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Expansion of the Low-Risk Substances in the Framework of the European Pesticide Regulation (EC) No 1107/2009

Published online by Cambridge University Press:  17 December 2021

Diane C. Robin  and
Patrice A. Marchand Open the ORCID record for Patrice A. Marchand [Opens in a new window]
Diane C. Robin
Affiliation:
Institut Technique de l’Agriculture Biologique (ITAB), 149 rue de Bercy, F-75595 Paris Cedex 12, France
Patrice A. Marchand*
Affiliation:
Institut Technique de l’Agriculture Biologique (ITAB), 149 rue de Bercy, F-75595 Paris Cedex 12, France
*
*Corresponding author. Email: [email protected]
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Abstract

Signed in 2009, the plant protection Commission Regulation EC No 1107/2009 created a new category of active substances, the low-risk substances, with specific status defined in Article 22. The initial and specific criteria, not suitable for microorganisms and natural substances, were modified in 2018, and the first low-risk substance, allocating Part D of Regulation EC No 540/2011, was granted in the same year. Since then, thirty-three low-risk substances have been granted with this specific status through approvals and renewals, while a larger list of potential low-risk substances from already-approved active substances was published. This list is only exploited during renewals, and this process would take another five years to complete. After four years of the implementation of this status, the number of such substances is still low, but is intended to increase slowly. Two more low-risk substances are already pending in 2021, which will bring the number of low-risk substances to thirty-five, while the initial list of potential low-risk substances (only renewals) included fifty-seven substances.

Keywords

active substancesArticle 22biocontrol agentslow-riskRegulation (EC) No 1107/2009
Type
Articles
Information
European Journal of Risk Regulation , Volume 13 , Issue 3 , September 2022 , pp. 514 - 531
Copyright
© The Author(s), 2021. Published by Cambridge University Press

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References

1 Regulation (EC) No 1107/2009 of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJ L 309/1.

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4 DC Robin and PA Marchand, “Low-Risk Substances, New Effective Category of Biocontrol Agents as Lever for Durable Crop Protection Products” (2021) 5 Chronicle of Bioresource Management 9.

5 Implementing Regulation (EU) No 540/2011 of 25 May 2011; Implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. OJ L 153/133.

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8 Marchand (2015), supra, note 2.

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11 Commission Implementing Regulation (EU) 2015/543 of 1 April 2015 approving the active substance COS-OGA, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. OJ L 90/1.

12 Commission Implementing Regulation (EU) 2015/553 of 7 April 2015 approving the active substance cerevisane, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. OJ L 92/86.

13 Commission Implementing Regulation (EU) 2019/676 of 29 April 2019 approving the low-risk active substance ABE-IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623), in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. C/2019/3050. OJ L 114/12.

14 Commission Implementing Regulation (EU) 2020/646 of 13 May 2020 approving the active substance Lavandulyl senecioate as a low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011. C/2020/2994. OJ L 151/3.

15 Commission Implementing Regulation (EU) 2020/1018 of 13 July 2020 approving ferric pyrophosphate as low-risk active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011. C/2020/4604. OJ L 225/9.

16 Commission Implementing Regulation (EU) 2020/1263 of 10 September 2020 approving the active substance sodium hydrogen carbonate as a low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011. C/2020/5988. OJ L 297/1.

17 Commission Implementing Regulation (EU) 2021/427 of 10 March 2021 approving the active substance 24-epibrassinolide as a low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011. C/2021/1514. OJ L 84/21.

18 Commission Implementing Regulation (EU) 2021/567 of 6 April 2021 approving the low-risk active substance aqueous extract from the germinated seeds of sweet Lupinus albus in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011. C/2021/2066. OJ L 118/6.

19 Commission Implementing Regulation (EU) 2015/1176 of 17 July 2015 approving the active substance Pepino mosaic virus strain CH2 isolate 1906, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. OJ L 192/1.

20 Commission Implementing Regulation (EU) 2016/951 of 15 June 2016 approving the low-risk active substance Trichoderma atroviride strain SC1, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. C/2016/3609. OJ L 159/6.

21 Commission Implementing Regulation (EU) 2016/952 of 15 June 2016 approving the low-risk active substance Saccharomyces cerevisiae strain LAS02 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. C/2016/3616. OJ L 159/10.

22 Commission Implementing Regulation (EU) 2017/406 of 8 March 2017 approving the low-risk active substance mild Pepino mosaic virus isolate VX1, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. C/2017/1478. OJ L 63/83.

23 Commission Implementing Regulation (EU) 2017/408 of 8 March 2017 approving the low-risk active substance mild Pepino mosaic virus isolate VC1, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. C/2017/1474. OJ L 63/91.

24 Commission Implementing Regulation (EU) 2017/806 of 11 May 2017 approving the low-risk active substance Bacillus amyloliquefaciens strain FZB24, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. C/2017/3042. OJ L 121/31.

25 Commission Implementing Regulation (EU) 2018/1278 of 21 September 2018 approving the low-risk active substance Pasteuria nishizawae Pn1 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. C/2018/5506. OJ L 239/4.

26 Marchand (2015), supra, note 2.

27 Commission Implementing Regulation (EU) 2015/1166 of 15 July 2015 renewing the approval of the active substance ferric phosphate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. OJ L 188/34.

28 Commission Implementing Regulation (EU) 2018/112 of 24 January 2018 renewing the approval of the low-risk active substance laminarin in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. C/2018/0247. OJ L 20/3.

29 Commission Implementing Regulation (EU) 2021/413 of 8 March 2021 renewing the approval of the low-risk active substance blood meal in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. C/2021/1444. OJ L 81/32.

30 Commission Implementing Regulation (EU) 2017/842 of 17 May 2017 renewing the approval of the low-risk active substance Coniothyrium minitans strain CON/M/91-08 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. C/2017/3208. OJ L 125/16.

31 Commission Implementing Regulation (EU) 2018/1075 of 27 July 2018 renewing the approval of the active substance Ampelomyces quisqualis strain AQ10, as a low-risk active substance, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. C/2018/4861. OJ L 194/36.

32 Commission Implementing Regulation (EU) 2019/151 of 30 January 2019 renewing the approval of the active substance Clonostachys rosea strain J1446 as a low-risk active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. C/2019/634. OJ L 27/26.

33 Commission Implementing Regulation (EU) 2019/1605 of 27 September 2019 approving the low-risk active substance Bacillus subtilis strain IAB/BS03, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. C/2019/6866. OJ L 250/49.

34 Commission Implementing Regulation (EU) 2019/1675 of 4 October 2019 renewing the approval of the active substance Verticillium albo-atrum strain WCS850 as a low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. C/2019/7073. OJ L 257/6.

35 Commission Implementing Regulation (EU) 2020/1003 of 9 July 2020 renewing the approval of the active substances Phlebiopsis gigantea strains VRA 1835, VRA 1984 and FOC PG 410.3 as low-risk substances in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. C/2020/4543. OJ L 221/127.

36 Commission Implementing Regulation (EU) 2021/134 of 4 February 2021 renewing the approval of the low-risk active substance Akanthomyces muscarius strain Ve6 (formerly Lecanicillium muscarium strain Ve6) in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. C/2021/527. OJ L 42/4.

37 DC Robin and PA Marchand, “Biocontrol active substances: evolution since the entry in vigour of Reg. 1107/2009” (2019) 75 Pest Management Science 950.

38 Pesticides Database v2.2, supra, note 6.

39 Marchand, supra, note 9; DC Robin and PA Marchand, “Evolution of Regulation (EU) No 540/2011 since Its Entry into Force” (2019) 7 Journal of Regulatory Science 1.

40 Commission notice of 27 July 2018 concerning a list of potentially low-risk active substances approved for use in plant protection (2018/C 265/02). OJ C265(4)/8.

41 Commission Implementing Regulation (EU) 2021/129 of 3 February 2021 renewing the approval of the active substance garlic extract in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. C/2021/517. OJ L 40/11.

42 Commission Implementing Regulation (EU) 2021/853 of 27 May 2021 renewing the approval of the active substance Streptomyces strain K61 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. C/2021/3571. OL L 188/56.

43 Pesticides Database v2.2, supra, note 6.

44 Exchange of views of the Committee on a draft Commission Implementing Regulation (EU) concerning the non-renewal of approval of the active substance Pythium oligrandum strain M1, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Draft Review Report SANTE/10332/2021 Rev. 0) during Standing Committee on Plants, Animals, Food and Feed, Section Phytopharmaceuticals – Legislation, 19–20 May 2021 (SANTE/10330/2021 Rev. 0).

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48 Exchange of views and possible opinion of the Committee on a draft Commission Implementing Regulation (EU) approving the new active substance Purpureocillium lilacinum strain PL11 as a low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Draft Review Report SANTE/10418/2021). Opinion favourable.

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51 DG Health and Food Safety. Overview report on a series of audits carried out in EU Member States in 2016 and 2017 in order to evaluate the systems in place for the Authorisation of Plant Protection Products. DG(SANTE) 2017-6250-MR:1-30, DOI: 10.2875/580084 (2017); European Parliament and Council. REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL On the experience gained by Member States on the implementation of national targets established in their National Action Plans and on progress in the implementation of Directive 2009/128/EC on the sustainable use of pesticides (2020), COM/2020/204 final.

52 DG Health and Food Safety, supra, note 51.

53 Exchange of views and possible opinion of the Committee on a draft Commission Implementing Regulation (EU) approving the low-risk active substance Bacillus amyloliquefaciens strain IT-45, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Draft Review Report SANTE/10762/2021) (SANTE/10760/2021); Exchange of views of the Committee on a draft Commission Implementing Regulation (EU) concerning the renewal of approval of the active substance Metarhizium brunneum strain M43 as a low-risk active substance, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Draft Review Report SANTE/10278/2021) (SANTE/10276/2021).

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60 Commission Implementing Regulation (EU) 2021/1165 of 15 July 2021 authorising certain products and substances for use in organic production and establishing their lists. C/2021/5149. OJ L 253/13.

61 Marchand, supra, note 9.

62 H Willer, J Trávníček, C Meier and B Schlatter, “The World of Organic Agriculture Statistics and Emerging Trends 2021” (2021) FiBL & IFOAM Organics International 1 <https://www.fibl.org/fileadmin/documents/shop/1150-organic-world-2021.pdf> (last accessed 23 November 2021).

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65 EGTOP, “Final Report on Plant Protection Products III” (2016) <https://ec.europa.eu/info/sites/default/files/food-farming-fisheries/farming/documents/final_report_egtop_plant_protection_iii_0.pdf> (last accessed 23 November 2021).

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67 EGTOP, “Final Report on Fertilisers IV and Plant Protection Products VI” (2021) <https://ec.europa.eu/info/sites/default/files/food-farming-fisheries/farming/documents/egtop-report-fertilisers-iv-and-plant-protection-products-vi_en.pdf> (last accessed 23 November 2021).

68 Willer et al, supra, note 62.

69 Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides. OJ L 309/71; DC Robin and PA Marchand, “Evolution of Directive (EC) No 128/2009 of the European Parliament and of the Council Establishing a Framework for Community Action to Achieve the Sustainable Use of Pesticides” (2019) 7 Journal of Regulatory Science 1.

70 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. The European Green Deal. (2019) OJ C 640/1.

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72 S Stehle and R Schulz, “Pesticide Authorization in the EU – Environment Unprotected?” 22 Environmental Science and Pollution Research 19632.

73 Exchange of views of the Committee on a draft Commission Regulation (EU) amending Annex II to Regulation (EC) No 1107/2009 as regards specific criteria for the approval of active substances that are micro-organisms (SANTE/10686/2021); Exchange of views of the Committee on a draft Commission Regulation (EU) amending Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for micro-organisms (SANTE/12040/2020); Exchange of views of the Committee on a draft Commission Regulation (EU) amending Regulation (EU) No 284/2013 as regards the information to be submitted for plant protection products and the specific data requirements for plant protection products containing micro-organisms (SANTE/12042/2020); Exchange of views of the Committee on a draft Commission Regulation (EU) amending Regulation (EU) No 546/2011 as regards specific uniform principles for evaluation and authorisation of plant protection products containing micro-organisms (SANTE/10716/2021).

74 Exchange of views of the Committee on a draft Commission Implementing Regulation (EU) concerning the renewal of approval of the active substance Metarhizium brunneum strain M43 as a low-risk active substance, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Draft Review Report SANTE/10278/2021) (SANTE/10276/2021); Exchange of views of the Committee on a draft Commission Implementing Regulation (EU) approving the active substance Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV) isolate BV-0004 as a low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Draft Review Report SANTE/11266/2021) (SANTE/11264/2021).

75 Vekemans and Marchand, supra, note 2; S Mladenović, “The Role of the European Food Safety Authority in the Active Substance Approval and Renewal Procedures within the EU Pesticide Policy” (2021) 90 Правни факултет Универзитета у Нишу 165.

76 V Storck, DG Karpouzas and F Martin-Laurent, “Towards a Better Pesticide Policy for the European Union” (2017) 575 Science of the Total Environment 1027.

77 E Bozzini, “EU Pesticide Regulation: Principles and Procedures” in Pesticide Policy and Politics in the European Union (London, Palgrave Macmillan 2017) pp 27–56.