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Posted: Feb 27, 2015
European Food Safety Authority publishes risk assessment of nanotechnologies in food and feed
(Nanowerk News) In accordance with European Food Safety Authority (EFSA)’s strategy for cooperation and networking with Member States, a Network for Risk Assessment of Nanotechnologies in Food and Feed was established in 2010. The overall goals of this Network are to facilitate harmonisation of assessment practices and methodologies; to enhance exchange of information and data between EFSA and MS; and to achieve synergies in risk assessment activities. The Annual reports of the Network inform the public and the EFSA Advisory Forum about its specific activities and achievements.
During 2014, the Network followed-up on its priority areas and contributed to the making of inventory lists of applications of Nanomaterials already present in the food/feed chain ("Annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed for 2014"; pdf). During its meeting in 2014, the Network dedicated most of its discussions on relevant research results for possible toxic effects following the oral route of exposure. The Network exchanged views on the technical aspects and implications of the definition for Nanomaterial. The network also shared its views on the ongoing and upcoming risk assessments of EFSA on applications comprising implicitly or explicitly nanoforms. The Network updated its list with national research and contact details of national laboratories that can analyse nanomaterials in complex matrices.
Developing networking and stronger co-operation with the Member States and strengthening EFSA’s relationship with its institutional partners (EU and international) and stakeholders are among the key recommendations formulated by EFSA’s Management Board. In accordance with EFSA’s strategy for co-operation and networking with Member States, the Scientific Network for Risk Assessment of Nanotechnologies in Food and Feed (hereafter referred to as ‘Nano Network’) was launched. The Nano Network had its inaugural meeting in February 2011 and following this, one meeting per year is scheduled.
The overall goals of the Nano Network are to provide a forum for dialogue among participants; build mutual understanding of risk assessment principles; enhance knowledge on and confidence in the scientific assessments carried out in EU; and to provide increased transparency in the current process among Member States and EFSA on nanotechnology. All this with the aim to raise the level of harmonisation of the risk assessments developed in the EU on nanotechnology.
The Network is composed of representatives from 21 Member States and Norway.In addition, observers to this Network represent the Former Yugoslav Republic of Macedonia, Turkey and Montenegro. There is also representation from the European Commission (DGSANTE and JRC), from the EFSA Scientific Committee and the relevant Units/Panels.
During 2014, the Network followed-up on its priority areas and contributed to the making of inventory lists of applications of Nanomaterials already present in the food/feed chain.
At its 2014 meeting the Network focussed again on updates of research results from toxicological studies relevant for the oral route of exposure. Member States representatives presented relevant studies. The type of nanomaterials that are now occurring in the food/feed chain are mainly Titaniumdioxide (TiO2) and Synthetic Amorphous Silica (SAS). The evidence bases for oral toxicity and for conducting comprehensive risk assessments of these two materials is building up, but more research remains needed. Challenges to draw firm risk assessment conclusions reside in (1) the intake estimation (2) the possible worst-case absorption and the dose-dependence of absorption (3) the potential irrelevance of high dose oral toxicity studies for risk assessment (4) the extrapolation of kinetic data from rat to man (5) the nanoparticle determination in tissues, and (6) the many differences between the types of nanoforms of one nanomaterial (e.g. in kinetics and toxicity). Some differences in behaviour of different nanoforms have been observed, but there is no clear overview. A new issue of concern is that absorption is not linear with dose: high dose studies are often used for tox testing for estimation of safe dose, while the high dose may result in aggregation, agglomeration, gelation and as a consequence dose-dependent absorption.
Challenges also remain to exist regarding the technical aspects for considering a material as a nanomaterial (NM) for the regulatory purpose of food labelling. The NanoDefine project (FP7) is expected to deliver by 2017 an implementable test-scheme for regulatory purposes to distinguish nano from non-nano.
The Network agreed that regardless the current challenges and regardless the % of nanoforms in the bulk material (particle size% or mass%), EFSA should assess the nano-fraction, no matter how small. Food law, as being implemented by the EFSA Panels is covering nanomaterials. Nanomaterials are addressed mainly by cross-referring to the Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain (EFSA Scientific Committee, 2011; pdf).
The Network also updated its list with contact details of national laboratories that have equipment and know-how for analysing certain nanomaterials in complex matrices.