Younes Maged, Aquilina Gabriele, Castle Laurence, Fowler Paul, Frutos Fernandez Maria Jose, Fürst Peter, Gundert-Remy Ursula, Gürtler Rainer, Husøy Trine, Manco Melania, Mennes Wim, Moldeus Peter, Passamonti Sabina, Shah Romina, Waalkens-Berendsen Ine, Wölfle Detlef, Wright Matthew, Benigni Romualdo, Bolognesi Claudia, Boon Polly, Chipman Kevin, De Knecht Joop, Sahlin Ullrika, Arcella Davide, Barmaz Stefania, Carfì Maria, Martino Carla, Tard Alexandra, Vianello Giorgia, Engel Karl-Heinz
EFSA J. 2021 Mar 2;19(3):e06435. doi: 10.2903/j.efsa.2021.6435. eCollection 2021 Mar.
Following a request from the European Commission, EFSA developed updated scientific guidance to assist applicants in the preparation of applications on smoke flavouring primary products. This guidance describes the scientific data to be included in the applications for the authorisation of new smoke flavouring primary products, as well as for the renewal or for the modification of existing authorisations, submitted respectively under Articles 7, 12 and 11 of Regulation (EC) No 2065/2003. Information to be provided in all applications relates to: the characterisation of the primary product, including the description of the source materials, manufacturing process, chemical composition, specifications and stability; the proposed uses and use levels and the assessment of the dietary exposure; the safety data, including information on the genotoxic potential of the identified components and of the unidentified fraction of the primary product, toxicological data other than genotoxicity and information on the safety for the environment. For the toxicological studies a tiered approach is applied, for which the testing requirements, key issues and triggers are described. A description of the standard uncertainties relevant for the evaluation of primary products and how these are considered in the standardised risk assessment procedure is also included. The applicant should generate the data requested in each section to support the safety assessment of the smoke flavouring primary product. On the basis of the submitted data, EFSA will assess the safety of the primary product and conclude whether or not it presents risks to human health and to the environment under the proposed conditions of use.
应欧盟委员会的要求，欧洲食品安全局（EFSA）制定了更新后的科学指南，以协助申请人准备关于烟熏香料初级产品的申请。本指南描述了在根据（EC）No 2065/2003号法规第7条、第12条和第11条分别提交的新烟熏香料初级产品授权申请、现有授权的续期申请或变更申请中应包含的科学数据。所有申请中应提供的信息包括：初级产品的特性，包括原料描述、制造工艺、化学成分、规格和稳定性；拟议用途和使用水平以及膳食暴露评估；安全数据，包括关于已识别成分和初级产品未识别部分的遗传毒性潜力的信息、除遗传毒性外的毒理学数据以及关于环境安全性的信息。对于毒理学研究，采用了分级方法，并描述了测试要求、关键问题和触发因素。还包括与初级产品评估相关的标准不确定度的描述以及在标准化风险评估程序中如何考虑这些不确定度。申请人应提供各部分要求的数据，以支持烟熏香料初级产品的安全性评估。根据提交的数据，EFSA将评估初级产品的安全性，并得出在拟议使用条件下它是否对人类健康和环境构成风险的结论。
