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Access to Regulatory Information on Agrochemicals – To which extent does Regulation 1107/2009 prevail over the EU Transparency Legislation?

Published online by Cambridge University Press:  20 January 2017

Gérardine Garçon
Gérardine Garçon*
Affiliation:
Central Legal Department, BASF SE
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Abstract

Agrochemicals belong to the best tested and evaluated substances in Europe. Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market (“Regulation 1107”) sets forth the requirements regarding quality, safety and efficacy of agrochemicals and provides which documentation has to be submitted in order to obtain regulatory approval. The documents filed with the regulatory authorities contain proprietary information and know-how of the registrants. Accordingly, registrants have a legitimate interest in confidential treatment. Regulation 1107 thus contains specific confidentiality provisions.

On the other hand, EU legislation on transparency, in particular the legislation implementing the Aarhus Convention, provides for rights of access to information held by institutions. Recently, a number of legal actions related to the regulatory procedures for agrochemicals have been based on the transparency legislation.

This report analyses the relationship between the transparency legislation and Regulation 1107 with regard to rights of access to information provided in the regulatory process for agrochemicals.

Type
Reports
Information
European Journal of Risk Regulation , Volume 3 , Issue 3 , September 2012 , pp. 393 - 400
Copyright
Copyright © Cambridge University Press 2012

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References

1 Regulation (EC) No 1107/2009 of the European Parliament and of the Council 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, 24.11.2009, p. 1.

2 UN/ECE Convention on Access to Information, Public Participation and Decision-Making and Access to Justice in Environmental Matters, done at Aarhus, Denmark on 25 June 1998.

3 See Case C-266/09, Stichting Natuur en Milieu v. College voor de toelating van gewerbeschermingsmiddelen en biociden, judgment of 16 December 2010, OJ C 55, 19.2.2011, p. 8; Case T-214/11, ClientEarth and PAN Europe v EFSA, OJ C 179, 18.6.2011, p. 18; Case T-232/11, Stichting Greenpeace Nederland and PAN Europe v Commission, OJ C 194, 2.7.2011, p. 19; with regard to information provided under REACH, a legal action has been brought against the ECHA where access to certain documents (related to names of registrants and to tonnages of dangerous substances placed on the market) is sought: see case T-245/11, ClientEarth and International Chemical Secretariat v ECHA, OJ C 194, 2.7.2011, p. 20.

4 Also see Garçon, Gérardine, “Aarhus and Agrochemicals: The Scope and Limitations of Access Rights in Europe”, 10(2) EurUP (2012), pp. 72 et sqqGoogle Scholar.

5 References to Articles not mentioning the legal act are references to Articles of Regulation 1107.

6 Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents, OJ L 145, 31.5.2001, p. 43.

7 Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies, OJ L 264, 25.9.2006, p. 13. This Regulation was adopted after the approval of the Aarhus Convention for the Community by Council Decision 2005(370) EC of 17 February 2005, OJ L 124, 17.5.2005, p.1.

8 Regulation 1107 thus provides that the Member States will decide what information is to be kept confidential. See Article 7(3), second subparagraph, for information received by the rapporteur Member State in the approval procedure for an agrochemical active substance, and Article 33(4), third subparagraph, for the information submitted to a Member State in the course of the procedure for authorization of agrochemical products.

9 Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC, OJ L 41, 14.2.2003, p. 26.

10 The EFSA been established by 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 Agency and laying down procedures in matters of food safety, OJ L 31 of 1.2.2002, p.1 (the “EFSA Founding Regulation”).

11 The Commission adopted a proposal for a recast of the Transparency Regulation already on 30 April 2008 (COM(2008) 229 final). On 21 March 2011, the Commission presented a new proposal for a modification of the Transparency Regulation with a view to aligning it to the new institutional scope of the rights of public access in the Lisbon Treaty. The legislative procedure is still ongoing.

12 See for example the definition of CBI in Art. 39(2) of the World Trade Organisation's Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement.

13 The scope of Art. 4(2), first indent, of the Transparency Regulation is not limited to the protection of CBI, but extends to any commercial interests. See also Epiney, in Fluck/Theuer (eds), Informationsfreiheitsrecht, Verordnung (EG) Nr. 1049/2001, at para. 51; von Holleben, in: Fluck/Fischer/von Hahn (eds), REACH + StoffR, Art. 118 REACH, at para 31; Fluck, REACH – Vertraulichkeit von Informationen versus Transparenz und Wirbeltierschutz, StoffR 2004, pp. 59 et sqq., at p. 64.

14 See joined cases C-514/07 P, C-528/07 P and C-532/07 P, Sweden v AVI, judgment of 21 September 2010, OJ C 317, 20.11.2010, p. 6.

15 Joined cases T-110/03, T-150/03 and T-405/03, Sison, judgment of 26 April 2005, [2005] ECR II-1429, at para. 50–55; joined cases T-391/03 and T-70/04, Franchet-Byk, judgment of 6 July 2006, [2006] ECR II-2023, at para. 82.

16 This is explicitly stated in the recitals of the preamble of Regulation 1107: recital (10) for active substances, recital (24) for plant protection products and recital (8) of both of them.

17 In recital (7) of the preamble of Regulation 1107, safety concerns are addressed: It is pointed out that the use of agrochemicals may involve risks and hazards, especially if placed on the market without having been officially tested and authorised.

18 Case C-266/09, Stichting Natuur en Milieu v. College voor de toelating van gewerbeschermingsmiddelen en biociden, supra note 3.

19 See Case C-266/09, Stichting Natuur en Milieu v. College voor de toelating van gewerbeschermingsmiddelen en biociden, supra note 3, at para 42; a report of the judgment of the ECJ is presented by Kaus, The Term “Emission” in the Domain of Freedom of Access to Information, EurUP 2011, pp. 293 et sqq.

20 For similar questions regarding information on chemical substances submitted under REACH see von Holleben, Öffentlicher Zugang zu Stoffinformationen nach REACH im Licht der Aarhus-Konvention, StoffR 2011, pp. 237 et sqq.

21 This follows from the basic legal principles how general rules and exceptions are to be interpreted which apply for all pieces of legislation, including the Aarhus Legislation. See also von Holleben, supra note 20, at p. 242.

22 Art. 8 of the Convention for the Protection of Human Rights and Fundamental Freedoms comprises, as part of the rights to respect for private life, also professional and commercial activities of natural and legal persons. To that end, see ECJ Case C-450/06, Varec SA v Belgian State, judgment of 14 February 2008, [2008] ECR I-00581, at para. 48; and the report of Kaus, supra note 19, at p. 295. For the protection of CBI see also Art. 39 of the TRIPS Agreement.

23 Case C-266/09, Stichting Natuur en Milieu v. College voor de toelating van gewerbeschermingsmiddelen en biociden, supra note 3, at para. 26 to 30.

24 Case C-240/09, Lesoochranarske zoskupenie VLK v Slovakia, judgment of 8 March 2011, at para. 49 to 51.

25 The Implementation Guide for the Aarhus Convention can be found under http://www.unece.org/env/pp/acig.pdf. The term “emission” is defined on p. 72.

26 See Art. 3(4) of Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control), OJ L 334 of 17.12.2010, p. 17. Directive 2010/75/EU replaced Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control OJ L 203 of 26.11.1996, p.28 where emissions where defined in Art. 2(5).

27 Von Holleben, supra note 20, at p. 242, notes that a broader interpretation may encourage unfair trading practices. Thus, the protection of CBI would almost be eroded.

28 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market, OJ L 230 of 19.8.1991, p. 1.

29 Case C-266/09, Stichting Natuur en Milieu v. College voor de toelating van gewerbeschermingsmiddelen en biociden, supra note 3, at paras. 50 et sqq.

30 As regards the restrictive interpretation of the grounds for disclosure of information set forth in Art. 118(2) of REACH (which addresses items of information similar to the items listed in Article 63(2) for the agrochemical sector) see von Holleben, supra note 13, at para. 43.

31 This interpretation is also supported by Kaus, supra note 19, at p. 295.

32 See Art. 8(1) and Article 8(2) of Regulation 1107.

33 The rapporteur Member State is, according to Article 7 (1), first subparagraph, the Member State to which the application is submitted. It is further set forth in Article 7(1), third subparagraph, that the application shall be examined by that Member State as proposed by the applicant, unless another Member State agrees to examine it.

34 See Article 9 (3), second subparagraph.

35 See supra note 10. Openness and transparency are considered essential by the EFSA as they provide the framework in which consumers can have confidence in its work.

36 European Food Safety Authority, Transparency in risk assessment carried out by EFSA: Guidance Document on procedural aspects, EFSA Journal (2006) 353, 1; it can be found under http://www.efsa.europa.eu/en/efsajournal/pub/353.htm.

37 See chapter 2.10. of the EFSA Guidance Document on procedural aspects, supra note 36. Confidentiality is also addressed in Article 39 of the EFSA Founding Regulation, supra note 10.

38 European Food Safety Authority, Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009, EFSA Journal 2011, 9(2):2092.

39 Case T-214/11, ClientEarth and PAN Europe v EFSA, supra note 3.