869569122

Monday. 16 Seplember

is planning lo bc publislicd in Bclgium. Draft dccrec hasbccn alrcady

Identification of tlie declarcr. identification of the substance, ąuantity of substance manufactured at the nanoscale placcd on the market during the reporting period, uses of the substance and identity of the Professional users. [6]

Denmark has launclted a public consultation. related to a draft execul-ive order for a national register of products and mixtures containing nanomaterials. The order is expected to come iuto force by 1 January 2014. [7]

Thcrc is also a group of Membcr States tliat suggest introducing European Registry of such products rather than national ones. As the result of these claims European Commission has issued a cali for tender to help it prepare an intpacl assessment fora nano registry. The infonn-ation rcqui red to be gathered includes: costs and administrative burdeli of such registry, possible effects on competiveness and potential bene-fits. [8]

REFERENCES

II] Second Regulatory Review on Nanomaterials. COM(2012) 572 finał:

[2]    Commission Rccommcndation of 18 October 2011 on the definition of nanomaterial (2011/696/EU);

[3]    Azoulay D.: Just out of REACH, Tlie Center for International En-vironmental Law (CIEL);

[4]    Public consultation relating to the REACH Annexes on Nanomaterials;

[5] Decree no. 2012-232 of 17 February 2012 on tlie annual declaration on substances at nanoscale in application of article R. 523-4 of the Environment codę:

[6] Draft - Royal decree regarding the placemenl on the market of substances manufactured at the nanoscale:

[7]    V, Zainzinger. Denmark consults on nanomaterial product register, ChemicalWatch,10 July 2013;

[8] EU Commission tenders nano-registry impact assessment. Cheinic-alWatch. 27 June 2013.

14:10    Imited orał

Regulatory Aspccts of Nanomaterials

Krzysztof Mamszcwski

Joint Research Cenlre, IHCP, l ia Fermi 1, Ispra 21020, Ilaly e-mail: [e-mail]

The potential benefits of nanotechnology and nanomaterials for society arc well knowa However. the large scalę use of particulate nanomaterials raises several issues regarding possible dctrimental elfects on hu-man health and the emironment, Tltis applies to particulate nanomaterials already produced and used in large quantities. as well as the huge rangę of novel nanomaterials presently under developmenl for different applications. These safety issues need to be addressed before any significant problems arise. For this reason a elear regulatory frantework is needed to address them. without stifling innovative re-search. and w ithout discouraging industiy frorn de\ eloping and introducing new proccsscs and consumer products based on nanomaterials. Such a frantework should also reassurc consumcrs about nanotechnology developments and foster tlie acceptance of nanoleclmology-based products. EU Iegislation applies in principle to nanotechnology and nanomaterials. and in recent ycars some specific pro\ isions for nanomaterials have additionally been introduccd into Iegislation. e.g., for cosmetic products. biocides. food Iabclling. and also for materials in contact with foods. Am nano-specific provisions must take into accouni that our currcnt understanding of phy siological responses to engineered nanomaterials is far front comprchensiyc. Improvcd nano-specific risk assessment and manageinent methods have to be det cloped and incor-porated into a good regulatoiy framework. based on validated testing methods. Further research and reliable scicntific data is uigently needed in tltis respect. Regarding labelling rcquirements. analytical methods for their iniplementation. based on the Commission recommendation for a regulatoiy definition of nanomaterials. also need to be developed and validated. This presentation proyides a brief overview of recent developments as summarized in the Coimnunication front tlie Comntis-sion in its Second Regulatory Revievv on Nanomaterials! 11. It addresses the major scientific challenges regarding iniplementation of nano-specific regulations. especially with respect to detennining w hether a materiał falls into the category of'nanomaterial' or not. It also touches on the cltallenging problem of detectioa quantification and character-isation of nanomaterials in complex matrices. for which methods may be tequired in both induslrial and official control laboratories. The presentation also discusses quality assurance tools such as reference materials and methods. including related databases. and emphasizes the role of the OECD Working Party on Manufactured Nanomaterials (WPMN), and the standardization activities of ISO and CEN, which help to foster a globally hannonised approach to the assessment of nanomaterials.

[1] EU Commission Communication COM (2012) 572 finał

14:40    Imited orał

International, European and national standardization actirity, reriew of puhlications and dcvclopcd projcets in nanotcchnologics

Jacek Woital

Insi i lnie ofAdvanced Manu/acluring Technology (IOS), Wrocławska 37A, Kraków 30-011, Poland

e-mail: [e-mail]

The dynamie developincnt of nanotechnologies in recent ycars makes it necessary to normalize the many issues related to nanotechnologies and nanosciences. In tlie current intemational (ISO). European (CEN) and national (PKN) standardization organrzations, new- organizational stmetures to cany out the standardization activities in the field of nan-otechnologies and related issues. Tltis presentation discusses the history, scope of activities and cooperation witli other organizations and major achieveinents of technical committees ISO/TC 229 and CEN/TC 352 and national committees (KT 207 and KT 314).

15:10    Im ited orał

Programme