On 30 June 2021, EFSA met with interested parties in the area of smoke flavourings (for the complete list of participants, please see the Agenda below) to discuss the new requirements for the assessment of smoke flavourings primary products as described by EFSA in the following recently published documents:
- EFSA Scientific Guidance for the preparation of applications on smoke flavouring primary products (EFSA FAF Panel, 2021)
- Questions and answers on the EFSA Scientific Guidance for the preparation of applications on smoke flavouring primary products (Minutes of the 22nd FAF Panel plenary meeting, 4-6 May 2021 – pp. 11-17)
- EFSA Administrative guidance on the preparation of applications on smoke flavourings primary products (EFSA, 2021)
The meeting provided an opportunity to address the questions from industry representatives with respect to scientific, methodological and procedural issues encountered during the preparation of applications for the renewal of currently authorised smoke flavouring primary products, to be submitted under Article 12 of Regulation (EC) No 2065/2003.
Industry representatives presented their views and questions and EFSA provided its feedback. The main points of discussion are summarised hereafter:
- The new provisions introduced by Regulation (EU) 2019/1381 (the “Transparency Regulation”), amending Regulation (EC) No 178/2002 (the “General Food Law”), related to the pre-submission phase of an application (i.e. pre-application identification, general pre-submission advice, list of intended studies for renewal pre-submission advice, notification of studies) were presented by EFSA. In particular, it was clarified that in the context of renewal applications, if a study has been commissioned or started before 27 March 2021, the provisions laid down in Articles 32c(1) and 32b(2) and (3) of the GFL do not apply even if on 27 March 2021 the study is still ongoing.
- Alternative toxicological study designs to the ones recommended in the EFSA scientific guidance on smoke flavourings were presented by contract research laboratories. It was clarified that applicants may always deviate from EFSA’s guidance documents, provided that they can justify their strategy and that the submitted information could address the safety endpoints as indicated in the guidance, allowing to conclude whether the smoke flavouring primary product is safe under the proposed conditions of use.
- Regarding the applicable timeline for the submission of renewal applications of smoke flavourings primary products, the Commission representative confirmed that the legal deadline foreseen in Article 12 of Regulation (EC) No 2065/2003 applies and that applications for the renewal of existing authorisations must be submitted at the latest 18 months before the expiry date of the existing authorisations. The Commission representative also indicated that for those smoke flavouring primary products for which a renewal would be requested in due time and for which delays in the renewal procedure would occur for reasons beyond the control of the authorisation holder, the Commission services were looking into options to ensure that there are no disruptions on the market while the applications would be examined.
The collaborative atmosphere and constructive dialogue achieved during the meeting contributed to enhance the mutual understanding between industry and regulators.