Flavouring Regulation

Prologue to the Flavouring Regulation

The new Regulation (EC) N° 1334 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foodstuffs was adopted on 16 December 2008 and entered into force on 20 January 2009.

The Regulation will apply as from 20 January 2011; during this period of time Member States must adapt their national legislation. The Community List of flavouring substances and source materials (Annex I of the Regulation) will have a different publication and application date, not determined up to now.

The Regulation repeals Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production as well as Commission Directive 91/71/EEC as from 20 January 2011.

EFFA has prepared a Guidance Document on the EC Regulation on Flavourings highlighting the major changes and seeking to establish EU wide industry guidance on the interpretation of the new rules introduced by the Regulation.

Major changes introduced by the new Regulation

1. The scope of the Regulation has been extended compared to the scope of current Directive 88/388 through the inclusion of the so-called food ingredients with flavouring properties (e.g. herbs and spices)

For further details please refer to the EFFA Guidance Document (Chapter I).

2. The new Regulation lays down general conditions for the use of flavourings, food ingredients with flavouring properties and source materials:

For further details please refer to the EFFA Guidance Document (Chapter II).

3. The new Regulation provides a set of new and/or modified definitions in the context of flavouring categories and manufacturing processes:

e.g. no distinction is made between nature-identical and artificial flavouring substances, both of which will be regarded as “Flavouring substances”.
e.g. a distinction is established between source materials considered as “food” and “non-food”.
For further details please refer to the EFFA Guidance Document (Chapter I).

4. The new Regulation stipulates new labelling requirements both for flavouring manufacturers (B2B) and (final) food manufacturers (B2C). These include:

e.g. packaging labelling of flavourings for downstream manufacturers and consumers must include details about the presence of food allergens and date of minimum durability.
e.g. labelling as “natural flavouring substance(s)” may only be used for flavourings where the flavouring part contains exclusively natural flavouring substances.
For further details please refer to the EFFA Guidance Document (Chapter IV)

5. A Union List of evaluated and approved (by EFSA) flavourings and source materials for use in and on foods will be established. The Union List (Annex I of the new Regulation) will cover:

flavouring substances;
other flavourings;
flavourings from the following flavouring categories when obtained from non-food sources: thermal process flavourings, flavour precursors, flavouring preparations;
source materials other than food;
thermal process flavourings for which the production conditions and/or the maximum levels for certain undesirable substances as set out in Annex V are not met.
For further details please refer to the EFFA Guidance Document (Chapter III)

6. The risk management of certain substances naturally present in certain food ingredients with flavouring properties (e.g. herbs, spices) and/or flavourings is based upon the “major contributor approach”:

e.g. maximum levels are established for the presence of these undesirable substances in food which contribute most to the human intake of these substances.
For further details please refer to the EFFA Guidance Document (Chapter II)

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