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sábado, 31 de dezembro de 2011

NANOTECNOLOGIE/ Una sfida vincente? La parola ai nipoti


Intervista a Leo Miglio

Le nanotecnologie sono considerate una delle cinque tecnologie chiave per lo sviluppo e l’innovazione europea dei prossimi dieci anni, come indicato dall’Agenda Europa 2020, e avranno un ruolo determinante nelle grandi sfide tecnologiche economiche e sociali del prossimo futuro: invecchiamento della popolazione, cambiamenti climatici, ottimizzazione dell’uso delle risorse (energia, acqua, cibo), tecnologie digitali e comunicazione globale, sviluppo di sistemi produttivi efficienti e sostenibili. 

È lo sfondo sul quale si sta svolgendo Mestre (Venezia) il congresso NanotechItaly, che è incentrato su questi temi: Nuovi materiali, Processi e Produzione, Salute e scienze della vita – Nanomedicina, Trasporto intelligente, Safe living, ICT & Nanoelettronica, Sviluppo Responsabile – nanotossicologia. A tal riguardo abbiamo intervistato il professor Leo Miglio, docente di Fisica dello Stato Solido e Nanotecnologie presso l’Università degli Studi di Milano Bicocca. 

Il congresso NanotechItaly si propone come sfida quella di usare le nanotecnologie per un’innovazione responsabile e sostenibile: di che cosa si tratta? 
Il concetto di “sostenibilità” è da riferirsi principalmente alle sorgenti di energia: un’innovazione è sostenibile se non consuma più energia di quanta ne produce e se non richiede un uso massiccio di sostanze rare. Si prendano ad esempio le celle solari: se l’energia che spendiamo per produrre nuove celle fosse maggiore di quella che loro stesse producono durante il loro ciclo di vita, questa non sarebbe un’innovazione sostenibile. D’altra parte, se ci fossero celle interamente realizzate in gallio, che è un elemento molto raro, in poco tempo finirebbe il gallio e con esso la nuova tecnologia; anche il petrolio non è una tecnologia rinnovabile! 
La responsabilità, invece, è una questione più filosofica: tutto si gioca nell’equilibrio tra il guadagno e il rischio dell’innovazione. Questo dipende in gran parte dal genere di prodotto di cui si parla: se un tessuto nanotecnologico, trattato ad esempio per essere reso anti-macchia, risulta essere inquinante occorre paragonare l’inquinamento dovuto al trattamento anti-macchia con il detersivo risparmiato. Se però si tratta di migliorare mediante le nanotecnologie la risoluzione di una lastra a raggi X, allora ci si permette di rischiare di più, nell’intento di fornire al paziente una diagnosi corretta salvaguardando la sua salute. 
In sintesi direi che un’innovazione si può definire responsabile e sostenibile se a distanza di due generazioni i nostri figli e i nostri nipoti ci ringrazieranno per averla adottata. 

Le nanotecnologie sono un soggetto adeguato a una simile sfida? 
Possono esserlo. Rispetto però a tecnologie più consolidate, da un lato presentano più opportunità, dall’altro è più difficile individuarne i rischi. Ad esempio per quanto riguarda i polmoni, conosciamo l’impatto delle sostanze chimiche, ma non quello dei nanotubi di carbonio. Le nanotecnologie sono un soggetto adeguato senza precedenti per l’innovazione, ma la novità che è la loro forza, è anche la loro debolezza. 

In quali ambiti le nanotecnologie possono rivelarsi una soluzione vincente? 
Innanzitutto possiamo osservare in quali ambiti hanno già dimostrato di essere una soluzione vincente: al primo posto vanno indubbiamente la microelettronica e l’optoelettronica, mondi in cui i componenti fondamentali dei dispositivi hanno raggiunto da tempo le dimensioni nanometriche. 
Da diversi anni le nanoparticelle vengono utilizzate nei prodotti cosmetici, come le creme idratanti. A livelli meno avanzati, invece, è l’industria farmaceutica. Catalizzatori industriali nanotecnologici sono recentemente entrati sul mercato con gli elettrodi delle batterie al litio, la cui superficie viene aumentata grazie a un ricoprimento di nanofili. Ultimamente ci sono applicazioni anche nella produzione di imballaggi alimentari: per prevenire l’insorgere di ossidazioni si inseriscono strati di nanoparticelle, detti film, di argilla nell’involucro che avvolge il prodotto. Sono stati realizzati anche imballaggi impermeabili ai gas, mentre le nanoparticelle di argento sono ormai ampiamente utilizzate per le loro proprietà antimicrobiche
Per il futuro speriamo che arrivino presto gli incapsulanti per i pesticidi e i medicinali: si tratta di gusci nanometrici forniti di recettori esterni che permettono di riconoscere le caratteristiche dell’ambiente in cui si trovano e di aprirsi solo quando abbiano raggiunto il luogo per cui sono stati programmati: le foglie delle piante piuttosto che le cellule tumorali. 

La realizzazione di oggetti nanostrutturati prevede due principali approcci: “bottom-up”(costruzione di nanostrutture a partire da mattoni più piccoli, atomi o molecole) e “top-down” (lavorazione di materiali in cui vengono “scavate” strutture nanometriche): quale ritiene possa rispondere meglio alla sfida? 
Queste due tecniche presentano grosse differenze, che si ripercuotono sul loro utilizzo. La micro e la nanoelettronica vengono realizzate con tecniche di tipo top-down: questi processi sono molto costosi ma se il valore aggiunto del prodotto finale è alto, non sono sprecati. Per esempio, nel caso dei componenti microelettronici che andranno a far funzionare un i-Pod il valore aggiunto del prodotto è assicurato. 
Facciamo un altro esempio chiarificatore: si decide di sviluppare un nuovo sacchetto trasparente per il pane che gli permetta di rilasciare l’umidità durante la giornata, senza essere ermetico, cosa che renderebbe il pane molle, e senza nemmeno lasciar passare troppa aria, altrimenti il pane si seccherebbe. 
Invece di utilizzare carta o plastica, si decide di realizzare un materiale nanostrutturato con pori che lascino passare le molecole di vapore acqueo senza permettere che entrino agenti biologici contaminanti, così il pane può durare due giorni anche a Bangkok! In questo caso sarebbe inopportuno utilizzare tecniche top-down: essendo basso il costo del prodotto, è preferibile una tecnica bottom-up, meno controllabile ma molto meno costosa. La scelta, dunque, dipende dalla natura del prodotto: le tecniche top-down permettono una maggior precisione ma hanno un costo elevato; viceversa le tecniche bottom-up hanno minor controllo del dettaglio ma costi più contenuti.
Autore: Anna Giorgioni

Constitution d’un groupe de travail "Nanomatériaux et santé – alimentation, environnement, travail"

L’Anses lance un appel à candidatures d’experts scientifiques afin de procéder à la constitution d’un groupe de travail (GT) « Nanomatériaux et santé – alimentation, environnement, travail ».


Parmi les risques émergents, les enjeux sanitaires liés au développement, aux usages et à la dispersion environnementale des nanomatériaux manufacturés occupent une place importante.

Les travaux d’expertise de l’Anses sur les nanomatériaux manufacturés concernent la veille scientifique, l’évaluation des risques sanitaires et environnementaux, les développements méthodologiques, les études visant à connaître l’exposition de populations spécifiques aux nanomatériaux et la diffusion d’information à différents publics. Le développement de l’activité de veille scientifique sur les nanomatériaux manufacturés et leurs risques éventuels pour la santé et l’environnement est essentiel pour assurer la cohérence entre les différents travaux d’expertise coordonnés par l’Agence.

Aussi, pour répondre à cette nécessité, l’Anses crée un groupe de travail (GT) pérenne « Nanomatériaux et santé – alimentation, environnement, travail » placé sous l’égide de son comité d’experts spécialisés « Agents physiques, nouvelles technologies et grands aménagements », qui aura pour mission de :

  •  réaliser annuellement un état des connaissances relatives aux risques sanitaires et environnementaux éventuels associés aux nanomatériaux manufacturés pour l’ensemble de leurs usages ;
  •  mettre en évidence les signaux émergents de danger et de risques associés aux nanomatériaux manufacturés pour l’ensemble de leurs usages ;
  •  contribuer à l’instruction des demandes d’expertises adressées à l’Agence ;
  •  proposer annuellement des recommandations d’orientations de recherche notamment destinées à alimenter l’appel à projet de recherche santé – environnement – travail de l’Agence ;
  •  appuyer l’Agence dans le dialogue avec la société dans le domaine des risques liés aux nanomatériaux manufacturés.
Les personnes compétentes intéressées peuvent consulter en bas de page les informations relatives à l’appel à candidatures et aux compétences recherchées.
Les candidatures seront déposées en ligne au plus tard le 27 janvier 2012 en suivant le lien http://expertise.anses.fr .
Les candidats pourront également joindre un curriculum vitae sous forme libre incluant éventuellement une liste des travaux et publications scientifiques.
Pour tout renseignement complémentaire, merci d’adresser vos questions par mail encliquant ici .

Fonte: Anses

Reinforcing EU legislation on health and safety at work

The effects of new technologies on health must be assessed and nanomaterials must be covered by current EU health and safety rules, says a resolution, passed on Thursday, on a mid-term review of the EU's 2007-2012 health and safety at work strategy.



Every year, 168,000 EU citizens die from work-related accidents or diseases and 7 million are injured in accidents, notes the resolution, which was drafted by Karima Delli (Greens/EFA, FR) and adopted with 371 votes in favour, 47 against and 15 abstentions.

Effect of new technologies
The potential risks of new technologies and harmful substances must be assessed, and legislation drafted to ensure that nanomaterials are covered by the current European Occupational Health and Safety regulation, says the text.

Protecting workers
Furthermore, individuals who legitimately warn of risks at work should be protected from any pressure to remain silent, say MEPs, calling on the Commission to propose a directive to protect these workers.

Stress at work
Work-related stress is a major obstacle to productivity in Europe, MEPs say, calling on the Commission to take measures to ensure that the EU Framework agreement on work-related stress of 8 October 2004 is duly implemented in every Member State and asking employees' and employers' organisations to raise awareness among employers, workers and their representatives of the need to reduce work-related stress.

REF. : 20111215IPR34231


U.S. Lead in Nanotechnology Depends on Growth of FDA and Gov’t Initiatives

European revenue from nanotech-enabled products is projected to surpass that of the U.S. by 2015, according to Lux Research.

U.S. Lead in Nanotechnology Depends on Growth of FDA and Gov’t Initiatives
The National Center for Toxicological Research (NCTR), which identifies issues related to new products like nanomaterials, was given $60 million for fiscal 2012. [© James Steidl - Fotolia.com]




      The recently enacted spending bill, which covered FDA, contained some good news for proponents of nanotechnology as well as the promise of more to come in years ahead. The latter will be harder to deliver considering the overall budget constraints of the U.S. Making good on the promise, however, is likely key to the country’s ability to at least retain its number one position in nanotechnology if not expand this lead.
      FDA’s National Center for Toxicological Research (NCTR) was approved $60 million for fiscal 2012, which was proposed by President Barack Obama and favored over the $51.5 million sought by the Republican-controlled House of Representatives. While NCTR’s latest approved budget did not increase compared to fiscal year 2011, at least it did not go down. NCTR’s duties include conducting peer-reviewed research to identify health and safety issues related to new medical products like nanomaterials.
      More importantly, perhaps, than this year’s money is language inserted into the spending bill’s House-Senate conference report by Sen. Mark Pryor (D-AR) endorsing future plans by the agency to fund that even further: “The conferees support FDA in its mission to expand upon current research in nanotechnology and support the eventual development of a Nanotechnology Core Center to meet its mission.”
      “Nanotechnology activities at FDA are focused on three main activities: (1) laboratory and product testing capacity; (2) scientific staff development and professional training; and (3) collaborative and interdisciplinary research to address product characterization and safety,” FDA spokeswoman Rita Chappelle told GEN. “These enterprise-wide programs are in addition to focused regulatory science research activities conducted at each of the FDA centers.”
      Lynn L. Bergeson, a founding member of the law firm Bergeson & Campbell, pointed out to GEN, however, that “while the FDA speaks to its well-established experience and expertise in assessing nano-enabled products, the transparent record of this expertise is less apparent. A center expressly devoted to FDA nano research would help strengthen the reality and the perception that FDA is expert in the regulation of nanoscale materials pertinent to FDA-regulated products.

      This Year in Nanotech

      During FY 2011, a Nanotechnology Core Facility overseen by NCTR and the agency’s Office of Regulatory Affairs (ORA) became operational at FDA’s Jefferson Laboratory campus in Arkansas. A similar facility at FDA’s White Oak headquarters campus, to be overseen by NCTR and several FDA centers, “is scheduled to be operational in FY 2012,” according to Chappelle.
      Sally Tinkle, Ph.D., deputy director of the National Nanotechnology Coordination Office of the National Science and Technology Council, told GEN that in October NCI’s Alliance for Nanotechnology in Cancer initiated Translation of Nanotechnology In Cancer (TONIC), a public-private consortium designed to promote translational R&D opportunities for nanotechnology-based cancer solutions. Consortium members will include government agencies and biopharma companies. Last year, NCI approved a second phase of an alliance program, awarding $30 million a year over five years in multi-institution research grants.
      On October 6, Pryor introduced the Nanotechnology Regulatory Science Act of 2011 (S.1662). It would direct FDA to develop safety regulations for companies using nanotech. FDA would be authorized to spend $48 million over three years: $15 million in the FY 2013, followed by $16 million and $17 million in FY 2014 and FY 2015, respectively.
      Also this year, the Obama administration has issued two nanotech-related reports through the National Nanotechnology Initiative (NNI). These positioned nanotech as a top science initiative, identified goals, and called for better coordination of research, training programs, and resources. Currently, NNI coordinates the individual and cooperative nanotechnology-related activities of FDA and 24 other federal agencies.

      Maintaining a Competitive Edge

      Dr. Tinkle acknowledged the tight budget climate as a continuing challenge for nanotech. The Obama administration has proposed raising NNI’s budget to $2.1 billion from $1.76 billion in FY 2011. But, in the current tight budget climate and with an election looming next year for Obama, all of the House, and one-third of the Senate, any extra funds for increased nanotech R&D are uncertain at best. Unless Congress hammers out a long-term deficit plan, FDA will lose money for nanotech and everything else through the forced 7.8% sequestration required by the Budget Control Act enacted in August.
      As Bergeson correctly notes, expanding NNI will be much easier said than done. “The challenges are, of course, of epic proportion,” Bergeson pointed out, such as the 17.3% drop in federal nanotech spending during FY 2010, a result of the weak economy.
      Washington’s difficulty in stepping up funding for nanotech has created an opening for other nations eager to grow their own nanotech industries. 
      According to data from Lux Research presented at a November 15 Congressional Nanotechnology Caucus briefing, European revenue from nanotech-enabled products is projected to surpass that of the U.S. by 2015, with both expected to rack up more than $1 trillion. Among individual nations, the U.S. remains at the top of corporate nanotech spending at nearly $3.5 billion as of 2010 followed by Japan (almost $3 billion) and then Germany (about $1 billion).
      “The rest of the world now understands the importance of this field, and many countries are building efforts that rival what has been established by the NNI,” Chad A. Mirkin, Ph.D., director of the Northwestern University International Institute for Nanotechnology, said in a testimony July 14 to the Senate Subcommittee on Science and Space. He identified China, Great Britain, Russia, Saudi Arabia, Singapore, and Taiwan as nations where research institutes have advanced nanotech.
      If the United States does not act now and aggressively pursue the development of nanoscience and nanotechnology,” Dr. Mirkin cautioned, “we will lose our position as the global leader in this transformative field. Moreover, we will lose the opportunities it can afford us to build our economy and new manufacturing base.”
      Dr. Mirkin called for expanding NNI by requiring its member agencies to assign senior executives to participate in coordination activities; by positioning the National Nanotechnology Coordination Office (NNCO) as NNI’s coordination entity; and by mandating that NNCO develop metrics for nanotechnology-specific programs using dedicated funding. He noted that 0.3% of NNI’s budget was recommended for NNCO by the President’s Council of Advisors on Science and Technology, on which he serves.
      Bergeson pointed out, “The identification of research priorities and their correlation with commercialization goals is more challenging as nanotechnology matures, and the most obvious of basic research needs are filled. Coupled with the usual turf battles and the sheer complexity of managing a national nanotechnology initiative, the task Dr. Tinkle faces is indeed daunting.
      “It is not the case that nano has not delivered on its enormous promise,” Bergeson continued. “The flattening of the global economy and the pressures domestically to reprioritize fiscal expenditures due to election-year pressures and the lack of a coherent Congressional commitment to nano has undermined U.S. dominance in this area,” she said.
      It’s hard to have coherence when nanotech activity is spread across 25 agencies. While NNI is praised among nano professionals, its funding is far smaller than its mission. Aligning NNI’s financial backing and goals is a longer-term project, but level funding for NNI in FY 2012 is a welcome first step.

Advanced Manufacturing Partnership: Where Does Nanomanufacturing Fit, and Where Should Investments Be Made?

Written by Jeff Morse, PhD
Image

The announcement of theAdvanced Manufacturing Partnership (AMP) by the White House last June, followed by regional workshops to identify technology approaches for U.S. government investment to create high-quality manufacturing jobs and enhance the global competitiveness, demonstrates the Obama administration’s commitment to revitalizing manufacturing in the US.  

The government/academic/industry AMP collaboration convened the workshops to exchange ideas between the AMP steering committee and stakeholders including entrepreneurs, manufacturing leaders, public officials, educators, students and the general public on how best to make it in America.  Topics for discussion included technology development, education, workforce development, and shared infrastructure and facilities. The AMP steering committee heard from private sector leaders representing a wide range of manufacturing sectors and global corporations, as well as from federal and state policymakers. In evaluating the Advanced Manufacturing Partnership and the intended impact towards a sustainable and growing manufacturing base in the U.S., several aspects of the dialogue provide encouragement while quantifying the magnitude of the challenges faced. For example, workforce training at the high school and junior college levels includes new curricula and strategies, yet still faces the challenge of reinvigorating the perception of manufacturing careers for future generations. Many states have already established and begun execution of roadmaps and efforts in this area.

Creating and carrying out a long-term strategy for enhancing the U.S. manufacturing base is a complex problem. Discussions at AMP workshops included lessons learned from astute industry leaders, government panels, and academic advisors.  The hardest work now will be to correlate these views into strategies for recapturing existing markets, and more importantly, capturing new and unique opportunities in growing global markets. For solid long-term progress in manufacturing, economic development, and job creation, America must rethink the innovation cycle to be able to promote technologies and markets that involve value-added manufacturing processes and innovations within the product development cycle.  For example, in the semiconductor industry where significant industry investment in the U.S. has been made for production of high-end processing and computing chips, lower-cost and higher-volume memory technologies and their attendant jobs and GDP have typically gone offshore where global manufacturing capabilities are now fully in place.  Similar examples can be found in other industries.  While the debate on the overarching reasons behind these trends is highly involved, the need to reverse the trends has evolved to a critical juncture. The U.S. must establish a long-term strategy for regaining its global manufacturing competitiveness, particularly with respect to emerging market opportunities. Complementing this strategy must be plans for implementing goals with optimal economic benefit and highest return on strategic investments, given limited federal and state funds and resources.


Positioned squarely in the middle of these discussions are industry markets involving  nanomanufacturing and nanotechnology-enabled products.  The federal investment in nanotechnology over the past decade through the National Nanotechnology Initiative (NNI) has positioned the US as a leader in the field, and recent reports by the President’s Council of Advisors on Science and Technology have recommended new directions and funding towards effective technology transfer and commercialization of nanotechnologies emerging from the research labs. 
Putting these recommendations into effect in a way that positively impacts economic development and job growth is the challenge at hand. 
Nanotechnology and nanomanufacturing remains a diverse, multidisciplinary technology base serving a range of industries in various forms, from the materials supply chain to intermediate producers to product integrators.  While public offerings and acquisitions of nanotechnology companies are trending up, the industries involved are still shifting within the value chain.  
Regardless, we can envision the emergence of new American industries and market opportunities where nanoscale technologies, materials, and emerging nanomanufacturing processes make an impact and demonstrate enhanced functionality and lower manufacturing costs that will make their adopters globally competitive. 
Printed flexible electronics is a prime example of a burgeoning industry wherein significant global growth is projected, yet a concerted industrial manufacturing base still remains at the early stages. At the recent IDTechEx Printed Electronics Conference, nanomaterials and advanced nanomanufacturing processes were claimed to be increased market share in a range of consumer products. As an example, coated nanomaterial inks are now competing in the $3 billion Indium Tin Oxide (ITO) market for transparent conductors, and silver nanowire electrodes are now being delivered in Samsung’s latest touchscreen products.  Combine this with progress in the emerging technology base for flexible displays, LED lighting, higher performing printed electronics, and energy harvesting and storage, and we may be witnessing a global displacement in the consumer electronics space, wherein new products and applications requiring new manufacturing platforms and infrastructure are upon us.

With the prospect of numerous new manufacturing paradigms impacting a range of industry sectors on a global basis, it is time to assess where the most significant opportunities are for both public-private partnerships, as well as fostering new and unique private partnerships to compete at the global scale while providing sustainable manufacturing infrastructure within the US. While the possibilities are many, and the debate on how to best implement this may be long and arduous, key steps and advice have already been provided.  In terms of effective technology transfer and commercialization, recent directives to simplify licensing and technology transfer from federal laboratories will help to promote activities towards this end. 
This could be complimented by similar legislation governing the rules for intellectual property licensing and technology transfer for public academic institutions, and policies for encouraging entrepreneurial activities.  Regarding federal nanotechnology R&D support, while there is some concern that the US risks losing its lead in terms of government investment in nanotechnology, the bigger picture must be kept in view.  
America still dominates in terms of private investment in nanotechnology, and the focus should be on quality of investment rather than quantity.  The infrastructure to encourage commercialization should be aimed to impact emerging manufacturing bases that will enhance US global competitiveness in strategic global markets.  Supporting this concept with the investment that has been made in core science, environmental health and safety, and nanomanufacturing research and development through the NNI provides a strong platform and infrastructure through which a long-term sustainable innovation cycle and manufacturing base can be established.  

As the NNN seeks to identify federal, regional, state, and local strategies towards this end, we seek comments and ideas from stakeholders in the nanotechnology community. Ideas may include targeted industries or nanomanufacturing platforms through which Advanced Manufacturing Partnership strategies may be implemented, or by which models of public-private, consortia-based or regional partnerships can be applied. Please send comments to nnn@nanomanufacturing.org.
Fonte: InterNano

Establishing the “Committee on Safety Management for Nanomaterials”


The Ministry of Economy, Trade and Industry (METI) will establish the “Committee on Safety Management for Nanomaterials” on the basis of the results obtained from the project “Research and Development of Nanoparticle Characterization Methods” commissioned by the New Energy and Industrial Technology Development Organization (NEDO) and the latest scientific knowledge. Specifically, the committee will focus on risks (especially in view of exposure to nanomaterials in products) caused by nanomaterials and study appropriate management procedures for nanomaterials considering the actual usage and life cycles.
The first meeting of the committee will be held on December 2.

1.  Purpose

Though nanomaterials are expected to be one of the sources of future innovation, considerable uncertainties regarding their hazardous properties exist and also concern for these hazardous properties caused by their particular shapes was pointed out. METI has compiled the “The Expert Meeting on Safety Measures for Nanomaterial Manufacturers etc.” (*1) in 2009 and has encouraged voluntary action by the industries by announcing the results of the “Nanomaterial Information Collection and Communication Program” (*2).
Further, in order to increase scientific knowledge on risks caused by nanomaterials (considering both their hazardous properties and exposure), the National Institute of Advanced Industrial Science and Technology (AIST) developed and disclosed, in the project “Research and Development of Nanoparticle Characterization Methods” (*3), reports on the risk assessment of manufactured nanomaterials (Risk Assessment of Manufactured Nanomaterials - Titanium Dioxide-, -Fullerene-, -Carbon Nanotubes- (*4)). METI has contributed to the collection of hazard information on 13 nanomaterials in an international joint program organized by OECD with the results of this project.
We will hold a meeting of the “Committee on Safety Management for Nanomaterials” to discuss risks arising from nanomaterials and to study appropriate management procedures of nanomaterials considering the actual usage and life cycles on the basis of the latest scientific knowledge etc. as described above.

2. Major Agenda

Classification of shapes and risks of nanomaterials to study appropriate management procedures for them

3. Schedule

  • The first meeting: 15:00 to 17:00 on Friday, December 2 
    Agenda: Purpose of the committee, report of the current status, organization of issues to be studied, future schedule, etc.
  • Interim report will be compiled around spring to summer in 2012

Release Date

November 30, 2011

Division in Charge

Chemical Management Policy Division, Manufacturing Industries Bureau

Proposed EU Biocidal Products Regulation Addresses Nanomaterials

On November 23, 2011, the European Union (EU) Council’s committee of the permanent representatives of each member state (COREPER) approved the compromise agreement on the proposed EU biocidal products regulation that would repeal and replace the biocidal products Directive 98/8/EC. 
Under the compromise reached by the EU Council and the European Parliament (EP), biocides would be reviewed regularly, with approvals or renewals valid for a maximum of ten years, and less for “problematic” substances. 

The proposed legislation states that there is “scientific uncertainty” about the safety of nanomaterials, and “to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials, if possible based on the work of appropriate international fora, and to specify that the approval of an active substance does not include the nanomaterial form unless explicitly mentioned.” The proposed legislation calls on the European Commission (EC) to “regularly review the provisions on nanomaterials in the light of scientific progress.”

The proposed legislation incorporates the EC’s recent recommendation on the definition of a nanomaterial, stating:
nanomaterial” means a natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm;
Fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials.
For the purposes of the definition of nanomaterial, ‘particle’, ‘agglomerate’ and ‘aggregate’ are defined as follows:
(a) ‘particle’ means a minute piece of matter with defined physical boundaries;
(b) ‘agglomerate’ means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components; [and]
(c) ‘aggregate’ means a particle comprising of strongly bound or fused particles.

The EC would have the authority to determine, at the request of a member state, whether a substance is a nanomaterial. It would also have the authority to adopt delegated acts to adapt the definition of nanomaterial “in view of technical and scientific progress and taking into account the Commission Recommendation.” Under the proposed legislation, where nanomaterials are used in a product, the risk to the environment and to health must be assessed separately. Labels would be required to include the name of all nanomaterials contained in biocidal products, followed by the word “nano” in brackets
Every five years, member states would be required to submit to the EC a report on the implementation of the biocides regulation in their respective territories. The report must address several topics, including information on the use of nanomaterials in biocidal products and the potential risks.
Both the EU Council and the EP must approve the proposed legislation. The EP is scheduled to vote on the proposed legislation in January 2012.



PLS - PROJETO DE LEI DO SENADO, Nº 131 de 2010

Autor:
SENADOR - Tião Viana
Ver imagem das assinaturas(pdf)


Ementa:
Altera o Decreto-Lei nº 986, de 21 de outubro de 1969, que institui normas básicas sobre alimentos, e a Lei nº 6.360, de 23 de setembro de 1976, que dispõe sobre a vigilância sanitária a que ficam sujeitos os medicamentos, as drogas, os insumos farmacêuticos e correlatos, cosméticos, saneantes e outros produtos, e dá outras providências, para determinar que rótulos, embalagens, etiquetas, bulas e materiais publicitários de produtos elaborados com recurso à nanotecnologia contenham informação sobre esse fato.


Assunto:
Social-Saúde

Data de apresentação:
12/05/2010

Situação atual:
Local:
14/12/2011 - Comissão de Assuntos Sociais

Situação:
14/12/2011 - AGUARDANDO DESIGNAÇÃO DO RELATOR

Indexação da matéria:
Indexação: PROJETO DE LEI, SENADO, ALTERAÇÃO, DISPOSITIVOS, DECRETO-LEI, NORMAS, ALIMENTOS, OBJETIVO, ACRÉSCIMO, DISPOSITIVOS, DIREITOS, CONSUMIDOR, ACESSO, INFORMAÇÕES, COMERCIALIZAÇÃO, COMPOSIÇÃO, ALIMENTOS, DESTINAÇÃO, CONSUMO, HUMANO, ANIMAL, PRODUÇÃO, RECURSO, NANOTECNOLOGIA. OBRIGATORIEDADE, INFORMAÇÕES, RÓTULO, EMBALAGEM, ETIQUETA, BULA, PUBLICIDADE, ALIMENTOS, FORMA, EXPRESSÃO, SÍMBOLO, DEFINIÇÃO, REGULAMENTO. ALTERAÇÃO, DISPOSITIVOS, LEGISLAÇÃO, VIGILÂNCIA SANITÁRIA, OBJETIVO, OBRIGATORIEDADE, INFORMAÇÕES, MEDICAMENTO, EXIBIÇÃO, COMERCIALIZAÇÃO, MARCA, EMBALAGEM, PRODUTO, PROPAGANDA COMERCIAL, DENOMINAÇÃO, CONFORMIDADE, UTILIZAÇÃO, FABRICAÇÃO NACIONAL, FABRICAÇÃO ESTRANGEIRA, APRESENTAÇÃO, FORMA, DIMENSÃO, EXPRESSÃO, EMBALAGEM, DEFINIÇÃO, REGULAMENTO.