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The Slow Decrease of Active Substance Candidates for Substitution in the Framework of the European Pesticide Regulation (EC) No 1107/2009

Published online by Cambridge University Press:  04 January 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; email: patrice.marchand@itab.asso.fr.
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Abstract

The specific status of active substance candidates for substitution (CfS) is detailed by Article 24 of plant protection Commission Regulation EC No 1107/2009 (PPP Regulation). The criteria of candidates for substitution are now clearly defined: low acceptable daily intake/acute reference dose/acceptable operator exposure level or two persistent, bio-accumulative or toxic criteria, or by nature of the critical effects: non-active isomers, carcinogen 1A/1B, toxic for reproduction 1A/1B or endocrine disruption properties, with these later properties now being well characterised. The total number of active substances CfS has been in constant evolution since 2011, with the first batch of candidates for substitution being published in 2015 and updated since then. After a slow decrease, growth is again observed, with another list of active substances being granted this status. CfS are substances targeted by the PPP Regulation that are supposed to be cancelled or non-renewed at the active substance level or substituted at the market authorisation level. CfS are also supposed to be replaced by substances with better toxicological profiles. However, after five years of implementation of the status, their number, which is intended to decrease, remains high, at sixty residual CfS. We exhibit here their evolution.

Type
Articles
Information
European Journal of Risk Regulation , Volume 14 , Issue 1 , March 2023 , pp. 191 - 212
Copyright
© The Author(s), 2021. Published by Cambridge University Press

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Footnotes

The author would like to thank Dr Trevor M. Fenning of Forest Research (UK) for providing helpful advice on the editing and writing of the manuscript. The author wishes to thanks the French Ministry of Ecology (MEDDE; CP ITAB PNPP V14 26-11-10, 2010-12). This work focused on active substances was supported by Office Français de Biodiversité (Biocontrôle 2012–2013; XP-BC 2017–2019; BiocontrôleExpansion 2019–2021). The authors declare no competing interests.

References

1 Commission Regulation (EC) 1107/2009 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.

2 S Jess, S Kildea, A Moody, G Rennick, AK Murchie and LR Cooke, “European Union policy on pesticides: implications for agriculture in Ireland” (2014) 70(11) Pest Management Science 1646.

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4 EC 2009, supra, note 1; Jess et al, supra, note 2.

5 EC 2009, supra, note 1; Commission Regulation (EC) 540/2011 as regards the list of approved active substances. OJ L 153/1.

6 EC 2009, supra, note 1.

7 DC Robin and PA Marchand, “Evolution of Regulation (EU) No 540/2011 since its entry into force” (2019) 7 Journal of Regulatory Science 1.

8 EU Pesticides Database <http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN> (last accessed 24 November 2020), replaced by EU Pesticides Database v.2.1 <https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/active-substances/?event=search.as > (last accessed 9 April 2021).

9 Commission Implementing Regulation (EU) 2015/408 on implementing Article 80(7) of Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market and establishing a list of candidates for substitution OJ L 67/18.

10 EU Pesticides Database, supra, note 8.

11 DC Robin and PA Marchand, “Biocontrol active substances: evolution since the entry in vigour of Reg. 1107/2009” (2019) 75(4) Pest Management Science 950.

12 Robin and Marchand, supra, note 7.

13 Commission Implementing Regulation (EU) 2017/2065 confirming the conditions of approval of the active substance 8-hydroxyquinoline, as set out in Implementing Regulation (EU) No 540/2011 and modifying Implementing Regulation (EU) 2015/408 as regards the inclusion of the active substance 8-hydroxyquinoline in the list of candidates for substitution. C/2017/7430. OJ L 295/40.

14 Commission Implementing Regulation (EU) 2019/1085 renewing the approval of the active substance 1-methylcyclopropene, 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, and amending the Annex to Commission Implementing Regulation (EU) 2015/408. OJ L 171/110.

15 Commission Implementing Regulation (EU) 2020/1295 amending Implementing Regulation (EU) 2015/408 as regards the inclusion of the active substances carbetamide, emamectin, flurochloridone, gamma-cyhalothrin, halosulfuron-methyl, ipconazole and tembotrione in the list of candidates for substitution. C/2020/6239. OJ L 303/18.

16 Commission Implementing Regulation (EU) No 486/2014 of 12 May 2014 withdrawing the approval of the active substance fenbutatin oxide, 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. OJ L 138/70.

17 Commission Regulation (EU) No 186/2014 of 26 February 2014 amending Regulation (EU) No 823/2012 as regards the expiry dates of the approval of the active substances ethoxysulfuron, oxadiargyl and warfarin. OJ L 57/22.

18 Commission Implementing Regulation (EU) 2016/864 of 31 May 2016 concerning the non-renewal of approval of the active substance triasulfuron, 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. OJ L 144/32.

19 Commission Implementing Regulation (EU) No 542/2011 of 1 June 2011 amending Implementing Regulation (EU) No 540/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances to take into account Directive 2011/58/EU amending Council Directive 91/414/EEC to renew the inclusion of carbendazim as active substance. OJ L 153/189.

20 EU 2015, supra, note 9.

21 Commission Implementing Regulation (EU) 2015/2105 of 20 November 2015 approving the active substance flumetralin, as a candidate for substitution, 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. OJ L 305/31.

22 Commission Implementing Regulation (EU) 2017/1115 of 22 June 2017 renewing the approval of the active substance propoxycarbazone 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/2017/4216. OJ L 162/38.

23 EFSA (European Food Safety Authority), “Conclusion on the peer review of the pesticide risk assessment of the active substance propoxycarbazone (variant evaluated propoxycarbazone-sodium)” (2016) 14(10) EFSA Journal 4612.

24 Exchange of views of the Committee on a draft Commission Implementing Regulation (EU) correcting Implementing Regulation (EU) 2015/408 as regards the deletion of the active substance propoxycarbazone from the list of candidates for substitution in Standing Committee on Plants, Animals, Food and Feed section Phytopharmaceuticals – Legislation of 19–20 May 2021 (SANTE/10304/2021).

25 Commission Implementing Regulation (EU) 2015/2047 of 16 November 2015 renewing the approval of the active substance esfenvalerate, as a candidate for substitution, 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 300/8; Commission Implementing Regulation (EU) 2016/146 of 4 February 2016 renewing the approval of the active substance lambda-cyhalothrin, as a candidate for substitution, 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 Implementing Regulation (EU) No 540/2011 OJ L 30/7; Commission Implementing Regulation (EU) 2016/139 of 2 February 2016 renewing the approval of the active substance metsulfuron-methyl, as a candidate for substitution, 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 Implementing Regulation (EU) No 540/2011 OJ L 27/7; Commission Implementing Regulation (EU) 2017/1531 of 7 September 2017 renewing the approval of the active substance imazamox, as a candidate for substitution, 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/2017/6036. OJ L 232/6; Commission Implementing Regulation (EU) 2017/1114 of 22 June 2017 renewing the approval of the active substance pendimethalin, as a candidate for substitution, 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/2017/4198. OJ L 162/32; Commission Implementing Regulation (EU) 2017/375 of 2 March 2017 renewing the approval of the active substance prosulfuron, as a candidate for substitution, 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/2017/1300. OL L 58/3; Commission Implementing Regulation (EU) 2018/755 of 23 May 2018 renewing the approval of the active substance propyzamide, as a candidate for substitution, 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/2018/2636. OL L 128/4; Commission Implementing Regulation (EU) 2019/1690 of 9 October 2019 renewing the approval of the active substance alpha-cypermethrin, as a candidate for substitution, 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/2019/7134. OL L 259/2; Commission Implementing Regulation (EU) 2019/158 of 31 January 2019 renewing the approval of the active substance methoxyfenozide, as a candidate for substitution, 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/2019/696. OL L 31/21; and Commission Implementing Regulation (EU) 2020/2105 of 15 December 2020 renewing the approval of the active substance etoxazole as a candidate for substitution 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/2020/8809. OJ L 425/96.

26 Commission Implementing Regulation (EU) 2018/1981 of 13 December 2018 renewing the approval of the active substances copper compounds, as candidates for substitution, 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/2018/8449. OJ L 317/16.

27 Robin and Marchand, supra, note 11; EU 2020, supra, note 13.

28 Commission Implementing Regulation (EU) 2020/2105 renewing the approval of the active substance etoxazole as a candidate for substitution. OJ L 425/96.

29 Commission Implementing Regulation (EU) 2020/1511 of 16 October 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances amidosulfuron, bifenox, chlorotoluron, clofentezine, clomazone, cypermethrin, daminozide, deltamethrin, dicamba, difenoconazole, diflufenican, fenoxaprop-P, fenpropidin, fludioxonil, flufenacet, fosthiazate, indoxacarb, lenacil, MCPA, MCPB, nicosulfuron, paraffin oils, picloram, prosulfocarb, sulphur, triflusulfuron and tritosulfuron. C/2020/7046. OL L 344/18.

30 Commission Implementing Regulation (EU) 2021/52 of 22 January 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mecoprop-P, mepiquat, metiram, oxamyl and pyraclostrobin. C/2021/291. OJ L 23/13.

31 Commission Implementing Regulation (EU) 2021/566 of 30 March 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, mepanipyrim, Metarhizium anisopliae (var. anisopliae) strain BIPESCO 5/F52, metconazole, metrafenone, pirimicarb, Pseudomonas chlororaphis strain MA342, pyrimethanil, Pythium oligandrum M1, rimsulfuron, spinosad, Streptomyces K61 (formerly “S. griseoviridis”), Trichoderma asperellum (formerly “T. harzianum”) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly “T. harzianum”) strain T11, Trichoderma gamsii (formerly “T. viride”) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram. C/2021/2028. OJ L 118/1.

32 Exchange of views of the Committee on a draft Commission Implementing Regulation (EU) concerning the non-renewal of approval of the active substance famoxadone, 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/12986/2019 Rev. 1) during Standing Committee on Plants, Animals, Food and Feed Section Phytopharmaceuticals – Legislation of 24–25 March 2021.

33 EFSA (European Food Safety Authority), CL Carrasco and PP Medina, “The 2019 European Union report on pesticide residues in food” (2021) 19(4) EFSA Journal 6491.

34 PA Marchand, “Novel plant protection regulation: new perspectives for organic production?” (2018) 4(1) Organic Farming 3.

35 Point 4 in Annex II of PPP Regulation, supra, note 1.

36 Directive 2009/128/EC establishing a framework for Community action to achieve the sustainable use of pesticides. OJ L 309/71–86.

37 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.

38 MC Vekemans and PA Marchand, “The European pesticides Harmonised Risk Indicator 1: a clarification of its displayed rendering” (2021) Risk Analysis, accepted with corrections for publication.

39 PA Marchand, “Basic substances: an approval opportunity for Low Concern Natural Products under EU pesticide regulation” (2015) 71(9) Pest Management Science 1197.

40 Commission Regulation (EU) 2018/605 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties. C/2018/2229. OJ L 101/33.

41 EU 2021, supra, notes 31 and 32.

42 EU Pesticides Database, supra, note 8.

43 EU 2020, supra, notes 29–31.

44 EU Pesticides Database, supra, note 8.

45 EC 2011, supra, note 5.

46 EU 2019, supra, note 25.

47 Exchange of views of the Committee on a draft Commission Implementing Regulation (EU) withdrawing the approval of the active substance alpha-cypermethrin 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. (SANTE/12548/2020) during Standing Committee on Plants, Animals, Food and Feed Section Phytopharmaceuticals – Legislation of 25–26 January 2021.

48 Exchange of views of the Committee on a draft Commission Implementing Regulation (EU) concerning renewing the approval of the active substance cypermethrin as a candidate for substitution 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 2018-11527 Rev. 6). (SANTE/10590/2021) during Standing Committee on Plants, Animals, Food and Feed Section Phytopharmaceuticals – Legislation of 19–21 May 2021.

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50 EU Pesticides Database, supra, note 8.

51 EC 2011, supra, note 5.

52 Vekemans and Marchand, 2021, supra, note 38.

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54 EU Pesticides Database, supra, note 8.

55 EU 2021, supra, note 32.

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58 EU 2018, supra, note 40.