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

Wording as published by the EP, in English.

1. Amendment 1Rejected

   Recital 34

   Tabled by Christophe Clergeau · S&D

   … to ensure transparency as regards the use of category 1 NGT plant Removed: varieties in order Added: varieties, to ensure that production chains that wish to remain free from NGT plants and NGT products can do Removed: so, Added: so and thereby safeguard consumer trust. NGT plants that have obtained a declaration … should contain, inter alia, information on the techniques used to obtain the Removed: traits. Added: traits as well as detection methods. For transparency reasons, the patent information and the licence declarations provided by …

2. Amendment 6Rejected

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

   Tabled by Christophe Clergeau · S&D

   Added: (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);

3. Amendment 7Rejected

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

   Tabled by Christophe Clergeau · S&D

   Added: (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);

4. Amendment 8Rejected

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

   Tabled by Christophe Clergeau · S&D

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

5. Amendment 9Rejected

   Article 27 – paragraph 1 – point c

   Tabled by Christophe Clergeau · S&D

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

6. Amendment 19Rejected

   Recital 18 a (new)

   Tabled by Anja Hazekamp, Emma Fourreau, João Oliveira +5 · The Left

   Added: (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 be subject to patent legislation, but should for the protection of intellectual property solely be subject to the Community Plant Variety Rights (CPVR) system, as laid down in Council Regulation (EC) No 2100/94, which allows the use of the breeder’s exemption. NGT plants, their derived seeds, their plant material, associated genetic material such as genes and gene sequences, and plant traits should therefore be excluded from patentability. The exclusion from patentability should be applied in a consistent manner across legislation. Furthermore, in order to avoid patents being granted or patent applications being submitted between the date of the entry into force of this Regulation and the application of its provisions, it should be ensured that plant material is excluded from patentability from the day of entry into force of this Regulation. For patents already granted or pending patent applications covering plant material, the effects of patents should be further limited. In addition, the Commission should assess and address, in the forthcoming study, how the broader problem of patents being granted, directly or indirectly, on plant material despite previous efforts to close loopholes, should be further addressed. The assessment should address in particular the role and impact of patents on breeders' and farmers' access to plant reproductive material, seed diversity and affordable prices, as well as on innovation and in particular on opportunities for SMEs. The report of the Commission should be accompanied by the appropriate legislative proposals in order to ensure further necessary adjustments are made to the intellectual property rights framework.

7. Amendment 20Rejected

   Recital 25 a (new)

   Tabled by Anja Hazekamp, Emma Fourreau, João Oliveira +5 · The Left

   Added: (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.

8. Amendment 23Rejected

   Article 24 a (new)

   Tabled by Anja Hazekamp, Emma Fourreau, João Oliveira +5 · The Left

   Added: 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.

9. Amendment 26Rejected

   Recital 1 a (new)

   Tabled by Martin Häusling · Verts/ALE

   Added: (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.

10. Amendment 27Rejected

    Recital 15 a (new)

    Tabled by Martin Häusling · Verts/ALE

    Added: (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.

11. Amendment 30Rejected

    Recital 68 a (new)

    Tabled by Martin Häusling · Verts/ALE

    Added: (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.

12. Amendment 31Rejected

    Article 4 a (new)

    Tabled by Martin Häusling · Verts/ALE

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

13. Amendment 32Rejected

    Article 10 – paragraph 1

    Tabled by Martin Häusling · Verts/ALE

    1. Removed: Plant Added: 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 … payment or free of charge, shall bear a label with the indication Removed: ‘NGT-1’, Added: ‘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 …

14. Amendment 33Rejected

    Article 10 – paragraph 1 a (new)

    Tabled by Martin Häusling · Verts/ALE

    Added: 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.

15. Amendment 34Rejected

    Article 11 a (new)

    Tabled by Martin Häusling · Verts/ALE

    Added: 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.

16. Amendment 36Rejected

    Article 37 a (new)

    Tabled by Martin Häusling · Verts/ALE

    Added: 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 without prejudice to the exclusions from patentability covered in paragraph 1.’ 2. In Article 8, 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, the following paragraphs are added: ‘1a. By way of derogation from paragraph 1, a plant product containing or consisting of genetic information obtained by a patentable technical process shall not be patentable if it is not distinguishable from plant products containing or consisting of the same genetic information obtained by an essentially biological process. 1b. 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. 1c. The protection conferred by a patent on a technical process that enables the production of 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.’ 1a Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (OJ L 213, 30.7.1998, p. 13).

17. Amendment 37Rejected

    Annex II – point 2 a (new)

    Tabled by Martin Häusling · Verts/ALE

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