ANNEX IIISPECIFIC REQUIREMENTS TO BE SATISFIED BY THE DOSSIER PROVIDED FOR IN ARTICLE 3 WITH RESPECT TO CERTAIN CATEGORIES OF ADDITIVES OR CERTAIN PART ICULAR SITUATIONS, AS PROVIDED FOR IN ARTICLE 7(5) OF REGULATION (EC) No 1831/2003

2.SENSORY ADDITIVES

2.2.Flavouring compounds

2.2.2.Section II: identity, characterisation and conditions of use of the additive; methods of analysis

2.2.2.1.Characterisation of active substance(s)/agent(s)

The whole of the subsection 2.2 of Annex II applies.

In addition:

For all groups of flavourings, the relevant identification number(s) (such as FLAVIS30, Council of Europe31, JECFA, CAS32 or any other internationally accepted numbering system) used specifically for the identification of flavouring products in feed and food shall always be provided when available.

  1. (1)

    Natural products — botanically defined

    The characterisation of the natural botanically defined products shall include the scientific name of the plant of origin, its botanical classification (family, genus, species, if appropriate subspecies and variety) and the common names and synonyms in as many European languages as possible or other language(s) (such as the one(s) of the place(s) of cultivation or origin) where available. The parts of the plant used (leaves, flowers, seeds, fruits, tubers, etc) and for lesser known plants the place of cultivation, identification criteria, and other relevant aspects of these plants shall be indicated. The major components of the extract shall be identified and quantified and its range or variability provided. Special attention shall be given to impurities as mentioned in subsection 2.1.4 of Annex II. The concentrations of substances of toxicological concern33 for humans or animals which may occur in the plant from which the extract is produced shall also be reported.

    The pharmacological or related properties of the plant of origin, its parts or of derived products thereof shall be fully investigated and reported.

  2. (2)

    Natural products — non plant origin

    An equivalent approach to the above may be used.

  3. (3)

    Natural or corresponding synthetic chemically defined flavourings

    Besides the general requirements of subsection 2.2.1.1 of Annex II, the origin of the flavouring shall be specified.