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Citation suggérée : Anses. (2022). Définition des nanomatériaux : enjeux, analyse et controverses (Saisine n° 2018-SA-0168). Maisons-Alfort : Anses, 128 p.; L’utilisation croissante des substances à l’état nanoparticulaire dans des secteurs d’activité trèsvariés a conduit les pouvoirs publics à faire évoluer la réglementation nationale et européenne pour prendre en compte leurs spécificités.La caractéristique dimensionnelle de ces substances, susceptible de conférer aux matériaux despropriétés ou comportements particuliers, laisse également entrevoir de probables différences en matière d’évaluation du risque (toxicité – écotoxicité et devenir dans l’environnement). Alors que ces substances sont souvent développées pour leurs propriétés spécifiques et considérées comme des vecteurs d’innovation, l’état des connaissances concernant les effets potentiels de ces substances sur l’environnement et la santé demeure généralement insuffisant pour en évaluer les risques (Anses 2014).En l’absence d’une définition pleinement partagée permettant de définir le périmètre des objetsconcernés, une première étape vers une meilleure connaissance a consisté à harmoniser levocabulaire employé (nano-objets, agrégats, agglomérats, nanomatériaux manufacturés, etc.) via la normalisation dans un premier temps, puis à établir une définition et des critères permettant de caractériser ces substances tels que leur taille, leur distribution, leur surface spécifique, etc.Au niveau européen, la recommandation du 18 octobre 2011 de la Commission européenne (CE)relative à la définition des nanomatériaux (2011/696/UE) a servi de référence à plusieurs reprisesdans les différents textes législatifs. Celle-ci s’est appuyée sur les travaux du Scenihr (ScientificCommittee on Emerging and Newly Identified Health Risks) portés sur ce sujet et publiés en 2010(Scenihr 2010).La Commission européenne avait proposé de s’appuyer sur cette définition pour adapter cellefigurant dans le Règlement n°1169/2011 relatif à l’information du consommateur sur les denréesalimentaires, notamment en y introduisant le seuil de 50 % de particules en nombre. Cetteproposition a été rejetée par le Parlement européen au motif que rien ne justifiait l’introduction d’un tel seuil, inadapté en l’occurrence pour répondre à la demande d’information du consommateur. En conséquence, seule la définition figurant dans le règlement relatif aux nouveaux aliments, à laquelle renvoie le Règlement n°1169/2011, s’applique dans le cadre des contrôles opérés par la Direction générale de la consommation, de la concurrence et de la répression des fraudes (DGCCRF) pour s’assurer de la bonne information du consommateur sur le caractère nanométrique des ingrédients mis en œuvre. Cette définition ne comporte pas de seuil, de sorte qu’un ingrédient est déclaré « nano » dès lors que la présence de nanoparticules est avérée. Dans la pratique, selon la méthodologie de contrôle développée par le Service commun des laboratoires, un ingrédient est considéré correspondre à un nanomatériau lorsque 10 % au moins des particules en présence sont de taille nanométrique.Actuellement, la définition de « nanomatériau » peut différer d’un règlement européen à l’autre(règlements sur les produits biocides, sur les produits cosmétiques, sur les nouveaux aliments, sur l’information des consommateurs sur les denrées alimentaires, sur les dispositifs médicaux). Les travaux portant sur la révision des annexes du Règlement 1907/2006 « REACH » pour l’adapter aux substances sous forme nanoparticulaire ont été publiés en 2018 (Règlement UE 2018/1881). Le projet de texte de ces annexes a été voté par la Commission en comité le 26 avril 2018 et est entré en application le 1 er janvier 2020. Le texte se réfère à la recommandation de définition européenne.Les définitions actuelles proposées dans la recommandation de la Commission de 2011 et dans les différents règlements comportent des différences et des imprécisions (seuil de 50 % en nombre, taille, notions d’insolubilité ou de bio-persistance dans le règlement cosmétique, etc.), régulièrement mises en avant par les parties prenantes. Celles-ci souhaitent l’établissement d’une définition plus claire et harmonisée. La Commission européenne avait annoncé dans plusieurs communications relatives à cette recommandation son intention de la réviser avant décembre 2014 pour mieux prendre en compte les spécificités de ces substances, l’avancée des connaissances et préciser certains points de la définition.Le Joint Research Center (JRC), service de recherche de la Commission européenne, a publié en2014 un premier rapport comportant des propositions relatives aux critères pouvant être pris enconsidération pour définir les nanomatériaux (Rauscher et al. 2015). Plus récemment, en préparation de la proposition de définition par la Commission européenne, le JRC a publié début 2019 un document support définissant les termes et concepts utiles liés à la définition (Rauscher, Roebben, et al. 2019) puis un autre rapport relatif cette fois-ci aux techniques analytiques d’identification des nanomatériaux (Rauscher, Mech, et al. 2019).Après plusieurs phases de discussion engagées dès 2012, la Commission a ouvert une courtephase de consultation publique (du 06/05/2021 au 30/06/2021) afin de recueillir les avis quant aux propositions d’évolution de la définition européenne datant de 2011. Cette phase de consultation s’est achevée par la publication d’une nouvelle Recommandation de définition le 10 juin 2022.

International audience; RNA interference is a promising crop protection technology that has seen rapid development in the past several years. Here, we investigated polyamino acid biopolymers, inorganic nanomaterials, and hybrid organic–inorganic nanomaterials for delivery of dsRNA and efficacy of gene knockdown using the model nematode Caenorhabditis elegans. Using an oral route of delivery, we are able to approximate how nanomaterials will be delivered in the environment. Of the materials investigated, only Mg–Al layered double-hydroxide nanoparticles were effective at gene knockdown in C. elegans, reducing marker gene expression to 66.8% of that of the control at the lowest tested concentration. In addition, we identified previously unreported injuries to the mouthparts of C. elegans associated with the use of a common cell-penetrating peptide, poly-l-arginine. Our results will allow the pursuit of further research into promising materials for dsRNA delivery and also allow for the exclusion of those with little efficacy or deleterious effects.

The recent years have witnessed an increased interest in developing (pre)-standardized procedures and guidance documents for a harmonized determination of parameters utilized in the risk assessment of nanomaterials. This consists in a variety of exposure- and hazard measurements, including "simple" physical-chemical values (e.g. size, charge) as well as biological end-points. Usually, these are standalone tests developed independently of one another. As a result, these parameters, that often are at the node of risk assessment trees, are determined under a number of experimental conditions. Nevertheless, one might wonder to which extent the non- occupational section of the life cycle of a nanomaterial can be accounted for by a sequence of tests. Indeed in an actual environment, the fate of a nanomaterial is under the control of a multiplicity of simultaneously interacting parameters, and does not necessarily obey the dichotomic process of usual risk assessment schemes. Mesocosm testing is an interesting alternative to performing separate determination of a collection of parameters. Indeed, mesocosms provide exposure and hazard data in a single experiment. The systems are allowed (and even expected) to evolve, as opposed to strictly controlled standards. Robustness of this method for monitoring the environmental effects of nanomaterials has been demonstrated. The critical factor over which theoperator has a control, is the exposure scenario (e.g. pulse vs. chronic contamination, applied dose). Here we show how guidance on how to carefully design this exposure, could translate into a standardized procedure for using mesocosm testing as risk assessment tool.

International audience; To address concerns about the safety of nanomaterials, the use of the safe(r) by design is attracting increasing interest in the development of these materials. Indeed, to reduce the risk associated with nanomaterials, the strategy consists in reducing the hazard or the exposure or both. While lowering the hazard may not be an option without comprising the functionality, reducing the exposure is usually easier to achieve. This often translates to design materials in which the active (and potentially hazardous) nanoparticle is surrounded by a shell /embedded in a matrix to protect against harmful effects and/or prevent release from the material.The effectiveness of this strategy rest on the stability of the composite, i.e. the strength of the bond between the nanoparticle and its shells as well as the resistance of the shell(s)/matrix during the use and end-of-life phases of the nano-enabled products. The material stability is examined after real/simulated aging with element specific probes. Here we present some examples taken from case studies using off the shelf products on how surface speciation informs about the efficiency of the product formulation in a safe(r) by design perspective.

International audience; Recent research efforts have gone into formalizing and standardizing the Safe by Design process of nanomaterials. This usually results in a structured and (most often) sequential approach deliberately putting the focus on hazard and exposure issues regarding the nanomaterial itself in a bottom-up progression of material development. However, this general strategy lacks flexibility. Within the project SERENADE, a case study examining photocatalytic paint failed to validate the generally accepted Safe by Design scheme. This example examined the product (paint in this case) rather than the nanomaterials it contains. It was found that the essential parameters, namely product specification and functionality, failed to fit into a rigid bottom-up approach and indicated the need for alternative Safe by Design strategies.

International audience; Developing safe nanomaterials has become a major concern in all the industry sectors using advanced materials. However, there are very few initiatives addressing this issue. The SERENADE project, with its long-term funding scheme, provided a unique opportunity to foster a coordinated, yet diverse approach to investigate the safe-by-design development of nanomaterials in a variety of application fields, using a targeted set of inter-disciplinary case studies. The originality of the approach was to cover as many multiple technology readiness levels (TRLs) and life cycle stages as possible, combined with shared hazard and end- of-life assessments in an effort towards a (more) comprehensive and resource driven research.

Eine Folge des Vietnamkrieges war das lang andauerndende Vermächtnis der Protestmusik. Oft verdeutlichten die Songtexte der Ära die Schrecken des Krieges und reflektierten die politische Meinung von Teilen der Bevölkerung. Viele dieser Lieder sind zu integralen Bestandteilen der Popkultur geworden, auch durch ihre Wiederverwendung in Medien, die die Ära behandeln. Diese Entwicklung mit der Bush Ära, die auch mit Konflikten wie den Angriffen des 11ten Septembers und den Kriegen im Irak und in Afghanistan konfrontiert war, zu vergleichen ist das Ziel dieser Arbeit, da beide Perioden und Kriege sehr verschiedene musikalische und lyrische Reaktionen auf diese Probleme aufzuweisen hatten. Im Gegenteil zur Protestmusik der Vietnam Ära gab es keine Lieder der Bush Jahre die sich über ihre Zeit hinaus im kollektiven Bewusstsein der betreffenden Generation festgesetzt haben. Ähnlich zum Vietnamkrieg wurden die Kriege in Irak und Afghanistan jedoch grösstenteils von Teilen der US Bevölkerung abgelehnt. Da wir uns in einer Zeit befinden in der die Spannungen zwischen den USA und dem Mittleren Osten, sowie dem Fernen Osten, immer wieder aufflammen, wäre es angebracht die Kritik der Musik aus der Vietnam Ära und der Bush Ära zu beachten. Meine komparative Analyse hat es zum Ziel die Gemeinsamkeiten und die Unterschiede in der Musik der beiden Ären zu untersuchen um die heutigen, international Konflikte besser zu verstehen und kritisieren zu können. Um die Gründe für diese Unterschiede zu finden, werden bestimmte Songs aus beiden Perioden im Detail analysiert. Dies wird durch einen vergleichenden Ansatz und ein Close Reading gewährleistet. Da kriegsunterstützende Musik auch behandelt werden muss, werden Richard Slotkin’s Ausführungen über die Beziehung der USA zu Gewalt ebenfalls als Referenz genutzt. Die These wird ebenfalls akademische Erkenntnisse zu spezifischen Bereichen des Themas anwenden um so genau wie möglich bestimmte Ergebnisse aufzuzeigen, welche zur Schlussfolgerung führen., The Vietnam War sparked a lasting legacy of protest music. Moreover, the lyrical exploits of the Vietnam era often detailed the horrors of war and reflected the political opinions of parts of the population. These songs have become staples of popular culture, especially in media treating the period. Comparing this trend to the years under the presidency of President George W. Bush, which themselves had a major conflict in the 9/11 attacks and the resulting wars in Iraq and Afghanistan, is then the aim of this thesis, as both eras and wars had very different responses musically and lyrically. Contrary to the Vietnam protest music, there has not been a historically lasting crop of songs that survived the Bush era and are as fondly remembered. However, similarly to the Vietnam War, the wars in Iraq and Afghanistan were largely opposed by parts of the US population. As we find ourselves again in an era of rising tensions between the US and both the Middle and Far East, we would do well to heed the criticisms of the protest songwriters of the Vietnam and War on Terror eras, and my comparative analysis aims to investigate the similarities and differences between the music of these eras to better understand and criticise the international conflicts of today. In order to find the causes for this difference, several songs from both the Vietnam era and the Bush era will be analysed in detail. This is accomplished through a comparative approach and close reading. As pro-war music has to be mentioned too, Richard Slotkin’s thoughts on violence in relation to the United States will be used as a reference to those. The thesis will also apply scholarly research that has been done on specific areas relevant to the topic in order to accurately depict certain findings that lead toward the conclusion.

International audience; In the past decade, mesocosms have emerged as a useful tool for the environmental study of engineered nanomaterials (ENMs) as they can mimic the relevant exposure scenario of contamination. Herein, we analyzed the scientific outcomes of aquatic mesocosm experiments, with regard to their designs, the ENMs tested, and the end points investigated. Several mesocosm designs were consistently applied in the past decade to virtually mimic various contamination scenarios with regard to ecosystem setting as well as ENMs class, dose, and dosing. Statistical analyses were carried out with the literature data to identify the main parameters driving ENM distribution in the mesocosms and the potential risk posed to benthic and planktonic communities as well as global ecosystem responses. These analyses showed that at the end of the exposure, mesocosm size (water volume), experiment duration, and location indoor/outdoor had major roles in defining the ENMs/metal partitioning. Moreover, a higher exposure of the benthic communities is often observed but did not necessarily translate to a higher risk due to the lower hazard posed by transformed ENMs in the sediments (e.g., aggregated, sulfidized). However, planktonic organisms were generally exposed to lower concentrations of potentially more reactive and toxic ENM species. Hence, mesocosms can be complementary tools to existing standard operational procedures for regulatory purposes and environmental fate and risk assessment of ENMs. To date, the research was markedly unbalanced toward the investigation of metal-based ENMs compared to metalloid-and carbon-based ENMs but also nanoenabled products. Future studies are expected to fill this gap, with special regard to high production volume and potentially hazardous ENMs. Finally, to take full advantage of mesocosms, future studies must be carefully planned to incorporate interdisciplinary approaches and ensure that the large data sets produced are fully exploited.

International audience; Traditional aging protocols typically examine only the e↵ects of a limited number of stresses, and relatively harsh conditions may trigger degradation mechanisms that are not observed in actual situations. Environmental aging is, in essence, the complex interaction of multiple mechanical, physicochemical and biological stresses. As yet, there is no (pre)standardized procedure that addresses this issue in a satisfactory manner. Mesocosm experiments can be designed to specifically cover the aging of nanomaterials while characterizing the associated exposure and hazard. The scenario of exposure and the life time of the nanomaterial appear as the predominant factors in the design of the experiment, and appropriate precautions need to be taken. This should the subject of guidance that may be divided into product/application categories. 1. The Importance of the Aging Factor There are still major knowledge gaps in the risk assessment of nanomaterials, especially in the post-production stages of their life cycle. However, in most cases, the use and end-of-life phases are by far the longest periods, and this extended duration is a potential concern with regard to exposure to nanomaterials, as well as associated hazards. Apart from a few exceptions, nanomaterials with the desired properties are not used "as is", but are embedded in the final product after several formulation steps (e.g., encapsulation, attachment/embedding into a matrix, etc.) for targeted functionality, better product safety, or simply ease of use. As a consequence, the pristine/isolated nanoparticle is no longer the only compound that needs to be considered in risk assessment. The nature and the structure of the bearing matrix control the exposure to the nanomaterial and the associated hazard. In other words, the entire nano-enabled product and its evolution with time, i.e., aging, become determining factors in the risk assessment. While a newly manufactured product should not be a concern for the consumer or the environment, aging is likely to change the mobility and the speciation of embedded nanomaterials, and may cause potential adverse e↵ects towards the consumer and/or the environment. As a consequence, attention needs to be paid to the degradation of the matrix, shell(s) and coating(s) surrounding the nanomaterial in order to avoid its release in a form that is, or might become, hazardous. It is noteworthy that understanding the (bio)physicochemical mechanisms of matrix degradation leading to nanomaterial release is challenging and requires the use of powerful characterization tools [1-3]. Therefore, even if release is a direct consequence of the degradation of the matrix, aging is often studied via the quantification of the release with simple metrics.