5 Amendments of Elsi KATAINEN related to 2023/0226(COD)
Amendment 111 #
Proposal for a regulation
Recital 23
Recital 23
(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 statThe use 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 theshould be clarified in Regulation (ECU) 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 175 #
Proposal for a regulation
Recital 40
Recital 40
(40) Given the novelty of the NGTs, it will be important to monitor closely the development and presence on the market of NGT plants and products and evaluate any accompanying impact on human and animal health, the environment and environmental, economic and social sustainability, including 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 particularly on the opportunities for SME. While a balance must be struck to ensure that patents do not unduly hinder the opportunities of SME in the market for NGT plants and products, it must be noted that patents play an important role for SME to facilitate access to finance, particularly in biotechnology. Information should be collected regularly and within five years after the adoption of the first decision allowing the deliberate release or the marketing of NGT plants or NGT products in the Union, the Commission should carry out an evaluation of this Regulation to measure the progress made towards the availability of NGT plants containing such characteristics or properties on the EU market. With regard to the impacts of patents, the Commission should present a first assessment by 2026 in order to ensure that where necessary, changes to the framework for intellectual property rights can be discussed in due time before a significant number of NGT plants can be expected to be placed on the market. The assessment should include an analysis of the functioning of licensing platforms.
Amendment 318 #
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The other Member States and the Commission may make scientifically justified comments to the verification report, with regard to the compliance with criteria set out in Annex I, within 20 days from the date of receipt of that report.
Amendment 363 #
Proposal for a regulation
Article 6 – paragraph 10
Article 6 – paragraph 10
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 4520 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).
Amendment 491 #
5 a. No later than 2026, the Commission shall present a report to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the role and impact of patents on breeders' and farmers' access to varied plant reproductive material, as well as on innovation and particularly on the opportunities for SME. Where appropriate to ensure breeders' and farmers' access to plant reproductive material, seed diversity and affordable prices, as well as the ongoing promotion of innovation, particularly with a view to opportunities for SME, the report shall be accompanied by a roadmap to address necessary adjustments in the intellectial property framework.