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  Food Flavouring - Flavouring Substances - Overview of the evaluation programmeslide

Overview of the evaluation programme

  1. Background
  2. Evaluation Program
  3. Evaluation status of the FGE's
  4. Status of the substances in the evaluation program

I Background

European Parliament and Council Regulation (EC) N° 2232/96 lays down a procedure for the establishment of a Community list of flavouring substances intended for use in and on food. The list is to be established by 31 December 2010.

The substances to be evaluated were introduced in a Register adopted by Commission Decision 2002/113/EC, amended by Commission Decision 2004/357/EC, Commission Decision 2005/389/EC, Commission Decision 2006/252/EC, Commission Decision 2008/478/EC and Commission Decision 2009/163/EC. The register lists in part A, flavouring substances in order of FL number. It furthermore contains the chemical group, names, synonyms, systematic names and numbers in the different inventories and lists of substances (CAS, EINECS, FEMA and CoE).
Part B of the Register which contained substances for which the protection of the intellectual property rights of the manufacturer has been requested, has been deleted.

The legally binding lists are those published in the Official Journal of the European Communities.

II. Evaluation Program

A programme for the evaluation of the registered substances was laid down by Commission Regulation 1565/2000/EC of 18 July 2000. This Regulation lays down what substances must be evaluated, the kind of information that must be provided and what procedure should be followed for the evaluation.

The following substances contained in the Register do not need to be re-evaluated within the present evaluation:

  • substances classified by the Scientific Committee for food (SCF) in Category 1 (substances considered safe in use),
  • substances classified by the Council of Europe (COE) in Category A (substances which may be used in foodstuffs),
  • substances classified by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) so as to present no safety concern at current levels of intake with the exception of substances which have been accepted on the sole basis that their estimated intake is lower than the threshold of concern of 1,5 µg per person per day, as laid down in the reports of the 46th, 49th, 51st and 53rd JECFA meetings,

In addition, substances that have since been classified by JECFA as to present no safety concern at current levels of intake since 2000 meeting are considered by EFSA, who may decide that no further evaluation is necessary.

All other substances need to be evaluated by EFSA. Only substances that are considered safe by EFSA will be proposed for inclusion in the positive list. For some substances additional toxicological information is required in order to finalise the evaluation.

The following substances that are considered toxicologically unacceptable when used as flavouring and have been removed from the register:

  • 4-allyl-1,2-dimethoxybenzene,
  • 1-allyl-4-methoxybenzene,
  • N-(4-hydroxy-3-methoxybenzyl)-8-methylnon-6-enamide,
  • propyl-4-hydroxybenzoate,
  • pentane-2,4-dione,
  • acetamide
  • 2-butylbuta-1,3-diene.

A large number of substances need to be re-evaluated as additional toxicological information is required in order to assure that the substances are safe when used as flavouring.

The evaluations are done by EFSA in Flavouring Groups Evaluations (FGE) of structurally related substances defined in Commission Regulation 1565/2000/EC.

III. Evaluation status of the FGE's

The attached document PDF gives an overview of the Flavouring Group Evaluations. Where an FGE has been officially published on the European Food Safety Authority, a direct link is made to that site. Updated 03-12-2009.

IV. Status of the Substances in the Evaluation Programme

The evaluation status of each individual substance can be found by using the search link. The FL number, EU chemical group, name, synonyms, systematic names and numbers in the different inventories of substances can be used.

Information can also found on newly notified substances that are not in the Register, but for which evaluation has been requested.

Evaluation details can be found in the published FGE in which the substances have been evaluated via the links above.

For the substances that have been evaluated and about which it is concluded that additional data is required in order to confirm that their use as flavouring is safe, the comment "additional data required" is given.

For substances belonging to FGE.19, the details are also given in the minutes of AFC panel meeting of 27-29 November 2007, see link in the above document.

The information given is maintained by the Commission. It does not have a legal status and it does not replace the current Register. No conclusions should be drawn from the status of a substance in the list and its safety for use as flavouring, unless specifically stated. The information can be updated and altered at any time.



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