Proposal for a Regulation of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1576/89, Council Regulation (EEC) No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC - Preparation for the informal trialogue

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1. Tekst

Preparation for the informal trialogue

COREPER is invited to approve the compromise proposal, included in the third column of the

Annex, with a view to the informal negotiations with the European Parliament.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL Council modification

Recital 5a (new)

Raw foodstuffs, which have not undergone any processing treatment and non compound foodstuffs such as spices, herbs, teas and infusions (e.g. fruit or herbal tea) as well as mixtures of spices and/or herbs, mixtures of tea and mixtures for infusion, as long as they are consumed as such and/or not added to the food, do not fall under the scope of this regulation.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 1 Council modification

Recital 6

Flavourings and food ingredients with flavouring properties may only be used if they fulfil the criteria laid down in this Regulation. They must be safe when used, and certain flavourings should, therefore, undergo a risk assessment before they can be permitted in food. Where possible, attention should be given to whether or not there could be any negative consequences for vulnerable groups, including the development of taste preferences in children. They should not mislead the consumer and their presence in food should, therefore, always be indicated by appropriate labelling. Misleading the consumer includes, but is not limited to, issues related to the nature, freshness and quality of ingredients used, the naturalness of a product or of the production process, or the nutritional quality of the product. Flavourings and food ingredients with flavouring properties may only be used if they fulfil the criteria laid down in this Regulation. They must be safe when used, and certain flavourings should, therefore, undergo a risk assessment before they can be permitted in food. They should not mislead the consumer and their presence in food should, therefore, always be indicated by appropriate labelling. Misleading the consumer includes, but is not limited to, issues related to the nature, freshness, quality of ingredients used, the naturalness of a product or of the production process, or the nutritional quality of the product. The approval of food flavourings should also take into account other factors relevant to the matter under consideration including societal, economic, traditional, ethical and environmental factors and the feasibility of controls.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL Council modification

Recital 8a (new)

Maximum levels for certain naturally occurring undesirable substances should focus on the food or food categories which contribute most to dietary intake. This would allow Member States to organise controls on a risk basis in line with Regulation (EC) No. 882/2004 on official feed and food controls. Food producers are however obliged to take into account the presence of these substances when using food ingredients with flavouring properties and /or flavourings for preparation of all food to ensure that food which is not safe is not placed on the market.

Council modification

Recital 9

Provisions should be established at Community level in order to prohibit or restrict the use of certain plant or, animal, microbiological or mineral materials which raise concern for human health in the production of flavourings and food ingredients with flavouring properties and their applications in food production.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 2

Recital 11

In order to ensure harmonisation, the risk assessment and approval of flavourings and source materials that need to undergo an evaluation should be carried out in accordance with the precautionary principle and the procedure laid down in Regulation (EC) No [...] [establishing a common authorisation procedure for food additives, food enzymes and food flavourings].

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL Council modification

Recital 12

Flavouring substances are chemically defined chemical substances with, which include flavouring properties substances obtained by chemical synthesis or isolated using chemical processes, and natural flavouring substances. An evaluation programme of flavouring substances is ongoing in accordance with Regulation (EC) No 2232/96 of the European Parliament and of the Council of 28 October 1996 laying down a Community procedure for flavouring substances used or intended for use in or on foodstuffs. Under that Regulation a list of flavouring substances is to be adopted within five years of adoption of that programme. A new deadline should be set for the adoption of that list. That list will be proposed for inclusion in the list referred to in Article 2(1) of Regulation (EC) No [...].

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL Council modification

Recital 13

Flavouring preparations are flavourings other than chemically defined chemical substances obtained from materials of vegetable, animal or mineral microbiological origin, by appropriate physical, enzymatic or microbiological processes, either in the raw state of the material or after processing for human consumption. Flavouring preparations produced from food do not need to undergo an evaluation or an approval procedure for use in and on foods unless there is doubt about their safety. However, the safety of flavouring preparations produced from non-food material should be evaluated prior to approval. and approved.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL Council modification

Recital 14

Regulation (EC) No 178/2002 defines food as any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. Materials of vegetable, animal or microbiological origin, for which it can be sufficiently demonstrated that hitherto there is significant evidence of use for they have been used for the production of flavourings, are considered as food materials for this purpose, even though some of these source materials, such as rose wood, oak wood chips and strawberry leaves, may not have been used for food as such. They do not need to be evaluated.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL Council modification

Recital 15

Likewise, thermal process flavourings produced from food under authorised specified conditions need not undergo an evaluation or an approval procedure for use in and on foods unless there is doubt about their safety. However, the safety of thermal process flavourings produced from non-food material produced under non authorised or not complying with certain conditions of production should be evaluated prior to approval and approved.

Council modification

Recital 17

Flavour precursors such as carbohydrates, oligo-peptides and amino acids impart flavour to food by chemical reactions occurring which occur during food processing. Flavour precursors produced from food do not need to undergo an evaluation or an approval procedure for use in and on foods unless there is doubt about their safety. However, the safety of flavour precursors produced from non-food material should be evaluated prior to approval and approved.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL Council modification

Recital 18

Other flavourings which do not fall under the definitions of the previously mentioned flavourings may be used in and on foods after they have undergone an evaluation and approval procedure. Examples could be flavourings obtained by heating oil or fat for a very short period to an extremely high temperature, giving a grill like flavour.

Council modification

Recital 19a (new)

Flavourings can contain food additives as permitted by [Regulation...on food additives] and/or other food ingredients for technological purposes such as for their storage, standardization, dilution or dissolution and stabilization.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 42

Council modification

Recital 20

A flavouring or a source material which falls under the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed should be authorised according subject to the authorisation procedure under that Regulation, prior with regard to its approval the safety assessment of the genetic modification, while the final authorisation of the flavouring or source material should be granted under this Regulation. EP Amendment 5 - Recital 22a (new) Council modification - Recital 20a (new)

Flavourings remain subject to the general labelling obligations as provided for in Directive 2000/13/EC and, as the case may be, in Regulations (EC) Nos 1829/2003 and 1830/2003. In addition, specific provisions on labelling of flavourings sold as such to the manufacturer or to the final consumer should be contained in this Regulation.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 4 Council modification

Recital 22

Specific information requirements should ensure that consumers are not misled concerning the source material used for the production of natural flavourings. The In particular, if the term natural is used to describe a flavour, the flavouring components used should entirely be from natural origin. In addition, the source of vanillin the flavourings should be labelled, except when the source materials referred to would not be recognized in the flavour or taste of the food. If a source is mentioned, at least [90] % of the flavouring component should be obtained from wood will, the material referred to. The other maximum [10] % can only be used for example, standardisation or to give a more fresh, pungent, ripe, green etc. note to the flavouring. When less than [90] % of the flavouring component derived from the source referred to has been used and the flavour of the source can still be recognised, the source should be revealed with the mentioning that other natural flavourings

have to be mentioned. been

added. E.g. cacao extract in which other natural flavourings have been added to impart banana note. When a source material is claimed in the description of natural flavourings, the fraction of the flavouring component other than that derived from this particular source should not reproduce or imitate the flavour of the source referred to

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL Council modification

Recital 23

Consumers should be informed if the smoky taste of a particular food is due to the addition of smoke flavourings. In accordance with Article 5 of Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs, the name under which the product is sold labelling should not confuse the consumer as to whether the product is smoked conventionally with fresh smoke or treated with smoke flavourings. This Directive needs to be adapted to the definitions of flavourings, smoke flavourings and the term `natural' for the description of flavourings laid down in the present Regulation.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 6

Recital 25, Footnote

OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).

Council modification

Recital 25a (new)

In particular power should be conferred on the Commission to amend the Annexes to this Regulation and to adopt appropriate transitional measures regarding the establishment of the Community list. Since those measures are of general scope and are designed to amend nonessential elements of this Regulation, and/or to supplement it by the addition of new nonessential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL Council modification

Recital 25b (new)

When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to use the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of measures described in Article 7 paragraph 2 and amendments to Annexes II to V.

Council modification

Recital 26

Annexes II to V to this Regulation should be adapted as necessary to scientific and technical progress, taking into account the information provided by producers and users of flavourings and/or resulting from the monitoring and controls by the Member States.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 7 Council modification

Article 1, Paragraph 1

This Regulation lays down rules on flavourings and food ingredients with flavouring properties for use in and on foods to ensure a high level of human health protection and consumer protection and the effective functioning of the internal market. and a high level of human health protection and consumer protection. This Regulation lays down rules on flavourings and food ingredients with flavouring properties for use in and on foods to ensure the effective functioning of the internal market and a high level of protection of human health protection and consumer protection of consumers' interests, including fair practices in food trade, taking account, where appropriate, the protection of the environment.

EP Amendment 8 Council modification

Article 2, Paragraph 1, Point (a)

flavourings which are used or intended to be used in or on foods, with the exception of smoke flavourings falling within the scope of without prejudice to more specific provisions laid down in Regulation (EC) No 2065/2003; flavourings which are used or intended to be used in or on foods, with the exception of smoke flavourings falling within the scope of without prejudice to more specific provisions laid down in Regulation (EC) No 2065/2003;

EP Amendment 9 Council modification

Article 2, Paragraph 1, Point (c)

food containing flavourings and and/or food ingredients with flavouring properties; food containing flavourings and/or food ingredients with flavouring properties;

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL Council modification

Article 2, Paragraph 1, Point (d)

source materials for flavourings and/or source materials for food ingredients with flavouring properties.

EP Amendment 45 - Article 2, Paragraph 2, Point (c)

Council modification - Article 2, Paragraph 2, Point (c) (new)

(b) raw or non-compound foods such as, but not exclusively, fresh, dried or frozen herbs and spices or tea/herbal infusions as such. b) raw foods; or non-compound foods; c) non-compound foods and mixtures of spices and/or herbs, mixtures of tea and mixtures for infusion as such as long as they have not been used as food ingredients. EP Amendment 11 Article 2, Paragraph 3

Where necessary, it may be decided in accordance with the regulatory procedure with scrutiny referred to in Article 18(2) Article 18(2a) whether or not a given substance or mixture of substances, material or type of food falls within the scope of this Regulation.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 12

Article 3, Paragraph 2, Point (a), (II a) (new)

which may contain food including food additives as permitted by Regulation (EC) No .../2007 of the European Parliament and of the Council of .... [on food additives];

EP Amendment 49

Council modification

Article 3, Paragraph 2, Point (b)

"flavouring substance" shall mean a chemically defined substance with flavouring properties which is obtained by appropriate natural processes or chemical synthesis; 'flavouring substance' shall mean a chemically defined chemical substance with flavouring properties Council modification

Article 3, Paragraph 2, Point (c)

'natural flavouring substance' shall mean a flavouring substance obtained by appropriate physical, enzymatic or microbiological processes from material of vegetable, animal or microbiological origin either in the raw state or after processing for human consumption by one or more of the traditional food preparation processes listed in Annex II; Natural flavouring substances correspond to substances that are naturally present and have been identified in nature;

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL Council modification

Article 3, Paragraph 2, Point (d)

'flavouring preparation' shall mean a product, other than a flavouring substance, obtained from: i) food by appropriate physical, enzymatic or microbiological processes either in the raw state of the material or after processing for human consumption by one or more of the traditional food preparation processes listed in Annex II and/or appropriate physical processes; and/or ii)

material of vegetable, animal

or microbiological origin, other than food, obtained by appropriate physical, enzymatic or microbiological processes, the material being taken as such or prepared by one or more of the traditional food preparation processes listed in Annex II and/or appropriate physical, enzymatic or microbiological processes;

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 13

Article 3, Paragraph 2, Point (h)

"other flavouring not elsewhere specified " shall mean a flavouring added or intended to be added to food in order to impart odour and/or taste and which does not fall under the definitions (b) to (g);

EP Amendment 14

Council modification

Article 3, Paragraph 2, Point (i)

"food ingredient with flavouring properties" shall mean a food ingredient other than flavourings which may be added to food for the main purpose of adding flavour to it or modifying its flavour and the use of which contributes significantly to the presence of substances in compound foods as specified in Part B of Annex III; `food ingredient with flavouring properties' shall mean a food ingredient other than flavourings which may be added to food for the main purpose of adding flavour to it or modifying its flavour and which contributes significantly to the presence in food of certain naturally occurring undesirable substances; EP Amendment 52

Article 3, Paragraph 2, Point (j a) (new)

"produced by GMOs" shall mean derived by using a GMO as the last living organism in the production process, but not containing or consisting of GMOs nor produced from GMOs;

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 15

Council modification

Article 3, Paragraph 2, Point (k)

"appropriate physical process" shall mean a physical process which does not intentionally modify the chemical nature of the components of the flavouring and does not involve, without prejudice to the listing of traditional food preparation processes in Annex II, in which the use of singlet oxygen, ozone, inorganic catalysts, metal catalysts organometallic reagents and/or UV radiation is not included. `appropriate physical process' shall mean a physical process which does not intentionally modify the chemical nature of the components of the flavouring and does not involve among others the use of singlet oxygen, ozone, inorganic catalysts, metal catalysts, organometallic reagents and/or UV radiation. "appropriate physical process" shall mean a physical process which does not intentionally modify the chemical nature of the components of the flavouring, without prejudice to the listing of traditional food preparation processes in Annex II and does not involve among others the use of singlet oxygen, ozone, inorganic catalysts, metal catalysts, organometallic reagents and/or UV radiation. Council modification

Article 3, Paragraph 3

For the purpose of the definitions listed in paragraph 2 (d), (e), (g) and (j), source materials for which hitherto there is significant evidence of use for the production of flavourings, are considered as food for the purpose of this Regulation.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 16 Article 3, Paragraph 4

Where necessary, it may be decided in accordance with the procedure referred to in Article 18(2) whether or not a given substance falls within a specific category listed in paragraph 2(b) to (j).

Council modification

Article 3, Paragraph 4 a (new)

Where necessary it Flavourings may be decided in accordance with the procedure referred to in Article 18(2) whether contain food additives as permitted by [Regulation... on food additives] and/or not a given substance falls within a specific category listed in paragraph 2(b) to (j). other food ingredients incorporated for technological purposes.

EP Amendment 17

Council modification

Article 4, Point (a)

they do not, on the basis of the scientific evidence available and the precautionary principle, pose a safety concern to the health of the consumer; they do not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer and

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 19

Article 4, Point (b a) (new)

their use has advantages and benefits for the consumer;

EP Amendment 20

Article 4, Point (b b) (new)

there is a reasonable technological need

Council modification

Article 4a (new)

Prohibition of non-compliant flavourings and/or non-compliant foodstuffs No person shall place on the market a flavouring, or any food in which such a flavouring and/or food ingredients with flavouring properties are present if their use does not comply with this Regulation.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 21

Council modification

Article 5, Paragraph 2

Maximum levels of When there is a justified scientific concern that certain substances, naturally present in flavourings and food ingredients with flavouring properties, in the compound foods may pose a safety concern to the health of the consumer, the Commission may, on its own initiative or on the basis of information provided by Member States, and following the opinion of the Authority, set maximum levels for these substances which will be listed in Part B of Annex III. shall not be exceeded as a result of the use of flavourings and food ingredients with flavouring properties in and on those foods. Maximum Without prejudice to Council Regulation No 1576/89 maximum levels of certain substances, naturally present in flavourings and/or food ingredients with flavouring properties, in the compound foods listed in Part B of Annex III shall not be exceeded as a result of the use of flavourings and/or food ingredients with flavouring properties in and on those foods. The maximum levels shall of the substances set out in Annex III apply to the compound foods as offered ready marketed, unless otherwise stated. By way of derogation from this principle, for consumption or dried and/or concentrated foods which need to be reconstituted the maximum levels apply to the food as prepared reconstituted according to the instructions of the manufacturer. on the label, taking into account the minimum dilution factor. [This article shall not apply for herbs and spices when used in food, which is prepared and served on the same site.]

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 46

Article 5, Paragraph 2 a (new)

By way of derogation from paragraph 2, the maximum levels shall not apply where a compound food contains no added flavourings and the only food ingredients with flavouring properties which have been added are fresh, dried or frozen herbs and spices.

EP Amendment 23

Council modification

Article 5, Paragraph 3

Detailed rules for the implementation of paragraph 2 may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 18(2) Article 18(2a). Detailed rules for the implementation of paragraph 2 may be adopted in accordance with the procedure referred to in Article 18(2), following the opinion of the European Food Safety Authority ('the Authority'), where necessary. Council modification

Article 6

1.

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. 2.

Flavourings and/or food

ingredients with flavouring properties produced from source materials listed in Part B of Annex IV may only be used under the conditions indicated in that Annex

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL Council modification

Article 7, Paragraph 1

Flavourings and food ingredients with flavouring properties for which an evaluation and approval is not required 1. The following flavourings

and food ingredients with flavouring properties may be used in or on foods without an approval under this Regulation, provided that they comply with Article 4: (a)

flavouring preparations

referred to in Article 3(2)(d)(i); (b) thermal process flavourings

referred to in Article 3(2)(e)(i) and which comply with the conditions for the production of thermal process flavourings and maximum levels for certain substances in thermal process flavourings set out in Annex V; (c)

flavour precursors referred to

in Article 3(2)(g)(i); food ingredients with flavouring properties.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL Council modification

Article 7, Paragraph 2, Subparagraph 1

Notwithstanding paragraph 1, if the Commission, a Member State or the European Food Safety Authority (`the Authority') expresses doubts concerning the safety of a flavouring or food ingredient with flavouring properties referred to in paragraph 1, a risk assessment of such flavouring or food ingredient with flavouring properties shall be carried out by the Authority. Articles 4 to 6 of Regulation (EC) No [procedural Regulation] shall then apply mutatis mutandis.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 24

Council modification

Article 7, Paragraph 2, Subparagraph 2

If necessary, the Commission shall adopt measures following the opinion of the Authority, in accordance with the regulatory procedure with scrutiny referred to in Article 18(2) Article 18(2a). Such measures shall be laid down in Annexes III, IV and/or V as appropriate. If necessary, the Commission shall adopt measures, following the opinion of the Authority, which are designed to amend non-essential elements of this Regulation, inter alia by supplementing it, in accordance with the regulatory procedure with scrutiny referred to in Article 18(23). Such measures shall be laid down in Annexes III, IV and/or V as where appropriate. On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 18 (4). Council modification

Article 8, Point (c)

thermal process flavourings obtained by heating ingredients which fall partially or totally under Article 3(2)(e)(ii) and/or for which the conditions for the production of thermal process flavourings and/or the maximum levels for certain undesirable substances set out in Annex V are not met;

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL Council modification

Article 9

Of the flavourings and source materials referred to in Article 8, 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.

EP Amendment 41

Council modification

Article 11

A flavouring or source material falling within the scope of Regulation (EC) No 1829/2003 and not already included in the Community list in Annex I to this Regulation may be included in the Community that list in accordance with this Regulation only after it has been authorised if it is covered by an authorisation in accordance with the procedure referred to in Article 7 of Regulation (EC) No 1829/2003. A flavouring or source material falling within the scope of Regulation (EC) No 1829/2003 may be included in the Community list in Annex I in accordance with the present Regulation only after when it has been authorised is covered by an authorisation in accordance with Regulation (EC) No 1829/2003.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL Council modification

Article 11 a (new)

Interpretation decisions

Where necessary, it may be decided in

accordance with the procedure referred to in Article 7 Article 18(2) as to: a)

whether or not a given

substance or mixture of Regulation (EC) No 1829/2003. substances, material or type of food falls within the categories in Article 2 (1) of this Regulation; b)

which specific category

listed in Article 3 paragraph 2 (b) to (j) a given substance belongs. c)

whether or not a particular

product belongs to a food category or is a food referred to in Annex I or Annex III B.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendments 27, 26, 28, 29, 43 and 30

Council modification

LABELLING PROVISIONS

SECTION 1

LABELLING OF FLAVOURINGS

NOT INTENDED FOR SALE TO

THE FINAL CONSUMER

Article 12

Labelling of flavourings not intended

for sale to the final consumer

1.

Flavourings not intended for Flavourings not intended for sale to the final consumer may be marketed only if their packaging, containers or accompanying documents bear the information provided for in Articles 13 and 14, which must be easily visible, clearly legible and indelible.

Flavourings not intended for sale to the final consumer may be marketed only if their packaging, containers or accompanying documents bear with the information labelling provided for in Articles 13 and 14, which must be easily visible, clearly legible and indelible. The information shall be in a language easily understandable to purchasers.

sale to the final consumer may be marketed only if they comply with the labelling provided for in Articles 13 and 14, which must be easily visible, clearly legible and indelible. The information provided for in Article 13 shall be in a language easily understandable to purchasers.

Article 13

General information requirements

2.

Within its own territory, the for labelling of flavourings

Member State in which the product is marketed may, in accordance with the rules of the Treaty, stipulate that this information shall be given in one or more of the official languages of the Community, to be determined by that Member State. This shall not preclude such information from being indicated in several languages.

1.

The packaging or containers Within its own territory, the Member State in which the product is marketed may, in accordance with the rules of the Treaty, stipulate that this information shall be given in one or more of the official languages of the Community, to be determined by

of flavourings not intended for sale to the final consumer shall bear the following information:

(a) the sales description: either the word `flavouring' or a more specific name or description of the flavouring;

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(b) the name or business name Article 13 that Member State. This shall not preclude such information from being indicated in several languages.

and address of the manufacturer or packager, or of a seller established within the Community General labelling requirements for flavourings not intended for sale to the

EP AM 26

; final consumer Article 13

(c) the statement either `for use General information labelling 1. Where flavourings not in food' or the statement `restricted use in food' or a more specific reference to its intended food use; requirements for labelling of intended for sale to the final consumer are sold singly or mixed with each other and/or with other food ingredients and/or to which other substances are added in accordance with Article 3 (4a), their packaging or containers shall bear the following information: flavourings not intended for sale to

the final consumer

(d) a list in descending order of 1. The packaging or containers of weight of: Where flavourings not intended for sale to the final consumer are sold singly or mixed with each other and/or with other food ingredients and/or to which other substances are added in accordance with Article 3 (4a), their packaging or containers shall bear the following information: (i) the categories of flavourings present; and

(ii) the names of each of the (a) the sales description: either the other substances or materials contained in the product, their Enumber and , where appropriate , the indication "produced from GMOs" ;

word `flavouring' or a more specific name or description of the flavouring;

(b) the statement either `for food' EP AM 27

or the statement `restricted use in food' or a more specific reference to its intended food use;

(a) the sales description: either the (e) an indication of the word `flavouring' or a more specific name or description of the flavouring;

maximum quantity of each component or group of components subject to quantitative limitation in food and/or appropriate information in clear and easily understandable terms enabling the purchaser to comply with this Regulation or other relevant Community legislation, including Regulation (EC) No 1829/2003;

address of the manufacturer or packager, or of a seller;

(d) a mark identifying the batch or lot;

(c) the statement either `for use in food' or the statement `restricted use in and on food' or a more specific reference to its intended food use;

(e) a list in descending order of weight of:

EP AM 28

(i) the categories of flavourings (f) if necessary, the special (c) if necessary, the special

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conditions for storage and use; present; and conditions for storage and/or use;

(g) a date of minimum durability; (ii) the names of each of the other (d) a mark identifying the batch substances or materials in the product or, where appropriate, their E-number and an indication in accordance with Regulation (EC) No 1829/2003;

(h) a mark identifying the batch or lot; or lot;

(e) a list in descending order of (i) the net quantity. weight of:

2.

By way of derogation from (i) the categories of flavourings (f) the name or business name and paragraph 1, the information required in points (c) to (g) of that paragraph may appear merely on the documents relating to the consignment which are to be supplied with or prior to the delivery, provided that the indication 'intended for the manufacture of food and not for retail sale' appears on an easily visible part of the packaging or container of the product in question.

present; and

address of the manufacturer or packager, or of a seller;

(ii) the names of each of the other substances or materials contained in the product or, where appropriate, their E-number;

(g) an indication of the maximum quantity of each component or group of components subject to quantitative limitation in food and/or appropriate information in clear and easily understandable terms enabling the purchaser to comply with this Regulation or other relevant Community legislation, including Regulation (EC) No 1829/2003;

(e f) the name or business name and address of the manufacturer or packager, or of a seller;

(g) an indication of the maximum Article 14

quantity of each component or group of components subject to quantitative limitation in food and/or appropriate information in clear and easily understandable terms enabling the purchaser to comply with this Regulation or other relevant Community legislation;

Specific information requirements

for the sales description of

(h) the net quantity; flavourings

1.

The term `natural' may only (i) a date of minimum durability be used to describe a flavouring in the sales description referred to in Article 13(1)(a) as provided for in paragraphs 2 to 6.

or use-by-date;

(j) where relevant, information on a flavouring or other substances referred to in this Article and listed in Annex IIIa to Directive 2000/13/EC as regards the indication of the ingredients present in foodstuffs.

(f) if necessary, the special 2. The term `natural' for the conditions for storage and use

description of a flavouring may only be used if the flavouring component comprises only flavouring

h)

the net quantity;

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preparations and/or natural flavouring substances.

(g i) a date of minimum durability 2. By way of derogation from paragraph 1, the information required in points (e), (g) and (j) of that paragraph may appear merely on the documents relating to the consignment which are to be supplied with or prior to the delivery, provided that the indication 'not for retail sale' appears on an easily visible part of the packaging or container of the product in question.

or use-by-date;

3.

The term "natural flavouring (h) a mark identifying the batch or substance(s)" may only be used for flavourings in which the flavouring component contains exclusively natural flavouring substances.

lot;

(i) the net quantity (j) where relevant, information on a flavouring or other substances referred to in this Article and listed in Annex IIIa to Directive 2000/13/EC as regards the indication of the ingredients present in foodstuffs.

4.

The term "natural" may only be used in combination with a reference to a food, food category or a vegetable or animal flavouring source if at least 95% [by w/w] of the flavouring component has been obtained from the source material referred to.
3.

By way of derogation from paragraph 1 of this article, where flavourings are supplied in tankers all of the information may appear merely on the accompanying documents relating to the consignment which are to be supplied with the delivery.
2.

By way of derogation from EP AM 29

paragraph 1, the information required in points (c) to e) and (g) of that paragraph may appear merely on the documents relating to the consignment which are to be supplied with or prior to the delivery, provided that the indication 'intended for the manufacture of food and not for retail sale' appears on an easily visible part of the packaging or container of the product in question.

The flavouring component may contain flavouring preparations and/or natural flavouring substances.

The description shall read "natural <<food(s) or food category or source(s)>> flavouring". Article 14 Specific requirements for use of the

term "natural"

5.

"Natural <<food(s) or food 1. If the term `natural' is used to category or source(s)>> flavouring with other natural flavourings" may only be used if the flavouring component is partially derived from the source material referred to and can easily be recognised. describe a flavouring in the sales description referred to in Article 13(1)(a) the provisions in paragraphs 2 to 6 shall apply. 3. By way of derogation from paragraph 1 of this article, where flavourings are supplied in tankers all of the information may appear merely on the accompanying documents relating to the
2.

The term `natural' for the description of a flavouring may only be used if the flavouring component comprises only flavouring

The flavouring component may contain flavouring preparations

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and/or natural flavouring substances. preparations and/or natural flavouring substances. consignment which are to be supplied with the delivery.

6.

The term "natural flavouring" may only be used if the flavouring component is derived from different source materials and where a reference to the source materials would not reflect their flavour or taste, and in the circumstances described in paragraphs 4 and 5 . 3. The term "natural flavouring substance(s)" may only be used for flavourings in which the flavouring component contains exclusively natural flavouring substances.

Article 14

Specific information requirements for

the sales description of flavourings use of the term "natural"

The term `natural' may only be

1.

The If the term `natural' may used in combination with a reference to a food, food category or a vegetable or animal flavouring source, if the flavouring component has been obtained exclusively or by at least [90%] [by w/w] from the source material referred to.

AM 43

only be is used to describe a flavouring in the sales description referred to in Article 13(1)(a) as provided for the provisions in paragraphs 2 to 6 shall apply.

The flavouring component may contain flavouring preparations and/or natural flavouring substances.

SECTION 2

2.

The term `natural' for the description of a flavouring may only be used if the flavouring component comprises only flavouring preparations and/or natural flavouring substances.

LABELLING OF

The maximum of [10%] (w/w) of the flavouring component derived from other source materials shall not reproduce the flavour of the source material referred to.

FLAVOURINGS INTENDED

FOR SALE TO THE FINAL

CONSUMER

Article 15

Labelling of flavourings intended for 3. The term "natural flavouring The description shall read "natural <<food(s) or food category or source(s)>> flavouring".

sale to the final consumer substance(s)" may only be used for flavourings in which the flavouring component contains exclusively natural flavouring substances. 1. 1. Without prejudice to Directive 2000/13/EC, Directive 89/396/EEC and, where appropriate, Regulation (EC) No 1829/2003, flavourings intended for sale to the final consumer may be marketed only if their packaging contains the statement either "for use in food" or the statement "restricted

5.

"Natural <<food(s) or food category or source(s)>> flavouring with other natural flavourings" may only be used if the flavouring component is partially derived from the source material referred to the flavour of which can easily be
4.

The term `natural' may only be used in combination with a reference to a food, food category or a vegetable or animal flavouring source, if at least 90% [by w/w] of the flavouring component has been obtained

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use in food" or a more specific reference to its intended food use, which must be easily visible, clearly legible and indelible. recognised. exclusively or by at least [90%] [by w/w] from the source material referred to.

6.

The term "natural flavouring" may only be used if the flavouring component is derived from different source materials and where a reference to the source materials would not reflect their flavour or taste.

EP AM 30

The maximum of [10%] (w/w) of the flavouring component may contain flavouring preparations and/or natural flavouring substances derived from other source materials shall not reproduce the flavour of the source material referred to.

2.

The term `natural' shall be used to describe a flavouring in the sales description referred to in Article 13(1)(a) only as provided for in Article 14.

Article 15

Labelling of flavourings intended for

sale to the final consumer

The description shall read "natural <<food(s) or food category or source(s)>> flavouring".

1.

Without prejudice to Directive 2000/13/EC, Directive 89/396/EEC and to Regulation (EC) No 1829/2003, flavourings sold singly or mixed with each other and/or with other food ingredients and/or to which other substances are added intended for sale to the final consumer may be marketed only if their packaging contains the statement either `for food' or the statement `restricted use in food' or a more specific reference to its intended food use, which must be easily visible, clearly legible and indelible.
5.

"Natural <<food(s) or food category or source(s)>> flavouring with other natural flavourings" may only be used if the flavouring component is partially derived from the source material referred to and, the flavour of which can easily be recognised.

The flavouring component may contain flavouring preparations and/or natural flavouring substances.

6.

The term "natural flavouring" 2. If the term `natural' is used to may only be used if the flavouring component is derived from different source materials and where a reference to the source materials would not reflect their flavour or taste.

describe a flavouring in the sales description referred to in Article 13(1)(a), Article 14 shall apply.

Article 16

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The flavouring component Other labelling requirements 7.

may contain flavouring preparations and/or natural flavouring substances.

Articles 12 to 15 shall apply without prejudice to more detailed or more extensive laws, regulations or administrative provisions regarding weights and measures or applying to the presentation, classification, packaging and labelling of dangerous substances and preparations or applying to the transport of such substances.

SECTION 2

LABELLING OF FLAVOURINGS

INTENDED FOR SALE TO THE

FINAL CONSUMER

Article 15

Labelling of flavourings intended for

sale to the final consumer

1.

Without prejudice to Directive 2000/13/EC, Directive 89/396/EEC and to Regulation (EC) No 1829/2003, flavourings sold singly or mixed with each other and/or with other food ingredients and/or to which other substances are added intended for sale to the final consumer may be marketed only if their packaging contains the statement either `for use in food' or the statement `restricted use in food' or a more specific reference to its intended food use, which must be easily visible, clearly legible and indelible.
2.

The If the term `natural' shall be is used to describe a flavouring in the sales description referred to in Article 13(1)(a) only as provided for in), Article 14 shall apply.

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Article 15a

Other labelling requirements

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 31 - Article 16, Paragraph 1 and a (new)

Council modification Article 16, Paragraph 1b (new)

1.

The food business operators or their representatives shall report to the Commission the annual amounts of flavouring substances added to foods in the Community and the use levels for each food category in the Community. 1. The food business operators A producer or user of a flavouring substance, or their representatives, shall report to, at the request of the Commission the annual amounts of flavouring substances, inform it of the amount of the substance added to foods in the Community and in a period of 12 months as well as the use levels for each food category specific food categories in the Community. Such information shall be made available to Member States by the Commission. 1. A producer or user of a flavouring substance shall inform the Commission immediately of any new scientific or technical information which is known and accessible to him which might affect the assessment of the safety of the flavouring substance.

1a. Where applicable, for a flavouring already approved under this Regulation which is prepared by production methods or starting materials significantly different from those included in the risk assessment of the Authority, before marketing the flavouring a producer or user shall submit to the Commission the necessary data to allow an evaluation of the flavouring with regard to the modified production method or characteristics to be undertaken by the Authority.

1a. The food industry user of the flavouring containing the flavouring substance and the producer of the flavouring shall in cooperation, at the request of the Commission, inform it of the actual use of the flavouring substance. The information provided in this context shall be treated as confidential data.

1b. A producer or user of flavourings and/or source materials shall inform the Commission immediately of any new scientific or technical information which might affect the assessment of the safety of the flavouring and/or source materials.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL Council modification

Article 17, Paragraph 1

Member States shall establish systems to monitor the consumption and use of flavourings set out in the Community list and the consumption of the substances listed in Annex III on a risk based approach and report their findings each year with appropriate frequency to the Commission and to the Authority

EP Amendment 32

Article 17, Paragraph 2

After the Authority has been consulted, a common methodology for the gathering of information by the Member States on the consumption and use of flavourings set out in the Community list and of the substances listed in Annex III may shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 18(2) Article 18(2a) . After the Authority has been consulted, a common methodology for the gathering of information by the Member States on the consumption and use of flavourings set out in the Community list and of the substances listed in Annex III may shall be adopted in accordance with the procedure referred to in Article 18(2) within two years after entry into force of this Regulation.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 33 Article 18, Paragraph 2a (new) - Council modification - Article 18, Paragraphs 3 and 4

2a. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 4.

Where reference is made to

this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

EP Amendment 34

Council modification

Article 19

Amendments to Annexes II to V to this Regulation to reflect scientific and technical progress shall be adopted in accordance with regulatory procedure with scrutiny referred to in Article 18(2) Article 18(2a). Amendments to Annexes II to V to this Regulation to reflect scientific and technical progress which are designed to amend non-essential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 18( 2 3), following the opinion of the Authority, where necessary. On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 18 (4).

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL Council modification

Article 21

1.

Directive 88/388/EEC, Decision 88/389/EEC and Directive 91/71/EEC are repealed from the date of the application referred to in Article 27, paragraph 2. 2.

Regulation (EC) No 2232/96

is repealed from the date of application of the list referred to in Article 2(2) of that Regulation. 3.

References to the repealed

acts shall be construed as references to this Regulation.

Council modification

Article 22, Title and Paragraph 1

Establishment of Introduction of the list of flavouring substances in the Community list of flavourings and source materials and transitional regime 1.

The Community list shall be

established by placing introducing the list of flavouring substances referred to in Article 2(2) of Regulation (EC) No 2232/96 in Annex I to this Regulation at the time of its adoption.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 35

Article 22, Paragraph 3

Any appropriate transitional measures may which are designed to amend non-essential elements of this Regulation, inter alia by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 18(2 3). Any appropriate transitional measures may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 18(2) Article 18(2a).

Council modification

Article 23, Paragraph 5

In Article 4(5), the first and second paragraphs, excluding the lists in points (a) and (b), shall be replaced by the following: "Only natural flavouring substances and flavouring preparations as defined in Article 3(2)(b) (c) and (d) of Regulation (EC) No [...] may be used in the preparation of the spirit drinks defined in Article 1(4), except in the case of those defined in Article 1 (4) (m), (n) and (p). However, flavouring substances as defined in Article 3(2) (b) of Regulation (EC) No [...] and flavouring preparations as defined in Article 3(2)(d) of that Regulation shall be authorized in liqueurs except those mentioned below:"

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 36

Council modification

Article 26, paragraph 1, indent 1

"flavourings" or a more specific name or description of the flavouring, if the flavouring component contains flavourings as defined in Article 3(2)(b), (c), (d), (e), (f), (g) and (h) of Regulation (EC) No [...] of the European Parliament and of the Council* [Regulation on flavourings]; "flavourings" or a more specific name or description of the flavouring, if the flavouring component contains flavourings as defined in Article 3(2)(b), (c), (d), (e), (f), (g) and (h) of Regulation (EC) No [...] of the European Parliament and of the Council [on flavourings];

EP Amendment 37

Council modification

Article 26, paragraph 1, indent 2

"smoke flavouring(s)", or a more specific name or description of the smoke flavouring(s), if the flavouring component contains flavourings as defined in Article 3 (2) (f) of Regulation EC No [...] [on flavourings] and imparts a smoky flavour to the food.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL Council modification

Article 26, paragraph 2, indent 2

The use of the term `natural' for the description of flavourings shall be used as laid down in accordance with Article 14 of Regulation (EC) No [...] [Regulation on flavourings]."

EP Amendment 38

Article 26, paragraph 2 a (new)

For flavourings produced from a source material falling under the scope of Regulation (EC) No 1829/2003, the indication "produced from GMOs" shall appear on the label.

For flavourings produced by an organism falling under the scope of Regulation (EC) No 1829/2003, no specific labelling shall be required.

Council modification

Article 27, Paragraph 1

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

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EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 44 - Article 27, Paragraph 2

Council modification - Paragraph 2 and 3

It shall apply from [please insert date] [24 months after entry into force]. However, Articles 9, 23 and 24 Article 9 shall apply from the date of application from ...* of the Community list. 2. It shall apply from [please insert date] [24 months after entry into force]. 3.

However Articles 9, 23 and 24

shall apply from the date of application of the Community list. and

______________

*

18 months after the entry into force

Council modification

Article 27, Paragraph 4

Article 19 shall apply from the date of the entry into force of this Regulation. Foods lawfully placed on the market or labelled prior to [24 months after the entry into force of this Regulation] which do not comply with this Regulation may be marketed until their date of minimum durability.

EP Amendment 39

Article 27, Paragraph 2 a (new)

Flavourings and food placed lawfully on the market before the abovementioned dates may continue to be used until stocks have been exhausted.

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ANNEX II

List of traditional food preparation processes by which natural flavouring substances and natural

flavouring preparations are obtained

Chopping Coating Cooking Heating, cooking, baking, frying (up to 240°C at atmospheric pressure) and pressure cooking (up to 120 °C) Cooling Cutting Distillation / rectification Drying Emulsification Evaporation Extraction, incl. solvent extraction in accordance with Directive 88/344/EEC Fermentation Filtration Grinding Heating Infusion Maceration Microbiological processes Mixing Peeling Percolation Pressing Refrigeration/Freezing Roasting / Grilling Squeezing Steeping

EP OPINION - FIRST READING COUNCIL POSITION COMPROMISE PROPOSAL EP Amendment 40

Annex III, Part B, Table

left blank See next pages

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ANNEX III

Presence of certain substances

Part A: Substances which may shall not be added as such to food

Agaric acid

Aloin

Capsaicin

1,2-Benzopyrone, coumarin

Hypericine

Beta-asarone

1-Allyl-4-methoxybenzene, estragole

Hydrocyanic acid

Menthofuran

4-Allyl-1,2-dimethoxybenzene, methyleugenol

Pulegone

Quassin

1-Allyl-3,4-methylene dioxy benzene, safrole

Teucrin A

Thujone (alpha and beta)

Part B: 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.

Name of the Compound food in which the presence of the substance is restricted Maximum level

substance [mg/kg] Beta-asarone Alcoholic beverages 1.0 1-Allyl-4methoxybenzene, Dairy products 50 Processed fruits, vegetables (incl. 50 mushrooms, fungi, roots, tubers, pulses and legumes), nuts and seeds

estragol

Fish products 50 Non-alcoholic beverages 10 Hydrocyanic acid Nougat, marzipan or its substitutes or similar products 50 Canned stone fruits 5 Alcoholic beverages 35 Menthofuran Mint/peppermint containing confectionery, except 500 micro breath freshening confectionery

Micro breath freshening confectionery* 3000 Chewing gum 1000 Mint/peppermint containing alcoholic 200 beverages

4-Allyl-1,2dimethoxybenzene, Dairy products 20 Meat preparations and meat products, including poultry and game 15 methyleugenol

Fish preparations and fish products 10

Soups and sauces 60 Ready-to-eat savouries 20 Non-alcoholic beverages 1 Pulegone Mint/peppermint containing confectionery, except 250 micro breath freshening confectionery

Micro breath freshening confectionery* 2000 Chewing gum 350 Mint/peppermint containing non-alcoholic beverages 20 Mint/peppermint containing alcoholic 100 beverages

Quassin Non-alcoholic beverages 0,5 Bakery wares 1 Alcoholic beverages 1.5 1-Allyl-3,4methylene Meat preparations and meat products, including poultry and game 15 dioxy

benzene, safrole

Fish preparations and fish products 15 Soups and sauces 25 Non-alcoholic beverages 1 Teucrin A Alcoholic beverages 2

Thujone (alpha and beta) Alcoholic beverages, except those produced from Artemisia species 10 Alcoholic beverages produced from 35 Artemisia species

Non-alcoholic beverages produced from Artemisia species

0,5

Coumarin [...] [...]

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publicatiedatum	02-10-2007
kenmerk	13210/07