Agnes G Oomen

• Professor
• Senior scientist at National Institute for Public Health and the Environment

Orthopedic hip implant failure due to adverse events, such as infection, are still a major problem leading to high morbidity and mortality. Over the years, various innovative biomaterials have been investigated to improve safety and functionality of implants. Although novel biomaterials show initial promising results, many fail at the (later) stage...

Re‐evaluation of silicon dioxide (E 551) as a food additive in foods for infants below 16 weeks of age and follow‐up of its re‐evaluation as food additive for uses in foods for all population groups EFSA Panel on Food Additives and Flavourings (FAF), Maged Younes, Gabriele Aquilina, Laurence Castle, Gisela Degen, Karl-Heinz Engel, Paul Fowler, Mari...

Plenty of new approach methodologies (NAMs) for risk assessment have been developed but only some are included in OECD Test Guidelines (TGs) for regulatory implementation. Nevertheless, NAMs are increasingly applied, e.g. for nanomaterial (NM) risk assessments. The EFSA Guidance on NM risk assessment suggests that NAM‐derived data concerning degrad...

New Approach Methodologies (NAMs), broadly understood to include in silico, in chemico, in vitro and ex vivo methods, show great potential in advancing risk assessment albeit their regulatory implementation is lagging. The EFSA Guidance on risk assessment of nanomaterials (EFSA Guidance on Nano‐RA) suggests nano‐specific risk assessment is best ach...

The current use of chemicals puts pressure on human and ecological health. Based on the Aarhus Convention, citizens have the right to have access to information on substances in their local environment. Providing this information is a major challenge, especially considering complex mixtures, as the current substance-by-substance risk assessment may...

Concepts of similarity applied to complex multicomponent advanced materials for an informed balance of performance and hazard.

The dissolution of a nanomaterial (NM) in an in vitro simulant of the oro-gastrointestinal (OGI) tract is an important predictor of its biodurability in vivo. The cascade addition of simulated digestive juices (saliva, stomach and intestine), including inorganic/organic biomacromolecules and digestive enzymes (complete composition, referred to as “...

The GRACIOUS Framework (www.h2020gracious.eu) supports the grouping of nanomaterials to streamline hazard testing of nanomaterials. The GRACIOUS Framework includes a template to generate grouping hypotheses based upon use and life cycle stage (to inform exposure route), physicochemical properties (what they are), fate or toxicokinetics (where they...

“Advanced Materials” (AdMas) represent the next technology frontier. According to the European Union, AdMas are materials that feature a series of exceptional properties or functionalities compared to conventional materials. Considering the progress made in the design and application of AdMas, their adverse effects are still largely unknown whilst...

Background Nanomaterials can exist in different nanoforms (NFs). Their grouping may be supported by the formulation of hypotheses which can be interrogated via integrated approaches to testing and assessment (IATA). IATAs are decision trees that guide the user through tiered testing strategies (TTS) to collect the required evidence needed to accept...

Background The EU-project GRACIOUS developed an Integrated Approach to Testing and Assessment (IATA) to support grouping high aspect ratio nanomaterials (HARNs) presenting a similar inhalation hazard. Application of grouping reduces the need to assess toxicity on a case-by-case basis and supports read-across of hazard data from substances that have...

Get access Share icon Skip to Main Content Log in | Register Search in: Nanotoxicology Latest Articles 0 Views 0 CrossRef citations to date 0 Altmetric Article Integrated approaches to testing and assessment for grouping nanomaterials following dermal exposure Exposure to different nanoforms (NFs) via the dermal route is expected in occupationa...

Nanocellulose is an emerging material for which several food-related applications are foreseen, for example, novel food, functional food, food additive or in food contact materials. Nanocellulose materials can display a range of possible shapes (fibers, crystals), sizes and surface modifications. For food-related applications in the EU, information...

The risk assessment of ingested nanomaterials (NMs) is an important issue. Here we present nine integrated approaches to testing and assessment (IATAs) to group ingested NMs following predefined hypotheses. The IATAs are structured as decision trees and tiered testing strategies for each decision node to support a grouping decision. Implications (e...

Introduction: Here, we describe the generation of hypotheses for grouping nanoforms (NFs) after inhalation exposure and the tailored Integrated Approaches to Testing and Assessment (IATA) with which each specific hypothesis can be tested. This is part of a state-of-the-art framework to support the hypothesis-driven grouping and read-across of NFs,...

Following a mandate from the European Commission, EFSA has developed a Guidance on Technical Requirements (Guidance on Particle-TR), defining the criteria for assessing the presence of a fraction of small particles, and setting out information requirements for applications in the regulated food and feed product areas (e.g. novel food, food/feed add...

The EFSA has updated the Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain, human and animal health. It covers the application areas within EFSA's remit, including novel foods, food contact materials, food/feed additives and pesticides. The updated guidance, now Scientific Committee Guidan...

The EU Chemicals Strategy for Sustainability is a first step to achieve the Green Deal ambition for a toxic-free environment, and ensure that chemicals are produced and used in a way that maximises their contribution to society while avoiding harm to our planet and to future generations. Advanced materials are predicted to play a pivotal role in ac...

Synthetic amorphous silica (SAS) is applied in food products as food additive E 551. It consists of constituent amorphous silicon dioxide (SiO2) nanoparticles that form aggregates and agglomerates. We reviewed recent oral toxicity studies with SAS. Some of those report tissue concentrations of silicon (Si). The results of those studies were compare...

The present opinion deals with an updated safety assessment of the food additive titanium dioxide (E 171) based on new relevant scientific evidence considered by the Panel to be reliable, including data obtained with TiO2 nanoparticles (NPs) and data from an extended one-generation reproductive toxicity (EOGRT) study. Less than 50% of constituent p...

Here we describe the development of an Integrated Approach to Testing and Assessment (IATA) to support the grouping of different types (nanoforms; NFs) of High Aspect Ratio Nanomaterials (HARNs), based on their potential to cause mesothelioma. Hazards posed by the inhalation of HARNs are of particular concern as they exhibit physical characteristic...

Titanium dioxide (TiO2) is used as a food additive (E171) and can be found in sauces, icings, and chewing gums, as well as in personal care products such as toothpaste and pharmaceutical tablets. Along with the ubiquitous presence of TiO2 and recent insights into its potentially hazardous properties, there are concerns about its application in comm...

Recent studies reported adverse liver effects and intestinal tumor formation after oral exposure to titanium dioxide (TiO2). Other oral toxicological studies, however, observed no effects on liver and intestine, despite prolonged exposure and/or high doses. In the present assessment, we aimed to better understand whether TiO2 can induce such effect...

The Risk Assessment Committee of the European Chemicals Agency issued an opinion on classifying titanium dioxide (TiO 2 ) as a suspected human carcinogen upon inhalation. Recent animal studies indicate that TiO 2 may be carcinogenic through the oral route. There is considerable uncertainty on the carcinogenicity of TiO 2 , which may be decreased if...

Silicon dioxide (silica, SiO2, SAS) and titanium dioxide (TiO2) are produced in high volumes and applied in many consumer and food products. As a consequence, there is a potential human exposure and subsequent systemic uptake of these particles. In this study we show the characterization and quantification of both total silicon (Si) and titanium (T...

Thanks to nanotechnology, an abundance of new products and nanomaterials for food can be developed. Nano-iron, for example, could be added to foods to fight anaemia and nano-packaging methods can be developed to improve the shelf life of products. Manufacturers are responsible for public safety and must meet legislation and regulations. But the cu...

The physico-chemical properties of manufactured nanomaterials (NMs) can be fine-tuned to obtain different functionalities addressing the needs of specific industrial applications. The physico-chemical properties of NMs also drive their biological interactions. Accordingly, each NM requires an adequate physico-chemical characterization and potential...

Nanotechnologies are characterized by a growing legacy of already marketed and novel manufactured nanomaterials (MNMs) and nano-enabled products with a lack of a coherent risk governance system to address their safety effectively. In response to this situation, a proactive system is needed to minimize the gap between the pace of innovation and the...

https://www.rivm.nl/bibliotheek/rapporten/2018-0181.pdf The term ’food contact materials’ describes packaging materials which are used for food and consumer items, such as pans, dishes and baking aids. Per- and polyfluoroalkyl substances (PFASs) are used in the construction of these materials because of their grease repelling qualities. It appears...

This paper presents a comprehensive review of European Union (EU) legislation addressing the safety of chemical substances, and possibilities within each piece of legislation for applying grouping and read-across approaches for the assessment of nanomaterials (NMs). Hence, this review considers both the overarching regulation of chemical substances...

This paper presents a comprehensive review of European Union (EU) legislation addressing the safety of chemical substances, and possibilities within each piece of legislation for applying grouping and read-across approaches for the assessment of nanomaterials (NMs). Hence, this review considers both the overarching regulation of chemical substances...

The European Food Safety Authority has produced this Guidance on human and animal health aspects (Part 1) of the risk assessment of nanoscience and nanotechnology applications in the food and feed chain. It covers the application areas within EFSA's remit, e.g. novel foods, food contact materials, food/feed additives and pesticides. The Guidance ta...

Background: Titanium dioxide (TiO2) is produced at high volumes and applied in many consumer and food products. Recent toxicokinetic modelling indicated the potential of TiO2 to accumulate in human liver and spleen upon daily oral exposure, which is not routinely investigated in chronic animal studies. A health risk from nanosized TiO2 particle co...

An Environmental Risk Assessment (ERA) for nanomaterials (NMs) is outlined in this paper. Contrary to other recent papers on the subject, the main data requirements, models and advancement within each of the four risk assessment domains are described, i.e., in the: (i) materials, (ii) release, fate and exposure, (iii) hazard and (iv) risk character...

The increasing application of nanomaterials and the notion that their distinct features compared to larger sized counterparts should be considered in safety assessment, has led to the development of risk assessment frameworks that are specific to nanomaterials. These frameworks aim to prioritise, rank or assess the safety of a nanomaterial efficien...

Nanotechnologies in Food provides an overview of the products and applications of nanotechnologies in agri-food and related sectors. Following on from the success of the first edition, this new edition has been revised and updated to bring the reader fully up to date on the emerging technological, societal, and policy and regulatory aspects in rela...

The NANoREG framework addresses the need to ease the nanomaterials safety assessment in the REACH Regulation context. It offers forward-looking strategies: Safe-by-Design, a Nanospecific Prioritisation and Risk Assessment, and Life Cycle Assessment. It is intended for scientific experts, regulatory authorities and industry

New research by the Dutch National Institute for Public Health and the Environment (RIVM) indicates that the health risk of playing sports on synthetic turf pitches with an infill of rubber granulate is virtually negligible. Therefore, it is considered safe for people to play sports on such pitches. The research was conducted following public conce...

Evaluation of health risks of playing sports on synthetic turf fields with rubber granulate. New research by the Dutch National Institute for Public Health and the Environment (RIVM) indicates that the health risk of playing sports on synthetic turf fields with an infill of rubber granulate is virtually negligible. Therefore, it is considered safe...

Titanium dioxide white pigment consists of particles of various sizes, from which a fraction is in the nano range (<100 nm). It is applied in food as additive E 171 as well as in other products, such as food supplements and toothpaste. Here, we assessed whether a human health risk can be expected from oral ingestion of these titanium dioxide nanopa...

Titanium dioxide (TiO2) is commonly applied to enhance the white colour and brightness of food products. TiO2 is also used as white pigment in other products such as toothpaste. A small fraction of the pigment is known to be present as nanoparticles (NPs). Recent studies with TiO2 NPs indicate that these particles can have toxic effects. In this pa...

Commercialization of nanotechnologies entails a regulatory requirement for understanding their environmental, health and safety (EHS) risks. Today we face challenges to assess these risks, which emerge from uncertainties around the interactions of manufactured nanomaterials (MNs) with humans and the environment. In order to reduce these uncertainti...

In the current paper, a new strategy for risk assessment of nanomaterials is described, which builds upon previous project outcomes and is developed within the FP7 NANoREG project. NANoREG has the aim to develop, for the long term, new testing strategies adapted to a high number of nanomaterials where many factors can affect their environmental and...

http://www.rivm.nl/bibliotheek/rapporten/2016-0049.pdf People living in the direct neighborhood of the Dupont/Chemours factory in Dordrecht have been exposed to perfluorooctanoic acid (PFOA) by air for many years. It is likely that they have been chronically exposed to higher values of PFOA than the limit value for chronic exposure derived by RIV...

An engineered nanomaterial (ENM) may actually consist of a population of primary particles, aggregates and agglomerates of various sizes. Furthermore, their physico-chemical characteristics may change during the various life-cycle stages. It will probably not be feasible to test all varieties of all ENMs for possible health and environmental risks....

The rapidly expanding manufacturing, production and use of nanomaterials has raised concerns for both worker and consumer safety. Various studies have been published in which induction of pulmonary inflammation after inhalation exposure to nanomaterials has been described. Nanomaterials can vary in aspects such as size, shape, charge, crystallinity...

Physicochemical properties of chemicals affect their exposure, toxicokinetics/fate and hazard, and for nanomaterials, the variation of these properties results in a wide variety of materials with potentially different risks. To limit the amount of testing for risk assessment, the information gathering process for nanomaterials needs to be efficient...

Nanomaterials (NMs) display many unique and useful physico-chemical properties. However, reliable approaches are needed for risk assessment of NMs. The present study was performed in the FP7-MARINA project, with the objective to identify and evaluate in vitro test methods for toxicity assessment in order to facilitate the development of an intellig...

A number of studies have shown that induction of pulmonary toxicity by nanoparticles of the same chemical composition depends on particle size, which is likely in part due to differences in lung deposition. Particle size mostly determines whether nanoparticles reach the alveoli, and where they might induce toxicity. For the risk assessment of nanom...

Aim: A horizon scan of nanomedicinal product on the market or undergoing clinical investigation by analyzing the current nanomedicinal landscape. Materials & methods: The horizon scan includes a search of literature, clinical trial registries and the internet. Results: This horizon scan yielded 175 nanomedicinal products. Most products were in...

Doses of conventional chemical substances in toxicity studies are traditionally described by administered mass. For deriving toxic doses of nanomaterials, mass and chemical composition alone may not be an adequate description of the dose as particles with the same chemical composition can have completely different toxic mass doses, depending on pro...

Abstract This study presents novel insights in the risk assessment of synthetic amorphous silica (SAS) in food. SAS is a nanostructured material consisting of aggregates and agglomerates of primary particles in the nanorange (<100 nm). Depending on the production process, SAS exists in four main forms, and each form comprises various types with dif...

Objective: The aim of this study was to obtain kinetic data that can be used in human risk assessment of titanium dioxide nanomaterials. Methods: Tissue distribution and blood kinetics of various titanium dioxide nanoparticles (NM-100, NM-101, NM-102, NM-103, and NM-104), which differ with respect to primary particle size, crystalline form and h...

Titanium dioxide (TiO2) is a common food additive used to enhance the white colour, brightness and sometimes flavour of a variety of food products. In this study seven food grade TiO2 materials (E171), 24 food products and three personal care products were investigated for their TiO2 content and the number-based size distribution of TiO2 particles...

http://www.ttl.fi/en/publications/Electronic_publications/Nanosafety_in_europe_2015-2025/Documents/nanosafety_2015-2025.pdf

Abstract Bringing together topic-related European Union-(EU)-funded projects, the so-called "NanoSafety Cluster" aims at identifying key areas for further research on risk assessment procedures for nanomaterials (NM). The outcome of NanoSafety Cluster Working Group 10, this commentary presents a vision for concern-driven integrated approaches for t...

Patulin is a mycotoxin for which a provisional maximum tolerable daily intake (PMTDI) of 400 ng/kg bodyweight/day has been set based on its most sensitive toxic effect, growth retardation. Apple containing products are the major source for patulin exposure, with major intake differences according to age and living region. Young children are most at...

In order to obtain more insight into the tissue distribution, accumulation, and elimination of cerium oxide nanoparticles after inhalation exposure, blood and tissue kinetics were investigated during and after a 28-day inhalation study in rats with micro- and nanocerium oxide particles (nominal primary particle size: < 5000, 40, and 5-10 nm). Powde...

Abstract This manuscript describes the follow-up study of our previous publication on the presence and risks of nanosilica in food. New information on the presence of nanosilica in the gastrointestinal tract is evaluated and information on nanosilica and Synthetic Amorphous Silica (SAS) is compared to asses its relevance for risk assessment of nano...

The presence, dissolution, agglomeration state, and release of materials in the nano-size range from food containing engineered nanoparticles during human digestion is a key question for the safety assessment of these materials. We used an in vitro model to mimic the human digestion. Food products subjected to in vitro digestion included (i) hot wa...

Interpretation and implications of the European Commission definition on nanomaterials In October 2011, the European Commission published the Recommendation on the Definition of Nanomaterial. RIVM considers this definition to be a good basis for further discussion that should focus on two aspects of the definition: the proposed size limits for nano...

This study uniquely describes all steps of the risk assessment process for the use of one specific nanomaterial (nanosilica) in food products. The aim was to identify gaps in essential knowledge and the difficulties and uncertainties associated with each of these steps. Several food products with added silica (E551) were analyzed for the presence,...

The Bioaccessibility Research Group of Europe (BARGE) has carried out an inter-laboratory trial of a proposed harmonised in vitro physiologically based ingestion bioaccessibility procedure for soils, called the Unified BARGE Method (UBM). The UBM includes an initial saliva phase and simulated stomach and intestine compartments. The trial involved t...

To develop and determine the safety of gold nanorods, whose aspect ratios can be tuned to obtain plasmon peaks between 650 and 850 nm, as contrast enhancing agents for diagnostic and therapeutic applications. In this study we compared the blood clearance and tissue distribution of cetyl trimethyl ammonium bromide (CTAB)-capped and polyethylene glyc...

Blood kinetics and tissue distribution of 20, 80 and 110 nm silver nanoparticles were investigated in rats up to 16 days after intravenous administration once daily for 5 consecutive days. Following both single and repeated injection, silver nanoparticles disappeared rapidly from the blood and distributed to all organs evaluated (liver, lungs, sple...

Nano-silver is used in an increasing number of products. Some of the applications have resulted in the concern of governments and the public, since little is known about the potential risks of nano-silver. In this review, an inventory is made to identify knowledge gaps that have to be filled before risks for both man and the environment can be asse...

Nowadays the development and applications of nanotechnology are of major importance in both industrial and consumer areas. However, the knowledge on human exposure and possible toxicity of nanotechnology products is limited. To understand the mechanism of toxicity, thorough knowledge of the toxicokinetic properties of nanoparticles is warranted. Th...

A test method for the determination of PAH relative bioaccessibility from contaminated soils was implemented and validated for use in risk assessment of soils from contaminated sites meeting performance requirement set for evaluation against regulatory limits. Relative bioaccessibilities of soil benzo(a)pyrene obtained with the test were linearly c...

This paper presents a multi-laboratory comparison study of in vitro models assessing bioaccessibility of soil-bound lead in the human gastrointestinal tract under simulated fasted and fed conditions. Oral bioavailability data from a previous human in vivo study on the same soil served as a reference point. In general, the bioaccessible lead fractio...

Children ingest soil. The amount ingested varies with the child's behaviour, and daily ingestion rates have been calculated to be between 39 and 270 mg day(-1). During play, children ingest soil both involuntarily and deliberately, and it can be assumed that the latter may result in ingestion of a larger soil particle size fraction and a larger soi...

A set of test methods for estimating the risk for human health (oral bioaccessibility tests) and groundwater (leaching tests) was applied to contaminated soils from three sites with different sources of contamination. The bioaccessible soil concentrations of the contaminants cadmium, lead, nickel, benzo(a)pyrene and dibenz(a,h)anthracene were consi...

The RIVM has developed a guideline to accurately determine, for a specific location, the amount of lead in soil that may pose a risk to human health. Such a determination will allow a more accurate risk assessment of lead-contaminated soil. Many sites in the Netherlands are contaminated with lead. Lead intoxication puts especially children at risk,...