Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Kos Durjava Mojca, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Sanz Yolanda, Villa Roberto Edoardo, Woutersen Ruud, Herman Lieve, Glandorf Boet, Prieto Miguel Maradona, Saarela Maria, Brozzi Rosella
EFSA J. 2020 May 27;18(5):e06143. doi: 10.2903/j.efsa.2020.6143. eCollection 2020 May.
Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of ProEquo as a feed additive for horses. This additive is a preparation single strain of intended for use as a zootechnical additive in feed for horses. The identity of the bacterial strain was not established. Consequently, the qualified presumption of safety approach to safety assessment cannot be applied, and separate studies on target animals, consumer and environmental safety are required. The tolerance trial provided could not be considered due to non-compliance with the minimum requirements. No additional studies or data were provided for the other safety aspects. Therefore, in the absence of data, the FEEDAP Panel was not in the position to conclude on the safety of ProEquo for the target animals, consumers of products derived from animals fed the additive and the environment. ProEquo should be considered a respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy potential of the additive to skin and eyes or on its dermal sensitisation potential. The FEEDAP Panel is not in the position to conclude on the efficacy of ProEquo for horses.
应欧盟委员会的要求，动物饲料添加剂及产品或物质专家小组（FEEDAP）被要求就ProEquo作为马用饲料添加剂的安全性和有效性发表科学意见。这种添加剂是一种单一菌株制剂，拟用作马饲料中的动物技术添加剂。该细菌菌株的身份尚未确定。因此，无法应用安全评估的合格安全性推定方法，需要对目标动物、消费者和环境安全进行单独研究。由于不符合最低要求，所提供的耐受性试验无法予以考虑。未针对其他安全方面提供额外的研究或数据。因此，在缺乏数据的情况下，FEEDAP专家小组无法就ProEquo对目标动物、食用添加该添加剂的动物产品的消费者以及环境的安全性得出结论。ProEquo应被视为一种呼吸道致敏剂。在缺乏数据的情况下，FEEDAP专家小组无法就该添加剂对皮肤和眼睛的刺激性潜力或其皮肤致敏潜力得出结论。FEEDAP专家小组无法就ProEquo对马的有效性得出结论。
