Scientific Opinion of Flavouring Group Evaluation 500 (FGE.500): rum ether
2017; Wiley; Volume: 15; Issue: 8 Linguagem: Inglês
10.2903/j.efsa.2017.4897
ISSN1831-4732
AutoresVittorio Silano, Claudia Bolognesi, Laurence Castle, Jean‐Pierre Cravedi, Karl‐Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Maria Rosaria Milana, André Penninks, Maria de Fátima Tavares Poças, Andrew Smith, Pavel Tlustoš, Detlef Wölfle, Holger Zorn, Corina‐Aurelia Zugravu, Ulla Beckman Sundh, Romualdo Benigni, Leon Brimer, Gerard J. Mulder, Agneta Oskarsson, Camilla Svendsen, Carla Martino, Wim Mennes,
Tópico(s)Effects and risks of endocrine disrupting chemicals
ResumoEFSA JournalVolume 15, Issue 8 e04897 Scientific OpinionOpen Access Scientific Opinion of Flavouring Group Evaluation 500 (FGE.500): rum ether EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)Search for more papers by this authorVittorio Silano, Vittorio SilanoSearch for more papers by this authorClaudia Bolognesi, Claudia BolognesiSearch for more papers by this authorLaurence Castle, Laurence CastleSearch for more papers by this authorJean-Pierre Cravedi, Jean-Pierre CravediSearch for more papers by this authorKarl-Heinz Engel, Karl-Heinz EngelSearch for more papers by this authorPaul Fowler, Paul FowlerSearch for more papers by this authorRoland Franz, Roland FranzSearch for more papers by this authorKonrad Grob, Konrad GrobSearch for more papers by this authorRainer Gürtler, Rainer GürtlerSearch for more papers by this authorTrine Husøy, Trine HusøySearch for more papers by this authorSirpa Kärenlampi, Sirpa KärenlampiSearch for more papers by this authorMaria Rosaria Milana, Maria Rosaria MilanaSearch for more papers by this authorAndré Penninks, André PenninksSearch for more papers by this authorMaria de Fátima Tavares Poças, Maria de Fátima Tavares PoçasSearch for more papers by this authorAndrew Smith, Andrew SmithSearch for more papers by this authorChristina Tlustos, Christina TlustosSearch for more papers by this authorDetlef Wölfle, Detlef WölfleSearch for more papers by this authorHolger Zorn, Holger ZornSearch for more papers by this authorCorina-Aurelia Zugravu, Corina-Aurelia ZugravuSearch for more papers by this authorUlla Beckman Sundh, Ulla Beckman SundhSearch for more papers by this authorRomualdo Benigni, Romualdo BenigniSearch for more papers by this authorLeon Brimer, Leon BrimerSearch for more papers by this authorGerard Mulder, Gerard MulderSearch for more papers by this authorAgneta Oskarsson, Agneta OskarssonSearch for more papers by this authorCamilla Svendsen, Camilla SvendsenSearch for more papers by this authorCarla Martino, Carla MartinoSearch for more papers by this authorWim Mennes, Wim MennesSearch for more papers by this author EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)Search for more papers by this authorVittorio Silano, Vittorio SilanoSearch for more papers by this authorClaudia Bolognesi, Claudia BolognesiSearch for more papers by this authorLaurence Castle, Laurence CastleSearch for more papers by this authorJean-Pierre Cravedi, Jean-Pierre CravediSearch for more papers by this authorKarl-Heinz Engel, Karl-Heinz EngelSearch for more papers by this authorPaul Fowler, Paul FowlerSearch for more papers by this authorRoland Franz, Roland FranzSearch for more papers by this authorKonrad Grob, Konrad GrobSearch for more papers by this authorRainer Gürtler, Rainer GürtlerSearch for more papers by this authorTrine Husøy, Trine HusøySearch for more papers by this authorSirpa Kärenlampi, Sirpa KärenlampiSearch for more papers by this authorMaria Rosaria Milana, Maria Rosaria MilanaSearch for more papers by this authorAndré Penninks, André PenninksSearch for more papers by this authorMaria de Fátima Tavares Poças, Maria de Fátima Tavares PoçasSearch for more papers by this authorAndrew Smith, Andrew SmithSearch for more papers by this authorChristina Tlustos, Christina TlustosSearch for more papers by this authorDetlef Wölfle, Detlef WölfleSearch for more papers by this authorHolger Zorn, Holger ZornSearch for more papers by this authorCorina-Aurelia Zugravu, Corina-Aurelia ZugravuSearch for more papers by this authorUlla Beckman Sundh, Ulla Beckman SundhSearch for more papers by this authorRomualdo Benigni, Romualdo BenigniSearch for more papers by this authorLeon Brimer, Leon BrimerSearch for more papers by this authorGerard Mulder, Gerard MulderSearch for more papers by this authorAgneta Oskarsson, Agneta OskarssonSearch for more papers by this authorCamilla Svendsen, Camilla SvendsenSearch for more papers by this authorCarla Martino, Carla MartinoSearch for more papers by this authorWim Mennes, Wim MennesSearch for more papers by this author First published: 24 August 2017 https://doi.org/10.2903/j.efsa.2017.4897Citations: 4 Correspondence: FIP@efsa.europa.eu Requestor: European Commission Question number: EFSA-Q-2012-00904 Panel members: Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, André Penninks, Maria de Fátima Tavares Poças, Vittorio Silano, Andrew Smith, Christina Tlustos, Detlef Wölfle, Holger Zorn and Corina-Aurelia Zugravu. Acknowledgements: The Panel wishes to thank the members of the Working Group on Flavourings: the hearing experts Vibe Beltoft and Karin Nørby for the support provided to this scientific opinion. Adopted: 14 June 2017 AboutSectionsPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to deliver a scientific opinion on the implications for human health of the flavouring rum ether [FL-no: 21.001] in the Flavouring Group Evaluation 500 (FGE.500), according to Regulation (EC) No 1331/2008 and Regulation (EC) No 1334/2008 of the European Parliament and of the Council. Rum ether is a complex mixture of volatile substances obtained by distillation of the reaction products of pyroligneous acid and ethyl alcohol under oxidative conditions in the presence of manganese dioxide and sulfuric acid. A total of 84 volatile constituents have been reported by the applicant. It is a colourless liquid with a rum-like odour and flavour. Its major uses are in the food categories beverages, confectionery and baked goods. The Panel decided to apply a congeneric group-based approach. The 84 reported constituents were allocated to 12 congeneric groups, based on structural and metabolic similarity. For eight of the congeneric groups, the Panel concluded that there is no safety concern at the intended conditions of use. However, the Panel concluded that substances in congeneric group 1 (ethanol and acetaldehyde) and congeneric group 12 (furan) are carcinogenic and genotoxic. The Panel also identified genotoxicity concerns for substances in congeneric group 3 (3-pentene-2-one). The exposure for congeneric group 10 (ethers of various structures) was above the Threshold of Toxicological Concern (TTC) applicable for this group, but a point of departure or health based guidance value that covers all the substances in this group could not be identified. The Panel concluded that according to the overall strategy for the risk assessment of flavouring substances, the presence of genotoxic substances as process-derived constituents of rum ether is of safety concern. 1 Introduction 1.1 Background and Terms of Reference as provided by the European Commission 1.1.1 Background The use of flavourings is regulated under Regulation (EC) No 1334/20081 of the European Parliament and Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods. On the basis of article 9(e) of this Regulation, an evaluation and approval are required for 'other flavourings' referred to in Article 3(2)(h). Regulation (EC) No 1331/20082 shall apply for the evaluation and approval of 'other flavourings'. The Commission has received from the European Flavour Association an application for an authorisation of a new 'other flavouring', named rum ether. In order for the Commission to be able to consider its inclusion in the Union list of flavourings and source materials (Annex I of Regulation (EC) No 1334/2008), the European Food Safety Authority (EFSA) should carry out a safety assessment of this substance. 1.1.2 Terms of Reference The European Commission requests EFSA to carry out a safety assessment on rum ether as 'other flavouring' in accordance with Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings. 1.2 Existing authorisations and evaluations In the US, the status 'Generally Recognised As Safe' (GRAS) has been allocated to rum ether by the industrial 'Flavour and Extract Manufactures Association' (FEMA) expert Panel (FEMA no 2996). The Panel is not aware of any official evaluations of rum ether performed by national or international authorities. 2 Data and methodologies A dossier with information on the flavouring rum ether has been submitted by the European Flavour Association (EFFA). The safety assessment of rum ether [FL-no: 21.001] has been carried out by EFSA in accordance with Commission Regulations (EC) No 1331/2008 and 1334/2008 as well as the procedures outlined in the EFSA scientific opinion: 'Guidance on the data required for the risk assessment of flavourings to be used in or on foods' (EFSA CEF Panel, 2010a), Part B. IV. 'Information to be supplied with an application for the authorisation of Other Flavourings' (see Appendix C). 3 Assessment 3.1 Technical data 3.1.1 Identity of the substance The flavouring is a complex mixture of volatile substances obtained by distillation of the esterification products of pyroligneous acid and ethyl alcohol, under oxidative conditions in the presence of sulfuric acid and manganese dioxide. Pyroligneous acid, also known as wood vinegar, is obtained by pyrolysis of wood as a by-product of charcoal production. Chemical name There is no single chemical name for the flavouring. The commonly used trivial name is 'rum ether'. Other names are 'ethyl oxyhydrate' and 'ZV8-253'. The chemical names of the substances reported by the applicant to be present in rum ether are given in Table 4 and Appendix A. Identification numbers CAS-number: 8030-89-5 (Unspecified. Pyroligneous acids, reaction products with ethyl alcohol, distillates) Chemical and structural formula, molecular weight The structures of the substances reported by the applicant to be present in rum ether are given in Table 4. 3.1.2 Organoleptic characteristics The flavouring has a rum-like odour and flavour. It is a colourless liquid (caramel is sometimes added to the final distillate for colouring purposes). 3.1.3 Manufacturing process Source materials The wood used to produce pyroligneous acid is hardwood of primarily white oak (Quercus alba and Quercus robur) and beech (Fagus sylvatica), and less commonly of hickory (Carya ovata). The trees have not been genetically modified. As reported by the applicant, the materials typically employed in the process are: 95% ethyl alcohol, pyroligneous acid, 93–96% sulfuric acid, manganese dioxide and for some preparations acetic acid. Production process Pyroligneous acid is added slowly with agitation to ethyl alcohol and manganese dioxide, along with acid (sulfuric acid, in some cases supplemented with acetic acid), with the temperature maintained below 40–50°C during the course of the reaction. The mixture is then distilled at atmospheric pressure. The fraction distilling between 60 and 100°C is collected and subjected to a rectification. The resulting product exhibits a final boiling range of 65–87°C. Alterations of this standard production process can include the use of different amounts of acetic acid. Furthermore, the 'head'- and 'tail'-fractions obtained during the rectification step may be partly readded to the distillate in amounts up to 20%. According to the applicant, the resulting final products still exhibit boiling points below 100°C, which is in line with the proposed specifications. 3.1.4 Composition In the course of the development of this opinion, the applicant provided several data sets on the composition of rum ether upon EFSA requests. The submission of February 2016 was the first that was considered suitable for assessment. It provided information on the volatile constituents in a total of 22 batches (Table 1). The volatile constituents were analysed using gas chromatography/flame ionisation detector (GC/FID) and GC/mass spectrometry (MS). The contents of the volatile constituents were determined on the basis of GC-peak area percentages relative to the total peak area in the chromatogram. No information on the consideration of individual, substance-specific GC-response factors has been provided. A total of 83 constituents were reported; on average 0.53% of the total peak area detected in the chromatograms remained unidentified. Despite shortcomings of the applied semiquantitative approach, this data set was considered for the safety assessment. In order to get information on the representativeness of the data shown in Table 1, the Panel asked the applicant to assign the batches to producers of rum ether in the European Union (EU) and to provide information on the reproducibility of the composition of individual products from these producers and on their production volumes in the EU. Upon this request, additional compositional data have been provided (Table 2), and this latest submission (September 2016) contained information on 27 commercial batches of rum ether, produced by four companies. According to the applicant, the analysed rum ether batches are representative products. The reported annual production volumes for flavouring purposes covered by this submission amount to 35 tonnes for company 1 (corresponding to 47.2% of the combined production volume of the four companies), 1.9 tonnes for company 2 (2.6%), 11.3 tonnes for company 3 (15.2%) and 26 tonnes for company 4 (35%). In the September 2016 submission, a total of 41 constituents have been reported by the applicant (Table 2). For the batches of company 4, only approximately 91% and 97%, respectively, of the detected GC peaks were identified and quantified. According to the total (%), excluding water, reported for the batches of companies 1–3, all peaks in the chromatograms have been identified and quantified with a detection limit of 0.01% (apart from furan) which is a factor of 10 higher than the minimum area of 0.001% reported in the February 2016 submission of compositional data (Table 1). The grey-shaded constituents in Table 1 are not present in the compositional overview that was submitted in September 2016 (Table 2). For the quantitation of furan, specific approaches based on the use of isotopically labelled internal standards have been reported by two companies. The investigated batches for which data were provided in the second submission differ in their compositions. Only seven volatile constituents (ethanol, ethyl acetate, ethyl propionate, ethyl butyrate, ethyl crotonate, formaldehyde diethylacetal and furan) have been reported in all investigated batches. On the other hand, it is noteworthy that the batches show a common compositional feature: ethanol, three esters (ethyl acetate, formate and propionate) and acetic acid constitute on average 95.4% (87.1–99.3%) of all batches. Also for the 22 batches analysed for the first submission (Table 1), ethanol, these three esters (ethyl acetate, formate and propionate) and acetic acid represent most of the material (sum of average concentrations 92%). In addition, the standard deviations for rum ether constituents between batches of individual producers are small. In the submission of September 2016, all batches presented contained furan. For the rum ether batches of three companies, the average furan content amounted to 0.006% (0.003–0.017%). Company 4 produces two types of rum ether: For the so-called 'normal type' rum ether (25 tonnes per year; corresponding to 96% of the total production volume of this company), the content of furan (0.006%) was comparable to the data provided by the other companies. For the so-called 'rum ether 10-fold' (production of 1 tonne per year) the content of furan (0.042%) is seven times higher than in the other batches. According to information provided for company 4, this 'rum ether 10-fold' is used to impart a typical spirit drink flavour ('Inländerrum') and at lower dosages for example to pralines or bakery wares. It has been stated that it may be possible to reduce the concentration of furan in a 'rum ether 10-fold', however not below 0.01% if the typical flavour is to be maintained. Because the submission of February 2016 is based on a higher GC sensitivity (down to 0.001 peak area %) than the submission of September 2016, the compositional data for the first submission were considered to provide a more complete insight into the presence of substances occurring at low concentrations. Therefore, these data will be used as basis for the subsequent risk assessment. However, there was also one constituent (i.e. acetaldehyde dimethylacetal, grey-shaded in Table 2) that has been reported in the submission of September 2016 which has not been listed in the submission of February 2016 (Table 1). This substance will also be included in the assessment. The evaluation will thus be based on a total of 84 constituents (83 reported in the submission from February 2016 and one additional substance in the submission from September 2016). Considering that rum ether is a mixture of volatiles, which are all anticipated to be amenable to GC analysis, the Panel considered the applied procedure involving the conversion of GC-peak areas to concentrations of volatile constituents as acceptable for the purpose of this evaluation. Despite the analytical shortcomings, the Panel considered the data sufficient: (a) to identify and semi-quantitate rum ether constituents and (b) to demonstrate the reproducibility of the production process. Table 1. Compositional data of 22 commercial rum ether batches (submission from February 2016)3 sorted according to maximum percentage peak areas as determined by GC/MS Chemical name MIN (% of peak area)a MAX (% of peak area)b # of batches Ethyl alcohol 27.320 83.000 22 Ethyl acetate 2.190 49.000 22 Ethyl formate 0.379 12.210 20 Ethyl propionate 0.090 7.470 22 Acetic acid 0.011 5.060 20 Methyl acetate 0.024 3.740 11 Acetaldehyde diethylacetal 0.058 2.107 13 Formaldehyde diethylacetal 0.100 1.640 20 Ethyl isovalerate 0.002 1.630 11 Ethyl valerate 0.011 1.610 9 Ethyl butyrate 0.014 1.390 14 Methyl alcohol 0.083 1.070 4 Diacetyl 0.011 0.520 9 Ethyl isobutyrate 0.003 0.480 13 2-Propenyl acetate 0.440 0.459 2 Acetaldehyde 0.018 0.361 15 Methyl propionate 0.006 0.360 7 Formic acid 0.160 0.320 3 Diethylether 0.003 0.318 10 Ethyl acrylate 0.008 0.280 10 Furfural 0.012 0.220 9 Ethyl crotonate 0.001 0.200 20 Acetone 0.004 0.176 14 2-Butanone 0.167 0.167 1 Propanoic acid 0.003 0.154 8 1-butanol 0.100 0.120 2 Butanal diethyl acetal 0.001 0.100 3 Ethyl methacrylate 0.003 0.100 4 Ethyl cyclopropanecarboxylate 0.080 0.080 1 2-Methylfuran 0.001 0.080 5 Ethyl 4-methylpentanoate 0.001 0.070 4 Ethyl 2-methylbutanoate 0.003 0.070 8 Ethyl 4-pentenoate 0.001 0.070 8 Ethyl 2-methyl-2-butenoate 0.051 0.068 2 Ethyl but-3-enoate 0.005 0.060 5 Methyl formate 0.008 0.052 8 3-Penten-2-one 0.051 0.051 2 Ethyl 2-pentenoate 0.005 0.050 4 1,1-Diethoxyacetone 0.005 0.045 4 Furan 0.001 0.040 14 Acetol 0.008 0.039 2 2-Methylcyclopentanone 0.034 0.034 2 2-Methyl-2-cyclopentenone 0.003 0.034 8 2-Acetylfuran 0.002 0.030 10 Ethyl lactate 0.007 0.027 2 Glyceraldehyde diethyl acetal 0.026 0.026 2 2-Ethoxytetrahydrofuran 0.008 0.023 6 Butanoic acid 0.004 0.020 3 Acetic anhydride 0.017 0.017 2 Allyl alcohol 0.017 0.017 2 Butyl acetate 0.017 0.017 2 3-Furaldehyde 0.017 0.017 2 2-Pentanone 0.017 0.017 2 Cyclopentanone 0.001 0.017 4 2,3-Pentanedione 0.015 0.015 2 2,5-Diethoxy-tetrahydropyran 0.002 0.015 4 Hydroxyacetaldehyde diethyl acetal 0.014 0.014 2 1-Hydroxy-2-butanone 0.011 0.011 1 Ethyl pent-3-enoate 0.008 0.010 2 Ethyl 3-methyl-but-3-enoate 0.007 0.008 2 Ethyl glycolate 0.008 0.008 1 1,1-Diethoxyhexan-2-one 0.001 0.007 4 Ethyl pyruvate 0.006 0.007 2 Ethyl levulinate 0.004 0.007 2 1,1,3-Triethoxy-butane 0.006 0.006 1 2-Cyclopenten-1-one 0.002 0.006 4 Propyl acetate 0.005 0.005 2 Diethoxytetrahydrofuran 0.004 0.005 2 Acetaldehyde ethyl methyl acetal 0.003 0.003 1 Diethyl succinate 0.003 0.003 1 Ethyl 3-methylpentanoate 0.003 0.003 2 Ethyl 2-furoate 0.003 0.003 3 Ethyl hexanoate 0.002 0.002 2 Isobutyl acetate 0.002 0.002 2 5-Methyl-2-furfural 0.002 0.002 1 Ethyl 5-methyl furoate 0.002 0.002 1 Propanal diethyl acetal 0.001 0.001 1 Isobutanal diethyl acetal 0.001 0.001 1 2-Methylbutanal diethyl acetal 0.001 0.001 1 3-Methylbutanal diethyl acetal 0.001 0.001 1 Ethyl nonanoate 0.001 0.001 2 Hexanal diethyl acetal 0.001 0.001 1 2-Furfural diethyl acetal 0.001 0.001 1 Waterc 0.174 22.600 20 GC/MS: gas chromatography/mass spectrometry. a Lowest reported ratio (%) of the peak area of the component in the GC-chromatogram of the rum ether, compared to the sum of the peak areas of all components. b Highest reported ratio (%) of the peak area of the component in the GC-chromatogram of the rum ether, compared to the sum of the peak areas of all components. c [%], determined via Karl Fisher. Table 2. Compositional data of 27 commercial rum ether batches (submission from September 2016)4 Company 1 Company 2 Company 3 Company 4 2 batches, (2014) 2 batches, (2011) 7 batches, (2009/2010) 3 batches, (2015) 7 batches, (2016) 4 batches ('normal') 2 batches ('10-fold') Water (%) 0.02–0.11 0.17 10.14 ± 0.68 9.83 ± 0.38 8.79 ± 0.34 7.92 ± 0.58 2.8–2.6 Volatile components (%) a , b Ethanol 83.00 81.16–81.99 41.23 ± 2.75 42.97 ± 0.49 43.55 ± 0.67 45.57 ± 0.88 27.09–27.55 Ethyl acetate 9.69–8.86 15.84–16.6 44.99 ± 2.69 44.01 ± 0.29 43.21 ± 0.60 31.41 ± 0.16 48.06–49.95 Ethyl formate –c 0.52–0.61 10.49 ± 1.08 9.66 ± 0.37 9.96 ± 0.30 3.44 ± 0.36 7.15–7.82 Ethyl propionate 1.63 0.79–0.81 1.45 ± 0.15 1.67 ± 0.13 1.62 ± 0.08 4.96 ± 0.48 7.23–7.7 Ethyl butyrate 0.02 0.11–0.12 0.16 ± 0.07 0.19 ± 0.01 0.17 ± 0 0.99 ± 0.05 1.39 Ethyl isobutyrate 0.07 0.03 – – – 0.23 ± 0.01 0.47–0.50 Ethyl valerate 1.21–1.61 0.01 – – – 0.11 ± 0.01 0.14–0.16 Ethyl isovalerate 1.12–1.63 0.01 – – – 0.06 ± 0 0.13 Ethyl 2-methylbutanoate 0.03 – – – – 0.10 ± 0 0.07 Ethyl 4-methylpentanoate – – – – – 0.07 ± 0.01 0.10 Ethyl but-3-enoate – – – – – 0.10 ± 0 0.06 Ethyl crotonate 0.09 0.03 0.16 ± 0.07 0.19 ± 0.01 0.17 ± 0 0.16 ± 0 0.14–0.19 Ethyl acrylate – 0.02 – – – 0.14 ± 0.01 0.27–0.29 Ethyl 4-pentenoate 0.02 – – – – 0.07 ± 0.01 0.06–0.08 Ethyl 2-pentenoate – – – – – 0.08 ± 0.03 0.10 Ethyl methacrylate 0.02 – – – – – – Methanol 1.04–1.07 – – – – – – Methyl formate – – 0.04 ± 0.01 0.01 ± 0 0.03 ± 0.01 – – Methyl acetate 0.88–0.97 0.02 – – – – – Methyl propionate 0.03 – – – – 0.29 ± 0.13 0.08–0.13 Propyl acetate – – 0.01 ± 0.02 0.05 ± 0 0.05 ± 0 – – 1-Butanol 0.1–0.12 – – – – – Butyl acetate 0.02 – – – – – – Formaldehyde diethylacetal 0.10 0.12 0.32 ± 0.05 0.31 ± 0.01 0.30 ± 0.02 1.45 ± 0.22 0.31–0.34 Acetaldehyde – 0.08 0.22 ± 0.09 0.43 ± 0.03 0.43 ± 0.08 – – Acetaldehyde diethylacetal – 0.08 0.60 ± 0.73 0.11 ± 0.02 0.23 ± 0.15 – – Acetaldehyde dimethyl acetal 0.60 – – – – Formic acid – – – – – 0.17 ± 0.05 0.1–0.32 Acetic acid – 0.06–0.12 0.05 ± 0.06 0.14 ± 0.02 0.19 ± 0.03 1.66 ± 1.42 0.29–1.87 Acetone – 0.01 0.14 ± 0.03 0.11 ± 0.01 0.13 ± 0.01 – 0.09–0.11 2-Pentanone 0.02 – – – – – – Cyclopentanone 0.02 – – – – – – 2-Methyl-2-cyclopentenone 0.02–0.03 0.01 – – – – – Diacetyl 0.02 0.01 – – – 0.09 ± 0.01 0.51–0.53 Furfural – 0.01 – – – 0.20 ± 0.04 0.10 3-Furaldehyde 0.02 – – – – – – Diethoxytetrahydrofuran – 0.004–0.005 – – – – – Diethylether – 0.01–0.02 0.20 ± 0.07 0.13 ± 0.02 0.1 ± 0.02 – – Furan 0.017 0.003–0.004 0.003 ± 0.001 0.003 ± 0.002 0.004 ± 0 0.006 ± 0.001 0.036–0.048 2-Methylfuran 0.07 – – – – 0.078 ± 0.103 0.10 2-Acetylfuran 0.02 – – – – – – Total (%) – excluding water 99.98–99.89 99.83 ± 0 100.05 ± 0.40 99.99 ± 0.05 100.15 ± 0.18 91.22 ± 0.57 96.08–96.74 a Regarding the analytic methodology for the volatile constituents, the following information was provided: company 1: GC/TOF-MS; companies 2 and 3: GC/FID; company 4: GC/MS, use of 1,2,3-trimethoxybenzene as an internal standard. b Average ratio (%) of the peak area of the component in the CG-chromatogram of the rum ether, compared to the sum of the peak areas of all components. In case of 2 batches analysed, ranges of ratios are indicated instead of averages. c Not identified. 3.1.5 Stability and reaction and fate in food No information has been provided on the stability of the flavouring, but shelf lives up to 6 months have been given by company 4 (submission from September 2016). No information has been provided on the interaction with food components. 3.1.6 Specifications The following specifications have been proposed by the applicant: Rum ether is the distillate produced by the treatment of pyroligneous acid (wood vinegar) with ethyl alcohol under acidic, oxidative and heating conditions. Raw materials for the production of the pyroligneous acid are white oak, beech, and hickory hardwoods. Rum ether shall all distil at a temperature not exceeding 100°C, at atmospheric pressure, and shall leave no residue on evaporation. The furan content shall not exceed 0.02%. Average ethanol and ethanol derivatives, expressed as ethanol, acetaldehyde, acetic acid, and their corresponding acetals and ethyl esters, minimum content 93%. Average methanol and methanol derivatives, expressed as methanol, formaldehyde, and their ester and acetal derivatives) not to exceed 2.5%. The Panel considered that the provision of limits for ethanol and methanol equivalents as proposed by the applicant is not sufficient and proposes that the maximum levels of the constituents listed in Table 2, expressed as mg/L, should be included in the specifications to define the composition of rum ether. 3.2 Structural/metabolic similarity of substances according to the congeneric group approach The applicant suggested to perform the evaluation of rum ether using the congeneric group approach as developed by Smith et al. (2005) for complex flavouring mixtures. Despite the described shortcomings, the Panel considered rum ether sufficiently defined to use the compositional data as basis for the congeneric group approach. The Panel decided to apply the approach as developed by Smith et al. (2005) for the assessment of rum ether with a number of modifications. The procedure used by Panel is as follows: The components are allocated to 12 groups of related substances ('congeneric groups') based on chemical structure and other information (e.g. considerations with respect to metabolism), if available (Table 3). Each component is allocated to a structural class according to Cramer et al. (1978). For each congeneric group, the 'generalised Cramer class' is determined on the basis of that group member which has the highest Cramer class number (I, II or III). In other words, the toxicity of the congeneric group is determined by the substance for which the highest toxicity may be anticipated, based on its chemical structure. For each component, the highest peak area % in any of the batches analysed is taken, and combined with the 'Added Portions Exposure Technique' (APET) exposure estimate for rum ether to obtain a maximised exposure estimate for each individual component. For each congeneric group, the exposure estimates are summed to obtain a maximised summed exposure estimate for the congeneric group. Subsequently, each congeneric group is evaluated as if it were a single substance. The exposure to the congeneric group does not raise a safety concern at the intended levels of use if the exposure to the group is below the Threshold of Toxicological Concern (TTC), for the respective Cramer structural class assigned to the congeneric group (i.e. 1,800 μg/person per day for Cramer structural class I, 540 μg/person per day for Cramer structural class II and 90 μg/person per day for Cramer structural class III). If the exposure is above the TTC, a margin of safety is calculated based on available toxicity data. This margin of safety should be sufficiently large to conclude that there is no safety concern for this congeneric group. If specific data are available that contraindicate the use of the TTC concept for the group (e.g. genotoxicity data) then that group cannot be evaluated in this way, in line with the decision tree for genotoxic substances described in the EFSA Guidance on the data required for the risk assessment of flavourings (EFSA CEF Panel, 2010a), and the entire flavouring cannot be concluded to be of no safety concern
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