Safety & Regulation

Consumer safety is the number one priority when it comes to the authorisation of flavouring ingredients. Here is an overview of Europe’s current legislation of this growing food production sector.

How and why are smoke flavourings regulated in the EU?

Smoke flavourings are a specific category of flavourings and are governed by specific set of regulations because of the uniqueness of the manufacturing process. In the EU, smoke flavouring primary products (SFPPs) should undergo a safety assessment before being placed on the market. The safety assessment done by 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 are renewable for 10-year periods on application.  

The authorisations granted under Regulation (EU) No 1321/2013 were due to expire on 1 January 2024. EFSA published the new Scientific Guidance for the preparation of applications on smoke flavouring primary products in March 2021. Authorisation holders had to submit their applications to request the renewal of their authorisations at the latest 18 months before the expiry date of the authorisation, i.e. by end of June 2022. The authorisation holders/applicants were under extreme time pressure to conduct all the necessary studies and submit the final dossiers by this deadline. 

  What is the current regulatory status of smoke flavourings in the EU?

Smoke flavourings are officially recognised in the EU Smoke Flavouring Regulation as a healthier means of imparting smoke taste than other available options, such as traditional smoking. They are also recognised as the best available technique for producing smoked foods, as per official EU guidance. 

Despite this, the EU Commission is expected to officially adopt decisions to refuse the renewal of existing authorisations of eight smoke flavouring primary products currently available on the EU market, due to concerns raised by the European Food Safety Authority (EFSA) regarding certain components found in smoke flavouring primary products.  

When the Commission adopts the decisions to not renew the marketing authorisations, smoke flavourings users in the EU would need to consider other options for smoking foods, or imparting smoke flavour. We expect that the Commission will allow five-year transition period for food products that are traditionally smoked and two years for other food categories. Food products will be permitted to be manufactured by using smoke flavourings during these transition periods:

 

  • Up to 1 July 2029 for food categories 1.7 (cheese and cheese products), 8 (meat), 9.2 (processed fish and fishery products including crustaceans and molluscs), 9.3 (fish roe) and their corresponding sub-categories. 
  • Up to 1 July 2026 for all other food categories. 
  • Products manufactured before these dates can stay on the market until their date of minimum durability or use by date.  

What concerns were raised by EFSA that lead to the EU commission’s decision not to renew the marketing authorisations of smoke flavouring primary products? 

EFSA used an updated methodology to assess the new data submitted by applicants. It recommends that if a single component of a complex mixture (like smoke flavourings) is confirmed as genotoxic, the whole mixture is to be considered as genotoxic. 

As noted by Wim Mennes, EFSA’s working group chair on flavourings, EFSA took a conservative approach to its assessments, meaning that they considered worst-case scenarios to estimate hazards and risks. The chance that such harmful effects would occur because of consumption of foods flavoured with smoke flavourings has not been investigated by EFSA.   

Kerry’s Primary Products contain furan-2(5H)-one and benzene-1,2-diol, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for these two components are above the threshold of toxicological concern (TTC) of 0.0025 mg/kg bw per day for DNA-reactive mutagens and/or carcinogens, the Panel concluded that the Primary Product raises concern with respect to genotoxicity.  

However, EFSA agreed that the results of the genotoxicity safety studies on the Kerry Red Arrow primary products were negative, meaning no harmful effects as a complete mixture. 

Will EFSA do a comparative study on SFPPs and traditional smoking?  

The Commission is finalising a mandate for EFSA to perform a comparative risk assessment on the different processes giving a smoke flavour to food. Furthermore, a monitoring recommendation for the presence of furan‐2(5H)‐one and benzene‐1,2‐diol in smoked meat, cheese and fish products is being discussed which would aim at gathering occurrence data in view of possible regulatory measures as regards the presence of furan‐2(5H)‐one and benzene‐1,2‐diol in traditionally smoked products.  

Are smoke flavouring primary products safe?   

The safety testing required by EFSA for three of Kerry primary products was completed using the highest dose levels possible. Even at these elevated levels NO harmful effects were found in Kerry Red Arrow products. For reference, the Primary Products (the complete mixture) were tested at levels that were 8,800 – 26,000 times higher than amounts humans would reasonably eat daily. To put this exposure into perspective, a toddler would have to eat at least 130 sausages a day to equal the highest level tested in the genotoxicity safety studies and that level still had NO harmful effects.   

The Kerry Red Arrow studies supporting lack of genotoxicity concerns were recently published in Environmental and Molecular Mutagenesis, a scientific journal that is very well respected by genotoxicity experts.   

 Additionally, you can review the complete reproductive/developmental toxicity screening tests in accordance with OECD test guidelines (TG) 421 by clicking here.