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The Transition to a New EU Plant Protection Regime – Legal Problems in the Regulatory Field*
Published online by Cambridge University Press: 20 January 2017
Abstract
The plant protection law within the European Union has been continuously developed over the past two decades. Whereas harmonized provisions for the placing of plant protection products on the common market were introduced by Council Directive 91/414/EEC of 15 July 1991 (hereinafter the “Directive”), almost two decades later, a revision of the Directive has been passed which takes, in order to ensure consistency throughout the Member States and to provide for simplification, the form of a regulation. Regulation (EC) No. 1107/2009 concerning the placing of plant protection products on the market (hereinafter the “Regulation”) was adopted on 21 October 2009.
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Footnotes
*
The author is attorney-at-law and member of the Central Legal Department of BASF SE.
*
This report was first published in a slightly different version with the title “Towards a new EU Plant Protection Regime – Legal Problems arising out of the Transition with Regard to Regulatory Approvals and Authorisations” in 8(1) StoffR (Berlin: Lexxion Publisher, 2011). The article gives the personal view of the author.
References
1 Council Directive 91/414/EEC concerning the placing of plant protection products on the market, OJ 1991 L 230/1.
2 Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and repealing Council Directives 79/117/eEEC and 91/414/EEC,OJ 2009 L 309/1.
3 A more detailed analysis of the legal problems in the regulatory field arising out of the transition from the Directive to the Regulation has been published by the author in January 2011, see Garçon, Gérardine, “Towards a new EU Plant Protection Regime – Legal Problems arising out of the Transition with Regard to Regulatory Approvals and Authorisations”, 1 StoffR (2011), pp. 2 et sqq. Google Scholar
5 Commission Regulation (EC) No 737/2007 on laying down the procedure for the renewal of the inclusion of a first group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances, OJ 2007 L 169/10.
6 Commission Regulation (EC) No. 33/2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I, OJ 2008 L 15/5.
7 See Art. 6(3) of the Directive which refers to the accordance with Annexes II and III of the Directive.
8 See Art. 78(1) of the Regulation.
9 The principle of national authorisation will be maintained even under the Regulation which divides the EU into three zones, see Art. 3 No.17 of the Regulation and Annex I to the Regulation. The term “zonal authorisation” which is sometimes used therefore is not correct. The assessment of the application for such authorisation is a zonal procedure (see Art. 36 of the Regulation), but the authorisation is granted by the particular Member States for their territories as per Art. 28 of the Regulation. The zonal procedure should be referred to as “zonal evaluation”.
10 The first case was Case 6/64, Costa v. E.N.E.L., [1964] ECR 1251, at para. 11.
11 See Case 106/77, Simmenthal II, [1978] ECR 629, at paras. 21–23.
12 See Case 103/88, Fratelli Costanzo, [1989] ECR 1839, at para. 32.
14 See Case C-224/97, Ciola, [1999], ECR I-2517, at paras. 33–34.
15 See Case C-341/98, Petersen, [2010], para. 80.
16 See Section I.2 above. For the sake of clarification: the seven active substances referred to in Article 80(1)(b) of the Regulation are even more advanced in the assessment procedure on the Application Date.
17 See. Art. 43 of the Regulation (Renewal of authorisation) and Art. 44 of the Regulation (Withdrawal or amendment of an authorisation).
18 The possibility to apply for provisional authorisations was however not part of the original proposal for the Regulation presented by the Commission (COM (2006) 388 final of 12.7.2006) nor did the Amended Proposal for a Regulation presented by the Commission following the first reading of the European Parliament (COM (2998) 93 final of 11.3.2008) contain such a provision, although the European Parliament adopted in the said first reading an amendment to introduce a system of provisional authorisation.
19 See Section II.1 above for the definitive authorisations for plant protection products granted prior to the Application Date of the Regulation.
20 See Section II.3.c.
21 For recently decided cases see Case C-409/06, Winner Wetten GmbH, [2010], at para. 67, Case F-45/07, Wolfgang Mandt, [2010], at para. 127.
22 See Section II.3.c.