Regulatory Framework for Nanomaterials in Agri-Food Systems

  • Kizhaeral S. SubramanianEmail author
  • S. K. Rajkishore


The use of nano-materials (NMs) in agri-food system is alarmingly increasing in the past few years, and this warrants to evolve a robust regulatory framework to gain the fruition of the nanotechnology while ensuring environmental safety. This is one of the maiden attempts to bring the information together for the readers to learn the current status of understanding. This chapter outlines the state-of-the-art information on risk assessment strategy for NMs and reviewed the current status of regulatory frameworks in a diverse countries with scientific advancement besides highlighting some key criteria for evolving a foolproof framework. The data have unequivocally demonstrated that the nano-regulatory frameworks available at present are digitally divided, and still lacks clarity. Among them, the European Union is taking a lead step in formulating a nano-regulatory framework for agricultural sector which needs to be further fine-tuned to evolve globally competitive nano-framework ensuring societal acceptance and environmental health. Based on the literature review, a conceptual framework has been suggested that encompasses pre-assessment phase, exposure assessment and risk characterization for regulating the applications of agricultural nanotechnologies.


Nano-materials Agriculture Nano-toxicity Regulatory framework Agri-food systems 


  1. Adholeya A, Das RK, Dubey MK, Kochar M, Singh R (2017) Zero draft policy on regulation of nanoproducts in agriculture. The Energy and Resources Institute (TERI), New DelhiGoogle Scholar
  2. Amenta V, Aschberger K, Arenaa M, Bouwmeester H, Moniz FB, Brandhoff P, Gottardo S, Marvin HJP, Mech A, Pesudo Q, Rauscher H, Schoonjans R, Vettori MV, Weigel S, Peters RJ (2015) Regulatory aspects of nanotechnology in the agri feed food sector in EU and non-EU countries. Regul Toxicol Pharmacol 73:463–476CrossRefGoogle Scholar
  3. Anusya P, Nagaraj R, Janavi GJ, Subramanian KS, Paliyath G, Subramanian J (2016) Pre-harvest sprays of hexanal formulation for extending retention and shelf-life of mango (Mangifera indica L.) fruits. Sci Hort 210:221–230Google Scholar
  4. Arts JHE, Hadi M, Irfan AM, Keene AM, Kreiling R, Lyon D, Maier M, Michel K, Petry T, Sauer UG, Warheit D, Weinch K, Wohlleben W, Landseidel R (2014) A critical appraisal of existing concepts for the grouping of nanomaterials. RegulToxicol Pharmacol 70:492–506Google Scholar
  5. Ashauer R, Escher BI (2010) Advantages of toxicokinetic and toxicodynamic modelling in aquatic ecotoxicology and risk assessment. J Environ Monit 12(11):2056–2061CrossRefGoogle Scholar
  6. Berekaa MM (2015) Nanotechnology in food Industry; Advances in food processing, packaging and food safety. Int J Curr Microbiol App Sci 4:345–357Google Scholar
  7. Bhushani JA, Anandharamakrishnan C (2014) Electrospinning and electrospraying techniques: potential food-based applications. Trends Food Sci Technol 38:21–33CrossRefGoogle Scholar
  8. Boverhof DR, Bramante CM, Butala JH, Clancy SF, Lafranconi M, West J, Gordon SC (2015) Comparative assessment of nanomaterial definitions and safety evaluation considerations. Regul Toxicol Pharmacol 73:137–150CrossRefGoogle Scholar
  9. Cassee FR, Muijser H, Duistermaat E, Freijer JJ, Geerse KB, Marijnissen JC, Arts JH (2002) Particle size-dependent total mass deposition in lungs determines inhalation toxicity of cadmium chloride aerosols in rats. Application of a multiple path dosimetry model. Arch Toxicol 76(5–6):277–286CrossRefGoogle Scholar
  10. Chou BYH, Liao CM, Lin MC, Cheng HH (2006) Toxicokinetics/toxicodynamics of arsenic for farmed juvenile milkfish Chanoschanos and human consumption risk in BFD-endemic area of Taiwan. Environ Int 32(4):545–553CrossRefGoogle Scholar
  11. Dekkers S, Oomen AG, Bleeker EAJ, Vandebriel RJ, Micheletti C, Cabellos J, Janer G, Fuentes N, Azquez-Campos SV, Borges T, Silva MJ, Prina-Mello A, Movia D, Nesslany F, Ribeiro AR, Leite PE, Groenewold M, Cassee FR, Sips AJAM, Dijkzeul A, Teunenbroek TV, Wijnhoven SWP (2016) Towards a nanospecific approach for risk assessment. Regul Toxicol Pharmacol 80:46–59CrossRefGoogle Scholar
  12. DeLoid GM, Cohen JM, Pyrgiotakis G (2015) Advanced computational modeling for in vitro nanomaterial dosimetry. Part Fibre Toxicol 12989-015-0109-1Google Scholar
  13. Demokritou P, Gass S, Pyrgiotakis G, Cohen JM, Goldsmith W, McKinney W, Frazer D, Ma J, Schwegler- Berry D, Brain J, Castranova V (2013) An in vivo and in vitro toxicological characterisation of realistic nanoscale CeO2 inhalation exposures. Nanotoxicology 7(8):1338–1350CrossRefGoogle Scholar
  14. Dharanivasan G, Sithanantham S, Kannan M, Chitra S, Kathiravan K, Janarthanan S (2017) Metal Oxide Nanoparticles Assisted Controlled Release of Synthetic Insect Attractant for Effective and Sustainable Trapping of Fruit Flies. J Clust Sci 28(4):2167–2183CrossRefGoogle Scholar
  15. Doak SH, Griffiths SM, Manshian B, Singh N, Williams PM, Browns AP, Jenkins GJ (2009) Confounding experimental considerations in nanogenotoxicology. Mutagenesis 24(4):285–293CrossRefGoogle Scholar
  16. Doak SH, Manshian B, Jenkins GJS, Singh JN (2012) In vitro genotoxicity testing strategy for nanomaterials and the adaptation of current OECD guidelines. Mutat Res 745(1–2):104–111CrossRefGoogle Scholar
  17. DST Dept of Science and Technology (2016) Guidelines and best practices for safe handling of nano-materials in research laboratories and industries. Centre for Knowledge Management of Nanoscience & Technology, Department of Science & Technology, Govt. of India, pp 1–24Google Scholar
  18. Dusinska M, Fjellsbo L, Magdolenova Z (2009) Testing strategies for the safety of nanoparticles used in medical applications. Nanomedicine (Lond) 4:605–607CrossRefGoogle Scholar
  19. Dusinska M, Pran ER, Carreira SC, Saunders M (2012) Critical evaluation of toxicity tests. In: Fadeel B, Pietroiusti A, Shvedova AA (eds) Adverse effects of engineered nanomaterials. Engineered nanomaterials: hazard, exposure and safety assessment. Academic press, Imprint of Elsevier, pp 6–63Google Scholar
  20. EC (2006) Regulation (EC) No 1907/2006 of the European Parliament and the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. Off J Eur Union L396:1–525Google Scholar
  21. EC (2011) Commission recommendation of 18 October 2011 on the definition of nanomaterial (Text with EEA relevance) (2011/696/EU). Off J Eur Union L275:38–40Google Scholar
  22. EC (2012) Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee e Second RegulatoryGoogle Scholar
  23. EC (2013) Commission delegated Regulation (EU) No 1363/2013 of 12 December 2013 amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers as regards the definition of engineered nanomaterials. Off J Eur Union L343:26–28Google Scholar
  24. ECHA (2012) Guidance on Information Requirements and Chemical Safety Assessment e Appendix R7-1 Recommendations for Nanomaterials Applicable to Chapter R7a Endpoint Specific Guidance. Guidance for the Implementation of REACH. European Chemicals Agency (ECHA), Helsinki, FinlandGoogle Scholar
  25. EFSA Scientific Committee (2011) Scientific opinion on guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. EFSA J. 9, 2140Google Scholar
  26. Eleftheriadou M, Pyrgiotakis G, Demokritou P (2017) Nanotechnology to the rescue using nano-enabled approaches in microbiological food safety and quality. Curr Opin Biotechnol 44:87–93CrossRefGoogle Scholar
  27. Epp A (2015) Nanoview—perception of nanotechnology by the German population and media coverage. In: 1st joint symposium on nanotechnology. BfR.
  28. Gallagher MJ, Allen A, Buchman JT, Qiu TA, Clement PL, Krause MOP, Gilbertson LM (2017) Research highlights: applications of life-cycle assessment as a tool for characterizing environmental impacts of engineered nanomaterials. Environ Sci-Nano 4:276–281CrossRefGoogle Scholar
  29. Ghaani M, Cozzolino CA, Castelli G, Farris S (2016a) An overview of the intelligent packaging technologies in the food sector. Trends Food Sci Technol 51:1–11CrossRefGoogle Scholar
  30. Ghaani M, Nasirizadeh N, Ardakani SAY, Mehrjardi FZ, Scampicchio M, Farris S (2016b) Development of an electrochemical nanosensor for the determination of gallic acid in food. Anal Methods 8:1103–1110CrossRefGoogle Scholar
  31. Gonzalez L, Sanderson BJS, Kirsch-Volders M (2011) Adaptations of the in vitro micronucleus assay for the genotoxicity assessment of nanomaterials. Mutagenesis 26(1):185–191CrossRefGoogle Scholar
  32. Haas KH (2013) Industrial relevant production processes for nanomaterials and nanostructures. Safety aspects of engineered nanomaterials. Pan Standford Publishing Pte. pp 30–66Google Scholar
  33. Hristozova D, Gottardo S, Semenzin E, Oomen A, Bos P, Peijnenburg W, Tongeren MV, Nowack B, Hunt N, Brunelli A, Scott FJJ, Tran L, Marcomini A (2016) Environ Int 95:36–53Google Scholar
  34. Hund-Rinke K, Schlich K (2014) The potential benefits and limitations of different test procedures to determine the effects of Ag nanomaterials and AgNO3 on microbial nitrogen transformation in soil. Environ Sci Eur 26(1):28CrossRefGoogle Scholar
  35. ISO (2015) ISO/TS 80004-1:2015 nanotechnologies—vocabulary—Part 1: core terms ISO/TS 80004-1:2015 nanotechnologies—vocabulary—Part 1: core terms. Geneva SwitzerlandGoogle Scholar
  36. Jeon CS (2016) Surface functionalization of bioanalytical applications: virus decorated gold microshells and modified synaptic cell adhesion molecules. PhD dissertation, Seoul National UniversityGoogle Scholar
  37. Jincy M, Djanaguiraman M, Jeyakumar P, Subramanian KS, Jayasankar S, Paliyath G (2017) Inhibition of phospholipase D enzyme activity through hexanal leads to delayed mango (Mangiferaindica L.) fruit ripening through changes in oxidants andantioxidant enzymes activity. SciHort 218:316–332Google Scholar
  38. Justo HR, Dayan T (2014) European risk governance of nanotechnology: explaining the emerging regulatory policy. Res Pol 44:1527–1530CrossRefGoogle Scholar
  39. Katouzian I, Jafari SM (2016) Nano-encapsulation as a promising approach for targeted delivery and controlled release of vitamins. Trends Food Sci Technol 53:34–48CrossRefGoogle Scholar
  40. Kleandrova VV, Luan F, González-Díaz H, Ruso JM, Speck-Planche A, Natália M, Cordeiro DS (2014) Computational tool for risk assessment of nanomaterials: novel QSTR-perturbation model for simultaneous prediction of ecotoxicity and cytotoxicity of uncoated and coated nanoparticles under multiple experimental conditions. Environ Sci Technol 48:86–94CrossRefGoogle Scholar
  41. Klöpffer W, Curran MA, Frankl P, Heijungs R, Köhler A, Olsen SI (2007) Nanotechnology and life cycle assessment. A systems approach to nanotechnology and the environment: synthesis of results obtained at a workshop Washington, DC 2–3 October 2006. European Commission, DG Research, jointly with the Woodrow Wilson International Center for ScholarsGoogle Scholar
  42. Kumar LY (2015) Role and adverse effects of nanomaterials in food technology. J Toxicol Health 2:2CrossRefGoogle Scholar
  43. Laux P, Tentschert J, Riebeling C, Braeuning A, Creutzenberg O, Epp A, Fessard V, Haas K, Haase A, Hund-Rinke K, Jakubowski N, Kearns P, Lampen A, Rauscher H, Schoonjans R, Stormer A, Theilmann A, Muhle U, Luch A (2018) Nanomaterials: certain aspects of application, risk assessment and risk communication. Arch Toxicol 92(1):121–141CrossRefGoogle Scholar
  44. Linkov I, TrumpBD WenderBA, SeagerTP Kennedy AJ, Keisler JM (2017) Integrate lifecycle assessment and risk analysis results, not methods. Nature Nanotechnol 12:740–743CrossRefGoogle Scholar
  45. Magdolenova Z, Collins A, Kumar A, Dhawan A, Stone V, Dusinska M (2014) Mechanisms of genotoxicity: a review of in vitroand in vivo studies with engineered nanoparticles. Nanotoxicology 8(3):233–278CrossRefGoogle Scholar
  46. Martirosyan A, Schneider YJ (2014) Engineered nanomaterials in food: implications for food safety and consumer health. Int J Environ Res Pub Health 11:5720–5750CrossRefGoogle Scholar
  47. Meyer DE, Curran MA, Gonzalez M (2009) An examination of existing data for the industrial manufacture and use of nanocomponents and their role in the life cycle impact of nanoproducts. Environ Sci Technol 43(5):1256–1263CrossRefGoogle Scholar
  48. Mishra S, Keswani C, Abhilash PC, Fraceto LF, Singh HB (2017) Integrated approach of agri-nanotechnology: challenges and future trends front. Plant Sci 8:471. Scholar
  49. Oberdörster G (2012) Nanotoxicology: in vitro-in vivo dosimetry. Environ Health Perspect 120(1):A13. Scholar
  50. OECD (2009) Preliminary review of OECD test guidelines for their applicability to manufactured nanomaterials, ENV/JM/MONO(2009)21Google Scholar
  51. OECD (2014) Report of the OECD expert meeting on the physical chemical properties of manufactured nanomaterials and test guidelines. Series on safety of manufactured nano-materials, 41, ENV/JM/MONO(2014)15Google Scholar
  52. OECD (2016) Physical-chemical parameters: measurements and methods relevant for the regulation of nano-materials.OECD workshop report. Series on safety of manufactured nano-materials, 63, ENV/JM/MONO(2016)2Google Scholar
  53. Pfuhler S, Elespuru R, Aardema MJ, Doak SH, Donner EM, Honma M, Kirsch-Volders M, Landsiedel R, Manjanatha M, Singer T, Kim JH (2013) Genotoxicity of nanomaterials: refining strategies and tests for hazard identification. Environ Mol Mutagen 54:229–239CrossRefGoogle Scholar
  54. Rajkishore SK, Subramanian KS, Natarajan N, Gunasekaran K (2013) Nanotoxicity at various trophic levels: a review. The Bioscan 8(3):975–982Google Scholar
  55. Rasmussen K, Alez MG, Kearns P, Sintes JR, Rossi F, Sayre P (2016) Review of achievements of the OECD working party on manufactured nanomaterials’ testing and assessment programme. From exploratory testing to test guidelines. Regul Toxicol Pharmacol 74:147–160CrossRefGoogle Scholar
  56. Rossi M, Cubadda F, Dini L, Terranova ML, Aureli F, Sorbo A, Passeri D (2014) Scientific basis of nanotechnology, implications for the food sector and future trends. Trends Food Sci Technol 40:127–148. Scholar
  57. Sabourin V, Ayande A (2015) Commercial opportunities and market demand for nanotechnologies in agribusiness sector. J Technol Manag Innov 10:40–51CrossRefGoogle Scholar
  58. SCENIHR (2009) Risk assessment of products of nanotechnologies, 19 JanuaryGoogle Scholar
  59. Sengül H, Theis TL, Ghosh S (2008) Toward sustainable nanoproducts: an overview of nanomanufacturing methods. J Indus Ecol 12(3):329–359CrossRefGoogle Scholar
  60. Sheehan B, Murphy IDF, Mullins M, Furxhi I, Costa AL, Simeone FC, Mantecca P (2018) Hazard screening methods for nanomaterials: a comparative study. Int J Mol Sci 19:649. Scholar
  61. Shvedova A, Pietroiusti A, Kagan V (2018) Nanotoxicology ten years later: lights and shadows. Toxicol Appl Pharmacol 15(299):1–2Google Scholar
  62. Sodano V, Verneau F (2014) Competition policy and food sector in the European Union. J Int Food Agribus Mark 26:155–172CrossRefGoogle Scholar
  63. Steinfeldt M, von Gleich A, Petschow U, Haum R (2007) Nanotechnologies, hazards and resource efficiency. Springer, HeidelbergCrossRefGoogle Scholar
  64. Subramanian KS, Manikandan A, Thirunavukkarasu M, Rahale CS (2015) In: Rai M et al (eds) Nanotechnologies in food and agriculture. Springer International Publishing, Switzerland, pp 69–80Google Scholar
  65. Subramanian KS, Raja K, Marimuthu S (2018) Multifarious applications of nanotechnology for enhanced productivity in agriculture. In: Singh HB, Mishra S, Fraceto LF, de Lima R (eds) Emerging trends in agri-nanotechnology: fundamentals and applied aspects. CAB International, pp 56–77Google Scholar
  66. Subramanian KS, Tarafdar JC (2009) Nanotechnology in soil science. In: Proceedings of the Indian society of soil science-platinum jubilee celebration, December 22–25, IARI Campus, New Delhi, pp 199Google Scholar
  67. Tantra R, Bouwmeester H, Bolea E, Rey-Castro C, David CA, Dogné, JM, Jarman J, Laborda F, Laloy J, Robinson KN, Undas AK, van der Zande M (2015) Suitability of analytical methods to measure solubility for the purpose of nanoregulation. Nanotoxicology 22:1–12Google Scholar
  68. TERI (2010) Nanotechnology development in India: building capability and governing the technology. The Energy and Research Institute (TERI) Briefing Paper, supported by IDRC, CanadaGoogle Scholar
  69. Thakur S, Thakur S, Kumar R (2018) Bio-nanotechnology and its role in agriculture and food industry. J Mol Genet Med 12:324. Scholar
  70. Tsai JW, Chen WY, Ju YR, Liao CM (2009) Bioavailability links mode of action can improve the long-term field risk assessment for tilapia exposed to arsenic. Environ Int 35(4):727–736CrossRefGoogle Scholar
  71. Tsang MP, Hristozov D, Zabeo A, Koivisto AJ, Jensen ACO, Jensen KA, Pang C, Marcomini A, Sonnemann G (2017) Probabilistic risk assessment of emerging materials: case study of titanium dioxide nanoparticles. Nanotoxicology 11:558–568CrossRefGoogle Scholar
  72. USEPA (US Environmental Protection Agency) (2007) US Environmental Protection Agency Nanotechnology White Paper. USEPA, Washington, DCGoogle Scholar
  73. Viji N, Chinnamuthu CR (2015) Iron oxide nanoparticles to break the of the world’s worst weed the Cyperusrotandus. Int J Agric Sci Res 5(3):259–266Google Scholar
  74. WHO (2017) WHO guidelines on protecting workers from potential risks of manufactured nanomaterialsGoogle Scholar
  75. Yang Y, Lin Y, Liao H (2017) Toxicity-based toxicokinetic/toxicodynamic assessment of bioaccumulation and nanotoxicity of zerovalent iron nanoparticles in Caenorhabditiselegans. Int J Nanomed 12:4607–4621CrossRefGoogle Scholar
  76. Zion Market Research (ZMR) (2016) Nanomaterials Market (Metal Oxide, Metals, Chemicals & Polymers and Others) for Construction, Chemical Products, Packaging, Consumer Goods, Electrical and Electronics, Energy, Health Care, Transportation and Other Applications: Global Market Perspective, Comprehensive Analysis and Forecast, 2016–2022. Accessed on 22 February 2018

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Authors and Affiliations

  1. 1.Department of Nano Science & TechnologyTNAUCoimbatoreIndia

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