Agnes G. Oomen
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View article: Minimising data needs to support the safer design of multicomponent nanomaterials – Application of grouping
Minimising data needs to support the safer design of multicomponent nanomaterials – Application of grouping Open
View article: Boosting advanced material's innovation – Are we regulatory prepared?
Boosting advanced material's innovation – Are we regulatory prepared? Open
In its policy communications, the European Commission placed advanced materials (AdMa) at the forefront of its strategic agenda, highlighting them as crucial elements to strive for a more sustainable, competitive, and resilient Europe. AdM…
View article: Supporting Safe-by-Design of Multicomponent Nanomaterials by Linking Functionality-Related Properties with Potential Safety Issues
Supporting Safe-by-Design of Multicomponent Nanomaterials by Linking Functionality-Related Properties with Potential Safety Issues Open
Advanced materials, including multicomponent nanomaterials (MCNMs), are rationally designed to show specific new or enhanced functionalities. They are considered key in solving current societal challenges, such as the energy transition, ye…
View article: Follow‐up of the re‐evaluation of silver (E 174) as a food additive (EFSA‐Q‐2023‐00169)
Follow‐up of the re‐evaluation of silver (E 174) as a food additive (EFSA‐Q‐2023‐00169) Open
Silver (E 174) is a food colour that was re‐evaluated by the EFSA ANS Panel (2016). The ANS Panel concluded that the information available then, was insufficient to assess the safety of silver as food additive. The major issues included li…
View article: Utilizing biomaterial surface properties to improve orthopedic hip implant safety and function in a Safe-by-Design approach
Utilizing biomaterial surface properties to improve orthopedic hip implant safety and function in a Safe-by-Design approach Open
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 functi…
View article: Expert perspectives on impact assessment of chemical mixtures in the living environment: Feasibility, knowledge integration and communication
Expert perspectives on impact assessment of chemical mixtures in the living environment: Feasibility, knowledge integration and communication Open
View article: Titanium Carbide Mxenes – Early Identification of Safety, Sustainability and Regulatory Issues
Titanium Carbide Mxenes – Early Identification of Safety, Sustainability and Regulatory Issues Open
View article: Minimising Data Needs to Support the Safe-by-Design of Multicomponent Nanomaterials – Application of Grouping
Minimising Data Needs to Support the Safe-by-Design of Multicomponent Nanomaterials – Application of Grouping Open
View article: Regulatory preparedness for multicomponent nanomaterials: Current state, gaps and challenges of REACH
Regulatory preparedness for multicomponent nanomaterials: Current state, gaps and challenges of REACH Open
View article: A Conceptual Framework for Safe-and-Sustainable-by-Design to Support Sustainable Business Model Innovation and New Product Development
A Conceptual Framework for Safe-and-Sustainable-by-Design to Support Sustainable Business Model Innovation and New Product Development Open
To reach a sustainable future and meet the UN’s Sustainable Development Goals (UN SDGs), business model innovation (BMI) needs to explore theoretical and practical intersections of the traditional innovation management (IM) and new product…
View article: Applicability of the European Commission’s framework on safe and sustainable by design to the pharmaceutical sector
Applicability of the European Commission’s framework on safe and sustainable by design to the pharmaceutical sector Open
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View article: 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 a food additive for uses in foods for all population groups
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 a food additive for uses in foods for all population groups Open
The present opinion is the follow‐up of the conclusions and recommendations of the Scientific Opinion on the re‐evaluation of silicon dioxide (E 551) as a food additive relevant to the safety assessment for all age groups. In addition, the…
View article: Review of New Approach Methodologies for Application in Risk Assessment of Nanoparticles in the Food and Feed Sector: Status and Challenges
Review of New Approach Methodologies for Application in Risk Assessment of Nanoparticles in the Food and Feed Sector: Status and Challenges Open
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…
View article: Proposal for a qualification system for New Approach Methodologies (NAMs) in the food and feed sector: example of implementation for nanomaterial risk assessment
Proposal for a qualification system for New Approach Methodologies (NAMs) in the food and feed sector: example of implementation for nanomaterial risk assessment Open
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 …
View article: Informing the public about chemical mixtures in the local environment: Currently applied indicators in the Netherlands and ways forward
Informing the public about chemical mixtures in the local environment: Currently applied indicators in the Netherlands and ways forward Open
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 majo…
View article: Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives
Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives Open
View article: Regulatory Preparedness for Multicomponent Nanomaterials: Current State, Gaps and Challenges of Reach
Regulatory Preparedness for Multicomponent Nanomaterials: Current State, Gaps and Challenges of Reach Open
View article: Similarity of multicomponent nanomaterials in a safer-by-design context: the case of core–shell quantum dots
Similarity of multicomponent nanomaterials in a safer-by-design context: the case of core–shell quantum dots Open
Concepts of similarity applied to complex multicomponent advanced materials for an informed balance of performance and hazard.
View article: Critical aspects in dissolution testing of nanomaterials in the oro-gastrointestinal tract: the relevance of juice composition for hazard identification and grouping
Critical aspects in dissolution testing of nanomaterials in the oro-gastrointestinal tract: the relevance of juice composition for hazard identification and grouping Open
Rational design of analytical criteria to perform dissolution testing of nanomaterials: the relevance of juice composition for hazard identification and grouping.
View article: Regulatory safety assessment of nanoparticles for the food chain in Europe
Regulatory safety assessment of nanoparticles for the food chain in Europe Open
Background: The risk assessment of small particles (including nanoparticles) in products used in the food chain in the EU falls within the remit of the European Food Safety Authority (EFSA) and has been under thorough scientific considerat…
View article: “Advanced materials” and the challenges on the horizon for testing their (eco)toxicity and assessing their hazard
“Advanced materials” and the challenges on the horizon for testing their (eco)toxicity and assessing their hazard Open
“Advanced Materials” (AdMas) represent the next technology frontier.
View article: Grouping of orally ingested silica nanomaterials via use of an integrated approach to testing and assessment to streamline risk assessment
Grouping of orally ingested silica nanomaterials via use of an integrated approach to testing and assessment to streamline risk assessment Open
View article: Grouping MWCNTs based on their similar potential to cause pulmonary hazard after inhalation: a case-study
Grouping MWCNTs based on their similar potential to cause pulmonary hazard after inhalation: a case-study Open
View article: Overview of potential adverse health effects of oral exposure to nanocellulose
Overview of potential adverse health effects of oral exposure to nanocellulose Open
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 s…
View article: Grouping Hypotheses and an Integrated Approach to Testing and Assessment of Nanomaterials Following Oral Ingestion
Grouping Hypotheses and an Integrated Approach to Testing and Assessment of Nanomaterials Following Oral Ingestion Open
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 deci…
View article: An Integrated Approach to Testing and Assessment to Support Grouping and Read-Across of Nanomaterials Following Inhalation Exposure
An Integrated Approach to Testing and Assessment to Support Grouping and Read-Across of Nanomaterials Following Inhalation Exposure Open
Here we describe the generation of hypotheses for grouping nanoforms (NFs) following inhalation exposure and the tailored Integrated Approach to Testing and Assessment (IATA) with which each specific hypothesis can be tested. This is part …
View article: An Integrated Approach to Testing and Assessment to Support Grouping and Read-Across of Nanomaterials After Inhalation Exposure
An Integrated Approach to Testing and Assessment to Support Grouping and Read-Across of Nanomaterials After Inhalation Exposure Open
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 c…
View article: Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles
Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles Open
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 informa…
View article: Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health
Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health Open
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, fo…
View article: Identification of emerging safety and sustainability issues of advanced materials: Proposal for a systematic approach
Identification of emerging safety and sustainability issues of advanced materials: Proposal for a systematic approach Open