All Knowledge & Insights By Date

On April 8, 2025, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “A Qualification System to Accelerate Development and Regulatory Implementation of New Approach Methodologies (NAMs)” by Andrea Haase, Ph.D., German Federal Institute for Risk Assessment (BfR), Shirin M. Usmani, Ph.D., BfR, Irene Cattaneo, European Food Safety Authority (EFSA), Maria Chiara Astuto, EFSA, and Francesco Cubadda, Ph.D., National Institute of Health (ISS). The authors...

The European Union (EU) Observatory for Nanomaterials (EUON) announced on September 26, 2024, that the European Food Safety Authority (EFSA) has published the following reports under its NAMs4NANO Project:...

POSTED IN INTERNATIONAL, LEGAL/REGULATORY ISSUES, OECD The Organization for Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials — Tour de Table. The Tour de Table compiles information provided by delegations on the occasion of the 22nd meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in June 2022. Below are highlights on...

The U.S. Food and Drug Administration (FDA) announced on May 3, 2023, that it has filed a color additive petition (CAP 3C0325), submitted by the Environmental Defense Fund (EDF), the Center for Environmental Health (CEH), the Center for Food Safety (CFS), the Center for Science in the Public Interest (CSPI), and the Environmental Working Group (EWG). 88 Fed. Reg. 27818. The petition proposes that FDA repeal the color additive regulation for titanium dioxide in 21 C.F.R....

The European Commission (EC) announced on October 8, 2021, that the Standing Committee on Plants, Animals, Food and Feed approved the EC’s proposal to ban the use of titanium dioxide (E171) as a food additive. The EC states that its proposal “is based on a scientific opinion by the European Food Safety Authority, which concluded that E171 could no longer be considered as safe when used as a food additive, in particular due to the fact that concerns regarding...

The European Food Safety Authority (EFSA) published a Scientific Opinion entitled “Safety assessment of the substance silver nanoparticles for use in food contact materials.” The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the additive silver nanoparticles intended to be used in plastics. All the silver particles were in the size range of 1-100 nanometers (nm), with about 15 nm mean diameter and 99% by number of particles...

The European Food Safety Authority (EFSA) has updated its “Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health.” The updated guidance, published on August 3, 2021, covers the application areas within EFSA’s remit, including novel foods, food contact materials, food and feed additives, and pesticides. The guidance takes into account relevant scientific studies on physico‐chemical properties, exposure assessment and hazard...

The European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) have received a draft assessment of glyphosate carried out by four European Union (EU) member states and have begun to consider the findings. According to ECHA’s June 15, 2021, press release, the national authorities of France, Hungary, the Netherlands, and Sweden — known as the Assessment Group of Glyphosate (AGG) — examined all the evidence submitted by the companies that are seeking renewed...

On May 6, 2021, the European Food Safety Association (EFSA) announced that E171 is no longer considered safe when used as a food additive.  The European Commission (EC) asked EFSA to update its safety assessment of the food additive titanium dioxide (E171).  EFSA states:  “Taking into account all available scientific studies and data, the Panel [on Food Additives and Flavorings] concluded that titanium dioxide can no longer be considered safe as a food additive. ...

The European Food Safety Authority (EFSA) announced on March 15, 2021, that it has begun a public consultation on a draft updated Guidance on the assessment of exposure of operators, workers, residents, and bystanders in risk assessment for plant protection products (PPP).  According to EFSA, the Guidance is designed to assist risk assessors and applicants when quantifying potential non-dietary, systemic exposures as part of the regulatory risk assessment for PPPs.  The Guidance is based on...

On November 19, 2020, the European Food Safety Authority (EFSA) published a report entitled “Environmental Risk Assessment (ERA) of the application of nanoscience and nanotechnology in the food and feed chain.”  The authors analyzed existing ERA guidance documents for their adequacy to cover issues that are specific for nanomaterials, but note that none of the guidance has a specific focus on the food and feed chain.  Each nanospecific issue was addressed by briefly reviewing the...

On September 15, 2020, the European Food Safety Authority (EFSA) called for grant proposals on the use of new approach methodologies (NAM) for the hazard assessment of cellulose nanofibers.  EFSA states that the use of cellulose at the nanoscale is increasing and requires an assessment.  According to EFSA, the main concern is that the nanoscale characteristics (e.g., length/shape of the fibers) may influence the toxicokinetic and hazardous properties of cellulose nanofibers....

The European Food Safety Authority (EFSA) has begun a public consultation on a draft document entitled “EFSA Guidance on Technical Requirements for Regulated Food and Feed Product Applications to Establish the Presence of Small Particles Including Nanoparticles.”  The draft Guidance sets out information requirements for applications in the regulated food and feed product areas and establishes criteria for assessing the presence of a fraction of small particles.  EFSA...

The European Food Safety Authority (EFSA) has announced a call for abstract submissions for oral presentations, posters, and poster pitches at its colloquium on “A coordinated approach to assess the human health risks of micro- and nanoplastics in food,” which will be held in Lisbon on June 8-9, 2020.  EFSA states that “[m]icroplastics are small particles of plastic less than 5mm in size; nanoplastics are even smaller, ranging from 1 to 100 nanometres (N.B. 1 nanometre...

On September 17, 2019, the European Food Safety Authority (EFSA) opened a consultation period on two pilot assessments of the risks posed to humans by residues of multiple pesticides in food.  EFSA is seeking comments from interested parties on the assessments.  The first assessment considers the chronic effects of multiple pesticides on the thyroid system.  The second looks at acute effects on the nervous system. EFSA produced the assessments in collaboration with the...

On July 12, 2019, the European Food Safety Authority (EFSA) published in the EFSA Journal its “Scientific opinion on the proposed amendment of the EU specifications for titanium dioxide (E 171) with respect to the inclusion of additional parameters related to its particle size distribution.”  The opinion addresses the assessment of data provided by interested business operators in support of an amendment of the European Union (EU) specifications for titanium dioxide (E 171)...

The European Food Safety Authority (EFSA) held a stakeholder workshop on April 1-2, 2019, on the implementation of its guidance on the risk assessment of applications of nanosciences and nanotechnologies in the food and feed chain.  As reported in our July 5, 2018, blog item, “EFSA Publishes New Guidance on Nanotechnologies in Food and Feed,” in July 2018, EFSA published new guidance on how to assess the safety of nanoscience and nanotechnology applications. ...

The European Food Safety Authority (EFSA) will hold a stakeholder workshop on nanoscience and nanotechnology on April 1-2, 2019, in Parma, Italy.  As reported in our July 5, 2018, blog item, “EFSA Publishes New Guidance on Nanotechnologies in Food and Feed,” in July 2018, EFSA published new guidance on how to assess the safety of nanoscience and nanotechnology applications.  The guidance covers novel foods, food contact materials, food and feed additives, and pesticides, taking into...

In July 2018, the Institute of Technology Assessment of the Austrian Academy of Sciences published an English version of Dossier No. 49, “Nanotechnological Applications for Food Contact Materials.”  The Dossier concludes that nanomaterials can significantly improve the properties of plastic materials, making nanocomposites “increasingly interesting for manufacturers, especially for food packaging.”  Nanomaterials used in food contact materials (FCM) in the European Union (EU)...

The July 2018 issue of the EFSA Journal includes an article entitled “Evaluation of four new studies on the potential toxicity of titanium dioxide used as a food additive (E 171).”  The European Commission (EC) asked the European Food Safety Authority (EFSA) to carry out a scientific evaluation on four studies on the potential toxicity of titanium dioxide used as a food additive (E 171) and to indicate whether they would merit re-opening EFSA’s 2016 opinion on...

The European Food Safety Authority (EFSA) issued a July 4, 2018, press release announcing the availability of new guidance on how to assess the safety of nanoscience and nanotechnology applications.  The guidance covers novel foods, food contact materials, food and feed additives, and pesticides, taking into account new developments that have taken place since publication of the previous guidance in 2011.  Potential future developments suggested in the scientific literature...

On April 16, 2018, the European Food Safety Authority (EFSA) published a report entitled “EU Insights — Consumer perceptions of emerging risks in the food chain.”  To understand better the views of European Union (EU) consumers on food-related emerging risks, EFSA surveyed 25 EU countries using three examples of emerging risks:  green smoothies, plastic rice, and nanoparticles.  According to the report, the study found that consumers tended to be more concerned about...

The European Food Safety Authority (EFSA) Panel on Food Contact Materials, Enzymes, Flavorings, and Processing Aids evaluated food contact material (FCM) Substance No. 1070, which incorporates selenium nanoparticles into the adhesive middle layer of multilayer laminates with an outside polyethylene terephthalate (PET) layer and an inner polyolefin (food contact) layer.  The results of the Panel’s evaluation are published in the January 2018 issue of the EFSA Journal in an...

Beginning on January 23, 2018, the European Commission (EC) opened a consultation period on the European Food Safety Authority (EFSA) risk assessment process (scientific advice).  The EC states it is seeking feedback on its process both as  a “follow-up to the commitments made by the Commission in reply to the European Citizens’ Initiative on glyphosate,” and in response to “citizens [that] have put into question the risk assessment based on studies provided by the...

On January 12, 2018, the European Food Safety Authority (EFSA) opened a public consultation on its draft guidance for the risk assessment of nanoscience and nanotechnology applications in the food and feed chain.  The guidance covers the relevant areas within EFSA’s remit, such as novel foods, food contact materials, food and feed additives, and pesticides.  EFSA notes that the guidance takes account of scientific developments that have taken place since publication of the previous...

The European Food Safety Authority (EFSA) requested a review of the already marketed and in-development applications of nanomaterials in the agri/feed/food sectors.  The results of the review are published in the August 2016 issue of Trends in Food Science & Technology in an article entitled “Nanomaterials for products and application in agriculture, feed and food.”  The article highlights include:...

On June 20, 2016, the European Food Safety Authority (EFSA) published a scientific opinion entitled “Priority topics for the development of risk assessment guidance by EFSA’s Scientific Committee in 2016-2018.”  EFSA asked its Scientific Committee to review its cross-cutting guidance for scientific assessments to identify gaps requiring either new or revised guidance.  The Scientific Committee identified topics to be included in its 2016-2018 work program without...

The European Food Safety Authority (EFSA) has begun a public consultation on its draft guidance on the preparation and presentation of an application for authorization of a novel food. As reported in our December 22, 2015, blog item, the European Commission (EC) promulgated a final novel foods regulation in December 2015. Under the regulation, food consisting of engineered nanomaterials should be considered a novel food. EFSA intends the draft document to provide guidance on the data needed...

The European Food Safety Authority (EFSA) published on January 11, 2016, the Scientific Network for Risk Assessment of Nanotechnologies in Food and Feed (Nano Network) annual report for 2015.  The report states that, during 2015, the Nano Network followed-up on its four priority topics:  (1) the need for an inventory of nanomaterials in products on the market; (2) the analysis and monitoring of products under development and on the market; (3) the need for suitable measuring...

On June 3, 2015, the General Court of the European Court of Justice issued a ruling in Luxembourg Pamol (Cyprus) Ltd. and Luxembourg Industries Ltd. (Luxembourg) vs. European Commission regarding the publication of information by the European Food Safety Authority (EFSA) in its peer reviewed draft assessment report of potassium phosphonate that Luxembourg claimed as confidential.  The case was brought by Luxembourg after EFSA rejected Luxembourg’s claim that certain information...

On May 22, 2015, the European Food Safety Authority (EFSA) issued a call for new scientific information relevant to the evaluation of the risk to bees in the European Union (EU) from the use of the three neonicotinoid pesticide active substances:  clothianidin, imidacloprid, and thiamethoxam (the substances). The call for data complies with the decision taken by the European Commission in May 2013, Commission Implementing Regulation (EU) No. 485/2013, to put in place measures to...

On February 16, 2015, the European Food Safety Authority (EFSA) published the 2014 annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed, which is intended to inform the public and the EFSA Advisory Forum about the Network’s specific activities and achievements.  EFSA states that, during 2014, the Network followed-up on its priority areas and contributed to making inventories of applications of nanomaterials already present in the food/feed...

The European Food Safety Authority (EFSA) published in the October 10, 2012, Official Journal of the European Union a call for tender to prepare a background document on the current knowledge in the field of nanotechnology and prepare an inventory of food additives/food contact materials/feed additives applications of nanotechnologies currently used and/or reasonably foreseen to be used. According to the tender specifications, the tasks will include: The length of the...

On May 10, 2011, the European Food Safety Authority (EFSA) published a guidance document for the risk assessment of engineered nanomaterial (ENM) applications in food and feed. According to EFSA, the guidance “is the first of its kind to give practical guidance for addressing potential risks arising from applications of nanoscience and nanotechnologies in the food and feed chain.” The guidance covers risk assessments for food and feed applications, including food additives, enzymes,...

On January 14, 2011, the European Food Safety Authority (EFSA) began a public consultation on a draft document entitled “Guidance on Risk Assessment Concerning Potential Risks Arising from Applications of Nanoscience and Nanotechnologies to Food and Feed.” According to EFSA, the draft guidance offers practical guidance for the risk assessment of applications involving the use of nanoscience and nanotechnology in the area of food and feed (including food additives, enzymes, flavorings, food...

On March 5, 2009, the European Food Safety Authority (EFSA) published a document entitled The Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety, which provides its scientific opinion on the potential risks arising from nanoscience and nanotechnologies on food and feed safety. EFSA’s Scientific Committee (SC) concluded that established international approaches to risk assessment can also be applied to engineered nanomaterials (ENM).  The SC...

On October 17, 2008, the European Food Safety Authority (EFSA) began a public consultation on its draft scientific opinion in relation to nanoscience and nanotechnologies and food and feed safety.  EFSA’s draft opinion focuses on engineered nano materials (ENM) that could be deliberately introduced into the food chain and elaborates on approaches to risk assessment. EFSA states that it “is not an assessment of any specific application of ENM.” According to EFSA,...

On January 23, 2008, the European Food Safety Authority (EFSA) issued a notice entitled “Call for Scientific Data on Applications of Nanotechnology and Nanomaterials used in Food and Feed.” According to the notice, EFSA is seeking data that could be useful as it prepares an initial scientific opinion for the European Commission (EC) regarding the risks arising from nanoscience and nanotechnologies on food and feed safety and the environment. The EC asked EFSA to identify the nature...

The European Food Safety Authority (EFSA) met the week of November 19, 2007, to begin reviewing the regulation and risk assessment of nanotechnology. The European Commission (EC) issued a mandate for a complete evaluation by March 31, 2008, but EFSA responded that, because of the range of differing properties and safety profiles, it will not be able to complete its review by this deadline. EFSA instead proposed to issue an initial scientific opinion by Summer 2008. EFSA...

On October 25-26, 2007, the European Commission (EC) held the First Annual Nanotechnology Safety for Success Dialogue. Presentations included:...