EFSA evaluation of glycerol
In assessing the acute exposure to glycerol (E 422) from slush ice drinks and de-alcoholised wine, the FAF Panel established an Acute Reference Dose (ARfD) of 125 mg/kg bw for a single consumption event, based on pharmacological effects observed in humans (with the potential for low blood sugar and loss of consciousness in children, in particular). As estimated acute exposures from both sources could exceed the ARfD across all population groups, the Panel recommended that the European Commission consider establishing numerical maximum levels for glycerol in beverages.
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.10057
SCCS opinions on the safety of silver, cannabidiol, and acetophenone in cosmetics
In 2024, following the classification of micron-sized particulate silver as a reproductive toxin in the EU, the SCCS concluded that it was not safe for use in rinse-off and leave-on cosmetic products. However, in the light of new data indicating that these small silver particles do not penetrate the skin, the Committee revised its opinion in 2025, providing preliminary scientific advice that micron-sized particulate silver was safe for use in rinse-off and leave-on products at respective concentrations of up to 0.2 and 0.3%. This advice has now been finalised, with additional guidance provided on safe levels in oral hygiene products (up to 0.2% in products for adults and 0.05% in mouthwashes intended for children) and nail products (up to 0.3%). The opinion does not apply to use in propellant-based spray products.
The Committee has also finalised its opinion on cannabidiol (CBD), concluding that it is safe when used at concentrations of up to 0.19% in dermal and oral cosmetic products (whether used alone or together). The presence of delta-9-tetrahydrocannabinol (THC) as an impurity in such products is safe at concentrations of up to 0.00025%.
In addition, a preliminary opinion has been issued on acetophenone present in cosmetics as a constituent of some natural complex substances. The Committee took into consideration the possible classification of acetophenone in the EU as a reproductive/developmental toxin, and additional sources of exposure (such as food and tobacco smoking), before concluding on a maximum safe concentration in cosmetic products of up to 100 ppm (0.01%).
Revised guidance on the classification of medical devices
The Medical Device Coordination Group (MDCG), comprising representatives of European Commission Member States, has released revised guidance designed to support manufacturers in the classification of medical devices in accordance with Annex VIII of the European Medical Device Regulation (MDR; Regulation (EU) 2017/74), providing an overview of the purpose of device classification and its practical relevance. Advice is provided on how to carry out device classification based on anticipated use, and how to apply individual classification rules, and practical examples are given.
ANSES evaluate lithium toxicity data
ANSES reviewed the available toxicity data on lithium and lithium compounds to calculate internal, oral and inhalation Toxicity Reference Values (TRVs) of exposure that would not be expected to elicit adverse health effects. Long-term studies in human patients demonstrated effects on organs including the kidney, thyroid and heart, or on reproduction and development, at the minimum therapeutic dose level of 0.5 mmol/L (about 3.5 mg/L) in serum or plasma. An internal TRV of 0.035 mg lithium equivalents (Li eq)/L was derived by applying an overall Uncertainty Factor (UF) of 100, comprising 10 for the use of an effect level as a PoD, and √10 (each) for intraspecies variation and data insufficiency. The same PoD and UFs (along with route-to-route considerations) were used for the derivation of a long-term oral TRV of 0.02 mg Li eq/kg bw/day and a long-term inhalation TRV of 0.05 mg Li eq/m3. In each case, the TRV values apply to lithium and its inorganic derivatives.
https://www.anses.fr/system/files/VSR-2024-MPEX-0101-RA.pdf
JECFA evaluation of inorganic arsenic and organoarsenic compounds
The technical report from JECFA’s 101st meeting (held in October 2025) has now been released; the Committee evaluated the safety of inorganic arsenic (iAs) and certain small and complex organoarsenic compounds as food contaminants. The following Committee decisions are of particular interest:
- iAs: newly available epidemiological studies provide additional support for the association between iAs exposure and Ischemic Heart Disease (IHD) as well as cancers of the lung, bladder and skin. A Benchmark Dose Lower Confidence Limit (BMDL0.5) of 0.3 µg/kg bw/day for IHD was selected as the critical Point of Departure (PoD). Based on estimated dietary exposure levels, the Committee found that the PoD may be exceeded by at least 2.5-fold even in areas where iAs contamination of drinking water is expected to be below 10 µg/L, and by up to 175-fold at higher levels of contamination. Thus, even in non-contaminated areas, there is a potential for human health concerns in both children and adults at mean dietary exposures.
- dimethylarsenate (DMA): a non-neoplastic Health-Based Guidance Value (HBGV) of 6 µg/kg bw/day was established, based on urinary bladder hyperplasia in female rats. Estimated dietary exposure levels to DMA ranged from 0.01-0.48 µg/kg bw/day, leading JECFA to conclude that such exposures were unlikely to be of concern for human health. In addition, from a neoplastic PoD of 1.03 mg/kg bw/day (based on the sporadic incidence of urinary bladder tumours in male rats), and considering the likely non-DNA-reactive Mode of Action (MoA), the Committee estimated Margins of Exposure (MoEs) of 2100 to >100,000, and concluded that dietary exposure to DMA is unlikely to pose a cancer risk.
- methylarsenate (MA): an HBGV of 5 µg/kg bw/day was established, based on kidney toxicity (glomerular nephropathy) in male mice. With dietary exposures estimated at <0.01-0.08 µg/kg bw/day, JECFA concluded that exposure to MA was unlikely to be of concern for human health.
https://www.who.int/publications/i/item/9789240121669
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Written by
Craig Freeman
Senior Toxicologist