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- Safety assessment of the substance phosphorus acid, triphenyl ester, polymer with alpha‐hydro‐omega‐hydroxypoly[oxy(methyl‐1,2‐ethanediyl)], C10‐16 alkyl esters, for use in food contact materialsPublication . EFSA FCM Panel (EFSA Panel on Food Contact Materials); Lambré, Claude; Crebelli, Riccardo; da Silva, Maria; Grob, Konrad; Lampi, Evgenia; Milana, Maria Rosaria; Pronk, Marja; Ščetar, Mario; Theodoridis, Georgios; Van Hoeck, Els; Waegeneers, Nadia; Cariou, Ronan; Castle, Laurence; Di Consiglio, Emma; Franz, Roland; Franz, Roland; Comandella, Daniele; Rivière, GillesThe EFSA Panel on Food Contact Materials (FCM) assessed the safety of phosphorus acid, triphenyl ester, polymer with alpha‐hydro‐omega‐hydroxypoly[oxy(methyl‐1,2‐ethanediyl)], C10‐16 alkyl esters, intended to be used as additive in acrylonitrile‐butadiene‐styrene copolymers (ABS) and high impact polystyrene (HIPS). The substance is a polymer with < 10% w/w low molecular weight fraction (< 1000 Da). The safety of its use in HIPS and ABS was already evaluated by the EFSA CEP Panel in 2019 and 2021, respectively. This opinion assesses the safety of the extension of the use to up to 0.25% w/w for ABS and to the contact with alcoholic and fatty food for HIPS. Migration tests were carried out with food simulants and samples containing the substance at the maximum intended levels. For ABS, the specific migration was below the limit of detection (LoD) of 0.005 mg/kg food (3% acetic acid and 10% ethanol) and up to 0.007 mg/kg food (20% and 50% ethanol). For HIPS, the specific migration was up to 0.020 mg/kg food (20% ethanol) and up to 0.039 mg/kg food (50% ethanol). The assessment of toxicological data was reported in the previous opinions and the corresponding conclusions are considered still valid. The FCM Panel concluded that the substance is not of safety concern for the consumer if its migration does not exceed 0.05 mg/kg food and it is used in ABS at up to 0.25% w/w in contact with aqueous, acidic, alcoholic and oil‐in‐water emulsion foods, and in HIPS at up to 0.2% w/w in contact with all types of food, in both materials for long term storage at room temperature and below, after hot‐fill and/or heating up to 100°C for up to 2 h. The use in contact with human milk and infant formula was excluded and hence was not addressed in this assessment.
- The effectiveness of heat prevention plans in reducing heat-related mortality across EuropePublication . Urban, Aleš; Huber, Veronika; Henry, Salomé; Plaza, Nuria Pilar; Tušlová, Lucie; Dasgupta, Shouro; Masselot, Pierre; Cvijanovic, Ivana; Mistry, Malcolm; Pascal, Mathilde; de'Donato, Francesca; Di Napoli, Claudia; Gosling, Simon N.; Kohnová, Silvia; Kyselý, Jan; Lüthi, Samuel; Pau, Louis-François; Ragettli, Martina S.; Ruuhela, Reija; Ryti, Niilo; das Neves Pereira da Silva, Susana; Zemah-Shamir, Shiri; Thiery, Wim; Vicedo-Cabrera, Ana-Maria; Wieczorek, Joanna; Sera, Francesco; Armstrong, Ben; Gasparrini, AntonioHeat-health warning systems and action plans, referred to as heat prevention plans (HPPs), are key public health interventions aimed at reducing heat-related mortality. Despite their importance, prior assessments of their effectiveness have yielded inconsistent results. The objective of this study is to systematically assess the effectiveness of HPPs in reducing heat-related mortality risk across Europe. We analysed daily mortality and mean temperature data from 102 locations in 14 European countries between 1990 and 2019. Using data from national experts, we identified the year of HPP implementation and categorised their development class. A three-stage analysis was conducted: (1) quasi-Poisson time series models were used to estimate location-specific warm-season exposure-response functions in 3 year subperiods; (2) mixed-effect meta-regression models with multilevel longitudinal structures were employed to quantify changes in pooled exposure-response functions due to HPP implementation, adjusted for long-term trends in heat-related mortality risks; and (3) the heat-related excess mortality due to HPP was calculated by comparing factual (with HPP) and counterfactual (without HPP) scenarios. Estimates are reported by country, region, and HPP class. HPP implementation was associated with a 25.2% [95% CI: 19.8% to 31.9%] reduction in excess deaths attributable to extreme heat, corresponding to 1.8 [95% CI: 1.3-2.4] avoided deaths annually per 100 000 inhabitants. This equates to an estimated 14 551 [95% CI: 10 118-19 072] total deaths avoided across all study locations following HPP implementation. No significant differences in HPP effectiveness were observed by European region or HPP class. Our findings provide robust evidence that HPPs substantially reduce heat-related mortality across Europe, accounting for temporal changes and geographical differences in risks. These results emphasise the importance of monitoring and evaluating HPPs to enhance adaptation to a warming climate.
- Safety evaluation of jagua (genipin‐glycine) blue as a food additivePublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Reginald; Frutos Fernandez, Maria Jose; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Barat Baviera, José Manuel; Degen, Gisela; Gott, David; Leblanc, Jean-Charles; Moldeus, Peter; Waalkens-Berendsen, Ine; Wölfle, Detlef; Civitella, Consuelo; Mech, Agnieszka; Medrano-Padial, Concepción; Tard, Alexandra; Zakidou, Panagiota; Rugger, LauraThe EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of jagua (genipin‐glycine) blue as a new food additive. Jagua (genipin‐glycine) blue is obtained by water extraction of the ground pulp of the peeled, unripe fruits of Genipa americana L. and is the result of a reaction between genipin (iridoid present in the fruit) and externally added glycine. This reaction leads to the formation of a blue‐coloured polymer and minor colouring components. In vitro Caco‐2 cell permeability test demonstrated a low permeability of jagua (genipin‐glycine) blue, but repeated dose toxicity studies showed organs discoloration and green‐coloured urine, demonstrating some absorption. The toxicological data set comprised acute, sub‐chronic toxicity, genotoxicity studies and also a 12‐month toxicity study including in utero exposure. Jagua (genipin‐glycine) blue was not genotoxic, and no adverse effects were observed in the repeated dose toxicity studies up to the highest doses tested. The Panel derived an acceptable daily intake (ADI) of 34 mg/kg bw per day or 12 mg/kg bw per day expressed as blue polymer, based on a no observed adverse effect level (NOAEL) of 3385 mg/kg bw per day, the highest dose tested, from the 12‐month toxicity study and an uncertainty factor of 100. At the proposed maximum use level exposure assessment scenario, the 95th percentile of exposure approximately ranged from 1 mg/kg bw per day in the elderly to 27 mg/kg bw per day in toddlers. The Panel noted that both the mean and 95th percentile estimates of exposure did not exceed the proposed ADI in all population groups. The same was true for the exposure to the blue polymer assuming a 40% content in the proposed food additive. The Panel concluded there is no safety concern for jagua (genipin‐glycine) blue as a food additive at the proposed use and use levels.