Reliability of Physical Properties Test Methods for Approving “Thickeners” as Foods for Special Dietary Uses: An Inter-Laboratory Validation Study

  • KUMAI Yasuhito
    National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition
  • SUZUKI Ippei
    National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition
  • TOUSEN Yuko
    National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition
  • KONDO Takashi
    National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition
  • KAYASHITA Jun
    Health Sciences Studies, Department of Intercultural Studies, Prefectural University of Hiroshima
  • CHIBA Tsuyoshi
    National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition
  • FURUSHO Tadasu
    Department of International Food and Agricultural Science, Tokyo University of Agriculture
  • TAKEBAYASHI Jun
    National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition

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Other Title
  • 特別用途食品「とろみ調整用食品」の表示許可に関する物性試験方法の信頼性─室間共同試験による妥当性確認
  • 特別用途食品「とろみ調整用食品」の表示許可に関する物性試験方法の信頼性 : 室間共同試験による妥当性確認
  • トクベツ ヨウト ショクヒン 「 トロミ チョウセイヨウ ショクヒン 」 ノ ヒョウジ キョカ ニ カンスル ブッセイ シケン ホウホウ ノ シンライセイ : シツカン キョウドウ シケン ニ ヨル ダトウセイ カクニン

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Abstract

<p> Objective: “Thickeners” as Foods for Special Dietary Uses are foods that have been approved by the government as thickeners suitable for people with dysphagia. In an approval examination, third-party organizations test whether the physical properties of a product meet standard criteria for approval. To ensure the fairness of the approval examination, the test results between laboratories should be highly reproducible. Thus, in this study, we investigated the reliability of the test method in an inter-laboratory study and discussed its fitness for purpose.</p><p> Methods: Three commercial xanthan gum-based thickeners were employed as samples. From December 2018 to February 2019, we conducted an inter-laboratory study involving ten laboratories. Each laboratory tested the physical characteristics of each sample according to the notification issued in March 2017. The results were evaluated to confirm the degree of agreement between the laboratories regarding analytical values and determinations.</p><p> Results: Regarding the performance requirements (solubility/dispersibility), serious discrepancies in the determinations between the laboratories were found. Regarding the performance requirements (temperature stability), although the determinations between laboratories were almost the same, analytical values were dispersed to some extent compared to the acceptance range, suggesting poor reproducibility. On the other hand, the test methods regarding viscosity requirements and performance requirements (temporal stability and resistance to saliva) seemed acceptable.</p><p> Discussion: In terms of the test methods issued in March 2017, the results for the performance requirements (solubility/dispersibility) were poorly reproducible, and thus the test conditions and determination criteria need to be realistically relaxed. Regarding the performance requirements (temperature stability), in order to improve the reproducibility, the addition concentration should be increased. Furthermore, to ensure the validity of the overall test methods, it would be helpful to add a stirring step immediately before the viscosity measurement and to set the addition concentration in the performance requirements to the design values indicated by the manufacturers.</p>

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