经过评估,专家小组得出结论,在拟议的使用条件下,预期推广使用植物固醇酯的的安全性尚未确定。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 the safety of an extension of use of the novel food 'plant sterol esters' when added to vegetable fat spreads and to liquid vegetable fat‐ba
sed emulsions for cooking and baking purposes pursuant to Regulation (EU 2015/2283. Member States expressed co
ncerns in relation to plant sterol oxidation products (POP and co
nsumption by non‐target population groups. The median ?.5% and P90 ?.28% value of the oxidation rates of plant sterols determined by a wide range of cooking experiments were used together with exposure estimates for plant sterol when added and cooked with vegetable fat spreads and liquids. The no‐observed adverse effect level (NOAEL of a subchro
nic rat study and an applied default uncertainty factor of 200 served to derive levels (i.e. 0.64 mg POP /kg body weight (bw per day co
nsidered safe for humans. This safe level of exposure would be exceeded at the P95 by all age groups when co
nsidering the P90 oxidation rate and using EFSA 's comprehensive food co
nsumption databa
se for assessing the potential exposure. When co
nsidering the median oxidation rate, the safe level of 0.64 mg POP /kg bw per day would be exceeded at the highest P95 intake estimates in children below 9 years of age. When co
nsidering an intake of the maximum authorised use level of 3 g plant sterols/person per day and oxidation rates of 0.5% and 2.28%, the resulting daily POP intakes per kg bw by an adult weighing 70 kg would be 0.21 and 0.98 mg/kg bw per day, respectively, the latter value exceeding 0.64 mg/kg bw per day. The Panel co
ncludes that the safety of the intended extension of use of plant sterol esters under the proposed co
nditions of use has not been established.
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