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

2.2. Flavouring compounds

2.2.1. Section I: summary of the dossier

The whole of Section I of Annex II applies.

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.

2.2.3. Section III: studies concerning the safety of the additive

For all flavourings, animal exposure and intake calculations both from natural exposure and following addition of the flavouring to feedingstuffs shall be provided.

For flavouring belonging to the group artificial substances, the whole of Section III of Annex II applies.

2.2.3.1. Studies concerning the safety of use of the additive for target animals

(1)

Natural products (either botanically defined or non–plant origin)

The safety of these products may be assessed on the basis of its major and characteristic components and also considering known substances of toxicological concern. If the major or characteristic components are not already authorised as chemically defined flavourings or as feed additives, then it has to be verified whether they are substances of toxicological concern for humans or animals, and its toxicological properties have to be provided in accordance with subsection 3.1 of Annex II.

(2)

Natural or corresponding synthetic chemically defined flavourings

If these substances are authorised flavourings for humans, the safety for target species may be assessed taking into account the comparison between the level of intake by the target species from feed proposed by the applicant with that by humans from food. Metabolism and toxicological data on which the assessment for human used was made shall be submitted.

In all other cases different from the case where both levels of intake are similar, such as where the level of intake by the target animal proposed be the applicant is substantially higher than that by human from food or where the substance is not authorised in food, the safety for the target animals may be assessed by taking into account the following data: the principle of threshold of toxicological concern(6), available toxicological and metabolism data for related compounds, and chemical structural alert consideration (following by analogy of the Commission Regulation (EC) No 1565/2000 of 18 July 2000 laying down the measures necessary for the adoption of an evaluation program in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council)(7).

Tolerance studies are needed only where threshold values are exceeded or cannot be determined.

2.2.3.2. Studies concerning the safety of use of the additive for consumers

Evidence that the metabolites of the flavouring do not result in an accumulation in the animal of products of toxicological concern for humans shall be provided. In the case that the use of the requested flavouring product as a consequence of its addition to feedingstuffs results in residues in food of animal origin, detailed calculation of consumer exposure shall be provided.

(a)

Metabolic and residue studies

(1)

Natural products (either botanically defined or non–plant origin)

The safety of these products for humans when used as flavourings in feed, as regards its metabolism, may be based on the metabolism (in the target animal) and residues studies of their major and characteristic components and the absence of substances of toxicological concern in the extract.

If the major or characteristic components are not already authorised as chemically defined flavourings or if the level of intake by the target animals from feed is substantially higher than that by humans from food, the whole of subsection 3.2.1 of Annex II is required.

(2)

Natural or corresponding synthetic chemically defined flavourings

If these products are not authorised as flavourings for humans or if the level of intake by the target animal from feed as proposed be the applicant is substantially higher than that by human from food, available data on metabolic fate shall be provided and used to assess the potential accumulation in edible tissues and products according to subsection 3.2.1 of Annex II.

(b)

Toxicological studies

(1)

Natural products (either botanically defined or non–plant origin)

The safety of these products for humans when used as flavouring in feed may be based on the toxicological data of their major or characteristic components and the absence of substances of toxicological concern in the extract.

A toxicological package is required when the metabolic studies of the major or characteristic compounds show that there is accumulation in animal tissues or products and the threshold of toxicological concern for the target animal is exceeded. This toxicological package shall comprise genotoxicity studies, including mutagenicity and a subchronic oral toxicity study, according to subsection 3.2.2 of Annex II.

(2)

Natural or corresponding synthetic chemically defined flavourings

A toxicological package comprising genotoxicity studies, including mutagenicity and a subchronic oral toxicity study, according to subsection 3.2.2 of Annex II, is required when the metabolic studies of these products show that there is accumulation in animal tissues or products and the threshold of toxicological concern for the target animal is exceeded.

2.2.3.3. Studies concerning the safety of use of the additive for users/workers

The whole of subsection 3.3 of Annex II applies.

2.2.3.4. Studies concerning the safety of use of the additive for the environment

The whole of subsection 3.4 of Annex II applies.

2.2.4. Section IV: studies concerning the efficacy of the additive

Evidence of the flavouring properties, usually on the basis of the published literature, shall be provided. This may also be demonstrated by experience of practical use, where available, otherwise animal studies may be required.

It has to be fully investigated and reported if the product object of the application exerts other functions in the feed, animal or food of animal origin besides the one in the definition of flavouring compounds in Annex I of Regulation (EC) No 1831/2003.

2.2.5. Section V: post-market monitoring plan

This section shall apply under provision of Article 7(3)(g) of Regulation (EC) No 1831/2003. That is, a post-market monitoring plan is required only for additives that are GMOs or are produced from GMOs.

(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.

(6)

JECFA (FAO/WHO, 1996, Food additive series 35, IPCS, WHO Geneva) corresponding threshold for target animal should be adjusted to take into account of animal weight and feed intake.

(7)

OJ L 180, 19.7.2000, p. 8.