REGULAÇÃO DA NANOTECNOLOGIA E NANOPLÁSTICOS DE UMA PERSPECTIVA GLOBAL

Daniel Francisco Nagao Menezes

doi:10.22171/rej.v26i43.3700

Authors

Daniel Francisco Nagao Menezes Universidade Presbiteriana Mackenzie

DOI:

https://doi.org/10.22171/rej.v26i43.3700

Keywords:

Nanotechnology, Nanomaterials, Nanoplastics, Harmonization, Regulatory Science

Abstract

Nanotechnology and more particularly nanotechnology-based products and materials have provided enormous potential for new solutions to many of the current challenges facing society. However, nanotechnology is also an area of product innovation that is sometimes developing faster than regulatory frameworks. While there has been significant advancement related to analytical approaches for labeling purposes, as well as the development of appropriate testing guidelines for nanomaterials and their safety assessment, there is still a need for greater collaboration and global consensus in the regulatory field. Furthermore, with society's growing concerns about plastic waste and small debris produced by the degradation of scattered plastic objects, the impact of micro and nanoplastics on humans and the environment is an emerging issue. Despite increased research and initial regulatory discussions on micro and nanoplastics, there are still knowledge gaps and therefore an urgent need for action. The text seeks to demonstrate that there are still some uncertainties and knowledge gaps in relation to physicochemical properties, environmental behavior and toxicological effects, especially since the tests described in the international literature are often carried out at the beginning of the product development process, and the material in the final product may behave differently. The harmonization of methodologies for quantification and risk assessment of nanomaterials and nanoplastics is a necessary measure and will be sought in this article.

Author Biography

Daniel Francisco Nagao Menezes, Universidade Presbiteriana Mackenzie

Graduação em Direito (PUC-Campinas), Especializações em Direito Constitucional e Direito Processual Civil (PUC-Campinas), em Didática e Prática Pedagógica no Ensino Superior (Centro Universitário Padre Anchieta), Mestre e Doutor em Direito Político e Econômico (Universidade Presbiteriana Mackenzie), Pós-Doutor em Direito (USP). Pós-Doutor em Economia (UNESP-Araraquara). Professor do Programa de Pós-Graduação em Direito Político e Econômico da Faculdade de Direito da Universidade Presbiteriana Mackenzie. Professor Colaborador da Maestría em Economía Social da Universidad Autónoma de Guerrero (Acapulco, México). Membro do CIRIEC-Brasil.

References

ADDAMO, A. M., et al. Top marine beach litter items in Europe: a review and synthesis based on beach litter data. Luxemburg: European Union, 2017.

ALEXY, P. et al. Managing the analytical challenges related to micro-and nanoplastics in the environment and food: filling the knowledge gaps. Food Additives & Contaminants, n. 37, p. 1-10, 2020.

AMENTA, V. et al. Regulatory aspects of nanotechnology in the agri/food sector in EU and non EU countries. Regulatory Toxicology and Pharmacology, n. 73, p. 463-476, 2015.

BINTEIN, S. Proposal of ECHA (the European chemicals agency) for a restriction of intentionally-added microplastics and nanoplastics. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

BOSNICK, K. Nanomaterials for reducing food-related waste. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS.

BOUDREAU, M. et al. Differential effects of silver nanoparticles and silver ions on tissue accumulation, distribution, and toxicity in the Sprague dawley rat following daily oral gavage administration for 13 weeks. Toxicological Sciense, v. 150, p. 131-160, 2016.

BOVERHOF, D. R. et al. Comparative assessment of nanomaterial definitions and safety evaluation considerations. Regulatory Toxicology and Pharmacology, v. 74, p. 137-150, 2015.

BURGESS, R. Overview of ecological studies on the fate and effects of nanomaterials in the marine environment. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

CHEN, H. Observations of nano-agrochemicals and nanoplastics in food and agriculture research. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

CLIFFORD, C. Normative and pre-normative activities for nanomaterials measurement and characterisation. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

COMANDELLA, D. et al. Quality of physicochemical data on nanomaterials: an assessment of data completeness and variability. Nanoscale, v. 12, p. 4695-4708, 2020.

CORRELA, M. et al. Analytical challenges and practical solutions for enforcing labelling of nanoingredients in food products in the European Union. In RUBIO, A. L. et. al. (orgs.) Nanomaterials for Food Applications. Amsterdã: Elsevier, 2019, p. 273-311.

CULLIS, P. Nanomedicines innovation network (NMIN): Canada's national centre of excellence in nanomedicines. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

DANA, D. A. Can the law track scientific risk and technological innovation? The problem of regulatory definitions and nanotechnology. Faculty working papers, paper 113, 2010. Disponível em: http://scholarlycommons.law.northwestern.edu/facultyworkingpapers/113. Acesso em 13 jul. 22.

DE JONG, W. Safety assessment of nanomaterials as ingredients for cosmetic products. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

DEVASAHAYAM, S. Nanotechnology and nanomedicine in market: a global perspective on regulatory issues. in MOHAPATRA, S. S. et. al. (orgs.) Characterization and Biology of Nanomaterials for Drug Delivery; Micro & Nano Technologies Series. Amsterdã: Elsevier, 2019, p. 488-522.

DE VLIEGER, J. Science-based regulations for non-biological complex drugs (NBCDs), nanomedicines and their similar. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

DINDA, A. Challenges in the development of an Indian guideline for nanopharmaceuticals. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

FESSARD, V. Genotoxicity of aluminium nanoparticles. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

FRIEDERSDORF, L. Leveraging advances in nanotechnology and international collaboration to address emerging contaminants. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

GAJANAN, K.; TIJARE, S. N. Applications of nanomaterials. Material Today, v. 5, p. 1093-1096, 2018.

GEISS, O. et al. Characterisation of food grade titania with repsect to nanoparticle content in pristine additives and in their related food products. Food Additives & Contaminants, vol. 37, p. 239-253, 2020.

GENCHI, G. G. et al. Smart materials meet multifunctional biomedical device: current and prospective implications for nanomedicine. Frontiers in Bioengineering and Biotechnology, v. 5, p. 80, 2017.

GIGAULT, J. et al. Current opinion: what is a nanoplastic? Environmental Pollution, v. 235, p. 1030-1034, 2018.

GILLILAND, D. What can the analytics of nanomaterials bring to the detection of nanoplastics? GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

GIUSTI, A. et al. Nanomaterial grouping: existing approaches and future recommendations. NanoImpact, v. 16, p. 100-182, 2019.

GOERING, P. Nanotechnology and medical devices: a regulatory science approach involving research, standards, and risk assessment. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

GONZALEZ, M. OECD work supporting the regulation of nanomaterials. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

GOTTARDO, S. et al. NANoREG framework for the safety assessment of nanomaterials. Ispra: European Union, 2017.

GREINER, R. Nano-sized delivery systems for food applications. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

HANTORO, I, et al. Microplastics in coastal areas and seafood: implications for food safety. Food Additives & Contaminants, v. 36, p. 674-711, 2019.

HARTMANN, N. B. Risks of micro- and nanoplastics to humans and the environment. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

HEALY, M. J. et al. Regulatory bioinformatics for food and drug safety. Regulatory Toxicology and Pharmacology, v. 80, p. 342-347, 2016.

HELD, A. Reference materials supporting legislation. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

HERZBERG, F. Towards grouping of nanomaterials: lessons learnt and remaining challenges. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

HODGE, G. et. al. New Global Frontiers in Regulation. The Age of Nanotechnology. Monash Studies in Global Movements Series. Cheltenham: Edward Elgar Publishing, 2009.

KAH, M. Nanopesticides and their deliberate application in agriculture. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

KAISER, D. Nanotechnology standards: progress on GSRS16 needs and ASTM international committee E56. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

KOLTSOV, D. Nanotechnology standards for industry, regulators and other stakeholders. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

LAMPEN, A. Micro- and nanoplastics in food: oral uptake, toxicology and initial aspects of risk assessment. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

LIMA DA CUNHA, C. E. Safe by design: creating nanomaterials of tomorrow. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

LYNCH, I. Harmonising detection, quantification and impact assessment of micro/nanoplastics in freshwater environmental hotspots. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

MCNAMARA, K.; TOFAIL, S. A. M. Nanoparticles in biomedical applications. Advances in Physics, v. 2, p. 54-88, 2017.

MECH, A et al. Nano or not nano? A structured approach for identifying nanomaterials according to the European Commission's definition. Small, v. 16, p. 200-228, 2020.

MECH, A. et al. The NanoDefine Methods Manual. Ispra: European Union, 2020.

MIERNICKI, M. et al. Legal and practical challenges in classifying nanomaterials according to regulatory definitions. Nature Nanotechnology, v. 14, p. 208-2016, 2019.

NALUBOLA, R. The FDA - Europe Office: our role and how you can engage with us. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

NELSON, B. Challenges in standardising in vitro assays for the evaluation of nano-enabled drug products. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

NGUYEN, B.; TUFENJI, N. Single particle-resolution fluorescence microscopy of nanoplastics. Environmental Science & Technology, v. 56, n. 10, p. 6426-6435, 2022.

OGAWA, K. Size-dependent toxicity of silver nanoparticles. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

OOMEN, A. et al. Bionanotechnologie – een verkenning. RIVM Briefrapport 2019-0001. Bilthoven: Rijksinstituut voor Volksgezondheid en Milieu, 2019.

PATRA, J. K. et al. Nano based drug delivery systems: recent developments and future prospects. Journal Nanobiotechnology, v.16, 2018.

PEREZ DE LA OSSA, D. H.; BREMER-HOFFMANN, S. Nanomedicines: EU regulatory experience, challenges and regulatory research work. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

POTTIER, A. NBTXR3, a first-in-class hafnium oxide nanoparticle radio-enhancer: journey from concept to clinical application. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

PUCHNER, E. M. et al. Nanopores formed by DNA origami: a review. FEBS Letters, v. 588, p. 3564-3570, 2014.

RASMUSSEN, K. Developing OECD test guidelines for regulatory testing of nanomaterials to ensure mutual acceptance of test data. Regulatory Toxicology and Pharmacology, v. 104, p. 74-83, 2019.

RAUSCHER, H. et al. An overview of concepts and terms used in the European Commission's definition of nanomaterials. Luxembourg: Publications Office of the European Union, 2019.

RAUSCHER, H. et al. Identification of nanomaterials through measurements. Ispra: European Union, 2019.

RESEARCH AND MARKETS. World Nanotechnology Markets to 2025: Robust R&D Scenario Characterizes Nanotechnology Industry, 2020. Dispoível em www.prnewswire.com. Acesso em 14 jul. 22.

ROEBBEN, G. et al. Reference materials and representative test materials: the nanotechnology case. Journal of Nanoparticle Research, v. 15, p. 1455, 2013.

SCHELLEKENS, H. et al. The therapeutic equivalence of complex drugs. Regulatory Toxicology and Pharmacology, v. 59, p. 176-183, 2011.

SCHOONJANS, R. Guidance on the human and animal risk assessment of the application of nanoscience and nanotechnology in the agri/food sector. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

SIMAK, J. Investigation of blood and endothelial toxicity of engineered nanoparticles using a PAMAM (polyamidoamine) dendrimer model. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

STONE, V. et al. A framework for grouping and read-across of nanomaterials supporting innovation and risk assessment. Nano Today, v. 35, 2020.

SUMREIN, A. Safety assessment of nanomaterials under REACH. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

THAKKAR, S. et al. Regulatory landscape of dietary supplements and herbal medicines from a global perspective. Regulatory Toxicology and Pharmacology, v. 114, 2020.

TONG, W. et al. Genomics in the land of regulatory Science Regulatory Toxicology and Pharmacology, v. 72, p. 102-116, 2015.

TOUSSAINT, B. et al. Review of micro- and nanoplastics contaminations in the food chain. Food Additives & Contaminants, v. 36, p. 639-673, 2019.

URMANN, K. et al. Aptamer-modified nanomaterials: principles and applications. BioNanoMaterials, v. 18, 2017.

WACKER, M. Translational nanomedicine how to predict clinical performance? GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.

ZOU, S. Characterisation of nanomaterials and their cytotoxicity assessment. GLOBAL SUMMIT ON REGULATORY SCIENCE 2019 ON NANOTECHNOLOGY AND NANOPLASTICS, 2019.