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Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of fumaric acid as a technological and sensory additive (functional groups: preservative and flavouring compounds, respectively) and for a new use of the additive as a technological additive (functional group: acidity regulator) for all animal species. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that fumaric acid remains safe under the authorised conditions of use for the terrestrial animals, consumers and the environment. However, the Panel cannot conclude on the safety for the aquatic animals under all authorised condition of use. Fumaric acid is irritant to skin, eyes and respiratory tract, and should be considered a skin and respiratory sensitiser due to the presence of nickel. The Panel also considers that the new use of the additive as an acidity regulator under proposed conditions of use would not introduce risks not already considered. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation (for its use as preservative and flavouring compound). The Panel is not in the position to conclude on the efficacy of fumaric acid as an acidity regulator in feed. [ABSTRACT FROM AUTHOR]

Electronic cigarettes (ECs) are battery-powered gadgets that heat liquid to produce an aerosol. Nicotine is a primary ingredient in some e-liquids; however, due to a lack of quality control regulations, the nicotine may become tainted, or the measured and labelled values may not correspond. To avoid such issues, it is essential to identify the components that contribute to erroneous nicotine quantification. Herein, the differences between free-base nicotine and nicotine salts are discussed, highlighting the lower volatility of nicotine salts and their longer persistence in the body. Discrepancies were noted in the concentration of nicotine salts in some e-liquid samples, with labelled and measured values of 48 and 68.8 mg/mL, respectively, in one sample, and 24 and 33.1 mg/mL, respectively, in another. Inconsistencies were also observed in e-liquids labelled as nicotine-free: one sample had a nicotine concentration of 21.80 mg/cartridge, while another had a concentration of 23.91 mg/mL. The review also covers differences in the potency, flavour, and storage of nicotine under various conditions. Additionally, the literature suggests that the components in ECs are separated into the liquid and vapour phases; thus, phase selection should be considered to ensure optimal experimental outcomes. For instance, the vapour phase comprises the greatest quantities of volatile organic compounds, even though nicotine has been detected in all phases. Finally, the role of ECs in smoking cessation is discussed. The reviewed findings underscore the need for further research on e-liquids, particularly regarding their long-term clinical effects. [ABSTRACT FROM AUTHOR]

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of fumaric acid as a technological and sensory additive (functional groups: preservative and flavouring compounds, respectively) and for a new use of the additive as a technological additive (functional group: acidity regulator) for all animal species. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that fumaric acid remains safe under the authorised conditions of use for the terrestrial animals, consumers and the environment. However, the Panel cannot conclude on the safety for the aquatic animals under all authorised condition of use. Fumaric acid is irritant to skin, eyes and respiratory tract, and should be considered a skin and respiratory sensitiser due to the presence of nickel. The Panel also considers that the new use of the additive as an acidity regulator under proposed conditions of use would not introduce risks not already considered. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation (for its use as preservative and flavouring compound). The Panel is not in the position to conclude on the efficacy of fumaric acid as an acidity regulator in feed.

The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of naringenin [FL‐no: 16.132] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. No other substances with sufficient structural similarity have been identified in existing FGEs that could be used to support a read‐across approach. The information provided on the manufacturing process, the composition and the stability of [FL‐no: 16.132] was considered sufficient. From studies carried out with naringenin, the Panel concluded that there is no concern with respect to genotoxicity. The use of naringenin as a flavouring substance at added portions exposure technique (APET) exposure levels is unlikely to pose a risk for drug interaction. For the toxicological evaluation of naringenin, the Panel requested an extended one‐generation toxicity study on naringenin, in line with the requirements of the Procedure and to investigate the consequence of a possible endocrine‐disrupting activity. The Panel considered that changes in thymus weight, litter size, post‐implantation loss and a consistent reduced pup weight in the high‐dose F2 generation could not be dismissed and selected therefore, the mid‐dose of 1320 mg/kg body weight (bw) per day for the parental males as the no observed adverse effect level (NOAEL) of the study. The exposure estimates for [FL‐no: 16.132] (31,500 and 50,000 μg/person per day for children and adults, respectively) were above the threshold of toxicological of concern (TTC) for its structural class (III). Using the NOAEL of 1320 mg/kg bw per day at step A4 of the procedure, margins of exposure (MoE) of 1590 and 630 could be calculated for adults and children, respectively. Based on the calculated MoEs, the Panel concluded that the use of naringenin as a flavouring substance does not raise a safety concern. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of sodium bisulphate (SBS) as a feed additive for all terrestrial animal species (category: technological additive; functional group: preservative), and for all terrestrial animal species other than cats, mink, pets and other non‐food‐producing animals (category: technological additive; functional group: acidity regulator). EFSA has also been asked to assess the new use of the product as an acidity regulator and flavouring compound in all pets and other non‐food‐producing animals except aquatic animals. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There is no evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all terrestrial animal species, consumer and the environment under the authorised conditions of use. The FEEDAP Panel considers that the proposed new use would not introduce risks not already considered in the previous assessment and therefore the same conclusions on all terrestrial animal species, consumers of products from animals fed the additive and the environment would apply. Regarding user safety, the additive is irritant to the skin, eyes and the respiratory tract, and should be considered a skin and respiratory sensitiser. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation. The Panel considers that the additive has the potential to be efficacious as an acidity regulator and sensory additive (flavouring compound) in feed for pet and non‐food‐producing animals (except aquatic animals). [ABSTRACT FROM AUTHOR]

Abstract The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of naringenin [FL‐no: 16.132] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. No other substances with sufficient structural similarity have been identified in existing FGEs that could be used to support a read‐across approach. The information provided on the manufacturing process, the composition and the stability of [FL‐no: 16.132] was considered sufficient. From studies carried out with naringenin, the Panel concluded that there is no concern with respect to genotoxicity. The use of naringenin as a flavouring substance at added portions exposure technique (APET) exposure levels is unlikely to pose a risk for drug interaction. For the toxicological evaluation of naringenin, the Panel requested an extended one‐generation toxicity study on naringenin, in line with the requirements of the Procedure and to investigate the consequence of a possible endocrine‐disrupting activity. The Panel considered that changes in thymus weight, litter size, post‐implantation loss and a consistent reduced pup weight in the high‐dose F2 generation could not be dismissed and selected therefore, the mid‐dose of 1320 mg/kg body weight (bw) per day for the parental males as the no observed adverse effect level (NOAEL) of the study. The exposure estimates for [FL‐no: 16.132] (31,500 and 50,000 μg/person per day for children and adults, respectively) were above the threshold of toxicological of concern (TTC) for its structural class (III). Using the NOAEL of 1320 mg/kg bw per day at step A4 of the procedure, margins of exposure (MoE) of 1590 and 630 could be calculated for adults and children, respectively. Based on the calculated MoEs, the Panel concluded that the use of naringenin as a flavouring substance does not raise a safety concern.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of sodium bisulphate (SBS) as a feed additive for all terrestrial animal species (category: technological additive; functional group: preservative), and for all terrestrial animal species other than cats, mink, pets and other non‐food‐producing animals (category: technological additive; functional group: acidity regulator). EFSA has also been asked to assess the new use of the product as an acidity regulator and flavouring compound in all pets and other non‐food‐producing animals except aquatic animals. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There is no evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all terrestrial animal species, consumer and the environment under the authorised conditions of use. The FEEDAP Panel considers that the proposed new use would not introduce risks not already considered in the previous assessment and therefore the same conclusions on all terrestrial animal species, consumers of products from animals fed the additive and the environment would apply. Regarding user safety, the additive is irritant to the skin, eyes and the respiratory tract, and should be considered a skin and respiratory sensitiser. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation. The Panel considers that the additive has the potential to be efficacious as an acidity regulator and sensory additive (flavouring compound) in feed for pet and non‐food‐producing animals (except aquatic animals).

Application of EOs in the food industry are wide‐ranging from preservation to production of food packaging materials. As a flavouring agent, citrus oil is one of the most popular EO used in food and beverages with other EOs. For instance, there are many studies relating the volatile compounds of sweet orange and more than 200 components of sweet orange EOs have been described as 'components of flavor'. Oxygenated derivatives, such as alcohols, ketones, aldehydes, esters and epoxides, provide preservative and flavour effects on food products but their levels are no more than 10% in citrus EOs generally. Therefore, deterpenation methods can be applied to EOs and oxygenated derivative concentrations would be increased. This study reviews primary oxyterpenes existing in citrus EOs, their use in the food industry, deterpenation methods applied to some types of citrus EOs and gives information about their main advantages and disadvantages. In conclusion, membrane separation techniques are proposed in order to purify citrus EOs on the basis of being environmentally friendly and not required any solvents both for separation. [ABSTRACT FROM AUTHOR]

Flavoring olive oil is an increasing trend in olive oil processing. Growing consumer interest in flavored olive oils by natural material brings the need to evaluate the key limiting factors which is its microbiological stability. The present research compares the microbiological quality of olive oil flavored by 3 flavors (rosemary, garlic, and lemon), prepared by 3 methods to determine changes during storage. The comprehensive microbiological analyses (total number of microorganisms [TCM], anaerobic sporulates, yeasts, molds, bacteria of the family Enterobacteriaceae, bacteria of the genus Salmonella spp., Clostridium botulinum, and lactic acid bacteria) were conducted during 12 months of storage. The best results in TCM were observed in the oil flavored by fresh garlic (0.24 log CFU/mL). The highest counts of anaerobic sporulates were detected in the dried rosemary olive oil (1.10 log CFU/mL). The flavoring materials have significantly higher counts of microorganism than flavored oils (p <.05). The obtained results demonstrated that microorganisms are capable to survive in flavored olive oil and the method of flavoring can affect their growth in a selective way according to the chemical characteristics. [ABSTRACT FROM AUTHOR]

Produksi bahan tambahan pangan Monosodium Glutamate (MSG) memiliki berbagai macam resiko, salah satu contoh resiko yang diduga terjadi yaitu kualitas produk tidak mencapai target yang ditentukan seperti produk rusak/ defect. Kualitas produk dapat dikontrol dengan cara pengendalian mutu terhadap produk MSG. Penelitian ini memiliki tujuan untuk mengetahui pengaruh ukuran kristal MSG terhadap kadar Cl, Fe, pH, Ai, kadar air,agar produk MSG dari berbagai jenis ukuran kristal guna memiliki mutu yang baik sesuai dengan standart spesifikasi dan dapat diterima di pasaran dengan baik. Rancangan percobaan pada penelitian ini menggunakan Rancangan Acak Lengkap (RAL) sederhana dengan 3 sampel ukuran MSG yang berbeda yaitu LC (Large Crystal) 30 mesh, RC (Regular Crystal) 40 mesh, FC 100 mesh (Fine Crystal), yang dilakukan sebanyak 3 kali pengulangan. Hasil dari penilitian diperoleh nilai rata-rata untuk setiap ikuran kristalnya 0,00393% untuk nilai Cl, 2,95% untuk nilai Fe, 6,88 untuk pH, 0,013nm untuk nilai Ai, 0,038% untuk kadar air.

Abstract Background Research that comprehensively documents preferences for different types of novel nicotine products in Australia is lacking, making it difficult for policymakers to determine where public health efforts should be focused. This study thus sought to explore Australian adolescent and adult e-cigarette users’ preferences for different types of e-cigarettes and e-liquids. Purchasing behaviours and sources of e-liquid were also examined. Methods An online survey was administered to 4,617 Australians aged 12 + years, 636 of whom had used an e-cigarette in the last 30 days and were the focus of this study. Among users, 45% also smoked tobacco cigarettes, 41% were non-smokers, and 14% had never smoked. Results The majority (82%) of e-cigarette users surveyed reported using nicotine-containing e-liquid in their devices. Fewer (60%) reported using non-nicotine e-liquid. The preference for nicotine over non-nicotine e-liquid was observed among all age and smoking groups. Most users (89%) reported using flavoured e-liquids, with adolescents (96%) significantly more likely than young adults (90%) and adults aged 25 + years (85%) to report using such e-liquids. Fruit flavours were the most popular among all subgroups. In terms of device type, disposable e-cigarettes were the most common product used among almost all groups; the exception being adults aged 25 + years who preferred systems with refillable tanks. Friends and tobacco retailers were the most frequently nominated sources of nicotine e-liquid among adolescents and young adults. Among adults aged 25 + years, tobacco retailers and the Internet were the most frequently nominated sources of these products. Conclusion Disposable e-cigarettes with flavoured, nicotine-containing e-liquid are popular among users of the devices, including adolescents. Measures that restrict the accessibility and availability of flavoured e-liquids and disposable e-cigarettes, and greater enforcement of laws regarding the sale and importation of nicotine e-liquids, are urgently needed to protect youth and never smokers from these products.

This work was carried out at the Flavoring Industries, its commission evaluation was updated on new trends in quality sensory, conducting a bibliographic search on the selection and training of evaluators. The information was processed using the content analysis and synthesis method. Attributes of flavorings, their acceptance-rejection zones, defects, and a methodology for selection and training of new candidates were established. The results are useful to provide answers about the sensory quality of the flavorings produced by Industries and those received from other international firms. [ABSTRACT FROM AUTHOR]

The Panel on Food additives and Flavourings (FAF) was requested to evaluate the flavouring substances 2,4‐dimethyl‐3‐thiazoline [FL‐no: 15.060] and 2‐isobutyl‐3‐thiazoline [FL‐no: 15.119] in Flavouring Group Evaluation 21 revision 6 (FGE.21Rev6). FGE.21Rev6 deals with 41 flavouring substances of which 39 have been already evaluated to be of no safety concern when based on the MSDI approach. For [FL‐no: 15.060 and 15.119], a concern for genotoxicity was raised in FGE.21. Genotoxicity data have been submitted for the supporting substance 4,5‐dimethyl‐2‐isobutyl‐3‐thiazoline [FL‐no: 15.032] evaluated in FGE.76Rev2. The concerns for gene mutations and clastogenicity are ruled out for [FL‐no: 15.032] and for the structurally related substances [FL‐no: 15.060 and 15.119], but not for aneugenicity. Therefore, the aneugenic potential of [FL‐no: 15.060 and 15.119] should be investigated in studies with the individual substances. For [FL‐no: 15.054, 15.055, 15.057, 15.079 and 15.135], (more reliable) information on uses and use levels is needed to (re)calculate the mTAMDIs in order to finalise their evaluation. Provided that information is submitted for [FL‐no: 15.060 and 15.119] with respect to potential aneugenicity, that would allow evaluation of these substances through the Procedure, also for these two substances, more reliable data on uses and use levels would be required. Upon submission of such data, additional data on toxicity may become necessary for all seven substances. For [FL‐no: 15.054, 15.057, 15.079 and 15.135], information on the actual percentages of stereoisomers in the material of commerce based on analytical data should be provided. [ABSTRACT FROM AUTHOR]

Background: Research that comprehensively documents preferences for different types of novel nicotine products in Australia is lacking, making it difficult for policymakers to determine where public health efforts should be focused. This study thus sought to explore Australian adolescent and adult e-cigarette users' preferences for different types of e-cigarettes and e-liquids. Purchasing behaviours and sources of e-liquid were also examined. Methods: An online survey was administered to 4,617 Australians aged 12 + years, 636 of whom had used an e-cigarette in the last 30 days and were the focus of this study. Among users, 45% also smoked tobacco cigarettes, 41% were non-smokers, and 14% had never smoked. Results: The majority (82%) of e-cigarette users surveyed reported using nicotine-containing e-liquid in their devices. Fewer (60%) reported using non-nicotine e-liquid. The preference for nicotine over non-nicotine e-liquid was observed among all age and smoking groups. Most users (89%) reported using flavoured e-liquids, with adolescents (96%) significantly more likely than young adults (90%) and adults aged 25 + years (85%) to report using such e-liquids. Fruit flavours were the most popular among all subgroups. In terms of device type, disposable e-cigarettes were the most common product used among almost all groups; the exception being adults aged 25 + years who preferred systems with refillable tanks. Friends and tobacco retailers were the most frequently nominated sources of nicotine e-liquid among adolescents and young adults. Among adults aged 25 + years, tobacco retailers and the Internet were the most frequently nominated sources of these products. Conclusion: Disposable e-cigarettes with flavoured, nicotine-containing e-liquid are popular among users of the devices, including adolescents. Measures that restrict the accessibility and availability of flavoured e-liquids and disposable e-cigarettes, and greater enforcement of laws regarding the sale and importation of nicotine e-liquids, are urgently needed to protect youth and never smokers from these products. [ABSTRACT FROM AUTHOR]

Abstract The Panel on Food additives and Flavourings (FAF) was requested to evaluate the flavouring substances 2,4‐dimethyl‐3‐thiazoline [FL‐no: 15.060] and 2‐isobutyl‐3‐thiazoline [FL‐no: 15.119] in Flavouring Group Evaluation 21 revision 6 (FGE.21Rev6). FGE.21Rev6 deals with 41 flavouring substances of which 39 have been already evaluated to be of no safety concern when based on the MSDI approach. For [FL‐no: 15.060 and 15.119], a concern for genotoxicity was raised in FGE.21. Genotoxicity data have been submitted for the supporting substance 4,5‐dimethyl‐2‐isobutyl‐3‐thiazoline [FL‐no: 15.032] evaluated in FGE.76Rev2. The concerns for gene mutations and clastogenicity are ruled out for [FL‐no: 15.032] and for the structurally related substances [FL‐no: 15.060 and 15.119], but not for aneugenicity. Therefore, the aneugenic potential of [FL‐no: 15.060 and 15.119] should be investigated in studies with the individual substances. For [FL‐no: 15.054, 15.055, 15.057, 15.079 and 15.135], (more reliable) information on uses and use levels is needed to (re)calculate the mTAMDIs in order to finalise their evaluation. Provided that information is submitted for [FL‐no: 15.060 and 15.119] with respect to potential aneugenicity, that would allow evaluation of these substances through the Procedure, also for these two substances, more reliable data on uses and use levels would be required. Upon submission of such data, additional data on toxicity may become necessary for all seven substances. For [FL‐no: 15.054, 15.057, 15.079 and 15.135], information on the actual percentages of stereoisomers in the material of commerce based on analytical data should be provided.

The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of hesperetin dihydrochalcone [FL-no: 16.137] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. The substance is structurally related to the group of flavonoids evaluated in FGE.32 and is the aglycone of neohesperidine dihydrochalcone. Based on the data provided for [FL-no: 16.137], the Panel considered that a read-across between hesperetin dihydrochalcone and the substances in FGE.32 is not needed. Nevertheless, the flavonoids evaluated in FGE.32 were considered in a cumulative exposure assessment. The information provided on the manufacturing process, the composition and the stability of [FL-no: 16.137] was considered sufficient. The Panel concluded that there is no concern with respect to genotoxicity. No absorption, distribution, metabolism and excretion (ADME) studies on [FL-no: 16.137] were provided, but studies investigating the ADME of neohesperidine dihydrochalcone were submitted. The Panel noted that [FL-no: 16.137] has the same fate in the organism, as that of neohesperidine dihydrochalcone and considered that [FL-no: 16.137] can be anticipated to be metabolised to innocuous products only. In a prenatal developmental toxicity study, no maternal or foetal toxicity was observed. In a 90-day toxicity study, indications were obtained that the substance affects thyroid hormone levels at all doses tested (100-1000 mg/kg bw per day). Since these changes were not accompanied by apical findings indicative of hypothyroidism, the Panel considered these hormonal effects as not adverse. Using 1000 mg/kg bodyweight (bw) per day as reference point, adequate margins of exposure were calculated for adults and children, when considering the chronic added portions exposure technique (APET) dietary exposure estimates. Cumulative chronic exposure estimates to [FL-no: 16.137] and the four structurally related substances evaluated in FGE.32 do not raise a safety concern. The use of [FL-no: 16.137] as food flavouring, under the proposed conditions of use, does not raise a safety concern., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the substance (E)-3-benzo[1,3]dioxol-5-yl-N,N-diphenyl-2-propenamide [FL-no: 16.135] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. The substance has not been reported to occur naturally and it is chemically synthesised. It is intended to be used as a flavouring substance in specific categories of food, but not intended to be used in beverages. The chronic dietary exposure to [FL-no: 16.135] estimated using the added portions exposure technique (APET), is calculated to be 780 µg/person per day for a 60-kg adult and 480 µg/person per day for a 15-kg 3-year-old child. [FL-no: 16.135] did not show genotoxic effects in bacterial mutagenicity and mammalian cell micronucleus assays in vitro. Developmental toxicity was not observed in a study in rats at the dose levels up to 1,000 mg/kg body weight (bw) per day. The Panel derived a BMDL of 101 mg/kg bw per day from a 90-day toxicity study. Based on this BMDL, adequate margins of exposure of 7,800 and 3,200 could be calculated for adults and children, respectively. The Panel concluded that there is no safety concern for [FL-no: 16.135], when used as a flavouring substance at the estimated level of dietary exposure calculated using the APET approach, based on the intended uses and use levels as specified in Appendix B. The Panel further concluded that the combined exposure to [FL-no: 16.135] from its use as a food flavouring substance and from its presence in toothpaste is also not of safety concern. [ABSTRACT FROM AUTHOR]

Monosodium glutamate (MSG) is used as flavour enhancer in food preparation. The regulations in Indonesia didn’t mention the maximum limit for using MSG. This resulted in the pro and contra regarding the side effects of MSG. On the other hand, complex process of fermentation, purification and crystallization were needed to make MSG. These various things led to the thought of finding alternative flavour enhancers that were relatively safer with simpler processes. The previous study has shown that oyster mushroom (Pleurotus ostreatus) was potential to be develop into a flavouring product as an alternative of MSG. Product formulations was needed to produce the accepted products by taste and economic. Sensory test was needed in the product development process to determine the panellists acceptance of the product. This study aims to provide the panellist preference for sensory tests. This study was an observational laboratory study, conducted on June 2018-April 2019, at Laboratorium Gizi/Kulinari, Universitas Respati Yogyakarta. The 1st sensory test was carried out to know the difference between the oyster mushroom-based flavouring formula and MSG, and the panelists preference level of the formula. The flavouring formula in the 2nd sensory test was made by adding a combination of sugar and salt. The 2nd phase of sensory test was carried out to find out the most acceptance formula by the panellists. Each sample was dissolved in warm water, then 30 ml for each sample was served. The basic ingredients of this formula were oyster mushroom flour which were prepared by soaking in 6.25 ppm of sodium bisulfite solution for 10 minutes, followed by cabinet drying with temperature of 50ºC for 30 hours. Formula 403 is the best flavouring formula based on sensory test results. Future studies can consider products using for food processing in the food service.

Abstract The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the substance (E)‐3‐benzo[1,3]dioxol‐5‐yl‐N,N‐diphenyl‐2‐propenamide [FL‐no: 16.135] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. The substance has not been reported to occur naturally and it is chemically synthesised. It is intended to be used as a flavouring substance in specific categories of food, but not intended to be used in beverages. The chronic dietary exposure to [FL‐no: 16.135] estimated using the added portions exposure technique (APET), is calculated to be 780 μg/person per day for a 60‐kg adult and 480 μg/person per day for a 15‐kg 3‐year‐old child. [FL‐no: 16.135] did not show genotoxic effects in bacterial mutagenicity and mammalian cell micronucleus assays in vitro. Developmental toxicity was not observed in a study in rats at the dose levels up to 1,000 mg/kg body weight (bw) per day. The Panel derived a BMDL of 101 mg/kg bw per day from a 90‐day toxicity study. Based on this BMDL, adequate margins of exposure of 7,800 and 3,200 could be calculated for adults and children, respectively. The Panel concluded that there is no safety concern for [FL‐no: 16.135], when used as a flavouring substance at the estimated level of dietary exposure calculated using the APET approach, based on the intended uses and use levels as specified in Appendix B. The Panel further concluded that the combined exposure to [FL‐no: 16.135] from its use as a food flavouring substance and from its presence in toothpaste is also not of safety concern.

Liquid smoke food flavouring is an alternative to traditional food smoking. Ageing treatment of liquid smoke can remove tar to improve a consistent sensory experience but traditionally takes months by storage. This study proposed a thermal treatment approach to accelerate the ageing process. Liquid smoke samples from kānuka and hickory woodchips were prepared by fast pyrolysis. The obtained liquid smoke samples were subjected to ageing by storing them at ambient temperature for 18 months. Accelerated ageing of liquid smoke was carried out by heat treatment at 80 °C for 24 and 48 h. Tar formed during the ageing process, with a yield ranging from 2.2 to 4.1 wt.%. Both ageing treatments resulted in decreases in bioactive content and their activities in terms of total phenolic content (TPC), total flavonoid content (TFC), ferric reducing antioxidant power assay (FRAP) and 2,2-diphenyl-1-picrylhydrazyl scavenging activity (DPPH). Chemical composition and principal component analyses indicated that liquid smoke chemical compositions were influenced by wood type and ageing conditions. It was found that thermal treatment at 80 °C for 24 h was sufficient to age liquid smoke. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for the renewal of authorisation of naringin as a sensory additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of naringin under the current authorised conditions of use is safe for the target species, the consumers and the environment. Naringin does not cause severe irritation or corrosion to eyes, is not irritant to the skin and is not classified as a dermal sensitiser. The FEEDAP Panel cannot conclude on the possible respiratory sensitisation of the additive, due to the lack of data. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

1. The following experiments were conducted to evaluate the effects of nonanoic acid (NA) in broilers and laying hens, at practical levels as a flavouring in complete feed. 2. In the first experiment, 1100, one-day-old Ross 308 chicks, half male and female, were randomly assigned to 50 floor pens containing 22 chicks each. Chicks were fed one of five treatment diets containing either 0 (control), 100, 300, 500 or 1,000 mg NA/kg complete feed for 42 days. 3. The NA treatment had no effect on ADFI, but there was a linear relationship with ADG and FCR. No differences were observed in blood parameters or tissue pathology among treatment groups. 4. In a second study, 150 Hyline hens aged 24 weeks old were randomly assigned to 50 pens containing three birds each. Laying hens were fed one of five treatment diets containing 0 (control), 100, 300, 500 or 1,000 mg NA/kg complete feed for 56 days. 5. Treatment with NA has no effect on live weight, ADFI or egg production in laying hens, and there were no observed changes in tissue pathology. 6. The results supported the toleration of NA in broilers or layers at dietary levels of up to 1,000 mg/kg. [ABSTRACT FROM AUTHOR]

Abstract Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for the renewal of authorisation of naringin as a sensory additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of naringin under the current authorised conditions of use is safe for the target species, the consumers and the environment. Naringin does not cause severe irritation or corrosion to eyes, is not irritant to the skin and is not classified as a dermal sensitiser. The FEEDAP Panel cannot conclude on the possible respiratory sensitisation of the additive, due to the lack of data. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

The migration of six flavourings to smoke aerosols and their effects on the physical and chemical properties of aerosols under heating condition were studied by using a smoking machine, combined with GC- MS/MS and fast particulate spectrometer. The results showed that; 1) The six flavourings were mainly evaporated by prototype at 350 °C. 2) The release and migration of the six flavourings showed different characteristics under heating and suction conditions. Isoamyl isovalerate and 2,3,5-trimethylpyrazine were transferred to particle phase and gas phase of aerosol, while the other four flavourings were only transferred to particle phase of aerosol. The total migration rates of geraniol and 2-acetylpyrrole to smoke aerosol were 2.8%~8.1%, and the other four flavourings were 17.6%~54.4%.3) Compared with the blank control, after adding 5% L-menthol or 1% and 2% WS-23, the release amount of nicotine, propylene glycol and glycerol from the tobacco materials to the aerosol was reduced by more than 20%, and their interception in the filter section was reduced by more than 10%. 4) When L-menthol was added to 5%, the particle number concentration decreased by 28% and count median diameter (CMD) increased by 8%. [ABSTRACT FROM AUTHOR]

Electronic cigarettes (ECs) are thought to be less harmful than traditional combustible cigarettes and were originally intended to help smokers quit. Over the past two decades, they have especially gained popularity with the younger generation. To date, there are over 7000 unique e‐liquid flavours available and over 400 different e‐cigarette brands. The accuracy of nicotine strength labelling in e‐liquids was assessed in this work. Twenty‐three studies from around the world were chosen to assess the level and frequency of nicotine mislabelling in 545 e‐liquid products. Nicotine strengths were most commonly mislabelled by between 5% and 20%, with the majority testing lower than what the label indicated. Fifteen European e‐liquids that were assessed were labelled as 20 mg/ml or less, yet when tested, they contained more than 20 mg/ml of nicotine. One e‐liquid that was supposed to contain no nicotine in fact contained 23.91 mg/ml of nicotine. Furthermore, the difference between the medians of the available labelled and experimental nicotine concentrations was significant (p < 0.001, Wilcoxon signed rank test). Preliminary studies show that high nicotine levels delivered via aerosol increase the risk for nicotine poisoning and cause airway inflammation. Other EC ingredients, such as flavourings, contribute to EVALI and 'popcorn lung'. There is evidence that certain flavourings, such as menthol, reinforce the effects of nicotine and modify drug absorption and metabolism. There is a global need for better quality control in EC products in order to make these safe for consumers. [ABSTRACT FROM AUTHOR]

Intake assessment and hazard profile of chemical substances are the two critical inputs in a safety assessment. Human intake assessment presents challenges that stem either from the absence of data or from numerous sources of variability and uncertainty, which have led regulators to adopt conservative approaches that inevitably overestimate intake. Refinements of intake assessments produce more realistic estimates and help prioritise areas of concern and better direct investment of resources. However, use levels (ULs), which represent the usual added amount of flavourings to food products, are the starting point for refined intake assessments, are data-intensive, and data availability is often a limitation. The work presented here was undertaken to investigate the use level patterns of substances used as flavourings in foods and to develop a systematic tool for data extrapolation based on chemical structure. The available dataset consists of use levels reported through eight industry surveys and hence are representative of industry uses rather than regulatory limits, which are higher by design and not realistic. A systematic statistical analysis was undertaken to determine whether the industry-reported UL data can be used to estimate use levels of flavouring substances belonging to the same chemical group for which such data are not available. Predictive modelling approaches were explored to evaluate relationships in the data and utilised additional variables relevant to technological considerations, such as volatility losses upon heat treatment, and Tanimoto index-based pair-wise structural similarity scores to determine whether more granular similarity information can reduce the within-group variability. The analyses indicated that the use levels of flavouring substances can reasonably be estimated based on the available data using chemical group classifications stratified by food category. Source of uncertainty and limitations are discussed. [ABSTRACT FROM AUTHOR]

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of l‐glutamine (≥ 98.0%) produced by fermentation using a genetically modified strain of Corynebacterium glutamicum (NITE BP‐02524). It is intended to be used in feed for all animal species and categories as nutritional additive (amino acid) and as sensory additive (flavouring compound). Viable cells of the production strain and its recombinant DNA were not detected in the additive. l‐Glutamine manufactured by fermentation using C. glutamicum NITE BP‐02524 does not give rise to any safety concern with regard to the genetic modification of the production strain. The use of l‐glutamine produced by fermentation using C. glutamicum NITE BP‐02524 in animal nutrition is considered safe for all animal species when applied as a nutritional additive to achieve an adequate amino acid profile in feed and to overcome potential glutamine shortages during critical periods of life. The proposed use level (25 mg/kg feed) when used as sensory additive (flavouring compound) is safe for all animal species. The uses of l‐glutamine produced using C. glutamicum NITE BP‐02524 as nutritional additive or as flavouring compound are considered safe for the consumer. l‐Glutamine produced using C. glutamicum NITE BP‐02524 is not toxic by inhalation, is non‐irritant to skin and eyes and is not a skin sensitiser. l‐Glutamine produced using C. glutamicum NITE BP‐02524 is considered safe for the environment. l‐glutamine is a non‐essential amino acid and it plays a physiological role as such. Recent evidence shows that glutamine may act as conditionally essential amino acid mainly in growing animals and has some specific effects e.g. in improving intestinal development and immune response. This amino acid produced by fermentation using C. glutamicum NITE BP‐02524 is regarded as an efficacious source of glutamine for all animal species. For supplemental l‐glutamine to be as efficacious in ruminants as in non‐ruminants, it would require protection against degradation in the rumen. The use of l‐glutamine as sensory additive at 25 mg/kg feed is considered efficacious.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐isoleucine produced by Escherichia coli FERM ABP‐10641 (i) to renew the authorisation and to extend the use of the additive in water for drinking when used as a nutritional additive for all animal species and (ii) to evaluate a new use as a flavouring additive for all animal species. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. l‐Isoleucine does not give rise to any safety concern regarding the production strain and its genetic modification. Considering that the production process has not been substantially modified and that no adverse effects have been reported in the literature search, the FEEDAP Panel considers that there is no evidence to reconsider the conclusions reached in previous assessments. Therefore, the Panel considers that the additive l‐isoleucine produced by E. coli FERM ABP‐10641 remains safe for the target species, consumer and for the environment when used as a nutritional additive in feed. The Panel extends these conclusions to the use of the additive as a flavouring compound. Regarding the use in water, the FEEDAP Panel reiterates its concerns over the safety for the target species of l‐isoleucine administered simultaneously via water for drinking and feed owing to the risk of nutritional imbalances and hygienic reasons. l‐Isoleucine is not irritant to skin and eyes and is not a dermal sensitiser but is hazardous by inhalation. The Panel confirms the previous conclusions that the additive is considered as a source of available isoleucine for non‐ruminant animal species when used as a nutritional additive. It requires protection against degradation in the rumen to be as efficacious in ruminants as in non‐ruminant species. The Panel considers the use of the additive in water for drinking to be equally effective than the use in feed when used as a nutritional additive. Since l‐isoleucine is used in food as a flavouring compound, and its function in feed is essentially the same as that in food no further demonstration of efficacy is necessary.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of l‐glutamine (≥ 98.0%) produced by fermentation using a genetically modified strain of Corynebacterium glutamicum (NITE BP‐02524). It is intended to be used in feed for all animal species and categories as nutritional additive (amino acid) and as sensory additive (flavouring compound). Viable cells of the production strain and its recombinant DNA were not detected in the additive. l‐Glutamine manufactured by fermentation using C. glutamicum NITE BP‐02524 does not give rise to any safety concern with regard to the genetic modification of the production strain. The use of l‐glutamine produced by fermentation using C. glutamicum NITE BP‐02524 in animal nutrition is considered safe for all animal species when applied as a nutritional additive to achieve an adequate amino acid profile in feed and to overcome potential glutamine shortages during critical periods of life. The proposed use level (25 mg/kg feed) when used as sensory additive (flavouring compound) is safe for all animal species. The uses of l‐glutamine produced using C. glutamicum NITE BP‐02524 as nutritional additive or as flavouring compound are considered safe for the consumer. l‐Glutamine produced using C. glutamicum NITE BP‐02524 is not toxic by inhalation, is non‐irritant to skin and eyes and is not a skin sensitiser. l‐Glutamine produced using C. glutamicum NITE BP‐02524 is considered safe for the environment. l‐glutamine is a non‐essential amino acid and it plays a physiological role as such. Recent evidence shows that glutamine may act as conditionally essential amino acid mainly in growing animals and has some specific effects e.g. in improving intestinal development and immune response. This amino acid produced by fermentation using C. glutamicum NITE BP‐02524 is regarded as an efficacious source of glutamine for all animal species. For supplemental l‐glutamine to be as efficacious in ruminants as in non‐ruminants, it would require protection against degradation in the rumen. The use of l‐glutamine as sensory additive at 25 mg/kg feed is considered efficacious. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐isoleucine produced by Escherichia coli FERM ABP‐10641 (i) to renew the authorisation and to extend the use of the additive in water for drinking when used as a nutritional additive for all animal species and (ii) to evaluate a new use as a flavouring additive for all animal species. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. l‐Isoleucine does not give rise to any safety concern regarding the production strain and its genetic modification. Considering that the production process has not been substantially modified and that no adverse effects have been reported in the literature search, the FEEDAP Panel considers that there is no evidence to reconsider the conclusions reached in previous assessments. Therefore, the Panel considers that the additive l‐isoleucine produced by E. coli FERM ABP‐10641 remains safe for the target species, consumer and for the environment when used as a nutritional additive in feed. The Panel extends these conclusions to the use of the additive as a flavouring compound. Regarding the use in water, the FEEDAP Panel reiterates its concerns over the safety for the target species of l‐isoleucine administered simultaneously via water for drinking and feed owing to the risk of nutritional imbalances and hygienic reasons. l‐Isoleucine is not irritant to skin and eyes and is not a dermal sensitiser but is hazardous by inhalation. The Panel confirms the previous conclusions that the additive is considered as a source of available isoleucine for non‐ruminant animal species when used as a nutritional additive. It requires protection against degradation in the rumen to be as efficacious in ruminants as in non‐ruminant species. The Panel considers the use of the additive in water for drinking to be equally effective than the use in feed when used as a nutritional additive. Since l‐isoleucine is used in food as a flavouring compound, and its function in feed is essentially the same as that in food no further demonstration of efficacy is necessary. [ABSTRACT FROM AUTHOR]

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐leucine produced by fermentation with Escherichia coli NITE BP‐02351 when used as nutritional additive or as feed flavouring compound in feed and water for drinking for all animal species. The product under assessment is l‐leucine produced by fermentation with a genetically modified strain of E. coli (NITE BP‐02351). The production strain and its recombinant DNA were not detected in the final products. l‐Leucine, manufactured by fermentation with E. coli NITE BP‐02351, does not give rise to any safety concern to the production strain. The use of l‐leucine produced with E. coli NITE BP‐02351 is safe for the target species when used to supplement the diet in appropriate amounts. It is safe at the proposed use level of 25 mg/kg when used as flavouring compound for all animal species. The use of l‐leucine produced by fermentation with E. coli NITE BP‐02351 in animal nutrition raises no safety concerns for consumers of animal products. The additive is not irritating to the skin or eyes and is not a skin sensitiser. There is a risk for persons handling the additive from the exposure to endotoxins by inhalation. The use of l‐leucine produced by E. coli NITE BP‐02351 as feed additive does not represent a risk to the environment. The additive l‐leucine produced by E. coli NITE BP‐02351 is regarded as an effective source of the amino acid l‐leucine when used as nutritional additive. For the supplemental l‐leucine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen. It is also considered efficacious as feed flavouring compound under the proposed conditions of use.

Abstract Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of an essential oil of Origanum vulgare ssp. hirtum (Link) leetsw. for all poultry species. The essential oil under assessment obtained ■■■■■ is specified to contain carvacrol ■■■■■ and thymol (7%). The remaining 30% of the composition remains uncharacterised. In the absence of these data, the FEEDAP Panel was unable to make a risk assessment of the additive for the target species, the consumer and the user. Use in animal production of the essential oil extracted from O. vulgare ssp. hirtum (Link) leetsw. is not expected to pose a risk for the environment. Since oregano and its extracts are universally recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary.

The exposure of humans to the aromatic hydrocarbon benzene should be minimized due to its carcinogenicity. Previous studies have reported on the presence of benzene, in particular in foods with added cherry aroma compounds, in particular benzaldehyde. To allow a reliable quantitation of benzene, a stable isotope dilution assay using (2H3)benzene as the internal standard was developed and solid phase microextraction (SPME) was used for volatile isolation followed by GC × GC–TOFMS analysis. Care was taken to avoid any exposure to light and to use materials during work-up, which were free of benzene contamination. The method, applied on 22 liquid foods with added flavour showed that benzene did not exceed a concentration of 1 µg/L in any sample (i.e. the limit established for drinking water). Furthermore, flavourings containing benzaldehyde and the corresponding raw material were analysed. The major source of benzene in flavourings turned out to be benzaldehyde itself. First insights into parameters supporting the formation pathway of benzene from benzaldehyde were obtained indicating that the presence of light and either acidic or alkaline conditions favoured benzene formation. [ABSTRACT FROM AUTHOR]

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Abstract EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), 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 a flavouring substance in specific categories of food but not intended to be used in beverages, except for milk and dairy based beverages that are opaque. The chronic dietary exposure to the substance estimated using the added portions exposure technique (APET), is calculated to be 225 μg/person per day for a 60‐kg adult and 142 μg/person per day for a 15‐kg 3‐year‐old child. A 90‐day oral gavage study in rats showed no adverse effects at 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 there is no safety concern for [FL‐no: 16.133], when used as a flavouring substance at the estimated level of dietary exposure calculated using the APET approach and based on the recommended uses and use levels as specified in Appendix B. This conclusion does not apply for use in beverages where the substance can be subject to phototransformation.

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.

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 40,5,7-trihydroxyflavanone or naringenin [FL-no: 16.132], in the Flavouring Group Evaluation 410 (FGE.410), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance occurs naturally in grapefruits, oranges and tomatoes. It is intended to be used as a flavouring substance with flavour-modifying properties in specific categories of food. Information on specifications and manufacturing of [FL-no: 16.132] were considered adequate; however, data on stability in food are incomplete. The Panel noted that the available genotoxicity studies have significant shortcomings and are insufficient to conclude on the genotoxic potential of naringenin. Therefore, [FL-no: 16.132] cannot be evaluated through the Procedure. Additionally, the Panel noted that inhibition of CYP 450 by [FL-no: 16.132] has been clearly demonstrated in animal species in vivo which implies that the substance may interact with the metabolism and elimination of medicines and no convincing information is available that this does not pose a risk to humans at the estimated levels of exposure. To continue with the safety assessment of [FL-no: 16.132], a bacterial gene mutation assay and an in vitro micronucleus assay (according to OECD guidelines 471, 487 and GLP) are required. Even if these studies do not indicate a genotoxic potential, additional toxicological data are needed to finalise the evaluation. [ABSTRACT FROM AUTHOR]

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of EFSA was requested to evaluate three flavouring substances, 2,5‐dimethyl‐4‐ethoxyfuran‐3(2H)‐one [FL‐no: 13.117], 2,5‐dimethylfuran‐3(2H)‐one [FL‐no: 13.119] and 4‐Acetyl‐2,5‐dimethylfuran‐3(2H)‐one [FL‐no: 13.175] in the Flavouring Group Evaluation 313 (FGE.313), using the Procedure in Commission Regulation (EC) No 1565/2000. The substances were considered in FGE.220, and revisions hereof, not to have genotoxic potential. They were evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that the two flavouring substances [FL‐no: 13.117, 13.119] do not give rise to safety concerns at their level of dietary intake, estimated on the basis of the Maximised Survey‐derived Daily Intake (MSDI) approach. For the flavouring substance [FL‐no: 13.175], toxicity data are required. Besides the safety assessment of the flavouring substance, the specifications for the materials of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the materials of commerce have been provided for the three flavouring substances. The Panel concluded that for 2,5‐dimethyl‐4‐ethoxyfuran‐3(2H)‐one [FL‐no: 13.117], 2,5‐dimethylfuran‐3(2H)‐one [FL‐no: 13.119] and 4‐acetyl‐2,5‐dimethylfuran‐3(2H)‐one [FL‐no: 13.175] for which the Modified Theoretical Added Maximum Daily Intakes (mTAMDIs) are above the thresholds for their structural class, more reliable exposure data are required for a re‐evaluation.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns 21 aromatic, aliphatic and alicyclic hydrocarbons [FL‐no: 01.002, 01.003, 01.004, 01.005, 01.006, 01.007, 01.008, 01.009, 01.010, 01.016, 01.017, 01.018, 01.019, 01.020, 01.024, 01.026, 01.029, 01.040, 01.045, 01.061 and 01.077] evaluated by the JECFA in 2005. FGE.78Rev1 considered 24 substances, but 4‐methyl‐1,1′‐biphenyl (JECFA‐no: 1334) and biphenyl (JECFA‐no: 1332) [former FL‐no: 01.011 and 01.013] are no longer supported by Industry for use as a flavouring substance in Europe. Moreover 1‐methylnaphthalene [FL‐no: 01.014] is in the process of being deleted from the Union List. This revision is owing to additional genotoxicity data on β‐caryophyllene [FL‐no: 01.007] and 90‐day studies in rats on β‐caryophyllene [FL‐no: 01.007] and myrcene [FL‐no: 01.008]. 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 specifications for the materials of commerce are adequate for all substances. The Panel concluded that the 21 aromatic, aliphatic and alicyclic hydrocarbons [FL‐no: 01.002‐01.010, 01.016‐01.020, 01.024, 01.026, 01.029, 01.040, 01.045, 01.061 and 01.077] do not give rise to safety concern at their levels of dietary intake, estimated on the basis of the MSDI approach.

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the flavouring substance spilanthol [FL-no: 16.121] in Flavouring Group Evaluation 303, Revision 1, using the Procedure according to Commission Regulation (EC) No 1565/2000. This revision is made as new 90 days toxicity data have been submitted for spilanthol [FL-no: 16.121]. The substance was considered not to have genotoxic potential. The substance was 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 concluded that spilanthol [FL-no: 16.121] does not give rise to safety concern at its level of dietary intake, estimated on the basis of the Maximum Surveyderived Daily Intake (MSDI) approach. Besides the safety assessment of the flavouring substance, the specifications for the material of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the material of commerce have been provided for the candidate substance.