PMID 32625282 Re-evaluation of oxidised starch (E 1404), monostarch phosphate (E 1410), distarch phosphate (E 1412), phosphated distarch phosphate (E 1413), acetylated distarch phosphate (E 1414), acetylated starch (E 1420), acetylated distarch adipate (E 1422), hydroxypropyl starch (E 1440), hydroxypropyl distarch phosphate (E 1442), starch sodium octenyl succinate (E 1450), acetylated oxidised starch (E 1451) and starch aluminium octenyl succinate (E 1452) as food additives 기관 재평가 의견서 · EFSA Journal, 2017 12종 일괄 재평가. 쥐 31,000 mg/kg까지 무영향, 사람 1회 25,000 mg 내약. 수치 ADI 불필요.
핵심요약
유럽집행위원회 요청으로 유럽식품안전청 식품첨가물패널이 변성전분 12종을 재평가한 의견서입니다. 사람에서 그대로 흡수되지 않고 장 효소에 상당히 가수분해된 뒤 장내 미생물이 발효시킵니다. 교차참조 방식으로 단기·장기 독성, 발암성, 생식독성 자료가 충분하다고 봤고 컴퓨터 예측 분석에서 유전독성 우려가 없었습니다. 쥐에게 하루 31,000 mg/kg까지 먹인 시험에서 사람 위해성 평가에 의미 있는 처리 관련 영향이 없었고, 사람에서는 1회 25,000 mg까지 잘 견뎠습니다. 결론은 보고된 사용 수준에서 일반 인구에 안전 우려 없음, 수치 허용량 불필요입니다.
원문 초록 보기
Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient sources added to Food (ANS) was asked to deliver a scientific opinion on the re-evaluation of 12 modified starches (E 1404, E 1410, E 1412, E 1413, E 1414, E 1420, E 1422, E 1440, E 1442, E 1450, E 1451 and E 1452) authorised as food additives in the EU in accordance with Regulation (EC) No 1333/2008 and previously evaluated by JECFA and the SCF. Both committees allocated an acceptable daily intake (ADI) 'not specified'. In humans, modified starches are not absorbed intact but significantly hydrolysed by intestinal enzymes and then fermented by the intestinal microbiota. Using the read-across approach, the Panel considered that adequate data on short- and long-term toxicity and carcinogenicity, and reproductive toxicity are available. Based on in silico analyses, modified starches are considered not to be of genotoxic concern. No treatment-related effects relevant for human risk assessment were observed in rats fed very high levels of modified starches (up to 31,000 mg/kg body weight (bw) per day). Modified starches (e.g. E 1450) were well tolerated in humans up to a single dose of 25,000 mg/person. Following the conceptual framework for the risk assessment of certain food additives, the Panel concluded that there is no safety concern for the use of modified starches as food additives at the reported uses and use levels for the general population and that there is no need for a numerical ADI. The combined exposure to E 1404-E 1451 at the 95th percentile of the refined (brand-loyal) exposure assessment scenario for the general population was up to 3,053 mg/kg bw per day. Exposure to E 1452 for food supplement consumers only at the 95th percentile was up to 22.1 mg/kg bw per day. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.