ArticleEFSA journal. European Food Safety Authority2021
Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles.
Article in EFSA journal. European Food Safety Authority, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 182 papers.
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Who cites it
182 citing papers in PubMed.
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- Safety and efficacy of a feed additive consisting of nicarbazin (NICACOX®) for chickens for fattening and chickens reared for laying (Huvepharma N.V.).EFSA journal. European Food Safety Authority · 2026Article
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- Safety assessment of the substance 1,3-benzenedicarboxamide, 5-[[[EFSA journal. European Food Safety Authority · 2026Article
- Metal-Organic Frameworks in Food Biotechnology: Opportunities, Challenges, and Future Perspectives for Probiotic Delivery, Precision Fermentation, and Circular Food Systems.Nanomaterials (Basel, Switzerland) · 2026Review
- Bioactive Compounds from Medicinal and Edible Plants for Anti-Aging: A Systematic Review of Molecular Mechanisms, Delivery Systems, and Clinical Evidence.Foods (Basel, Switzerland) · 2026Review
- Physicochemical characterisation of iron oxides and hydroxides applied as food additive E 172.Food chemistry: X · 2026Article
- Safety of lacto-N-triose II as a novel food pursuant to Regulation (EU) 2015/2283.EFSA journal. European Food Safety Authority · 2026Article
- Review
122 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
31 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 additives, food contact materials and pesticides). These requirements apply to particles requiring specific assessment at the nanoscale in conventional materials that do not meet the definition of engineered nanomaterial as set out in the Novel Food Regulation (EU) 2015/2283. The guidance outlines appraisal criteria grouped in three sections, to confirm whether or not the conventional risk assessment should be complemented with nanospecific considerations. The first group addresses solubility and dissolution rate as key physicochemical properties to assess whether consumers will be exposed to particles. The second group establishes the information requirements for assessing whether the conventional material contains a fraction or consists of small particles, and its characterisation. The third group describes the information to be presented for existing safety studies to demonstrate that the fraction of small particles, including particles at the nanoscale, has been properly evaluated. In addition, in order to guide the appraisal of existing safety studies, recommendations for closing the data gaps while minimising the need for conducting new animal studies are provided. This Guidance on Particle-TR complements the Guidance on risk assessment of nanomaterials to be applied in the food and feed chain, human and animal health updated by the EFSA Scientific Committee as co-published with this Guidance. Applicants are advised to consult both guidance documents before conducting new studies.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.