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.
