Scientific motivations and criteria to consider updating EFSA scientific assessments

Hardy, Anthony; Benford, Diane; Halldórsson, Thorhallur I.; Jeger, Michael; Knutsen, Katrine Helle; More, Simon J.; Mortensen, Alicja; Naegeli, Hanspeter; Noteborn, Hubert; Ockleford, Colin; Ricci, Antonia; Rychen, Guido; Schlatter, Josep R.; Silano, Vittorio; Solecki, Roland; Turck, Dominique; Brock, T.C.M.; Chesson, Andrew; Kärenlampi, Sirpa; Lambré, Claude; Sanz, Yolande; Goumperis, Tilemachos; Kleiner, Juliane; Maurici, Daniela

doi:10.2903/j.efsa.2017.4737

Cited by 7 publications

(6 citation statements)

References 10 publications

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“…As mentioned in the conclusions of the 2011 SC Guidance, it will require updating to stay aligned with innovations and fast developments in this area. This is in line with EFSA's strategy of revision of cross-cutting guidance documents (EFSA Scientific Committee, 2015), as well as with the scientific motivation and criteria to consider in updating EFSA scientific assessments document (EFSA Scientific Committee, 2017a).…”

Section: Background As Provided By Efsasupporting

confidence: 75%

Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain: Part 1, human and animal health

Hardy¹,

Benford²,

Halldórsson³

et al. 2018

EFS2

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170

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The European Food Safety Authority has produced this Guidance on human and animal health aspects (Part 1) of the risk assessment of nanoscience and nanotechnology applications in the food and feed chain. It covers the application areas within EFSA's remit, e.g. novel foods, food contact materials, food/feed additives and pesticides. The Guidance takes account of the new developments that have taken place since publication of the previous Guidance in 2011. Potential future developments are suggested in the scientific literature for nanoencapsulated delivery systems and nanocomposites in applications such as novel foods, food/feed additives, biocides, pesticides and food contact materials. Therefore, the Guidance has taken account of relevant new scientific studies that provide more insights to physicochemical properties, exposure assessment and hazard characterisation of nanomaterials. It specifically elaborates on physicochemical characterisation of nanomaterials in terms of how to establish whether a material is a nanomaterial, the key parameters that should be measured, the methods and techniques that can be used for characterisation of nanomaterials and their determination in complex matrices. It also details the aspects relating to exposure assessment and hazard identification and characterisation. In particular, nanospecific considerations relating to in vivo/in vitro toxicological studies are discussed and a tiered framework for toxicological testing is outlined. It describes in vitro degradation, toxicokinetics, genotoxicity as well as general issues relating to testing of nanomaterials. Depending on the initial tier results, studies may be needed to investigate reproductive and developmental toxicity, immunotoxicity, allergenicity, neurotoxicity, effects on gut microbiome and endocrine activity. The possible use of read-across to fill data gaps as well as the potential use of integrated testing strategies and the knowledge of modes/mechanisms of action are also discussed. The Guidance proposes approaches to risk characterisation and uncertainty analysis, and provides recommendations for further research in this area.

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Section: Background As Provided By Efsasupporting

confidence: 75%

Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain: Part 1, human and animal health

Hardy¹,

Benford²,

Halldórsson³

et al. 2018

EFS2

Self Cite

170

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“…This is in line with the EFSA Scientific Committee recommendation to implement its cross-cutting guidance documents through communication, presentation and monitoring in order to increase the awareness, uptake and consistent use by EFSA's Panels and Units as relevant (EFSA, 2013(EFSA, , 2015(EFSA, , 2017). This is in line with the EFSA Scientific Committee recommendation to implement its cross-cutting guidance documents through communication, presentation and monitoring in order to increase the awareness, uptake and consistent use by EFSA's Panels and Units as relevant (EFSA, 2013(EFSA, , 2015(EFSA, , 2017).…”

Section: Post-adoption Monitoring Of the Implementation Of Guidance Dsupporting

confidence: 70%

“…Regular feedback on the impact of applying the guidance needs to be collected and "lessons learnt" during the implementation are gathered in this process. This is in line with the EFSA Scientific Committee recommendation to implement its cross-cutting guidance documents through communication, presentation and monitoring in order to increase the awareness, uptake and consistent use by EFSA's Panels and Units as relevant (EFSA, 2013(EFSA, , 2015(EFSA, , 2017).…”

Section: Post-adoption Monitoring Of the Implementation Of Guidance Dsupporting

confidence: 66%

EFSA cross‐cutting guidance lifecycle

Maurici¹,

Matas²,

Gervelmeyer³

2018

EFS3

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This document describes the lifecycle of cross-cutting guidance documents in EFSA. Cross-cutting guidance documents deal with matters of a horizontal nature in fields that affect scientific areas covered by more than one Panel. The main objective of developing cross-cutting guidance documents is to harmonise food and feed safety risk assessment in EFSA. The document outlines the procedures for the identification of needs for cross-cutting guidance documents, their development, implementation, their review and revision.

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“…A proper evaluation of the safety of titanium dioxide as a food additive would require considering all data available and not only selected data. The EFSA SC also provided Guidance on when the database should be re‐evaluated in light of new evidence (EFSA Scientific Committee, ).…”

Section: Discussionmentioning

confidence: 99%

“…In order to address this mandate, the approach described in the ‘Scientific opinion on scientific motivations and criteria to consider updating EFSA scientific assessments’ adopted by the EFSA Scientific Committee in 2017 (EFSA Scientific Committee, ) was followed.…”

Section: Data and Methodologiesmentioning

confidence: 99%

Evaluation of four new studies on the potential toxicity of titanium dioxide used as a food additive (E 171)

Younes¹,

Aggett²,

Aguilar³

et al. 2018

EFS2

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The European Commission requested EFSA to carry out a scientific evaluation on four studies on the potential toxicity of titanium dioxide (TiO 2 ) used as a food additive (E 171) and to indicate whether they would merit re-opening the existing opinion of EFSA on the safety of TiO 2 (E 171) as a food additive. The results of the Bettini et al. (2017) study did not provide enough justification for a new carcinogenicity study, but, should additional useful mechanistic information become available, this could be reconsidered in future. The new in vitro findings in the Proquin et al. (2017) study did not modify the conclusion on the genotoxicity of TiO 2 as stated in the previous EFSA opinion of 2016 on the safety of TiO 2 (E 171) as a food additive. The effects of engineered TiO 2 nanoparticles reported by the Guo et al. (2017) study were of uncertain biological significance and therefore of limited relevance for the risk assessment of the food additive TiO 2 (E 171). There was significant uncertainty in the risk assessment performed by Heringa et al. (2016), which did not include a weight of evidence analysis of the whole database. The Panel considered that the four studies evaluated, highlighted some concerns but with uncertainties, therefore their relevance for the risk assessment was considered limited and further research would be needed to decrease the level of uncertainties. Overall, three of the studies, reporting that TiO 2 induced various effects in in vitro and in vivo models, may be useful for hazard identification of TiO 2 . In the fourth study by Heringa et al. (2016), numerous assumptions were made, which resulted in large uncertainty in their conclusion. Altogether, the Panel concluded that the outcome of the four studies did not merit re-opening the existing opinion of EFSA related to the safety of TiO 2 (E 171) as a food additive.

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Scientific motivations and criteria to consider updating EFSA scientific assessments

Cited by 7 publications

References 10 publications

Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain: Part 1, human and animal health

Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain: Part 1, human and animal health

EFSA cross‐cutting guidance lifecycle

Evaluation of four new studies on the potential toxicity of titanium dioxide used as a food additive (E 171)

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