In compliance with Article 43 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) reviewed the maximum residue levels (MRLs) for copper compounds in light of the EFSA Scientific Committee opinion on the re-evaluation of the health-based guidance values (HBGVs) and exposure assessment from all sources. Based on the exposure calculations performed according to three different scenarios, the updated occurrence data and the residues from the new intended uses are not expected to have an impact on the chronic exposure calculations conducted under the framework of the EFSA Scientific Committee assessment. Therefore, the conclusions of the previous assessment by EFSA Scientific Committee are still valid. Since the current copper exposure is expected to cover all sources of copper, including the uses of copper as plant protection products (PPPs), it can be concluded that the authorised PPP uses for copper compounds and the new intended PPP uses present no health risk for the population, including children. Due to copper being also a micronutrient and ubiquitous in the environment, as requested in the mandate, the dietary risk assessment was performed following a different approach than the standard methodology for the dietary risk assessment of pesticide residues in the framework of setting and reviewing MRLs under Regulation (EC) No 396/2005 and in the peer review of pesticides under Regulation (EU) No 1107/2009. Therefore, all MRL proposals are suggested for further consideration by risk managers.
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http://dx.doi.org/10.2903/j.efsa.2025.9271 | DOI Listing |
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of CNCM I-5642 (PP102I) as a zootechnical feed additive (functional group: physiological condition stabiliser) for dogs. In a previous opinion, the FEEDAP Panel concluded that PP102I was safe for dogs and the environment. Regarding the safety for the users, the Panel concluded that the additive should be considered a skin and respiratory sensitiser.
View Article and Find Full Text PDFThe EFSA Panel on Food Additive and Flavourings (FAF Panel) provides a scientific opinion on the safety assessment of the proposed use of pea fibre concentrate (FIPEA) as a food additive. FIPEA is a powder consisting mainly of dietary fibres (i.e.
View Article and Find Full Text PDFThe European Commission requested EFSA to provide a scientific opinion on the equivalence between the heat treatment process of feathers and down with dry heat to a temperature of 100°C for 30 min and the treatment set up in Commission Regulation (EU) No 142/2011, in terms of inactivation of relevant pathogens. To be considered at least equivalent to the methods in the legislation, the alternative method should be able to reduce the concentration of or Senftenberg by at least 5 log and the infectious titre of and by at least 3 log. An extensive literature search (ELS) was conducted to identify studies in which the log reduction or the D value of the indicators were determined after dry heating in matrices with low moisture/water activity.
View Article and Find Full Text PDFArch Toxicol
March 2025
Department of Chemistry and Pharmaceutical Science, Amsterdam Institute of Molecular and Life Sciences, Vrije Universiteit Amsterdam, De Boelelaan 1108, 1081 HZ, Amsterdam, The Netherlands.
The kidney is a major organ dictating excretion rates of chemicals and their metabolites from the body and thus renal clearance is frequently a major component of pharmaco-(toxico)-kinetic profiles. Within the nephron, the proximal tubule is the major site for xenobiotic reabsorption from glomerular filtrate and xenobiotic secretion from the blood into the lumen via the expression of multiple inward (lumen to interstitium) and outward transport systems (interstitium to lumen). While there exist several human proximal tubular cell culture options that could be utilized for modelling the proximal tubule component of renal clearance, they do not necessarily represent the full complement of xenobiotic transport processes of their in vivo counterparts.
View Article and Find Full Text PDFThe Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the safety of monacolins from red yeast rice (RYR), which have been placed under Union scrutiny in Part C of Annex III in accordance with Article 8(4) of Regulation (EC) No 1925/2006. The NDA Panel reviewed the additional scientific data submitted during the period of scrutiny, which included analytical data on the composition of RYR supplements, the intake of monacolins from other dietary sources, in vitro bioaccessibility and cytotoxicity data of monacolins vs. other statins, nutrivigilance/post-marketing data, case reports and clinical studies.
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