The EFSA Journal (2007) 484, 1-7

Transcription

1 The EFSA Journal (2007) 484, 1-7 Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to a notification from CEPS on cereals used in distillates for spirits, pursuant to Article 6 paragraph 11 of Directive 2000/13/EC SUMMARY (Request Nº EFSA-Q ) (adopted on 3 May 2007) In addition to the information submitted to obtain temporary exemption, the applicant provided further information regarding distillates made from cereals which include whisky, Kornbrand, gin, vodka and made wine produced using vodka, liqueur and similar beverages. The beverages in question are widely consumed in the European Union. A literature review that includes information up to April 2006 failed to reveal allergic reactions after consumption of distillates made from cereals, although underreporting cannot be excluded. Further evidence of the unlikelihood of distillates made from cereals to elicit allergic reactions stems from additional analytical data on potential residual proteins and their allergenicity in the distillates and the distillation process. The analytical methodology did not address the allergenic activity of residual protein levels in the final product using appropriate human sera. Neither epidemiological studies nor double-blind placebo-controlled food challenge studies in clinical settings have been carried out to address possible adverse allergic reactions to distilled spirit drinks due to cereal allergens. Based on the data submitted by the applicant, the Panel notes that proteins and peptides are not carried over into the distillate during a properly controlled distillation process, at least not in amounts higher than 1 mg/l for total proteins and 0.4 mg/kg for gluten. The Panel considers that distillates made from cereals are unlikely to trigger a severe allergic reaction in susceptible individuals. KEY WORDS Allergenicity, distillates, cereals, protein content, gluten, celiac disease, wheat allergy. Page 1 of 7

2 BACKGROUND In November 2003, the European Parliament and the Council adopted Directive 2003/89/EC 1 amending Directive 2000/13/EC, as regards indication of the ingredients present in foodstuffs. Annex IIIa of the Directive specifies a list of food ingredients or substances that are known to trigger allergic reactions or intolerances in sensitive individuals for which no labelling exemptions are allowed. Whenever the listed ingredients/substances or their derivatives are used in the production of foodstuffs, they must be labelled. Article 1, paragraph 11, subparagraph 2 of the Directive establishes a procedure allowing for temporary labelling exemption of derivatives from ingredients listed in Annex IIIa for which it has been scientifically established that it is not possible for them to cause adverse reactions. In accordance with this provision, submissions of requests for temporary labelling exemption were notified to the Commission before 25 August The Commission, after consultation with the European Food Safety Authority, adopted a list (Directive 2005/26/EC 2 ) of those ingredients which are temporarily excluded from Annex IIIa until 25 November 2007, pending the final results of the notified studies. Consequently, applicants who submitted a dossier in 2004 on the basis of subparagraph 2, resulting in the inclusion of a product in the list of Directive 2005/26/EC, and who are seeking exclusion of that product from Annex IIIa beyond 25 November 2007 will have to submit a request enclosing the final results of the notified scientific studies. Therefore in the context of the permanent labelling exemption procedure, the European Food Safety Authority is asked to provide scientific opinions on the submissions in accordance with the present terms of reference. TERMS OF REFERENCE In accordance with Article 29 (1) (a) of Regulation (EC) N 178/2002, the European Commission requests the European Food Safety Authority to evaluate the scientific data submitted by European Spirits Organisation (CEPS) in the framework of the procedure laid down in Article 6, paragraph 11 of Directive 2000/13/EC. On the basis of that evaluation, EFSA is requested to issue an opinion on the information provided, and particularly to consider the likelihood of adverse reactions triggered in susceptible individuals by the consumption of the following ingredients/substances used under the conditions specified by the applicant: cereals used in distillates for spirits ASSESSMENT Taking account of the potential allergen content and well documented clinical allergic reaction in individuals sensitive to the stated material (cereals) (NDA, 2004a), it is appropriate for the 1 Directive 2003/89/EC of the European Parliament and of the Council amending Directive 2000/13/EC as regards indication of the ingredients present in foodstuffs. OJ L , p Commission Directive 2005/26/EC of 21 March 2005 establishing a list of food ingredients or substances provisionally excluded from Annex IIIa of Directive 2000/13/EC of the European Parliament and of the Council. OJ L 75, , p Page 2 of 7

3 Panel to assess the likelihood that the finished product may cause a reaction in a cereal allergic consumer. In 2004, the Panel issued an Opinion on a notification submitted by European Spirits Organisation (CEPS) to the European Commission pursuant to Article 6, paragraph 11 of Directive 2000/13/EC as amended by Directive 2003/89/EC, for temporary exemption from labelling (NDA, 2004b). Under the framework of permanent exemption from labelling, the present Opinion is based on the assessment of an updated dossier from CEPS, which contains additional information and data mainly with regard to literature review and laboratory-based, in vitro tests. 1. Manufacturing process Distillates made from gluten-containing cereals (e.g. wheat, rye, barley, oats) include whisky, Kornbrand, gin, vodka, made wine produced from vodka, liqueur, and similar beverages. The processes involved in production of cereal-based distillates comprise cereal processing (i.e. extraction of starch from cereals and conversion to fermentable sugars), fermentation (conversion of sugars to alcohol by action of yeast), distillation (concentration of alcohol, removal of non-volatiles, control of flavour) and post-distillation processes (flavouring, maturation, etc.). Distillation can be achieved in two ways, by simple (or batch) distillation or by continuous (fractional) distillation. In principle, both systems should prevent transfer of nonvolatile material from the feedstock into the final product. In batch distillation for malt whisky production, considerable amounts of non volatile and high boiling point compounds are transferred from the wash to the low wines. This mass transfer phenomenon is not explained by the vapour-liquid equilibrium distillation theory, but it is rather related to the generation of the mist formed by a burst of the foam surface in the wash still (Ohtake et al., 1995). However, the modern distillation apparatus are multi-stage systems involving one or more rectifying columns or continuous counter current vapour liquid contacting systems which should make it unlikely that significant levels of high molecular weight, high boiling point compounds such as allergenic proteins and peptides will be carried over into the distillate. The applicant has provided a model study performed in the laboratory with a standard distillation apparatus showing that bovine serum albumin (BSA) does not distil. Although the results are those expected, they cannot be taken as the definitive proof, since the conditions of the experiment are different from those applied in the industrial production process (number of theoretical plates, dimensions of the columns, steam flow). In addition, the distillation of pure protein solutions in the laboratory, without the presence of additional components typically found in industrial distillation matrices, can result in different foaming, boiling homogeneity, steam carry over, and do not represent the same industrial conditions. However, no studies presented in the open literature provided evidence that proteins do have a vapour pressure and there is general agreement in the scientific community that they do not distil (Ohtake et al., 1995, Oldani et al., 2001). 2. Evidence of non-allergenicity 2.1 History of non-allergenicity of the product Page 3 of 7

4 The applicant has performed a literature review using the PubMed database of the US National Library of Medicine, which includes information up to April 2006, and failed to identify any reports linking celiac symptoms or wheat allergy with the consumption of distilled beverages. The PubMed database included over 14 million citations for biomedical articles from MEDLINE and additional life science journals dating back to the 1950s. Titles and abstracts were searched for COELIAC or CELIAC and WHEAT ALLERGY, which identified a large number of literature reports (11,301 and 236 respectively). Linking of these search terms with specific alcoholic beverages (WHISKY or WHISKEY, GIN, VODKA) and with DISTILLED SPIRITS yielded no published reports. Use of the more general term ALCOHOL with COELIAC or CELIAC identified a number of literature reports, but of those referring to celiac disease, none reported distilled beverage alcohol causing celiac symptoms but referred to the alcohol solubility of gliadins. Combination of ALCOHOL with WHEAT ALLERGY gave no reported literature. Combination of ALLERG* and DISTILLED SPIRITS identified one reference which was a review of allergic and asthmatic reactions to alcoholic drinks (Vally and Thompson, 2003). From this review most sensitivities to alcoholic drinks do not appear to be immune mediated, but are more frequently pharmacological intolerances to specific chemicals in these drinks. Where allergic and asthmatic reactions to specific non-alcohol components have been reported, these are almost wholly concerned with non-distilled drinks. Only one reported investigation of spirit consumption triggering asthmatic attacks could be found, however the substance causing the reaction was not identified (Breslin et al., 1973). Patients reacted to specific drinks but not to the equivalent amount of ethanol. Skin prick tests for routine common allergens gave no reaction to wheat. The applicant s literature search did not reveal allergic reactions after consumption of distillates made from cereals. It remains possible that adverse effects due to drinking of distillates made from cereals may not be perceived as due to wheat allergens or gluten but rather be attributed to alcohol, and under-reporting may thus have occurred. 2.2 Laboratory-based tests In vitro studies The applicant asserts that the physico-chemical properties of the allergenic materials of cereals will result in their complete lack of volatility, and hence their absence from products obtained by distillation. The applicant supports this assertion with information from several specific reports of small scale or ad hoc analyses indicating there is a very low level of cereal-derived protein in spirits derived from cereals: Campbell (1988) described a crude gravimetric approach to the detection of potential allergens in two alcohol distillates which concluded that the levels of protein would be minimal (less than 0.05 mg/l). Oldani et al. (2001) reported an enzyme-linked immunosorbent assay (ELISA) based study of several common cereal-derived spirits which concluded that the level of gluten was less than mg/l. Page 4 of 7

5 An ELISA-based study of samples from several points in the distillation production process for grain neutral spirits, and 3 crude alcohol samples, which concluded that the levels of cereal proteins were less than mg/kg. The analytical studies described report the examination of 39 bottled products and 76 samples of distillates produced using cereal as a raw material prior to distillation. The samples comprised ethyl alcohol of agricultural origin, whisk(e)y, Kornbrand, gin/gin concentrate, vodka, made wine produced using vodka and liqueur samples. Of these, 86 samples were analysed for total protein content and 45 samples were analysed for gluten. Two analytical methodologies were employed to determine the presence of proteins in the spirit samples: the Bradford Analysis Microassay, with a limit of detection (LOD) of 0.5 mg/l for BSA, which accounted for a LOD of 1mg/L for wheat proteins, and the AAA-Direct Analysis with a LOD of 0.05 mg/l for amino acids and 0.5 mg/l for proteins. Samples for which a positive response was detected using the Bradford Microassay were tested with the AAA- Direct Analysis. 15 positive responses with the Bradford Microassay method for Malt New Make Spirits/Bourbon distillates were confirmed by the AAA-Direct Analysis at a protein level of mg/l. Only in one sample the protein content was higher than 1 mg/l (1.3 mg/l), but it was not confirmed in a repeated experiment. These two methods are appropriate for their intended purpose. No gluten was detected in any of the 115 samples analysed by ELISA with a LOD of 10 mg/kg. With a pre-concentration step, the LOD can reach 1 mg/kg, and 0.4 mg/kg when the concentration factor is taken into account. The calibration and recovery factor experiments were satisfactory. The analytical data presented indicate that cereal proteins are not transported into the products of distillation during spirit manufacture at a level above 1 mg/kg. The analytical methodology did not address the allergenic activity of residual protein levels in the final product using appropriate human sera Animal studies No animal studies were provided or referred to in the data submitted. 2.3 Clinical studies Skin tests No systematic skin prick testing studies in cereal allergic individuals exposed to distillates have been reported. Only one case report of spirit consumption triggering asthmatic attacks could be found, however the substance causing the reaction was not identified (Breslin et al., 1973). Skin prick tests for routine common allergens gave no reaction to wheat. Hence, this case report does not indicate gluten or cereal allergen involvement in the responses noted Double-blind placebo-controlled food challenge (DBPCFC) No DBPCFC studies in sensitive individuals have been performed. Page 5 of 7

6 Figueredo et al. (1999) report a case of a Type 1 allergy to barley malt and corn triggered by beer consumption, but the patient showed no reaction to oral provocation tests with a distilled spirit (10 ml-50 ml). This indicates that responses due to drinking beverages that contain cereals are possible, but in this case the distillate did not appear to cause such effects. Firm conclusions cannot be drawn, as the data pertain to one case report only Epidemiological studies The applicant has not carried out epidemiological studies in order to investigate possible adverse reactions to distilled spirit drinks due to cereal allergens or gluten. CONCLUSIONS Based on the data submitted by the applicant, the Panel notes that proteins and peptides are not carried over into the distillate during a properly controlled distillation process, at least not in amounts higher than 1 mg/l for total proteins and 0.4 mg/kg for gluten. The Panel considers that distillates made from cereals are unlikely to trigger a severe allergic reaction in susceptible individuals. DOCUMENTATION PROVIDED TO EFSA Dossier submitted by the European Spirits Organisation (CEPS) to the European Commission pursuant to Article 6, paragraph 11 of Directive 2000/13/EC on 25 August REFERENCES Breslin ABX, Hendrick DJ, Pepys J (1973). Effect of disodium cromoglycate on asthmatic reactions to alcoholic beverages. Clinical Allergy 3: Campbell JA (1988). The Question of Gluten in Distilled Alcohol. Journal of the Canadian Dietetic Association, 49:204. Figueredo E, Quirce S, Del Amo A, Cuesta J, Arrieta I, Lahoz C, Sastre J (1999). Beer-induced anaphylaxis: identification of allergens. Allergy 54: NDA (Scientific Panel on Dietetic Products, Nutrition and Allergies) (2004a). Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission relating to the evaluation of allergenic foods for labelling purposes. The EFSA Journal 32, NDA (Scientific Panel on Dietetic Products, Nutrition and Allergies) (2004b). Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies related to a notification from CEPS on distillates made from cereals pursuant to Article 6 paragraph 11 of Directive 2000/13/EC. The EFSA Journal 130, Page 6 of 7

7 Ohtake K, Yamasaki H, Kojima K (1995). Evaluation of mass-transfer by mist as a new parameter in the control of wash distillation. Proceedings of the Fourth Aviemore Conference on Malting, Brewing and Distilling. Ed. By Campbell I and Priest FG. Institute of Brewing, London, UK, pp Oldani A, Iametti S, Bonomi F, Scafuri L (2001). In alcoholic cereal derived beverages are there still gluten traces? Tecnica Molitoria 7: Vally H and Thompson PJ (2003). Invited Review: Allergic and asthmatic reactions to alcoholic drinks. Addiction Biology 8: PANEL MEMBERS Jean-Louis Bresson, Albert Flynn, Marina Heinonen, Karin Hulshof, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Andreu Palou, Hildegard Przyrembel, Seppo Salminen, John (Sean) J Strain, Stephan Strobel, Inge Tetens, Henk van den Berg, Hendrik van Loveren and Hans Verhagen. ACKNOWLEDGEMENT The Scientific Panel on Dietetic Products, Nutrition and Allergies wishes to thank Taraneh Dean, Martin Stern and Jean-Michel Wal for their contributions to the draft opinion. Page 7 of 7