銆€銆€椋熷搧浼欎即缃戣  2019骞�1鏈�25鏃ワ紝娆х洘椋熷搧瀹夊叏灞€锛�EFSA锛夊彂甯冧簡鍏充簬3-缇熷熀涓侀吀鍜�3-缇熷熀涔欓吀鐨勫叡鑱氳仛閰� [poly锛堬紙R锛夆€�3鈥恏ydroxybutyrate鈥恈o鈥愶紙R锛夆€�3鈥恏ydroxyhexanoate锛塢锛圥HBH锛夊畨鍏ㄨ瘎浼扮粨鏋溿€�

 

銆€銆€缁忚繃璇勪及锛岄叾鍜屽姞宸ュ姪鍓傚皬缁勶紙 CEP 锛夊皬缁勫緱鍑虹粨璁猴紝濡傛灉PHBH鐗╄川鍦ㄥ娓╂垨鏇翠綆鐨勬俯搴︿笅鍗曠嫭浣跨敤鎴栦笌鍏朵粬鑱氬悎鐗╂贩鍚堜娇鐢ㄨ秴杩�6涓湀锛屽娑堣垂鑰呮潵璇村苟涓嶅畨鍏紝浣嗕笉闇€瑕佸崟鐙檺鍒躲€�

 

銆€銆€閮ㄥ垎鍘熸枃鎶ラ亾濡備笅锛�

 

銆€銆€The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids 锛圕EP Panel锛� assessed the safety of poly锛堬紙R锛夆€�3鈥恏ydroxybutyrate鈥恈o鈥愶紙R锛夆€�3鈥恏ydroxyhexanoate锛� 锛圥HBH锛夛紝 CAS No 147398鈥�31鈥�0 and food contact material 锛團CM锛� substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism 锛圕upriavidus necator锛夈€� Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl鈥恡erminated or with crotyl鈥� and hexenyl end鈥恎roups from dehydration of hydroxyl end鈥恎roups. In the absence of calibration standards, the total oligomer migration was set at the overall migration values. Other degradation products are crotonic acid and 锛圗锛夆€�2鈥恏exenoic acid. Crotonic acid is authorised for use in FCMs with a specific migration limit 锛圫ML锛� of 0.05 mg/kg food. For 锛圗锛夆€�2鈥恏exenoic acid, no indication for genotoxicity was identified by the EFSA CEF Panel in its group evaluation of flavouring substances in FGE.05Rev2 锛圗FSA CEF Panel, 2010b锛夈€� The other migrating substances detected, 鈻犫枲鈻犫枲鈻狅紝 are from the authorised substance 'palm oil and/or palm fatty acid distillate' 锛團CM substance No 9锛� 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 concern for genotoxicity. From the repeated dose 90鈥恉ay oral toxicity study in rats, the Panel identified the no鈥恛bserved鈥恆dverse鈥恊ffect level 锛圢OAEL锛� at the highest dose tested in males, 1,364 mg/kg body weight 锛坆w锛� per day. The Panel concluded that the potential for bioaccumulation of oligomers is low. Overall, the CEP Panel concluded that the substance PHBH is not of safety concern for the consumer if it is used alone or blended with other polymers in contact with all kinds of food during more than 6 months at room temperature or below, including hot鈥恌ill 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 crotonic acid should not exceed the SML of 0.05 mg/kg food. As the migration of 锛圗锛夆€�2鈥恏exenoic acid can be expected to be always lower than that of crotonic acid, no individual restriction is necessary.

 

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