Status re-authorisation process Smoke Flavouring Primary Products

Dear customer,

We herewith inform you on the latest developments regarding the reauthorisation process of Smoke Flavouring Primary Products (SFPPs) in the European Union (EU).

In total, there are eight renewal applications. Last November, EFSA published scientific opinions on the safety of all SFPPs based on the first sets of data submitted.

For six SFPPs EFSA concluded that they raise concern with respect to genotoxicity due to the presence of two individual components (benzene-1,2-diol, which is an authorised flavouring substance in the EU, and furan-2(5H)-one, which is a common heat formed component that can be found in many foods, like chocolate and coffee). For the other two SFPPs EFSA could not rule out safety concerns for genotoxicity due to lack of data. These eight opinions do, however, mean that the Primary Products are safe as currently used, meaning no harmful effects as a complete mixture.

The safety testing required by EFSA was completed using the highest dose levels possible. Even at these elevated levels no harmful effects were found. 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.

Recently, the European Commission published their position, to be presented and discussed at the SCoPAFF-meeting of April 24. We regretfully have to inform you that the EU Member States have voted in favour of this position.

This means that the existing eight authorisations of SFPPs will not be renewed.

The communication from the European Commission is as follows:

“Following extensive discussions with Member States and stakeholders, the Regulation sets out different phase-out periods to give time for producers and operators to adapt to the new rules. When used to replace traditional smoking (e.g. hams, fish, cheeses) the phase-out period is 5 years. For uses where the smoke flavouring is added for extra flavour (e.g. soups, crisps, sauces), the phase-out period will be 2 years. The Regulation will be formally adopted by the Commission in the coming weeks, to enter into force later this spring.”

For now, all smokes supplied by Ruitenberg Ingredients can be used in the European market for the duration of those transition periods.

We regret that the European Commission has failed to take the opportunity to continue a more environmental friendly and safer way of creating tasteful smoky products.

We wish to stay in close contact with our smoke customers as well as suppliers to continue our collaboration developing the best alternative solutions for you.

In case of further questions, please contact your account manager.

Kind regards,
Ruitenberg Ingredients B.V.

Ward van der Kaaij
Managing Director