SCIENTIFIC OPINION. Abstract

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1 SCIENTIFIC OPINION ADOPTED: February 07 doi:.90/j.efsa.07.7 Scientific Opinion on Flavouring Group Evaluation 7, Revision (FGE.07Rev): saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched-chain carboxylic acids from chemical group EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), Vittorio Silano, Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer G urtler, Trine Husøy, Sirpa K arenlampi, Maria Rosaria Milana, Andre Penninks, Maria de Fatima Tavares Pocßas, Andrew Smith, Christina Tlustos, Detlef W olfle, Holger Zorn, Corina-Aurelia Zugravu, Ulla Beckman Sundh, Leon Brimer, Pasquale Mosesso, Gerard Mulder, Maria Anastassiadou and Wim Mennes Abstract The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate flavouring substances attributed to the Flavouring Group Evaluation 07, including four new substances but--en--ol, non--en-e-ol, hex--en--one and -nonene--one [FL-nos: 0., 0.87, 07.6 and 07.] in this Revision, using the Procedure in Commission Regulation (EC) No 6/000. None of the substances was considered to have genotoxic potential. The substances were evaluated through a stepwise approach that integrates information on the structureactivity relationships, intake from current uses, toxicological of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that all substances do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the Maximised Survey-derived Daily Intake (DI) approach. Besides the safety assessment of the flavouring substances, the s for the materials of commerce have also been considered anound adequate. For 0 substances, further information is required based on comparison of the modified Theoretical Added Maximum Daily Intakes (mtamdis) with the TTCs. This would include more reliable intake data and then, if required, additional toxicological data. 07 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. Keywords: flavouring substances, aliphatic secondary alcohols, ketones, esters, FGE.07, FGE.6 Requestor: European Commission Question numbers: EFSA-Q , 0070, 007, 007 Correspondence: fip@efsa.europa.eu EFSA Journal 07;():7

2 Flavouring Group Evaluation 07 Revision Panel members: Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer G urtler, Trine Husøy, Sirpa K arenlampi, Wim Mennes, Maria Rosaria Milana, Andre Penninks, Maria de Fatima Tavares Pocßas, Vittorio Silano, Andrew Smith, Christina Tlustos, Detlef W olfle, Holger Zorn and Corina-Aurelia Zugravu. Acknowledgements: The Panel wishes to thank the members of the Working Group on Flavourings: Ulla Beckman Sundh, Leon Brimer, Karl-Heinz Engel, Paul Fowler, Rainer G urtler, Trine Husøy, Wim Mennes and Gerard Mulder for the preparatory work on this scientific opinion and the Working Group on Genotoxicity: Mona-Lise Binderup, Claudia Bolognesi, Riccardo Crebelli, Rainer G urtler, Francesca Marcon, Daniel Marzin and Pasquale Mosesso for the preparatory work on this scientific opinion and the hearing experts: Vibe Beltoft and Karin Nørby, and EFSA staff: Maria Anastassiadou, Maria Carfi and Annamaria Rossi for the support provided to this scientific opinion. Suggested citation: EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), Silano V, Bolognesi C, Castle L, Cravedi J-P, Engel K-H, Fowler P, Franz R, Grob K, G urtler R, Husøy T, K arenlampi S, Milana MR, Penninks A, Tavares Pocßas MF, Smith A, Tlustos C, W olfle D, Zorn H, Zugravu C-A, Beckman Sundh U, Brimer L, Mosesso P, Mulder G, Anastassiadou M and Mennes W, 07. Scientific Opinion on Flavouring Group Evaluation 7, Revision (FGE.07Rev): saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched-chain carboxylic acids from chemical group. EFSA Journal 07;():7, 8 pp. doi:.90/j.efsa.07.7 ISSN: European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. EFSA Journal 07;():7

3 Flavouring Group Evaluation 07 Revision Table of contents Abstract.... Introduction..... Background and Terms of Reference as provided by the requestor Background Terms of Reference Interpretation of the terms of reference History of the evaluation.... Assessment..... Presentation of the substances in FGE.07Rev Identity of the substances Stereoisomers Specifications Natural occurrence in food..... Intake data Estimated daily per capita intake (DI approach) Intake estimated on the basis of the modified TAMDI (mtamdi)..... Absorption, distribution, metabolism and excretion..... Application of the procedure for the safety evaluation of flavouring substances Comparison of the intake estimations based on the DI and the mtamdi approach Considerations of combined intakes from use as flavouring substances Genotoxicity Toxicity Acute toxicity Short-term and subchronic toxicity Reproductive and developmental toxicity Other studies.... Conclusions... Documentation provided to EFSA... References... 6 Abbreviations... Appendix A Procedure for the safety evaluation... Appendix B Summary of safety evaluations... Appendix C Use levels/mtamdi... Appendix D Metabolism Appendix E Toxicity summary tables... 6 Appendix F Natural food occurrence EFSA Journal 07;():7

4 Flavouring Group Evaluation 07 Revision. Introduction.. Background and Terms of Reference as provided by the requestor... Background The use of flavourings is regulated under Regulation (EC) No /008 of the European Parliament and Council of 6 December 008 on flavourings and certain food ingredients with flavouring properties for use in and on foods. On the basis of Article 9(a) of this Regulation, an evaluation and approval are requireor flavouring substances. The Union list of flavourings and source materials was established by Commission Implementing Regulation (EC) No 87/0. The list contains flavouring substances for which the scientific evaluation should be completed in accordance with Commission Regulation (EC) No 6/000. On 7 September 0, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids adopted an opinion on Flavouring Group Evaluation 0 (FGE.0): consideration of genotoxic potential on a,b-unsaturated aliphatic ketones with terminal double bonds and precursors from chemical subgroup.. of FGE.9. The Panel concluded that for the two representative substances, oct--en--one [FL-no: 07.08] and pent--en--one [FL-no: 07.], the positive effects in the bacterial mutagenicity assays cannot be overruled by one negative and one equivocal gene mutation test in mammalian cells. Accordingly, an in vivo Comet assay on the first site of contact (e.g. the stomach or duodenum) and on the liver is requesteor the most potent substance, pent--en--one. As an alternative, a transgenic animal assay would also be acceptable. On March 0, the applicant submitted additional studies on the representative substances [FL-no: 07.] and [FL-no: 07.08]. These studies are intended to cover the substances in this group, namely: FL-nos: 0.0, 0.099, 0., 0., 0.6, 0., 0.87, 07.6, 07., 09.8 and Terms of Reference The European Commission requests the European Food Safety Authority (EFSA) to evaluate the new information and, depending on the outcome, proceed to the full evaluation on the flavouring substances in accordance with Commission Regulation (EC) No 6/ Interpretation of the terms of reference In FGE.0 Revision, EFSA evaluated the additional data on genotoxicity submitteor the substances, oct--en--one [FL-no: 07.08] and pent--en--one [FL-no: 07.], by the flavour industry. For these substances, being the representative of four of the flavouring substances in FGE.07, the Panel concluded that the concern for a genotoxic potential could be ruled out. As a follow up to this conclusion, the substances, but--en--ol [FL-no: 0.], non--en-e-ol [FL-no: 0.87], hex-- en--one [FL-no: 07.6] and -nonene--one [FL-no: 07.], were evaluated by the Panel in accordance with the Procedure described in Commission Regulation (EC) No 6/000, in line with the background and terms of references as provided by the European Commission.... History of the evaluation The first version of the Flavouring Group Evaluation 07, FGE.07, dealt with saturated and unsaturated aliphatic secondary alcohols, ketones and esters with secondary alcohol moiety. The first revision of FGE.07, FGE.07Rev, included the assessment of six additional flavouring substances [FL-nos: 0.90, 07.6, 07.0, 07.6, and 09.96]. No new data on toxicity Regulation (EC) No /008 of the European Parliament and of the Council of 6 December 008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 60/9, Regulations (EC) No /96 and (EC) No /008 and Directive 000//EC. OJ L,..008, p. 0. Commission implementing Regulation (EU) No 87/0 of October 0 adopting the list of flavouring substances provided for by Regulation (EC) No /96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No /008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 6/000 and Commission Decision 999/7/EC. OJ L 67,..0, p. 6. Commission Regulation (EC) No 6/000 of 8 July 000 laying down the measures necessary for the adoption of an evaluation programme in application of Regulation (EC) No /96. Official Journal of the European Communities , L 80, p EFSA Journal 07;():7

5 Flavouring Group Evaluation 07 Revision were provided. For two of the new substances, [FL-nos: 07.6 and 07.0], data on metabolism were provided. Additional information on 0 flavouring substances [FL-nos: 0., 0., 0.8, 0.77, 0.8, 0.8, 07.6, 07.7, 07.8, 07.8, 07.0, 09.0, 09., 09., 09.8, 09., 09.86, 09.88, 09.9 and ] was made available since the FGE.07 was published. The second revision of FGE.07, FGE.07Rev, included the assessment of two additional flavouring substances [FL-nos: 0. and 07.9]. No new data on toxicity and metabolism were provided. The third revision of FGE.07, FGE.07Rev, included the assessment of one additional candidate substance [FL-nos: 07.6]. Toxicity data (acute toxicity, 8-days study and an Ames test) were submitted. No metabolism data were provideor this substance. A search in open literature did not provide any further data on toxicity or metabolism for this substance. Furthermore additional information on the s for eight candidate substances requested in FGE.07Rev had been submitted by industry and included in this FGE. The fourth revision of FGE.07, FGE.07Rev, included the assessment of five additional candidate substances [FL-nos: 0., 0.9, 0., and 07.0]. These substances had been considered with respect to genotoxicity in FGE.06 (EFSA CEF Panel, 0) and the Panel concluded that the data available ruled out the concern for genotoxicity and accordingly the substances could be evaluated through the Procedure. FGE Adopted Link Substances FGE FGE.07Rev FGE.07Rev FGE.07Rev FGE.07Rev FGE.07Rev The present revision of FGE.07, FGE.07Rev includes the assessment of four additional candidate substances [FL-nos: 0., 0.87, 07.6 and 07.]. These substances had been considered with respect to genotoxicity in FGE.0Rev (EFSA CEF Panel, 06). Based on new genotoxicity data submitted by the flavour industry, the Panel concluded that the concern for genotoxicity could be ruled out, and therefore, the four substances could be evaluated through the Procedure in FGE.07Rev. A search in open literature for these four new substances conducteor metabolism and toxicity did not reveal any pertinent new information.. Assessment.. Presentation of the substances in FGE.07Rev... Identity of the substances The present Flavouring Group Evaluation 7, Revision (FGE.07Rev), using the Procedure as referred to in the Commission Regulation (EC) 6/000 (the Procedure shown in schematic form in Appendix A), deals with saturated and unsaturated aliphatic acyclic secondary alcohols, ketones and esters with a secondary alcohol moiety. These flavouring substances belong to the chemical group of Annex I of Commission Regulation (EC) No 6/000. The flavouring substances (candidate substances) are closely related to 67 flavouring substances (supporting substances) evaluated at the st, 9th and 69th meetings of the Joint FAO/WHO Expert Committee on Food Additives (JEFCA) in the group Saturated Aliphatic Acyclic Secondary Alcohols, Ketones, and Related Saturated and Unsaturated Esters (, 000a, 00a, 00, 009b). The candidate substances under consideration in the present evaluation are listed in Table, as well as their chemical Register names, FLAVIS- (FL-), Chemical Abstract Service- (CAS-), Council of Europe- (CoE-) and Flavor and Extract Manufacturers Association- (FEMA-) numbers, and structures. Seven flavouring substances are saturated aliphatic acyclic secondary alcohols [FL-nos: 0.077, 0., 0.8, 0.77, 0.8, 0.8 and 0.90]; seven are unsaturated aliphatic secondary alcohols [FL-nos: 0., 0., 0., 0.87, 0.9, 0. and 0.] of which five contain a terminal double bond [FL-nos: 0., 0., 0.87, 0.9 and 0.]; are saturated aliphatic ketones [FL-nos: 07.07, 07.08, 07.0, 07.7, 07.8, 07.60, 07.78, 07.8, 07.8, 07.8, EFSA Journal 07;():7

6 Flavouring Group Evaluation 07 Revision 07.89, and 07.0]; are unsaturated aliphatic ketones [FL-nos: 07.6, 07.6, 07.6, 07.98, 07.0, 07.0, 07., 07.6, 07.9 and 07.6] of which seven contain a terminal double bond [FL-nos: 07.6, 07.6, 07.0, 07.0, 07., 07.9 and 07.6] and 6 are esters of aliphatic acyclic secondary alcohols and linear or branched-chain aliphatic carboxylic acids [FL-nos: 09.0, 09., 09., 09.8, 09., 09.86, 09.88, 09.9, 09.60, 09.60, , , , , and 09.96]. The hydrolysis products of the candidate esters are listed in Appendix B, Table B.. The names and structures of the 67 supporting substances are listed in Appendix B, Table B., together with their evaluation status (CoE, 99; SCF, 99;, 999a, 00a, 00, 009b).... Stereoisomers It is recognised that geometrical and optical isomers of substances may have different properties. Their flavour may be different; they may have different chemical properties resulting in possible variability in their absorption, distribution, metabolism, elimination and toxicity. Thus, information must be provided on the configuration of the flavouring substance, i.e. whether it is one of the geometrical/ optical isomers, or a defined mixture of stereoisomers. The available s of purity will be considered in order to determine whether the safety evaluation carried out for candidate substances for which stereoisomers may exist can be applied to the materials of commerce. Flavouring substances with different configurations should have individual chemical names and codes (CAS number, FLAVIS number, etc.). Twenty-seven candidate substances possess a chiral centre [FL-nos: 0., 0., 0., 0., 0.8, 0.77, 0.8, 0.87, 0.90, 0.9, 0., 0., 07.7, 07.8, 07.8, 07.9, 09.0, 09., 09., 09.8, 09., 09.86, 09.88, 09.9, , and 09.96] and two of the candidate substances possess two chiral centres [FL-nos: 0.8 and 07.0] (see Table ). Due to the presence and the position of double bonds, candidate substances can exist as geometrical isomers [FL-nos: 0., 0.9, 0., 0., 07.6, 07.98, 07.6, 07.9, and ]. (EFFA, 0; EFFA, 0) (see Table ).... Specifications Purity criteria for all candidate substances have been provided by the flavour industry (EFFA, 00a,c, 007c; Flavour Industry, 006,009). Judged against the requirements in Annex II of Commission Regulation (EC) No 6/000, the information is adequate for all candidate substances (EFFA, 0, 0, 06, 07) (see Section.. and Table ). Adequate s including purity and identity for the materials of commerce have been provideor all the candidate substances. 6 EFSA Journal 07;():7

7 Flavouring Group Evaluation 07 Revision Table : Specification summary of the substances in the flavouring group evaluation 7, Revision FL-no EU register name Structural formula FEMA no CoE no CAS no Pentan--ol Methylhept--en--ol Phys. form Mol. formula Mol. weight Liquid CHO 88. Liquid C8H6O But--en--ol 98-- Liquid CH8O 7. 0.,-Dimethylbutan--ol Liquid C6HO.8 0.,6-Dimethylocta-,,7-trien--ol 0.8 Dodecan--ol Methylhexan--ol Methylpentan--ol Methylpentan--ol Non--en--ol Liquid CH6O. Liquid CH6O 86. Liquid C 7 H 6 O 6.0 Liquid C 6 H O.8 Liquid C6HO.8 Liquid C 9 H 8 O. Solubility (a) Solubility in ethanol (b) Slightly soluble Slightly soluble Slightly soluble Slightly soluble Slightly soluble Insoluble Slightly soluble Insoluble Slightly soluble Practically insoluble or insoluble Boiling point, C (c) Melting point, C ID test Assay minimum 98% 77 (0 hpa) 9% 90 9% 0 9% 0 9% 9 ( hpa) 9 9% 9% 9% 99% 9 98% Refrac. Index (d) Specification comments Spec. gravity (e) Racemate (EFFA, 00a) Racemate (EFFA, 06) Racemate (EFFA, 00a) Racemate Mixture of E/Z stereoisomers: 080% (E) (EFFA, 0) Racemate (EFFA, 00a) Racemate (EFFA, 00a) Racemate (EFFA, 0) Racemate (EFFA, 00a) Racemate (EFFA, 06) 7 EFSA Journal 07;():7

8 Flavouring Group Evaluation 07 Revision FL-no EU register name Structural formula FEMA no CoE no CAS no 0.90 Nonan--ol Phys. form Mol. formula Mol. weight Liquid C9H0O Octa-,-dien--ol Liquid C8HO Undeca-,-dien--ol Liquid CH0O (Z)--Hepten--ol Liquid C7HO Methylheptan--one Pentan--one Liquid C 8 H 6 O 8. Liquid C H O 86. Solubility (a) Solubility in ethanol (b) Practically insoluble or insoluble Practically insoluble or insoluble Practically insoluble or insoluble Insoluble Insoluble Partly soluble Boiling point, C (c) Melting point, C ID test Assay minimum 9 9% 87 9% NMR 9% 9% 6 9% 99% Refrac. Index (d) Specification comments Spec. gravity (e) Racemate (EFFA, 0) Racemate (EFFA, 07) Mixture of E/Z stereoisomers: 6090% (E) (EFFA, 0) Racemate (EFFA, 07) Mixture of E/Z stereoisomers: 6090% (E) (EFFA, 0) CASrn refers to the (Z)- isomer only. CASrn in the Union List to be changed to Racemate (EFFA, 07) Mixture of E/Z stereoisomers: (Z)-isomer (approx. 9%), (E)-isomer (approx. %). Minor constituents -heptanol (< ), trans--hepten--ol (< %), cis--hepten--ol (< %) (EFFA, 0) CAS nr does not specify the geometrical isomer Name in the Union List to be changed to -Hepten--ol 8 EFSA Journal 07;():7

9 Flavouring Group Evaluation 07 Revision FL-no EU register name Structural formula FEMA no CoE no CAS no Decan--one ,6-Dimethyloct-6-en- -one (mixture of E and Z) ,- Dimethylundecan-- one Phys. form Mol. formula Mol. weight Liquid CH0O Liquid CH8O Dodecan--one Heptadecan--one Liquid CH6O 98. Liquid CHO 8. Solid C7HO Hex--en--one Liquid C6HO Hex--en--one Liquid C6HO Methylbutan--one Methylheptan--one Liquid CHO 86. Liquid C8H6O Methylheptan--one -8- Liquid C8H6O 8. Solubility (a) Solubility in ethanol (b) Insoluble Insoluble Insoluble Insoluble Insoluble Practically insoluble or insoluble Slightly soluble Slightly soluble Insoluble Insoluble Boiling point, C (c) Melting point, C ID test Assay minimum 98% 80 ( hpa) NMR 9% (6 hpa) 9% 9 ( hpa) 0 99% ( hpa) 8 9% 8 9% 8 9% 9 9% 67 9% 8 9% Refrac. Index (d) Specification comments Spec. gravity (e) n.a. n.a Mixture of E/Z isomers: 0 80% (E) (EFFA, 07) Racemate (EFFA, 00a) Racemate (EFFA, 00a) 9 EFSA Journal 07;():7

10 Flavouring Group Evaluation 07 Revision FL-no EU register name Structural formula FEMA no CoE no CAS no Methylpentan--one Nonan--one Pseudo-ionone Tetradecan--one Phys. form Mol. formula Mol. weight Liquid C6HO 0.6 Liquid C9H8O. Liquid CH0O 9.0 Solid CH8O Tridec--en--one Liquid CHO ,,6-Trimethylhepta-,-dien--one ,,- Trimethylpentadecan- -one Liquid CH6O Liquid C8H6O Nonene--one -6-7 Liquid C9H6O (Z)--Octen--one [R- (E) ]--Isopropyl-8- methylnona-6,8-dien- -one Liquid C8HO 6.0 Liquid CHO 9. Solubility (a) Solubility in ethanol (b) Insoluble Insoluble Insoluble Insoluble Insoluble Practically insoluble or insoluble Insoluble Insoluble Practically insoluble or insoluble Practically insoluble or insoluble Boiling point, C (c) Melting point, C ID test Assay minimum 7 9% 88 9% (6 hpa) 9% 6 (6 hpa) 9% 9 ( hpa) NMR 9% 8 9% 7 ( hpa) 9% 80 (6 hpa) 9% NMR 9% 8 9% Refrac. Index (d) Specification comments Spec. gravity (e) n.a. n.a Racemate (EFFA, 00a) Mixture of E/Z stereoisomers: > 0% EE (EFFA, 0) Racemate (EFFA, 00a) EFSA Journal 07;():7

11 Flavouring Group Evaluation 07 Revision FL-no EU register name Structural formula FEMA no CoE no CAS no Decen--one sec-heptyl isovalerate sec-butyl acetate sec-butyl butyrate sec-butyl formate sec-butyl hexanoate sec-hept-(cis)-enyl acetate sec-heptyl acetate sec-heptyl hexanoate Isopropyl decanoate Phys. form Mol. formula Mol. weight Liquid CH8O Liquid CHO 00. Liquid C6HO 6.6 Liquid C8H6O. Liquid CHO. Liquid CH0O Liquid C 9 H 6 O 6. Liquid C 9 H 8 O 8. Liquid C H 6 O. Liquid C H 6 O Isopropyl dodecanoate -- Liquid CH0O.0 Solubility (a) Solubility in ethanol (b) Slightly soluble Soluble Insoluble Slightly soluble Slightly soluble Slightly soluble Insoluble Insoluble Insoluble Insoluble Insoluble Insoluble Boiling point, C (c) Melting point, C ID test Assay minimum 06. IR NMR 99% NMR 9% 9% 9% 9 9% 8 ( hpa) NMR 9% 8 9% 7 9% 6 (0 hpa) 9% 88 ( hpa) 9% ( hpa) 9% Refrac. Index (d) Specification comments Spec. gravity (e) Racemate (EFFA, 00a) Racemate (EFFA, 00a) Racemate (EFFA, 00a) Racemate (EFFA, 00a) Racemate (EFFA, 00a) Racemate (EFFA, 00a) Racemate (EFFA, 00a) Racemate (EFFA, 00a) EFSA Journal 07;():7

12 Flavouring Group Evaluation 07 Revision FL-no EU register name Structural formula FEMA no CoE no CAS no Phys. form Mol. formula Mol. weight Solubility (a) Solubility in ethanol (b) Boiling point, C (c) Melting point, C ID test Assay minimum Refrac. Index (d) Specification comments Spec. gravity (e) Isopropyl hexadecanoate Isopropyl octanoate Liquid C9H8O 98. Liquid C H O Isopropyl valerate Liquid C 8 H 6 O sec-octyl acetate (Z)-Hept--enyl- butyrate Octan--yl formate Liquid CH0O Liquid C H 0 O 8.8 Liquid C9H8O 8. Insoluble Insoluble Insoluble Practically insoluble or insoluble Practically insoluble or insoluble Practically insoluble or insoluble 9% ( hpa) 9% 6 9% 9 9% 9% 7 (9 hpa) IR NMR 98% Racemate (EFFA, 0) Racemate (EFFA, 0) Racemate (EFFA, 0) FL-no: FLAVIS number; FEMA: Flavor and Extract Manufacturers Association; CoE: Council of Europe; CAS: Chemical Abstract Service; ID: identity; : mass spectrometry; NMR: nuclear magnetic resonance; IR: infrared spectroscopy. (a): Solubility in water, if not otherwise stated. (b): Solubility in 9% ethanol, if not otherwise stated. (c): At atm (,0. hpa), if not otherwise stated. (d): At 0 C, if not otherwise stated. (e): At C, if not otherwise stated. EFSA Journal 07;():7

13 Flavouring Group Evaluation 07 Revision... Natural occurrence in food Forty-five of the candidate substances have been reported to occur naturally. These occurrences include among others: milk and milk products as cheese of various types, beef, chicken, guinea hen, lamb and mutton, fish, oysters, scallops and shrimps, passion fruit, plum, papaya, strawberry, citrus fruits, apples, hop oil, camomile, tomatoes and potatoes, cocoa and tea, maize, nuts and different alcoholic beverages. The highest quantified natural occurrences in foods are presented in Table (full data set are available in Appendix F). Table : Candidate substances reported to occur naturally in food (VCF online 06) FL-no Name Quantitative data reported Pentan--ol Up to mg/kg in tea 0. 6-Methylhept--en--ol Up to 0 mg/kg in citrus fruits 0.,6-Dimethylocta-,,7-trien--ol Up to 0 mg/kg in sage Pentan--one Up to mg/kg in mushroom 09. sec-butyl acetate Up to 67 mg/kg in vinegar 09.9 sec-heptyl hexanoate Up to 6,6 mg/kg in passion fruit For eight candidate substances listed in Table no natural occurrence data have been identified (VCF online, 06). Table : Candidate substances for which no natural occurrence data in food are available (VCF online, 06) FL-no Name 07.6 Hex--en--one 07.0 Tridec--en--one 07. -Nonene--one 07.9 [R-(E)]--Isopropyl-8-methylnona-6,8-dien--one Decen--one 09. sec-butyl hexanoate (Z)-Hept--enyl- butyrate Octan--yl formate.. Intake data Annual production volumes of the flavouring substances as surveyed by industry can be used to calculate the Maximised Survey-derived Daily Intake (DI) by assuming that the production figure only represents 60% of the use in food due to underreporting and that % of the total European Union (EU) population are consumers (SCF, 999). However, the Panel noted that due to year-to-year variability in production volumes, to uncertainties in the underreporting correction factor and to uncertainties in the percentage of consumers, the reliability of intake estimates on the basis of the DI approach is difficult to assess. The Panel also noted that in contrast to the generally low per capita intake figures estimated on the basis of this DI approach, in some cases, the regular consumption of products flavoured at use levels reported by the flavour industry in the submissions would result in much higher intakes. In such cases, the human exposure s below which exposures are not considered to present a safety concern might be exceeded. Considering that the DI model may underestimate the intake of flavouring substances by certain groups of consumers, the Scientific Committee on Food (SCF) recommended also taking into account the results of other intake assessments (SCF, 999). One of the alternatives is the Theoretical Added Maximum Daily Intake (TAMDI) approach, which is calculated on the basis of standard portions and upper use levels (SCF, 99) for flavourable beverages anoods in general, with exceptional levels for particular foods. This method is regarded as a conservative estimate of the actual intake by most consumers because it is based on the assumption that the consumer regularly eats and drinks several food products containing the same flavouring substance at the upper use level. EFSA Journal 07;():7

14 Flavouring Group Evaluation 07 Revision One option to modify the TAMDI approach is to base the calculation on normal rather than upper use levels of the flavouring substances. This modified approach is less conservative (e.g. it may underestimate the intake of consumers being loyal to products flavoured at the maximum use levels reported). However, it is considered as a suitable tool to screen and prioritise the flavouring substances according to the neeor refined intake data (EFSA, 00).... Estimated daily per capita intake (DI approach) The intake estimation is based on the DI approach, which involves the acquisition of data on the amounts used in food as flavourings (SCF, 999). These data are deriverom surveys on annual production volumes in Europe. These surveys were conducted in 99 by the International Organization of the Flavour Industry (IOFI), in which flavour manufacturers reported the total amount of each flavouring substance incorporated into food sold in the EU during the previous year (IOFI, 99). The intake approach does not consider the possible natural occurrence in food. Average per capita intake (DI) is estimated on the assumption that the amount added to food is consumed by % of the population (Eurostat, 998). This is deriveor candidate substances from estimates of annual volume of production provided by industry and incorporates a correction factor of 0.6 to allow for incomplete reporting (60%) in the industry surveys (SCF, 999). In the present (FGE.07Rev, the total annual volume of production of the candidate substances for use as flavouring substances in Europe has been reported to be approximately 690 kg (EFFA, 00b,c, 007c; Flavour industry, 009) anor 6 of the 67 supporting substances approximately 70,000 kg (isopropyl alcohol accounts for 690,000 kg and acetone for 0,000 kg) (cited by the (999a). For three supporting substances, no EU annual volumes of production are available (, 00; IOFI, 99) (Tables and B.). Table : Tonnage data and DI for candidate and supporting substances FGE.07Rev 9.7 (8 substances) FGE.07Revsupp 7,8 ( substances) Tonnage (kg/year) DI (lg/capita per day) Class I Class II Class I Class II 69.0 ( substances),096 (0 substances).9 (8 substances) 90, ( substances) Total 7,88,7 90,0,0 DI: Maximised Survey-derived Daily Intake ( substances), (0 substances) On the basis of the annual volumes of production reporteor the candidate substances, the daily per capita intakes for each of these flavourings have been estimated (Table B.). Approximately 90% of the total annual volume of production for the candidate substances (EFFA, 00b, 007c) is accounted for by one candidate substance, 9-decen--one [FL-no: 07.6]. The estimated daily per capita intake of this candidate substance from use as a flavouring substance is 7 lg/capita per day. The daily per capita intakes for each of the remaining substances is less than lg/capita per day (Table B.).... Intake estimated on the basis of the modified TAMDI (mtamdi) The methoor calculation of modified Theoretical Added Maximum Daily Intake (mtamdi) values is based on the approach used by SCF up to 99 (SCF, 99). The assumption is that a person may consume a certain amount of flavourable foods and beverages per day. For the present evaluation of the candidate substances, information on food categories and normal and maximum use levels,,6,7 were submitted by the flavour industry (EFFA, 00a,c, 007a,b,c; EU figure 7 million. This figure relates to EU population at the time for which production data are available, and is consistent (comparable) with evaluations conducted prior to the enlargement of the EU. No production data are available for the enlarged EU (Eurostat, 998). Normal use is defined as the average of reported usages and maximum us is defined as the 9th percentile of reported usages (EFFA, 00d). 6 The normal and maximum use levels in different food categories have been extrapolaterom figures deriverom model flavouring substances (EFFA, 00). 7 The use levels from food category Confectionery have been inserted as default values for food category. Alcoholic beverages for substances for which no data have been given for food category. (EFFA, 007a). EFSA Journal 07;():7

15 Flavouring Group Evaluation 07 Revision Flavour Industry, 006, 009, EFFA, 06). The candidate substances are used in flavoureood products divided into the food categories, outlined in Annex III of the Commission Regulation (EC) No 6/000, as summarised in Table. For the present calculation of mtamdi, the reported normal use levels were used. In the case where different use levels were reporteor different food categories, the highest reported normal use level was used. Table : Use in various food categories for candidate substances for which data on use have been provided Food category Description Flavourings used 0.0 Dairy products, excluding products of category All 0.0 Fats and oils, anat emulsions (type water-in-oil) All except [FL-no: 07.6] 0.0 Edible ices, including sherbet and sorbet All 0. Processeruits All 0. Processed vegetables (including mushrooms & fungi, Only [FL-no: 07.6] roots & tubers, pulses and legumes), and nuts & seeds 0.0 Confectionery All except [FL-no: 07.0] 06.0 Cereals and cereal products, including flours & starches All except [FL-nos: 0. & 07.6] from roots & tubers, pulses & legumes, excluding bakery 07.0 Bakery wares All except [FL-no: 07.6] 08.0 Meat and meat products, including poultry and game All except [FL-nos: 0. & 07.6] 09.0 Fish anish products, including molluscs, crustaceans and echinoderms According to the flavour industry, the normal use levels for the candidate substances are in the range of 0 mg/kg food, and the maximum use levels are in the range of 0 mg/kg (EFFA, 00a,b,c,d, 007a,b,c, 06; Flavour Industry, 006, 009). The mtamdi values for the 8 candidate substances from structural class I (see Section.) range from,600 to,900 lg/person per day. For the candidate substance from structural class II, the mtamdi range from,00 to 6,600 lg/person per day. For detailed information on use levels and intake estimations based on the mtamdi approach, see Appendix C... Absorption, distribution, metabolism and excretion All except [FL-nos: , 0. & 07.6].0 Eggs and egg products None.0 Sweeteners, including honey None.0 Salts, spices, soups, sauces, salads, protein products etc. All except [FL-nos: 07.6, 0. & 07.6].0 Foodstuffs intendeor particular nutritional uses All. Non-alcoholic ( soft ) beverages, excl. dairy products All. Alcoholic beverages, incl. alcohol-free and low-alcoholic All except [FL-no: 07.0] counterparts.0 Ready-to-eat savouries All except [FL-nos: 0., 07.7, & 07.6] 6.0 Composite foods (e.g. casseroles, meat pies, mincemeat) foods that could not be placed in categories All In general, aliphatic secondary alcohols and ketones are expected to be rapidly absorbed in the gastrointestinal tract. The candidate aliphatic esters are expected to be hydrolysed enzymatically to their component secondary alcohols and carboxylic acids. The carboxylic acids are completely oxidised in the fatty acid pathway and the tricarboxylic acid pathway (see Appendix D). Secondary alcohols may undergo oxidation to the corresponding ketone; however, in the in vivo situation, the alcohol is removerom the equilibrium by conjugation to glucuronic acid, which represents the major pathway of metabolism for secondary alcohols. The glucuronides of the candidate secondary alcohols are expected to be eliminated via the urine (Felsted and Bachur, 980; Kasper and Henton, 980;, 999a). EFSA Journal 07;():7

16 Flavouring Group Evaluation 07 Revision In general, the major metabolic pathway for aliphatic ketones is reduction of the ketone to the corresponding secondary alcohol and subsequent excretion as glucuronic acid conjugate (Felsted and Bachur, 980;, 999a). Short-chain ketones (C < ) that contain a carbonyl function at the C position may undergo oxidation to yield an alpha-keto carboxylic acid, which through decarboxylation will be oxidised to carbon dioxide and a simple aliphatic carboxylic acid that will enter the fatty acid pathway and citric acid cycle (Dietz et al., 98). Ketones may also be metabolised by omega- or omega--oxidation yielding a hydroxy-ketone that may be further reduced to a diol and excreted in the urine as glucuronic acid conjugate. Longer chain aliphatic ketones (C ) are primarily metabolised via reduction, but omega- and omega--oxidation are competing pathways at high concentrations (Dietz et al., 98; Topping et al., 99). Omega--oxidation of certain aliphatic ketones may yield gamma-diketones, which may give rise to neuropathy of giant-axonal type. The metabolic pathway includes oxidation of the omega--carbon, first to a hydroxy-ketone and then to a diketone. The gamma-spacing of the carbonyl functions has been shown to be a prerequisite for neurotoxic effects, thus, only ketones with this structural feature may yield the neurotoxic metabolites. Neurotoxic effects are, however, only observed at relatively high dosages (Topping et al., 99). One of the candidate substances, -methylheptan--one [FL-no: 07.8], may potentially be oxidised to a gamma-diketone. Twelve of the candidate substances, but--en--ol,,6-dimethylocta-,,7-triene--ol, non--en-- ol, octa-,-dien--ol, undeca-,-dien--ol, hex--en--one, hex--en--one, tridec--en--one,,,6-trimethylhepta-,-dien--one, -nonene--one, ([R-(E)]--isopropyl-8-methylnona-6,8-dien-- one and 9-decen--one [FL-nos: 0., 0., 0.87, 0.9, 0., 07.6, 07.6, 07.0, 07.0, 07., 07.9 and 07.6] have terminal double bonds. These double bonds may be oxidised to the corresponding epoxides. Epoxides are highly reactive molecules, due to the large strain associated with this three-membered ring structure, and they react easily with nucleophilic sites of cellular macromolecules. However, epoxides will be conjugated with glutathione by glutathione S-transferases or hydrolysed to diols by epoxide hydrolases. These two reactions can be considered to be detoxications (Sanchez and Kauffman, 0). -Alkenes are metabolised by P0 through both double bond oxidation to the corresponding epoxide and allylic oxidation (Chiappe et al., 998). The rates of the two reactions measured with different P0 isoforms indicate that epoxide formation is generally favoured (Chiappe et al., 998). Based on the low levels of intake of alkenones and alkenols characterised by a carbonyl or an alcohol group in addition to the terminal double bond, it is expected that the detoxication reactions of the formed epoxides (conjugation with glutathione or epoxide hydrolase mediated hydrolysis) would not be saturated and would outweigh the rate of epoxide formation. The presence of the terminal double bond is therefore not considered of concern under the intended conditions of use. In addition to reduction and oxidation pathways, low molecular weight alcohols and ketones may be excreted unchanged in expired air (Brown et al., 987). Concluding remarks on metabolism Fifty-two of the candidate substances, seven saturated aliphatic acyclic secondary alcohols, seven unsaturated aliphatic secondary alcohols, saturated aliphatic ketones, unsaturated aliphatic ketones and 6 esters of aliphatic acyclic secondary alcohols and linear and branched-chain aliphatic carboxylic acids, may be expected to be metabolised to innocuous substances at the estimated levels of intake, based on the DI approach, as flavouring substances. One candidate substance, -methylheptan--one [FL-no: 07.8], may be oxidised to a potentially neurotoxic gamma-diketone. Therefore, this substance will be evaluated via the B-side of the Procedure (see section.). More detailed information on the metabolism of candidate substances is given in Appendix D... Application of the procedure for the safety evaluation of flavouring substances The application of the Procedure is based on intakes estimated on the basis of the DI approach. Where the mtamdi approach indicates that the intake of a flavouring substance might exceed its corresponding of concern, a formal safety assessment is not carried out using the Procedure. In these cases, the Panel requires more precise data on use and use levels. For comparison of the intake estimations based on the DI approach and the mtamdi approach, see Section EFSA Journal 07;():7

17 Flavouring Group Evaluation 07 Revision For the safety evaluation of the candidate substances the Procedure as outlined in Appendix A was applied, based on the DI approach. The stepwise evaluations of the substances are summarised in Table B.. Step Twenty-eight of the candidate substances [FL-nos: 0.077, 0., 0., 0.8, 0.77, 0.8, 0.8, 0.90, 0., 07.08, 07.78, 07.9, 09.0, 09., 09., 09.8, 09., 09.86, 09.88, 09.9, 09.60, 09.60, , , , , and 09.96] are classified in structural class I, according to the decision tree approach presented by Cramer et al. (Cramer et al., 978). The remaining candidate substances [FL-nos: 0., 0., 0.87, 0.9, 0., 07.07, 07.0, 07.6, 07.7, 07.8, 07.60, 07.6, 07.6, 07.8, 07.8, 07.8, 07.89, 07.98, 07.99, 07.0, 07.0, 07.0, 07., 07.6 and 07.6], which are unsaturated aliphatic secondary alcohols or acyclic aliphatic saturated or unsaturated ketones, are in structural class II. Step Fifty-two candidate substances were considered to be metabolised to innocuous products and would not be expected to saturate available detoxification pathways at estimated levels of intake, based on the DI approach, from use as flavouring substances. Therefore, these substances proceed via the A-side of the Procedure scheme (Appendix A). One candidate substance, - methylheptan--one [FL-no: 07.8], cannot be predicted to be metabolised to innocuous products and therefore, proceeds to step B. Step A The 8 candidate substances assigned to structural class I, have estimated European daily per capita intakes ranging from 0.00 to. lg (Table 6). These intakes are below the of concern of,800 lg/person per day for structural class I. The unsaturated aliphatic secondary alcohols and ketones, which have been assigned to structural class II, have estimated European daily per capita intakes ranging from 0.00 to 7 lg (Table 6). These intakes are below the of concern of 0 lg/person per day for structural class II. Based on results of the safety evaluation sequence, the candidate substances proceeding via the A-side of the Procedure do not pose a safety concern when used as flavouring substances at the estimated levels of intake, based on the DI approach. Step B The estimated per capita intake of -methylheptan--one [FL-no: 07.8] of 0. lg/capita per day does not exceed the of concern for structural class II of 0 lg/person per day. Accordingly, the candidate substance proceeds to step B of the Procedure. Step B On the basis of a study on the neurotoxic effects of orally administered -methylheptan--one [FLno: 07.8] to male rats, a no observed adverse effect level (NOAEL) of 8 mg/kg body weight (bw) per day was established (IBM Corp., 989). This NOAEL provides a margin of safety of. 9 7 based on the estimated intake of the candidate substance of 0. lg/capita per day. Based on results of the safety evaluation sequence, this candidate substance does not pose a safety concern when used as flavouring substance at the estimated level of intake, based on the DI approach... Comparison of the intake estimations based on the DI and the mtamdi approach The estimated intakes for the 8 candidate substances in structural class I based on the mtamdi approach range from,600 to,900 lg/person per day. For three [FL-nos: 07.08, and 07.9] of these 8 substances, the mtamdi is below the of concern of,800 lg/person per day. The estimated intake for the candidate substances assigned to structural class II based on the mtamdi range from,00 to 6,600 lg/person per day, which are all above the of concern for structural class II substances of 0 lg/person per day. Therefore, for 0 candidate substances, further information is required. This would include more reliable intake data and then, if required, additional toxicological data. For comparison of the DI and mtamdi values, see Table EFSA Journal 07;():7

18 Flavouring Group Evaluation 07 Revision Table 6: Estimated intakes based on the DI approach and the mtamdi approach FL-no EU register name DI (lg/capita per day) mtamdi (lg/person per day) Structural class TTC (lg/person per day) Pentan--ol 0.9,900 Class I, Methylhept--en--ol 0.006,900 Class I,800 0.,-Dimethylbutan--ol 0.,900 Class I, Dodecan--ol 0.,900 Class I, Methylhexan--ol 0.,900 Class I, Methylpentan--ol 0.,900 Class I, Methylpentan--ol 0.00,900 Class I, Nonan--ol 0.0,900 Class I, (Z)--Hepten--ol 0.0,00 Class I, Pentan--one 0.,600 Class I, Methylbutan--one 0.07,600 Class I, [R-(E)]--Isopropyl-8-0.,600 Class I,800 methylnona-6,8-dien--one 09.0 sec-heptyl isovalerate 0.00,900 Class I, sec-butyl acetate 0.00,900 Class I, sec-butyl butyrate.,900 Class I, sec-butyl formate 0.,900 Class I, sec-butyl hexanoate 0.0,900 Class I, sec-hept-(cis)-enyl acetate 0.0,900 Class I, sec-heptyl acetate 0.,900 Class I, sec-heptyl hexanoate 0.,900 Class I, Isopropyl decanoate 0.,900 Class I, Isopropyl dodecanoate 0.,900 Class I, Isopropyl hexadecanoate 0.0,900 Class I, Isopropyl octanoate.,900 Class I, Isopropyl valerate 0.0,00 Class I, sec-octyl acetate 0.0,900 Class I, (Z)-Hept--enyl- butyrate 0.79,900 Class I, Octan--yl formate 0.,900 Class I, But--en--ol 0.00,900 Class II 0 0.,6-Dimethylocta-,, ,900 Class II 0 trien--ol 0.87 Non--en--ol 0.8,900 Class II Octa-,-dien--ol 0.06,900 Class II 0 0. Undeca-,-dien--ol 0.06,900 Class II Methylheptan--one 0.9,600 Class II Decan--one 0.,600 Class II ,6-Dimethyloct-6-en--one 0.00,600 Class II 0 (mixture of E and Z) ,-Dimethylundecan ,00 Class II 0 one 07.8 Dodecan--one 0.7,600 Class II Heptadecan--one 0.,600 Class II Hex--en--one 0.0,600 Class II Hex--en--one 0.09,600 Class II Methylheptan--one 0.00,600 Class II Methylheptan--one 0.,600 Class II Methylpentan--one.,600 Class II EFSA Journal 07;():7

19 Flavouring Group Evaluation 07 Revision FL-no EU register name DI (lg/capita per day) mtamdi (lg/person per day) Structural class TTC (lg/person per day) Nonan--one 0.,600 Class II Pseudo-ionone 0.,600 Class II Tetradecan--one 0.07,600 Class II Tridec--en--one 0.0,600 Class II ,,6-Trimethylhepta-,- 0.0,600 Class II 0 dien--one 07. -Nonene--one 0.00,600 Class II ,, ,00 Class II 0 Trimethylpentadecan--one 07.6 (Z)--Octen--one ,600 Class II Decen--one 7 6,600 Class II 0 DI: Maximised Survey-derived Daily Intake; mtamdi: modified Theoretical Added Maximum Daily Intake; TTC: toxicological of concern..6. Considerations of combined intakes from use as flavouring substances Because of structural similarities of candidate and supporting substances, it can be anticipated that many of the flavourings are metabolised through the same metabolic pathways and that the metabolites may affect the same target organs. Furthermore, in case of combined exposure to structurally relatelavourings, the pathways could be overloaded. Therefore, combined intake should be considered. As flavourings not included in this FGE may also be metabolised through the same pathways, the combined intake estimates presented here are only preliminary. Currently, the combined intake estimates are only based on DI exposure estimates, although it is recognised that this may lead to underestimation of exposure. After completion of all FGEs, this issue should be readdressed. The total estimated combined daily per capita intake of structurally relatelavourings is estimated by summing the DI for individual substances. On the basis of the reported annual production volumes in Europe (EFFA, 00b, c, 007c; Flavour Industry, 009), the total estimated daily per capita intake as flavourings of the 8 candidate flavouring substances assigned to structural class I is 6 lg, which does not exceed the of concern for a substance belonging to structural class I of,800 lg/person per day. For the combined intake of the candidate flavouring substances assigned to structural class II is 78 lg, which does not exceed the of concern for a substance belonging to structural class II of 0 lg/person per day. The candidate substances are structurally related to 67 supporting substances evaluated by the JEFCA at its st, 9th and 69th meetings in the groups Saturated aliphatic acyclic secondary alcohols, ketones, and related saturated and unsaturated esters (, 000a, 00a, 00, 009b). The total combined intake of candidate and supporting substances of structural class I and II would be 90,0 lg/capita per day and,0 lg/capita per day, respectively. Both intakes exceed the of their structural class of,800 and 0 lg/person per day. However, the major contribution (> 99%) was provided by two supporting substances, namely acetone [FL-no: 07.00] (6,0 lg/capita per day) and isopropanol [FL-no: 0.079] (8,000 lg/capita per day). These are present in the body as endogenous compounds, which are easily eliminated, either by excretion into the urine and exhaled air or after enzymatic metabolism (Morgott, 99). Therefore, they would not be expected to give rise to perturbations outside the physiological range (, 999a). Excluding the two major contributors, the estimated total combined intake (in Europe) for the candidate (Table 6) and supporting substances (Table B.) belonging to structural class I would be 0 lg/capita per day, which does not exceed the of concern for the corresponding structural class (,800 lg person per day); the estimated total combined intake (in Europe) for the candidate (Table 6) and supporting substances (Table B.) belonging to structural class II would be,0 lg/capita per day, which is.6 fold higher than the of concern for the corresponding structural class (0 lg/person per day). Five of the supporting substances from structural class II, oct--en--ol, heptan--one, undecan--one, nonan-- one and tridecan--one [FL-nos: 0.0, 07.00, 07.06, and 07.], contribute with,00 lg/capita per day to the combined DI of,0 lg/capita per day (Table B.). A 90-day study for 9 EFSA Journal 07;():7

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