Outcome of the European Parliament's second reading
(Strasbourg, 7 to 10 July 2008)
I. INTRODUCTION
The Rapporteur, Mrs Mojca DRCAR MURKO (ALDE - SI), presented a recommendation consisting of 28 amendments to the common position for the above proposal for a Regulation on behalf of the Committee on the Environment, Public Health and Food Safety. In accordance with the provisions of Article 251 (2) of the EC Treaty and the joint declaration on practical arrangements for the codecision procedure
1 , a number of informal contacts have taken
place between the Council, the European Parliament and the Commission with a view to reaching an agreement on this dossier at second reading, thereby avoiding the need for a conciliation procedure.
1 OJ C 145, 30.6.2007, p.5 11479/08
In this context, the ALDE, EPP/ED, PES, Greens/EFA and EUL/NGL political groups presented a compromise amendment to the common position. This amendment had been agreed during the informal contacts referred to above. II.
DEBATE
For details of the debate, which was held on 7 July 2008, please see doc. 11477/08. III.
VOTE
When it voted on 8 July 2008, the plenary adopted the compromise amendment to the common position. No other amendments were adopted. The amendment adopted corresponds to what was agreed between the three institutions. Once this amendment has been scrutinised by the legal linguists of the Council and the Parliament, the Council should be in a position to approve it.
1
The text of the amendment adopted and the European Parliament's legislative resolution are set out in the Annex hereto. The amendment is presented in the form of a consolidated text where added wordings are highlighted in bold and italics, the symbol " " indicates deleted text and the symbol " " indicates changes of a linguistic or clerical nature.
____________________
1 Delegations with legal-linguistic observations can send them to the secretariat of the Council's legal-linguistic service (secretariat.jl-codecision@consilium.europa.eu) until 1 August 2008.
11479/08
ANNEX
(8.7.2008)
Flavourings and certain food ingredients with flavouring properties ***II
European Parliament legislative resolution of 8 July 2008 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) 1 ,
having regard to its position at first reading 2 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.
1 OJ C 111 E, 6.5.2008, p. 46.
2 Texts adopted, 10.7.2007, P6_TA(2007)0323. 11479/08
P6_TC2-COD(2006)0147
Position of the European Parliament adopted at second reading on 8 July 2008 with a view to
the adoption of Regulation (EC) No .../2008 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 1601/91, Regulations (EC) No 2232/96 and (EC) o 110/2008
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95
thereof,
Having regard to the proposal from the Commission,
Having regard to the Opinion of the European Economic and Social Committee 1 ,
Acting in accordance with the procedure laid down in Article 251 of the Treaty 2 ,
Whereas:
(1) Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the
Member States relating to flavourings for use in foodstuffs and to source materials for their
production 3 needs to be updated in the light of technical and scientific developments. In the interests of clarity and efficiency Directive 88/388/EEC should be replaced by this
Regulation.
(2) Council Decision 88/389/EEC of 22 June 1988 on the establishment, by the Commission, of
an inventory of the source materials and substances used in the preparation of flavourings 4 provides for the establishment of that inventory within 24 months of its adoption. That
Decision is now obsolete and should be repealed.
1 OJ C 168, 20.7.2007, p. 34.
2 Position of the European Parliament of 10 July 2007 (not yet published in the Official Journal), Council Common Position of 10 March 2008 (OJ C 111 E, 6.5.2008, p. 46) and Position of the
European Parliament of 8 July 2008.
3 OJ L 184, 15.7.1988, p. 61. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 4 OJ L 184, 15.7.1988, p. 67. 11479/08
(3) Commission Directive 91/71/EEC of 16 January 1991 completing Council
Directive 88/388/EEC on the approximation of the laws of the Member States relating to
flavourings for use in foodstuffs and to source materials for their production 1 lays down rules on the labelling of flavourings. Those rules are replaced by this Regulation and the Directive
should now be repealed.
(4) The free movement of safe and wholesome food is an essential aspect of the internal market
and contributes significantly to the health and well-being of citizens, and to their social and
economic interests.
(5) In order to protect human health, this Regulation should cover flavourings, source materials
for flavourings and foods containing flavourings. It should also cover certain food ingredients
with flavouring properties which are added to food for the main purpose of adding flavour and
which contribute significantly to the presence in food of certain naturally occurring
undesirable substances (hereinafter referred to as "food ingredients with flavouring
properties"), their source material and foods containing them.
(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.
(7) Flavourings are used to improve or modify the odour and/or taste of foods for the benefit of
Flavourings and food ingredients with flavouring properties should only be
the consumer.
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.
The use of flavourings must not mislead the
consumer and their presence in food should, therefore, always be indicated by appropriate
labelling. Flavourings should however not be used in such a way that they mislead the
consumer about issues related to, amongst other things, 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, the precautionary principle and the feasibility of controls.
1 OJ L 42, 15.2.1991, p. 25. 11479/08
(8) Since 1999, the Scientific Committee on Food and subsequently the European Food Safety
Authority (hereinafter referred to as "the Authority") established by Regulation (EC)
No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down
the general principles and requirements of food law, establishing the European Food Safety
Authority and laying down procedures in matters of food safety 1 have expressed opinions on a number of substances occurring naturally in source materials for flavourings and food
ingredients with flavouring properties which, according to the Committee of Experts on
Flavouring Substances of the Council of Europe, raise toxicological concern. Substances for
which the toxicological concern was confirmed by the Scientific Committee on Food should
be regarded as undesirable substances which should not be added as such to food.
(9) Due to their natural occurrence in plants, undesirable substances might be present in
flavouring preparations and food ingredients with flavouring properties. The plants are used
traditionally as food or food ingredients. Appropriate maximum levels should be established
for the presence of these undesirable substances in foods which contribute most to the human
intake of these substances, taking into account both the need to protect human health and their
unavoidable presence in traditional foods.
(10) Maximum levels for certain naturally occurring undesirable substances should focus on the
food or food categories which contribute most to dietary intake. Should additional naturally occurring undesirable substances pose a risk to the health of the consumer, maximum levels should 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 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 2 . 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.
(11) Provisions should be established at Community level in order to prohibit, or restrict the use
of, certain plant, 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.
1 OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 202/2008 (OJ L 60, 5.3.2008, p. 17).
2 OJ L 165, 30.4.2004, p. 1. Corrected version in OJ L 191, 28.5.2004, p. 1. Regulation as last amended by Council Regulation (EC) No 301/2008 (OJ L 97, 9.4.2008, p. 85). 11479/08
(12) Risk assessments should be carried out by the Authority.
(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 the European Parliament and of the
Council of ... establishing a common authorisation procedure for food additives, food enzymes and food flavourings
1+ .
(14) Flavouring substances are defined chemical substances, which include flavouring 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 2 . 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 .../...
+ [establishing a common authorisation procedure for food additives, food enzymes and food flavourings].
(15) Flavouring preparations are flavourings other than defined chemical substances obtained from
materials of vegetable, animal or 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 and approved.
(16) 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 they have hitherto been used for the production of flavourings,
are considered to be food materials for this purpose, even though some of these source
materials, such as rose wood and strawberry leaves, may not have been used for food as such.
They do not need to be evaluated.
1 OJ L ....
+ OJ: Please fill in the number, the date and the OJ reference.
2 OJ L 299, 23.11.1996, p. 1. Regulation as amended by Regulation (EC) No 1882/2003. + OJ: Please fill in the number . 11479/08
(17) Likewise, thermal process flavourings produced from food under 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 or not complying with certain conditions of production should be evaluated
and approved.
(18) Regulation (EC) No 2065/2003 of the European Parliament and of the Council of
10 November 2003 on smoke flavourings used or intended for use in or on foods 1 lays down a procedure for the safety assessment and approval of smoke flavourings and aims to establish a
list of primary smoke condensates and primary tar fractions the use of which is authorised to
the exclusion of all others.
(19) Flavour precursors such as carbohydrates, oligo-peptides and amino acids impart flavour to
food by chemical reactions 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 and approved.
(20) 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. An example could be flavourings which are obtained by heating oil or fat
to an extremely high temperature for a very short period of time, resulting in a grill-like
flavour.
(21) Material of vegetable, animal, microbiological or mineral origin other than food may only be
authorised for the production of flavourings after its safety has been evaluated scientifically. It
might be necessary to authorise the use of only certain parts of the material or to set
conditions of use.
(22) Flavourings can contain food additives as permitted by Regulation (EC) No .../... of the
European Parliament and of the Council of ... on food additives 2+ and/or other food ingredients for technological purposes such as for their storage, standardisation, dilution or
dissolution and stabilisation.
1 OJ L 309, 26.11.2003, p. 1. 2 OJ L ....
+ OJ: Please fill in the number, the date and the OJ reference 11479/08
(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 1 should be authorised according to that Regulation as under this Regulation.
well as
(24) Flavourings remain subject to the general labelling obligations provided for in
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 2 and, as the case may be, in Regulations (EC) No 1829/2003 and Regulation (EC) No 1830/2003 of the European Parliament and of the Council of
22 September 2003 concerning the traceability and labelling of genetically modified
organisms and the traceability of food and feed products produced from genetically modified
organisms 3 . In addition, specific provisions on the labelling of flavourings sold as such to the manufacturer or to the final consumer should be contained in this Regulation.
(25) Flavouring substances or flavouring preparations should only be labelled as "natural" if they
comply with certain criteria which ensure that consumers are not misled.
(26) Specific information requirements should ensure that consumers are not misled concerning
the source material used for the production of natural flavourings. In particular, if the term
natural is used to describe a flavour, the flavouring components used should be entirely of
natural origin. In addition, the source of the flavourings should be labelled, except when the
source materials referred to would not be recognised in the flavour or taste of the food. If a
source is mentioned, at least 95% of the flavouring component should be obtained from the
material referred to. As the use of flavourings should not mislead the consumer, the other
maximum 5% can only be used for standardisation or to give a, for example, more fresh,
pungent, ripe or green note to the flavouring. When less than 95% of the flavouring
component derived from the source referred to has been used and the flavour of the source
can still be recognised, the source should be revealed together with a statement that other
natural flavourings have been added, for example cacao extract in which other natural
flavourings have been added to impart a banana note.
1 OJ L 268, 18.10.2003, p. 1. Regulation as last amended by Regulation (EC) No 298/2008 (OJ L 97, 9.4.2008, p. 64).
2 OJ L 109, 6.5.2000, p. 29. Directive as last amended by Commission Directive 2007/68/EC (OJ L 310, 28.11.2007, p. 11). 3 OJ L 268, 18.10.2003, p. 24. 11479/08
(27) Consumers should be informed if the smoky taste of a particular food is due to the addition of
smoke flavourings. In accordance with Directive 2000/13/EC, the labelling should not
confuse the consumer as to whether the product is smoked conventionally with fresh smoke or
treated with smoke flavourings. Directive 2000/13/EC needs to be adapted to the definitions
of flavourings, smoke flavourings and the term "natural" for the description of flavourings
laid down in this Regulation.
(28) For the evaluation of the safety of flavouring substances for human health, information on the
consumption and use of flavouring substances is crucial. The amounts of flavouring
substances added to food should therefore be checked on a regular basis.
(29) The measures necessary for the implementation of this Regulation should be adopted in
accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures
for the exercise of implementing powers conferred on the Commission 1 .
(30) In particular the Commission should be empowered 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, inter alia by supplementing it with 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.
(31) 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 apply the urgency
procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of measures
described in Article 8(2) and amendments to Annexes II to V to this Regulation.
(32) 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.
(33) In order to develop and update Community law on flavourings in a proportionate and
effective way, it is necessary to collect data, share information and coordinate work between
Member States. For that purpose, it may be useful to undertake studies to address specific
issues with a view to facilitating the decision-making process. It is appropriate that the
Community finance such studies as part of its budgetary procedure. The financing of such
measures is covered by Regulation (EC) No 882/2004.
1 OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11). 11479/08
(34) Pending the establishment of the Community list, provision should be made for the evaluation
and approval of flavouring substances which are not covered by the evaluation programme
provided for in Regulation (EC) No 2232/96. A transitional regime should therefore be laid
down. Under that regime such flavouring substances should be evaluated and approved in accordance with the procedure laid down in Regulation (EC) No .../...
+ [establishing a
common authorisation procedure for food additives, food enzymes and food flavourings].
However, the time periods provided for in that Regulation for the adoption by the Authority
of its opinion and for the submission by the Commission to the Standing Committee on the
Food Chain and Animal Health of a draft regulation updating the Community list should not
apply, because priority should be given to the ongoing evaluation programme.
(35) Since the objective of this Regulation, 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, in the interests of market unity
and a high level of consumer protection, be better achieved at Community level, the
Community may adopt measures, in accordance with the principle of 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 that
objective.
(36) Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on the
definition, description and presentation of aromatised wines, aromatised wine-based drinks
and aromatised wine-product cocktails 1 and Regulation (EC) o 110/2008 of the European Parliament and of the Council of 15 January 2008 on the definition, description, presentation,
labelling and the protection of geographical indications of spirit drinks 2 need to be adapted to certain new definitions laid down in this Regulation.
(37) Regulations (EEC) No 1601/91, (EC) No 2232/96 and (EC) o 110/2008 and
Directive 2000/13/EC should be amended accordingly,
HAVE ADOPTED THIS REGULATION:
+ OJ: Please fill in the number .
1 OJ L 149, 14.6.1991, p. 1. Regulation as last amended by the 2005 Act of Accession. 2 OJ L 39, 13.2.2008, p. 16. 11479/08
CHAPTER I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter
This Regulation lays down rules on flavourings and food ingredients with flavouring properties for
use in and on foods with a view to ensuring the effective functioning of the internal market whilst ensuring
a high level of protection of human health and a high level of consumer protection,
protection of consumer interests and fair practices in food trade, taking into account,
including
where appropriate, the protection of the environment.
For those purposes, this Regulation provides for:
(a) a Community list of flavourings and source materials approved for use in and on foods, set
out in Annex I (hereinafter referred to as the "Community list");
(b) conditions of use of flavourings and food ingredients with flavouring properties in and on
foods;
(c) rules on the labelling of flavourings.
Article 2
Scope
-
1.This Regulation shall apply to:
(a) flavourings which are used or intended to be used in or on foods, without prejudice to
more specific provisions laid down in Regulation (EC) No 2065/2003;
(b) food ingredients with flavouring properties;
(c) food containing flavourings and/or food ingredients with flavouring properties;
(d) source materials for flavourings and/or source materials for food ingredients with
flavouring properties.
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2.This Regulation shall not apply to:
(a) substances which have exclusively a sweet, sour or salty taste;
(b) raw foods;
(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 as long as they
have not been used as food ingredients.
Article 3
Definitions
-
1.For the purposes of this Regulation, the definitions laid down in Regulations (EC) o 178/2002 and 1829/2003 shall apply.
-
2.For the purposes of this Regulation, the following definitions shall also apply: (a) "flavourings" shall mean products:
(i) not intended to be consumed as such, which are added to food in order to impart odour and/or taste;
or modify
(ii) made or consisting of the following categories: flavouring substances, flavouring preparations, thermal process flavourings, smoke flavourings, flavour precursors
or other flavourings or mixtures thereof;
(b) "flavouring substance" shall mean a defined chemical substance with flavouring
properties;
(c) "natural flavouring substance" shall mean a flavouring substance obtained by
appropriate physical, enzymatic or microbiological processes from material of
vegetable, animal or microbiological origin either in the raw state or after processing for
human consumption by one or more of the traditional food preparation processes listed
in Annex II. Natural flavouring substances correspond to substances that are naturally
present and have been identified in nature;
(d) "flavouring preparation" shall mean a product, other than a flavouring substance,
obtained from:
(i) food by appropriate physical, enzymatic or microbiological processes either in the raw state of the material or after processing for human consumption by one or
more of the traditional food preparation processes listed in Annex II;
11479/08
and/or
(ii) material of vegetable, animal or microbiological origin, other than food, 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;
(e) "thermal process flavouring" shall mean a product obtained after heat treatment from a
mixture of ingredients not necessarily having flavouring properties themselves, of
which at least one contains nitrogen (amino) and another is a reducing sugar; the
ingredients for the production of thermal process flavourings may be:
(i) food;
and/or
(ii) source material other than food;
(f) "smoke flavouring" shall mean a product obtained by fractionation and purification of a
condensed smoke yielding primary smoke condensates, primary tar fractions and/or
derived smoke flavourings as defined in points (1), (2) and (4) of Article 3 of
(g) "flavour precursor" shall mean a product, not necessarily having flavouring properties
itself, intentionally added to food for the sole purpose of producing flavour by breaking
down or reacting with other components during food processing; it may be obtained
from:
(i) food;
and/or
(ii) source material other than food;
(h) "other flavouring" 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 definitions (b) to (g);
(i) "food ingredient with flavouring properties" shall mean a food ingredient other than
flavourings which may be added to food for the main purpose of adding flavour to it or
modifying its flavour and which contributes significantly to the presence in food of
certain naturally occurring undesirable substances;
11479/08
(j) "source material" shall mean material of vegetable, animal, microbiological or mineral
origin from which flavourings or food ingredients with flavouring properties are
produced; it may be:
(i) food;
or
(ii) source material other than food;
(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.
-
3.For the purpose of the definitions listed in paragraph 2(d), (e), (g) and (j), source materials for which hitherto there is significant evidence of use for the production of flavourings shall be
considered as food for the purpose of this Regulation.
4.
Flavourings may contain food additives as permitted by Regulation (EC) No .../... + [on food additives] and/or other food ingredients incorporated for technological purposes.
CHAPTER II
CONDITIONS FOR USE OF FLAVOURINGS, FOOD INGREDIENTS WITH FLAVOURING
PROPERTIES AND SOURCE MATERIALS
Article 4
General conditions for use of flavourings or food ingredients with flavouring properties
Only flavourings or food ingredients with flavouring properties which meet the following
conditions may be used in or on foods:
(a) they do not, on the basis of the scientific evidence available, pose a safety risk to the health of
the consumer and
(b) their use does not mislead the consumer.
+ OJ: Please fill in the number . 11479/08
Article 5
Prohibition of non-compliant flavourings and/or non-compliant food
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.
Article 6
Presence of certain substances
-
1.Substances listed in Part A of Annex III shall not be added as such to food.
-
2.Without prejudice to Regulation (EC) o 110/2008, 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.
-
3.Detailed rules for the implementation of paragraph 2 may be adopted in accordance with the regulatory procedure referred to in Article 21(2), following the opinion of the European Food
Safety Authority (hereinafter referred to as the "Authority"), where necessary.
Article 7
Use of certain source materials
-
1.Source materials listed in Part A of Annex IV shall not be used for the production of flavourings and/or food ingredients with flavouring properties.
-
2.Flavourings and/or food ingredients with flavouring properties produced from source materials listed in Part B of Annex IV may be used only under the conditions indicated in that
Annex.
11479/08
Article 8
Flavourings and food ingredients with flavouring properties for which evaluation and approval are
not required
-
1.The following flavourings and food ingredients with flavouring properties may be used in or on foods without an evaluation and approval under this Regulation, provided that they comply
with Article 4:
(a) flavouring preparations referred to in Article 3(2)(d)(i);
(b) thermal process flavourings referred to in Article 3(2)(e)(i) which comply with the
conditions for the production of thermal process flavourings and maximum levels for
certain substances in thermal process flavourings set out in Annex V;
(c) flavour precursors referred to in Article 3(2)(g)(i);
(d) food ingredients with flavouring properties.
-
2.Notwithstanding paragraph 1, if the Commission, a Member State or 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 .../....../...
+ [establishing a common authorisation procedure for food additives, food enzymes and food flavourings]. shall then apply mutatis mutandis. 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 21(3). Such
measures shall be laid down in Annexes III, IV and/or V where appropriate. On imperative
grounds of urgency, the Commission may use the urgency procedure referred to in Article
21(4).
+ OJ: Please fill in the number . 11479/08
CHAPTER III
COMMUNITY LIST OF FLAVOURINGS AND SOURCE MATERIALS APPROVED FOR USE
IN OR ON FOODS
Article 9
Flavourings and source materials for which an evaluation and approval is required
This Chapter shall apply to:
(a) flavouring substances;
(b) flavouring preparations referred to in Article 3(2)(d)(ii);
(c) thermal process flavourings obtained by heating ingredients which fall partially or totally
within 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;
(d) flavour precursors referred to in Article 3(2)(g)(ii);
(e) other flavourings referred to in Article 3(2)(h);
(f) source materials other than food referred to in Article 3(2)(j)(ii).
Article 10
Community list of flavourings and source materials
Of the flavourings and source materials referred to in Article 9, only those included in the
Community list may be placed on the market as such and used in or on foods under the conditions
of use specified therein, where applicable.
11479/08
Article 11
Inclusion of flavourings and source materials in the Community list
-
1.A flavouring or source material may be included in the Community list, in accordance with the procedure laid down by Regulation (EC) No .../....../... + [establishing a common
authorisation procedure for food additives, food enzymes and food flavourings]., only if it
complies with the conditions set out in Article 4 of this Regulation.
-
2.The entry for a flavouring or source material in the Community list shall specify:
(a) the identification of the flavouring or the source material approved;
(b) where necessary, the conditions under which the flavouring may be used.
-
3.The Community list shall be amended in accordance with the procedure referred to in Regulation (EC) No .../....../... + [establishing a common authorisation procedure for food additives, food enzymes and food flavourings]..
Article 12
Flavourings or source materials falling within the scope of Regulation (EC) No 1829/2003
1.
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.
2.
When a flavouring already included on the Community list, is produced from a different source falling within the scope of Regulation (EC) o 1829/2003, it will not require a new authorisation under this Regulation, as long as the new source is covered by an authorisation in accordance with Regulation (EC) o 1829/2003 and the flavouring complies with the specifications established under this Regulation.
+ OJ: Please fill in the number .
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Article 13
Interpretation decisions
Where necessary, it may be decided in accordance with the regulatory procedure referred to in
Article 21(2):
(a) whether or not a given substance or mixture of substances, material or type of food falls
within the categories listed in Article 2(1);
(b) to which specific category, defined in Article 3(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, Part B.
CHAPTER IV
LABELLING
Article 14
Labelling of flavourings not intended for sale to the final consumer
-
1.Flavourings not intended for sale to the final consumer may only be marketed with the labelling provided for in Articles 15 and 16, which must be easily visible, clearly legible and
indelible. The information provided for in Article 15 shall be in a language easily
understandable to purchasers.
-
2.Within its own territory, the Member State in which the product is marketed may, in accordance with the Treaty, stipulate that the information provided for in Article 15 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 15
General labelling requirements for flavourings not intended for sale to the final consumer
-
1.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 with other substances added to them in
accordance with Article 3(4), their packaging or containers shall bear the following
information:
11479/08
(a) the sales description: either the word "flavouring" or a more specific name or
description of the flavouring;
(b) the statement either "for food" or the statement "restricted use in 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) in descending order of weight, a list of:
(i) the categories of flavourings present and
(ii) the names of each of the other substances or materials in the product or, where appropriate, their E-number;
(f) the name or business name and address of the manufacturer, packager or seller;
(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 law;
(h) the net quantity;
(i) a date of minimum durability or use-by-date;
(j) where relevant, information on a flavouring or other substances referred to in this
Article and listed in Annex IIIa to Directive 2000/13/EC as regards the indication of the
ingredients present in foodstuffs.
-
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.
-
3.By way of derogation from paragraph 1, 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.
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Article 16
Specific requirements for use of the term "natural"
-
1.If the term "natural" is used to describe a flavouring in the sales description referred to in Article 15(1)(a) the provisions of paragraphs 2 to 6 of this Article 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.
-
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 description shall read "natural <<food(s) or food category or source(s)>> flavouring".
-
5.The term "natural <<food(s) or food category or source(s)>> flavouring with other natural flavourings" may only be used if the flavouring component is partially derived from the
source material referred to, the flavour of which can easily be recognised.
-
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.
Article 17
Labelling of flavourings intended for sale to the final consumer
-
1.Without prejudice to Directive 2000/13/EC, Council Directive 89/396/EEC of 14 June 1989
on indications or marks identifying the lot to which a foodstuff belongs 1 and Regulation (EC) No 1829/2003, flavourings sold singly or mixed with each other and/or with other food
ingredients and/or to which other substances are added and which are intended for sale to the
final consumer may be marketed only if their packaging contains the statement either "for
food" or "restricted use in food" or a more specific reference to their intended food use, which
must be easily visible, clearly legible and indelible.
-
2.If the term "natural" is used to describe a flavouring in the sales description referred to in Article 15(1)(a), Article 16 shall apply.
1 OJ L 186, 30.6.1989, p. 21 . Directive as last amended by Directive 92/11/EEC (OJ L 65, 11.3.1992, p. 32).
11479/08
Article 18
Other labelling requirements
Articles 14 to 17 shall be 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.
CHAPTER V
PROCEDURAL PROVISIONS AND IMPLEMENTATION
Article 19
Reporting by the food business operators
-
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
insofar as this information is not required for the
safety assessment.
Information on the use levels for specific food categories in the Community shall be made
available to Member States by the Commission.
-
2.Where applicable, for a flavouring already approved under this Regulation which is prepared by production methods or starting materials significantly different from those included in the
risk assessment of the Authority, a producer or user shall, before marketing the flavouring,
submit to the Commission the necessary data to allow an evaluation of the flavouring to be
undertaken by the Authority with regard to the modified production method or characteristics.
-
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.
-
4.Detailed rules for the implementation of paragraph 1 shall be adopted in accordance with the regulatory procedure referred to in Article 21(2).
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Article 20
Monitoring and reporting by the Member States
-
1.Member States shall establish systems to monitor the consumption and use of flavourings set out in the Community list and the consumption of the substances listed in Annex III on a risk-
based approach, and shall report their findings with appropriate frequency to the Commission
and to the Authority.
-
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 ... * .
Article 21
Committee
-
1.The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health.
-
2.Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
-
3.Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
-
4.Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Article 22
Amendments to Annexes II to V
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 21(3), following the opinion of the
Authority, where necessary.
-
*Two years after the entry into force of this Regulation. 11479/08
On imperative grounds of urgency, the Commission may use the urgency procedure referred to in
Article 21(4).
Article 23
Community financing of harmonised policies
The legal basis for the financing of measures resulting from this Regulation shall be Article 66(1)(c)
of Regulation (EC) No 882/2004.
CHAPTER VI
TRANSITIONAL AND FINAL PROVISIONS
Article 24
Repeals
-
1.Directive 88/388/EEC, Decision 88/389/EEC and Directive 91/71/EEC shall be repealed from ... .
-
2.Regulation (EC) No 2232/96 shall be repealed from the date of application of the list referred to in Article 2(2) of that Regulation.
-
3.References to the repealed acts shall be construed as references to this Regulation.
Article 25
Introduction of the list of flavouring substances into the Community list of flavourings and source
materials and transitional regime
-
1.The Community list shall be established by introducing the list of flavouring substances referred to in Article 2(2) of Regulation (EC) No 2232/96 into Annex I to this Regulation at
the time of its adoption.
24 months after the entry into force of this Regulation. 11479/08
2.
Pending the establishment of the Community list, Regulation (EC) No .../... + [establishing a common authorisation procedure for food additives, food enzymes and food flavourings] shall
apply for the evaluation and approval of flavouring substances which are not covered by the
evaluation programme provided for in Article 4 of Regulation (EC) No 2232/96.
By way of derogation from that procedure, the periods of six months and nine months referred to in Article 5(1) and Article 7 of Regulation (EC) No .../... + [establishing a common
authorisation procedure for food additives, food enzymes and food flavourings] shall not
apply to such evaluation and approval.
-
3.Any appropriate transitional measures 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 21(3).
Article 26
Amendment to Regulation (EEC) No 1601/91
Article 2(1) is hereby amended as follows:
-
1.In point (a), the first sub-indent of the third indent shall be replaced by the following:
"- flavouring substances and/or flavouring preparations as defined in Article 3(2)(b) and (d) 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 foods
+ , and/or
____________________
OJ L ......";
-
2.In point (b), the first sub-indent of the second indent shall be replaced by the following:
"- flavouring substances and/or flavouring preparations as defined in Article 3(2)(b) and (d) of Regulation (EC) No .../... ++ , and/or";
+ OJ: Please fill in the number .
+ OJ: Please fill in the number, date and relevant OJ reference of this Regulation. ++ OJ: Please fill in the number of this Regulation. 11479/08
-
3.In point (c), the first sub-indent of the second indent shall be replaced by the following:
"- flavouring substances and/or flavouring preparations as defined in Article 3(2)(b) and (d) of Regulation (EC) No .../... ++ , and/or".
Article 27
Amendment to Regulation (EC) No 2232/96
Article 5(1) of Regulation (EC) No 2232/96 shall be replaced by the following:
"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.".
Article 28
(EC) o 110/2008
Amendment to Regulation
Regulation (EC) o 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) o
of the European Parliament and of the Council of ... on flavourings and certain
.../...
-
*+ + + + food ingredients with flavouring properties for use in and on foods 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) o
+ + + + .../... ;" 3.
In Annex I, point (9) 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) o .../... + + + + ."
+ OJ: Please fill in the number of this Regulation.
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4.
Annex II shall be amended as follows:
(a) Point 19(c) shall be replaced by the following:
"(c) Other flavouring substances as defined in Article 3(2)(b) of Regulation (EC) o + + + +
.../... 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 20(c) shall be replaced by the following:
"(c) Only flavouring substances as defined in Article 3(2)(b) of Regulation (EC) o + + + +
.../... 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) Point 21(a) (ii) shall be replaced by the following:
"(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."
(d) Point 23(c) shall be replaced by the following:
"(c) Other flavouring substances as defined in Article 3(2)(b) of Regulation (EC) o + + + +
.../... 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."
(e) Point 24(c) shall be replaced by the following:
natural flavouring substances as defined in Article 3(2)(c) of Regulation
"(c) Other
+ + + +
(EC) o .../... 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."
+ OJ: Please fill in the number of this Regulation.
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(f) Point 30(a) shall be replaced by the following:
"(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) o .../...
+ + + + and/or
flavouring preparations as defined in Article 3(2)(d) of that Regulation."
(g) In point 32(c), the first subparagraph and the introductory part of the second
subparagraph shall be replaced by the following:
"(c) Flavouring substances as defined in Article 3(2)(b) of Regulation (EC) o + + + +
.../... and 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)
+ + + +
o .../... 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) o + + + +
.../... 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 flavour 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 natural flavouring substances as defined in Article 3(2)(c) of Regulation (EC) o .../...
+ + + + of cloves or cinnamon or a combination of these methods."
(j) Point 44(c) shall be replaced by the following: 11479/08
"(c) Other flavourings, flavouring substances and/or flavouring preparations as + + + +
defined in Article 3(2)(h), (b) and (d) of Regulation (EC) o .../... 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".
_______________
OJ ...
Article 29
Amendment to Directive 2000/13/EC
In Directive 2000/13/EC, Annex III shall be replaced by the following:
"Annex III
DESIGNATION OF FLAVOURINGS IN THE LIST OF INGREDIENTS
-
1.Without prejudice to paragraph 2, flavourings shall be designated by the terms
-
-"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 of ... on
flavourings and certain food ingredients with flavouring properties for use in and on foods
++ ;
-
-"smoke flavouring(s)", or "smoke flavouring(s) produced from <<food(s) or food category or source(s)>>" (e.g. smoke flavouring produced from beech), 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.
-
2.The term "natural" for the description of flavourings shall be used in accordance with Article 16 of Regulation (EC) No .../... + .
____________________
OJ L ......".
+ OJ: Please fill in the number of this Regulation. ++ OJ: Please fill in the number, date and relevant OJ reference of this Regulation. 11479/08
Article 30
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the
Official Journal of the European Union.
It shall apply from ...
.
Article 10 shall apply from 18 months after the date of application of the Community list.
Articles 26 and 28 shall apply from the date of application of the Community list.
Article 22 shall apply from ...
. Foods lawfully placed on the market or labelled prior to ... which do not comply with this Regulation may be marketed until their date of minimum durability or use-
by-date.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at ,
For the European Parliament For the Council
The President The President
24 months after the entry into force of this Regulation. Date of entry into force of this Regulation. 11479/08
ANNEX I
Community list of flavourings and source materials approved for use in and on foods
11479/08
ANNEX II
List of traditional food preparation processes
Chopping Coating
Heating, cooking, baking, frying (up to 240°C at Cooling atmospheric pressure) and pressure cooking (up to
120°C)
Cutting Distillation/rectification Drying Emulsification
Evaporation Extraction, incl. solvent extraction in accordance with Directive 88/344/EEC
Fermentation Filtration Grinding
Infusion Maceration
Microbiological processes Mixing Peeling Percolation
Pressing Refrigeration/Freezing Roasting/Grilling Squeezing Steeping
11479/08
ANNEX III
Presence of certain substances
Part A: Substances which 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)
11479/08
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 Maximum level the presence of the substance is restricted mg/kg Beta-asarone Alcoholic beverages 1,0
1-Allyl-4- Dairy products Processed fruits, vegetables (incl. mushrooms, 50 methoxybenzene, Estragol
-
*fungi, roots, tubers, pulses and legumes), nuts and
seeds Fish products Non-alcoholic beverages 50 50 10
Hydrocyanic acid Nougat, marzipan or its substitutes or similar 50 products Canned stone fruits Alcoholic beverages
5
35
Menthofuran Mint/peppermint containing confectionery, except
micro breath freshening confectionery Micro breath freshening confectionery Chewing gum Mint/peppermint containing alcoholic beverages 500 3 000 1 000 200 4-Allyl-1,2-dimethoxy- Dairy products Meat preparations and meat products, including 20 benzene, Methyleugenol
-
*poultry and game Fish preparations and fish products Soups and sauces Ready-to-eat savouries Non-alcoholic beverages 15
10 60 20 1
11479/08
Pulegone Mint/peppermint containing confectionery, except
micro breath freshening confectionery Micro breath freshening confectionery Chewing gum Mint/peppermint containing non-alcoholic 250 2 000 350
beverages Mint/peppermint containing alcoholic beverages 20 100
Quassin Non-alcoholic beverages Bakery wares Alcoholic beverages 0,5 1 1,5 1-Allyl-3,4-methylene Meat preparations and meat products, including
dioxy benzene, safrole * 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 1 5 5 2 Liqueurs 2 with a bitter taste Other alcoholic beverages
Thujone (alpha and Alcoholic beverages, except those produced from
beta) Artemisia species Alcoholic beverages produced from Artemisia 10
35
species Non-alcoholic beverages produced from Artemisia
species 0,5
*
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. After consultation with the Member States and the
Authority, based on data made available by the Member States and on the newest scientific
information, and taking into account the use of herbs and spices and natural flavouring
preparations, the Commission, if appropriate, proposes amendments to this derogation.
1 As defined in Annex II, Point 30 of Regulation (EC) o 110/2008.
2 As defined in Annex II, Point 32 of Regulation (EC) o 110/2008.
11479/08
Coumarin Traditional and/or seasonal bakery ware containing
a reference to cinnamon in the labelling Breakfast cereals including muesli Fine bakery ware, with the exception of traditional 50 20
and/or seasonal bakery ware containing a reference
to cinnamon in the labelling Desserts 15
5
11479/08
ANNEX IV
List of source materials to which restrictions apply for their use in the production of flavourings and
food ingredients with flavouring properties
Part A: Source materials which shall not be used for the production of flavourings and food ingredients with flavouring properties
Source material Latin name
Common name
Tetraploid form of Acorus calamus L. Tetraploid form of Calamus
Part B: Conditions of use for flavourings and food ingredients with flavouring properties produced from certain source materials
Source material Latin name
Conditions of use
Common name
Quassia amara L. and Quassia Flavourings and food ingredients with flavouring Picrasma excelsa (Sw) properties produced from the source material may only be used for the production of beverages and
bakery wares
Laricifomes officinales White agaric mushroom Flavourings and food ingredients with flavouring (Vill.: Fr) Kotl. et Pouz properties produced from the source material may or only be used for the production of alcoholic Fomes officinalis beverages
Hypericum perforatum St John's wort L.
Teucrium chamaedrys Wall germander L.
11479/08
ANNEX V
Conditions for the production of thermal process flavourings and maximum levels for certain
substances in thermal process flavourings
Part A: Conditions for the production:
(a) The temperature of the products during processing shall not exceed 180°C.
(b) The duration of the thermal processing shall not exceed 15 minutes at 180°C with correspondingly longer times at lower temperatures, i.e. a doubling of the heating
time for each decrease of temperature by 10°C, up to a maximum of 12 hours.
(c) The pH during processing should not exceed the value of 8,0.
Part B: Maximum levels for certain substances
Maximum levels
Substance
g/kg
2-amino-3,4,8-trimethylimidazo [4,5-f] quinoxaline (4,8-DiMeIQx) 50 2-amino-1-methyl-6-phenylimidazol [4,5-b]pyridine (PhIP) 50
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- 4 feb '08COM(2008)48 - Aanpassing van bijlage I bij Verordening 882/2004 inzake officiële controles op de naleving van de wetgeving inzake diervoeders en levensmiddelen en de voorschriften inzake diergezondheid en dierenwelzijn
- 22 dec '06COM(2006)912 - Wijziging van Verordening (EG) nr. 1829/2003 inzake genetisch gemodificeerde levensmiddelen en diervoeders, wat de aan de Commissie verleende uitvoeringsbevoegdheden betreft
- 28 jul '06COM(2006)427 - Aroma’s en bepaalde voedselingrediënten met aromatiserende eigenschappen voor gebruik in of op levensmiddelen en tot wijziging van Verordening 1576/89, Verordening 1601/91, Verordening (EG) nr. 2232/96 en richtlijn 2000/13/EG
- 15 dec '05COM(2005)125 - Definitie, de aanduiding, de presentatie en de etikettering van gedistilleerde dranken
- 5 feb '03COM(2003)52 - Officiële controles van diervoeders en levensmiddelen
- 11 dec '02COM(2002)719 - Wijziging van Besluit 1999/468/EG tot vaststelling van de voorwaarden voor de uitoefening van de aan de Commissie verleende uitvoeringsbevoegdheden
- 15 jul '02COM(2002)400 - In of op levensmiddelen gebruikte of te gebruiken rookaroma's
- 27 dec '01COM(2001)789 - Aanpassing van de bepalingen betreffende de comités die de Commissie bijstaan in de uitoefening van haar uitvoeringsbevoegden die zijn vastgelegd in volgens de procedure van artikel 251 van het Verdrag goedgekeurde besluiten van het Europees Parlement en de Raad
- 26 jul '01COM(2001)425 - Genetisch gemodificeerde levensmiddelen en diervoeders
- 26 jul '01COM(2001)182 - Traceerbaarheid en etikettering van genetisch gemodificeerde organismen en de traceerbaarheid van met genetisch gemodificeerde organismen geproduceerde levensmiddelen en diervoeders en tot wijziging van Richtlijn 2001/18/EG

