PMID 32625570 Re-evaluation of xanthan gum (E 415) as a food additive 기관 재평가 의견서 · EFSA Journal, 2017 수치 ADI 불필요·일반 인구 안전 우려 없음. 214 mg/kg 10일에서 일부 복부 불편감(이상반응 아님). 12주 미만 영아 미적용.
핵심요약
유럽식품안전청 식품첨가물패널의 잔탄검(E 415) 재평가 의견서입니다. 정밀 노출은 일반 인구 어린이 최대 64 mg/kg, 건강기능식품 섭취 어린이 고노출 38 mg/kg, 특수의료용도식품·특수조제식품을 먹는 영아 115 mg/kg으로 추정됐습니다. 그대로 흡수되지 않고 장내 미생물이 발효시킵니다. 만성·발암성 시험 최고 용량에서 이상반응 보고가 없었고 유전독성 우려도 없었습니다. 성인이 214 mg/kg까지 열흘 반복 섭취한 시험은 전반적으로 잘 견뎠으나 일부가 복부 불편감을 겪었고 이는 바람직하지 않지만 이상반응은 아닌 것으로 분류됐습니다. 결론은 수치 허용량 불필요, 일반 인구 안전 우려 없음이며 영유아 특수의료용도식품에서도 업계 보고 농도에서 우려가 없다고 봤습니다. 이 재평가는 생후 12주 미만 영아에는 적용되지 않습니다.
원문 초록 보기
The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of xanthan gum (E 415) as food additive. Following the conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010, the Panel considered that adequate exposure and toxicity data were available. Based on the reported use levels, a refined exposure of up to 64 mg/kg bw per day in children for the general population, 38 mg/kg bw per day for children consumers only of food supplements at the high level exposure and 115 mg/kg bw per day for infants consuming foods for special medical purposes and special formulae (FSMPs), were estimated. Xanthan gum (E 415) is unlikely to be absorbed intact and is expected to be fermented by intestinal microbiota. No adverse effects were reported at the highest doses tested in chronic and carcinogenicity studies and there is no concern with respect to the genotoxicity. Repeated oral intake by adults of xanthan gum up to 214 mg/kg bw per day for ten days was well tolerated, but some individuals experienced abdominal discomfort, an undesirable but not adverse effect. The Panel concluded that there is no need for a numerical ADI for xanthan gum (E 415), and that there is no safety concern for the general population at the refined exposure assessment of xanthan gum (E 415) as food additive. Considering the outcome of clinical studies and post-marketing surveillance, the Panel concluded that there is no safety concern from the use of xanthan gum (E 415) in FSMPs for infants and young children at concentrations reported by the food industry. The current re-evaluation of xanthan gum (E 415) as a food additive is not considered to be applicable for infants under the age of 12 weeks. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.