The European Flavour Association (EFFA) acknowledges the recent amendments to the Union List of Smoke
Flavouring Primary Products (SFPPs) as set out in Commission Implementing Regulation (EU) 2024/2067. This regulation, effective from 21/08/2024, removes entries SF-001 to SF-010 from the list of authorised SFPPs.
What are flavourings, what are smoke flavourings and how are they regulated?
Flavourings are ingredients that bring taste and variety to food. In one form or another flavourings have been used since ancient times to impart or modify taste. We invite you to have a look at our animation video or our infographic for more information on how flavourings are produced and assessed.
In the EU, all flavourings are rigorously checked against safety provisions laid down by the authorities.
Flavourings are regulated by the Flavouring Regulation (EC) No 1334/2008. Smoke flavourings are a specific category of flavourings and are governed by a specific set of regulations1 and they are labelled separately to flavourings in the ingredient list.
As an alternative to traditional smoking, also smoke flavourings can be used in some food categories: meat, fish or cheese, but also soups, snacks, sauces, savoury products, and plant-based alternatives to impart a smoky taste.
More information can be found on the following EFSA website and Commission website:
- Smoke flavourings | EFSA (europa.eu)
- Smoke flavouring renewals - existing - European Commission (europa.eu)
What happened until now?
In the EU, smoke flavourings should undergo a safety assessment before being placed on the market. The safety assessment done by the European Food Safety Authority (EFSA) of a specific SFPP should be followed by a risk- management decision as to whether the product should be entered on the EU list of authorised SFPPs. The authorisation granted is valid throughout the EU for 10 years and is renewable for 10-year periods on application.
The authorisations granted under Regulation (EU) No 1321/2013 were due to expire on 1 January 2024.
Authorisation holders had to make their submissions to request the renewal of their authorisations at the latest 18 months before the expiry date of the authorisation, i.e. by the end of June 2022. EFSA published the new Scientific Guidance for the preparation of applications on smoke flavouring primary products in March 2021.
For two SFPPs, i.e. SF-007 and SF-010, the authorisation holders did not submit applications to renew their authorisations. The authorisations of these SFPPs were expired on 1 January 2024 (and were not extended).
For the other eight smoke flavouring primary products [SF-001, SF-002, SF-003, SF-004, SF-005, SF-006, SF-008, SF-009], authorisation holders submitted applications to renew their authorisations by the deadline laid down in regulation (EC) 2065/2003 for the evaluation by EFSA (European Food Safety Authority). For each of those eight products, EFSA has published opinions in November 2023 and concluded either that the SFPPs evaluated “raiseconcern with respect to genotoxicity” or that “the potential safety concern for genotoxicity [of the SFPP] cannot be ruled out”.
It is worth noting, as Wim Mennes, EFSA’s working group chair on flavourings, noted, that “EFSA takes a conservative approach to its assessments, meaning that [they] consider worst-case scenarios to estimate hazards and risks”
There are three relevant aspects that EFSA pointed out regarding this assessment in the Q & A with Wim Mennes:
- The emergence of potential effects depends on factors such as an individual's genetics and dietary habits.
- EFSA has not investigated the likelihood of harmful effects from consuming foods flavoured with smoke flavourings.
- Maintaining a balanced diet typically lowers the risk of exposure to food-related hazards.
What are the next steps?
On 1 August 2024, Commission Implementing Regulation (EU) 2024/2067 (voted by MS on 24 April and adopted on 31 July 2024) was published. This regulation amends Implementing Regulation (EU) No 1321/2013 as regards the deletion of entries SF-001 to SF-010 from the Union List (UL) of authorised smoke flavouring primary products, meaning after a phase-out period, smoke flavourings will no longer be permitted for use in the EU.
Transitional periods
For derived flavourings (containing any of the eight above mentioned SFPPs) and final food & beverage products (containing flavourings with any of those eight SFPPs), transitional periods are foreseen:
• Until 1 July 2029 for some food categories: cheese and cheese products, meat, processed fish and fishery products including crustaceans and molluscs, fish roe and their corresponding sub-categories;
• Until 1 July 2026 for all other food categories.
Finally, we would like to highlight the commitment of the Flavour Industry to work in compliance with the relevant legislation.
For further information, we invite you to contact EFFA directly at info@effa.eu.