Villa Roberto Edoardo, Azimonti Giovanna, Bonos Eleftherios, Christensen Henrik, Durjava Mojca, Dusemund Birgit, Gehring Ronette, Glandorf Boet, Kouba Maryline, López-Alonso Marta, Marcon Francesca, Nebbia Carlo, Pechová Alena, Prieto-Maradona Miguel, Röhe Ilen, Theodoridou Katerina, Bastos Maria de Lourdes, Benfenati Emilio, Brantom Paul, Chesson Andrew, Schlatter Josef, Westendorf Johannes, Manini Paola
EFSA J. 2025 Jul 30;23(7):e9543. doi: 10.2903/j.efsa.2025.9543. eCollection 2025 Jul.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the leaves of L. (basil tincture) when used as a sensory additive in feed and in water for drinking for all animal species. The product is a ■■■■■ solution, with a dry matter content of approximately 1.79%. Basil tincture contains on average 0.187% (w/w) total polyphenols (of which 0.0247% are flavonoids). Methyleugenol (0.0006%) and estragole (0.00005%) were detected in the additive. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of basil tincture is very unlikely to induce adverse effects in long-living and reproductive animals and is of no safety concern for species for fattening at the following concentrations in complete feed: 65 mg/kg for chickens for fattening, 97 mg/kg for laying hens, 87 mg/kg for turkeys for fattening, 140 mg/kg for pigs for fattening, 116 mg/kg for piglets, 170 mg/kg for sows, 291 mg/kg for veal calves, 256 mg/kg for cattle for fattening, sheep/goats and horses, 166 mg/kg for dairy cows, 102 mg/kg for rabbits, 292 mg/kg for salmonids, 307 mg/kg for dogs, 256 mg/kg for cats and 500 mg/kg for ornamental fish. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is very unlikely to induce adverse effects at 65 mg/kg complete feed. No safety concerns were identified for the consumer and the environment from the use of the additive in animal feed. Regarding user safety, basil tincture should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. When handling the additive, exposure of unprotected users to methyleugenol and estragole may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since the leaves of are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy was necessary.
应欧盟委员会的要求，欧洲食品安全局（EFSA）被要求就罗勒叶酊剂（罗勒酊）用作所有动物饲料和饮用水中的感官添加剂时的安全性和有效性发表科学意见。该产品为一种■■■■■溶液，干物质含量约为1.79%。罗勒酊平均含有0.187%（w/w）的总多酚（其中0.0247%为黄酮类化合物）。在该添加剂中检测到甲基丁香酚（0.0006%）和草蒿脑（0.00005%）。欧洲食品安全局动物饲料添加剂和产品或物质专家小组（FEEDAP）得出结论，在全价饲料中以下浓度下，罗勒酊用于长寿和繁殖动物时极不可能产生不良影响，对于育肥动物也不存在安全问题：育肥鸡65毫克/千克、产蛋鸡97毫克/千克、育肥火鸡87毫克/千克、育肥猪140毫克/千克、仔猪116毫克/千克、母猪170毫克/千克、犊牛291毫克/千克、育肥牛256毫克/千克、绵羊/山羊和马256毫克/千克、奶牛166毫克/千克、兔子102毫克/千克、鲑鱼29２毫克/千克、犬307毫克/千克、猫256毫克/千克、观赏鱼500毫克/千克。这些结论已外推至其他生理相关物种。对于任何其他物种，在全价饲料中添加65毫克/千克时，该添加剂极不可能产生不良影响。在动物饲料中使用该添加剂对消费者和环境不存在安全问题。关于使用者安全，罗勒酊应被视为对皮肤和眼睛有刺激性，以及皮肤和呼吸道致敏剂。在处理该添加剂时，未受保护的使用者可能会接触到甲基丁香酚和草蒿脑。因此，为降低风险，应尽量减少使用者的接触。由于罗勒叶被认为可用于食品调味，其在饲料中的功能与在食品中基本相同，因此无需进一步证明其有效性。
