FSA Letter, 14 March 2005

FLAVOURINGS - Commission Working Group on Flavourings -1st March 2005

The Working Group met recently, and this letter gives an update on discussions relating to:

• EC Register of flavourings substances
• The regulation to replace the flavourings framework directive 88/388/EEC

EC Register of flavourings substances

The European Food Safety Authority (EFSA) has recently adopted three flavouring group evaluations (on FGE 7, 9 and 11) as part of the ongoing work to evaluate the 2800 chemically defined flavourings on the proposed EC register. Following the format of previous opinions two different approaches to estimating the intake of flavouring substances were considered: Maximised Survey-derived Intake Daily Intake (MSDI) and a modified Theoretical Added Maximum Daily Intake (m-TAMDI). The Commission has proposed that a meeting be arranged with relevant stakeholders to discuss how best to estimate intakes for flavouring substances as these two approaches produce dissimilar results.

The Commission estimates that the evaluation process will have been completed and the positive list adopted and published in July 2007, as opposed to the original deadline of July 2005. In the meantime, the Commission has proposed that the register of substances being evaluated and an explanation of the status of the evaluation process be published on their website. A revised procedure for notifying new non-confidential substances for inclusion in the evaluation process will be circulated by the Commission shortly. New substances cannot be added to the register as such, but may be submitted to EFSA for evaluation following agreement from the relevant MS.

Pentane-2, 4-dione

This flavouring substance was evaluated by EFSA as part of flavouring group 11 (FGE 11). The panel considered that the available data indicated this substance is genotoxic in vivo and in vitro and therefore advised that its use as a flavouring substance is not acceptable on safety grounds. The Standing Committee on the Food Chain and Animal Health adopted an amendment to the flavouring register to delete this substance at their meeting on 14 February. We expect this proposal to be published in the Official Journal of the European Union in April. In light of this opinion, the Commission will contact the flavouring industry to indicate that it should no-longer be used as a flavouring substance.

The EFSA opinion notes that this substance is little used. In addition, the British Essence Manufacturers Association (BEMA) has indicated that they are not aware of its use as a flavouring in the UK . However, industry should ensure that this substance is not used in the future.

Regulation to replace the flavourings framework directive 88/388/EEC

The latest proposal (WGF/002/02 rev3) is similar to that last discussed at a Commission Working Group meeting in July 2004. The main changes are:

• Articles 2 and 3 have been interchanged.
• Article 2- smoke flavourings are excluded from the scope as separate legislation exists for these flavourings. However, the labelling of smoke flavourings is covered by this Regulation. The term `sour' has been added to the list of tastes that are not included in the scope of the Regulation. Raw or non-compound foods, such as spices, herbs or tea as such are excluded from the scope of the Regulation.
• Article 3- definitions for `appropriate physical process' and `genetically modified organism (GMO)' have been included.
• Article 7, 1 (b) this new paragraph requires that once the regulation has been adopted the Commission be notified of the annual amounts of flavouring substances added to food.
• Article 14 - a new indent (j) on flavourings that consist of, or contains or is produced from a GMO has been added.
• Article 14, 2- defines the labelling requirement for the term `natural'.
• Article 19 - this new article relates to the requirement to monitor flavouring intake.
• Article 22 - this new article covers the funding of relevant Community projects to establish a harmonised policy and system for food flavourings and food ingredients with flavouring properties.
• Annex I- part B has been deleted which covered a list of appropriate physical processes.
• Annex II - coumarin has been deleted from the list of substances that cannot be used as flavourings following EFSA's opinion that a TDI can be set for this substance. Accordingly coumarin has been added to the register for flavouring substances.
• Annex IV - the conditions for the production of thermal process flavourings and the maximum levels for certain undesirable substances have been amended to be in line with those issued by the Council of Europe.

Next Steps

No date has been set for the next meeting of the Working Group but this is expected to be in May.

Note: The latest version of the document, WGF/002/02 rev3, does not appear to be available on-line.