The EFSA Journal (2004) 154, 1-5

Transcription

1 The EFSA Journal (2004) 154, 1-5 Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to a notification from BSI on nuts (almonds, walnuts) extracts used as flavours in distillates pursuant to Article 6 paragraph 11 of Directive 2000/13/EC (Request EFSA-Q ) (adopted on 2 December 2004) SUMMARY Nuts are a common cause of allergic reactions. Multiple nut sensitivities are frequent and often associated with peanut allergies, but cross-reacting allergens have not been identified. A few micrograms may cause reactions in sensitised individuals, but threshold doses derived from clinical studies of patients with oral allergy syndrome are very variable and do not allow the determination of a threshold dose for labelling purposes. Information is provided by the applicant to support the temporary labelling exemption of nuts (almonds, walnuts) extracts used as flavour in distillates. The scientific data submitted by the applicant are insufficient to predict the likelihood of adverse reactions in nut allergic individuals. In some cases, ethanolic (wine distillate) extracts of nuts and/or nut shells of walnuts and almonds are added during the production of brandies, after all distillation steps have been performed. There have been no reports of adverse reactions following consumption of such brandies; however, underreporting cannot be ruled out. No systematic studies using DBPCFC (double-blind placebo-controlled food challenge) testing in allergic patients were reported, nor were there proposals to perform such studies. In principle, it seems probable that nut proteins will be extracted from the nuts and nut shells by the ethanolic or aqueous extraction procedures described. The question is therefore how much protein is present, of what type and in what form. The analytical data presented do not convincingly demonstrate the absence of potentially significant levels of allergenic residues. Further information is therefore required. A rigorously designed and conducted programme of analytical and immunological study is needed, followed, if necessary, by clinical trials in nut allergic individuals for ultimate confirmation. KEY WORDS Allergenicity, brandy, almond, walnut, extract, wine distillate. Page 1 of 5

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 ingredients that are known to trigger allergic reactions or intolerances for which no labelling exemptions are allowed. Whenever the listed ingredients or their derivatives are used in the production of foodstuffs, they must be labelled. Article 1, paragraph 11 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 request for temporary labelling exemption were notified to the Commission before 25 August The Commission shall, not later than 25 November 2004, and after consultation with the European Food Safety Authority, adopt a list of those ingredients which shall be temporarily excluded from Annex IIIa, pending the final results of the notified studies, or at the latest until 25 November Therefore, 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 the Bundesverband der Deutschen Spirituosen-Industrie und Importeure e.v. (BSI) in the framework of the procedure laid down for temporary labelling exemptions 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, pending the final results of the studies undertaken, 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: Nuts (almonds, walnuts) extracts used as flavour in distillates. ASSESSMENT Nuts are a common cause of allergic reactions. Multiple nut sensitivities are frequent and often associated with peanut allergies, but cross-reacting allergens have not been identified. A few micrograms may cause reactions in sensitised individuals, but threshold doses derived from clinical studies of patients with oral allergy syndrome are very variable and do not allow the determination of a threshold dose for labelling purposes (NDA, 2004). 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 Page 2 of 5

3 1. Manufacturing process According to the applicant, ethanolic (wine distillate) and aqueous extracts of treated almond shells and of walnuts or walnut shells are added to brandies as flavourings. The extraction procedures vary considerably with respect to extraction time and treatment. Total levels of incorporation of the nut and nut shell extracts in the final product are from ca. 1 to 20%. The nut or nut shell extracts are filtered, but not distilled. Full details of the filtration process were not provided. 2. Characterisation of the product Extracts of almond shell and/or walnut or walnut shell are added to wine distillates during the production of some brandies. 3. Evidence of non-allergenicity 3.1 History of non-allergenicity of the product Sales of spirit drinks in the EU in 2002 totalled over 215 million cases (of 8.4 litres, i.e. 12 bottles of 70 cl per case). The scientific literature does not reveal allergenic reactions to brandies, made of wine distillates to which extracts of almond shell or walnuts/shell are added. It should, however, be mentioned that adverse effects due to drinking of spirit drinks may not readily be attributed to allergens present, but rather be attributed to alcohol, and underreporting may thus have occurred. The dossier does not provide quantitative information on consumption of such brandies, nor does it provide a quantitative estimate of almond or walnut allergic individuals consuming such brandies. 3.2 Laboratory-based tests In vitro studies Three types of analytical investigation were undertaken: a) Total protein measurements A sample of shredded almond shell and two shredded almond shell extracts were analysed for total protein content by Kjeldahl method. No protein was detected in any of the three samples (limit of detection (LOD) 0.08%, i.e. 800 mg/kg). No results for walnut shell or walnut extracts were given. The sensitivity of the total protein determination method was not sufficient to demonstrate that no significant levels of protein were present in the samples. Page 3 of 5

4 b) ELISA assay for almond and walnut proteins Three samples (one each of Chantré, Mariacron and Attaché brandies) and two samples of Springer nut extract were assayed for both almond protein (using Neogen Veratox kit) and walnut protein (FARRP ELISA). No almond or walnut proteins were detected in the samples. The reported lower LOD of the almond assay was 2.5 mg/kg, and of the walnut assay 1 mg/kg. A single sample of Asbach Uralt brandy was assayed for almond protein (Neogen Veratox kit). No almond protein was detected (< LOD of 2.5 mg/kg). The provenance and specificity of the ELISA tests employed, and their relevance and applicability to the detection of allergens in ethanolic extracts of nuts or nut shells was not explored, so the question remains as to whether any immunologically significant, ethanolsoluble allergens would be detected. Also the tests were not sufficiently sensitive to detect potentially significant levels of residual allergens in the brandies. Further improvement/refinement of the analytical methods is required to increase their sensitivity. Without more detailed description of the analytical methodology employed, the Panel is uncertain as to the reliability and sensitivity of the test systems used for detection. c) PCR (Polymerase Chain Reaction) assay for DNA Three samples of brandy ( Chantré, Mariacron and Attaché ) were analysed by PCR for traces of walnut and for almond DNA. No almond or walnut DNA was detected in the brandies. The relevance of these DNA determinations is questionable, as they do not directly indicate levels of potential allergens Animal studies No animal studies were presented or referred to in the submitted dossier. 3.3 Clinical studies No immunochemical characterisation was provided (e.g. IgE binding studies using sera from well characterised patients). No skin prick test studies were performed. No information on the ability of nut shell-derived proteins to trigger allergic response in sensitive individuals was provided. Immunochemical characterisation and IgE-binding studies should be obtained followed by appropriate clinical studies, if necessary, before a firm conclusion could be drawn on the likelihood of these products triggering adverse reaction in susceptible individuals. Page 4 of 5

5 CONCLUSIONS AND RECOMMENDATIONS The scientific data submitted by the applicant are insufficient to predict the likelihood of adverse reactions in nut allergic individuals. In some cases, ethanolic (wine distillate) extracts of nuts and/or nut shells of walnuts and almonds are added during the production of brandies, after all distillation steps have been performed. There have been no reports of adverse reactions following consumption of such brandies, however, underreporting cannot be ruled out. No systematic studies using DBPCFC testing in allergic patients were reported, nor were there proposals to perform such studies. In principle, it seems probable that nut proteins will be extracted from the nuts and nut shells by the ethanolic or aqueous extraction procedures described. The question is therefore how much protein is present, of what type and in what form. The analytical data presented do not convincingly demonstrate the absence of potentially significant levels of allergenic residues. Further information is therefore required. A rigorously designed and conducted programme of analytical and immunological study is needed, followed, if necessary, by clinical trials in nut allergic individuals for ultimate confirmation. DOCUMENTATION PROVIDED TO EFSA Data submitted by the Bundesverband der Deutschen Spirituosen-Industrie und Importeure e.v. (BSI) to the European Commission pursuant to Article 6 paragraph 11 of Directive 2000/13/EC, 23 August REFERENCES NDA (2004). 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 32,1-197http:// PANEL MEMBERS Wulf Becker, Francesco Branca, Daniel Brasseur, Jean-Louis Bresson, Albert Flynn, Alan A. Jackson, Pagona Lagiou, Martinus Løvik, Geltrude Mingrone, Bevan Moseley, Andreu Palou, Hildegard Przyrembel, Seppo Salminen, Stephan Strobel, Henk van den Berg, and Hendrik van Loveren. ACKNOWLEDGEMENT The Scientific Panel on Dietetic Products, Nutrition and Allergies wishes to thank John P. G. Wilkins, Elide Pastorello, Martin Stern, and Jean-Michel Wal for their contributions to the draft opinion. Page 5 of 5