Brussels, 16 January 2017 To: WHOM IT MAY CONCERN Subject: GSO 05 FDS 707/2016 ‘Flavorings Permitted for Use in Foodstuffs’ The International Organization of the Flavor Industry (IOFI) represents the global flavor industry and assists the industry in regulatory and scientific matters. IOFI has its head office in Geneva, Switzerland and operational offices in Brussels, Belgium and Washington DC, USA. Members of IOFI are national and regional associations of the flavor industry, as well as international companies active in the development, production and trade of flavorings. More on the IOFI membership can be found at www.iofi.org containing the list of IOFI member associations and companies. In response to the WTO Notifications G/SPS/N/ARE/86, G/SPS/N/BHR/163, G/SPS/N/KWT/12, G/SPS/N/OMN/63, G/SPS/QAT/67, G/SPS/N/SAU/218 and G/SPS/N/YEM/8, IOFI wishes to provide the following comments and suggestions regarding the following sections of the GSO 05 FDS 707/2016 ‘Flavorings Permitted for Use in Foodstuffs’: Definitions (Section 3): - Overall IOFI is very supportive of the alignment with the GSO 2365/2014 ‘Guidelines for the Use of Flavorings in Food’ definitions, except for the addition of a definition for “Flavor enhancers” (3.3). “Flavor enhancers” are Food Additives as defined by the Codex Alimentarius ‘Class Names and the International Numbering System for Food Additives’ (CAC/GL 36-1989) and therefore “Flavor enhancers” should not be covered by the ‘Flavorings Permitted for Use in Foodstuffs’ standard. Moreover, as nowhere in the GSO 05 FDS 707/2016 there is any reference to flavor enhancer use, IOFI recommends to remove the definition for Flavor enhancers from GSO 05 FDS 707/2016. - The definition for “Flavors prepared with thermal treatment” (3.2.4) seems to be incomplete. IOFI suggests inserting ‘with correspondingly longer times at lower temperatures, i.e. a doubling of the heating time for each decrease of temperature by 10°C’ as follows: Flavors prepared with thermal treatment: Are products obtained according to GMP by heating [a mixture of components] to a temperature not exceeding 180°C for a period not exceeding 15 minutes with correspondingly longer times at lower temperatures, i.e. a doubling of the heating time for each decrease of temperature by 10°C. Labelling (Section 8): IOFI noticed that this section refers to both labelling of prepackaged food containing flavorings (8.1 and 8.2) and the labelling of the flavorings sold as such (8.3 and 8.4). Therefore, IOFI suggests to enter a reference to GSO 2365/2014 ‘Guidelines for the Use of Flavorings in Foods’ between 8.2 and 8.3 as follows- phrase in italics to be entered: 8.2 Kind of the flavor according to what is mentioned in Item 3 Without prejudice to the labelling requirements provided in GSO 2365/2014 referenced in 2.3 the following information shall be declared on the label in Arabic of flavorings ‘sold as such’ 8.3 Phrase “for food use” shall be written in case of industrial use, and mention used product name. 8.4 Code number (if found). Permitted flavorings (Table (3)): All permitted flavorings appear to be listed in the Codex Alimentarius Commission (CAC/MISC 62016) List of Codex Specifications for Food Additives and/or the European Union (EU) Commission Implementing Regulation 872/2012 adopting a list of flavoring substances. However, the list presented in Table (3) does NOT contain the following JECFA flavoring substances listed in CAC/MISC 6-2016: i.e. JECFA 2189, 2190 and 2192, JECFA 2194 through 2207, JECFA 2209 and 2210. These JECFA flavoring substances need to be added to Table (3) to be fully in line with CAC/MISC 6. Moreover, the IOFI Secretariat anticipates the update of CAC/MISC 6 resulting from the likely decision at the next Codex Committee on Food Additives meeting (CCFA 49th), which will be held in Macao, China, 20-24 March 2017, to include flavorings evaluated at the 82nd Joint FAO/WHO Expert Committee on Food Additives (JECFA) meeting (Geneva, 6-17 June 2016). At the 79th meeting JECFA finalized evaluations of the following flavoring substances: JECFA 2211, JECFA 2213 through 2221, JECFA 2223 through 2228, JECFA 2230 through 2233. These substances will very likely be included in the next update of the CAC/MISC 6 after their endorsement by the Codex Alimentarius Commission in July 2017. The enclosure to this letter provides the detailed list of JECFA substances suggested to be included in Table (3). The EU Commission list of flavoring substances permitted in the EU is also a dynamic list undergoing regular updates. Table (3) has correctly addressed recent changes to the EU list, except for the deletion of the flavoring substance 3-acetyl-2,5-dimethylthiophene (Commission Regulation (EU) No 545/2013). Because JECFA also concluded that 3-acetylthiophene-2,5dimethylthiophene (JECFA 1051) should not be used as a flavoring agent (79th JECFA meeting) the substance was subsequently removed from the CAC/MISC 6 as well. Likewise, it has to be removed from Table (3). Addressing regular modifications of the EU and the Codex CAC/MISC 6 lists point to the need for establishing a robust mechanism for regular update of the GSO 707 to account for deletions and/or the introduction of new flavoring substances in Table (3). Therefore, IOFI recommends the inclusion of appropriate text in Table (3) GSO 707/2016 with the objective of inviting users of the standard to report about errors or omissions in the Table (3) to the attention of the GSO secretariat. E.g. ‘Users of this Standard are invited to inform the GSO responsible secretariat about errors or omissions in Table (3) flavorings permitted for in foodstuffs. Please provide suggested corrections with supporting evidence to [contact details]’ to be inserted at the top or the bottom of Table (3). ALTERNATIVELY, IOFI suggests that in lieu of published updates of the permitted list (Table (3)) to include new flavoring substances the final GSO 707/1216 also contains a specific approval for use of those substances that have undergone conclusive safety evaluation by the following authoritative bodies regarding safety of flavoring substances, i.e.: 2 Flavoring substances evaluated by the Joint FAO/WHO Experts Committee on Food Additives (JECFA) as “posing no safety concerns at current levels of intake” (Link1) and listed in the List of Codex Specifications for Food Additives (CAC/MISC 6-2015) or published in the JECFA Database of Flavoring Specifications (http://www.fao.org/food/food-safety-quality/scientificadvice/jecfa/jecfa-flav/en/) Materials that have “no safety concern at estimated levels of intake as flavoring substances” following evaluation by the European Food Safety Authority (EFSA) (Link). Materials that are deemed to be Generally Recognized As Safe (GRAS) under conditions of intended use as flavoring substances or approved flavoring substances by the US Food and Drug Administration (FDA), including GRAS determinations published by the Expert Panel of the Flavor and Extract Manufacturer’s Association of the United States (FEMA) (Link). The FEMA GRAS program is actually the (single) source of flavoring substances that are selected for evaluation by JECFA. IOFI wishes to point out that many countries in the world, including Australia/New Zealand, Egypt, South Korea, the Philippines, Mexico and many Latin American countries have adopted such an ‘approval by reference’ approach for the permitted use of flavoring substances in their food regulations. In order to support the ‘approval by reference’ approach, IOFI developed the so-called IOFI Global Reference List (GRL) that is a publicly available (www.iofi.org) and open-ended ‘positive’ list of flavoring substances used in the global trade, based on the safety evaluation outcomes from JECFA, EFSA and FEMA. The IOFI GRL is actively maintained by the IOFI Secretariat and it serves as the reference list for the global flavor industry. We thank you for your kind consideration of the IOFI comments and suggestions. The IOFI Secretariat staff remains available for further information and discussion. Sincerely yours, IOFI Secretariat International Organization of the Flavor Industry (IOFI) Avenue des Arts, 6 1210 Brussels, Belgium [email protected] Tel: +32 2 214 20 50 Enclosure: Substances to be added to GSO FDS 707/2016 3 List of Substances in MISC 06 missing in GSO FDS 707/2016 Name CAS Sodium 3-Methyl-2-oxobutanoate Sodium 4-Methyl-2oxopentanoate Sodium 3-Methyl-2oxopentanoate FL No. Adoption in MISC 06 631.1 08.051 2008 633.1 08.052 2008 632.1 08.093 2008 JECFA FEMA 2-Ethoxy-3-isopropylpyrazine 72797-16-1 2129 4632 2013 Cassyrane 1-Cyclopropane¬methyl-4methoxybenzene 871465-49-5 2189 4731 - 2015 16510-27-3 2190 4759 - 2015 2,4-Nonadiene 56700-78-8 2192 4292 - 2015 4-Methyl-cis-2-pentene 691-38-3 2194 4650 - 2015 1-Nonene 124-11-8 2195 4651 - 2015 1,3,5,7-Undecatetraene Mixture of methyl cyclohexadiene and methylene cyclohexene 116963-97-4 2196 4652 - 2015 30640-46-1 2197 4311 - 2015 2,2,6,7Tetramethyl¬bicyclo[4.3.0]nona4,9(1)-dien- 8-ol 97866-86-9 2198 4521 - 2015 dl-Camphor 76-22-2 2199 4513 - 2015 l-Fenchone 7787-20-4 2200 4519 - 2015 2,2,6,7Tetramethyl¬bicyclo[4.3.0]nona4,9(1)-dien- 8-one Ethyl 3-(2-hydroxyphenyl) propanoate 97844-16-1 2201 4522 - 2015 20921-04-4 2202 4758 - 2015 3-[3-(2-Isopropyl-5methylcyclohexyl)-ureido]-butyric acid ethyl ester 1160112-208 2203 4766 - 2015 4-Amino-5-(3-(isopropylamino)2,2-dimethyl-3- oxopropoxy)-2methylquinoline-3-carboxylic acid 1359963-680 2204 4774 - 2015 Triethylthialdine 54717-17-8 2205 4748 15.054 2015 2-Isopropyl-4-methyl-3-thiazoline 67936-13-4 2206 4767 - 2015 Myricitrin 17912-87-7 2207 4491 - 2015 1-(2,4-Dihydroxyphenyl)-3-(3hydroxy-4- methoxyphenyl) propan-1-one 50297-39-7 2209 4764 - 2015 (−)-Matairesinol 580-72-3 2210 4762 - 2015 - 2015 2014; 2015 4-Amino-5-(3-(isopropylamino)2,2-dimethyl-3- oxopropoxy)-2methylquinoline-3-carboxylic acid hemisulfate monohydrate salt Nerolidol oxide 2204 1424-83-5 2137 4536 - 4 List of Substances evaluated by JECFA in 2016 (82nd meeting) Name Ethyl alpha-acetylcinnamate CAS 620-80-4 JECFA 2211 FEMA 4597 Ethyl 2-hydroxy-3-phenylpropionate 15399-05-0 2213 4598 Cinnamaldehyde propyleneglycol acetal 2-Phenylpropanal propyleneglycol acetal 9-Decen-2-one 895950 2214 4596 67634-23-5 2215 4595 35194-30-0 2216 4706 Yuzunone 1009814-14-5 2217 4691 1,5-Octadien-3-ol 83861-74-9 2218 4732 3,5-Undecadien-2-one 68973-20-6 2219 4746 3-Methyl-5-(2,2,3-trimethylcyclopent3-en-1-yl)pent-4-en-2-ol (±)-Cyclohexylethanol 67801-20-1 2220 4775 1193-81-3 2221 4794 beta-Angelicalactone 591-11-7 2222 4438 2-(2-Hydroxy-4-methyl-3cyclohexenyl)propionic acid gammalactone 2-(2-Hydroxyphenyl) cyclopropanecarboxylic acid deltalactone N1-(2,3-Dimethoxybenzyl)-N2-(2(pyridin-2-yl)ethyl) oxalamide (R)-N-(1-Methoxy-4-methylpentan-2yl)-3,4-dimethylbenzamide (E)-N-[2-(1,3-benzodioxol-5-yl)ethyl]3-(3,4- dimethoxyphenyl)prop-2enamide (E)-3-Benzo[1,3]dioxol-5-yl-N,Ndiphenyl-2-propenamide 2,5-Dimethyl-3(2H)-furanone 57743-63-2 2223 4140 5617-64-1 2224 4270 FL No. evaluated by JECFA 2016 2016 2016 2016 07.262 2016 2016 02.194 2016 2016 2016 2016 08.006 2016 10.057 2016 2016 851670-40-1 2225 4741 851669-60-8 2226 4751 2016 2016 125187-30-6 2227 4773 1309389-73-8 2228 4788 1440-67-0 2230 4101 2,5-Dimethyl-4-ethoxy-3(2H)furanone 5-Methyl-3(2H)-furanone 65330-49-6 2231 4104 3511-32-8 2232 4176 Ethyl 2,5-dimethyl-3-oxo-4(2H)-furyl carbonate 39156-54-2 2233 4546 2016 2016 13.119 2016 13.117 2016 2016 2016 5
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