Technical hearing on the draft scientific guidance for the preparation of applications on smoke flavourings primary products

Follow online:
Registration opendeadline: 30 October 2020 - 23:59 (CET)
5 November 2020

14.00-18.00 (CET)


Smoke flavourings are a specific category of flavourings produced by pyrolysis of wood. Their use in the EU is governed by Regulations (EC) No 1334/2008, No 2065/2003, No 627/2006 and No 1321/2013. Authorisations are granted in the EU for 10 years and are renewable upon application by the authorisation holders at the latest 18 months before the expiry date.

On 25 September 2019, the European Commission asked EFSA to prepare an updated consolidated guidance for the submission of applications on smoke flavouring primary products under the above-mentioned regulations, taking into account the experience gained by EFSA from 2005 to 2012 during the assessment of the currently authorised smoke flavouring products in the EU and the numerous relevant scientific and technical documents published by EFSA since then.

Following the request from the European Commission, EFSA developed an updated draft scientific guidance document for the preparation of applications on smoke flavouring primary products which describes the scientific data to be included in applications for the authorisation of new smoke flavouring primary products, as well as for the modification or for the renewal of the existing authorisations, submitted respectively under Articles 7, 11 and 12 of Regulation (EC) No 2065/2003.

A public consultation has been launched by EFSA's FAF Panel on the draft guidance on 05/10/2020 in order to collect comments from interested parties, submitted in writing to EFSA by 16/11/2020. For further information on the public consultation, please visit this link.

A technical hearing has been organised by EFSA, during the public consultation period, to consult with the interested parties on the draft scientific guidance document.

Objectives of the meeting

EFSA invites stakeholders for an exchange of views on the draft scientific guidance for the preparation of applications on smoke flavourings primary products. EFSA is seeking comments and feedback on this draft which will be considered by EFSA’s experts prior to finalisation of the guidance document.

Structure of the meeting

Plenary session and breakout sessions in which stakeholders will have the opportunity to follow presentations, ask questions, comment on and discuss the draft scientific guidance on smoke flavouring primary products with EFSA scientists.

Draft Agenda:


Agenda point



Welcome and introduction of the participants

Karl-Heinz Engel


Introduction to the event

Overview of the public consultation on the draft scientific guidance on smoke flavouring primary products

Carla Martino


Regulatory update on smoke flavouring primary products

EC representative



Presentation of the content of the EFSA draft scientific guidance on smoke flavouring primary products

  1. Characterisation of smoke flavourings primary products

Karl-Heinz Engel


  1. Proposed uses and exposure assessment


Q&A session






  1. Safety data - Genotoxicity

Rainer Gürtler


  1. Safety data – Toxicity other than genotoxicity

Wim Mennes


  1. Uncertainty

Ullrika Sahlin


Q&A session



Conclusions and recommendations

Karl-Heinz Engel

Who should attend?

The meeting is intended for all interested stakeholders.

On-line registrations

The registration form is available here 

Please note that registration may close once the maximum number of 100 participants is reached or, at the latest, by 30 October 2020

Practical information

The meeting will be held virtually. Remote participants will be given the opportunity to ask questions after the presentation of each section of the draft guidance document. Questions can be submitted in writing in a dedicated tool during the meeting.

Questions collected online will be monitored and clustered by the Q&A moderators, who will interact with the chair to address them during the Q&A sessions.

Queries that cannot be addressed during the meeting, will be answered in writing after the event. All questions will be included and addressed in a report to be published after the event.


Do not hesitate to contact events [at] for any questions you may have.