Scientific Guidance for the preparation of applications on smoke flavouring primary products
EFSA Panel on Food Additives and Flavourings (FAF), Maged Younes, Gabriele Aquilina, Laurence Castle, Paul Fowler, María José Frutos Fernández, Peter Fürst, Ursula Gundert‐Remy, Rainer Gürtler, Trine Husøy, Melania Manco, Wim Mennes, Peter Moldéus, Sabina Passamonti, Romina Shah, Ine Waalkens‐Berendsen, Detlef Wölfle, Matthew Wright, Romualdo Benigni, Claudia Bolognesi, Polly Boon, Kevin Chipman, Joop de Knecht, Ullrika Sahlin, Davide Arcella, Stefania Barmaz, Maria Carfì, Carla Martino, Alexandra Tard, Giorgia Vianello, Karl‐Heinz Engel
Abstract
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.