DRAFT STATEMENT OF THE COUNCIL'S REASONS
I. INTRODUCTION
On 28 July 2006, the Commission adopted its proposal on flavourings and certain food
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ingredients with flavouring properties for use in foods . The proposal is based on Article 95 of the Treaty establishing the European Community.
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The European Parliament adopted its Opinion in first reading on 10 July 2007 .
Following the European Parliament's first reading opinion, the Commission submitted an
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amended proposal on 24 October 2007 .
On 10 March 2008, the Council adopted its common position in accordance with Article
251(2) of the Treaty.
In carrying out its work, the Council also took account of the opinion of the European
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Economic and Social Committee adopted on 25 April 2007 .
1
12182/06. 2
11639/07. 3
14509/07, COM(2007)671 final 4
EESC/2007/604, OJ C 168, 20.7.2007, p. 29.
II. OBJECTIVE OF THE PROPOSED REGULATION
The aim of the proposed Regulation, as part of four proposals designed to overhaul the
Community's rules on food improvement agents, is to update the Community rules on
flavourings and certain food ingredients with flavouring properties, taking into account the
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technological and scientific developments in this area as well as the developments in food 6
legislation in the European Community, in particular, the new legislation on food safety .
The proposed Regulation provides for the establishment of a Community list of flavourings
and of source materials approved for use, as well as for rules on labelling the flavourings.
The objective of the proposed Regulation is to ensure the proper functioning of the internal
market, including fair practices in food trade, and a high level of protection of human health,
of consumer interests and of the environment.
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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 foods and to source materials for their production (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)) will be replaced.
6 Approved 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 (OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4)).
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III. ANALYSIS OF THE COMMON POSITION
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1.Introductory remarks
The common position reflects the result of the examination of the Commission's proposal by
the Council. The Council introduced a number of modifications in the text, some of them
inspired by the amendments proposed by the European Parliament. On its own initiative, the
Council introduced some of the European Parliament amendments in each of the three
sectoral proposals, with a view to harmonising their provisions. The modifications introduced
by the Council may be summed up as follows:
· Preference for a single legal basis: Article 95 of the Treaty.
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According to established case-law , the legal basis for an act must be determined having regard to its own aim and content. If the examination of a Community measure reveals that
it serves a two-fold purpose or that it has a two-fold component and if one of those is
identifiable as the main or predominant purpose or component, whereas the other is merely
incidental, the act must be based on a single legal basis, namely that required by the main
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or predominant purpose or component . In this case, the Council considered that the agricultural aspects of the proposal are merely incidental while the internal market
objective is the main or predominant purpose or component and as such, in line with the
case law of the ECJ, it decided to retain Article 95 as the sole legal basis.
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In addition to changes already introduced by the Council, Article 26 will require update due to entry into force on 20 February 2008 of the Regulation (EC) No 110/2008 of the European Parliament and of the Council on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89 (OJ L 39, 13.2.2008). 8
See Case 45/86 Commission v Council [1987] ECR 1493, paragraph 11; Case C-300/89 Commission v Council (Titanium Dioxide) [1991] ECR I-2867, paragraph 10; Case C-268/94 Portugal v Council [1996] ECR I-6177, paragraph 22; and Case C-176/03 Commission v Council [2005] ECR I-0000, paragraph 45. 9
See Case C-36/98 Spain v Council [2001] ECR I-779, paragraph 59; Case C-211/01 Commission v Council [2003] ECR I-8913, paragraph 39; and Case C-338/01 Commission v Council [2004] ECR I-4829, paragraph 55.
· "Misleading the consumer" (in line with amendment 1, second part).
The Council included, in recital 7, elements integrating the notion of misleading the
consumer.
· Protection of the environment
The Council considered that, apart from scientific evidence, the authorisation of the
flavourings should also take into account other relevant factors, such as the protection of
the environment. The Council also included a reference to the protection of the
environment among the objectives of the proposed Regulation.
· Clarification of the scope and definitions (in line with amendment 8).
The Council clarified that smoke flavourings are not completely excluded from the scope
of the proposed Regulation. It opted for complementary application of two Regulations, i.e.
this Regulation would apply in the absence of more specific rules in the Regulation (EC)
2065/2003 on smoke flavourings 10 .
Furthermore, it was made clear that the Regulation would also not apply to mixtures of
herbs and/or spices, mixtures of tea and mixtures for infusions, as long as they are not used
as food ingredients (in line with amendment 45).
The clarification of Article 2(2) can be found in recital 6.
The Council paid particular attention to the accuracy of definitions and their consistency
with other Community legislation. Clarifications were made in line with amendments 12
and 14. The term "flavourings not elsewhere specified" in amendment 13 has the same
meaning as the Commission formulation "other flavouring", meaning flavouring not
defined under points b) to g) of Article 3. The Council favours the latter, which is more
clear in the context of Article 3.
10
OJ L 309, 26,11,2003, p.1
· Introduction of the regulatory comitology procedure with scrutiny (in line with
amendments 24, 33, 34, 35).
The Council adapted the proposal to the new comitology procedure rules, requiring the
regulatory procedure with scrutiny to be applied for the adoption of measures
supplementing the Regulation.
The Council also introduced the urgency procedure to enable the Commission to modify,
on the imperative ground of urgency, restrictions for the use of flavourings and food
ingredients with flavouring properties for which an approval is not required and if
appropriate to amend Annexes II to V.
· Interpretation decisions.
The Council regrouped all the provisions on interpretation decisions into a new single
article and, as they would not supplement the Regulation, made them subject to the
regulatory comitology procedure without scrutiny.
· Provision prohibiting the placing on the market of non compliant flavourings or food
containing such flavourings.
For reasons of clarity, legal certainty and proper functioning of the market, the Council
inserted an article on the prohibition on placing non-compliant flavourings and/or food
ingredients with flavouring properties on the market. This is consistent with proposals on
food additives and on food enzymes.
· Use of the term "natural" flavouring.
To safeguard consumer interests, the Council agreed that the term "natural" may only be
used with a reference to a food, food category or a vegetable or animal flavouring source if
at least 95% by w/w has been obtained from the source material referred to (in line with
amendment 29).
The Council has however added that the 5 % of the flavouring component derived from
other source materials shall not reproduce the flavour of the source material referred to.
· Authorisation of flavourings falling within the scope of Regulation (EC) 1829/2003 of the
European Parliament and of the Council of 22 September 2003 on genetically modified
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food and feed (in line with amendments 41 and 42). The Council agrees that, for any substance, the two authorisation procedures (one for its
use as a flavouring and the other with respect to its genetic modifications) can be carried
out simultaneously, which is in line with the above amendments. The Council subjected
that principle to some drafting changes in order to make the provision more compatible
with Regulation (EC) No 1829/2003.
· Labelling
The Council streamlined labelling provisions, respecting the distinction between "business
to business" labelling and labelling requirements for products intended for the sale to the
final consumer. Although the Council organised the labelling chapter in a way different
from that proposed by the European Parliament, the principles underlying its content are
the same and are in line with amendments 5, 29 and 30.
· Transitional measures for products already on the market (in line with amendment 39).
The Council provided for a 2 years transition period from the date of entry into force of the
proposed Regulation. Foods lawfully placed on the market or labeled during this 2 years
may be marketed until their date of minimum durability or use-by-date.
The Commission has accepted the common position agreed by the Council.
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2.The amendments of the European Parliament
In its Plenary vote on 10 July 2007, the European Parliament adopted 43 amendments to the
proposal. In its common position, the Council incorporated, in full or in principle, 27
amendments.
11
OJ L 268, 18.10.2003, p. 1.
Amendments incorporated in the common position
In addition to amendments mentioned in part 1 above, the common position incorporates, in
full or in principle, other European Parliament's first reading amendments, aimed at
improving or clarifying the text, in particular amendments 4, 6, 7, 9, 12, 14, 31, 36, 41, 42. .
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Amendments not introduced
The Council was not able to accept all amendments, sometimes because it did not consider
that they would bring drafting clarity (see amendments 13 and 37) or for the specific reasons
outlined below:
Precautionary principle (amendments 2, 17 recital 13 and Article 4(a)). The precautionary principle is one of the general principles underlying the general food
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law . Consequently, it applies to the proposed Regulation with no need for a specific reference to it. Moreover, in the risk analyses framework, the precautionary principle
can only be taken into account in the context risk management, never in the risk
assessment phase as suggested by the European Parliament.
Definition of "appropriate physical process" (amendment 15 Article 3(2)(k)). The traditional food preparation processes listed in Annex II should not be confused with the "appropriate physical process" defined in Article (3)(2)(k).
Definition of "flavouring substance" (amendment 49 Article 3(2)(b)). The Council indicated, in recital 14, through which processes the flavouring substance
can be produced. The amendment would restrict the methods that can be used.
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Numbering of Articles in this part refers to the text of the common position.
13 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 (OJ L 31, 1.2.2002, p.1. Regulation as last amended by Regulation (EC) No 575/2006 (OJ L 100, 8.4. 2006, p. 34).
Decisions submitted to the regulatory comitology procedure without scrutiny (amendments 11, 16, 23, 32 Article 13(a), 13(b), 6(3), 20(2)).
Decisions on whether or not a given substance falls within the scope of the Regulation
(amendment 11); rules implementing methods on how to monitor Annex IIIB
(amendment 23) and the common methodology for monitoring of the consumption and
use of flavourings (amendment. 32) are of an interpretative nature and would not
supplement the Regulation. Therefore, they do not fall within the scope of the
regulatory comitology procedure with scrutiny.
Labelling of genetically modified organisms (GMOs) (amendments 27, 28, 38 Article 15(1)(e)(ii) and (g), Article 29 (2a new)): As mentioned in recital 24, flavourings
remain subject to the labelling provisions defined in Directive 2000/13 of the European
Parliament and of the Council of 20 March 2000 on the approximation of the laws of the
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Member States relating to the labelling, presentation and advertising of foodstuffs and in Regulation (EC) No 1829/2003 on genetically modified food and feed and their
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labelling (Articles 12 and 13 of the later). The Council insisted on retaining the consistency between "GMOs" Regulation, Directive 2000/13/EC ("Labelling Directive)
and this Regulation. Therefore, the Council did not accept amendments 27 and 38 as
they are already covered by Regulation 1829/2003. Amendment 28 is not necessary as
the term "other relevant Community legislation" in Article 15(1) (g) in the common
position also includes the above-mentioned Regulation.
A definition of general scope, such as the one proposed in amendment 52 would have to be part of Regulation 1829/2003 and not of the proposed Regulation.
14
OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive 2007/68/EC (OJ L 310, 28.11.2007, p. 11). 15
OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p.34).
Conditions for use (amendments 19 and 20 Article 4(ba new) and Article 4(bb new)). The Council did not include a reference to the benefit of the consumer and to the technological need as general conditions for the use of flavourings because their
implementation would have been not possible owing to possible subjective
interpretations. These two aspects are already covered in the definition of flavourings,
which states that they are added to food to impart odour and/or taste.
Labelling.
Although the Council organised the labelling chapter in a way different from that
proposed by the European Parliament, the principles underlying its content are in line
with some of the amendments related to Articles 14 to 18. However, the Council was
not able to accept the suggestions relating to labelling of GMOs as explained above
(amendments 27, 28, 38) and amendment 26, which is not consistent with other specific
Community legislation and may create barriers to trade. Amendment 43 is not in line
with the spirit of the provisions of Article 16, which aims at providing adequate
information to the consumers and protecting consumer interests.
Entry into force of Articles 10, 26, 27 (amendment 44 Article 30(2). Amendment 44 was not accepted as Articles 10, 26 and 27 can only apply after the
Community list of authorized flavourings and source materials has become applicable.
In addition, the date of application of that Community list can only be determined after
it has been adopted through the comitology procedure with scrutiny pending the
outcome of the evaluation by EFSA as referred to in Article 4 of Regulation (EC)
2232/96.
Presence of toxic substances (Amendments 21, 40, 46 Article 6(2), Annex IIIB, Article 6(2a new)).
Substances in Annex III B of the proposed Regulation pose a toxicological problem, confirmed by the Scientific Committee on Food (SCF) or EFSA. Knowing that these
substances are a toxicological problem, they must be regulated based on the most recent
scientific advice available. The Council attached great importance to using a risk-based
approach to set maximum limits in this Regulation. For the Council, amendments 21
and 40 go against the need to provide a high level of protection of human health.
The Council considered that a general exclusion, as suggested by amendment 46, in respect of the application of Annex III B to compound food to which only herbs and
spices have been added is too broad and would not provide sufficient protection the
consumers. The Council considers, in line with the principle of proportionality, that the
exclusion from maximum levels set in Annex III B is justified for the use of herbs and
spices under the condition that they are used in compound foods which are prepared and
consumed on the same site and thus will not affect cross-boarder trade.
IV. Conclusions
The Council believes that the common position represents a balance of concerns and interests
that would respect the objectives of the Regulation. It looks forward to constructive
discussions with the European Parliament with a view to the early adoption of the Regulation
ensuring a high level of human health and consumer protection.
_____________________
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