Turck Dominique, Castenmiller Jacqueline, Hirsch Ernst Karen-Ildico, Kearney John, Knutsen Helle Katrine, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Pelaez Carmen, Pentieva Kristina, Siani Alfonso, Thies Frank, Tsabouri Sophia, Vinceti Marco, Marchelli Rosangela, van Loveren Henk, Martínez Silvia Valtueña, de Henauw Stefaan
EFSA J. 2020 May 15;18(5):e06118. doi: 10.2903/j.efsa.2020.6118. eCollection 2020 May.
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on barley starch to be used in the manufacturing of several foods as ingredient, of the food additive modified starch and of glucose syrups pursuant to Article 21(2) of Regulation (EU) No 1169/2011, as notified by Lyckeby Starch AB. The applicant provided information on the manufacturing process and data on the content of total protein, gluten and allergenic proteins in barley starch. The applicant also performed IgE-binding tests, which were considered inconclusive by the Panel. No human intervention studies with barley starch or food products thereof were provided by the applicant, except for a DBPCFC with barley starch hydrolysate in cereal allergic individuals. The Panel notes that glucose syrups based on barley have been already exempted from allergen labelling as per Annex II of Regulation (EU) No 1169/2011 and that the current application is for the exemption from labelling of all foods manufactured from barley starch. In all the scenarios considered for the anticipated intake, the calculated total protein intake from barley starch was above the MED/MOED for wheat (expressed in mg of wheat protein) in adults (10 mg) and children (2 mg). The Panel concludes that the data available are insufficient to conclude on the likelihood of adverse allergic reactions in cereal-allergic individuals upon consumption of barley starch under the conditions of use proposed by the applicant, and that the consumption of foodstuffs produced from barley starch as starting (raw) material or foodstuffs containing barley starch as an ingredient is unlikely to cause an adverse reaction in individuals with coeliac disease who are not allergic to cereals, provided that the value of gluten for 'gluten-free' foods (20 mg/kg) is not exceeded.
应欧盟委员会要求，欧洲食品安全局（EFSA）营养、新型食品及食品过敏原专家小组（NDA）被要求依据欧盟第1169/2011号法规第21(2)条，就Lyckeby Starch AB公司通报的、用于制造多种食品成分、食品添加剂改性淀粉和葡萄糖浆的大麦淀粉发表科学意见。申请人提供了制造工艺信息以及大麦淀粉中总蛋白、面筋蛋白和致敏蛋白含量的数据。申请人还进行了IgE结合试验，但专家小组认为该试验结果不具决定性。除了对谷物过敏个体进行的双盲安慰剂对照食物激发试验（DBPCFC）外，申请人未提供关于大麦淀粉或其食品产品的人体干预研究。专家小组注意到，根据欧盟第1169/2011号法规附件二，基于大麦的葡萄糖浆已免于过敏原标签标注，而当前申请是为了免除所有由大麦淀粉制造的食品的标签标注。在所有预期摄入量的设想情景中，计算得出的成年人（10毫克）和儿童（2毫克）从大麦淀粉中摄入的总蛋白量高于小麦的估计每日膳食摄入量/最低观察到有害作用剂量（以小麦蛋白毫克数表示）。专家小组得出结论，现有数据不足以确定在申请人提议的使用条件下，谷物过敏个体食用大麦淀粉后发生不良过敏反应的可能性，并且以大麦淀粉为起始（原料）材料生产的食品或含有大麦淀粉作为成分的食品，在不超过“无麸质”食品中麸质含量标准（20毫克/千克）的情况下，不太可能对非谷物过敏的乳糜泻患者个体引起不良反应。
