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sexta-feira, 24 de janeiro de 2014

NANoREG – A common European approach to the regulatory testing of Manufactured Nanomaterials

The innovative and economic potential of Manufacture Nanomaterials (MNMs) is threatened by limited understanding of MNM safety aspects along the value chains. Substantial efforts have given insights in toxicity of and exposure to MNMs.

However, today's knowledge is not comprehensive enough for regulatory purposes, answering open questions is urgently required. The outstanding approach of NANoREG will provide the right answers to Society, Industry and the National Regulation and Legislation Authorities.

The innovative and economic potential of Manufactured Nano Materials (MNMs) is threatened by a limited understanding of the related EHS (Environmental Health and Safety) issues. While toxicity data is continuously becoming available, the relevance to regulators is often unclear or unproven. The shrinking time to market of new MNM drives the need for urgent action by regulators. NANoREG is the first FP7 project to deliver the answers needed by regulators and legislators on EHS by linking them to a scientific evaluation of data and test methods.
Based on questions and requirements supplied by regulators and legislators, NANoREG will:
(i) provide answers and solutions from existing data, complemented with new knowledge,
(ii) Provide a tool box of relevant instruments for risk assessment, characterisation, toxicity testing and exposure measurements of MNMs,
(iii) develop, for the long term, new testing strategies adapted to innovation requirements,
(iv) Establish a close collaboration among authorities, industry and science leading to efficient and practically applicable risk management approaches for MNMs and products containing MNMs.
The interdisciplinary approach involving the three main stakeholders (Regulation, Industry and Science) will significantly contribute to reducing the risks from MNMs in industrial and consumer products.
NANoREG starts by analysing existing knowledge (from WPMN-, FP- and other projects). This is combined with a synthesis of the needs of the authorities and new knowledge covering the indentified gaps, used to fill the validated NANoREG tool box and data base, conform with ECHA's IUCLID DB structure.
To answer regulatory questions and needs NANoREG will set up the liaisons with the regulation and legislation authorities in the NANoREG partner countries, establish and intensify the liaisons with selected industries and new enterprises, and develop liaisons to global standardisation and regulation institutions in countries like USA, Canada, Australia, Japan, and Russia.

1. Providing legislators with a set of tools for risk assessment and decision making instruments for the short to medium term, by gathering data and performing pilot risk assessment, including exposure monitoring and control, for a selected number of nanomaterials used in products;
2. Developing for the long term, new testing strategies adapted to a high number of nanomaterials where many factors can affect their environmental and health impact.
3. Establishing a close collaboration among authorities and industry with regard to the knowledge required for appropriate risk management, and create the basis for common approaches, mutually acceptable datasets and risk management practices.

Linking regulatory questions and needs to answers from science
NANoREG is the first project of any EU Framework Programme to combine the questions and needs of regulatory and legislation authorities with the science community, thereby delivering the knowledge required to provide unambiguous answers. The NANoREG approach is structured in seven steps:
A)   Working out the requirements and questions of the national regulation and legislation authorities, complemented with general knowledge about gaps, such as defined in the RIPoN 2/3 ports or by SG6 of OECD. 
B)    Development of an interdisciplinary solution strategy within WP 1 in order to structure R&D activities preparing the answers and solutions.
C)    Performing R&D and validation projects in order to elaborate a solid ground for recommendations, answering the questions and needs of decision makers of legislation authorities and industry. Independent test and case studies examining the answers and solutions.
D)    Synthesis of validated information to respond to the questions and requirements for the national regulation and legislation authorities.
E)    Synthesis and answers to solutions.
F)    Transferring the knowledge to the national authorities and experts in workshops, dissemination of the not protected findings to all stakeholders, nationally and internationally; monitoring the exploitation of the results by the national regulation and legislation authorities.
G)   Collecting all tested instruments, recommendations etc. in the "NANoREG INSTRUMENT TOOL BOX" for regulators and legislators.

Fonte: NANoREG