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1.
Antioxidants (Basel) ; 12(4)2023 Apr 19.
Article in English | MEDLINE | ID: mdl-37107334

ABSTRACT

Metabolic syndrome has been associated in many studies with working in shifts. Even if the mechanistic details are not fully understood, forced sleep deprivation and exposure to light, as happens during night shifts, or irregular schedules with late or very early onset of the working program, lead to a sleep-wake rhythm misalignment, metabolic dysregulation and oxidative stress. The cyclic melatonin secretion is regulated by the hypothalamic suprachiasmatic nuclei and light exposure. At a central level, melatonin promotes sleep and inhibits wake-signals. Beside this role, melatonin acts as an antioxidant and influences the functionality of the cardiovascular system and of different metabolic processes. This review presents data about the influence of night shifts on melatonin secretion and oxidative stress. Assembling data from epidemiological, experimental and clinical studies contributes to a better understanding of the pathological links between chronodisruption and the metabolic syndrome related to working in shifts.

2.
Nutrients ; 15(4)2023 Feb 07.
Article in English | MEDLINE | ID: mdl-36839202

ABSTRACT

Beer is one of the most consumed drinks worldwide. It contains numerous categories of antioxidants, phenolic products, traces of group B vitamins, minerals (selenium, silicon, potassium), soluble fibers and microorganisms. Low or moderate beer consumption, with or without alcohol, showed positive effects on health by stimulating the development of a healthy microbiota. In the present review we focused on four components responsible with interaction with gut microbiota: microorganisms, polyphenols, fiber and melanoidins, their presence in usual beers and on perspectives of development of fortified beers with enhanced effects on gut microbiota. Though microorganisms rarely escape pasteurization of beer, there are new unpasteurized types that might bring strains with probiotic effects. The polyphenols from beer are active on the gut microbiota stimulating its development, with consequent local anti-inflammatory and antioxidant effects. Their degradation products have prebiotic action and may combat intestinal dysbiosis. Beer contains dietary fiber such as non-starchy, non-digestible carbohydrates (ß-glucans, arabinoxylans, mannose, fructose polymers, etc.) that relate with gut microbiota through fermentation, serving as a nutrient substrate. Another type of substances that are often considered close to fiber because they have an extremely low digestibility, melanoidins (melanosaccharides), give beer antioxidant and antibacterial properties. Though there are not many research studies in this area, the conclusion of this review is that beer seems a good candidate for a future functional food and that there are many pathways by which its ingredients can influence in a positive manner the human gut microbiota. Of course, there are many technological hinderances to overcome. However, designing functional beers fortified with fiber, antioxidants and probiotics, with a very low or no alcoholic content, will counteract the negative perception of beer consumption, will nullify the negative effects of alcohol, while simultaneously exerting a positive action on the gut microbiota.


Subject(s)
Beer , Gastrointestinal Microbiome , Humans , Beer/analysis , Polyphenols/analysis , Phenols/analysis , Antioxidants/pharmacology
3.
Article in English | MEDLINE | ID: mdl-35742513

ABSTRACT

Considering the major limitations of the latest studies conducted in Romania on the knowledge, attitudes and practices (KAPs) of antibiotic use and antibiotic resistance, we conducted this study to assess this major public health threat. A cross-sectional survey based on a validated questionnaire was conducted among the general population of Romania for a period of 5 months, i.e., September 2021-January 2022. The questionnaire was distributed using Google Form and it covered demographic characteristics and KAP assessments consisting of 12 items on knowledge, 10 items on attitudes and 3 items on practices. Latent class analyses (LCAs) were conducted to group respondents based on their responses. The response rate was 77%, of which females responded in a greater number (n = 1251) compared to males (n = 674). For most of the respondents (67.32%, n = 1296), the education level was high school, while 23.58% (n = 454) of respondents were college graduates. One in three Romanians (33.3%) know the WHO predictions related to this topic. Overall, the Romanian population is less disciplined when it comes to completing antibiotic treatments, as 29.19% of the respondents stop the course of antibiotic administration if their symptoms improve. The key findings from the present study may help policy makers in designing targeted interventions to decrease confusion, ambiguity or misconceptions about antibiotic use.


Subject(s)
Anti-Bacterial Agents , Health Knowledge, Attitudes, Practice , Anti-Bacterial Agents/therapeutic use , Cross-Sectional Studies , Drug Resistance, Microbial , Female , Humans , Latent Class Analysis , Male , Romania , Surveys and Questionnaires
4.
Antioxidants (Basel) ; 11(2)2022 Jan 27.
Article in English | MEDLINE | ID: mdl-35204124

ABSTRACT

Hop plant (Humulus lupulus L.) has been used by humans for ages, presumably first as a herbal remedy, then in the manufacturing of different products, from which beer is the most largely consumed. Female hops cones have different useful chemical compounds, an important class being antioxidants, mainly polyphenols. This narrative review describes the main antioxidants in hops, their bioavailability and biological effects, and the results obtained by now in the primary and secondary prevention of several non-communicable diseases, such as the metabolic syndrome related diseases and oncology. This article presents in vitro and in vivo data in order to better understand what was accomplished in terms of knowledge and practice, and what needs to be clarified by additional studies, mainly regarding xantohumol and its derivates, as well as regarding the bitter acids of hops. The multiple protective effects found by different studies are hindered up to now by the low bioavailability of some of the main antioxidants in hops. However, there are new promising products with important health effects and perspectives of use as food supplements, in a market where consumers increasingly search for products originating directly from plants.

5.
Exp Ther Med ; 23(2): 150, 2022 Feb.
Article in English | MEDLINE | ID: mdl-35069831

ABSTRACT

An ectopic pregnancy (EP) involves the implantation of the gestational sac outside the uterine cavity. In the event of diagnosing an EP, the current medical approach is to avoid surgery and to preserve fertility whenever possible; therefore, methotrexate (MTX)-based therapy has become prominent in recent years. MTX, a drug usually used to treat severe forms of autoimmune diseases and several types of cancer, has proven its utility in the conservative treatment of EPs. The success rate of MTX correlates with lower values of ß subunit of human chorionic gonadotropin hormone (ß-hCG) serum levels, especially below 2,000 mUI/ml, side effects being insignificant. In the present study, the results obtained concerning the success rate of MTX in the conservative treatment of EPs were obtained at the Department of Obstetrics and Gynecology of the Bucharest University Emergency Hospital from January 2014 to December 2020. The aim of the present study was to highlight the necessity for revising current guidelines for ectopic pregnancy medical treatment in order to manage this pathology optimally and to select carefully the proper treatment, whether medical, surgical or expectant management, so that morbidity is reduced to a minimum.

6.
Exp Ther Med ; 23(1): 23, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34815775

ABSTRACT

Pemphigoid gestationis is considered to be a rare pregnancy exclusive bullous disease, which modifies the course of the pregnancy, with difficulties in the management of the pruritus and skin lesions as well as a possible change in the neonatal outcome. Differential diagnosis of skin lesions and pruritus in pregnancy is challenging, and complementary investigations such as skin biopsy or laboratory tests are indispensable. The correct diagnosis and proper treatment could change the natural course of a pregnancy at risk and could improve maternal and fetal morbidity. We present the case of a patient with pemfigoid gestationis with the aim to highlight: i) the management of this pregnancy-associated skin disorder which transfers this pregnancy into a category of high obstetrical risk pregnancy; ii) the particularities of the course of the pregnancy; and iii) the importance in the differential diagnosis of pregnancy dermatoses. The particularity of this case of pemphigoid gestationis was the acute fetal distress in the absence of intrauterine growth restriction that is frequently found in this pathology, and the management of a rare pregnancy skin condition that currently has no standard treatment.

7.
Foods ; 10(9)2021 Sep 06.
Article in English | MEDLINE | ID: mdl-34574220

ABSTRACT

Several processed food products may contain toxic compounds considered risk factors for human health. Known for its possible carcinogenic effects, acrylamide is an organic compound periodically analyzed by the entities responsible for consumer safety. Knowing the acrylamide content of food offers the possibility of implementing corrective measures when needed, targeted at lowering its level. The aim of the paper was to screen for the presence of acrylamide in four products consumed almost daily in Romania and calculate acrylamide exposure by consuming one serving. Expressed in µg/kg coffee has the highest average acrylamide content (199), followed by potato chips (134), pretzels (120), and bread (14). Results regarding the acrylamide content in one serving showed the highest levels of acrylamide in pretzels (10.20 µg/serving), followed by potato chips (4.00 µg/serving), coffee (2.20 µg/cup), and bread (0.40 µg/slice). The calculation of the acrylamide content for one serving of the studied products will facilitate the following studies on the dietary acrylamide intake of the Romanian population, studies which, to our knowledge, have not been performed so far.

8.
Exp Ther Med ; 22(3): 993, 2021 Sep.
Article in English | MEDLINE | ID: mdl-34345275

ABSTRACT

Plant-based nutrition has become extremely popular in the contemporary era. Its positive effects are sustained by many studies, but one of its risks is that it is almost completely devoid of vitamin B12. In the present study, we analyzed the effects of two types of vitamin B12 supplements, cyancobalamin and methylcobalamin on the level of active serum vitamin (holotranscobalamin) in a group of Romanian individuals (n=42) following a (vegan) plant-based diet. The results revealed that cyancobalamin gives better results in maintaining B12, as quantified by the holotranscobalamin value (median=150 pcg/l) when compared with methylcobalamin (median=78.5 pcg/l). The frequency of administration, regardless of the quantity in one dose, is another important factor in maintaining the holotranscobalamin level within suitable limits. More frequent intakes give more optimal results. Vegans trying to supplement with alternative products (algae, kombucha, other fermented products), had the lowest levels of holotranscobalamin, always bellow the recommended level of 35 pcg/l (median=29 pcg/l). Vegans must be educated on B12 supplementation, about the pharmaceutical forms on the market and their performances and on choosing the optimal plan in order to avoid the onset of B12 deficiency.

9.
Exp Ther Med ; 21(3): 261, 2021 Mar.
Article in English | MEDLINE | ID: mdl-33603868

ABSTRACT

Methods to prevent the development of pathologies due to placental dysfunctions, such as gestational hypertension and preeclampsia, are the main approaches for obtaining the best maternal and fetal antepartum and postpartum prognosis. During 5 years of study (January, 2015 to December, 2019), the cases of pregnancy and puerperium complicated with pathology due to placental dysfunction were analyzed. The main objective was to determine the magnitude of the impact of thrombophilia on the development of an entity of gestational hypertension disorder. We compared the impact of thrombophilia and its associated complications in patients with gestational hypertension with moderate and severe preeclampsia. Thus, we found obesity, thrombophilia, and underlying cardiac pathology to be significant risk factors for severe preeclampsia. Regarding the comparative analysis of the risk factors and complications associated with patients with mild preeclampsia compared with those with severe preeclampsia, the presence in severe preeclampsia of thrombophilia, endocrine, liver, and cardiac pathology was higher and, a higher rate of complications was observed; complications included fetal death, intrauterine growth restriction (IUGR), prematurity, fetal arrhythmia with acute fetal distress, HELLP syndrome, and placental abruption. Thrombophilia has a significant effect on the development of severe preeclampsia, and oligohydramnios as specific complication of mild preeclampsia. Factors indicating an increased risk of progression from mild preeclampsia to severe preeclampsia are in addition to inherited thrombophilia the underlying pathologies, namely cardiac, hepatic, and endocrine factors.

10.
J Med Life ; 14(6): 748-755, 2021.
Article in English | MEDLINE | ID: mdl-35126743

ABSTRACT

The wide access to varied, attractive, and aggressively promoted information can induce pregnant women to think that any form of complementary therapy can be a saving solution for a medical problem because these therapies are natural, therefore, harmless. Updated information from literature about indications, benefits, limits, and risks of phytotherapy in pregnancy was presented. Valuable therapeutic resources with proven clinical efficacy (evidence-based medicine) were presented for each trimester of pregnancy, during labor, postpartum, but also during breastfeeding. For some phytotherapeutics, there are scientific studies. There is also a detailed presentation about some possibilities for therapeutic errors, which should be avoided during pregnancy. Positive results of phytotherapy deserve to be known and applied by the obstetrician for the certain benefit of future mothers.


Subject(s)
Obstetrics , Breast Feeding , Female , Humans , Mothers , Phytotherapy , Pregnancy , Pregnant Women
11.
Exp Ther Med ; 20(3): 2423-2428, 2020 Sep.
Article in English | MEDLINE | ID: mdl-32765727

ABSTRACT

The prevalence of pathologies due to placental dysfunction superimposed on pregnancy is constantly increasing. The prognosis of the cases complicated by gestational hypertension is usually good, significantly better compared with that of the cases associating preeclampsia. About half of the cases with gestational hypertension will progress to preeclampsia, the risk of decompensation being inversely proportional to the gestational age of the onset of gestational hypertension. The present study, analyzed the cases of pregnancy and postpartum complicated by pathologies related to placental dysfunction, during a period of 5 years. The risk factors analyzed were the presence of infections during pregnancy, diabetes, thrombophilia, pregnancy obtained by in vitro fertilization, abnormal adherence of the placenta, obesity, multiple pregnancy, the presence of an earlier hepatic, endocrine, renal, cardiac or autoimmune pathology, and the existence of an uterine malformation. Obesity appears with a significantly increased incidence in patients with gestational hypertension and middle preeclampsia. Intrauterine growth restriction appears with a significantly increased incidence in patients with mild preeclampsia. Complications such as prematurity, acute fetal distress and abruption of placentae had a significantly increased incidence in patients with severe preeclampsia. Thus, obese patients have a higher risk of moderate preeclampsia, following gestational hypertension and finally severe preeclampsia.

12.
Exp Ther Med ; 20(3): 2460-2464, 2020 Sep.
Article in English | MEDLINE | ID: mdl-32765734

ABSTRACT

During pregnancy, maternal diet is a modifiable factor that impacts the birth outcome. Since the nutritional needs of a pregnant women vary during preconception, gestational and breastfeeding period, it is necessary to adapt the diet and lifestyle, optimally under the personalized nutrition guidance of a specialist. High quality research regarding diet during pregnancy remains challenging as nutritional concerns also vary according to religion, financial income, age and education of the pregnant woman, as well as specific traditions of each country, limited number of dietitians with special training in maternal nutrition. The obstetrician usually plays a major role in dietary counselling and the use of nutritional monitoring tools can help identify pregnant women who may be at risk due to an inappropriate diet. The age of the pregnant women can be important when it comes to dietary and lifestyle changes. In this context, we addressed a questionnaire to 100 pregnant women in third trimester of pregnancy in order to evaluate a possible correlation between the age and the dietary behavior and lifestyle of a pregnant woman. Furthermore, the maternal compliance with dietary recommendations in pregnancy and the exposure to various risks due to unhealthy nutrition were also analysed in the study.

13.
Adv Exp Med Biol ; 1088: 497-528, 2018.
Article in English | MEDLINE | ID: mdl-30390267

ABSTRACT

Muscle atrophy may occur under different circumstances throughout a person's life. These conditions include periods of immobilization of a limb or of the whole body and aging accompanied by the onset of sarcopenia. Muscle mass is reduced as a result of decreased protein synthesis or increased protein degradation. Most studies aim to prevent the degradation of muscle proteins, but the way in which protein synthesis can be stimulated is often neglected. This study will provide an up-to-date review regarding nutritional considerations and resistance exercise countermeasures in the prevention of muscle mass loss and recovery of muscle mass in muscle atrophy secondary to immobilization or in sarcopenic obesity. We do not address muscle atrophy in disease states associated with inflammation (rheumatoid arthritis, COPD, cancer cachexia, AIDS, burns, sepsis, and uremia) which are governed by particular mechanisms of muscle loss.


Subject(s)
Diet Therapy , Muscle Proteins/metabolism , Muscle, Skeletal/pathology , Muscular Atrophy/prevention & control , Sarcopenia/prevention & control , Humans , Nutritional Requirements , Resistance Training
14.
EFSA J ; 15(1): e04660, 2017 Jan.
Article in English | MEDLINE | ID: mdl-32625256

ABSTRACT

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3-oxopropoxy)-2-methylquinoline-3-carboxylic acid [FL-no: 16.130], in the Flavouring Group Evaluation 407 (FGE.407), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intended to be used as both the parent compound and its hemisulfate monohydrate salt as a flavouring substance with modifying properties in specific categories of food. The chronic dietary exposure to the substance estimated using the added portions exposure technique (APET), is calculated to be 882 µg/person per day for a 60-kg adult and 547 µg/person per day for a 15-kg 3-year-old child. There is no concern with respect to genotoxicity. A 90-day dietary administration study in rats showed no adverse effects for doses up to 100 mg/kg body weight (bw) per day, providing an adequate margin of safety. Developmental toxicity was not observed in a study with rats at the dose levels up to 1,000 mg/kg bw per day. The Panel concluded that [FL-no: 16.130] and its hemisulfate monohydrate salt are not expected to be of safety concern at the estimated levels of dietary exposure calculated using the APET approach. This conclusion applies only to the use of the substance as a flavour modifier as requested and when used at the levels as specified for foods from different food categories.

15.
EFSA J ; 15(1): e04661, 2017 Jan.
Article in English | MEDLINE | ID: mdl-32625257

ABSTRACT

This scientific opinion of EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the risk assessment of the additive tungsten oxide, CAS No 39318-18-8 and FCM No 1064, for use in food contact materials as a reheat agent in polyethylene terephthalate (PET) at a maximum use level of 75 ppm (75 mg/kg PET). The substance is a mixture of tungsten oxides with tungsten at different oxidative levels. The average oxidation level of tungsten in the oxides is 2.86 corresponding to 19.93% oxygen content. Detailed information on impurities is provided as confidential. Specific migration from PET plaques with the substance at 150 mg/kg (double the maximum intended use level of 75 mg/kg) was determined into 95% ethanol, as a worst-case simulant for PET due to its swelling effect. Under these test conditions, the specific migration, measured as tungsten using ICP-MS, was at the level of 1 µg/kg. The Panel considered that due to the insolubility of the substance, this low migration will be typical for any foreseeable use as a reheat additive in PET. Two in vitro genotoxicity studies, a bacterial gene mutation test and an in vitro micronucleus assay, performed in accordance with the OECD Guidelines and in compliance with GLP, were provided by the applicant for the substance tungsten oxide and were considered negative by the CEF Panel. According to a scientific opinion on strategy for genotoxicity testing (EFSA, 2011), the three genotoxic endpoints, gene mutation, chromosomal and numerical aberrations, are covered by these two tests. The CEF Panel concluded that the substance tungsten oxide is not of safety concern for the consumer if the additive is used as a reheat agent in PET. For other technical functions or for use in other polymers, the migration should not exceed 50 µg/kg (expressed as tungsten).

16.
EFSA J ; 15(1): e04662, 2017 Jan.
Article in English | MEDLINE | ID: mdl-32625258

ABSTRACT

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of 29 aliphatic secondary alcohols, ketones and related esters evaluated by JECFA at the 59th and 69th meetings in 2002 and 2008. This revision is made due to the inclusion of nine additional substances cleared for genotoxicity concern in FGE.205 Revision 1. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern and available data on metabolism and toxicity. The Panel agrees with the application of the Procedure as performed by JECFA for all 29 substances considered in this FGE. For all substances, the Panel concludes that there is 'no safety concern at the estimated levels of intake as flavouring substances based on the MSDI approach'. For all 29 substances, the specifications for the materials of commerce have also been considered and found adequate. Ten out of the 14 substances for which use levels became available exceed the modified theoretical added maximum daily intake (mTAMDI) and more reliable exposure data are required to finalise their evaluation. On the basis of such data, additional toxicological data might become necessary. For 15 substances, use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment to finalise the evaluation.

17.
EFSA J ; 15(2): e04724, 2017 Feb.
Article in English | MEDLINE | ID: mdl-32625416

ABSTRACT

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the mixture of methyl-branched and linear C14-C18 alkanamides, derived from fatty acids, for use in food contact materials as a slip or release agent at up to 1% w/w in polyolefins. The final materials are intended for contact with foodstuffs other than fatty foods for long-term storage at room temperature including short heating. No thermal degradation of the substance is expected under manufacturing process conditions of polyolefins. Specific migration from low-density polyethylene (LDPE) made with 0.37% of the substance into 3% acetic acid and 10% ethanol was up to 0.68 mg/kg. Based on negative results in a bacterial mutation test and in an in vivo micronucleus test, there was no evidence of a genotoxic potential of the substance. Impurities were determined and the main ones were tested in a bacterial mutation test giving negative results. Along with the negative results from the in vivo micronucleus test on the substance containing the impurities, there was no evidence of a genotoxic potential of the impurities. Based on a 28-day study on the substance, the Panel noted that there is sufficient margin of safety between the no observed adverse effect level (NOAEL) and the maximum exposure of consumers that could occur at a migration level of 5 mg/kg food, to cover uncertainties about toxic effects due to potential accumulation of slowly hydrolysed branched amide species of the substance during chronic exposure. The CEF Panel concluded that the substance is not of safety concern for consumers if it is used in the manufacture of polyolefin articles intended for contact with all foodstuffs other than fatty foods and the migration does not exceed 5 mg/kg food. The 5 mg/kg food migration should not apply to n-stearamide.

18.
EFSA J ; 15(3): e04725, 2017 Mar.
Article in English | MEDLINE | ID: mdl-32625434

ABSTRACT

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate 53 flavouring substances attributed to the Flavouring Group Evaluation 07, including four new substances but-3-en-2-ol, non-1-en-e-ol, hex-1-en-3-one and 1-nonene-3-one [FL-nos: 02.131, 02.187, 07.161 and 07.210] in this Revision 5, using the Procedure in Commission Regulation (EC) No 1565/2000. None of the 53 substances was considered to have genotoxic potential. The substances were evaluated through a stepwise approach that integrates information on the structure-activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that all 53 substances do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the 'Maximised Survey-derived Daily Intake' (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate. For 50 substances, further information is required based on comparison of the 'modified Theoretical Added Maximum Daily Intakes' (mTAMDIs) with the TTCs. This would include more reliable intake data and then, if required, additional toxicological data.

19.
EFSA J ; 15(3): e04726, 2017 Mar.
Article in English | MEDLINE | ID: mdl-32625435

ABSTRACT

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate N-(2-methylcyclohexyl)-2,3,4,5,6-pentafluoro-benzamide [FL-no: 16.119] in the Flavouring Group Evaluation 302, using the Procedure in Commission Regulation (EC) No 1565/2000. The substance is intended to be used as a flavour modifier and the current evaluation is only applicable to this use. Information on the ratios of diastereoisomers of the substance has been provided (cis 20-40% and trans 60-80%). Information on the ratio of enantiomers is lacking. The available data on genotoxicity do not preclude the evaluation of the candidate substance [FL-no: 16.119] through the Procedure. The substance was evaluated through the B-side of the Procedure. A 'No Observed Adverse Effect Level' (NOAEL) of 55 mg/kg body weight (bw) per day could be derived for [FL-no: 16.119] from a 90-day subchronic toxicity study in rats. This NOAEL provides an adequate margin of safety of 1.4 × 106, based on the 'Maximised Survey-Derived Daily Intake' (MSDI) of 2.4 µg/capita per day. Based on the 'modified Theoretical Added Maximum Daily Intake' (mTAMDI) approach, the Panel concluded that more information is needed on use and use levels. Besides the safety assessment of this flavouring substance, the specifications for the material of commerce have also been considered. Additional information on the stereoisomeric composition of the flavouring substance is required.

20.
EFSA J ; 15(3): e04727, 2017 Mar.
Article in English | MEDLINE | ID: mdl-32625436

ABSTRACT

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of four flavouring substances consisting of isopulegone and three other substances evaluated by JECFA at the 55th meeting. This revision is made due to additional toxicity data available for (1R,2S,5R)-isopulegol [FL-no: 02.067]. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. p-Mentha-1,4(8)-dien-3-one [FL-no: 07.127] is no longer supported by the flavour industry and was not evaluated. In agreement with JECFA, the Panel evaluated the candidate substances in this Flavouring Group Evaluation (FGE) via the B-side of the Procedure. Based on a no observed adverse effect level (NOAEL) from a 90-day oral toxicity study on [FL-no: 02.067], adequate margins of safety for the three candidate substances could be calculated. Therefore, the Panel agrees with the JECFA conclusion, 'No safety concern at estimated levels of intake as flavouring substances' based on the maximised survey-derived daily intake (MSDI) approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and found adequate. For the three substances evaluated in this FGE, use levels have become available and the modified theoretical added maximum daily intakes (mTAMDIs) were estimated. For [FL-no: 02.067 and 07.067], the mTAMDI exceeds the toxicological threshold of concern for their structural classes and need more refined exposure assessment to finalise the evaluation.

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