Title: Safety evaluation of manufactured nanomaterials by characterisation of their potential genotoxic hazard.

Priority area: Improve citizen’s health security

Context of the Joint Action:
A call for a Joint Action on "the Safety of Nanomaterials" under Section 3.2 "Improve citizens' health security" of the Community Public Health Program work program was published on Thursday, 26 February 2009, following an initial proposal by France ( DGS). This Joint action was approved in July 2009 for 6.2 millions of Euros of which 2.9 M€ (46%) were funded by European Commission’s health programme, while partners and some ministries of the participating Member States (Belgium, France, Germany, and Netherlands) provide the remaining.
The Action was launched on 18-19 March at the AFSSET (Paris, France) the project aims to obtain a sound and reliable method for detecting the potential genotoxicity of manufactured nanomaterials within 3 years.

Executive summary

Nanotechnology is a highly strategic industrial and economic sector revealing enormous potential benefits for many societal and environmental domains. Human exposure to manufactured nanomaterials used in consumer products may occur during several phases of their life cycle: from synthesis, production and inclusion in the final products to the release of manufactured nanomaterials to the environment (through industrial emissions or product disposal).
Nanotoxicology, that study of the potential adverse effects of chemicals (in our case nanomaterials) on living organisms, is thus attracting the attention of the public and of governments worldwide.

The lack of scientific knowledge and absence of evidence of the health and safety potential hazards of nanotechnology products, however, make regulation very difficult (source January 2009 SCENIHR opinion, http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_023.pdf picto-target)

The general objective of the Joint Action is a high added-value complement to the Member States’ policies and contributes to improve citizens’ health security and also participates in the EU’s leadership position in this field as well as in ongoing international work ( OECD, ISO…). The aim of the Joint Action is highly relevant in the current context. It targets crucial items identified in the programme providing a genuine European dimension as 16 institutions from 11 Member States, including new Member States, are involved.

The methods and means implemented include 4 scientific Work Packages (WPs) with the aim of:

puce-fleche Strengthening, expanding and sharing the knowledge required for hazard, exposure and overall risk assessment of manufactured nanomaterials (MNs), in particular by building a strategy able to generate relevant and reliable data for EU public health authorities (scopes 1,2,3).
puce-fleche Accelerating the exploitation of existing data, FP6 (Sixth Frame Work Programme) and FP7 (Seventh Frame Work Programme) projects such as. NANOINTERACT (http://www.nanointeract.net picto-target), NANOSTRAND, NANOSH, NANOSAFE http://www.nanosafe.org/scripts/home/publigen/content/templates/show.asp?P=100&L=EN&ITEMID=50 picto-target), and the exchange of best practices in risk assessment and management, thus minimising the potentially harmful long-term effects of MNs. The Joint Action may offer society alert signals for genotoxic substances leading to potential cancers or reproductive diseases. It constitutes a first step towards creating a future programme by public health authorities based on long-term animal studies or epidemiological population surveillance (scopes 1,2,3).
puce-fleche Promoting the establishment of a robust methodology to screen potentially genotoxic MNs. To achieve this, fully characterised MNs widely used in consumer products are tested with standard in vitro assays completed with specific tests. Using these results, a ring test (among participating MS laboratories) for the relevant assays is performed. This methodology may be used by regulatory control bodies and industrials to check for possible genotoxicity as alternative techniques to animal experimentation. In vivo assays are conducted to characterise the toxicokinetics of selected MNs and validate the in vitro data. Standard Operating Procedures ( SOPs) will be used and if lacking, will be established as a priority. If needed, the audit of laboratories (cross evaluation) and/or staff training is planned to ensure that the laboratories involved conduct their studies following the SOPs contributing then to highlight national reference laboratories in this field (scope 2).

Major expected outcomes of this Joint Action are:

puce-fleche Increasing health information and knowledge about the human and environmental safety of MNs by generating relevant and reliable data sets by:

puce Distinguishing specific hazards regarding the physical and chemical parameters of MNs.

puce Establishing a correlation between in vivo and in vitro geno-toxicological data and completing information on manufactured nanomaterial bioaccumulation by identifying target organs.

puce Promoting a robust reliable methodology for testing potential genotoxicity of MNs by exchanging best practices through a round robin test. The MNs to be tested are widely available in many kinds of products, namely TiO2 and SiO2 MNs, but also carbon nanotubes ( CNT) which, according to the literature, might present toxicological effects in experimental animals similar to asbesto 

puce-fleche The JA will provide quick, reliable and economical tests to assess potential genotoxicity of MNs with alert signals useful for society and industries. Distinguishing specific hazards regarding the physical and chemical parameters of MNs.

Last Updated on Tuesday, 15 March 2011 10:58