2017
DOI: 10.1002/cite.201600076
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Regulatory Aspects of Nanomaterials in the EU

Abstract: Nanomaterials are present in almost any industrial sector and addressed in corresponding legislation. The EC has developed a recommendation of the term nanomaterial for regulatory purposes. Due to uncertainties regarding the safety of nanomaterials, it is necessary to develop best practices and facilitate harmonization of assessment practices. However, more research with specific relevance for regulatory questions is still needed, in particular regarding the implementation of the definition of nanomaterials, t… Show more

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Cited by 165 publications
(76 citation statements)
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“…Additionally, the impact of nanoparticles on the properties of the packaging films, such as barrier properties and transparency, should also be considered. However, the safety evaluation and approval for use of such nanoparticles in food packaging remains the greatest challenge due to the difficulties in the evaluation of the safety of nanoparticles in general (Radusin and others ) as well as constraints associated with the current legislative landscape (Amenta and others ; Radusin and others ; Rauscher and others ).…”
Section: Nanoparticlesmentioning
confidence: 99%
“…Additionally, the impact of nanoparticles on the properties of the packaging films, such as barrier properties and transparency, should also be considered. However, the safety evaluation and approval for use of such nanoparticles in food packaging remains the greatest challenge due to the difficulties in the evaluation of the safety of nanoparticles in general (Radusin and others ) as well as constraints associated with the current legislative landscape (Amenta and others ; Radusin and others ; Rauscher and others ).…”
Section: Nanoparticlesmentioning
confidence: 99%
“…Although they are composed of materials that are well known since decades, evaluation of engineered nanomaterials poses a particular regulatory challenge . The European Commission (EC) and the Food and Drug Administration (FDA) are directing efforts towards more unified testing and assessment criteria . In the past, membership to the family of nanomaterials was granted on the basis of physical dimensions; however, modern regulation and guidelines by the FDA and the EC are going away from this strict size dependence and extend the family also to microsized agglomerates.…”
Section: Regulatory and Toxicological Aspectsmentioning
confidence: 99%
“…Nanoparticles (NPs) are NMs that have all three dimensions between 1 and 100 nm. A material can also be considered as a NM if its volume-specific surface area is larger than 60 m 2 cm À3 (Rauscher et al, 2017). However, the term NM in nanomedicine extends this commonly accepted definition to particles with dimensions up to 1000 nm (Schütz et al, 2013a).…”
Section: Introductionmentioning
confidence: 99%