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| dossier | COM(2023)411 - Met bepaalde nieuwe genomische technieken verkregen planten en de daarvan afgeleide levensmiddelen en diervoeders. |
|---|---|
| document | COM(2023)411  |
| datum | 5 juli 2023 |
EUR million (to three decimal places)
| Year | Year | Year | Year | TOTAL | |||
| 2025 | 2026 | 2027 | 2027 et seqq | ||||
| DG: SANTE | |||||||
| • Human resources | 0,000 | 0,000 | 0,000 | 0,000 | 0,000 | ||
| • Other administrative expenditure | 0,000 | 0,000 | 0,000 | 0,000 | 0,000 | ||
| TOTAL DG SANTE | Appropriations | 0,000 | 0,000 | 0,000 | 0,000 | 0,000 | |
| TOTAL appropriations | (Total commitments = Total payments) | 0,000 | 0,000 | 0,000 | 0,000 | 0,000 | |
| under HEADING 7 | |||||||
| of the multiannual financial framework |
EUR million (to three decimal places)
| Year | Year | Year | TOTAL | |||
| 2025 | 2026 | 2027 et seqq | ||||
| TOTAL appropriations | Commitments | 0,505 | 0,830 | 1,099 | 2,434 | |
| under HEADINGS 1 to 7 | ||||||
| of the multiannual financial framework | Payments | 0,131 | 0,337 | 1,966 | 2,434 |
For information, reduction of the SMP Food Chain line to increase Heading 1 unallocated margin to compensate for the increase of EFSA line from the Heading 2b unallocated margin.
EUR million (to three decimal places)
| HEADING 1 - Single Market, Innovation and Digital | Year | Year | Year | TOTAL | ||
| 2025 | 2026 | 2027 | ||||
| Operational appropriations | ||||||
| 03 02 06 Contributing to a high level of health and welfare for humans, animals and plants | Commitments | (1a) | 0,405 | -0,830 | -1,099 | -2,334 |
3.2.2.Estimated output funded with operational appropriations
Commitment appropriations in EUR million (to three decimal places)
| Indicate objectives and outputs | Year | Year | Year | TOTAL | ||||||
| 2025 | 2026 | 2027 et seqq | ||||||||
| OUTPUTS | ||||||||||
| Type[1] | Average cost | No | Cost | No | Cost | No | Cost | Total No | Total cost | |
| SPECIFIC OBJECTIVE No 1 : Procedures for the deliberate release and placing on the market ensure that NGT plants and derived food/feed products are as safe as their conventional counterparts, while not entailing unnecessary regulatory burden. | ||||||||||
| Verification on equivalence of NGT plants to conventional plants : New EFSA task to determine before placing on the market or before field trials whether the notified NGT plant meets pre-defined equivalence criteria (Preparatory work, Assessment of equivalence to predefined criteria) | 0,041 | 0,217 | 0,330 | 0,589 | ||||||
| Placing on the market of NGT plants and food/feed - related tasks- Extension of the EFSA capacity to risk assess new applications for the placing on the market of NGT plants and food/feed and to provide scientific/technical advice before the authorisation procedure in pre-determined cases ( Preparatory work and Risk Assessment of NGT applications) | 0,113 | 0,286 | 0,412 | 0,812 | ||||||
| Verification on equivalence of NGT plants to conventional plants -Outsourcing for molecular data verification (18 notifications) | 0,090 | 0,090 | 0,090 | 0,270 | ||||||
| Expansion of the E-Submission Food Chain (ESFC) to include exchange of information and maintenance and development and maintenance of a public register for:A new domain in the FIP/ESFC system | 0,100 | 0,000 | 0,000 | 0,100 | ||||||
| Placing on the market of NGT plants and food/feed - related tasks -Preparatory work (Cost of indemnities and expert meetings and Cost of contracts supporting RA ) | 0,150 | 0,150 | 0,150 | 0,450 | ||||||
| Subtotal for specific objective No 1 | 0,494 | 0,744 | 0,982 | 2,221 | ||||||
| SPECIFIC OBJECTIVE No 2 .Deliberate release and placing on the market of NGT plants and derived food/feed products that feature a wide range of plant species and traits by various developers | ||||||||||
| Verification on equivalence of NGT plants to conventional plants - New EFSA task to determine before placing on the market or before field trials whether the notified NGT plant meets pre-defined equivalence criteria : Intake steps | 0,000 | 0,048 | 0,065 | 0,113 | ||||||
| Placing on the market of NGT plants and food/feed - related tasks- Extension of the EFSA capacity to risk assess new applications for the placing on the market of NGT plants and food/feed and to provide scientific/technical advice before the authorisation procedure in pre-determined cases (Pre-submission advice and Intake steps) | 0,011 | 0,038 | 0,052 | 0,100 | ||||||
| Subtotal for specific objective No 2 | 0,011 | 0,086 | 0,117 | 0,214 | ||||||
| TOTALS | 0,505 | 0,830 | 1,099 | 2,434 |
i.Summary of estimated impact on EFSA’s Human Resources
| Total | ||||
| 2025 | 2026 | 2027 and et seqq |
in EUR million (to three decimal places)
| Temporary agents (AD Grades) | 0,165 | 0,505 | 0,687 | 1,358 |
| Temporary agents (AST grades) | 0,000 | 0,084 | 0,172 | 0,256 |
| Contract staff | 0,000 | 0,000 | 0,000 | 0,000 |
| Seconded National Experts | 0,000 | 0,000 | 0,000 | 0,000 |
| Total | 0,165 | 0,590 | 0,859 | 1,614 |
Staff requirements (FTE): Total posts Union funded
| Temporary agents (AD Grades) | 2,0 | 4,0 | 4,0 | 4,0 |
| Temporary agents (AST grades) | 0,0 | 1,0 | 1,0 | 1,0 |
| Contract staff | 0,0 | 0,0 | 0,0 | 0,0 |
| Seconded National Experts | 0,0 | 0,0 | 0,0 | 0,0 |
| Total | 2,0 | 5,0 | 5,0 | 5,0 |
The staff costs have been adjusted in such a way that the newly recruited staff is accounted for 6 months during the year of recruitment.
3.2.3.Summary of estimated impact on administrative appropriations
–✓ The proposal/initiative does not require the use of appropriations of an administrative nature
–◻ The proposal/initiative requires the use of appropriations of an administrative nature, as explained below:
EUR million (to three decimal places)
| Year N 68 | Year N+1 | Year N+2 | Year N+3 | Enter as many years as necessary to show the duration of the impact (see point 1.6) | TOTAL |
| HEADING 7 of the multiannual financial framework | ||||||||
| Human resources | ||||||||
| Other administrative expenditure | ||||||||
| Subtotal HEADING 7 of the multiannual financial framework |
| Outside HEADING 7 69 of the multiannual financial framework | ||||||||
| Human resources | ||||||||
| Other expenditure of an administrative nature | ||||||||
| Subtotal outside HEADING 7 of the multiannual financial framework |
| TOTAL |
The appropriations required for human resources and other expenditure of an administrative nature will be met by appropriations from the DG that are already assigned to management of the action and/or have been redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints.
3.2.3.1.Estimated requirements of human resources
–✓ The proposal/initiative does not require the use of human resources.
–◻ The proposal/initiative requires the use of human resources, as explained below:
Estimate to be expressed in full time equivalent units
| Year N | Year N+1 | Year N+2 | Year N+3 | Enter as many years as necessary to show the duration of the impact (see point 1.6) | ||||
| • Establishment plan posts (officials and temporary staff) | ||||||||
| 20 01 02 01 (Headquarters and Commission’s Representation Offices) | ||||||||
| 20 01 02 03 (Delegations) | ||||||||
| 01 01 01 01 (Indirect research) | ||||||||
| 01 01 01 11 (Direct research) | ||||||||
| Other budget lines (specify) | ||||||||
| • External staff (in Full Time Equivalent unit: FTE) 70 | ||||||||
| 20 02 01 (AC, END, INT from the ‘global envelope’) | ||||||||
| 20 02 03 (AC, AL, END, INT and JPD in the delegations) | ||||||||
| XX 01 xx yy zz 71 | - at Headquarters | |||||||
| - in Delegations | ||||||||
| 01 01 01 02 (AC, END, INT - Indirect research) | ||||||||
| 01 01 01 12 (AC, END, INT - Direct research) | ||||||||
| Other budget lines (specify) | ||||||||
| TOTAL |
XX is the policy area or budget title concerned.
The human resources required will be met by staff from the DG who are already assigned to management of the action and/or have been redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints.
Description of tasks to be carried out:
| Officials and temporary staff | 1)managing (AD) and supporting (AST) the GMO panel in its risk assessment activities for NGT plants under the authorisation procedure 2)Assessing (AD) and supporting the assessment (AST) the equivalence to predefinded criteria of NGT plants under the notification procedure 3)Supporting the applicants and performing the completeness check (AD) for NGT plants under the notification procedure 4)Giving scientific advice (AD) to the the applicant to NGT plants containing traits that contribute to sustainability under the authorisation procedure 5)Supporting the applicant and performing the completeness (AD) check for NGT plants under the authorisation prodecudre |
| External staff |
3.2.4.Compatibility with the current multiannual financial framework
The proposal/initiative:
–✓ can be fully financed through redeployment within the relevant heading of the Multiannual Financial Framework (MFF).
The increase of appropriations for EFSA budget line 06 10 02 European Food Safety Authority in years 2025 to 2027 by 2,3 million EUR, will be covered from the unallocated margin under Heading 2b. To preserve the neutrality of this proposal towards the EU budget, an equal reduction of the SMP Food chain budget line 03 02 06 will be applied, resulting in an increase of the Heading 1 margin by the same amount. The required financing of 0,100 million EUR under the line 03 02 06 - Contributing to a high level of health and welfare for humans, animals and plants will be covered by internal redeployment.
–✓ requires use of the unallocated margin under the relevant heading of the MFF and/or use of the special instruments as defined in the MFF Regulation.
– As a consequence of the budgetary mechanism described above, the unallocated margin of Heading 2b will decrease by EUR 2,3 million over the years 2025-2027 while the unalocated margin of Heading 1 will increase by the same amount.◻ requires a revision of the MFF.
Explain what is required, specifying the headings and budget lines concerned and the corresponding amounts.
3.2.5.Third-party contributions
The proposal/initiative:
–✓ does not provide for co-financing by third parties
–◻ provides for the co-financing by third parties estimated below:
Appropriations in EUR million (to three decimal places)
| Year N 72 | Year N+1 | Year N+2 | Year N+3 | Enter as many years as necessary to show the duration of the impact (see point 1.6) | Total | |||
| Specify the co-financing body | ||||||||
| TOTAL appropriations co-financed |
3.3.Estimated impact on revenue
–✓ The proposal/initiative has no financial impact on revenue.
–◻ The proposal/initiative has the following financial impact:
–◻ on own resources
–◻ on other revenue
–please indicate, if the revenue is assigned to expenditure lines ◻
EUR million (to three decimal places)
| Budget revenue line: | Appropriations available for the current financial year | Impact of the proposal/initiative 73 | ||||||
| Year N | Year N+1 | Year N+2 | Year N+3 | Enter as many years as necessary to show the duration of the impact (see point 1.6) | ||||
| Article …………. |
For assigned revenue, specify the budget expenditure line(s) affected.
Other remarks (e.g. method/formula used for calculating the impact on revenue or any other information).
(1) An umbrella term used to describe a variety of techniques that can alter the genetic material of an organism and that have emerged or have been developed since 2001, when the Union legislation on genetically modified organisms (GMOs) was adopted.
(2) Genetic modification techniques developed prior to 2001, when the Union GMO legislation was adopted.
(3) An umbrella term used to describe newer techniques of mutagenesis that induce mutation(s) in selected target locations of the genome without insertion of foreign genetic material
(4) Insertion of genetic material (e.g. a gene) into a recipient organism from a donor that is sexually compatible (crossable). The exogenous genetic material can be introduced without (cisgenesis) or with modifications/rearrangements (intragenesis).
(5) Crossable means that there are no natural barriers to the interbreeding of two plants from the same or different species.
(6) EFSA Panel on Genetically Modified Organisms, Scientific opinion addressing the safety assessment of plants developed using Zinc Finger Nuclease 3 and other Site-Directed Nucleases with similar function. EFSA Journal 2012;10(10):2943. doi:10.2903/j.efsa.2012.2943. EFSA Panel on Genetically Modified Organisms, ‘Applicability of the EFSA Opinion on SDNs type 3 for the safety assessment of plants developed using SDNs type 1 and 2 and oligonucleotide-directed mutagenesis’, EFSA Journal 2020;18(11):6299. https://doi.org/10.2903/j.efsa.2020.6299 EFSA Panel on Genetically Modified Organisms, 2012. Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA Journal 2012;10(2):2561. EFSA Panel on Genetically Modified Organisms, 2022. Updated scientific opinion on plants developed through cisgenesis and intragenesis. EFSA Journal 2022;20(10):7621, 33 pp. https://doi.org/10.2903/j.efsa.2022.7621 . EFSA Panel on Genetically Modified Organisms, 2021. Scientific Opinion on the evaluation of existing guidelines for their adequacy for the molecular characterisation and environmental risk assessment of genetically modified plants obtained through synthetic biology. EFSA Journal 2021;19(2):6301, 21 pp. https://doi.org/10.2903/j.efsa.2021.6301 EFSA Panel on Genetically Modified Organisms, 2022. Scientific Opinion on the evaluation of existing guidelines for their adequacy for the food and feed risk assessment of genetically modified plants obtained through synthetic biology. EFSA Journal 2022;20 (7):7410, 25 pp. https://doi.org/10.2903/j.efsa.2022.7410
(7) A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system. COM (2020) 381 final
(8) Safeguarding food security and reinforcing the resilience of food systems. COM (2022) 133 final.
(9) Trade Policy Review - An Open, Sustainable and Assertive Trade Policy. COM (2021) 66 final
(10) Judgement of the Court of Justice of 25 July 2018, Confédération paysanne and Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt, C-528/16, ECLI:EU:C:2018:583.
(11) SWD(2021) 92
(12) EU Biodiversity Strategy for 2030 Bringing nature back into our lives, COM/2020/380 final
(13) COM (2022)305 final, 2022/0196 (COD), https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52022PC0305&qid=1674645473396
(14) OJ L 150, 14.6.2018, p. 1–92.
(15) SWD(2023) 411
(16) Food Chain Evaluation Consortium (2010)
(17) GHK Consulting (2011)
(18) https://food.ec.europa.eu/system/files/2022-09/sc_modif-genet_consultation-strategy-ngts.pdf
(19) https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13119-Legislation-for-plants-produced-by-certain-new-genomic-techniques_en
(20) https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13119-Legislation-for-plants-produced-by-certain-new-genomic-techniques/public-consultation_en
(21) https://doi.org/10.2875/282347
(22) Schneider, K., Barreiro-Hurle, J., Kessel, G., et al., 2023. Economic and environmental impacts of disease resistant crops developed with cisgenesis. EUR 31355, Publication office of the European Union, Luxembourg; Sánchez, B., Barro, F., Smulders, M. J. M. et al. 2023. Socioeconomic impact of low-gluten, celiac-safe wheat developed through gene editing, EUR 31380 EN, Publications Office of the European Union, Luxembourg.
(23) Parisi, C. and Rodriguez Cerezo, E., Current and future market applications of new genomic techniques, EUR 30589 EN, Publications Office of the European Union, Luxembourg, 2021, ISBN 978-92-76-30206-3, doi:10.2760/02472, JRC123830.
(24) Broothaerts, W., Jacchia, S., Angers, A. et al., New Genomic Techniques: State-of-the-Art Review, EUR 30430 EN, Publications Office of the European Union, Luxembourg, 2021, ISBN 978-92-76-24696-1, doi:10.2760/710056, JRC121847; European Commission, Directorate-General for Research and Innovation, New techniques in agricultural biotechnology, Publications Office, 2017, https://data.europa.eu/doi/10.2777/574498
(25) EFSA Panel on Genetically Modified Organisms, 2022. Statement on criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis. EFSA Journal 2022;20(10):7618, 12 pp. https://doi.org/10.2903/j.efsa.2022.7618
(26) EFSA Panel on Genetically Modified Organisms, 2022. Updated scientific opinion on plants developed through cisgenesis and intragenesis. EFSA Journal 2022;20(10):7621, 33 pp., https://doi.org/10.2903/j.efsa.2022.7621
(27) SWD(2023) 412
(28) In the impact assessment, this verification procedure is referred to as ‘notification procedure’. That terminology is not used in the legislative proposal to avoid confusion with the notification procedure in Directive 2001/18/EC.
(29) Regulation (EU) 2021/1119
(30) COM (2021) 82 final
(31) SEC(2023) 411
(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).
(33) Insights and solutions stemming from EU-funded research and innovation projects on plant breeding strategies may contribute to address detection challenges, ensure traceability and authenticity, and promote innovation in the area of new genomic techniques. More than 1,000 projects were funded under the Seventh Framework Programme and successor Horizon 2020 programme with an investment of over 3 billion Euros. Horizon Europe support to new collaborative research projects on plant breeding strategies is also ongoing, SWD(2021) 92.
(34) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM/2019/640 final.
(35) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A Farm to Fork Strategy for a fair, healthy and environmentally friendly food system, COM/2020/381 final.
(36) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, EU Biodiversity Strategy for 2030: Bringing nature back into our lives, COM/2020/380 final.
(37) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions forging a Climate-Resilient Europe - The New EU Strategy on Adaptation to Climate Change, COM(2021) 82 final
(38) Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, Safeguarding food security and reinforcing the resilience of food systems, COM (2022) 133 final; Food and Agriculture Organisation of the United Nations (FAO), 2022, Gene editing and agrifood systems, Rome, ISBN 978-92-5-137417-7.
(39) European Commission, Directorate-General for Research and Innovation, A sustainable bioeconomy for Europe – Strengthening the connection between economy, society and the environment: updated bioeconomy strategy, Publications Office, 2018, https://data.europa.eu/doi/10.2777/792130.
(40) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Trade Policy Review - An Open, Sustainable and Assertive Trade Policy, COM(2021)66 final.
(41) Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (OJ L 268, 18.10.2003, p. 24).
(42) Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1).
(43) Judgement of the Court of Justice of 25 July 2018, Confédération paysanne and Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt, C-528/16, ECLI:EU:C:2018:583.
(44) Council Decision (EU) 2019/1904 of 8 November 2019 requesting the Commission to submit a study in light of the Court of Justice’s judgment in Case C-528/16 regarding the status of novel genomic techniques under Union law, and a proposal, if appropriate in view of the outcomes of the study ( OJ L 293, 14.11.2019, p. 103 ).
(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.
(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).
(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).
(48) EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins E, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta, J, Fernandez Dumont A, Gennaro A, Lenzi, P, Lewandowska A, Munoz Guajardo IP, Papadopoulou N and Rostoks N, 2022. Updated scientific opinion on plants developed through cisgenesis and intragenesis. EFSA Journal 2022;20(10):7621, 33 pp. https://doi.org/10.2903/j.efsa.2022.7621.
(49) EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Naegeli H, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Mullins E, Nogué F, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta J, Gennaro A, Paraskevopoulos K, Raffaello T and Rostoks N, 2020. Applicability of the EFSA Opinion on site-directed nucleases type 3 for the safety assessment of plants developed using site-directed nucleases type 1 and 2 and oligonucleotide-directed mutagenesis. EFSA Journal 2020;18(11):6299, 14 pp. https://doi. org/10.2903/j.efsa.2020.6299.
(50) EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins E, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Fernandez A, Gennaro A, Papadopoulou N, Raffaello T and Schoonjans R, 2022. Statement on criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis. EFSA Journal 2022;20(10):7618, 12 pp. https://doi.org/10.2903/j.efsa.2022.7618.
(51) European Network of GMO Laboratories (ENGL), Detection of food and feed plant products obtained by new mutagenesis techniques, 26 March 2019 (JRC116289); 13 June 2023 (JRC133689; EUR 31521 EN)
(52) COM(2023) 414 final
(53) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 031 1.2.2002, p. 1).
(54) OJ L 123, 12.5.2016, p. 1
(55) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(56) SWD(2023) 412
(57) Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).
(58) Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (OJ L 317, 23.11.2016, p. 4).
(59) COM(2023) 414 final
(60) Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (OJ L 10, 16.1.2004, p. 5).
(61) OJ L 123, 12.5.2016, p. 1.
(62) As referred to in Article 58(2)(a) or (b) of the Financial Regulation.
(63) Details of budget implementation methods and references to the Financial Regulation may be found on the BUDGpedia site: https://myintracomm.ec.europa.eu/corp/budget/financial-rules/budget-implementation/Pages/implementation-methods.aspx
(64) Objectives emphasised under Art. 30 of EFSA’s Financial Regulation: (i) effectiveness, efficiency and economy of operations; (ii) reliability of reporting; (iii) safeguarding of assets and information; (iv) prevention, detection, correction and follow-up of fraud and irregularities; and (v) adequate management of risks relating to the legality and regularity of the underlying transactions.
(65) Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations.
(66) EFTA: European Free Trade Association.
(67) Candidate countries and, where applicable, potential candidates from the Western Balkans.
(68) Year N is the year in which implementation of the proposal/initiative starts. Please replace "N" by the expected first year of implementation (for instance: 2021). The same for the following years.
(69) Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research.
(70) AC= Contract Staff; AL = Local Staff; END= Seconded National Expert; INT = agency staff; JPD= Junior Professionals in Delegations.
(71) Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines).
(72) Year N is the year in which implementation of the proposal/initiative starts. Please replace "N" by the expected first year of implementation (for instance: 2021). The same for the following years.
(73) As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. gross amounts after deduction of 20 % for collection costs.
Top
EUROPEAN COMMISSION
Brussels, 5.7.2023
COM(2023) 411 final
ANNEXES
to the
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625
{SEC(2023) 411 final} - {SWD(2023) 411 final} - {SWD(2023) 412 final} - {SWD(2023) 413 final}
ANNEX I
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.
ANNEX II
Risk assessment of category 2 NGT plants and category 2 NGT food and feed
Part 1 of this Annex describes the general principles to be followed to perform the environmental risk assessment of category 2 NGT plants referred to in Article 13, points (c) and (d), Article 14(1), point (e), and Article 19(3), point (a), and the safety assessment of category 2 NGT food and feed referred to in Article 19(1), point (b). Part 2 describes specific information for the environmental risk assessment of category 2 NGT plants and Part 3 describes specific information for the safety assessment of category 2 NGT food and feed.
Part 1- General principles and information
The environmental risk assessment shall be carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC.
The type and amount of information necessary for the environmental risk assessment of category 2 NGT plants laid down in Annex III of Directive 2001/18/EC and for the food and feed safety assessment of category 2 NGT food and feed shall be adapted to their risk profile. Factors to be considered include:
(a)the characteristics of the NGT plant, in particular the trait(s) introduced, the function of the modified or inserted genome sequence(s) and the function of any gene disrupted by the insertion of a cisgene or parts thereof;
(b)prior experience with the consumption of similar plants or their products;
(c)prior experience with the cultivation of the same plant species or plant species exhibiting similar traits or in which similar genome sequences have been modified, inserted or disrupted;
(d)the scale and conditions of the release;
(e)the intended conditions of use of the NGT plant.
The environmental risk assessment of category 2 NGT plants and the risk assessment of category 2 NGT food and NGT feed shall consist of the following:
(a)hazard identification and characterisation;
(b)exposure assessment;
(c)risk characterisation.
The following information shall always be required:
(a)hazard identification and characterisation
(i)information relating to the recipient plant or, where appropriate, to the parental plants;
(ii)molecular characterisation.
The information shall be provided by collating already available data from scientific literature or from other sources or generating scientific data where necessary by performing appropriate experimental or bioinformatic studies.
(b)exposure assessment
Information shall be provided on the likelihood of each identified potential adverse effect. This shall be evaluated taking into consideration, as relevant, the characteristics of the receiving environment(s), the intended function, the dietary role, the expected level of use of the food and feed in the EU and the scope of the application for authorisation.
(c)risk characterisation
The applicant shall base its risk characterisation of NGT plants and foods and feed on information from hazard identification, hazard characterisation and exposure assessment. The risk shall be characterised by combining, for each potential adverse effect, the magnitude with the likelihood of that adverse effect occurring to provide a quantitative or semi quantitative estimation of the risk. Where relevant, the uncertainty for each identified risk shall be described.
Any information on hazard identification and characterisation specified under Parts 2 and 3 shall only be required if the specific characteristics and the intended use of the category 2 NGT plant or category 2 NGT food or feed give rise to a plausible risk hypothesis that can be addressed utilising the specified information.
Part 2 - Specific information for the environmental risk assessment of category 2 NGT plants concerning hazard identification and characterisation
(1)Analysis of agronomic, phenotypic and compositional characteristics
(2)Persistence and invasiveness
(3)Potential gene transfer
(4)Interactions of the NGT plant with target organisms
(5)Interactions of the NGT plant with non-target organisms
(6)Impacts of the specific cultivation, management and harvesting techniques
(7)Effects on biogeochemical processes
(8)Effects on human and animal health
Part 3–Specific information for the safety assessment of category 2 NGT food and feed concerning hazard identification and characterisation
(1)Analysis of agronomic, phenotypic and compositional characteristics
(2)Toxicology
(3)Allergenicity
(4)Nutritional assessment
ANNEX III
Traits referred to in Article 22
Part 1
Traits justifying the incentives referred to in Article 22:
(1)yield, including yield stability and yield under low-input conditions;
(2)tolerance/resistance to biotic stresses, including plant diseases caused by nematodes, fungi, bacteria, viruses and other pests;
(3)tolerance/resistance to abiotic stresses, including those created or exacerbated by climate change;
(4)more efficient use of resources, such as water and nutrients;
(5)characteristics that enhance the sustainability of storage, processing and distribution;
(6)improved quality or nutritional characteristics;
(7)reduced need for external inputs, such as plant protection products and fertilisers.
Part 2
Traits excluding the application of the incentives referred to in Article 22: tolerance to herbicides.
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