食品伙伴网讯2021??1日,据欧盟食品安全局(EFSA)消息,欧盟食品添加剂和调味剂(FAF)研究小组就交联丙烯酸聚合物-卡波姆(carbomer)作为新型食品添加剂的安全性发表科学意见
经过评估,专家小组认为,如果固体食品补充剂的建议最大使用水平降低到申请人报告的典型使用水平,接触卡波姆不会引起安全问题。部分原文报道如下:
The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of crossl
inked polyacrylic acid polymers (carbomer) proposed for use as food additive in solid and liquid food supplements. Carbomer is formed from the monomer, acrylic acid, which is polymerised and crossl
inked with allyl pentaerythritol (APE). The polymers are synthesised in ethyl acetate using ■■■■ as free-radical polymerisation initiator. In vivo data showed no evidence for systemic availability or biotransformation of carbomer. Carbomer does not raise a co
ncern regarding genotoxicity. Co
nsidering the available data set, the Panel derived an acceptable daily intake (ADI) of 190 mg/kg body weight (bw) per day ba
sed on a no observed adverse effect level (NOAEL) of 1,500 mg/kg bw per day from a sub-chro
nic 13-week study in rat, applying a compound specific uncertainty factor (UF) of 8. At the proposed maximum use levels, the exposure estimates ranged at the mean from 1.1 to 90.2 mg/kg bw per day and at the p95 from 12.5 to 237.4 mg/kg bw per day. At the proposed typical use level, the exposure estimates ranged at the mean from 0.7 to 60.2 mg/kg bw per day and at the p95 from 10.3 to 159.5 mg/kg bw per day. The Panel noted that the maximum proposed use levels would result in exposure estimates close to or above the ADI. The Panel also noted that level of exposure to carbomer from its proposed use is likely to be an overestimation. Taking a co
nservative approach, the Panel co
nsidered that exposure to carbomer would not give rise to a safety co
ncern if the proposed maximum use level for solid food supplements is lowered to the typical use level reported by the applicant.
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