Rychen Guido, Aquilina Gabriele, Azimonti Giovanna, Bampidis Vasileios, Bastos Maria de Lourdes, Bories Georges, Chesson Andrew, Cocconcelli Pier Sandro, Flachowsky Gerhard, Kolar Boris, Kouba Maryline, López-Alonso Marta, Puente Secundino López, Mantovani Alberto, Mayo Baltasar, Ramos Fernando, Saarela Maria, Villa Roberto Edoardo, Wallace Robert John, Wester Pieter, Lundebye Anne-Katrine, Nebbia Carlo, Renshaw Derek, Innocenti Matteo Lorenzo, Gropp Jürgen
EFSA J. 2018 Mar 28;16(3):e05215. doi: 10.2903/j.efsa.2018.5215. eCollection 2018 Mar.
Butylated hydroxyanisole (BHA) is a waxy solid consisting for > 98.5% of the active substance, a mixture of 3--butyl-4-hydroxyanisole and 2--butyl-4-hydroxyanisole. It is intended to be used as an antioxidant in feedingstuffs for all animal species and categories. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered BHA up to 150 mg/kg complete feed as safe for all animal species except for cats, for which a safe dose could not be established from the tolerance data. BHA is rapidly absorbed from the gastrointestinal tract; it is metabolised rapidly and excreted as such and as metabolites in the urine and faeces. The proportions of the different metabolites vary depending on species and dose. No accumulation of BHA or metabolites was observed in tissues. The Panel concluded that no concern for consumer safety would arise from the use of BHA as a feed additive at the maximum concentration of 150 mg/kg feed. The additive should be considered a skin, eye irritant and a potential skin sensitiser. Exposure of the user via inhalation was considered unlikely; therefore, a risk is not expected. The use of BHA at the maximum concentration proposed is unlikely to pose a risk to the environment. BHA is authorised as an antioxidant for food use at comparable use levels, therefore, no studies were required to demonstrate the efficacy of BHA as an antioxidant in feedingstuffs for all animal species.
丁基羟基茴香醚（BHA）是一种蜡状固体，活性物质含量>98.5%，由3-丁基-4-羟基茴香醚和2-丁基-4-羟基茴香醚的混合物组成。它拟用作所有动物种类和类别的饲料抗氧化剂。动物饲料添加剂及产品或物质专家委员会（FEEDAP）认为，在全价饲料中BHA含量高达150毫克/千克时，除猫以外的所有动物种类均安全，从耐受性数据无法确定猫的安全剂量。BHA可迅速从胃肠道吸收；它迅速代谢，并原样以及作为代谢产物随尿液和粪便排出。不同代谢产物的比例因物种和剂量而异。未在组织中观察到BHA或代谢产物的蓄积。专家委员会得出结论，在饲料中以150毫克/千克的最高浓度使用BHA作为饲料添加剂不会引起消费者安全问题。该添加剂应被视为皮肤和眼睛刺激物以及潜在的皮肤致敏剂。认为使用者不太可能通过吸入接触；因此，预计不存在风险。以建议的最高浓度使用BHA不太可能对环境构成风险。BHA在类似使用水平下被批准作为食品抗氧化剂，因此，无需进行研究来证明BHA作为所有动物种类饲料抗氧化剂的功效。
