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本文引用的文献

1
Scientific opinion on the renewal of the authorisation of Scansmoke SEF7525 (SF-004) as a smoke flavouring Primary Product.关于重新批准Scansmoke SEF7525(SF-004)作为烟用香料初级产品的科学意见。
EFSA J. 2023 Nov 16;21(11):e08366. doi: 10.2903/j.efsa.2023.8366. eCollection 2023 Nov.
2
Guidance on aneugenicity assessment.非整倍体性评估指南。
EFSA J. 2021 Aug 5;19(8):e06770. doi: 10.2903/j.efsa.2021.6770. eCollection 2021 Aug.
3
Scientific Guidance for the preparation of applications on smoke flavouring primary products.烟雾调味基料产品申请制备的科学指南。
EFSA J. 2021 Mar 2;19(3):e06435. doi: 10.2903/j.efsa.2021.6435. eCollection 2021 Mar.
4
Guidance on the renewal of the authorisation of feed additives.饲料添加剂授权续期指南。
EFSA J. 2021 Jan 7;19(1):e06340. doi: 10.2903/j.efsa.2021.6340. eCollection 2021 Jan.
5
Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment.食品安全评估中毒理学关注阈值方法的使用指南。
EFSA J. 2019 Jun 6;17(6):e05708. doi: 10.2903/j.efsa.2019.5708. eCollection 2019 Jun.
6
Genotoxicity assessment of chemical mixtures.化学混合物的遗传毒性评估。
EFSA J. 2018 Dec 18;17(1):e05519. doi: 10.2903/j.efsa.2019.5519. eCollection 2019 Jan.
7
Clarification of some aspects related to genotoxicity assessment.关于遗传毒性评估相关某些方面的阐释
EFSA J. 2017 Dec 18;15(12):e05113. doi: 10.2903/j.efsa.2017.5113. eCollection 2017 Dec.
8
Guidance on the assessment of the safety of feed additives for the target species.目标物种饲料添加剂安全性评估指南。
EFSA J. 2017 Oct 17;15(10):e05021. doi: 10.2903/j.efsa.2017.5021. eCollection 2017 Oct.
9
A comparison of the tumors induced by coal tar and benzo[a]pyrene in a 2-year bioassay.在一项为期两年的生物测定中,煤焦油和苯并[a]芘诱发肿瘤的比较。
Carcinogenesis. 1998 Jan;19(1):117-24. doi: 10.1093/carcin/19.1.117.

对由含猫和狗用烟熏调味提取物制剂组成的饲料添加剂进行重新授权评估(丹麦阿泽利斯公司)

Assessment of the feed additive consisting of a preparation containing a smoke flavouring extract for cats and dogs for the renewal of the authorisation (Azelis Denmark A/S).

作者信息

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, Brantom Paul, Chesson Andrew, Schlatter Josef, Westendorf Johannes, Manini Paola

出版信息

EFSA J. 2024 Oct 24;22(10):e9030. doi: 10.2903/j.efsa.2024.9030. eCollection 2024 Oct.

DOI:10.2903/j.efsa.2024.9030
PMID:39449761
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11500204/
Abstract

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 authorisation of a preparation containing a smoke flavouring extract for cats and dogs. The applicant provided data demonstrating that the additive currently on the market does not fully comply with the conditions of authorisation, but with newly proposed specifications based on different analytical methods. Considering that the additive under assessment contains benzofuran and styrene, for which a potential concern for genotoxicity has been identified, and that the whole mixture raises a potential concern for genotoxicity, additional data would be needed to complete the assessment. Therefore, the FEEDAP Panel is not in the position to conclude on the safety for cats and dogs. The additive is authorised for use in feed for cats and dogs, and therefore, there is no need to perform an assessment of the safety for the consumer and the environment. Regarding user safety, the additive 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 potential genotoxic substances may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

摘要

应欧盟委员会的要求,欧洲食品安全局(EFSA)被要求就一份含有猫犬用烟熏调味提取物制剂的授权续期申请评估提供科学意见。申请人提供的数据表明,目前市场上的添加剂不完全符合授权条件,但符合基于不同分析方法新提出的规格。考虑到所评估的添加剂含有苯并呋喃和苯乙烯,已确定对其遗传毒性存在潜在担忧,且整个混合物对遗传毒性也存在潜在担忧,因此需要更多数据来完成评估。因此,饲料添加剂和动物营养产品专家小组无法就该添加剂对猫和狗的安全性得出结论。该添加剂已被批准用于猫和狗的饲料,因此,无需对消费者和环境的安全性进行评估。关于使用者安全,该添加剂应被视为对皮肤和眼睛有刺激性,且为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潜在的遗传毒性物质。因此,为降低风险,应尽量减少使用者的接触。在授权续期的背景下,无需评估该添加剂的功效。