Regulation (EC) No 1334/2008 of the European

Public Conference on Regulations on Food Additives and Novel Foods

Regulation (EC) No 1334/2008 of the European

Parliament and of the Council on Flavourings

14 October 2010

Bangkok

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Article 1 Subject matter

-Intention to ensure effective functioning of the internal market

-Ensuring high level of protection of human health

-Ensuring high level of consumer protection

-Taking into account protection of the environment

-List of approved flavourings and source materials (Annexes I)

-Conditions of use of flavourings and food ingredients with flavouring

properties

-Rules on labelling of flavourings

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Article 2 Scope

Regulation shall apply to

- Flavourings without prejudice to more specific regulations on smoke flavourings (Regulation (EC) No 2065/2003

- Food ingredients with flavouring properties

- Food containing flavourings and/or food ingredients with flavouring propertiesproperties

- Source materials for flavourings and/or food ingredients with flavouring properties

Except from scope:

- Substances having exclusively a sweet, sour or salty taste

- Raw foods

- Non compound foods and mixtures as such as long as they have not been used as food ingredients

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Article 3 Definitions

• Regulations (EC) No 178/2002 (Basic Food Law) and (EC) No 1829/2003

(Genetically Modified Food and Feed)

• „flavourings“

• „flavouring substance“

• „natural flavouring substance“

• „flavouring preparation“ • „flavouring preparation“

• „thermal process flavouring“

• „smoke flavouring“ (Regulation (EC) No. 2065/2003)

• „flavour precursor“

• „other flavouring“

• „food ingredient with flavouring properties“

• „source material“

• „appropriate physical process“

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Article 4 General conditions for use

• No safety concern to the health of the consumer

• No misleading of the consumer• No misleading of the consumer

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Article 5 Prohibition of non-compliant food

• No person shall place on the market a flavouring or any food in which such

a flavouring and/or food ingredient with flavouring properties are present if a flavouring and/or food ingredient with flavouring properties are present if

their use does not comply with this Regulation.

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Article 6 Presence of certain substances

• Substances listed in Part A of Annex III shall not be added as such to food.

• Maximum levels of certain substances, naturally present in flavourings and • Maximum levels of certain substances, naturally present in flavourings and

food ingredients with flavouring properties in certain compound food as

consumed to which flavourings and /or food ingredients with flavouring

properties have been added; without prejudice to Regulation (EC) No

110/2008 (spirit drinks)

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Article 7 Use of certain source materials

• Source materials listed in Part A of Annex IV shall not be used for the

production of flavourings and/or food ingredients with flavouring properties.

• Flavourings and/or food ingredients with flavouring properties produced

from source materials listed in Part B of Annex IV may be used only under

the conditions indicated in that Annex.

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Article 8 Substances not to be approved

• Flavouring preparations obtained from food

• Thermal process flavourings obtained from food and complying with the

provisions set in Annex V

• Flavour precursers obtained from food• Flavour precursers obtained from food

• Food ingredients with flavouring properties

• The substances have to comply with the general conditions for use laid

down in Article 4.

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Article 9 Substances to be approved

• Flavouring substances

• Flavouring preparations obtained from material other than food

• Thermal process flavourings obtained from material other than food and/or

not complying with the provisions set in Annex Vnot complying with the provisions set in Annex V

• Flavour precursers obtained from material other than food

• Other flavourings

• Source materials other than food

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Article 10 Community list

• Of the flavourings and source materials to be approved (Article 9) only

those included in the Community list may be placed on the market as such

and used in or on foods under the conditions of use specified therein,

where applicable.

• Article 10 shall apply from 18 months after the date of application of the

Community list of flavouring substances.

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Article 11 Inclusion in the Community list

• A flavouring or source material my be included in the Community list only if

it complies with the conditions of use set out in Article 4

• The entry shall specify:

• the identification of the flavouring or the source material and

• where necessary, the conditions under which the flavouring may be used

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Article 12 Compliance with Regulation (EC) No

1829/2003

• A flavouring or source material falling within the scope of Regulation (EC)

No 1829/2003 has to be covered by an authorisation in accordance with No 1829/2003 has to be covered by an authorisation in accordance with

that Regulation.

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Article 13 Interpretation decisions

• Different interpretation decisions may be decided by Comitology.• Different interpretation decisions may be decided by Comitology.

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Articles 14 to 18 Labelling

• See separate presentation on labelling • See separate presentation on labelling

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Article 19 Information obligations

• Information of the Commission of the amount of a flavouring substance

added to food in a 12 months period by the producer or user (on request)

• Information of the Commission of new production methods or starting

material for already approved substances by the producer or user prior to

placing on the market to allow a new evaluation by the European Food

Safety Authority (EFSA)

• Information of the Commision of any new scientific or technical information

by the producer or user

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Article 20 Monitoring

• Member States shall establish systems to monitor the consumption and

use of flavourings set out in the Community list and substances listed in

Annex III on a risk-based approach, and shall report their findings with

appropiate frequency to the Commisison and EFSA.

• After consutation of EFSA a common methodology shall be adopted.

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Article 21 Committee

• Procedural regulation for deciding by comitology• Procedural regulation for deciding by comitology

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Article 22 Amendments to Annexes II to IV

• Annexes II to IV may be amended by the regulatory procedure with • Annexes II to IV may be amended by the regulatory procedure with

scrutiny to reflect scientific and technical progress

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Article 23 Community financing

• Rules on financing relevant for the Commission• Rules on financing relevant for the Commission

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Article 24 Repeals

• A number of legal texts which are supersedet by the Regulation shall be

repealed from 20 January 2011.

• Regulation (EC) No 2232/96 shall be repealed from the date of application

of the list referred to in Article 2(2) of that Regulation (positive list of

flavouring substances).

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Article 25 Introduction of the Community list

• The Community list of flavouring substances according to Article 2(2) of

Regluation (EC) No 2232/96 shall be introduced into Annex I to this

Regulation at the time of its adoption.

• Regulation (EC) No. 1331/2008 shall apply for the evaluation and approval

of flavouring substances which are not covered by the evaluation

programme provided for in Article 4 of Regulation (EC) No 2232/96.

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Article 26 Amendments to Reg. (EEC) No 1601/91

• Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules

on the definition, description and presentation of aromatised wines,

aromatised wine-based drinks and aromatised wine-product cocktails is

adapted to certain new definitions laid down in this regulation.

• The amendment shall apply from the date of application of the Community

list of flavouring substances.

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Article 27 Amendment to Reg. (EC) No 2232/96

• The positive list of flavouring substances referred to in Article 2(2) shall be • The positive list of flavouring substances referred to in Article 2(2) shall be

adopted by 31 December 2010 at the latest.

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Article 28 Amendment to Reg. (EC) No 110/2008

• Regulation (EC) No 110/2008 of the European Parliament and of the

Council of 15 January 2008 on the definition, description, presentation,

labelling and the protection of geographical indications of spirit drinks is

adapted to certain new definitions laid down in this Regulation.

• The amendment shall apply from the date of application of the Community

list of flavouring substances.

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Article 29 Amendment to Directive 2000/13/EC

• See separate presentation on labelling

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Article 30 Entry into force

• The Regulation shall apply in general from 20 January 2011.• The Regulation shall apply in general from 20 January 2011.

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Annex III Presence of certain substances

• The maximum levels in Part B are established on a risk based approach.• The maximum levels in Part B are established on a risk based approach.

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