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Impact of Brexit on Zonal Approval Procedures and Mutual Recognition Procedures in Plant Protection Legislation

Published online by Cambridge University Press:  30 January 2020

Alexander KOOF*
Affiliation:
Dr. iur., Lawyer at the law firm KOOF & KOLLEGEN Rechtsanwälte, Linnich, Germany, email: alexander.koof@koof.eu.

Abstract

On 29 March 2017, the UK made use of Article 50 of the Treaty on European Union (TEU) and thus initiated its withdrawal from the European Union. As a result, the UK left the European Union on 31 January 2020 (23:00 UTC). This paper provides a legal assessment of the impact of the UK’s withdrawal from the European Union (Brexit) on zonal authorisation and mutual recognition procedures regarding the authorisation of plant protection products. Many legal issues are unclear in this respect due to the lack of European and national case law. The German Administrative Court of Braunschweig had to decide in an urgent procedure on the effects of Brexit with regards to the authorisation of a plant protection product in the mutual recognition procedure.

Type
Articles
Copyright
© The Author(s), 2020. Published by Cambridge University Press

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Footnotes

The author wishes to thank Ms Helen Kreinacke for review.

References

1 Also referred to as “pesticides”. The term “plant protection product” is a legal term defined in Article 2(1) Regulation (EC) No 1107/2009.

2 Glyphosate is a plant protection active substance used to control weeds. The active substance has been approved at the EU level and is approved for use in PPPs in several European countries. The active substance glyphosate has been approved in Germany since 1974 in herbicides for weed control. Glyphosate is the most widely used herbicide worldwide. It is absorbed by all green plant parts. Glyphosate is diffused throughout the plant and leads to complete wilting and death of plants.

3 A fungicide is an active substance that kills fungi or their spores or prevents their growth.

4 Insecticides are used to kill, repel or inhibit insects.

5 Plant protection law makes no fundamental distinction between synthetic PPPs, natural substances and microorganisms, because natural substances and microorganisms can also pose risks. However, the special characteristics of these groups are taken into account in the approval procedure. Pesticides that are used outside of agriculture (eg pesticides against hygiene pests or wood preservatives) are not considered to be PPPs, but fall within a separate legal area in the EU as so-called biocide products.

6 The European Commission maintains a database containing the most relevant information on all active substances: the current status in the EU, toxicological data, links to assessment reports and decisions and maximum residue levels: <https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database> (last accessed 30 November 2019). Various toxicological limit values are derived from the study results, such as the acceptable daily intake (ADI), the acute reference dose (ARfD) and the acceptable operator exposure level (AOEL).

7 This is mainly due to the following circumstances: on the one hand, PPPs contain, in addition to one or more active substances, other ingredients such as solvents, emulsifiers and carriers. These co-formulants should also be taken into account in the authorisation procedure. On the other hand, the risk assessment of a PPP not only takes into account the substance properties, but also the intended use. For example, health risks for users depend on how the product is formulated (eg as a liquid concentrate or sprinkling granulate) and on the application technique.

8 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21.10.2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, OJ No L 309, p 1, Celex No 32009R1107; refer to the variants of plant protection authorisation procedures, Koof, P, “Die Bedeutung des Unionsrechts für das Verhältnis des Bundesamtes für Verbraucherschutz und Lebensmittelsicherheit zu den Beteiligungsbehörden” (2018) 2 StoffR 65Google Scholar.

9 In 1991, Directive 91/414/EEC started the harmonisation of the authorisation of PPPs in the EU. In 2009, this Directive was replaced by Regulation (EC) No 1107/2009 concerning the placing of PPPs on the market, which now forms the basis of Union law. In addition, there are implementing regulations and technical guidance documents that regulate details of the procedures. The main principles are as follows: (1) The active substances of PPPs are evaluated in an EU procedure. (2) Every PPP (ie commercial product) requires an authorisation in each Member State in which it is to be placed on the market. Such authorisations shall be granted by the European Member States. (3) EU legislation sets out the data requirements that an applicant must submit for an active substance approval and for a product authorisation. (4) Maximum residue levels for active substances of PPPs in food and feed are set at the EU level in a Community procedure. (5) European Member States are required to monitor the sale and use of PPPs and to check food and feed for residues. The EU lays down standards for this and checks compliance with them.

10 See Annex I of Regulation (EC) No 1107/2009: the following Member States belong to zone A (north): Denmark, Estonia, Latvia, Lithuania, Finland and Sweden. The Member States Belgium, Czech Republic, Germany, Ireland, Luxembourg, Hungary, Netherlands, Austria, Poland, Romania, Slovenia, Slovakia and the UK belongs to zone B (centre). Bulgaria, Greece, Spain, France, Italy, Cyprus, Malta and Portugal belong to zone C (south).

11 The EU is divided into three zones in accordance with Art 3(17) Regulation (EC) No 1107/2009 in conjunction with Annex I: north (Denmark, Estonia, Finland, Latvia, Lithuania and Sweden), central (Belgium, Germany, Ireland, Luxembourg, Netherlands, Austria, Poland, Romania, Slovakia, Slovenia, Czech Republic, Hungary and the UK) and south (Bulgaria, France, Greece, Italy, Malta, Portugal, Spain and Cyprus).

12 VG Braunschweig, Court decision from 12 April 2018 – 9 A 44/16, para 81.

13 See Art 35 Regulation (EC) No 1107/2009.

14 Refer to the variants of PPP authorisation procedures, Koof, supra, note 8. On the binding effect in the zonal approval procedure and the mutual recognition procedure, see VG Braunschweig, Court decision from 30 November 2016 – 9 A 27/16; VG Braunschweig, Court decision from 30 November 2016 – 9 A 28/16; VG Braunschweig, Court decision from 12 April 2018 – 9 A 26/16; VG Braunschweig, supra, note 12.

15 United Kingdom of Great Britain and Northern Ireland; hereinafter referred to as the UK.

16 Treaty on European Union (consolidated version), Official Journal EU No C 326, 26 October 2012, pp 1–39, OJ C 326, pp 13–39.

17 In accordance with the request of the British government, the EU decided on 28 October 2019 to extend the withdrawal period pursuant to Art 50 (3) TEU until 31 January 2020.

18 BVL, Notification of 18 September 2018, p 1.

19 The abbreviation ZV3 is used by the BVL for zonal approval procedures in accordance with Art 33 et sqq. of the Regulation (EC) No 1107/2009, in which Germany acts as the cMS.

20 The abbreviation ZVU is used by the BVL for mutual recognition procedures in accordance with Art 40 et sqq. Regulation (EC) No 1107/2009.

21 BVL, supra, note 18, p 1.

22 BVL, supra, note 18, pp 1–2.

23 CZSC, “Brexit: what happens when the UK is zRMS” (2019) <https://circabc.europa.eu/sd/a/f7ac216c-37fc-43bd-93d6-760ada52261e/Communication%20Central%20Zone%20on%20ZRMS%20and%20Brexit.pdf> (last accessed 30 November 2019). According to the Guidance Document on zonal evaluation and mutual recognition under Regulation (EC) No 1107/2009 (SANCO/13169/2010, rev. 9, 11 July 2014, p 5), communication within and between zones is crucial for the effective functioning of the zonal licensing system and should therefore be facilitated by the establishment of the following institutions: an inter-zonal steering committee and three zonal steering committees. A zonal steering committee is set up in each zone, in which all Member States of a zone participate. The zonal steering committee shall meet every two months to discuss specific applications and issues raised in the inter-zonal steering committee. For the Central Zone, the CZSC was established in 2010 with the aim of promoting harmonisation and avoiding duplication of work through cooperation. Since 2017, the CZSC has been supported by the CZSC Secretariat (zonal secretariat).

24 European Commission, “Questions and answers related to the United Kingdom’s withdrawal from the European Union with regard to plant protection products and pesticide residues” (18 February 2019) <https://ec.europa.eu/info/sites/info/files/file_import/qa-plant-protection-products_en_0.pdf> (last accessed 30 November 2019).

25 ibid.

26 ibid.

27 BVL, “Zulassung von Pflanzenschutzmitteln – Deutschland schließt sich der Position der EU-Kommission zum Umgang mit dem Brexit an” (26 February 2019) <https://www.bvl.bund.de/SharedDocs/Fachmeldungen/04_pflanzenschutzmittel/2019/2019_02_26_Fa_Brexit_Zulassungsverfahren.html> (last accessed 30 November 2019).

28 BVL, supra, note 27.

29 ibid.

30 ibid.

31 VG Braunschweig, Court order from 03 April 2019 – 9 B 23/19.

32 Consolidated versions of the Treaty on European Union and the Treaty on the Functioning of the European Union, OJ C 326, 26.10.2012, pp 47–390.

33 The national courts are responsible for applying EU law. However, when an issue relating to the interpretation of the law is raised before a national court or tribunal, the court or tribunal may seek a preliminary ruling from the ECJ. If it is a court of last instance, it is compulsory to refer the matter to the Court.

34 See I Carreno and T Dolle, “The Regulatory Framework on Plant Protection Products in the United Kingdom after Brexit” (2017) 8 European Journal of Risk Regulation 766, 766–71.

35 Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, OJ L 29 of 31 January 2020, pp 7–187 <https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:22020A0131(01)> (last accessed 9 March 2020).

36 See European Commission, supra, note 24, No 3.

37 European Commission, “Notice to stakeholders – Withdrawal of the United Kingdom and EU rules on plant protection products” (23 January 2018) <https://ec.europa.eu/info/sites/info/files/file_import/plant_protection_products_en.pdf> (last accessed 30 November 2019).

38 See VG Braunschweig, Court decision from 30 November 2016 – 9 A 27/16; VG Braunschweig, Court decision from 30 November 2016 – 9 A 28/16.

39 See VG Braunschweig, Court decision from 30 November 2016 – 9 A 27/16; VG Braunschweig, Court decision from 30 November 2016 – 9 A 28/16; VG Braunschweig, Court decision from 12 April 2018 – 9 A 26/16; VG Braunschweig, supra, note 12.

40 A third country is a country that is not a member of the EU.

41 See European Commission, supra, note 24; European Commission, supra, note 37.

42 Supra, note 35.

43 European Commission, supra, note 24, No 13.

44 BVL, supra, note 27.

45 VG Braunschweig, supra, note 31, p 4.

46 ibid. It is wrong that the Administrative Court of Braunschweig refers in the resolution to the withdrawal of “Great Britain” from the EU. The court fails to recognize that the term “Great Britain” is the geographical name for the largest of the British Isles with the countries England, Wales and Scotland. The UK describes the political unity of Great Britain (England, Wales and Scotland) and Northern Ireland. The United Kingdom of Great Britain and Northern Ireland is a sovereign state that is an official member of the EU, NATO and the United Nations. On 29 March 2017, the UK triggered Art 50 TEU and thus initiated the withdrawal from the EU.

47 VG Braunschweig, supra, note 31, p 4.

48 ibid, p 4.

49 ibid, p 5.

50 ibid, p 5.

51 ibid, p 5.

52 ibid.

53 ibid.

54 ibid.

55 ibid.

56 ibid.

57 ibid.

58 See European Commission, supra, note 24, No 12; BVL, supra, note 27.

59 VG Braunschweig, supra, note 31, pp 5-6.

60 ibid, p 6.

61 ibid.

62 ibid.

63 ibid.

64 ibid.

65 ibid.

66 ibid, p 7.

67 See European Commission, supra, note 24, No 11; BVL, supra, note 27.

68 Council of the European Union, Note of 11 April 2008 – 8034/08.

69 BVL, “Zulassung von Pflanzenschutzmitteln - Zulassungen aus UK können anerkannt werden, sofern die Antragstellung vor dem Brexit erfolgt” (26 June 2019) <https://www.bvl.bund.de/SharedDocs/Fachmeldungen/04_pflanzenschutzmittel/2019/2019_06_26_Fa_Korrektur_Brexit_Zulassungsverfahren.html> (last accessed 30 November 2019).

70 ibid.

71 VG Braunschweig, supra, note 31, p 7.

72 The BVL has not announced its legal opinion in this respect. However, according to the corrected BVL report of 26 February 2019, the BVL does not seem to share this legal opinion because the BVL emphasises the application for mutual recognition before Brexit. See BVL, supra, note 27.

73 VG Braunschweig, supra, note 12, paras 57, 72.

74 ibid.

75 ibid.

76 See Art 35(3) Regulation (EC) No 1107/2009.

77 See Art 36(1) (3) Regulation (EC) No 1107/2009.

78 VG Braunschweig, supra, note 12, para 57.

79 European Commission, supra, note 24, No 12; CZSC, supra, note 23.

80 European Commission, supra, note 24, No 12.

81 VG Braunschweig, supra, note 31, p 6; VG Braunschweig, Court decision from 30 November 2016 – 9 A 27/16; VG Braunschweig, Court decision from 30 November 2016 – 9 A 28/16; A Koof, “Zulassung von Pflanzenschutzmitteln im zonalen Zulassungsverfahren – Anmerkung zu VG Braunschweig, Urt. v. 12.04.2018, Az. 9 A 44/16” (2018) 5 StoffR 205, 206.

82 BVL, supra, note 27.

83 ibid.

84 European Commission, supra, note 24, No 11; CZSC, supra, note 23.

85 European Commission, supra, note 24, No 11.

86 Supra, note 35.

87 The so-called fall-back zRMS. European Commission, supra, note 24, No 12.

88 CZSC, supra, note 23.

89 European Commission, supra, note 24, No 11.

90 Supra, note 35.

91 No 11; CZSC, supra, note 23; European Commission, supra, note 24; BVL, supra, note 27.

92 European Commission, supra, note 24, No 12.

93 ibid.

94 ibid.

95 ibid.