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Commission of the European Communities


Report Title: Accompanying Document to "nanosciences and Nanotechnologies: an Action Plan for Europe 2005-2009. Second Implementation Report 2007-2009"
Report ID: 505
Date: 10/29/2009
Report Type: Working Document
URL: [LexUriServ.do]
Country: European Union
Organization: Commission of the European Communities
Summary: This document is the accompanying working document to the Second Implementation Report 2007-2009 of the European Action Plan for nanotechnology (see report ID 416). While the Report outlines nanotechnology developments for each policy area of the Action Plan, this working document contains in-depth detail for all headings in the Plan, including references to additional information.
Archived Copy: LexUriServ_505_3511.pdf



Report Title: Nanosciences and Nanotechnologies: An Action Plan for Europe 2005-2009. First Implementation Report 2005-2007
Report ID: 468
Date: 9/6/2007
Report Type: Government Report
URL: [LexUriServ.do]
Country: European Union
Organization: Commission of the European Communities
Summary: In 2005, the European Commission enacted a 16-page action plan for the development of the "integrated, safe and responsible" strategy towards nanotechnology. The action plan covers 2005-2009, and this document is the first of two implementation reports. It covers 2005-2007, during which the "integrated, safe, and responsible" approach towards nanotechnology has become the core of the EU’s nanotechnology policy. Research and development expenditures have greatly increased and funding is expected to double in the future. In the next Research Framework Programme, research infrastructures will continue to be supported and new programs are being enacted to foster collaboration between research and industry. Work continues to inform the public about nanotechnology and to improve safety knowledge. International collaboration on safety standards is also underway, and future dialogues are planned.
Archived Copy: First Implementation Report_468_1297.pdf



Report Title: Commission Staff Working Document
Report ID: 417
Date: 10/29/2009
Report Type: Information Sheet
URL: [LexUriServ.do]
Country: European Union
Organization: Commission of the European Communities
Summary: This Staff Working Document contains detailed information on progress regarding nanotechnology policy, while the Communication to which it is attached outlines the key developments in each policy area of the Action Plan, identifies current challenges, and draws conclusions relevant to the future European nanotechnology policy. This document follows the headings of the Action Plan (apart from the last one, on coordination, which is dealt with only in the Communication). International cooperation is now an integral part of the Commission’s policy in all areas of the Action Plan, and is dealt with mainly under the respective policy areas.
Archived Copy: eu 2nd implementation report accompanying paper_417_2950.pdf



Report Title: Nanosciences and Nanotechnologies: an Action Plan for Europe 2005-2009. Second Implementation Report 2007-2009
Report ID: 416
Date: 10/29/2009
Report Type: Advisory Report
URL: [LexUriServ.do]
Country: European Union
Organization: Commission of the European Communities
Summary: This Communication outlines the key developments during 2007-2009 in each policy area of the Action Plan, identifies current challenges, and draws conclusions relevant to the future European nanotechnology policy. Where appropriate, for completeness and continuity, the report includes developments in preceding years. Additional, detailed supporting information is available in the accompanying Staff Working Document. As an overall remark, the past two years have seen a substantial development of nanotechnology, supported by a further growth in research funding and the active development of policy. The fact that there is constant realization of novel applications and products of nanotechnology necessitates further efforts to address societal and safety concerns in order to ensure the safe and sustainable development of nanotechnology.
Archived Copy: EU 2nd implementation report 2007 09_416_6149.pdf



Report Title: Preparing for Our Future: Developing a Common Strategy for Key Enabling Technologies
Report ID: 381
Date: 9/30/2009
Author: The Commission of the European Communities
Report Type: Guidance Document
URL: [communication_key_enabling_technologies_en.pdf]
Country: European Union
Organization: Commission of the European Communities
Summary: In a comprehensive review of E.U. policy regarding key enabling technologies (KETs), such as micro- and nanoelectronics and photonics, the Commission finds that the design of an industrial policy framework for enabling high technologies needs to be founded upon a widely shared and broadly-based EU-wide strategic vision that includes a shared long-term vision and strong partnership will be required between the EU, its Member States, businesses and key stakeholders. One manifestation of this end is the establishment of a high-level expert group tasked with developing such a strategy. Emphasis should be placed on assessing the competitive situation of the relevant technologies in the EU, analysis of the available public and private R&D capacities for KETs in the EU, and propose specific policy recommendations for a more effective industrial deployment of KETs in the EU. For the immediate future, the current policy framework of state aid rules, trade aspects, access to finance within the forthcoming innovation act, and reinforcing existing initiatives and/or proposing direct actions in the field of specific enabling high technologies will remain intact.
Archived Copy: communication_key_enabling_technologies_sec1257_en_381_8848.pdf



Report Title: COM(2007)872: Proposal for a Regulation of the European Parliament and of the Council on Novel Foods and Amending Regulation (EC) No XXX/XXXX [common procedure]
Report ID: 153
Date: 1/14/2008
Author: Commission of the European Communities
Report Type: Legislation
URL: [COM872_novel_food_proposal_en.pdf]
Country: European Union
Organization: Commission of the European Communities
Summary: The European Commission adopted a proposal to revise the Novel Foods Regulation (EC) No 258/97 with a view to improving the access of new and innovative foods to the EU market, while maintaining a high level of consumer protection and ensuring food safety. Under the draft regulation, novel foods would be subject to centralized authorization procedure. The Commission will receive the application for authorization and the European Food Safety Authority will carry out the scientific assessment on the product. The one door - one key approach will be taken for the approval of novel foods, just as it will be for food additives, food enzymes and food flavorings. This means that the applicant may make one application for approval covering all these possible uses of the substance in question. The proposal also sets out data protection rules, which aim to protect newly developed foodstuffs once authorized, and encourage companies to invest in developing new types of foods and food production techniques. Moreover, a notification procedure is introduced for foods which have not been traditionally sold in the EU but which have a safe history of use in third countries.
Archived Copy: COM872_novel_food_proposal_en_153_5869.pdf



Report Title: Draft Commission (EC) No /.. of amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) as regards Annexes IV and V
Report ID: 152
Date: 1/1/2008
Author: Stavros Dimas, Gnter Verheugen
Report Type: Draft Report
URL: [regulation_annexes_iv_v_en.pdf]
Country: European Union
Organization: Commission of the European Communities
Summary: Upon carrying out a reviewing pursuant to Article 138(4) of the Regulation (EC) No 1907/2006 of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), the Commission of European communities decided that certain amendments should also be made to Annex V of the regulation. Specifically, Annex V of the regulation should be replaced with Annex II to this regulation. This is done in light of several provisions of the Regulation 1907/2006 that establish registration obligations for community manufacturers or importers of substances on their own, in preparations or articles, as well as provisions concerning evaluation of substances and the obligations of downstream users. Article 2(7)(a) of this regulation furthermore provides that substances included in Annex IV are exempted from Titles II, V and VI of the same regulation as sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties. The review carried out by the Commission has revealed that three substances listed in Annex IV should be removed from that annex, as insufficient information is known about these substances for them to be considered as causing minimum risk because of their intrinsic properties. This is the case with vitamin A, as that substance may present significant risks of reproductive toxicity. Furthermore, three noble gases (helium, neon and xenon) fulfill the criteria for inclusion into Annex IV and should therefore be moved there from Annex V. Moreover, it is appropriate to add certain types of glass and ceramic frits which do not meet the classification criteria set out in Directive 67/548/EEC and which do not have dangerous constituents above the relevant concentration limits.



Archived Copy: regulation_annexes_iv_v_en_152_1283.pdf



Report Title: Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee, Regulatory Aspects of Nanomaterials
Report ID: 136
Date: 6/17/2008
Author: European Commission
Report Type: Government Communication
URL: [comm_2008_0366_en.pdf]
Country: European Union
Organization: Commission of the European Communities
Summary: As part of the European Commission's commitment to nanotechnology safety, the Commission announced a review of pertinent EU legislation. This document is a Communication from the Commission which examines current nanomaterial regulation and identifies present and future regulatory gaps which will be addressed. While current regulations cover nanomaterial safety in principle, the Commission calls for improved implementation which will enhance these precautions further. Knowledge of nanomaterial classification, hazards, exposure, risk assessment, and risk management must be improved. The Communication also explains the Commissions numerous directives and working groups which are currently working to better identify and regulate nanotechnology-related risks. Within three years of the publication of this Communication, the Commission will issue a report on the progress of its efforts.



Report Title: Accompanying Document to the Communication from the Commission to the European Parliament, the Council, and the European Economic and Social Committee: Regulatory Aspects of Nanomaterials, Summary of legislation in relation to health, safety, and environment aspects of nanomaterials, regulatory research needs and related measures
Report ID: 71
Date: 6/17/2008
Report Type: Committee Report
URL: [com_regulatory_aspect_nanomaterials_2008_en.pdf]
Country: European Union
Organization: Commission of the European Communities
Summary: This working document summarizes existing European Union legislation which is relevant to the regulation of nanomaterials. Legislation such as the chemical regime REACH, while not explicitly aimed at controlling nanomaterials, does control some aspects of production and distribution. Other current laws involving areas such as food safety, waste disposal, and cosmetics also control nanomaterials. An additional need for research in the areas of environment, health, and safety is identified. This document also discusses efforts at standardizing risk assessment methodologies and solving the “knowledge gap” of nanomaterials.



Report Title: Regulatory Aspects of Nanomaterials
Report ID: 68
Date: 1/1/2008
Report Type: Working Document
Country: Other
Organization: Commission of the European Communities
Summary: This report summarizes European legislation in relation to health, safety and environment aspects of nanomaterials, regulatory research needs and related measures. In 2008, the Commission of the European Communities summarized the parts of European legislation most relevant to nanotechnologies and nanomaterials. This summary served as the foundation for conclusions reported in the Commission Communication on Regulatory Aspects of Nanotechnology. It reported that REACH, a chemical regulation agency, will broaden and compliment current regulations by placing the responsibility for safe use of substances on manufactures, importers, and users of substances instead of a single regulatory system. Furthermore, it identified the Framework Directive 89/391/EEC as the most important legislation in health and safety because it requires employers to identify and eliminate risks at the workplace that deal with nanomaterials. In addition, this document reported that legislation will determine the conditions in which products can be placed on the market and established ways to guarantee that regulatory requirements are followed. The legislative regulations range from biocides and cosmetics to food preparation and additives, but it does not cover all consumer products. The document also discusses the regulations in place to ensure that industrial activities are environmental friendly. Finally, the document explains the steps in place to promote cooperation in human health and environment safety in relation to nanomaterial manufacturing. These include standardization in classifications and measurement, as well as the establishment of ethics regulations. In this report, the SCCP is requested to review and, if appropriate, to amend its notes of guidance for the testing and their safety evaluation of cosmetic ingredients containing nanomaterials. Particular attention should be paid to the skin absorption and resorption of these substances, especially with differing skin conditions and different sizes of particles. The question of whether mass unit is the appropriate basis for regulating the exposure to nanomaterials may need to be addressed as well. In the light of theses findings, the SCCP may need to review existing opinions on nanosized materials as cosmetic ingredients and may need to identify which additional elements are required for the submission of a safety-file. The Committee is asked to give its opinion as a matter of priority that should be answered by the end of 2005. The unique contribution of this report is its clear focus on assessing the state of scientific knowledge concerning engineered nanomaterials from the perspective of risk assessment and regulation. In doing so, it clarifies the nature of the regulatory approach that would most effectively address the issues presented by nanomaterials and products that make use of them. The panel hopes that its findings and recommendations will provide a science-based assessment that will assist the sponsors in meeting the international challenge of effectively regulating engineered nanomaterials that enter trade and commerce.



 
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