Regulatory challenges of nanomaterials in food and feed

Nanomaterials are increasingly being added to food handling and packaging materials, or directly, to human food and animal feed. To ensure the safety of such engineered nanomaterials (ENMs), in May 2011, the European Food Safety Authority (EFSA) published a guidance document on Risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. It states that risk assessment should be performed by following a step-wise procedure. Whenever human or animal exposure to nanomaterials is expected, the general hazard characterisation scheme requests information from in vitro genotoxicity, toxicokinetic and repeated dose 90-day oral toxicity studies in rodents. Numerous prevailing uncertainties with regard to nanomaterial characterisation and their hazard and risk assessment are addressed in the guidance document. This article discusses the impact of these knowledge gaps on meeting the goal of ensuring human safety. The EFSA's guidance on the risk assessment of ENMs in food and animal feed is taken as an example for discussion, from the point of view of animal welfare, on what level of uncertainty should be considered acceptable for human safety assessment of products with non-medical applications, and whether animal testing should be considered ethically acceptable for such products.

Assessment of in vitro human dermal absorption studies on pesticides to determine default values, opportunities for read-across and influence of dilution on absorption

Assessment of in vitro human dermal absorption studies on pesticides to determine default values, opportunities for read-across and influence of dilution on absorption

Bisphenol A (BPA) hazard assessment protocol

BackgroundThe use of nanomaterials in the food and feed chain is expected to keep increasing in the years to come. While this brings exciting prospects to both industry and consumers, it also entails important considerations regarding their risk assessment and potential detrimental effects following human exposure. Aiming to standardise the risk assessment of nanomaterials, the European Food Safety Authority (EFSA) has recently published a new guidance where in vitro tests are indicated to play a key role. Scope and approachHere, we summarise the latest EFSA guidance aiming to bring it to a wider readership. Recent examples from the literature are critically reviewed regarding their adherence to the recommended methods, thus providing a basis for read-across justifications in future studies. This paper also looks into emerging technologies that may accelerate the development and approval of novel nanomaterials in food while reducing the need of animal studies. Key findings and conclusionsFew publications cover the extensive list of in vitro studies and parameters recommended by the EFSA. Nevertheless, some address specific sections (e.g. physicochemical characterisation or cytotoxicity) in a very comprehensive manner and we expect this review to contribute towards a better understanding of the importance of following a methodical approach in the risk assessment of novel nanomaterials in food. Lastly, emerging organ-on-chip technologies may arise as impactful tools to run toxicokinetics studies at high-throughput and with significant in vitro-in vivo correlation.

In response: Challenges for future risk assessments--A governmental perspective.

Nanotechnology can contribute to the development of innovative applications in the agriculture, food and feed sector by e.g. enabling improved delivery of nutrients or increased efficacy of agrichemicals. It is expected that applications will increase in the near future and may therefore become a relevant source of human exposure to nanomaterials (NM). To gain more up-to date information, RIKILT and the Joint Research Centre (JRC) were commissioned by the European Food Safety Authority (EFSA) to prepare an inventory of currently used and reasonably foreseen applications of NM in agriculture and food/feed production and carried out a review of regulatory aspects concerning NM in both EU and non-EU countries. An analysis of the information records in the inventory shows that nano-encapsulates, silver and titanium dioxide are the most frequent type of NM listed and that food additives and food contact materials are the most frequent types of application. A comparison between marketed applications and those in development indicates a trend from inorganic materials (e.g. silver) towards organic materials (nano-encapsulates, nanocomposites). Applications in novel food, feed additives, biocides and pesticides are currently mostly at a developmental stage. The review of EU and non-EU legislation shows that currently a few EU legal acts incorporate a definition of a nanomaterial and specific provisions for NM, whereas in many non-EU countries a broader approach is applied, which mainly builds on guidance for industry.

Harmonised collection of national food consumption data in Europe

The registration of pesticides follows guidance published by the European Food Safety Authority (EFSA). As a default, the EFSA guidance document on risk assessment for birds and mammals assumes that animals feed exclusively on pesticide-treated fields. However, the guidance document suggests refining the risk via the proportion of food animals obtain from a treated field or specific crop (expressed via the portion of diet obtained from a treated area [PT value]). The EFSA guidance equalizes the portion of food taken from a treated area per day with the portion of time spent potentially foraging over the course of a day within this area. Therefore, radiotracking is commonly used to gather species-, crop-, and season-specific PT data, and radio telemetry of continuously tracked farmland species can deliver individual PT values for a given day, crop, and species. In the present study the authors introduce a way of calculating long-term PT values based on empirically recorded data via telemetry field studies for the most appropriate use in wildlife risk assessment of pesticides. The novel aspect of the proposal is that the authors follow the prerequisite given by EFSA to cover the long-term risk by introducing 21-d PT values that aim to cover both intra- and inter-individual variability of foraging focal farmland species in cropped habitats. Currently, the intra-individual variability is not taken into account for PT calculations. The authors demonstrate this approach and discuss EFSA guidance input requirements for PT values recorded in field studies, based on a PT field study conducted with woodpigeons (Columba palumbus) radiotracked in an agricultural landscape in the United Kingdom. The results indicate that a 21-d PT value considering intra-individual variability gives a more appropriate PT value for long-term risk assessments. Environ Toxicol Chem 2017;36:1270-1277. © 2016 SETAC.

Politicized and prescriptive regulation of genetically modified (GM) crops has unintended adverse effects, including misdirected resources and reduced benefits. In the case of animal testing, this suboptimal use of resources includes the needless sacrifice of animals. Whole-food animal feeding studies are generally of negligible value in the risk assessment of GM crops, a position that was affirmed by the European Food Safety Authority (EFSA). Contrary to EFSA’s 2011 position, in 2013, the European Commission directed that 90-day rat studies be conducted for new GM events. As no EFSA guidance was available for hypothesis-free 90-day rat feeding studies, EFSA interpreted this as a mandate to develop a prescriptive study design. Recently, EFSA has retroactively required 90-day rat studies be completed under new study guidelines for previously approved component single events as part of the approval of breeding stacks. Having been unable to secure a derogation (exemption) from EFSA, a new compulsory 90-day rat study was conducted with TC1507 maize to support a breeding-stack submission. As previously shown, TC1507 maize does not adversely affect rats. This politically driven additional animal testing is risk disproportionate, at odds with European and international standards for animal welfare, and provides no scientific value to the safety assessment for GM breeding stacks.

EFSA JournalVolume 7, Issue 6 1138 OpinionOpen Access Application (EFSA-GMO-RX-1507) for renewal of authorisation for the continued marketing of existing products produced from maize 1507 for feed use, under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International, Inc./Mycogen Seeds 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 June 2009 https://doi.org/10.2903/j.efsa.2009.1138Citations: 7 Panel members: Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick Du Jardin, Niels Bohse Hendriksen, Lieve Herman, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Ilona Kryspin-Sørensen, Harry A. Kuiper, Ingolf Nes, Nickolas Panopoulos, Joe Perry, Annette Pöting, Joachim Schiemann, Willem Seinen, Jeremy B. Sweet and Jean-Michel Wal Acknowledgement: The European Food Safety Authority wishes to thank the members of the Working Groups on Molecular Characterisation, Food-Feed and Environment, as well as the following members of its staff: Antonio Fernandez Dumont, Zoltan Diveki and Karine Lheureux for the preparation of this opinion. Adoption date: 28 May 2009 Published date: 11 June 2009 Question number: EFSA-Q-2007-144 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 References EFSA (2004a) Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the notification (Reference C/NL/00/10) for the placing on the market of insect-tolerant genetically modified maize 1507, for import and processing. The EFSA Journal, 124, 1– 18. www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/opinion_gmo_05_en*l.pdf. EFSA (2004b). Opinion of the Scientific Panel on Genetically Modified Organisms on the use of antibiotic resistance genes in genetically modified plants. The EFSA Journal 48: 1–18, www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/opinion_gmo_05_en*l.pdf. EFSA (2005a) Opinion of the Scientific Panel on Genetically Modified Organisms on an application (reference EFSA-GMO-NL-2004-02) for the placing on the market of insect-tolerant genetically modified maize 1507, for food use. The EFSA Journal, 182, 1– 22. EFSA (2005b) Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the notification (Reference C/ES/01/01) for the placing on the market of insect-tolerant genetically modified maize 1507 for import, feed and industrial processing and cultivation. The EFSA Journal, 181, 1– 33. EFSA (2006a) Guidance document for the renewal of authorisations of existing GMO products lawfully placed on the market, notified according to Articles 8 and 20 of Regulation (EC) No 1829/2003. The EFSA Journal, 435, 1– 14. EFSA (2007). Statement of the Scientific Panel on Genetically Modified Organisms on the safe use of the nptII antibiotic resistance marker gene in genetically modified plants adopted on 22–23 March 2007, www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620775641.htm. Einspanier, R., Lutz, B., Rief, S., Berezina, O., Zverlov, V., Schwarz, W., Mayer, J., 2004. Tracing residual recombinant feed molecules during digestion and rumen bacterial diversity in cattle fed transgenic maize. European Food Research and Technology, 218: 269– 273. Guertler, P., Lutz, B., Kuehn, R., Meyer, H.H.D., Einspanier, R., Killermann, B., Albrecht, C., 2008. Fate of recombinant DNA and Cry*1Ab protein after ingestion and dispersal of genetically modified maize in comparison to rapeseed by fallow deer (Dama dama). European Journal of Wildlife Research, 54: 36– 43. Icoz, I., Stotzky, G. 2008. Fate and effects of insect-resistant Bt crops in soil ecosystems. Soil Biology and Biochemistry, 40: 559– 586. Keese, P., 2008. Risks from GMOs due to horizontal gene transfer. Environmental Biosafety Research, 7: 123– 149. Ladies, G.S., Bardina, L., Cressman, R.F., Mattsson, J.L., Sampson, H.A., 2006. Lack of cross-reactivity between the Bacillus thuringiensis derived protein Cry IF in maize grain and dust mite Der p7 protein with human sera positive for Der p7-IgE. Regulatory Toxicology and Pharmacology 44 (2), 136– 143. Lutz, B., Wiedermann, S., Einspanier, R., Mayer, J., Albrecht, C, 2005. Degradation of Cry*1Ab Protein from genetically modified maize in the bovine gastrointestinal tract. Journal of Agricultural and Food Chemistry, 53: 1453– 1456. Lutz, B., Wiedemann, S., and Albrecht, C, 2006. Degradation of transgenic Cry*1Ab DNA and protein in Bt-176 maize during the ensiling process. J Anim Physiol Anim Nutr, 90, 116– 123. Wiedemann, S., Lutz, B., Kurtz, H., Schwarz F.J., Albrecht, C., 2006. In situ studies on the time-dependent degradation of recombinant corn DNA and protein in the bovine rumen. Journal of Animal Science, 84: 135– 144. Citing Literature Volume7, Issue6June 20091138 ReferencesRelatedInformation

Greek Motorway Concession Contracts in Progress under Financial Stress: A Rebalancing Proposal

After a brief introduction of Articles 290 and 291 TFEU, the Chapter goes on to an analysis of the European Union's legal framework with reference to (i) the delegation of powers to the Commission contained in other legislative texts (ii) the specific perimeter and limits provided by the ECSPR, as well as to (iii) the revocation power (so-called veto power) granted by Article 44 ECSPR to the Parliament and the Council. The author also mentions and explains the direct reference that Article 44 makes to the Interinstitutional Agreement of Better Law-Making. The latter's goal is to improve the way European legislators operate and help European Institutions and bodies to collaborate and cooperate with each other to make the functioning of the EU clearer and smoother: such benefits could also be achieved in relation to the regulation of crowdfunding activities.

Purpose: The rapid advancement of digital technologies has necessitated robust security measures to protect information systems against escalating cyber threats. The objective is to study the effectiveness of the command line interface (CLI) in IT system security management. Design/methodology/approach: This paper explores the efficacy of the command line interface (CLI) in managing IT system security and examines the potential of integrating biometric data into cryptographic mechanisms. We delve into the CLI's precision and flexibility, which enable the execution of complex security tasks and its seamless integration with advanced security tools. Furthermore, we investigate the incorporation of biometrics, such as fingerprints and facial recognition, into encryption processes, offering enhanced security by binding access to individual biometric identifiers. Findings: Our findings suggest that while CLI remains a vital tool for security specialists, the convergence of CLI with biometric authentication can significantly fortify the security of information systems. Practical implications: The paper addresses the challenges and opportunities presented by this integration, including privacy concerns and the need for secure handling of biometric data. We also discuss the implications of such technologies in the context of the European Union's legal framework on cybersecurity. Originality/value: The article is aimed at those involved in cyber security management. The article presents the possibility of using biometric attestations to support the security of IT systems. Keywords: cybersecurity, European Union cybersecurity legislation, cryptographic mechanisms, data encryption, multi-factor authentication. Category of the paper: research paper.

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