УЛОГА ЕВРОПСКЕ АГЕНЦИЈЕ ЗА БЕЗБЕДНОСТ ХРАНЕ У ПОСТУПЦИМА ОДОБРЕЊА И ОБНОВЕ ОДОБРЕЊА АКТИВНЕ СУПСТАНЦЕ У ОКВИРУ ПОЛИТИКЕ ПЕСТИЦИДА ЕВРОПСКЕ УНИЈЕ
Ključne reči:
Децентрализоване агенције ЕУ, Европска агенција за безбедност хране, политика пестицида ЕУ, одобрење активне супстанце, обнова одобрења активне супстанце, Опште законодавство у области хране, Регулатива о производима за заштиту биља, Регулатива о транспарентности
Sažetak
The EU decentralised agencies are involved in various sectorial EU policies and related composite procedures. One of the agencies, the European Food Safety Authority (EFSA), has a prominent role in the composite procedures within the EU pesticide policy – the active substance approval and renewal procedures. These procedures represent the initial steps in the complex administrative process of placing on the market and control of use of plant protection products. The procedures are arranged under the linear risk analysis model within which the scientific risk assessment is performed by Member States and EFSA, and political risk management is performed by the Commission and Member States in the comitology procedure. After a brief analysis of the key stages and outcomes of the procedures, the paper discusses two topics. The first relates to the properties of three key aspects of EFSA’s role in the procedures: 1) involvement in adopting guidance documents; 2) publishing appropriate documents and deciding on confidentiality requests; and 3) preparing and submitting the conclusion, its main scientific output related to active substance. The second topic includes five elements of confidence in EFSA regarding the course and outcome of the procedure: efficiency, independence, transparency, high scientific quality and effective risk communication. The paper discusses the properties of the elements, the main identified challenges associated with them, as well as ongoing and future responses to these challenges, especially those introduced by the Transparency Regulation, adopted in 2019 and applicable from 27 March 2021.
Reference
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European Commission. (2021). Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances and on the MRL application procedure. SANTE/10182/2021. 23 February 2021.
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European Food Safety Authority. (2021a). Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances and on the maximum residue level (MRL) application procedure. EFSA Journal: EFSA supporting publications. 18 (3). 1–77.
European Food Safety Authority. (2021b). Practical arrangements concerning transparency and confidentiality. 18 January 2021.
European Food Safety Authority. (2021c). Practical arrangements concerning confidentiality in accordance with Articles 7(3) and 16 of Regulation (EC) No 1107/2009. 11 January 2021.
European Food Safety Authority. (2021d). Practical arrangements on pre-submission phase and public consultations. 11 January 2021.
European Food Safety Authority. (2020). Programming document 2021–2023. 17 December 2020.
European Food Safety Authority. (2019a). Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances. EFSA Journal: EFSA Supporting Publications. 16 (4). 1–49.
European Food Safety Authority. (2019b). Network on Pesticide Steering Meeting: Minutes of the 24th meeting held on 09–10 April 2019, Parma (Agreed on 06 May 2019).
European Food Safety Authority. (2018). EFSA rules on competing interest management. Parma. 1 July 2018.
European Food Safety Authority. (2017a). Action plan for improving the peer review process. EFSA Journal: EFSA Supporting Publications. 14 (2). 1–9.
European Food Safety Authority. (2017b). Risk Communication Guidelines When Food is Cooking up a Storm: Proven Recipes for Risk Communications. Parma.
European Food Safety Authority. (2017c). EFSA’s policy on independence. Parma. 21 June 2017.
European Food Safety Authority. (2015). Network of Pesticide Steering: Minutes of the 17th meeting held on 11–12.11.2014, Parma (Agreed on 10 February 2015).
European Food Safety Authority. (2014a). Risk Communication Guidelines When Food is Cooking up a Storm: Proven Recipes for Risk Communications. Parma.
European Food Safety Authority. (2014b). EFSA rules on Declarations of Interest. Parma. 31 July 2014.
European Food Safety Authority. (2011). Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009. EFSA Journal. 9 (2). 1–49.
Hardy, A., Fontier, H. (2011). Editorial: Conclusions on Pesticides. EFSA Journal. 9 (6). 1–4.
Hofmann, H. C. H. (2009). Composite decision making procedures in EU administrative law. In Hofmann, H. C. H., Türk, A. H. (eds.). Legal Challenges in EU Administrative Law: Towards an Integrated Administration (pp. 136–167). Cheltenham, Northampton: Edward Elgar Publishing.
Ludden, V., Godfrey, E., Kobilsky, A., Hahn, F., Jansen, L. (2018). The 3rd Independent External Evaluation of EFSA 2011–2016: Final Report, Coffey International Development Ltd; Ramboll Management Consulting, Retrieved 11 February 2021, from https://www.efsa.europa.eu/sites/default/files/3rd-Evaluation-of-EFSA_Final-Report100818.pdf.
Morvillo, M. (2020). Glyphosate Effect: Has the Glyphosate Controversy Affected the EU’s Regulatory Epistemology? European Journal of Risk Regulation. 11 (3). 422–435.
Nganga, J., Bisonni, M., Christodoulou, M. (2018). Guidelines for submission and evaluation of applications for the approval of active substances in pesticides. Brussels: European Parliament – Policy Department for Economic, Scientific and Quality of Life Policies.
Ossege, C. (2015). Driven by Expertise and Insulation? The Autonomy of European Regulatory Agencies. Politics and Governance. 3 (1). 101–113.
Paskalev, V. (2020). The Clash of Scientific Assessors: What the Conflict over Glyphosate Carcinogenicity Tells Us about the Relationship between Law and Science. European Journal of Risk Regulation. 11 (3). 520–538.
Rimkutė, D. (2018). Mapping the practices of scientific (risk assessment) evaluation of active substances used in plant protection products. In Dinu, A., Karamfilova, E. Regulation (EC) 1107/2009 on the Placing of Plant Protection Products on the Market (pp. IV–1–130). Brussels: European Parliamentary Research Service.
Rimkutė, D. (2015). Explaining Differences in Scientific Expertise Use: The Politics of Pesticides. Politics and Governance. 3 (1). 114–127.
Robinson, C., Portier, C. J., Čavoški, A., Mesnage, R., Roger, A., Clausing, P., Whaley, P., Muilerman, H., Lyssimachou, A. (2020). Achieving a High Level of Protection from Pesticides in Europe: Problems with the Current Risk Assessment Procedure and Solutions. European Journal of Risk Regulation. 11 (3). 450–480.
Röttger-Wirtz, S. (2020a). Case C-616/17 Blaise and Others: The precautionary principle and its role in judicial review – Glyphosate and the regulatory framework for pesticides. Maastricht Journal of European and Comparative Law. 27 (4). 529–542.
Röttger-Wirtz, S. (2020b). WP2 D.2.3 Glyphosate case study. Retrieved 22 January 2021, from https://recipes-project.eu/sites/default/files/2020-10/_CS6_Glyphosate.pdf.
Smith, A., Terry, S., Detken, D. (2012). 10 Years of the European Food Safety Authority (EFSA) and the EU Food Safety System. European Food and Feed Law Review. 7 (3). 111–116.
Vogel, D. (2012). The Politics of Precaution: Regulating Health, Safety, and Environmental Risks in Europe and the United States. Princeton, Oxford: Princeton University Press.
Vos, E., Athanasiadou, N., Dohmen, L. (2020). EU Agencies and Conflicts of Interests. Brussels: European Parliament – Policy Department for Citizens' Rights and Constitutional Affairs.
Legal acts
Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, OJ L 252, 19.9.2012, p. 26–32.
Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and repealing Commission Implementing Regulation (EU) No 844/2012, C/2020/7982, OJ L 392, 23.11.2020, p. 20–31.
Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active 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, OJ L 93, 3.4.2013, p. 1–84.
Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market, OJ L 230, 19.8.1991, p. 1–32.
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 Authority and laying down procedures in matters of food safety, OJ L 31, 1.2.2002, p. 1–24.
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. 1–50.
Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC, PE/41/2019/REV/1, OJ L 231, 6.9.2019, p. 1–28.
Alemanno, A. (2008). The European Food Safety Authority at Five. European Food and Feed Law Review. 3 (1). 2–24.
Bozzini, E. (2018). Assessing criteria and capacity for reliable and harmonised ‘hazard identification’ of active substances. In Dinu, A. and Karamfilova, E. Regulation (EC) 1107/2009 on the Placing of Plant Protection Products on the Market (pp. II–1–102). Brussels: European Parliamentary Research Service.
Bozzini, E. (2017). Pesticide Policy and Politics in the European Union: Regulatory Assessment, Implementation and Enforcement. Cham: Springer International Publishing AG.
Chatzopoulou, S., Leiva Eriksson, N., Eriksson, D. (2020). Improving Risk Assessment in the European Food Safety Authority: Lessons From the European Medicines Agency. Frontiers in Plant Science. 11. 349–359.
Christoforou, T. (2004). The Precautionary Principle, Risk Assessment, and the Comparative Role of Science in the European Community and the US Legal Systems. In Vig, N. J. and Faure, M. G. (eds.). Green Giants? Environmental Policies of the United States and the European Union (pp. 17–51). Cambridge, Massachusetts, London: MIT Press.
Commission of the European Communities. (2006). Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions: A Thematic Strategy on the Sustainable Use of Pesticides. COM (2006) 372 final. Brussels. 12.7.2006.
European Commission. (2021). Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances and on the MRL application procedure. SANTE/10182/2021. 23 February 2021.
European Commission. (2020a). Commission Staff Working Document Accompanying the document Report from the Commission to the European Parliament and the Council: Evaluation of Regulation (EC) No 1107/2009 on the placing of plant protection products on the market and of Regulation (EC) No 396/2005 on maximum residue levels of pesticides. SWD (2020) 87 final. Brussels. 20.5.2020.
European Commission. (2020b). 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: A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system. COM (2020) 381 final. Brussels. 20.5.2020.
European Commission. (2020c). Report from the Commission to the European Parliament and the Council: Evaluation of Regulation (EC) No 1107/2009 on the placing of plant protection products on the market and of Regulation (EC) No 396/2005 on maximum residue levels of pesticides. COM (2020) 208 final. Brussels. 20.5.2020.
European Commission. (2019a). 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. COM (2019) 640 final. Brussels. 11.12.2019.
European Commission. (2019b). Implementation schedule: Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances. SANTE–10914–2019 rev.0. 22 March 2019.
European Commission. (2018a). Commission Staff Working Document: The REFIT Evaluation of the General Food Law (Regulation (EC) No 178/2002). SWD (2018) 38 final, part 1/2. Brussels. 15.1.2018.
European Commission. (2018b). Commission Staff Working Document: The REFIT Evaluation of the General Food Law (Regulation (EC) No 178/2002). SWD (2018) 38 final, part 2/2. Brussels. 15.1.2018.
European Commission. (2013). Commission Communication in the framework of the implementation of Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active 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. OJ C 95. 3.4.2013. p. 1–20.
European Court of Auditors. (2012). Management of Conflicts of Interest in Selected EU Agencies. Special Report No. 15. Luxembourg: European Court of Auditors.
European Food Safety Authority. (2021a). Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances and on the maximum residue level (MRL) application procedure. EFSA Journal: EFSA supporting publications. 18 (3). 1–77.
European Food Safety Authority. (2021b). Practical arrangements concerning transparency and confidentiality. 18 January 2021.
European Food Safety Authority. (2021c). Practical arrangements concerning confidentiality in accordance with Articles 7(3) and 16 of Regulation (EC) No 1107/2009. 11 January 2021.
European Food Safety Authority. (2021d). Practical arrangements on pre-submission phase and public consultations. 11 January 2021.
European Food Safety Authority. (2020). Programming document 2021–2023. 17 December 2020.
European Food Safety Authority. (2019a). Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances. EFSA Journal: EFSA Supporting Publications. 16 (4). 1–49.
European Food Safety Authority. (2019b). Network on Pesticide Steering Meeting: Minutes of the 24th meeting held on 09–10 April 2019, Parma (Agreed on 06 May 2019).
European Food Safety Authority. (2018). EFSA rules on competing interest management. Parma. 1 July 2018.
European Food Safety Authority. (2017a). Action plan for improving the peer review process. EFSA Journal: EFSA Supporting Publications. 14 (2). 1–9.
European Food Safety Authority. (2017b). Risk Communication Guidelines When Food is Cooking up a Storm: Proven Recipes for Risk Communications. Parma.
European Food Safety Authority. (2017c). EFSA’s policy on independence. Parma. 21 June 2017.
European Food Safety Authority. (2015). Network of Pesticide Steering: Minutes of the 17th meeting held on 11–12.11.2014, Parma (Agreed on 10 February 2015).
European Food Safety Authority. (2014a). Risk Communication Guidelines When Food is Cooking up a Storm: Proven Recipes for Risk Communications. Parma.
European Food Safety Authority. (2014b). EFSA rules on Declarations of Interest. Parma. 31 July 2014.
European Food Safety Authority. (2011). Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009. EFSA Journal. 9 (2). 1–49.
Hardy, A., Fontier, H. (2011). Editorial: Conclusions on Pesticides. EFSA Journal. 9 (6). 1–4.
Hofmann, H. C. H. (2009). Composite decision making procedures in EU administrative law. In Hofmann, H. C. H., Türk, A. H. (eds.). Legal Challenges in EU Administrative Law: Towards an Integrated Administration (pp. 136–167). Cheltenham, Northampton: Edward Elgar Publishing.
Ludden, V., Godfrey, E., Kobilsky, A., Hahn, F., Jansen, L. (2018). The 3rd Independent External Evaluation of EFSA 2011–2016: Final Report, Coffey International Development Ltd; Ramboll Management Consulting, Retrieved 11 February 2021, from https://www.efsa.europa.eu/sites/default/files/3rd-Evaluation-of-EFSA_Final-Report100818.pdf.
Morvillo, M. (2020). Glyphosate Effect: Has the Glyphosate Controversy Affected the EU’s Regulatory Epistemology? European Journal of Risk Regulation. 11 (3). 422–435.
Nganga, J., Bisonni, M., Christodoulou, M. (2018). Guidelines for submission and evaluation of applications for the approval of active substances in pesticides. Brussels: European Parliament – Policy Department for Economic, Scientific and Quality of Life Policies.
Ossege, C. (2015). Driven by Expertise and Insulation? The Autonomy of European Regulatory Agencies. Politics and Governance. 3 (1). 101–113.
Paskalev, V. (2020). The Clash of Scientific Assessors: What the Conflict over Glyphosate Carcinogenicity Tells Us about the Relationship between Law and Science. European Journal of Risk Regulation. 11 (3). 520–538.
Rimkutė, D. (2018). Mapping the practices of scientific (risk assessment) evaluation of active substances used in plant protection products. In Dinu, A., Karamfilova, E. Regulation (EC) 1107/2009 on the Placing of Plant Protection Products on the Market (pp. IV–1–130). Brussels: European Parliamentary Research Service.
Rimkutė, D. (2015). Explaining Differences in Scientific Expertise Use: The Politics of Pesticides. Politics and Governance. 3 (1). 114–127.
Robinson, C., Portier, C. J., Čavoški, A., Mesnage, R., Roger, A., Clausing, P., Whaley, P., Muilerman, H., Lyssimachou, A. (2020). Achieving a High Level of Protection from Pesticides in Europe: Problems with the Current Risk Assessment Procedure and Solutions. European Journal of Risk Regulation. 11 (3). 450–480.
Röttger-Wirtz, S. (2020a). Case C-616/17 Blaise and Others: The precautionary principle and its role in judicial review – Glyphosate and the regulatory framework for pesticides. Maastricht Journal of European and Comparative Law. 27 (4). 529–542.
Röttger-Wirtz, S. (2020b). WP2 D.2.3 Glyphosate case study. Retrieved 22 January 2021, from https://recipes-project.eu/sites/default/files/2020-10/_CS6_Glyphosate.pdf.
Smith, A., Terry, S., Detken, D. (2012). 10 Years of the European Food Safety Authority (EFSA) and the EU Food Safety System. European Food and Feed Law Review. 7 (3). 111–116.
Vogel, D. (2012). The Politics of Precaution: Regulating Health, Safety, and Environmental Risks in Europe and the United States. Princeton, Oxford: Princeton University Press.
Vos, E., Athanasiadou, N., Dohmen, L. (2020). EU Agencies and Conflicts of Interests. Brussels: European Parliament – Policy Department for Citizens' Rights and Constitutional Affairs.
Legal acts
Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, OJ L 252, 19.9.2012, p. 26–32.
Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and repealing Commission Implementing Regulation (EU) No 844/2012, C/2020/7982, OJ L 392, 23.11.2020, p. 20–31.
Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active 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, OJ L 93, 3.4.2013, p. 1–84.
Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market, OJ L 230, 19.8.1991, p. 1–32.
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 Authority and laying down procedures in matters of food safety, OJ L 31, 1.2.2002, p. 1–24.
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. 1–50.
Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC, PE/41/2019/REV/1, OJ L 231, 6.9.2019, p. 1–28.
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2021/07/05
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