RECOMMENDATION FOR SECOND READING on the Council common position for adopting 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 Regulations (EEC) No 1576/89 and (EEC) No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC

13.5.2008 - (16677/3/2007 – C6‑0139/2008 – 2006/0147(COD)) - ***II

Committee on the Environment, Public Health and Food Safety
Rapporteur: Mojca Drčar Murko

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the Council common position for adopting 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 Regulations (EEC) No 1576/89 and (EEC) No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC

(16677/3/2007 – C6‑0139/2008 – 2006/0147(COD))

(Codecision procedure: second reading)

The European Parliament,

–   having regard to the Council common position (16677/3/2007 – C6‑0139/2008),

–   having regard to its position at first reading[1] on the Commission proposal to Parliament and the Council (COM(2006)0427),

–   having regard to Article 251(2) of the EC Treaty,

–   having regard to Rule 62 of its Rules of Procedure,

–   having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Food Safety (A6‑0177/2008),

1.  Approves the common position as amended;

2.  Instructs its President to forward its position to the Council and Commission.

Amendment  1 Council common position – amending act Recital 6
Council common position	Amendment
(6) 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 within the scope of this Regulation.	(6) 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 do not fall within the scope of this Regulation.
Justification
There is evidence that a herb does not display the same toxicological effect of concern as an individual component within. Setting maximum levels for such components may lead to increased use of herb extracts, and questions remain as to whether this will provide greater consumer protection.
Amendment  2 Council common position – amending act Recital 7
Council common position	Amendment
(7) Flavourings and food ingredients with flavouring properties should 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. Their use must 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 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.	(7) Flavourings and food ingredients with flavouring properties should 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. Their use must 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 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.
Justification
First part of the amendment (1) adopted by Parliament at the first reading, which was deleted by the Council. Inclusion of the development of taste preferences in children indicates Parliament’s moderate approach in regard of use of flavourings in foods.
Amendment  3 Council common position – amending act Recital 10
Council common position	Amendment
(10) 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 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. 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.	(10) Should certain naturally occurring undesirable substances in compound foods pose a risk to the health of the consumer and maximum levels be set following the opinion of the Authority, Member States should organise controls on a risk basis in line with Regulation (EC) No 882/2004 of the European Parliament and of Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. Food producers are 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.
Justification
This recital is new. Rapporteur proposes the amendment aiming at bringing it into line with the agreed Parliament’s position on certain undesirable substances occurring naturally in compound foods (in particular with the amendments 13 to the Article 5, paragraph 2 and amendment 23 to the Part B of Annex III).
Amendment  4 Council common position – amending act Recital 13
Council common position	Amendment
(13) 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 procedure laid down in Regulation (EC) No …/… of … establishing a common authorisation procedure for food additives, food enzymes and food flavourings.	(13) 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 …/… of ... establishing a common authorisation procedure for food additives, food enzymes and food flavourings.
Justification
Amendment (2) adopted at the first reading aiming at placing the precautionary principle in the centre of the flavourings’ risk assessments.
Amendment  5 Council common position – amending act Recital 23
Council common position	Amendment
(23) A flavouring or a source material which falls within 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 subject to the authorisation procedure under that Regulation with regard to the safety assessment of the genetic modification, while the final authorisation of the flavouring or source material should be granted under this Regulation.	(23) 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 as well as under this Regulation.
Justification
This amendment has been agreed by the Parliament at the first reading. The duplication of approval procedures should be avoided. The rapporteur believes that consistent approach across three regulations affecting flavourings, additives and enzymes is needed.
Amendment  6 Council common position – amending act Article 1 - paragraph 1
Council common position	Amendment
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 and protection of consumers' interests, including fair practices in food trade, taking into account, where appropriate, the protection of the environment.	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 including fair practices in food trade, taking into account, where appropriate, the protection of the environment.
Justification
Amendment (7) adopted at the first reading - in doubt for the consumer - is considered a guideline for interpreting possibly ambiguous provisions of the Regulation.
Amendment  7 Council common position – amending act Article 2 - paragraph 2 - point (c)
Council common position	Amendment
(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.	(c) non-compound foods and mixtures such as, but not exclusively, fresh, dried or frozen spices and/or herbs, mixtures of tea and mixtures for infusion as such.
Justification
This amendment reinstates the Parliament's position at First Reading
Amendment  8 Council common position – amending act Article 2 - paragraph 2 a (new)
Council common position	Amendment
	2a. Where necessary, it may be decided in accordance with the regulatory procedure with scrutiny referred to in Article 21(3) whether or not a given substance or mixture of substances, material or type of food falls within the scope of this Regulation.
Justification
This amendment (11) is needed in order to bring the text into line with the provisions of the new comitology procedure.
Amendment  9 Council common position – amending act Article 3 - paragraph 2 - point k
Council common position	Amendment
(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, inter alia, the use of singlet oxygen, ozone, inorganic catalysts, metal catalysts, organometallic reagents and/or UV radiation.	(k) "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, inter alia, the use of singlet oxygen, ozone, inorganic catalysts, metal catalysts, organometallic reagents and/or UV radiation.
Justification
This amendment (15) was agreed by the Parliament at the first reading. It takes into consideration traditional food processes, but it was not accepted by the Council.
Amendment  10 Council common position – amending act Article 4 - point a
Council common position	Amendment
(a) they do not, on the basis of the scientific evidence available, pose a safety risk to the health of the consumer and	(a) they do not, on the basis of the scientific evidence available and the precautionary principle, pose a safety risk to the health of the consumer and
Justification
Amendment (17) adopted at the first reading. As in the current legislation on food additives, a clear benefit for the consumer must be a central requirement in the authorization process for flavourings.
Amendment  11 Council common position – amending act Article 4 - point b a (new)
Council common position	Amendment
	(ba) their use has advantages and benefits for the consumer, and
Justification
The amendment (19) adopted at the first reading aims at balancing advantages and disadvantages in adding flavourings to food.
Amendment  12 Council common position – amending act Article 4 - point b b (new)
Council common position	Amendment
	(bb) there is a reasonable technological need.
Justification
Amendment (20) adopted by the Parliament at the first reading underlines the Parliament's position in regard of the authorization process of flavourings. Both amendments (11 and 12) aim at recommending moderate use of flavourings in food.
Amendment  13 Council common position – amending act Article 6 - paragraph 2
Council common position	Amendment
2. Without prejudice to Regulation (EC) 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 of the substances set out in Annex III shall apply to foods as marketed, unless otherwise stated. By way of derogation from this principle, for dried and/or concentrated foods which need to be reconstituted, the maximum levels shall apply to the food as reconstituted according to the instructions on the label, taking into account the minimum dilution factor.	2. When there is a justified scientific concern that certain substances, naturally present in flavourings and food ingredients with flavouring properties, in 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.
Justification
Amendment (21) agreed by the Parliament at the 1st reading. The purpose of extending the scope of the regulation to include food ingredients with flavouring properties is to assist in the control of certain substances naturally present in flavourings and food ingredients with flavouring properties. The maximum levels should be listed in Part B of Annex III following the opinion of the Authority when justified scientific concern has been raised that those substances in compound foods may pose a safety concern to the health of the consumer.
Amendment  14 Council common position – amending act Article 6 - paragraph 2 a (new)
Council common position	Amendment
	2a. 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.
Justification
The amendment (46) agreed by the Parliament at the first reading. There is no scientific evidence that an herb displays the same toxicological effect of concern that an isolated component within it. Setting maximum levels for such components may lead to increased use of herb extracts and the Parliament doubts whether this will provide better consumer protection.
Amendment  15 Council common position – amending act Article 12
Council common position	Amendment
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 this Regulation only when it is covered by an authorisation in accordance with Regulation (EC) No 1829/2003.	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 that list in accordance with this Regulation only if it is covered by an authorisation in accordance with Regulation (EC) No 1829/2003.
Justification
This amendment has been agreed by the Parliament at the first reading. The duplication of approval procedures should be avoided. The rapporteur believes that consistent approach across three regulations affecting flavourings, additives and enzymes is needed.
Amendment  16 Council common position – amending act Article 15 - paragraph 1 - point (f)
Council common position	Amendment
(f) the name or business name and address of the manufacturer, packager or seller;	(f) the name or business name and address of the manufacturer, packager or seller established in the Community;
Justification
Amendment 26, adopted by Parliament at first reading, is intended to ensure traceability and should be applied to the provisions on labelling of Directive 2000/13/EC as regards the final consumer. It follows that the operator should be established in the EU.
Amendment  17 Council common position – amending act Article 15 - paragraph 2
Council common position	Amendment
2. By way of derogation from paragraph 1, the information required in points (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 "not for retail sale" appears on an easily visible part of the packaging or container of the product in question.	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.
Justification
In contrast to the Commission amended proposal (24/10/07)the Common position does not foresee the possibility to include information on flavouring or other substances referred to in this Article and listed in Annex III a to Directive 2000/13/EC (i.e. allergen labelling), in the accompanying documents. The Rapporteur proposes to extend the possibility to give certain information on the documents relating to the consignment of containers of flavourings not intended for sale to the final consumer.
Amendment  18 Council common position – amending act Article 16 - paragraph 4 - subparagraph 1
Council common position	Amendment
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 the flavouring component has been obtained exclusively or by at least 95% by w/w from the source material referred to. The maximum of 5% (w/w) of the flavouring component derived from other source materials shall not reproduce the flavour of the source material referred to.	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 the flavouring component has been obtained exclusively or by at least 95% by w/w from the source material referred to.
Justification
This amendment has been agreed by the Parliament at the first reading. The Rapporteur believes that there should be no restriction to the 5% of the flavouring component derived from other source material as long as other source materials are also natural, and hence the total 100% is obtained from natural sources.
Amendment  19 Council common position – amending act Article 16 - paragraph 6
Council common position	Amendment
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.	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.
Justification
This amendment was adopted by Parliament at the first reading. The rapporteur proposes its reinstatement.
Amendment  20 Council common position – amending act Article 19 - paragraph 1
Council common position	Amendment
1. A producer or user of a flavouring substance, or the representative of such producer or user, shall, at the request of the Commission, inform it of the amount of the substance added to foods in the Community in a period of 12 months as well as the use levels for 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, or the representative of such producer or user, shall, at the request of the Commission, inform it of the amount of the substance added to foods in the Community in a period of 12 months. The information provided in this context shall be treated as confidential data. Information on the use levels for specific categories in the Community shall be made available to Member States by the Commission.
Justification
The Rapporteur reintroduces reworded part of the adopted amendment 31, which was deleted by the Council.
Amendment  21 Council common position – amending act Article 19 -paragraph 3
Council common position	Amendment
3. 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.	3. A producer or user of flavourings and/or source materials shall inform the Commission immediately of any new scientific or technical information which is known and accessible to him and which might affect the assessment of the safety of the flavouring substance.
Justification
Part of the amendment (31) agreed by the parliament at the 1st reading.
Amendment  22 Council common position – amending act Article 20 - paragraph 2
Council common position	Amendment
2. After the Authority has been consulted, a common methodology for the gathering by Member States of information on the consumption and use of flavourings set out in the Community list and of the substances listed in Annex III shall be adopted in accordance with the regulatory procedure referred to in Article 21(2) by ...*	2. After the Authority has been consulted, a common methodology for the gathering by Member States of information on the consumption and use of flavourings set out in the Community list and of the substances listed in Annex III shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 21(3) by ...*.
Justification
Amendment (32) adopted by the Parliament at the first reading is needed in order to bring the text into line with the provisions of the new comitology procedure.
Amendment  23 Council common position – amending act Article 26 Regulation (EEC) No 1576/89
Council common position Amendment Amendment to Regulation (EEC) No 1576/89   Amendment to Regulation (EC) No 110/2008 Regulation (EEC) No 1576/89 is hereby amended as follows:   Regulation (EC) No 110/2008 is hereby amended as follows:     1. In Article 5(2), point (c) shall be replaced by the following:   "(c) contain 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;".   2. In Article 5(3), point (c) shall be replaced by the following:   “(c) contain one or more flavourings as defined in Article 3(2)(a) of Regulation (EC) No …/…*;” 1. Article 1(4)(m) shall be amended as follows:   3. In Annex I, point (9) shall be replaced by the following: (a) In point (1)(a), the second subparagraph shall be replaced by the following:   “(9) Flavouring Flavouring means using in the preparation of a spirit drink one or more of the flavourings defined in Article 3(2)(a) of Regulation (EC) No …/…*.”   4. Annex II shall be amended as follows:   (a) Point 19(c) shall be replaced by the following: "Other flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No …/… of the European Parliament and of the Council of ... on flavourings and certain food ingredients with flavouring properties for use in and on foods1, and/or aromatic plants or parts of aromatic plants may be used in addition, but the organoleptic characteristics of juniper must be discernible, even if they are sometimes attenuated;   "(c) Other flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No …/… of the European Parliament and of the Council of ... on flavourings and/or flavouring preparations as defined in Article 3(2)d of that Regulation, and/or aromatic plants or parts of aromatic plants may be used in addition, but the organoleptic characteristics of juniper must be discernible, even if they are sometimes attenuated;" (b) Point 2(a) shall be replaced by the following:   (b) Point 20(c) shall be replaced by the following: "The drink may be called "gin" if it is produced by flavouring organoleptically suitable ethyl alcohol of agricultural origin with flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No …/…∗∗ and/or flavouring preparations as defined in Article 3(2)(d) of that Regulation so that the taste is predominantly that of juniper;"   "(c) Only flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No …/…* and/or flavouring preparations as defined in Article 3(2)(d) of that Regulation shall be used for the production of gin so that the taste is predominantly that of juniper;" (c) In point 2(b), the first subparagraph shall be replaced by the following:   (c) Point 21(a) (ii) shall be replaced by the following: "The drink may be called "distilled gin" if it is produced solely by redistilling organoleptically suitable ethyl alcohol of agricultural origin of an appropriate quality with an initial alcoholic strength of at least 96 % vol. in stills traditionally used for gin, in the presence of juniper berries and of other natural botanicals provided that the juniper taste is predominant. The term "distilled gin" may also apply to a mixture of the product of such distillation and ethyl alcohol of agricultural origin with the same composition, purity and alcoholic strength. Flavouring substances and/or flavouring preparations, both of which are specified in (a), may also be used to flavour distilled gin. London gin is a type of distilled gin."   "(ii) the mixture of the product of such distillation and ethyl alcohol of agricultural origin with the same composition, purity and alcoholic strength; flavouring substances and/or flavouring preparations as specified in category 20(c) may also be used to flavour distilled gin." 2. In Article 1(4)(n)(1), the second subparagraph shall be replaced by the following:   (d) Point 23(c) shall be replaced by the following: "Other flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No …/…* and/or flavouring preparations as defined in Article 3(2)(d) of that Regulation may additionally be used but there must be a predominant taste of caraway."   "(c) Other flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No …/…* and/or flavouring preparations as defined in Article 3(2)(d) of that Regulation may additionally be used but there must be a predominant taste of caraway." 3. In Article 1(4)(p), the first subparagraph shall be replaced by the following:   (e) Point 24(c) shall be replaced by the following: "Spirit drinks with a predominantly bitter taste produced by flavouring ethyl alcohol of agricultural origin with flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No …/… and/or flavouring preparations as defined in Article 3(2)(d) of that Regulation."           “(c) Other natural flavouring substances as defined in Article 3(2)(c) of Regulation (EC) No …/… and/or flavouring preparations as defined in Article 3(2)(d) of that Regulation may additionally be used, but the flavour of these drinks is largely attributable to distillates of caraway (Carum carvi L.) and/or dill (Anethum graveolens L.) seeds, the use of essential oils being prohibited.“ 4. In Article 1(4)(u), the first subparagraph shall be replaced by the following:   (f) Point 30(a) shall be replaced by the following: "A spirit drink produced by flavouring ethyl alcohol of agricultural origin with flavouring of cloves and/or cinnamon using one of the following processes: maceration and/ or distillation, redistillation of the alcohol in the presence of parts of the plants specified above, addition of flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No …/… of cloves or cinnamon or a combination of these methods."   " (a) Bitter-tasting spirit drinks or bitter are spirit drinks with a predominantly bitter taste produced by flavouring ethyl alcohol of agricultural origin with flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No …/…* and/or flavouring preparations as defined in Article 3(2)(d) of that Regulation." 5. In Article 4(5), the first and second paragraphs, excluding the lists in points (a) and (b), shall be replaced by the following:   (g) In point 32(c), the first subparagraph and the introductory part of the second subparagraph shall be replaced by the following: "Only natural flavouring substances and flavouring preparations as defined in Article 3(2)(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 …/… shall be authorised in liqueurs except those mentioned below:".   " (c) Flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No …/…* and the flavouring preparations as defined in Article 3(2)(d) of that Regulation may be used in the preparation of liqueur. However, only natural flavouring substances as defined in Article 3(2)(c) of Regulation (EC) No …/…* and flavouring preparations as defined in Article 3(2)(d) of that Regulation shall be used in the preparation of the following liqueurs:"   (h) Point 41(c) shall be replaced by the following:   "(c) Only 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 may be used in the preparation of egg liqueur or advocaat or avocat or advokat."                   (i) Point 44(a) shall be replaced by the following:   “(a) Väkevä glögi or spritglögg is a spirit drink produced by flavouring ethyl alcohol of agricultural origin with natural flavouring of cloves and/or cinnamon using one of the following processes: maceration and/ or distillation, redistillation of the alcohol in the presence of parts of the plants specified above, addition of flavouring substances as defined in Article 3(2)(c) of Regulation (EC) No …/… of cloves or cinnamon or a combination of these methods.”   (j) Point 44(c) shall be replaced by the following:   “(c) Other flavourings, flavouring substances and/or flavouring preparations as defined in Article 3(2)(a), (b), and (d) of Regulation (EC) No …/… may also be used, but the flavour of the specified spices must be predominant.”   (k) In point (c) of paragraphs 25, 26, 27, 28, 29, 33, 34, 35, 36, 37, 38, 39, 40, 42, 43, 45 and 46, the word "preparations" shall be replaced by "flavouring preparations".
Justification
The aim of this amendment is to adapt the new spirit drinks regulation (EC) No 110/2008. It replaces the Common position text adapting the old regulation (EEC) No 1576/89. The deletion of the category “nature-identical“ category must allow the producers of the traditional spirits aquavit and väkevä glögi to only use natural flavouring substances for the sake of their quality image. Regarding the latter, flavouring substances and preparations must be allowed.
Amendment  24 Council common position – amending act Article 28 Regulation (EC) No 2232/96 Article 5 - paragraph 1
Council common position Amendment 1. The list of flavouring substances referred to in Article 2(2) shall be adopted in accordance with the procedure referred to in Article 7 by 31 December 2008 at the latest. 1. The list of flavouring substances referred to in Article 2(2) shall be adopted in accordance with the procedure referred to in Article 7 by 31 December 2010 at the latest.
Justification
The Community list of flavourings (“the list of flavouring substances referred to in Article 2(2) of Regulation 2232/96”) should only be adopted after the completion of the evaluation program. Since the evaluation is not completed and since it is unlikely that the program will be finalised by the end of 2008 or even 2009, the postponement of the publication and adoption of the Community list for at least 2 years seems justified.
Amendment  25 Council common position – amending act Article 29 Directive 2000/13/EC Annex III - paragraph 1 - indent 2
Council common position Amendment - "smoke flavouring(s)" if the flavouring component contains flavourings as defined in Article 3 (2) (f) of Regulation (EC) No .../...* and imparts a smoky flavour to the food. - "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 .../...* and is used or mixed internally to impart a smoky flavour to the food. A designation in the list of ingredients is not required when the approved smoke product is used on the surface of the food product in the smoking process to obtain a smoke colour, texture and flavour.
Justification
This amendment (37), agreed by the Parliament at the 1st reading, provides the opportunity for referring to specific smoke flavourings so that consumers would be properly informed about salmon flavouring, bacon flavouring, barbecue flavouring and so on.
The second part of this amendment was not tabled at the first reading. It concerns the processes when smoke condensates are used in an alternative smoking process which besides flavour also influences colour, consistency and preservation of foods. The Rapporteur believes that it should be tabled for the second reading as findings of the EFSA, issued on 29 June 2007, confirmed that the use of smoke flavourings is generally considered to be of less health concern than the traditional smoking process.
Amendment  26 Council common position – amending act Article 30 - paragraph 2 a (new)
Council common position	Amendment
	Article 10 shall apply from 18 months after the date of application of the Community list.
Justification
The amendment (44) agreed by the Parliament at the first reading.
Amendment  27 Council common position – amending act Article 30 - paragraph 3
Council common position	Amendment
Articles 10, 26 and 27 shall apply from the date of application of the Community list.	Articles 26 and 27 shall apply from the date of application of the Community list.
Justification
The amendment (44) adopted by the Parliament at the 1st reading.
Amendment  28 Council common position – amending act Annex III - part B
Council common position
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
These maximum levels shall not apply to compound foods which are prepared and consumed on the same site, contain no added flavourings and contain only herbs and spices as food ingredients with flavouring properties.
Name of the substance Compound food in which the presence of the substance is restricted Maximum levelmg/kg   Beta-asarone Alcoholic beverages 1,0 1-Allyl-4-methoxybenzene, estragol Dairy products Processed fruits, vegetables (incl. mushrooms, fungi, roots, tubers, pulses and legumes), nuts and seeds Fish products Non-alcoholic beverages 50 50     50 10 Hydrocyanic acid Nougat, marzipan or its substitutes or similar products Canned stone fruits Alcoholic beverages 50   5 35 Menthofuran Mint/peppermint containing confectionery, except micro breath freshening confectionery Micro breath freshening confectionery Chewing gum Mint/peppermint containing alcoholic beverages 500   3000 1000 200 4-Allyl-1,2-dimethoxy-benzene, methyleugenol Dairy products Meat preparations and meat products, including poultry and game Fish preparations and fish products Soups and sauces Ready-to-eat savouries Non-alcoholic beverages 20 15   10 60 20 1 Pulegone Mint/peppermint containing confectionery, except micro breath freshening confectionery Micro breath freshening confectionery Chewing gum Mint/peppermint containing non-alcoholic beverages Mint/peppermint containing alcoholic beverages 250   2000 350 20   100 Quassin Non-alcoholic beverages Bakery wares Alcoholic beverages 0,5 1 1.5 1-Allyl-3,4-methylene dioxy benzene, safrole Meat preparations and meat products, including poultry and game Fish preparations and fish products Soups and sauces Non-alcoholic beverages 15   15 25 1 Teucrin A Bitter-tasting spirit drinks or bitter[2] Liqueurs[3] with a bitter taste Other alcoholic beverages 5 5 2   Thujone (alpha and beta) Alcoholic beverages, except those produced from Artemisia species Alcoholic beverages produced from Artemisia species Non-alcoholic beverages produced from Artemisia species 10   350,5   Coumarin Traditional and/or seasonal bakery ware containing a reference to cinnamon in the labelling Breakfast cereals including muesli Fine bakery ware, with exception of traditional and/or seasonal bakery ware containing a reference to cinnamon in the labelling Desserts 50 20   15       5
Amendment by Parliament
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 substance Compound food in which the presence of the substance is restricted Maximum level [mg/kg] ▐
Justification
The amendment agreed by the Parliament at the first reading linked to the amendment to Article 5, par. 2 providing a blank list unless harmfulness of certain naturally occurring undesirable substances is assessed by the Authority. A similar solution is laid down in Article 8 and Annex III of the Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods.

• [1]  Texts adopted, 10.7.2007, P6_TA(2007)0323.
• [2]               As defined in Article 1(4)(p) of Regulation 1576/89.
• [3]  As defined in Article 1(4)(r) of Regulation 1576/89.

EXPLANATORY STATEMENT

Compared with the Commission's proposal for the Regulation, in the common position the Council has reorganised the articles and chapter headings and cleared up ambiguous areas. In doing so it took into account a number of Parliament’s amendments. Regrettably some of those which in its first reading Parliament considered essential were not included

Parliament intends to defend those amendments agreed at the first reading which it believes are the basis for a balanced and practicable Regulation, taking into account scientific and technological development in the flavourings industry. Apart from food safety and the strengthening the internal market by ensuring a level playing field for all producers, other consumer interests also need to be taken into account, and prominent among them is the desire for food to be as natural as possible.

It is not necessarily the case that all flavourings which are safe from a toxicological point of view are actually beneficial to consumers. Parliament wishes to highlight in particular the right of the consumer to choose. In the procedure for approval of flavourings, e.g. ‘reasonable technological need’ is tackling other EU strategies, such as the fight against obesity, as the addition of excessively potent flavourings can mask the poor quality of prepared food.

The Council and Parliament take a different stance on the issue of certain food ingredients with flavouring properties for use in and on foods, and on the maximum levels of those ingredients laid down in Annex III.

The Scientific Committee on Food (SCF) and the European Food Safety Authority (EFSA) have found that herbal constituents safrole, estragole and methyleugenol, belonging to the chemical class of the alkenylbenzenes , are genotoxic and carcinogenic compounds. The carcinogenicity of these compounds was demonstrated in animal experiments using relatively high doses of single compounds. Human are exposed to these compounds in much lower doses that the doses used in animal experiments. No data exist on interactions between naturally occuring undesirable compounds and other substances in herbs and spices.

Parliament noted the Council’s argument that the maximum permitted levels in Annex III are already laid down in Directive 88/388/EC, but believes that this in itself indicates that the justification for limiting the use of herbs and spices in prepared food is (still) insufficient. In the last twenty years the Member States have not developed a methodology to monitor what practical effects on consumers' health the maximum levels have had. They have not carried out any research in the field either.

Parliament therefore believes that it is not proven that prepared food in which certain Annex III ingredients are naturally present has the same toxicological potential as certain natural ingredients when they are tested in isolation. It bases this position on recent toxicological studies which take into account the fact that people are exposed to alkenylbenzene in complex food matrices. The matrix effects of foods or a combination of foods on certain ingredients in nature are known. They are caused by chemical links with other parts of the food or by the action of other ingredients which increase or reduce the effects. The hypothesis is that these effects differ from case to case, and so they need to be researched on a case-by-case basis.

Parliament advocates reversing the burden of proof in this case. The principle of herb and spice producers having to disprove a legal presumption of harmfulness for each product individually is contentious. It would be more logical to turn the procedure around. Where there is a scientifically justified suspicion that certain substances in food eaten by people are harmful to health, the maximum permitted values could be included in Annex III on the basis of an opinion to that effect from the Authority.

Parliament also took account of the fact that the active principles in herb mixtures change on a seasonal basis. Seasonal changes would require expensive tests to be carried out that would probably exceed the market value of the herb and spice mixes, so prepared food producers could well decide in advance to replace herbs with flavourings. This is not what European consumers want. In taking this stance Parliament also took into account the fact that the Regulation does not limit the use of herbs and spices as such and that in the common position the Council also abolished the maximum values for substances in Annex III which are added to food prepared on the same site. Parliament believes that the justification for this – the presumed small proportion of harmful substances in food prepared in that way – could be extended to foods in general.

PROCEDURE

Title	Flavourings and food ingredients with flavouring properties
References	16677/3/2007 – C6-0139/2008 – 2006/0147(COD)
Date of Parliament’s first reading – P number	10.7.2007                     T6-0323/2007
Commission proposal	COM(2006)0427 - C6-0259/2006
Amended Commission proposal	COM(2007)0671
Date receipt of common position announced in plenary	13.3.2008
Committee responsible        Date announced in plenary	ENVI 13.3.2008
Rapporteur(s)        Date appointed	Mojca Drčar Murko 14.9.2006
Date adopted	6.5.2008
Result of final vote	+: –: 0:	54 0 0
Members present for the final vote	Georgs Andrejevs, Pilar Ayuso, Irena Belohorská, Johannes Blokland, John Bowis, Frieda Brepoels, Hiltrud Breyer, Dorette Corbey, Magor Imre Csibi, Chris Davies, Avril Doyle, Mojca Drčar Murko, Jill Evans, Anne Ferreira, Karl-Heinz Florenz, Matthias Groote, Françoise Grossetête, Satu Hassi, Jens Holm, Caroline Jackson, Christa Klaß, Eija-Riitta Korhola, Holger Krahmer, Urszula Krupa, Aldis Kušķis, Marie-Noëlle Lienemann, Jules Maaten, Linda McAvan, Riitta Myller, Péter Olajos, Miroslav Ouzký, Vladko Todorov Panayotov, Vittorio Prodi, Frédérique Ries, Dagmar Roth-Behrendt, Carl Schlyter, Horst Schnellhardt, Richard Seeber, Kathy Sinnott, Bogusław Sonik, María Sornosa Martínez, Antonios Trakatellis, Thomas Ulmer, Åsa Westlund, Anders Wijkman, Glenis Willmott
Substitute(s) present for the final vote	Inés Ayala Sender, Anne Laperrouze, Kartika Tamara Liotard, Alojz Peterle, Bart Staes, Lambert van Nistelrooij
Substitute(s) under Rule 178(2) present for the final vote	Armando França, Raül Romeva i Rueda