- MeSH
- akreditace normy MeSH
- dokumentace metody normy MeSH
- Evropská unie MeSH
- lidé MeSH
- reagenční diagnostické soupravy * zásobování a distribuce MeSH
- řízení kvality MeSH
- řízení rizik normy MeSH
- schvalování diagnostických testů normy MeSH
- směrnice jako téma MeSH
- spotřebitelská bezpečnost produktů normy MeSH
- zdravotnické prostředky zásobování a distribuce MeSH
- Check Tag
- lidé MeSH
- MeSH
- akreditace MeSH
- dokumentace normy trendy MeSH
- Evropská unie MeSH
- lidé MeSH
- reagenční diagnostické soupravy * klasifikace normy MeSH
- referenční standardy MeSH
- řízení kvality MeSH
- řízení rizik metody normy MeSH
- schvalování diagnostických testů normy MeSH
- směrnice jako téma MeSH
- zdravotnické prostředky normy MeSH
- Check Tag
- lidé MeSH
- Klíčová slova
- studie ENSEMBLE, vakcína JOHNSON &JOHNSON,
- MeSH
- COVID-19 prevence a kontrola MeSH
- klinické zkoušky, fáze III jako téma MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- randomizované kontrolované studie jako téma MeSH
- stažení léku z trhu z bezpečnostních důvodů * MeSH
- trombóza nitrolebních žilních splavů MeSH
- vakcíny proti COVID-19 * škodlivé účinky MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- práce podpořená grantem MeSH
- Geografické názvy
- Spojené státy americké MeSH
According to the European Union regulation, some countries have established a pre-market notification system for food supplements while others have not. As this regulation is unfulfilled, a notified and marketed food supplement ingredient in one country may be forbidden in another. Even though food supplements shall not be placed on the market if unsafe, some products may still expose the consumers to risks. The risk is increased by easier access due to worldwide dissemination fostered by the internet and free movement of goods in the European Union. The Rapid Alert System for Food and Feed and the Emerging Risks Exchange Network are described. To date, the European Union legislation does not include a provision to establish a dedicated vigilance system for food supplements (Nutrivigilance). Six European Union countries have nevertheless set up national systems, which are presented. The present lack of European Union data collection harmonization, does not allow easy cooperation between countries. This article advocates for creating a coordinated European Nutrivigilance System to detect and scrutinize adverse effects of food supplements. This, to help in directing science-based risk assessments and reinforce the science-based decision of policy makers to improve public health safety.
ABSTRACT: Cronobacter is a bacterial genus that includes seven species, and the species Cronobacter sakazakii is most related to meningitis and septicemia in infants associated with powdered infant formula (PIF). The objectives of this study were to evaluate the presence of C. sakazakii and to determine the microbiological quality of PIF for infant consumption. To do this, a total of 128 PIF samples were analyzed in four brands and countries (Chile, Mexico, Holland, and Brazil), considering three types of PIF: premature (PIF1), infant (PIF2), and follow-up (PIF3). Aerobic plate counts (APC) and Enterobacteriaceae (ENT) were assessed in accordance with Chilean official standards. The outer membrane protein A (ompA) gene was amplified to detect Cronobacter spp. and the fusA gene was amplified to identify C. sakazakii by using the PubMLST Web site and BLAST (NCBI). The antibiotic resistance profile was performed according to the Clinical and Laboratory Standards Institute standards. The pathogen was quantified by the most probable number (MPN). The results showed that APC median values for PIF1, PIF2, and PIF3 were 3.2, 4.9, and 4.8 log CFU g-1, respectively. The APC were higher in PIF2 (P < 0.01) from Holland (P < 0.01) in the commercial brand 4 (P < 0.01). The ENT median values in PIF1, PIF2, and PIF3 were 1.8, 1.5, and 1.7 log CFU g-1, respectively. Five strains of C. sakazakii and one strain of Cronobacter malonaticus were identified as having values between 0.023 and 2.3 MPN/g. All strains (100%) harbored the ompA, plasminogen activator (cpa), and hemolysin (hly) virulence genes. To conclude, C. sakazakii was found in four PIF samples from four Chilean products and one from Mexico, which is distributed throughout America. C. sakazakii strains exhibit virulence factors and resistance to ampicillin, thus posing a risk when PIFs are consumed by infants. HIGHLIGHTS:
- MeSH
- Cronobacter sakazakii * MeSH
- Cronobacter MeSH
- kojenec MeSH
- kontaminace potravin analýza MeSH
- lidé MeSH
- náhražky mateřského mléka * mikrobiologie normy MeSH
- potravinářská mikrobiologie MeSH
- prášky, zásypy, pudry MeSH
- spotřebitelská bezpečnost produktů MeSH
- Check Tag
- kojenec MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Brazílie MeSH
- Chile MeSH
- Latinská Amerika MeSH
- Mexiko MeSH
- Nizozemsko MeSH
Despite widespread and prolonged use of adult novelties, their health safety is not regularly tested or legally regulated. In the EU, adult novelties are subjected to the General Product Safety Directive, placing the burden of proof regarding safe products onto the manufacturers. The aim of our pilot study was to expand knowledge on potential application of in vitro methods for hazard prediction of extracts from final products. We subjected extracts of 20 adult novelties, purchased on the Czech market to toxicological tests including NRU cytotoxicity assay, sensitization tests DPRA and LuSens and the YES/YAS endocrine assay. Four samples produced cytotoxicity. Sensitization potential was recorded by DPRA (three samples) while the LuSens reported ten samples. Regarding endocrine disruption, three samples produced antiestrogen and antiandrogen effects. Six samples exhibited androgenic potential and one sample showed estrogenic potential. Positive results with possible health effects were recorded repeatedly for samples made of ABS, PVC and latex. The study has confirmed promising usefulness of our test methods combination with regard to safety testing of this type of consumer products. The results should be evaluated with care, however, the data bring added-value to the limited knowledge of mixture toxicology and are indicative for further testing.
- MeSH
- buňky BALB 3T3 MeSH
- endokrinní disruptory toxicita MeSH
- fibroblasty účinky léků fyziologie MeSH
- hra a hračky * MeSH
- lidé MeSH
- myši MeSH
- pilotní projekty MeSH
- plastické hmoty toxicita MeSH
- Saccharomyces cerevisiae účinky léků fyziologie MeSH
- sexuální chování účinky léků fyziologie MeSH
- spotřebitelská bezpečnost produktů normy MeSH
- techniky in vitro metody MeSH
- testy akutní toxicity metody MeSH
- zvířata MeSH
- Check Tag
- lidé MeSH
- myši MeSH
- zvířata MeSH
- Publikační typ
- časopisecké články MeSH
