Risk Assessment Of Nanotechnologies Research Articles

Annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed for 2020

The Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed (the Nano Network) was established in 2010 by the EFSA Advisory Forum, in accordance with EFSA's strategy for cooperation and networking with Member States. This Nano Network exchanges information and expertise between EFSA and Member States. It enhances dialogue among members, builds mutual understanding of risk assessment principles, improves knowledge and confidence in the scientific assessment carried out in the European Union, and increases the transparency of the process among Member States and EFSA. The annual reports of the Nano Network inform the public, stakeholders and research communities about the specific activities and achievements of the Nano Network. In 2020, the yearly meeting was held concomitantly with the 17th meeting of the EFSA cross-cutting Working Group on Nanotechnologies, and converted to virtual network meeting in line with the measures established by EFSA to reduce the risk of coronavirus infection. The purpose of this annual meeting was to ensure information and knowledge exchange with risk assessor delegates of European Member States on the ongoing activities and further research priorities. The Nano Network members were informed on the last updates of the Guidance documents produced by EFSA in the field of Nanotechnologies, which are currently under finalisation. The Network was asked to contribute to the finalisation of the Guidances as well as their further implementation and dissemination.

Annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed for 2019

Annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed for 2019

The nanotechnology application and workforce health and safety - a study of the Malaysia laws, statutory regulations and guidelines on nanotechnology

In Malaysia perspective, the application of nanotechnology is crucial towards achieving the country’s objective as a developed nation by 2020. This paper aims to examine the current Malaysia laws and statutory regulations of nanotechnology applications, to investigate the occupational diseases and work-related accidents associate to nanotechnology and to examine the risk assessment and management practices executed by the nanotechnology-based manufacturers to facilitate the potential effects of nanomaterials. Nanotechnology is a technology that incorporates nanomaterials, which is extremely small materials in size, equivalent to 1/80,000th of the width of a human hair. Due to their distinctive size, these nanomaterials may contribute to the significant health risks and hazards. The findings conclude that there is no specific law and statutory regulation on nanotechnology application exists in Malaysia. Thus, the none existence of nanotechnology laws means there is no protection of persons at work. Malaysia is currently formulating safety standards relevant to nanotechnology. Recently, the Department of Occupational Safety and Health (DOSH) has published the Guideline on Control and Safe Handling Nano Materials by the end of 2018. It provides information and recommendations on handling nanomaterials in the workplace. According to the DOSH personnel that there is no record of occupational disease and work-related accidents related to nanotechnology per se. In relation to the risk assessment and management activities, most of the respondents from the nanotechnology-based manufacturer indicated that there is no nanotechnology risk assessment and management practices being executed in their workplace. Most of them also concluded that they have no knowledge about the latest guideline published by the DOSH on control and safe handling of nanomaterials in the workplace.

Distinguishing the sources of silica nanoparticles by dual isotopic fingerprinting and machine learning

One of the key shortcomings in the field of nanotechnology risk assessment is the lack of techniques capable of source tracing of nanoparticles (NPs). Silica is the most-produced engineered nanomaterial and also widely present in the natural environment in diverse forms. Here we show that inherent isotopic fingerprints offer a feasible approach to distinguish the sources of silica nanoparticles (SiO2 NPs). We find that engineered SiO2 NPs have distinct Si–O two-dimensional (2D) isotopic fingerprints from naturally occurring SiO2 NPs, due probably to the Si and O isotope fractionation and use of isotopically different materials during the manufacturing process of engineered SiO2 NPs. A machine learning model is developed to classify the engineered and natural SiO2 NPs with a discrimination accuracy of 93.3%. Furthermore, the Si–O isotopic fingerprints are even able to partly identify the synthetic methods and manufacturers of engineered SiO2 NPs.

Annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed for 2018

Regulatory preparedness is an important strategic objective of EFSA, particularly for developing techniques used in the food and feed chain such as Nanotechnologies. The Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed was established in 2010 by the EFSA Advisory Forum to exchange information and expertise with Member States. Over the recent years, this Network has become more involved in regulatory preparedness through practical cooperation on a EFSA risk assessment guidance. After an extensive consultation with the Network, in July 2018, EFSA published the first part of the Guidance on the applications of nanoscience and nanotechnologies in the food and feed chain for human and animal health. The 2018 meeting was dedicated to the discussion on the implementation of this guidance and Member States presented their experiences or research linked to aspects of the EFSA Guidance. This report aims to inform the public, stakeholders and research communities about the implementation issues arising from the pilot cases and application of the EFSA Guidance. The pilot phase of the EFSA Guidance continues until the end of 2019 and further feedback is expected from Stakeholders through the workshop on 1-2 April 2019. The Guidance will be then revised and published in 2020. The Network has also identified key topics for further research to strengthen regulatory science.

Annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed for 2017

To enhance cooperation with EU Member States on nanomaterials, EFSA established in 2010 the Network for Risk Assessment of Nanotechnologies in Food and Feed. This Network facilitates the exchange of information between EFSA and Member States, as well as the prioritisation of risk assessment activities. The publication of this annual report informs the public, stakeholders and research communities about elements of risk assessment that need expert advice or further development. During the 2017 meeting hosted in Parma by EFSA, the Network contributed to the draft guidance document for risk assessment of nanotechnologies in the food and feed chain: Part 1, human health. Twenty Member State delegates participated at the meeting and provided their expert advice and comments on the document. Together with the working group members, the comments were addressed or clarified during the meeting. This resulted in a draft version of the guidance ready to be launched for public consultation from January‐March 2018.

How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities

The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration (FDA) was established to assess the potential impact of nanotechnology on drug products. One of the working group's major initiatives has been to conduct a comprehensive risk management exercise regarding the potential impact of nanomaterial pharmaceutical ingredients and excipients on drug product quality, safety, and efficacy. This exercise concluded that current review practices and regulatory guidance are capable of detecting and managing the potential risks to quality, safety, and efficacy when a drug product incorporates a nanomaterial. However, three risk management areas were identified for continued focus during the review of drug products containing nanomaterials: (1) the understanding of how to perform the characterization of nanomaterial properties and the analytical methods used for this characterization, (2) the adequacy of in vitro tests to evaluate drug product performance for drug products containing nanomaterials, and (3) the understanding of properties arising from nanomaterials that may result in different toxicity and biodistribution profiles for drug products containing nanomaterials. CDER continues to actively track the incorporation of nanomaterials in drug products and the methodologies used to characterize them, in order to continuously improve the readiness of our science- and risk-based review approaches. In parallel to the risk management exercise, CDER has also been supporting regulatory research in the area of nanotechnology, specifically focused on characterization, safety, and equivalence (between reference and new product) considerations. This article provides a comprehensive summary of regulatory and research efforts supported by CDER in the area of drug products containing nanomaterials and other activities supporting the development of this emerging technology.

Annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed for 2016

EFSA Supporting PublicationsVolume 13, Issue 12 1145E Technical reportOpen Access Annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed for 2016 European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this authorReinhilde Schoonjans, Reinhilde SchoonjansSearch for more papers by this author European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this authorReinhilde Schoonjans, Reinhilde SchoonjansSearch for more papers by this author First published: 16 December 2016 https://doi.org/10.2903/sp.efsa.2016.EN-1145Citations: 1 Requestor: EFSA Question number: EFSA-Q-2016-00351 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL References Heringa M, Geraets L, van Eijkeren JCH, Vandebriel RJ, Jong WH and Oomen A, 2016. Risk assessment of titanium dioxide nanoparticles through oral exposure, including toxicokinetic considerations. Nanotoxicology, 10 (10), 1515– 1525, doi: 10.1080/17435390.2016.1238113 Rompelberg C, Heringa MB, van Donkersgoed, Drijvers J, Roos A, Westenbrink S, Peters R, van Bemmel G, Brand W and Oomen A 2016. Oral intake of added titanium dioxide and its nanofraction from food product, food supplements and toothpaste by the Dutch population. Nanotoxicology, 10 (10), 1404– 1414, doi: 10.1080/17435390.2016.1222457 Citing Literature Volume13, Issue12December 20161145E ReferencesRelatedInformation

Sustainable nanotechnology decision support system: bridging risk management, sustainable innovation and risk governance

The significant uncertainties associated with the (eco)toxicological risks of engineered nanomaterials pose challenges to the development of nano-enabled products toward greatest possible societal benefit. This paper argues for the use of risk governance approaches to manage nanotechnology risks and sustainability, and considers the links between these concepts. Further, seven risk assessment and management criteria relevant to risk governance are defined: (a) life cycle thinking, (b) triple bottom line, (c) inclusion of stakeholders, (d) risk management, (e) benefit–risk assessment, (f) consideration of uncertainty, and (g) adaptive response. These criteria are used to compare five well-developed nanotechnology frameworks: International Risk Governance Council framework, Comprehensive Environmental Assessment, Streaming Life Cycle Risk Assessment, Certifiable Nanospecific Risk Management and Monitoring System and LICARA NanoSCAN. A Sustainable Nanotechnology Decision Support System (SUNDS) is proposed to better address current nanotechnology risk assessment and management needs, and makes. Stakeholder needs were solicited for further SUNDS enhancement through a stakeholder workshop that included representatives from regulatory, industry and insurance sectors. Workshop participants expressed the need for the wider adoption of sustainability assessment methods and tools for designing greener nanomaterials. © 2016, Springer Science+Business Media Dordrecht.

Annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed for 2015

EFSA Supporting PublicationsVolume 13, Issue 1 939E Technical reportOpen Access Annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed for 2015 European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author First published: 11 January 2016 https://doi.org/10.2903/sp.efsa.2016.EN-939 Published date: 11 January 2016 Question number: EFSA-Q-2015-00596 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL References EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2014. Statement on the safety assessment of the substance silicon dioxide, silanated, FCM Substance No 87 for use in food contact materials. EFSA Journal 2014; 12(6):3712, 7 pp. doi:10.2903/j.efsa.2014.3712 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 Journal 2011; 9(5):2140 [ 36 pp.] doi:10.2903/j.efsa.2011.2140. Available online: http://www.efsa.europa.eu/ sites/default/files/scientific_output/files/main_documents/2140.pdf JRC, 2015: JRC science for policy report. Joint Research Centre. Towards a review of the EC Recommendation for a definition of the term "nanomaterial". doi:10.2788/678452. Available at: http://publications.jrc.ec.europa.eu/repository/bitstream/JRC95675/towards%20review%20ec%20 rec%20def%20nanomaterial%20-%20part%203_report_online%20id.pdf RIKILT and JRC, 2014. Inventory of Nanotechnology applications in the agricultural, feed and food Sector. EFSA Supporting Publication 2014: EN-621, 125. Available online: http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/621e.pdf Volume13, Issue1January 2016939E ReferencesRelatedInformation

EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed

EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed

Annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed for 2014

EFSA Supporting PublicationsVolume 12, Issue 2 762E Technical reportOpen Access Annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed for 2014 European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author First published: 19 February 2015 https://doi.org/10.2903/sp.efsa.2015.EN-762Citations: 1 Published date: 19 February 2015 Question number: EFSA-Q-2014-00737 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Citing Literature Volume12, Issue2February 2015762E RelatedInformation

State of the art on the initiatives and activities relevant to risk assessment and risk management of nanotechnologies in the food and agriculture sectors

The Food and Agriculture Organization of the United Nations (FAO) and World Health Organization (WHO) conducted an international expert meeting on the potential food safety implications of the application of nanotechnologies in the food and agriculture sectors in June 2009.The present report reviews national, regional and international activities on the risk assessment and risk management of nanomaterials in the food and agriculture sectors that have been carried out between 2009 and 2012. The full report of the work is presented in a FAO/WHO paper available at http://www.fao.org/food/food-safety-quality/a-z-index/nano. Information and data have been collected on national and international approaches that identify and implement strategies to address potential hazards associated with the use of nanotechnology-related products or techniques. Selected activities by international governmental and nongovernmental organizations were reviewed and the significant achievements are noted. Meta-analysis of scientific reviews addressing risk assessment of nanotechnologies in the food and agriculture sectors was conducted and key principles for the safety assessment of nanomaterials were identified.It was concluded that although the concepts of potential use of nanomaterials in food and the implied benefits for stakeholders including consumers have not changed significantly since 2009, there are new products being developed and claimed to enter the market and national and international interests in considering the needs for applying regulations on engineered nanomaterials are increasing. The number of published risk assessment of products used in foods that are nanomaterials or contain particles that fall within applicable definitions is growing slowly.Several data gaps with respect to interaction between nanomaterials and food matrices, behaviours of nanomaterials in the human body, methods to determine such interactions and behaviours, and the relevance of such data for risk assessment continue to exist. The international collaboration in the area of nanomaterials and nanotechnology in food and agriculture must be strengthened. International efforts on risk assessment and risk communication may benefit from the experience gained at the national and regional levels. Should a sufficient number of case studies of risk assessment of commercial products become available with time, a review of approaches applied and results obtained could support the development of risk assessment procedures acceptable at the international level.

Annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed for 2013

Annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed for 2013

CDER Risk Assessment Exercise to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products

The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration was established to assess the possible impact of nanotechnology on drug products. The group is in the process of performing risk assessment and management exercises. The task of the working group is to identify areas where CDER may need to optimize its review practices and to develop standards to ensure review consistency for drug applications that may involve the application of nanotechnology. The working group already performed risk management exercises evaluating the potential risks from administering nanomaterial active pharmaceutical ingredients (API) or nanomaterial excipients by various routes of administration. This publication outlines the risk assessment and management process used by the working group, using nanomaterial API by the oral route of administration as an example.

Annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed for 2012

EFSA Supporting PublicationsVolume 9, Issue 12 362E Technical reportOpen Access Annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed for 2012 European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author First published: 05 December 2012 https://doi.org/10.2903/sp.efsa.2012.EN-362 Published date: 5 December 2012 Question number: EFSA-Q-2012-00294 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Volume9, Issue12December 2012362E RelatedInformation

EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed

EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed

Nanotechnology risk assessment from a waste management perspective: Are the current tools adequate?

The burgeoning nanotechnology industry is rapidly generating new forms of waste streams generically referred herein as nanowastes. However, little is known about the fate and behavior of these waste streams and their impacts thereof in different ecological systems despite their increasingly widespread dispersion into the environment through production, distribution, handling, and nanomaterials (NMs) incorporation into bulk products processes. In this paper, risk assessment of nanotechnology from a waste management perspective was examined to elucidate potential new forms of challenges nanowastes may likely pose to the current legislative and waste management systems. This was through the identification of several knowledge gaps that merit urgent attention in order to increase our collective understanding of managing nanowastes safely, responsibly, and sustainably. The paper presents the identified gaps and consequently proposes a qualitative risk assessment of nanowastes to address some of the current challenges. The applicability of the proposed model is illustrated through several examples. In addition, the first nanowastes classification protocol presented in this article show that a given nanomaterial may result in generating nanowaste streams of different forms with variant hazard levels ranging from benign to extremely being hazardous waste streams - a dramatic phenomenon from the conventional waste streams due to macroscale chemicals. The study shows that it is in the early days to draw broad generic classification of different nanowastes, and each stream may require their risk profile be assessed on a case-by-case basis. We conclude by presenting several recommendations on what needs to be done in dealing with nanowastes as means of avoiding unintended long-term consequences of nanotechnology.

Review of health safety aspects of nanotechnologies in food production

Due to new, previously unknown, properties attributed to engineered nanoparticles many new products are introduced in the agro-food area. Nanotechnologies cover many aspects, such as disease treatment, food security, new materials for pathogen detection, packaging materials and delivery systems. As with most new and evolving technologies, potential benefits are emphasized, while little is known on safety of the application of nanotechnologies in the agro-food sector. This review gives an overview of scientific issues that need to be addressed with priority in order to improve the risk assessment for nanoparticles in food. The following research topics are considered to contribute pivotally to risk assessment of nanotechnologies and nanoparticles in food products. • Set a definition for NPs to facilitate regulatory discussions, prioritization of research and exchange of study results. • Develop analytical tools for the characterization of nanoparticles in complex biological matrices like food. • Establish relevant dose metrics for nanoparticles used for both interpretation of scientific studies as well as regulatory frameworks. • Search for deviant behavior (kinetics) and novel effects (toxicity) of nanoparticles and assess the validity of currently used test systems following oral exposure. • Estimate the consumer exposure to nanoparticles.

Nanotechnology, risk and the environment: a review

Nanotechnologies are already interacting with the environment. Scientists and engineers are manipulating matter at the nanoscale, and these nanoscale processes and products are being used by industry in commercially available products. These products are either applied directly to the environment or end up in the environment through indirect pathways. This review examines the state of current environmental risk assessment of nanotechnologies. Nanotechnology is described generally, then both the possible benefits of nanotechnology and the risks are reviewed in a traditional way. Subsequently, a philosophical criticism of the traditional way of looking at risks is offered.