Division 2.2.2.1 Characterisation of active substance(s)/agent(s)
United Kingdom
The whole of the subsection 2.2 of Annex II applies.
In addition:
- (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 concernf4 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.
Annotations
Footnotes
- f1
-
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).
- f2
-
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.
- f3
-
CAS Number (CAS No) Chemical Abstracts Service Registry Number, unique identifier for chemical substances widely used in chemical inventory listings.
- f4
-
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.