食品伙伴网讯2019??5日，
欧盟食品安全局＇a href='//www.sqrdapp.com/news/tag_10.html' class='zdbq' title='EFSA相关食品资讯' target='_blank'>EFSA）发布了关于3-羟基丁酸?-羟基
乙酸的共聚聚 [poly（（R）?‐hydroxybutyrate‐co‐（R）?‐hydroxyhexanoate）]（PHBH）安全评估结果、/div>
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经过评估，酶和加工助剂小组（ CEP ）小组得出结论，如果PHBH物质在室温或更低的温度下单独使用或与其他聚合物混合使用超?个月，对消费者来说并不安全，但不需要单独限制、/div>
部分原文报道如下９/div>
The EFSA Panel on Food Co
ntact Materials, Enzymes and Processing Aids （CEP Panel assessed the safety of poly（（R）?‐hydroxybutyrate‐co‐（R）?‐hydroxyhexanoate （PHBH）， CAS No 147398?1? and food co
ntact material （FCM substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism （Cupriavidus necator） Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl‐terminated or with crotyl and hexenyl end‐groups from dehydration of hydroxyl end‐groups. In the absence of calibration standards, the total oligomer migration was set at the overall migration values. Other degradation products are croto
nic acid and （E）?‐hexenoic acid. Croto
nic acid is authorised for use in FCMs with a specific migration limit （SML of 0.05 mg/kg food. For （E）?‐hexenoic acid, no indication for genotoxicity was identified by the EFSA CEF Panel in its group e
valuation of flavouring substances in FGE.05Rev2 （EFSA CEF Panel, 2010b） The other migrating substances detected, ■■■■■， are from the authorised substance 'palm oil and/or palm fatty acid distillate' （FCM substance No 9 used as a carbon source for the fermentation and do not give rise to safety concern. A PHBH oligomer mixture was synthesized to simulate that migrating. It did not give rise to co
ncern for genotoxicity. From the repeated dose 90‐day oral toxicity study in rats, the Panel identified the no‐observed‐adverse‐effect level （NOAEL at the highest dose tested in males, 1,364 mg/kg body weight （bw per day. The Panel co
ncluded that the potential for bioaccumulation of oligomers is low. Overall, the CEP Panel co
ncluded that the substance PHBH is not of safety co
ncern for the co
nsumer if it is used alone or blended with other polymers in co
ntact with all kinds of food during more than 6 mo
nths at room temperature or below, including hot‐fill or a short heating up phase. The specific migration of all oligomers < 1,000 Da should not exceed 5 mg/kg food. The migration of croto
nic acid should not exceed the SML of 0.05 mg/kg food. As the migration of （E）?‐hexenoic acid can be expected to be always lower than that of croto
nic acid, no individual restriction is necessary.
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