PMID 32625872 Re-evaluation of propane-1,2-diol (E 1520) as a food additive 기관 재평가 의견서 · EFSA Journal, 2018 ADI 25 mg/kg 유지. 실제 노출은 평균·P95 모두 어느 인구 집단에서도 ADI 미만.
핵심요약
유럽식품안전청 식품첨가물패널이 프로판-1,2-디올(E 1520)의 안전성을 재평가한 의견서입니다. 1996년 식품과학위원회가 설정한 허용량은 25 mg/kg이었습니다. 이 성분은 위장관에서 잘 흡수되고 장기·조직에 널리 분포하며 젖산과 피루브산으로 산화되는 것이 주 대사 경로입니다. 아만성 독성 시험에서 처리 관련 영향이 없었고 유전독성 우려도 없었습니다. 개 2년 시험의 최고 용량 5,000 mg/kg에서 적혈구 파괴 증가를 시사하는 혈액학적 변화가 있었으나, 쥐 2년 만성 시험에서는 2,500 mg/kg까지 이상반응이 없어 허용량 산출의 근거가 됐습니다. 생식·발생 독성에서도 이상반응이 없었습니다. 노출 평가 결과 정보가 있는 식품 분류에서는 과대추정 가능성이 크고, 정밀 시나리오의 평균과 P95 모두 어느 인구 집단에서도 허용량을 넘지 않았습니다.
원문 초록 보기
The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of propane-1,2-diol (E 1520) when used as a food additive. In 1996, the Scientific Committee on Food (SCF) established an acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day for propane-1,2-diol. Propane-1,2-diol is readily absorbed from the gastrointestinal and is expected to be widely distributed to organs and tissues. The major route of metabolism is oxidation to lactic acid and pyruvic acid. At high concentrations, free propane-1,2-diol is excreted in the urine. No treatment-related effects were observed in subchronic toxicity studies. The available data did not raise concern with respect to genotoxicity. Haematological changes suggestive of an increased red blood cell destruction with a compensatory increased rate of haematopoiesis were observed at the highest dose level (5,000 mg/kg bw per day) in a 2-year study in dogs. No adverse effects were reported in a 2-year chronic study in rats with propane-1,2-diol (up to 2,500 mg/kg bw per day). The SCF used this study to derive the ADI. No adverse effects were observed in the available reproductive and developmental toxicity studies. Propane-1,2-diol (E 1520) is authorised according to Annex III in some food additives, food flavourings, enzymes and nutrients and it is then carried over to the final food. Dietary exposure to E 1520 was assessed based on the use levels and analytical data. The Panel considered that for the food categories for which information was available, the exposure was likely to be overestimated. Considering the toxicity database, the Panel concluded that there was no reason to revise the current ADI of 25 mg/kg bw per day. The Panel also concluded that the mean and the high exposure levels (P95) of the brand-loyal refined exposure scenario did not exceed the ADI in any of the population groups from the use of propane-1,2-diol (E 1520) at the reported use levels and analytical results. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.