Commission Regulation (EC) No 429/2008Show full title

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

In general, in the case of the group ‘natural products’, whole plants, animals and other organisms and parts of these or products thereof resulting from very limited processing such as crushing, grinding or drying (e.g. many herbs and spices), shall not be considered as falling under this functional group flavourings of the category sensory additives.

For the purposes of the evaluation of applications of these products, flavourings are classified as follows:

1.

Natural products:

1.1.

Natural products — botanically defined.

1.2.

Natural products — non-plant origin.

2.

Natural or corresponding synthetic chemically defined flavourings

3.

Artificial substances.

The relevant group, to which the product object of the application belongs, shall be indicated. In case the product does not fit into any of the above groups, this shall be mentioned and justified.

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 FLAVIS(1), Council of Europe(2), JECFA, CAS(3) 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)

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 concern(4) 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)

Natural products — non plant origin

An equivalent approach to the above may be used.

(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.

2.2.2.2. Method of production and manufacture

The whole of the subsection 2.3 of Annex II applies.

In the case of non chemically well defined natural products, usually complex mixtures of many compounds obtained by an extraction process, a detailed description of the extraction process shall be provided. It is recommended to use in the description the relevant terminology such as essential oil, absolute, tincture, extract and related terms(5) widely used for botanically defined flavouring products to describe the extraction process. The extraction solvents used shall be specified, the precautions taken to avoid residues of the solvents, and the levels of residues where these are of toxicological concern if their presence would be unavoidable. The terms used to characterise the extract may include a reference to the method of extraction.

2.2.2.3. Methods of analysis

(1)

For natural products (either botanically defined or non-plant origin) which do not contain substances of toxicological concern for humans or animals, the standard requirement for methods of analysis of subsection 2.6 of Annex II may be replaced by a simpler qualitative method of analysis fit for the purpose for major or characteristic components of the product.

(2)

For natural or corresponding synthetic chemically defined flavourings which are not substances of toxicological concern for humans or animals the standard requirement for methods of analysis of subsection 2.6. of Annex II may be replaced by a simpler qualitative method of analysis fit for the purpose.

The whole of subsection 2.6 of Annex II applies for all other flavourings, such as those natural extracts which contain substances of toxicological concern, natural or corresponding synthetic chemically defined flavourings which are substances of toxicological concern themselves and artificial flavourings.

(1)

Identification number for chemically defined flavouring substances used in FLAVIS, the EU Flavour Information System, the database used within the Commission Regulation (EC) No 1565/2000 of 18 July 2000 (OJ L 180, 19.7.2000 p. 8) laying down the measures necessary for the adoption of an evaluation programme in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council (OJ L 299, 23.11.1996, p. 1).

(2)

CoE no.: Council of Europe number used for botanically defined flavouring products in the Council of Europe's Report no. 1 on ‘Natural sources of flavourings’, Volume I, Strasbourg, 2000 and its subsequent volumes.

(3)

CAS Number (CAS No) Chemical Abstracts Service Registry Number, unique identifier for chemical substances widely used in chemical inventory listings.

(4)

For the purpose of this section of this Regulation, ‘substance of toxicological concern’ means a substance with a tolerable daily or weekly intake (TDI or TWI), an ADI, or with a restriction in its use, or an active principle as defined in Council Directive 88/388/EEC relating to flavourings for use in foodstuffs and to source materials for their production, or an undesirable substance.

(5)

Defined in Appendix 4 of the Council of Europe's Report no. 1 on ‘Natural sources of flavourings’, Volume I, Strasbourg, 2000.