Open AccessScientific Guidance for the preparation of applications on smoke flavouring primary products
Author(s) -
Younes Maged,
Aquilina Gabriele,
Castle Laurence,
Fowler Paul,
Frutos Fernandez Maria Jose,
Fürst Peter,
GundertRemy Ursula,
Gürtler Rainer,
Husøy Trine,
Manco Melania,
Mennes Wim,
Moldeus Peter,
Passamonti Sabina,
Shah Romina,
WaalkensBerendsen 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 KarlHeinz
Publication year - 2021
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2021.6435
Subject(s) - authorization , product (mathematics) , risk analysis (engineering) , primary (astronomy) , food contact materials , smoke , european commission , risk assessment , computer science , business , environmental health , european union , medicine , food packaging , engineering , waste management , computer security , physics , geometry , mathematics , astronomy , economic policy , mechanical engineering
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.