Basic and low-risk substances under European Union pesticide regulations: a new choice for biorational portfolios of small and medium-sized enterprises

Open access

Abstract

Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 established a framework for Community action to bring about the sustainable use of pesticides and encourage low concern biorationals. Basic substances described in article 23 of EC phytopharmaceutical Regulation No 1107/2009 consist of a new operative category for crop protection products with 16 substances approved so far. Another status, ruled by article 22 is also operative with 11 approved low-risk substances (see EU pesticide database). Now small and medium-sized enterprises (SMEs) have the opportunity to register biorationals at the EU level in one of the two categories. Our institute previously provided technical expertise on how to complete the Basic Substance Application (BSA), together with a description of first results. However it is clear that there is a need for a shorter survey of the two parallel procedures for SMEs. Here we provide a concise sequence of the necessary steps for SMEs, including strategic approach, a rapid steps description, a timeframe for the global pathway, up to the final step, after approval by the Plants, Animals, Food and Feed Standing Committee (PAFF). We present in detail the advantages and limitations of the two statutes. The introduction of approved substances into organic farming is also discussed. Currently basic and low-risk substance pathways are now accessible for biorationals handled by SMEs. Therefore, the option is open for SMEs to seek a possibly low-risk active substances endorsement with market authorizations or a basic substance approval with no plant protection product claims depending on the selected strategy.

Abstract

Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 established a framework for Community action to bring about the sustainable use of pesticides and encourage low concern biorationals. Basic substances described in article 23 of EC phytopharmaceutical Regulation No 1107/2009 consist of a new operative category for crop protection products with 16 substances approved so far. Another status, ruled by article 22 is also operative with 11 approved low-risk substances (see EU pesticide database). Now small and medium-sized enterprises (SMEs) have the opportunity to register biorationals at the EU level in one of the two categories. Our institute previously provided technical expertise on how to complete the Basic Substance Application (BSA), together with a description of first results. However it is clear that there is a need for a shorter survey of the two parallel procedures for SMEs. Here we provide a concise sequence of the necessary steps for SMEs, including strategic approach, a rapid steps description, a timeframe for the global pathway, up to the final step, after approval by the Plants, Animals, Food and Feed Standing Committee (PAFF). We present in detail the advantages and limitations of the two statutes. The introduction of approved substances into organic farming is also discussed. Currently basic and low-risk substance pathways are now accessible for biorationals handled by SMEs. Therefore, the option is open for SMEs to seek a possibly low-risk active substances endorsement with market authorizations or a basic substance approval with no plant protection product claims depending on the selected strategy.

References

  • Arnault I., Lombarkia N., Joy-Ondet S., Romet L., Brahim I., Meradi R., Nasri A., Auger J., Derridj S. 2016. Foliar application of microdoses of sucrose to reduce codling moth Cydia pomonella L. (Lepidoptera: Tortricidae) damage to apple trees. Pest Management Science 72 (10): 1901-1909. DOI: https://doi.org/10.1002/ps.4228

  • Czaja K., Goralczyk K., Strucinski P., Hernik A., Korcz W., Minorczyk M., Łyczewska M., Ludwicki J.K. 2015. Biopesticides - towards increased consumer safety in the European Union. Pest Management Science 71 (1): 3-6. DOI: https://doi.org/10.1002/ps.3829

  • DGSanté. 2014a. Sanco Guideline 10363/2012-rev.9. Available on: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_basic-subst_guidance.pdf

  • DGSanté. 2014b. SANCO/11470/2012-rev. 8 20 March 2014. Guidance document on botanical active substances used in plant protection products. Available on: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_appproc_guide_doss_botanicals-rev-8.pdf. [Accessed: January 12, 2017]

  • DGSanté. 2014c. SANCO/10069/2013-rev.3. Available on: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_basic-subst_list-candidates.pdf [Accessed: January 12, 2017]

  • DGSanté. 2015. SANCO/11188/2013-rev. 2 of 14.9.2015 Guidance document on criteria for the inclusion of active substances into Annex IV of Regulation (EC) No 396/2005. Available on: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_mrl_guidelines_sanco-2013-11188.pdf. [Accessed: January 12, 2017]

  • DGSanté. 2016a. SANCO/12545/2014-rev. 2; March 2016. Guidance document for applicants on preparing dossiers for the approval or renewal of approval of a micro-organisms including viruses according to regulation (EU) No 283/2013and regulation (EU) No 284/2013. Available on: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_applicants-microbial_en.pdf [Accessed: January 12, 2017]

  • DGSanté. 2016b. SANTE/12815/2014-rev. 5.2 May 2016. Guidance document on semiochemical active substances and plant protection products. Available on: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_doss_semiochemicals-201605.pdf [Accessed: January 12, 2017]

  • DGSanté. 2017a. EU Pesticide Database. Available on: http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN then select “advanced search” and later select “type” “basic substances” [Accessed: January 12, 2017]

  • DGSanté. 2017b. EU Pesticide Database. Available on: http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN then select “advanced search” and later select “type” “low-risk substances” [Accessed: January 12, 2017]

  • EC. 2000. Directive 2000/60/EC of the European Parliament and of the Council of 23.10.2000 establishing a framework for Community action in the field of water policy. Official Journal of the European Union L 327: 1-72.

  • EC. 2002. 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 (1) (the Authority). It should be clarified that the Authority performs a risk assessment whilst the Commission should perform the risk management role and take the final decision on an active substance. Provisions should be included to ensure the transparency of the evaluation process. Official Journal of the European Union L 31: 1-24.

  • EC. 2008a. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16.12.2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. Official Journal of European Union L 353: 1-84.

  • EC. 2008b. Regulation (EC) No 889/2008 of 5.9.2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control. Official Journal of European Union L 250: 1-84.

  • EC. 2009a. Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides. Official Journal of the European Union L 309: 71-86.

  • EC. 2009b. Regulation (EC) No 1107/2009 of the European Parliament and 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. Official Journal of the European Union L 309: 1-50.

  • EC. 2009c. Expert group for technical advice on organic production (EGTOP) established by Commission Decision 2009/427/EC of 23.4.2009 on the effort of Member States to reduce their greenhouse gas emissions to meet the Community’s greenhouse gas emission reduction commitments up to 2020. Official Journal of European Union L 140: 136-148.

  • EFSA. 2011. 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 9 (2): 2092. DOI: 10.2903/j.efsa.2011.2092.

  • EU. 2014a. Qualified Majority system. Available on: http://europa.eu/legislation_summaries/glossary/qualified_majority_en.htm [Accessed: January 12, 2017]

  • EU. 2014b. Regulation (EU) 563/2014 of 2 3.5.2014 approving the basic substance chitosan hydrochloride. Official Journal of the European Union L 156: 5-7.

  • EU. 2014c. Implementing Regulation (EU) 652/2014 of 14.5.2014 laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material, amending Council Directives 98/56/EC, 2000/29/EC and 2008/90/EC, Regulations (EC) No 178/2002, (EC) No 882/2004 and (EC) No 396/2005 of the European Parliament and of the Council, Directive 2009/128/EC of the European Parliament and of the Council and Regulation (EC) No 1107/2009 of the European Parliament and of the Council and repealing Council Decisions 66/399/EEC, 76/894/EEC and 2009/470/EC. Official Journal of European Union L 189: 1-32.

  • EU. 2015a. Implementing Regulation (EU) 2015/408 of 11.3.2015 on implementing Article 80 (7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution. Official Journal of European Union L 67: 18-22.

  • EU. 2015b. Implementing Regulation (EU) 2015/543 of 1.04.2015 approving the active substance COS-OGA, 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. Official Journal of European Union L 157: 1-163.

  • EU. 2015c. Implementing Regulation (EU) 2015/553 of 7.4.2015 approving the active substance cerevisane, 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. Official Journal of European Union L 92: 86-88.

  • EU. 2016a. Implementing Regulations (EU) No 2016/673 of 29.4.2016 amending Regulation 889/2008 Official Journal of European Union L 116, 30.4.2016, p. 8-22.

  • EU. 2017a. Implementing Regulation (EU) 2017/842 of 17.5.2017 approving the low-risk active substance Coniothyrium minitans strain CON/M/91-08. Official Journal of the European Union L 125: 16-20.

  • EU. 2017b. Implementing Regulation (EU) 2017/428 of 10.3.2017 approving the basic substance clayed charcoal. Official Journal of European Union L 66, 11.3.2017, p. 1-3.

  • EU. 2017c. Implementing Regulation (EU) 2017/1432 of 07.8.2017 amending Regulation (EC) 1107/2009 of the European Parliament and the council concerning the placing of plant protection products on the market as regards the criteria for the approval of the low-risk substance. Official Journal of the European Union L 205: 59-62.

  • Marchand P.A. 2015. Basic substances: an opportunity for approval of low-concern substances under EU pesticide regulation. Pest Management Science 71 (9): 1197-1200. DOI: https://doi.org/10.1002/ps.3997

  • Marchand P.A. 2016. Basic substances under EC 1107/2009 phytochemical regulation: experience with non-biocide and food products as biorationals. Journal of Plant Protection Research 56 (3): 271-277. DOI: https://doi.org/10.1515/jppr-2016-0041

  • Marchand P.A. 2017a. Basic substances under EU pesticide regulation: An Opportunity for Organic Production? Organic farming 3 (1): 16-19. DOI: 10.12924/of2017.03010016

  • Marchand P.A. 2017b. Basic substances as renewable and affordable crop protection products”. Chronicle of Bioresource Management 1 (2): 065-066.

  • Skevas T., Oude Lansink A.G.J.M., Stefanou S.E. 2013. Designing the emerging EU pesticide policy: A literature review. NJAS - Wageningen Journal of Life Sciences 64-65: 95-103, DOI: 10.1016/j.njas.2012.09.001

  • Villaverde J.J., Sevilla-Moran B., Sandin-Espana P., Lopez-Goti C., Alonso-Prados J.L. 2014. Biopesticides in the framework of the European Pesticide Regulation (EC) No. 1107/2009. Pest Management Science 70 (1): 2-5. DOI: https://doi.org/10.1002/ps.3663

  • Villaverde J.J., Sandin-Espana P., Sevilla-Moran B., Lopez-Goti C., Alonso-Prados J.L. 2016a. Biopesticides from natural products: current development, legislative framework, and future trends. BioResources 11 (2): 5618-5640. DOI: https://doi.org/10.15376/biores.11.2.villaverde

  • Villaverde J.J., Sevilla-Moran B., Lopez-Goti C., Alonso-Prados J.L., Sandin-Espana P. 2016b. Trends in analysis of pesticide residues to fulfil the European Regulation (EC) No. 1107/2009. Trends in Analytical Chemistry 80: 568-580. DOI: https://doi.org/10.1016/j.trac.2016.04.017

Arnault I., Lombarkia N., Joy-Ondet S., Romet L., Brahim I., Meradi R., Nasri A., Auger J., Derridj S. 2016. Foliar application of microdoses of sucrose to reduce codling moth Cydia pomonella L. (Lepidoptera: Tortricidae) damage to apple trees. Pest Management Science 72 (10): 1901-1909. DOI: https://doi.org/10.1002/ps.4228

Czaja K., Goralczyk K., Strucinski P., Hernik A., Korcz W., Minorczyk M., Łyczewska M., Ludwicki J.K. 2015. Biopesticides - towards increased consumer safety in the European Union. Pest Management Science 71 (1): 3-6. DOI: https://doi.org/10.1002/ps.3829

DGSanté. 2014a. Sanco Guideline 10363/2012-rev.9. Available on: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_basic-subst_guidance.pdf

DGSanté. 2014b. SANCO/11470/2012-rev. 8 20 March 2014. Guidance document on botanical active substances used in plant protection products. Available on: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_appproc_guide_doss_botanicals-rev-8.pdf. [Accessed: January 12, 2017]

DGSanté. 2014c. SANCO/10069/2013-rev.3. Available on: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_basic-subst_list-candidates.pdf [Accessed: January 12, 2017]

DGSanté. 2015. SANCO/11188/2013-rev. 2 of 14.9.2015 Guidance document on criteria for the inclusion of active substances into Annex IV of Regulation (EC) No 396/2005. Available on: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_mrl_guidelines_sanco-2013-11188.pdf. [Accessed: January 12, 2017]

DGSanté. 2016a. SANCO/12545/2014-rev. 2; March 2016. Guidance document for applicants on preparing dossiers for the approval or renewal of approval of a micro-organisms including viruses according to regulation (EU) No 283/2013and regulation (EU) No 284/2013. Available on: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_applicants-microbial_en.pdf [Accessed: January 12, 2017]

DGSanté. 2016b. SANTE/12815/2014-rev. 5.2 May 2016. Guidance document on semiochemical active substances and plant protection products. Available on: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_doss_semiochemicals-201605.pdf [Accessed: January 12, 2017]

DGSanté. 2017a. EU Pesticide Database. Available on: http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN then select “advanced search” and later select “type” “basic substances” [Accessed: January 12, 2017]

DGSanté. 2017b. EU Pesticide Database. Available on: http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN then select “advanced search” and later select “type” “low-risk substances” [Accessed: January 12, 2017]

EC. 2000. Directive 2000/60/EC of the European Parliament and of the Council of 23.10.2000 establishing a framework for Community action in the field of water policy. Official Journal of the European Union L 327: 1-72.

EC. 2002. 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 (1) (the Authority). It should be clarified that the Authority performs a risk assessment whilst the Commission should perform the risk management role and take the final decision on an active substance. Provisions should be included to ensure the transparency of the evaluation process. Official Journal of the European Union L 31: 1-24.

EC. 2008a. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16.12.2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. Official Journal of European Union L 353: 1-84.

EC. 2008b. Regulation (EC) No 889/2008 of 5.9.2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control. Official Journal of European Union L 250: 1-84.

EC. 2009a. Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides. Official Journal of the European Union L 309: 71-86.

EC. 2009b. Regulation (EC) No 1107/2009 of the European Parliament and 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. Official Journal of the European Union L 309: 1-50.

EC. 2009c. Expert group for technical advice on organic production (EGTOP) established by Commission Decision 2009/427/EC of 23.4.2009 on the effort of Member States to reduce their greenhouse gas emissions to meet the Community’s greenhouse gas emission reduction commitments up to 2020. Official Journal of European Union L 140: 136-148.

EFSA. 2011. 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 9 (2): 2092. DOI: 10.2903/j.efsa.2011.2092.

EU. 2014a. Qualified Majority system. Available on: http://europa.eu/legislation_summaries/glossary/qualified_majority_en.htm [Accessed: January 12, 2017]

EU. 2014b. Regulation (EU) 563/2014 of 2 3.5.2014 approving the basic substance chitosan hydrochloride. Official Journal of the European Union L 156: 5-7.

EU. 2014c. Implementing Regulation (EU) 652/2014 of 14.5.2014 laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material, amending Council Directives 98/56/EC, 2000/29/EC and 2008/90/EC, Regulations (EC) No 178/2002, (EC) No 882/2004 and (EC) No 396/2005 of the European Parliament and of the Council, Directive 2009/128/EC of the European Parliament and of the Council and Regulation (EC) No 1107/2009 of the European Parliament and of the Council and repealing Council Decisions 66/399/EEC, 76/894/EEC and 2009/470/EC. Official Journal of European Union L 189: 1-32.

EU. 2015a. Implementing Regulation (EU) 2015/408 of 11.3.2015 on implementing Article 80 (7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution. Official Journal of European Union L 67: 18-22.

EU. 2015b. Implementing Regulation (EU) 2015/543 of 1.04.2015 approving the active substance COS-OGA, 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. Official Journal of European Union L 157: 1-163.

EU. 2015c. Implementing Regulation (EU) 2015/553 of 7.4.2015 approving the active substance cerevisane, 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. Official Journal of European Union L 92: 86-88.

EU. 2016a. Implementing Regulations (EU) No 2016/673 of 29.4.2016 amending Regulation 889/2008 Official Journal of European Union L 116, 30.4.2016, p. 8-22.

EU. 2017a. Implementing Regulation (EU) 2017/842 of 17.5.2017 approving the low-risk active substance Coniothyrium minitans strain CON/M/91-08. Official Journal of the European Union L 125: 16-20.

EU. 2017b. Implementing Regulation (EU) 2017/428 of 10.3.2017 approving the basic substance clayed charcoal. Official Journal of European Union L 66, 11.3.2017, p. 1-3.

EU. 2017c. Implementing Regulation (EU) 2017/1432 of 07.8.2017 amending Regulation (EC) 1107/2009 of the European Parliament and the council concerning the placing of plant protection products on the market as regards the criteria for the approval of the low-risk substance. Official Journal of the European Union L 205: 59-62.

Marchand P.A. 2015. Basic substances: an opportunity for approval of low-concern substances under EU pesticide regulation. Pest Management Science 71 (9): 1197-1200. DOI: https://doi.org/10.1002/ps.3997

Marchand P.A. 2016. Basic substances under EC 1107/2009 phytochemical regulation: experience with non-biocide and food products as biorationals. Journal of Plant Protection Research 56 (3): 271-277. DOI: https://doi.org/10.1515/jppr-2016-0041

Marchand P.A. 2017a. Basic substances under EU pesticide regulation: An Opportunity for Organic Production? Organic farming 3 (1): 16-19. DOI: 10.12924/of2017.03010016

Marchand P.A. 2017b. Basic substances as renewable and affordable crop protection products”. Chronicle of Bioresource Management 1 (2): 065-066.

Skevas T., Oude Lansink A.G.J.M., Stefanou S.E. 2013. Designing the emerging EU pesticide policy: A literature review. NJAS - Wageningen Journal of Life Sciences 64-65: 95-103, DOI: 10.1016/j.njas.2012.09.001

Villaverde J.J., Sevilla-Moran B., Sandin-Espana P., Lopez-Goti C., Alonso-Prados J.L. 2014. Biopesticides in the framework of the European Pesticide Regulation (EC) No. 1107/2009. Pest Management Science 70 (1): 2-5. DOI: https://doi.org/10.1002/ps.3663

Villaverde J.J., Sandin-Espana P., Sevilla-Moran B., Lopez-Goti C., Alonso-Prados J.L. 2016a. Biopesticides from natural products: current development, legislative framework, and future trends. BioResources 11 (2): 5618-5640. DOI: https://doi.org/10.15376/biores.11.2.villaverde

Villaverde J.J., Sevilla-Moran B., Lopez-Goti C., Alonso-Prados J.L., Sandin-Espana P. 2016b. Trends in analysis of pesticide residues to fulfil the European Regulation (EC) No. 1107/2009. Trends in Analytical Chemistry 80: 568-580. DOI: https://doi.org/10.1016/j.trac.2016.04.017

Journal of Plant Protection Research

The Journal of Polish Society of Plant Protection, Committee of Plant Protection; Polish Academy of Sciences, Institute of Plant Protection – National Research Institute

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