Abstract
Nanomaterial’s applications have been reported for a number of specific product areas, including foods and medical products. Food and drug products are subject to regulatory oversight in many countries to ensure their safety and effectiveness. As the field of nanomaterials develops fast, countries/regions have begun to develop, improve, and/or articulate regulatory strategies for foods and medical products. They invest in regulatory science and other research efforts to support the responsible development of nanomaterials in these areas. In 2010, a project was started by the OECD (Organization for Economic Co-operation and Development) working party on nanomaterials (WPN). The objective of the project was to provide an inventory, summary, and overview of regulatory strategies, legislative regimes, and government-sponsored regulatory science research and other research programs, institutions, and infrastructure in foods and medical products using the nanomaterials. This project was performed from 2011 to 2012. The 12 WPN delegations are Australia, Canada, the European Union, France, Germany, Japan, Korea, the Netherlands, Norway, Poland, the Russian Federation, and the United States. The Committee for Scientific and Technological Policy (CSTP) agreed to the release of this report in January 2013. This book chapter discusses the necessity and progress in nanomaterial’s safety regulations in food and drug industry.
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References
Amenta V, Aschberger K, Arena M, Bouwmeester H, Moniz FB, Brandhoff P, Gottardo S, Marvin HJ, Mech A, Pesudo LQ, Rauscher H (2015) Regulatory aspects of nanotechnology in the agri/feed/food sector in EU and non-EU countries. Regul Toxicol Pharmacol 73:463–476
Bai C (2005) Ascent of nanoscience in China. Science 309:61–63
Bumbudsanpharoke N, Ko S (2015) Nano-food packaging: an overview of market, migration research, and safety regulations. J Food Sci 80:R910–R923
Chau C-F, Wu S-H, Yen G-C (2007) The development of regulations for food nanotechnology. Trends Food Sci Technol 18:269–280
Chaudhry Q, Scotter M, Blackburn J et al (2008) Applications and implications of nanotechnologies for the food sector. Food Addit Contam 25:241–258
Chen L, Remondetto GE, Subirade M (2006) Food protein-based materials as nutraceutical delivery systems. Trends Food Sci Technol 17:272–283; and IOM (Institute of Medicine) (2009) Nanotechnology in food products: workshop summary. The National Academies Press, Washington, DC
Chun AL (2009) Will the public swallow nanofood? Nat Nanotechnol 4:790–791
Cushen M, Kerry J, Morris M, Cruz-Romero M, Cummins E (2013) Migration and exposure assessment of silver from a pvc nanocomposite. Food Chem 139:389–397
Dallas P, Sharma VK, Zboril R (2011) Silver polymeric nanocomposites as advanced antimicrobial agents: classification, synthetic paths, applications, and perspectives. Adv Colloid Interf Sci 166:119–135
De Lima R, Feitosa L, Pereira ADES, De Moura MR, Aouada FA, Mattoso LHC, Fraceto LF (2010) Evaluation of the genotoxicity of chitosan nanoparticles for use in food packaging films. J Food Sci 75:N89–N96
De Moura MR, Mattoso LH, Zucolotto V (2012) Development of cellulose-based bactericidal nanocomposites containing silver nanoparticles and their use as active food packaging. J Food Eng 109:520–524
Esumi K, Takei N, Yoshimura T (2003) Antioxidant-potentiality of gold–chitosan nanocomposites. Colloids Surf B: Biointerfaces 32:117–123
EFSA Scientific Committee (2011) Guidance for risk assessment of engineered nanomaterials. The EFSA Journal 9: 2140. https://doi.org/10.2903/j.efsa.2011.2140.
EU (2006) Regulation (ec) no 1907/2006 of the European parliament and of the council: 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. Europe Union, L 396.
European Commission (2009) Commission recommendation on a code of conduct for responsible nanosciences and nanotechnologies research & council conclusions on responsible nanosciences and nanotechnologies research. Directorate-General for Research, Communication Unit.
European Commission (2011) Commission Recommendation of 18 October 2011 on the definition of nanomaterial. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32011H0696&from=DE.
European Commission (2013) General report on reach: Report from the commission to the European parliament, the council, the European economic and social committee and the committee of the regions. COM(2013) 49 final. Europe Commission. Brussels, Belgium.
European Commission (2022) Commission Recommendation of 10 June 2022 on the definition of nanomaterial. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022H0614(01).
FAO and WHO (2013) State of the art on the initiatives and activities relevant to risk assessment and risk manaagement of nanotechnologies in the food and agriculture sectors. Rome, Italy.
Fletcher N, Bartholomaeus A (2011) Regulation of nanotechnologies in food in Australia and New Zealand. Int Food Risk Anal J 1:33–40
Foulkes R, Man E, Thind J, Yeung S, Joy A, Hoskins C (2020) The regulation of nanomaterials and nanomedicines for clinical application: current and future perspectives. Biomater Sci 8:4653
George J, Siddaramaiah (2012) High performance edible nanocomposite films containing bacterial cellulose nanocrystals. Carbohydr Polym 87:2031–2037
Hansen SF, Baun A (2012) European regulation affecting nanomaterials – review of limitations and future recommendations. Dose Response 10:364–383
He X, Hwang HM (2016) Nanotechnology in food science: functionality, applicability, and safety assessment. J Food Drug Anal 24:671–681
He X, Aker WG, Fu PP, Hwang H-M (2015a) Toxicity of engineered metal oxide nanomaterials mediated by nano–bio–eco–interactions: a review and perspective. Environ Sci Nano 2:564–582
He X, Aker WG, Huang M-J, Watts JD, Hwang H-M (2015b) Metal oxide nanomaterials in nanomedicine: applications in photodynamic therapy and potential toxicity. Curr Top Med Chem 15:1887–1900
He X, Aker WG, Pelaez M, Lin Y, Dionysiou DD, Hwang H-M (2016a) Assessment of nitrogen–fluorine-codoped TiO2 under visible light for degradation of bpa: implication for field remediation. J Photochem Photobiol A Chem 314:81–92
He X, Sanders S, Aker WG, Lin Y, Douglas J, Hwang H-M (2016c) Assessing the effects of surface bound humic acid on the phototoxicity of anatase and rutile TiO2 nanoparticles in vitro. J Environ Sci 42:50–60
He X, Fu P, Aker WG, Hwang H-m (2018) Toxicity of engineered nanomaterials mediated by nano- bio-eco interactions. J Environ Sci Health 36:21–42
He X, Deng H, Aker WG, Hwang H-M (2019) Regulation and Safety of Nanotechnology in the Food and agriculture industry, Chapter 23. pp 517–525. https://doi.org/10.1201/9780429297038-23
Hwang HM, Ray PC, Yu H, He X (2012) Toxicology of designer/engineered metallic nanoparticles. In: Luque R, Varma R (eds) Sustainable preparation of metal nanoparticles: methods and applications. Royal Society of Chemistry, Cambridge, UK
Jong WHD, Borm PJA (2008) Drug delivery and nanoparticles: applications and hazards. Int J Nanomedicine 3(2):133–149
Magnuson BA, Jonaitis TS, Card JW (2011) A brief review of the occurrence, use, and safety of food-related nanomaterials. J Food Sci 76:R126–R133
Medeiros BGDS, Souza MP, Pinheiro AC, Bourbon AI, Cerqueirs MA, Vicente AA, Carneiro-da-Cunha MG (2014) Physical characterisation of an alginate/lysozyme nano-laminate coating and its evaluation on “coalho” cheese shelf life. Food Bioprocess Technol 7:1088–1098
Merisko-Liversidge EM, Liversidge GG (2008) Drug nanoparticles: formulating poorly water-soluble compounds. Toxicol Pathol 36:43–48
NNI (National Nanotechnology Initiative) (2011) Environmental, Health, and Safety Research Strategy, Executive Office of the President. http://nano.gov/node/681
OECD (2013 Apr 24) Regulatory frameworks for nanotechnology in foods and medical products: summary results of a survey activity. OECD Science, Technology and Industry Policy papers, no. 4. OECD Publishing, Paris. https://doi.org/10.1787/5k47w4vsb4s4-en
OECD description of nanotechnology. Accessible online at: www.oecd.org/sti/nano
Paciotti GF, Myer L, Weinreich D et al (2004) Colloidal gold: a novel nanoparticle vector for tumor directed drug delivery. Drug Deliv 11:169–183
Parisi C, Vigani M, Rodriguez-Cerezo E (2015) Agricultural nanotechnologies: what are the current possibilities? NanoToday 10:124–127
Priolo MA, Gamboa D, Holder KM, Grunlan JC (2010) Influence of clay concentration on the gas barrier of clay-polymer nanobrick wall thin film assemblies. Nano Lett 10:4970–4974
Research and Markets (2017) The global market for nanotechnology and nanomaterials 2010–2027. Scott, N. and H. Chen 2013. Nanoscale science and engineering for agriculture and food systems. Industrial Biotechnology 9:17–18.
Scott N, Chen H (2013) Nanoscale science and engineering for agriculture and food systems. Ind Biotechnol 9:17–18
Subhan MA, Choudhury KP, Neogi N (2021) Advances with molecular nanomaterials in industrial manufacturing applications. Nano 1(2):75–97
Tager J (2015) Pre-market testing of nanomaterials in food is both practical and necessary. Nat Nanotechnol 10:285–286
Taylor AA, Schierz A, Freeman EL (2017) New nanomaterial regulations require detailed information from industry, exponent engineering and scientific consulting. Environ Perspect Newsl, 888.656.EXPO.
U.S. FDA (2015a) FDA issues guidance on the use of nanomaterials in food for animals. Food and Drug Administration, U.S. Department of Health and Human Services. https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm457112.htm.
U.S. FDA (2015b) FDA’s approach to regulation of nanotechnology products. Food and Drug Administration, U.S. Department of Health and Human Services. https://www.fda.gov/scienceresearch/specialtopics/nanotechnology/ucm301114.htm.
U.S. FDA (2015c) Guidance for industry: Use of nanomaterials in food for animals. In Guidance for industry: Use of nanomaterials in food for animals. Food and Drug Administration, U.S. Department of Health and Human Services.
U.S. FDA (2014) Guidance for industry: Assessing the effects of significant manufacturing process changes, including emerging technologies, on the safety and regulatory status of food ingredients and food contact substances, including food ingredients that are color additives. Food and Drug Administration, U.S. Department of Health and Human Services. https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm300661.htm.
U.S. FDA (2022) Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry APRIL 2022. Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry | FDA.
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Subhan, M.A., Subhan, T. (2022). Nanomaterial’s Safety Regulations in Food and Drug Industry. In: Shanker, U., Hussain, C.M., Rani, M. (eds) Handbook of Green and Sustainable Nanotechnology. Springer, Cham. https://doi.org/10.1007/978-3-030-69023-6_94-1
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DOI: https://doi.org/10.1007/978-3-030-69023-6_94-1
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