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, Galobart Jaume, Manini Paola, Navarro-Villa Alberto, Pizzo Fabiola, Plaza Daniel Pagés, Radovnikovic Anita, Vettori Maria Vittoria, Amaduzzi Angelica
EFSA J. 2024 Oct 24;22(10):e9019. doi: 10.2903/j.efsa.2024.9019. eCollection 2024 Oct.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of fumaric acid as a technological and sensory additive (functional groups: preservative and flavouring compounds, respectively) and for a new use of the additive as a technological additive (functional group: acidity regulator) for all animal species. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that fumaric acid remains safe under the authorised conditions of use for the terrestrial animals, consumers and the environment. However, the Panel cannot conclude on the safety for the aquatic animals under all authorised condition of use. Fumaric acid is irritant to skin, eyes and respiratory tract, and should be considered a skin and respiratory sensitiser due to the presence of nickel. The Panel also considers that the new use of the additive as an acidity regulator under proposed conditions of use would not introduce risks not already considered. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation (for its use as preservative and flavouring compound). The Panel is not in the position to conclude on the efficacy of fumaric acid as an acidity regulator in feed.
应欧盟委员会的要求，欧洲食品安全局（EFSA）被要求就富马酸作为一种技术和感官添加剂（分别为功能类别：防腐剂和调味化合物）的授权续期申请以及该添加剂作为所有动物物种的技术添加剂（功能类别：酸度调节剂）的新用途评估发表科学意见。申请人提供了证据，证明市场上现有的该添加剂符合现行授权条件。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，在陆生动物、消费者和环境的授权使用条件下，富马酸仍然是安全的。然而，在所有授权使用条件下，该小组无法就其对水生动物的安全性得出结论。富马酸对皮肤、眼睛和呼吸道有刺激性，由于含有镍，应被视为皮肤和呼吸道致敏剂。该小组还认为，在拟议的使用条件下将该添加剂用作酸度调节剂的新用途不会带来尚未考虑到的风险。在授权续期（用作防腐剂和调味化合物）的背景下，无需评估该添加剂的功效。该小组无法就富马酸作为饲料酸度调节剂的功效得出结论。
