m mm 
COMMISSION OF THE EUROPEAN COMMUNITIES 
COM(93) 609 final - COD 478 
Brussels, 1 December 1993 
Proposal for a 
EUROPEAN PARLIAMENT AND COUNCIL REGULATION (EC) 
laying down a Community procedure for flavouring substances 
used in foodstuffs 
(presented by the Commission) 
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EXPLANATORY MEMORANDUM 
1. Article 5(1) of Directive 88/388/EEC^1> states that: 
"The Council, acting in accordance with the procedure laid down in 
Article 100a of the Treaty, shall adopt 
1. Appropriate provisions concerning: 
- flavouring sources composed of foodstuffs, and of herbs and spices 
normally considered as foods, 
- flavouring sources composed of vegetable or animal raw materials 
not normally considered as foods, 
- flavouring substances obtained by appropriate physical processes or 
by enzymatic or microbiological processes from vegetable or animal 
raw mater ials, 
- chemically synthesized or chemically isolated flavouring substances 
chemically identical to flavouring substances naturally present in 
foodstuffs or in herbs and spices normally considered as foods, 
- chemically synthesized or chemically isolated flavouring substances 
chemically identical to flavouring substances naturally present in 
vegetable or animal raw materials not normally considered as foods, 
- chemically synthesized or chemically isolated flavouring substances 
other than those referred to in the fourth and fifth indents, 
- source materials used for the production of smoke flavourings or 
process flavourings, and the reaction conditions under which they 
are prepared." 
This Regulation deals with flavouring substances. Where necessary, other 
provisions will be proposed for the other categories of flavourings. 
2. The Scientific Committee for Food was consulted in December 1991 
concerning the principles of the safety evaluation of flavouring 
substances. Its opinion was published (29th series). It recommended 
that flavouring substances should be subject to an appropriate safety 
evaluation. The Committee agreed to take into account the findings of 
Council of Europe's committee of experts on flavourings, the Food and 
Drug Administration (FDA) and the Flavours and Extracts Manufacturers 
Association (FEMA). The Committee has also defined criteria for the 
safety evaluation of flavouring substances. The flavouring substances 
will be evaluated in groups of substances having a similar chemical 
structure. 
(1) 0J No L 184, 15.7.1988, p. 61 
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This Regulation defines general criteria (Annex I) for the use of 
flavouring substances in foodstuffs. On the basis of these general 
criteria and the opinion of the Scientific Committee for Food, a 
Community positive list of flavouring substances will be drawn up by 
a committee procedure. The substances deemed acceptable by the 
Scientific Committee for Food will be included in the list; given that 
technical measures are involved, the committee procedure Is the most 
appropriate. This list will be drawn up in stages. 
After 31 December 1993, the food industry will have to use the 
flavouring substances which have been subject to the procedure laid 
down in this Regulation. Some members of the industry will therefore 
have to adapt their manufacturing processes. 
This draft Regulation is unlikely to have any negative effect on 
employment. 
Justification of the proposal with regard to the principle of 
subsidiar i ty 
What are the objectives of the proposed measure in terms of the 
obligations of the Community? 
The main aims of the proposed Regulation are 
to achieve a high level of protection for consumers 
- to improve the free movement of goods in the internal market, and 
to create greater legal certainty for economic operators and, in 
particular, for the food industry 
in relation to the use of flavouring substances in foodstuffs. 
These objectives satisfy the requirements of Article 100a of the 
Treaty and fit in with Article 5 of 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. 
Does the proposed measure involve any sharing of competence with the 
Member States? 
Yes, competence is shared. 
What is the scale of the problem? 
The legislative situation differs widely from one Member State to 
another. Some States have compiled positive lists of flavouring 
substances, others are content with the general principle of non-
toxicity or a list of prohibited substances. These differences 
constitute barriers to trade in foodstuffs containing flavourings. 
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What is the most effective solution,'given the respective resources of 
the Community and of the Member States? 
In line with the recommendations of the Scientific Committee for Food 
(see 29th report - 1993) flavouring substances are required to undergo 
an appropriate toxicologicaI evaluation. In view of the number of 
substances involved (between 2000 and 3000), these evaluations should 
be undertaken at Community level using resources that exist in the 
Member States under the auspices of scientific cooperation. 
What concrete added value does the envisaged Community measure have 
and what would be the cost of failing to act? 
The proposed regulation will facilitate the free movement of 
foodstuffs in the Community. Failure to act would perpetuate the 
compartmentalIzation of national markets. 
What means of action are available to the Community? 
The completion of the internal market necessitates the use of a 
binding legal instrument. 
Are uniform rules necessary or would a directive specifying general 
objectives and leaving it to the Member States to adopt appropriate 
measures to implement them suffice? 
Total harmonization is necessary because the ultimate aim is to have a 
Community list of substances that are toxicologically acceptable. 
r 
Proposal for a 
EUROPEAN PARLIAMENT AND COUNCIL REGULATION (EC) 
laying down a Community procedure for flavouring substances 
used in foodstuffs 
r Cx -
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty establishing the European Community 
and in particular Article 100a thereof. 
Having regard to the proposal from the Commission,^1) 
Having regard to the opinion of the Economic and Social Committee,^) 
Having consulted the Scientific Committee for Food, 
Whereas 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 product ion,^3^ provides for 
the adoption by the Council of the appropriate provisions concerning 
flavouring substances, 
Whereas differences between national laws relating to flavourings hinder 
the free movement of foodstuffs and may create conditions of unequal 
competition, thereby directly affecting the establishment or functioning of 
the common market, 
Whereas the approximation of those laws is necessary if the free movement 
of foodstuffs is to be achieved, 
Whereas, according to the scope and effects of the proposed action, the 
Community measures envisaged by this Regulation are not only necessary but 
indispensable for the attainment of the stated objectives, and whereas 
these objectives cannot be achieved by Member States individually, 
(1) 0J L 184, 15.07.1988, p. 61 
(2) 
(3) 0J No L 184, 15.07.1988, p. 61 
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Whereas laws relating to flavourings for use in foodstuffs should take 
account primarily of human health requirements but also, within the limit 
required for the protection of health, of economic and technical needs, 
Whereas it is necessary to establish general criteria for the use of 
flavouring substances, 
Whereas on the basis of the most recent scientific advice it Is necessary 
to lay down a list of flavouring substances that may be used in food. 
Whereas this list must be open and capable of being amended in the light of 
scientfic and technical developments; 
Whereas it may be necessary for health reasons to adopt conditions of use 
for certain flavouring substances, 
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HAVE ADOPTED THIS REGULATION; 
Article 1 
1. This Regulation lays down the procedure for the establishment of rules 
in respect of the flavouring substances referred to In the third, 
fourth, fifth and sixth indents of Article 5(1) of Council Directive 
88/388/EEC. 
2. This Regulation shall apply to flavouring substances used or intended 
for use in or on foodstuffs to impart odour and/or taste, as defined 
in Article 1(2)(b) of Directive 88/388/EEC. 
3. This Regulation shall apply without prejudice to specific directives 
permitting substances covered by this Regulation to be used for 
purposes other than those mentioned in Article 1(2). 
Art icle 2 
1. Only flavouring substances conforming to the general criteria set out 
in Annex I of this Regulation may be used in foodstuffs. 
2. A list of flavouring substances the use of which is authorized to the 
exclusion of all others will be laid down. This list may be drawn up 
in stages. 
This list shall be adopted in accordance with the procedure laid down 
in Article 4 and may include conditions under which flavouring 
substances may be added. 
3. Flavouring substances will be included in the list mentioned in 
paragraph 1 on the basis of the general criteria described in Annex I. 
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Art icle 3 
This Regulation shall apply without prejudice to the Community 
provisions governing the use, in certain foodstuffs, of certain 
categories of flavouring substances as defined in Article 1 of 
Directive 88/388/EEC. 
However, flavouring substances of these categories must conform with 
Annex I. 
Art icle 4 
The Commission shall be assisted by the Standing Committee for Foodstuffs 
set up by Council Decision 69/414/EEC^5^. The representative of the 
Commission shall submit to the committee a draft of the measures to be 
taken. The committee shall deliver its opinion on the draft, within a time 
limit which the chairman may lay down according to the urgency of the 
matter, if necessary by taking a vote. 
The opinion shall be recorded in the minutes in addition, each Member 
State shall have the right to ask to have its position recorded in the 
minutes. 
The Commission shall take the utmost account of the opinion delivered by 
the committee. It shall inform the committee of the manner in which its 
opinion has been taken into account. 
(5) OJ No L 291, 19.11.1969, p. 9 
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Art icle 5 
Member States may not prohibit, restrict or obstruct the marketing, or the 
use in foodstuffs, of flavouring substances if these comply with the 
provisions of this Regulation. 
Art icle 6 
Measures to bring existing Community provisions into line with this 
Regulation shall be adopted according to the procedure laid down in 
Art icle 4. 
Art icle 7 
This Regulation shall enter into force on 31 December 1993. 
This Regulation shall be binding in its entirety and directly applicable in 
all Member States. 
'Done at 
For the CounciI 
The President 
For the European Parliament 
The President 
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Annex I 
General criteria for the use of flavouring substances: 
1. Flavouring substances can be approved provided that-
- they present no risk to the health of the consumer, 
so far as can be judged on the scientific evidence available 
- and their use does not mislead the consumer, for instance by 
disguising the effects of the use of faulty raw materials or 
of undesirable manufacturing practices. 
2. To assess the possible harmful effects of a flavouring substance, it 
must be subjected to appropriate toxicological evaluation. When a 
flavouring substance contains or consists of a genetically modified 
organism within the meaning of Article 2(1) and (2) of Council 
Directive 90/220/EEC^65, Articles 11 to 18 of Directive 90/220/EEC 
will not be applicable. However, the evaluation of the safety of this 
flavouring substance must take into account environmental safety as 
provided for in Directive 90/220/EEC. 
3. All flavouring substances must be kept under constant supervision and 
must be reevaluated whenever necessary. 
(6) OJ L 117, 8.5.1990, p. 15 
ISSN 0254-1475 
COM(93) 609 final 
DOCUMENTS 
EN 10 
Catalogue number : CB-CO-93-666-EN-C 
ISBN 92-77-62319-5 
Office for Officiai Publications of the European Communities 
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