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

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1.

Tekst

In view of the Working Party meeting on 17 and 18 September 2007, delegations will find

attached Presidency suggestions for possible compromises on the above-mentioned

Regulation with a view to reach agreement with the European Parliament on the basis of a

Council's common position.

________________

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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.

Recital 5a (new)

Council modification

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DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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. Recital 6

EP Amendment 1 covered by Council modification Council modification

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DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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.

Recital 8a (new)

Council modification

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DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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.

Recital 9

Council modification

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].

Recital 11

acceptable EP Amendment 2

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DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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 [...].

Recital 12

Council modification

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DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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.

Recital 13

Council modification

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DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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.

Recital 14

Council modification

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PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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.

Recital 15

Council modification

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.

Recital 17

Council modification

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PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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.

Recital 18

Council modification

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.

Recital 19a (new)

Council modification

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DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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 to that Regulation, prior to its approval as well as under this Regulation. 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. Recital 20

EP Amendment 42 covered by Council modification Council modification

Food flavourings should remain subject to the general labelling obligations as provided for in Directive 2000/13/EC and, where appropriate, in Regulation (EC) No 1829/2003. In addition, specific provisions on labelling of flavourings sold as such to the manufacturer or to the final consumer should be included in this Regulation. 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. Recital 22a (new)

EP Amendment 5

acceptable

Recital 20a (new)

Council modification

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DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

Specific information requirements should ensure that consumers are not misled concerning the source material used for the production of natural flavourings. The source of vanillin obtained from wood will, for example, have to be mentioned. 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 Recital 22

EP Amendment 4 covered by Council modification Council modification

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DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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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PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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.

Recital 23

Council modification

Recital 25

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

Footnote acceptable EP Amendment 6

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DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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 non-essential elements of this Regulation, and/or to supplement it by the addition of new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Recital 25a (new)

Council modification

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.

Recital 25b (new)

Council modification

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PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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.

Recital 26

Council modification

Since the objective of the action to be taken, namely to lay down Community rules on the use of flavourings and certain food ingredients with flavouring properties in and on foods, cannot be sufficiently achieved by the Member States and can therefore, by reason of market unity and high level of consumer protection, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity subsidiary as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

Recital 29

Council modification

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PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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. Article 1

Paragraph 1

covered by Council modification

EP Amendment 7

Council modification

Article 2

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; Paragraph 1

Point (a) acceptable EP Amendment 8

Council modification

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DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

Article 2

Paragraph 1

food containing flavourings and and/or food ingredients with flavouring properties; food containing flavourings and/or food ingredients with flavouring properties; Point (c) acceptable EP Amendment 9

Council modification

Article 2

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

Paragraph 1

Point (d)

Council modification

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PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

Article 2 (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; Paragraph 2 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. Point (c)

covered by Council modification

EP Amendment 45

and Point (c) (new)

Council modification

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.

Article 2

not acceptable. Already covered in Article 11 a (new)

Paragraph 3

EP Amendment 11

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DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

Article 3

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];

Paragraph 2

not acceptable. Already covered in Article 3 paragraph 4a (new)

Point (a), (II a) (new)

EP Amendment 12

Article 3 "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 Paragraph 2

Point (B) not acceptable EP Amendment 49

Council modification

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DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

'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;

Article 3

Paragraph 2

Point (c)

Council modification

'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;

Article 3

Paragraph 2

Point (d)

Council modification

and/or

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PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

  • 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;

Article 3

"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);

Paragraph 2

not acceptable Point (h)

EP Amendment 13

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DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

`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;

"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;

Article 3

Paragraph 2

Point (i) covered by Council modification EP Amendment 14

Council modification

Article 3

"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;

Paragraph 2

not acceptable Point (j a) (new)

EP Amendment 52

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DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

"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. Article 3

Paragraph 2

Point (k)

EP Amendment 15

Council modification

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. Article 3

Paragraph 3

Council modification

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PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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).

Article 3

not acceptable. Already covered in Article 11a (new)

Paragraph 4

EP Amendment 16

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.

Article 3

Paragraph 4 a (new)

Council modification

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 Article 4

Point (a)

not acceptable

EP Amendment 17

Council modification

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PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

Article 4,

their use has advantages and benefits for the consumer;

Point (b a) (new) not acceptable EP Amendment 19

Article 4

there is a reasonable technological need

Point (b b) (new) not acceptable EP Amendment 20

Prohibition of non-compliant flavourings and/or non-compliant foodstuffs

Article 4a (new)

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.

Council modification

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DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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

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.

Article 5

Paragraph 2

covered by Council modification

EP Amendment 21

dried

Council modification

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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PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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.

Article 5

Paragraph 2 A (new) not acceptable EP Amendment 46

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. Article 5

Paragraph 3

not acceptable

EP Amendment 23

Council modification

  • 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.

Article 6

  • 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

Council modification

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PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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 Article 7

to in Article 3(2)(d)(i);

Paragraph 1

(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;

Council modification

(c) flavour precursors referred to in Article 3(2)(g)(i);

(d) food ingredients with flavouring properties.

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PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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.

Article 7

Paragraph 2

Subparagraph 1

Council modification

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EP amendments

Reference Council position (First reading)

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). Article 7

Paragraph 2

Subparagraph 2 covered by Council modification EP Amendment 24

Council modification

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;

Article 8

Point (c)

Council modification

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PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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.

Article 9

Council modification

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 Article 11

when it has been

EP Amendment 41 covered by Council modification authorised is covered by an authorisation in accordance with Regulation (EC) No 1829/2003.

Council modification

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PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

Interpretation decisions

Where necessary, it may be decided in accordance with the procedure referred to in Article 7 Article 18(2) as to:

Article 11 a (new)

Council modification

  • 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 amendments

Reference Council position (First reading)

CHAPTER IV

Council modification: Articles 12 to 15a (new)

EP amendments: 27; 26; 28; 29; 43 and 30

LABBELING For labelling provisions see Annex I Articles 12 to 15

  • 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.

Article 16

Paragraph 1 and a(new)

  • 1. 
    A producer or user of a flavouring EP Amendment 31

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.

Paragraph 1b(new)

Council modification

1a. Where applicable, for a

flavouring already approved under this Regulation which is prepared by production methods or starting materials significantly different from

1a. The food industry user of the flavouring containing the flavouring substance and the producer of the

covered by Council modification

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PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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. 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. 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

.

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

Article 17

Paragraph 1 Council modification

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PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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. Article 17

Paragraph 2 not acceptable EP Amendment 32

  • 3. 
    Where reference is made to 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.

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.

Article 18

Paragraph 2a (new)

EP Amendment 33 covered by Council modification

  • 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.

Paragraphs 3 and 4

Council modification

12502/07

DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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.

Article 19

EP Amendment 34 covered by Council modification Council modification On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 18 (4).

12502/07

DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

Article 21 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. Council modification

  • 3. 
    References to the repealed acts shall be construed as references to this Regulation.

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

Article 22

Title and Paragraph 1 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.

Council modification

12502/07

DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

Any appropriate transitional measures may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 18(2) Article 18(2a).

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).

Article 22

Paragraph 3 covered by Council modification EP Amendment 35

12502/07

DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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).

Article 23

Paragraph 5 Council modification

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:"

12502/07

DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

"flavourings" or a more specific name

"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];

Article 26

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];

paragraph 1

indent 1

acceptable

EP Amendment 36

Council modification

"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. Article 26

paragraph 1

indent 2

not acceptable

EP Amendment 37

Council modification

Article 26

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]."

paragraph 2

indent 2

Council modification

12502/07

DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

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.

Article 26

paragraph 2 a (new) not acceptable EP Amendment 38

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

Article 27

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

Paragraph 1 Council modification

  • 2. 
    It shall apply from [please insert Article 27

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. ______________ * 18 months after the entry into force

date] [24 months after entry into force].

Paragraph 2

  • 3. 
    However Articles 9, 23 and 24 shall apply from the date of application of the Community list. and

EP Amendment 44

not acceptable

Paragraph 2 and 3

Council modification

12502/07

DG I

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

Article 19 shall apply from the date of the entry into force of this Regulation.

Article 27

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.

Paragraph 4

Council modification

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

Article 27

Already covered by

Paragraph 2 A (new)

Paragraph 4

EP Amendment 39

12502/07

DG I

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

PROPOSAL ON FOOD FLAVOURINGS

EP amendments

Reference Council position (First reading)

Annex III,

Part B,

See next pages

left blank not acceptable Table

EP Amendment 40

12502/07

DG I

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 [...] [...]

ANNEX I

Council modifications (doc. 11829/1/07 REV1) with related EP amendments

CHAPTER IV

LABELLING

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

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.

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 that Member State. This shall not preclude such information from being indicated in several languages.

Article 13

General information labelling requirements for labelling of flavourings not intended for sale

to the final consumer

  • 1. 
    The packaging or containers 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:

(a) the sales description: either the word `flavouring' or a more specific name or description of the flavouring; (b) the name or business name and address of the manufacturer or packager, or of a seller; (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;

(c) if necessary, the special conditions for storage and/or use; (d) a mark identifying the batch or lot; (e) a list in descending order of weight of: (i) the categories of flavourings present; and (ii) the names of each of the other substances or materials contained in the product

or, where appropriate, their E-number;

EP 27: Article 13, paragraph 1, point (d) (ii):

[(ii) the names of each of the other substances or materials contained in the product or, where appropriate, their E-number and, where appropriate, the indication "produced from GMOs";]

Compromise proposal: not acceptable.

(e f)

the name or business name and address of the manufacturer or packager, or of a

seller;

EP 26: Article 13, paragraph 1, point (b):

[(b) the name or business name and address of the manufacturer or packager, or of a seller

established within the Community;]

  • : 
    acceptable

Compromise proposal

(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;

EP 28: Article 13, paragraph 1, point (e):

[(e) 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;]

Compromise proposal: acceptable

(f) if necessary, the special conditions for storage and use h) the net quantity; (g i) a date of minimum durability or use-by-date;

(h) a mark identifying the batch or 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.

  • 2. 
    By way of derogation from 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. 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.

Article 14

Specific information requirements for the sales description of flavourings

use of the term "natural"

  • 1. 
    The If the term `natural' may 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.

  • 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.
  • 3. 
    The term "natural flavouring substance(s)" may only be used for flavourings in which the flavouring component contains exclusively natural flavouring substances.

The term `natural' may only be used in combination with a reference to a food, food

4.

category or a vegetable or animal flavouring source, if at least 90% [by w/w] of the

flavouring component has been obtained exclusively or by at least [90%] [by w/w]

from the source material referred to.

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.

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

flavouring".

EP 29: Article 14, paragraph 4, subparagraph 1:

[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% 95% [by w/w] of the flavouring component has been obtained from the source material referred to.]

Compromise proposal: not acceptable

  • 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.

The term "natural flavouring" may only be used if the flavouring component is derived

6.

from different source materials and where a reference to the source materials would not

reflect their flavour or taste.

7.

EP 43: Article 14, paragraph 6, subparagraph 1:

[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.]

Compromise proposal: not acceptable

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

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.

EP 30: Article 15, paragraph 1:

[1. Without prejudice to Directive 2000/13/EC, Directive 89/396/EEC and, where

appropriate, Regulation (EC) No 1829/2003, flavourings sold 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.]

Compromise proposal: Covered by Council modification

  • 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.

Article 15a

Other labelling requirements

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.

________________

2.

Originele weergave

afbeelding document
 
 

3.

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