经过评估,专家小组得出结论,在建议的使用条件下,牛乳骨桥蛋白作为新型食品是安全的。部分原文报道如下:
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on bovine milk osteopo
ntin (bmOPN) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF co
ncerns OPN derived from bovine whey. The NF is intended to be used at a maximum use level of 151 mg/L, in infant formula (IF), follow-on formula (FoF) and ready-to-eat dairy-ba
sed meals for children up to 35 mo
nths of age. As compared to the co
ncentrations naturally present in cows milk and co
ncentrations found in IF on the market reported in the literature, the proposed use level of the NF represents an a
bout 10-fold higher co
ncentration of bmOPN. The intended use levels of the NF would provide bmOPN at a co
ncentration within the range of human milk (hm) OPN. In a 6-mo
nth study, 14, 72 and 140 mg bmOPN/L in reco
nstituted (as consumed) IF were given to 279 infants in order to study possible effects on frequency and severity of adverse events, and growth, formula intake and stool consistency. Despite that a number of inco
nsistencies and limitations were noted in the study report, the Panel co
nsiders that the results obtained from this study do not raise safety concerns. Co
nsidering the source of the NF, that neither the toxicological studies nor the provided infant study do raise safety concerns, and the low bmOPN plasma levels in infants resulting from the co
nsumption of the NF, the Panel co
nsiders that the margin of exposure (i.e. 36) between the NOAEL of the subchro
nic toxicity study (1,200 mg/kg bw per day) and the highest P95 estimate for infants (33.4 mg/kg bw per day) is sufficient. The Panel co
ncludes that the NF is safe under the proposed co
nditions of use.
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