scholarly journals Risk Assessment of RYR Food Supplements: Perception vs. Reality

2021 ◽  
Vol 8 ◽  
Author(s):  
Laura Righetti ◽  
Chiara Dall'Asta ◽  
Renato Bruni
Keyword(s):  
Risk Assessment ◽  
Food Supplements ◽  
Red Yeast Rice ◽  
The European Union ◽  
Health Claim ◽  
Active Constituent ◽  
Safety Issues ◽  
Good Manufacturing Practices ◽  
Daily Dose ◽  
The Eu

Thirty-seven red yeast rice (RYR) food supplements were screened for their mycotoxin and natural statin content. Products included pure RYR capsules and multi-ingredient formulations with standardized amounts of monacolin K (MK), marketed both online and retail in the European Union. In terms of mycotoxins, citrinin (CIT) was found in all the monitored products. As CIT content ranged from 100 to 25100 μg/kg, only four products were compliant with maximum EU levels in force until April 2020, while a single product was compliant with the limit of 100 μg/kg introduced after that date. Four contaminated products were labeled as “citrinin free”. In terms of natural statins, nine products had a lower content vs. label statements (from −30 to −83%), while for 24 a larger MK amount (from 10 to 266%) was noticed. Three products had a negligible MK content and only 19 offered a daily dosage exceeding 10 mg as dictated by the health claim granted by EFSA in the EU. No sample had label values compliant with pharmaceutical Good Manufacturing Practices requirements (95–105% content of active constituent). Variable, but small amounts of simvastatin (0.1–7.5 μg per daily dose) were found in 30 samples. These results suggest that limited efficacy and reported safety issues may stem from an under-regulated and undercontrolled market, weakening both effectiveness and risk assessment evaluations.

scholarly journals Food Supplements for Weight Loss: Risk Assessment of Selected Impurities

Nutrients ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 954
Author(s):  
Alexandra Figueiredo ◽  
Isabel Margarida Costa ◽  
Tânia Alexandra Fernandes ◽  
Luísa Lima Gonçalves ◽  
José Brito
Keyword(s):  
Risk Assessment ◽  
Weight Loss ◽  
Hazard Index ◽  
Food Supplement ◽  
Food Supplements ◽  
The European Union ◽  
X Ray ◽  
Daily Dose ◽  
Carcinogenic Effects ◽  
High Concentrations

Nowadays, food supplements are widely consumed, often without any medical supervision. In this study, 25 food supplements for weight loss, randomly purchased from five different suppliers in the European Union, were analysed by Wavelength Dispersive X ray Fluorescence spectrometry (WDXRF). The aim of this study was the risk assessment of trace elements and the mixture of elements present in food supplements for weight loss. The obtained Hazard Index (0.11) showed no potential risk of non-carcinogenic effects to human health. However, since humans are frequently exposed by different routes and/or sources to toxic metals, the additional consumption of these products may cause potential toxicological risks that cannot be ignored. In one analysed food supplement (FS), the simultaneous presence of Pb and Mn in high concentrations was detected. In two, FS chromium concentrations were above the reference daily dose. Unconformities were detected between the labelled and the detected values, which emphasises the misinformation of labels. This highlights the need for a deeper surveillance of food supplements.

scholarly journals Food Safety Governance and Guardianship: The Role of the Private Sector in Addressing the EU Ethylene Oxide Incident

Foods ◽  
2022 ◽  
Vol 11 (2) ◽  
pp. 204
Author(s):  
Aleksandra Kowalska ◽  
Louise Manning
Keyword(s):  
Food Safety ◽  
Ethylene Oxide ◽  
Collaborative Governance ◽  
Vital Role ◽  
Animal Origin ◽  
The European Union ◽  
Sesame Seeds ◽  
Safety Issues ◽  
Food And Feed ◽  
The Eu

Sesame seeds within the European Union (EU) are classified as foods not of animal origin. Two food safety issues associated with sesame seeds have emerged in recent years, i.e., Salmonella contamination and the presence of ethylene oxide. Fumigation with ethylene oxide to reduce Salmonella in seeds and spices is not approved in the EU, so its presence in sesame seeds from India was a sentinel incident sparking multiple trans-European product recalls between 2020–2021. Following an interpretivist approach, this study utilises academic and grey sources including data from the EU Rapid Alert System for Food and Feed (RASFF) database to inform a critical appraisal of current EU foods not of animal origin legislation and associated governance structures and surveillance programs. This is of particular importance as consumers are encouraged towards plant-based diets. This study shows the importance of collaborative governance utilizing data from company testing and audits as well as official regulatory controls to define the depth and breadth of a given incident in Europe. The development of reflexive governance supported by the newest technology (e.g., blockchain) might be of value in public–private models of food safety governance. This study contributes to the literature on the adoption of risk-based food safety regulation and the associated hybrid public–private models of food safety governance where both regulators and private organizations play a vital role in assuring public health.

scholarly journals National Food Safety Systems in the European Union: A Comparative Survey

2013 ◽  
Vol 2 (1) ◽  
Author(s):  
Andreas Hadjigeorgiou ◽  
Elpidoforos S. Soteriades ◽  
Anastasios Philalithis ◽  
Anna Psaroulaki ◽  
Yiannis Tselentis ◽  
...  
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
Food Safety ◽  
The European Union ◽  
Member States ◽  
Eu Member States ◽  
Comparative Survey ◽  
Safety Systems ◽  
Central Level ◽  
The Eu

This paper is a comparative survey of the National Food Safety Systems (NFSS) of the European Union (EU) Member-States (MS) and the Central EU level. The main organizational structures of the NFSS, their legal frameworks, their responsibilities, their experiences, and challenges relating to food safety are discussed. Growing concerns about food safety have led the EU itself, its MS and non-EU countries, which are EU trade-partners, to review and modify their food safety systems. Our study suggests that the EU and 22 out of 27 Member States (MS) have reorganized their NFSS by establishing a single food safety authority or a similar organization on the national or central level. In addition, the study analyzes different approaches towards the establishment of such agencies. Areas where marked differences in approaches were seen included the division of responsibilities for risk assessment (RA), risk management (RM), and risk communication (RC). We found that in 12 Member States, all three areas of activity (RA, RM, and RC) are kept together, whereas in 10 Member States, risk management is functionally or institutionally separate from risk assessment and risk communication. No single ideal model for others to follow for the organization of a food safety authority was observed; however, revised NFSS, either in EU member states or at the EU central level, may be more effective from the previous arrangements, because they provide central supervision, give priority to food control programs, and maintain comprehensive risk analysis as part of their activities.

scholarly journals An analysis of characteristics of post-authorisation studies registered on the ENCePP EU PAS Register

F1000Research ◽  
2017 ◽  
Vol 6 ◽  
pp. 1447 ◽  
Author(s):  
Robert Carroll ◽  
Sreeram V. Ramagopalan ◽  
Javier Cid-Ruzafa ◽  
Dimitra Lambrelli ◽  
Laura McDonald
Keyword(s):  
Risk Assessment ◽  
Chart Review ◽  
Drug Utilisation ◽  
Data Capture ◽  
Primary Data ◽  
European Medicines Agency ◽  
Therapeutic Area ◽  
The European Union ◽  
Study Designs ◽  
The Eu

Background: The objective of this study was to investigate the study design characteristics of Post-Authorisation Studies (PAS) requested by the European Medicines Agency which were recorded on the European Union (EU) PAS Register held by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Methods: We undertook a cross-sectional descriptive analysis of all studies registered on the EU PAS Register as of 18th October 2016. Results: We identified a total of 314 studies on the EU PAS Register, including 81 (26%) finalised, 160 (51%) ongoing and 73 (23%) planned. Of those studies identified, 205 (65%) included risk assessment in their scope, 133 (42%) included drug utilisation and 94 (30%) included effectiveness evaluation. Just over half of the studies (175; 56%) used primary data capture, 135 (43%) used secondary data and 4 (1%) used a hybrid design combining both approaches. Risk assessment and effectiveness studies were more likely to use primary data capture (60% and 85% respectively as compared to 39% and 14% respectively for secondary). The converse was true for drug utilisation studies where 59% were secondary vs. 39% for primary. For type 2 diabetes mellitus, database studies were more commonly used (80% vs 3% chart review, 3% hybrid and 13% primary data capture study designs) whereas for studies in oncology, primary data capture were more likely to be used (85% vs 4% chart review, and 11% database study designs). Conclusions: Results of this analysis show that study objectives and therapeutic area influence PAS design in terms of type of data capture used.

scholarly journals One is okay, more is better? Pharmacological aspects and safe limits of nutritional supplements

2007 ◽  
Vol 66 (4) ◽  
pp. 493-507 ◽  
Author(s):  
Pamela Mason
Keyword(s):  
Food Supplements ◽  
Health Food ◽  
Nutrition Survey ◽  
Safety Issues ◽  
Upper Limits ◽  
Wide Availability ◽  
Potential Benefits ◽  
Safe Limits ◽  
The Uk ◽  
The Eu

The use of vitamins, minerals and other supplements has increased considerably during recent years. In the National Diet and Nutrition Survey of British adults aged 19–64 years 40% of those surveyed were taking supplements. In 2005 sales of dietary supplements in the UK were approximately £325·7×106in ‘bricks and mortar’ shops (excluding health food shops). The physiological effects of vitamins and minerals in amounts approximating to the UK reference nutrient intake or the EU RDA are well understood in terms of reducing the risk of micronutrient deficiency. However, the effects of vitamins, minerals and other supplements in larger amounts have attracted much attention in recent decades, and these effects, some of which may be pharmacological, are not as well categorised. Some of these effects are beneficial, some are not. Although vitamins and minerals and other supplements are generally safe at higher doses, there are some safety issues that are relevant in the context of the wide availability of supplements without a doctor's prescription. Thus, several authorities throughout the world have established upper limits (UL) for the intake of vitamins and minerals, and the EU is in the process of setting maximum permitted levels (MPL) for vitamins and minerals in food supplements. The present paper discusses the potential benefits and safety issues relating to the use of supplements at doses higher than the RDA. The rationale for the establishment of UL is also discussed, explaining the differences between the values set by different authorities and the expected guidance and legislation from the European Commission on MPL for vitamins and minerals in food supplements.

Quantitative risk assessment to compare the risk of rabies entering the UK from Turkey via quarantine, the Pet Travel Scheme and the EU Pet Movement Policy

2009 ◽  
Vol 138 (8) ◽  
pp. 1114-1125 ◽  
Author(s):  
V. RAMNIAL ◽  
R. KOSMIDER ◽  
O. AYLAN ◽  
C. FREULING ◽  
T. MÜLLER ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Companion Animals ◽  
Domestic Animals ◽  
Current Level ◽  
Quantitative Risk Assessment ◽  
The European Union ◽  
European Regulation ◽  
Annual Probability ◽  
The Uk ◽  
The Eu

SUMMARYRabies was eradicated from the UK in 1922 through strict controls of dog movement and investigation of every incident of disease. Amendments were made to the UK quarantine laws and the Pet Travel Scheme (PETS) was subsequently introduced in 2000 for animals entering the UK from qualifying listed countries. European Regulation 998/2003 on the non-commercial movement of pet animals initiated the European Union Pet Movement Policy (EUPMP) in July 2004. The introduction of EUPMP harmonized the movement of pet animals within the EU (EUPMPlisted) but raised the possibility of domestic animals entering the UK from a non-EU state where rabies is endemic (EUPMPunlisted). A quantitative risk assessment was developed to estimate the risk of rabies entering the UK from Turkey via companion animals that are incubating the disease and enter through PETS or EUPMP compared to quarantine. Specifically, the risk was assessed by estimating the annual probability of rabies entering the UK and the number of years between rabies entries for each scheme. The model identified that the probability of rabies entering the UK via the three schemes is highly dependent on compliance. If 100% compliance is assumed, PETS and EUPMPunlisted (at the current level of importation) present a lower risk than quarantine, i.e. the number of years between rabies entry is more than 170 721 years for PETS and 60 163 years for EUPMPunlisted compared to 41 851 years for quarantine (with 95% certainty). If less than 100% compliance is assumed, PETS and EUPMPunlisted (at the current level of importation) present a higher risk. In addition, EUPMPlisted and EUPMPunlisted (at an increased level of importation) present a higher risk than quarantine or PETS at 100% compliance and at an uncertain level of compliance.

A quantitative UHPLC-MS/MS method for citrinin and ochratoxin A detection in food, feed and red yeast rice food supplements

2016 ◽  
Vol 9 (3) ◽  
pp. 343-352 ◽  
Author(s):  
J.A.L. Kiebooms ◽  
B. Huybrechts ◽  
C. Thiry ◽  
E.K. Tangni ◽  
A. Callebaut
Keyword(s):  
Risk Assessment ◽  
Ochratoxin A ◽  
High Performance ◽  
Food Supplements ◽  
Red Yeast Rice ◽  
Red Yeast ◽  
Relative Standard ◽  
Future Data ◽  
Food And Feed ◽  
Feed Samples

Mycotoxins may cause deleterious effects (among others nephrogenic, hepatogenic, carcinogenic, teratogenic, neurogenic) in animals and humans, therefore they have been intensely studied and monitored over the years. For citrinin (CIT), a nephrotoxic mycotoxin, however, this has not yet been the case. According to the latest European Food Safety Authority report, a correct risk assessment of CIT was not possible due to the lack of occurrence data. Besides, traces of CIT or its metabolite, dehydrocitrinone are widely (in up to 90% of samples) present in human urine according to recent Belgian and German scientific reports, which might imply chronic exposure. Only recently, a European maximum limit has been set for CIT in cholesterol reducing food supplements including red yeast fermented rice (RYR). During production of RYR through fungal (among others Monascus purpureus) fermentation of rice other components, like CIT, as well as nephrotoxic ochratoxin A (OTA) may form. Consequently, the present work attempted develop to a robust and routinely applicable ultra-high performance liquid chromatographytandem mass spectrometry (UHPLC-MS/MS) method for the analysis of CIT and OTA in food, feed and in RYR food supplements. The method was successfully validated based on EU/657/2002 and EU/519/2014 in RYR food supplements and wheat flour, achieving respective limits of quantification (LOQ) for CIT of 0.4 μg/kg and 0.1 μg/kg and for OTA of 15 μg/kg and 0.4 μg/kg. The average between-day recoveries varied from 72 to 110% with relative standard deviations ≤16%. Single-day validation in rice, curry and apple matrices showed LOQs ranging from 0.3-1.0 μg/kg. Next, the occurrence of CIT/OTA was surveyed in 138 RYR, food and feed samples, proving the potential of this method for future data acquisition within a risk assessment framework specifically for CIT, while also gaining information about the (co-)occurrence of OTA in edible matrices.

Assessing the effectiveness of the EU AML regime: Detecting and investigating cases of trafficking in human beings

2018 ◽  
Vol 9 (4) ◽  
pp. 464-485
Author(s):  
Þorbjörg Sveinsdóttir
Keyword(s):  
Risk Assessment ◽  
Money Laundering ◽  
Focal Point ◽  
The European Union ◽  
Human Beings ◽  
Modus Operandi ◽  
Control Regulation ◽  
Trafficking In Human Beings ◽  
Private Actors ◽  
The Eu

The effectiveness of anti-money-laundering (AML) mechanisms within the European Union (EU), in the context of the detection and investigation of trafficking in human beings (THB), is the focal point of this article. The article begins by examining the EU’s emphasis on proactive financial investigations in cases of THB and then moves on to examine EU AML framework. Special attention is paid to the 4th AML Directive (Directive (EU) 2015/849), the Second Transfer of Funds Regulation (Regulation (EU) 2015/847), the Second Payment Services Directive (Directive (EU) 2015/2366) and the Cash Control Regulation (Regulation (EC) 1889/2005). The modus operandi of traffickers operating within the EU when laundering the proceeds of their crimes is then studied, with the view of assessing the effectiveness of the framework. The analysis shows that the EU AML framework fails to capture some common modes of money laundering (ML) in THB cases and in addition, it is less effective when the criminal proceeds are laundered within the EU. The analysis furthermore shows that the EU AML regime is largely dependent on the ML risk assessment of private actors, many who do not comply with their AML obligations and are widely insufficiently monitored within the Member States (MS). The article concludes that the limitations of the EU AML framework and it’s enforcement in the MS have resulted in difficulties both in detecting ML associated with THB and in gathering evidence during THB investigations.

scholarly journals Critical discussion of the current environmental risk assessment (ERA) of veterinary medicinal products (VMPs) in the European Union, considering changes in animal husbandry

2021 ◽  
Vol 33 (1) ◽  
Author(s):  
Ruth Haupt ◽  
Céline Heinemann ◽  
Jason Jeremia Hayer ◽  
Simone Magdalene Schmid ◽  
Miriam Guse ◽  
...  
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
Phase I ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Animal Husbandry ◽  
The European Union ◽  
Medicinal Products ◽  
The Eu ◽  
Veterinary Medicinal Products

Abstract Background Veterinary medicinal products (VMPs) administered to livestock might affect the environment. Therefore, an environmental risk assessment (ERA) is conducted during the approval process of VMPs. In the European Union (EU), the ERA, which was established approximately 10 years ago, consists of two phases. In the present review, we examined the first phase. In this phase, VMPs are subjected to a decision-making process comprising 19 questions and several tables with default values published in the “Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (European Medicines Agency 2016).” Since a proportion of livestock husbandry systems is currently shifting toward ecological husbandry and free-range production systems, there is a lower risk of VMP consumption in general, but livestock excretions possibly containing VMPs might be directly released into the environment instead of being stored and applied as manure. In the present study, the first phase of the current ERA of VMPs in the EU was critically discussed with respect to the changes in animal husbandry. The large number of default values used in the ERA were checked for topicality. In a three-step approach, firstly trends and changes in animal husbandry in Europe that might be relevant for the ERA were collected, secondly, the interactions between Phase I and animal husbandry were evaluated and thirdly, the default values used in Phase I were verified in order to identify research gaps. Results Several default values used in the current ERA were identified as outdated. Together with the lack of valid data (e.g., on animal husbandry systems or VMP treatments), this may have an impact on the predicted environmental concentration (PEC) as the central decision threshold of the ERA. Conclusions The results of the present study indicate that an update of the ERA of VMPs in the EU is required to consider the changes in animal husbandry. Several aspects related to this issue are critically discussed.

Quantitative risk assessment model of canine rabies introduction: application to the risk to the European Union from Morocco

2010 ◽  
Vol 138 (11) ◽  
pp. 1569-1580 ◽  
Author(s):  
S. NAPP ◽  
M. CASAS ◽  
S. MOSET ◽  
J. L. PARAMIO ◽  
J. CASAL
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
Western Europe ◽  
Assessment Model ◽  
Quantitative Risk Assessment ◽  
Total Probability ◽  
Risk Assessment Model ◽  
The European Union ◽  
Annual Probability ◽  
The Eu

SUMMARYAlthough rabies incidence in humans in Western Europe is low, the repeated importation of rabid animals from enzootic areas threatens the rabies-free status of terrestrial animals and challenges the public health systems in this area. Most rabid animals imported into the European Union (EU) in recent years came from Morocco. The aim of this study was to develop a probabilistic risk assessment model to estimate the probability of rabies introduction, which was applied to the risk to the EU from dogs coming from Morocco. The mean annual probability of rabies introduction was 0·21 (90% CI 0·02–0·65). The pathways that contributed the most to this probability were: (a) EU citizens who adopted a dog in Morocco (59% of the total probability) and (b) EU citizens who travelled with their dog to Morocco by ferry (34% of the total probability). The model showed a marked seasonality in the risk of rabies with almost 40% of the annual probability occurring during the months of July and August. The application of stricter border controls (assuming 100% compliance) would result in a >270-fold reduction in the likelihood of rabies introduction into the EU from Morocco.

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