Nanomaterials – Definition, General Regulatory aspects and action Plan

Communication From Commission of 3 October 2012 - Second Regulatory Review on Nanomaterials /* COM/2012/0572 final */

Commission Recommendation of 18 October 2011 on the definition of nanomaterial (2011/696/EU)

European Parliament Resolution of 24 April 2009 on regulatory aspects of nanomaterials (2008/2208(INI))

Communication From The Commission, of 29 October 2009 - Nanosciences and Nanotechnologies: an Action Plan for Europe 2005-2009. Second Implementation Report 2007-2009 /* COM/2009/0607 final */

Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee - Regulatory aspects of nanomaterials [SEC(2008) 2036] /* COM/2008/0366 final */

Communication from the Commission, of September 2007 - Nanosciences and Nanotechnologies: an action plan for Europe 2005-2009. First Implementation Report 2005-2007 /* COM/2007/0505 final */

Communication from the Commission of June 2005 - Nanosciences and nanotechnologies- an action plan for Europe 2005-2009 /* COM/2005/0243 final */

Communication from the Commission of May 2004 - Towards a European strategy for nanotechnology /* COM/2004/0338 final */ 

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Chemical substances

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

Specific Advice on Fulfilling Information Requirements for Nanomaterials under REACH (RIP-oN 2) – Final Project Report 

Specific Advice on Exposure Assessment and Hazard/Risk Characterisation for Nanomaterials under REACH (RIP-oN 3) – Final Project Report

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Substances and mixtures

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 december 2008 on classification, labelling and packaging of substances and mixtures (CLP)

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Cosmetics

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products

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Medical Devices

Proposal for a Regulation Of The European Parliament And Of The Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 /* COM/2012/0542 final - 2012/0266 (COD) */

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Biocidal and plant protection products

Regulation (EU) No 528/2012 of the European Parliament and of the Council Of 22 May 2012 concerning the making available on the market and use of biocidal products.

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market.

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Food

Commission Delegated Regulation (EU) No 1363/2013 of 12 December 2013 amending Regulation (EU) N.o 1169/2011 on the provision of food information to consumers as regards the definition of ‘engineered nanomaterials

Commission Regulation (EU) No 1183/2012 of 30 November 2012 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food 

Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers

Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food

Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food

EFSA Scientific Committee;  Scientific Opinion on Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. EFSA Journal 2011;9(5):2140 [36 pp.]

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PToNANO

Scientific papers in peer-reviewed  journals/books 


Louro, H.; Tavares, A.; Vital, N.; Costa, P.M.; Alverca, E.; Zwart,E.; de Jong, W.H.; Fessard, V.; Lavinha, J. ; Silva, M.J. Integrated approach to the in vivo genotoxic effects of a titanium dioxide nanomaterial using LacZ plasmid-based transgenic mice. Environmental and Molecular Mutagenesis. 2014. 55 (6), 500–509.
Tavares, A., Louro, H., Antunes, S., Quarré, S., Simar, S., Temmerman, P.D., Verleysen, E., Mast, J., Jensen, K.A., Norppa, H., Nesslany, F., Silva, M.J. Genotoxicity evaluation of nanosized titanium dioxide, synthetic amorphous silica and multi-walled carbon nanotubes in human lymphocytes. Toxicology in Vitro. 28 (2014) 60–69. 
Louro, H., Borges, T., Silva, M.J. Nanomateriais manufaturados – Novos desafios para a saúde pública. Revista Portuguesa de Saúde Pública. 2013. 31(2):145–157. 
Louro, H., Bettencourt, A., Gonçalves,  L.M., Almeida, A.J., Silva, M.J. Role of nanogenotoxicology studies in safety evaluation of nanomaterials. In: Nanotechnology applications in tissue engineering. Eds: Sabu Thomas,Yves Grohens, Neethu Ninan. Elsevier2014 , in press.
Louro, H.; Pinto, M.; Vital, N.; Tavares, A.M.; Costa, P.M.; Silva, M.J. The LacZ plasmid-based transgenic mouse model: an integrative approach to study the genotoxicity of nanomaterials. In Genotoxicity and DNA repair. A pratical approach. Eds. L. Maria Sierra and Isabel Gaivão. Humana Press, Springer, NY. 2014  In press. 
 

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Other publications   


Louro, H. Nanomateriais Manufaturados: Avaliação de segurança através da caracterização dos seus efeitos genéticos, Escola nacional de Saúde Pública da Universidade Nova de Lisboa, PhD thesis in Public Health. 
Louro, H.; Tavares, A., Leite, E., Silva, M.J. Nanotecnologias e Saúde Pública. Tecnohospital. 59 (Set /Out 2013) 12-15.
Louro, H.; Tavares, A.; Antunes, S., Vital, N., Lavinha, J., Silva, M.J. Caracterização da genotoxicidade de nanomateriais manufaturados e potencial impacto na saúde humana. Observações- Boletim epidemiológico. 2(4) Abril-Junho 2013.23-24. ISSN: 2182-8873 (online), Ed. Instituto Nacional de Saúde Doutor Ricardo Jorge, IP (Available at www.insa.pt)
Louro, H.; Tavares, A.; Antunes, S., Vital, N., Lavinha, J., Silva, M.J. Caracterização da genotoxicidade de nanomateriais manufaturados e potencial impacto na saúde humana. Observações- Boletim epidemiológico. 2(4) Abril-Junho 2013.23-24. ISSN: 2182-8873 (online), Ed. Instituto Nacional de Saúde Doutor Ricardo Jorge, IP. (Available at www.insa.pt)
Norppa, H., Siivola, K., Fessard, V., et al., Tavares, A., Louro, H., Silva, M.J. Deliverable 5: In vitro testing strategy for nanomaterials including database.  Final report. March 2013. (Available at http://www.nanogenotox.eu/.)

Langlais, C. et al., Louro, H.; Vital, N.; Silva, M. J., Wallin, H.; Jackson, P. Kyjowska, Z., Petersen, L.; Pedersen, L., de Jong, W. Deliverable 6: Characterisation of manufactured nanomaterials for their clastogenic/aneugenic effects or DNA damage potentials and correlation analysis. Final report. March 2013. (Available at http://www.nanogenotox.eu/.)

Antunes, S., Lavinha, J., Louro, H., Tavares, A., Silva, M.J., Vital N. et al. Facilitating the safety evaluation of manufactured nanomaterials by characterising their potential genotoxic hazard. Final Publishable report. March 2013. (Available at http://www.nanogenotox.eu/)

 

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