Rychen Guido, Aquilina Gabriele, Azimonti Giovanna, Bampidis Vasileios, Bastos Maria de Lourdes, Bories Georges, Chesson Andrew, Flachowsky Gerhard, Gropp Jürgen, Kolar Boris, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Mantovani Alberto, Mayo Baltasar, Ramos Fernando, Saarela Maria, Villa Roberto Edoardo, Wallace Robert John, Wester Pieter, Brantom Paul, Dierick Noël Albert, Glandorf Boet, Herman Lieve, Kärenlampi Sirpa, Aguilera Jaime, Anguita Montserrat, Cocconcelli Pier Sandro
EFSA J. 2018 May 18;16(5):e05270. doi: 10.2903/j.efsa.2018.5270. eCollection 2018 May.
Hemicell HT/HT-L is an additive that presents endo-1,4-β-mannanase produced by a genetically modified strain of . This additive is aimed to be used as a feed additive for chickens for fattening/reared for laying, turkeys for fattening/reared for breeding, weaned piglets, pigs for fattening and minor poultry and porcine species. In a previous assessment, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) established the safety of the additive regarding the production strain, target species, consumer and user. However, limitations on the data regarding the absence of the production strain and its DNA did not permit to conclude on the safety of the additive for the environment. In that assessment, the Panel considered that the additive has a potential to be efficacious in the target species with the exception of pigs for fattening and in minor porcine species. The applicant provided new data to address the limitations identified. New data provided allowed the FEEDAP Panel to conclude that production strain and its recombinant DNA are not detected in the intermediate product used to formulate the additive. Therefore, the Panel concluded that the additive does not pose any environmental safety concern. Regarding the efficacy in pigs for fattening, the applicant provided a new analysis of the trials previously assessed which allowed the Panel to conclude that the additive has a potential to improve the feed to gain ratio at 32,000 U/kg feed. No data was provided regarding the efficacy in minor porcine species. However, considering the data available in major porcine species and that the mode of action of enzymes is well-known and can be reasonably be considered to be similar among porcine species the Panel extrapolated the conclusion drawn in pigs for fattening to minor porcine species for fattening.
半纤维素HT/HT-L是一种添加剂，它含有由一种转基因菌株产生的内切-1,4-β-甘露聚糖酶。这种添加剂旨在用作育肥鸡/产蛋鸡、育肥火鸡/种用火鸡、断奶仔猪、育肥猪以及小型家禽和猪品种的饲料添加剂。在先前的评估中，欧洲食品安全局动物饲料添加剂和产品或物质专家委员会（FEEDAP）确定了该添加剂在生产菌株、目标物种、消费者和使用者方面的安全性。然而，由于缺乏生产菌株及其DNA的数据，无法就该添加剂对环境的安全性得出结论。在该评估中，专家委员会认为，除育肥猪和小型猪品种外，该添加剂在目标物种中可能有效。申请人提供了新的数据以解决所发现的局限性。所提供的新数据使FEEDAP专家委员会得出结论，在用于配制该添加剂的中间产品中未检测到生产菌株及其重组DNA。因此，专家委员会得出结论，该添加剂不存在任何环境安全问题。关于育肥猪的功效，申请人对先前评估的试验进行了新分析，并使专家委员会得出结论，该添加剂在饲料中添加量为32,000 U/kg时有可能提高饲料转化率。未提供关于小型猪品种功效的数据。然而，考虑到主要猪品种的现有数据，并且酶的作用方式是众所周知的，并且可以合理地认为在猪品种中相似，因此专家委员会将育肥猪的结论外推至小型育肥猪品种。
