragraph is added: ‘3 a. Paragraphs 2 and 3 shall be wi…

    Excerpt — full text in the official PDF.
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16. Amendment 16S&DCouncil position · Article 37 b (new)
    Amendment

    Article37b Amendments to Directive 98/44/EC 2. In Article 8 of Directive 98/44/EC, the following paragraph is added: ‘2a. By way of derogation from paragraphs 1 and 2, the protection conferred by a patent on a biological material possessing specific characteristics as a result of the invention shall not extend to biological material possessing the same characteristics that is obtained independently of the patented biological material and from essentially biological processes, or to biological material obtained from such material through propagation or multiplication.’ 3. In Article 9 of Directive 98/44/EC, the following paragraphs are added: ‘1a. By way of derogation from paragraph 1, a plan…

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17. Amendment 17The LeftCouncil position · Citation 1 a (new)
    Amendment

    The European Parliament rejects the Council position.

    official amendment document ↗
18. Amendment 18The LeftCouncil position · Recital 1 a (new)
    Amendment

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

    official amendment document ↗
19. Amendment 19The LeftCouncil position · Recital 18 a (new)
    Amendment

    (18a) The European Parliament has called for the Union and its Member States not to grant patents on biological material and to safeguard the freedom to operate and the breeders’ exemption for varieties. It should be ensured that breeders have full access to the genetic material of NGT plants, which by definition are not transgenic plants. Access to genetic materials can best be secured when the right of patent holders is exhausted in the hand of the breeder (breeder’s exemption). As current provisions in patent law do not provide for a full breeder’s exemption, it should be ensured that patents should not restrict the use of NGT plants by breeders and farmers. Hence, NGT plants should not b…

    Excerpt — full text in the official PDF.
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20. Amendment 20The LeftCouncil position · Recital 25 a (new)
    Amendment

    (25a) Traceability requirements for food and feed produced from NGTs should be established to facilitate the accurate labelling of such products, in accordance with the requirements of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, so as to ensure that accurate information is available to operators and consumers to enable them to exercise their freedom of choice in an effective manner, as well as to enable control and verification of labelling claims. Requirements for food and feed produced from NGTs should be similar in order to avoid discontinuity of information in cases of change in end use.

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21. Amendment 21The LeftCouncil position · Article 4 a (new)
    Amendment

    Article4a Exclusion from patentability NGT plants, plant material, parts thereof, genetic information and the process features they contain shall not be patentable.

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22. Amendment 22The LeftCouncil position · Article 10 – paragraph 1 a (new)
    Amendment

    1a. Appropriate document-based traceability for NGTs shall be provided by the transmission and holding of information that products contain or consist of NGT plants and product, and the unique codes for those NGTs, at each stage of their placing on the market.

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23. Amendment 23The LeftCouncil position · Article 24 a (new)
    Amendment

    Article24a Measures to avoid the unintended presence of category 2 NGT plants Member States shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003.

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24. Amendment 24The LeftCouncil position · Article 37 a (new)
    Amendment

    Article37a Amendments to Directive 98/44/EC 1. Article 4 of Directive 98/44/EC on the legal protection of biotechnological inventions is amended as follows: (a) In paragraph 1, the following points are added: ‘(c) NGT plants, plant material, parts thereof, genetic information and process features they contain, as defined in Regulation (EU) .../... [O.J. please insert the number of this Regulation]; (d) plants, plant material, parts thereof, genetic information and process features they contain that can be yielded by techniques excluded from the scope of Directive 2001/18/EC as listed in Annex I B to that directive.’ (b) the following paragraph 4 is added: ‘4. Paragraphs 2 and 3 shall be with…

    Excerpt — full text in the official PDF.
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25. Amendment 25Verts/ALECouncil position

    Replaces or inserts a longer passage — full text in the official document.

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26. Amendment 26Verts/ALECouncil position · Recital 1 a (new)
    Amendment

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

    official amendment document ↗
27. Amendment 27Verts/ALECouncil position · Recital 15 a (new)
    Amendment

    (15a) NGT plants with the potential to persist, reproduce or spread in the environment, within or beyond fields, should be evaluated with the highest level of scrutiny in respect of the impact of such plants on nature and the environment.

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28. Amendment 28Verts/ALECouncil position · Recital 25 a (new)
    Amendment

    (25a) Traceability requirements for food and feed produced from NGTs should be established to facilitate the accurate labelling of such products, in accordance with the requirements of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, so as to ensure that accurate information is available to operators and consumers to enable them to exercise their freedom of choice in an effective manner, as well as to enable control and verification of labelling claims. Requirements for food and feed produced from NGTs should be similar in order to avoid discontinuity of information in cases of change in end use.

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29. Amendment 29Verts/ALECouncil position · Recital 57 a (new)
    Amendment

    (57a) The European Parliament has called for the Union and its Member States not to grant patents on biological material and to safeguard the freedom to operate and the breeders’ exemption for varieties. It should be ensured that breeders have full access to the genetic material of NGT plants, which by definition are not transgenic plants. Access to genetic materials can best be secured when the right of patent holders is exhausted in the hand of the breeder (breeder’s exemption). As current provisions in patent law do not provide for a full breeder’s exemption, it should be ensured that patents should not restrict the use of NGT plants by breeders and farmers. Hence, NGT plants should not b…

    Excerpt — full text in the official PDF.
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30. Amendment 30Verts/ALECouncil position · Recital 68 a (new)
    Amendment

    (68a) Effective traceability, labelling and environmental monitoring rely on the availability of reliable, accurate and validated detection methods capable of identifying and quantifying relevant substances, organisms or products. The development and use of appropriate detection methods, including those enabled by NGTs, are therefore essential to ensure transparency, consumer confidence and the effective implementation of Union law.

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31. Amendment 31Verts/ALECouncil position · Article 4 a (new)
    Amendment

    Article 4a Exclusion from patentability NGT plants, plant material, parts thereof, genetic information and the process features they contain shall not be patentable.

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32. Amendment 32Verts/ALECouncil position · Article 10 – paragraph 1
    Current text

    1. Plant reproductive material, including for breeding and scientific purposes, that contains or consists of category 1 NGT plants and is made available to third parties, whether in return for payment or free of charge, shall bear a label with the indication ‘NGT-1’, followed by the identification numbers of the NGT plants it has been derived from.

    Amendment

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

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33. Amendment 33Verts/ALECouncil position · Article 10 – paragraph 1 a (new)
    Amendment

    1a. Appropriate document-based traceability for NGTs shall be provided by the transmission and holding of information that products contain or consist of NGT plants and product, and the unique codes for those NGTs, at each stage of their placing on the market.

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34. Amendment 34Verts/ALECouncil position · Article 11 a (new)
    Amendment

    Article11a Withdrawal of the decision If the monitoring results show that there is a risk to health or the environment, or if new scientific data supports that hypothesis, the competent authority may withdraw its decision referred to in Article 6(8) or statement referred to in Article 7(5). The withdrawal decision must be sent by registered mail to the beneficiary of the decision, who shall have 15 days in which to make observations. In that case, the marketing of the NGT plant or product shall be prohibited from the day following the date of receipt of the registered letter.

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35. Amendment 35Verts/ALECouncil position · Article 24 a (new)
    Amendment

    Article 24a Measures to avoid the unintended presence of category 2 NGT plants Member States shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003.

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36. Amendment 36Verts/ALECouncil position · Article 37 a (new)
    Amendment

    Article37a Amendments to Directive 98/44/EC 1. Article 4 of Directive 98/44/EC1a on the legal protection of biotechnological inventions is amended as follows: (a) In paragraph 1, the following points are added: ‘(ba) NGT plants, plant material, parts thereof, genetic information and process features they contain, as defined in Regulation (EU) .../... [O.J. please insert the number of this Regulation]; (bb) plants, plant material, parts thereof, genetic information and process features they contain that can be yielded by techniques excluded from the scope of Directive 2001/18/EC as listed in Annex I B to that directive.’ (b) the following paragraph is added: ‘3a. Paragraphs 2 and 3 shall be w…

    Excerpt — full text in the official PDF.
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37. Amendment 37Verts/ALECouncil position · Annex II – point 2 a (new)
    Amendment

    (2a) Potential to persist, reproduce or spread in the environment, within or beyond fields

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38. Amendment 38ESNCouncil position · Article 5 – paragraph 1
    Current text

    1. The rules which apply to GMOs in Union legislation shall not apply to category 1 NGT plants that fulfil the conditions of Article 4, point (a), or to category 1 NGT products that fulfil the conditions of Article 4, point (b).

    Amendment

    1. The rules of Union law applicable to genetically modified organisms shall not apply to NGT1 plants that fulfil the conditions laid down in Article 4(1) or 4(1a) or to NGT products derived therefrom, without prejudice to the labelling, traceability and information requirements laid down in Article 10.

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39. Amendment 39ESNCouncil position · Article 10 - Title
    Current text

    Labelling of category 1 NGT plant reproductive material, including breeding material, and transparency of information

    Amendment

    Labelling of NGT1 plant reproductive material, including breeding material, and of food and feed derived from NGT1 plants and transparency of information

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40. Amendment 40ESNCouncil position · Article 10 – paragraph 1 a (new)
    Amendment

    1a. Food containing, consisting of or produced from NGT1 plants or containing ingredients produced from NGT1 plants shall bear a clear, visible and easily legible indication that it has been ‘produced from NGT1 plants’. That indication shall be accompanied by the identification number of the NGT1 plant or plants concerned.

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41. Amendment 41ESNCouncil position · Article 10 – paragraph 1 b (new)
    Amendment

    1b. Where a food consists of several ingredients, the indication shall appear in the list of ingredients directly next to the ingredient concerned. Where there is no list of ingredients, the indication shall appear on the labelling of the food.

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42. Amendment 42ESNCouncil position · Article 10 – paragraph 1 c (new)
    Amendment

    1c. Feed containing, consisting of or produced from NGT1 plants shall bear a clear, visible and easily legible indication that it has been ‘produced from NGT1 plants’. That indication shall be accompanied by the identification number of the NGT1 plant or plants concerned.

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43. Amendment 43ESNCouncil position · Article 10 – paragraph 1 d (new)
    Amendment

    1d. Operators shall, at every stage of the placing on the market of food and feed derived from NGT1 plants, share the information necessary to comply with this Article. That information shall include the NGT1 status and the relevant identification number or numbers.

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