Common Position (EC) No 7/2008 of 10 March 2008 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to the adoption of a Regulation of the European Parliament and of the Council on food additives Text with EEA relevance
Date: 2008-03-10
Institutions: Council of the European Union
Subjects: approximation of laws, consumer protection, food additive, food safety, foodstuff, foodstuffs legislation, labelling, public health

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COMMON POSITION (EC) No 7/2008

adopted by the Council of 10 March 2008

with a view to adopting Regulation (EC) No …/2008 of the European Parliament and of the Council
of … on food additives

(Text with EEA relevance)

(2008/C 111 E/02)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European Com-
munity, 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),

(5)

Acting in accordance with the procedure
Article 251 of the Treaty (2),

laid down in

Whereas:

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.

A high level of protection of human life and health
should be assured in the pursuit of Community policies.

This Regulation replaces previous Directives and Deci-
sions concerning food additives permitted for use in
foods with a view to ensuring the effective functioning of
the internal market and a high level of protection of
human health and the interests of consumers via compre-
hensive and streamlined procedures.

(1)

(2)

(3)

(4)

for particular nutritional uses (3) and the use of certain
food colours for the health marking of meat and the
decoration and stamping of eggs. It also harmonises the
use of food additives in food additives and food enzymes
thus ensuring their safety and quality and facilitating their
storage and use. This has not previously been regulated at
Community level.

and/or

flavour

Food additives are substances that are not normally
consumed as food itself but are added to food intention-
ally for a technological purpose described in this Regu-
lation, such as the preservation of food. All food additives
should be covered by this Regulation, and therefore in
the light of scientific progress and technological develop-
ment the list of functional classes should be updated.
However, substances should not be considered as food
the purpose of
additives when they are used for
imparting
for nutritional
taste or
purposes, such as salt replacers, vitamins and minerals.
Moreover, substances considered as foods which may be
used for a technological
sodium
chloride or saffron for colouring and food enzymes
should also not fall within the scope of this Regulation.
However, preparations obtained from foods and other
natural source material that are intended to have a tech-
nological effect in the final food and which are obtained
by selective extraction of constituents (e.g. pigments) rela-
tive to the nutritive or aromatic constituents, should be
considered additives within the meaning of this Regu-
lation. Finally, food enzymes are covered by Regulation
(EC) No …/2008 of the European Parliament and of the
Council of … on food enzymes and amending Council
Directive
(EC)
No 1493/1999, Directive 2000/13/EC and Regulation
(EC) No 258/97 (4), which excludes the application of
this Regulation.

83/417/EEC,

Regulation

function,

such as

Council

This Regulation harmonises the use of food additives in
foods in the Community. This includes the use of food
by Council Directive
additives
89/398/EEC of 3 May 1989 on the approximation of the
laws of the Member States relating to foodstuffs intended

in foods

covered

(6)

Substances not consumed as food itself but used inten-
tionally in the processing of foods, which only remain as
residues in the final food and do not have a technological
effect in the final product (processing aids), should not be
covered by this Regulation.

(1) OJ C 168, 20.7.2007, p. 34.
(2) Opinion of the European Parliament of 10 July 2007 (not yet published
in the Official Journal), Council Common Position of 10 March 2008,
Position of the European Parliament of … (not yet published in the
Official Journal) and Council Decision of …

(3) OJ L 186, 30.6.1989, p. 27. 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) See page 32 of this Official Journal.

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(7)

(8)

Food additives should be approved and used only if they
fulfil the criteria laid down in this Regulation. Food addi-
tives must be safe when used, there must be a technolo-
gical need for their use, and their use must not mislead
the consumer and must be of benefit to the consumer.
Misleading the consumer includes, but is not limited to,
issues related to the nature, freshness, quality of ingredi-
ents used, the naturalness of a product or of the produc-
tion process, or the nutritional quality of the product.
food additives should also take into
The approval of
to the matter under
account other
consideration including societal, economic,
traditional,
ethical and environmental factors and the feasibility of
controls. The use and maximum levels of a food additive
should take into account the intake of the food additive
from other sources and the exposure to the food additive
by special groups of consumers (e.g. allergic consumers).

relevant

factors

Food additives must comply with the approved specifica-
tions, which should include information to adequately
identify the food additive,
including origin, and to
describe the acceptable criteria of purity. The specifica-
tions previously developed for food additives included in
Commission Directive 95/31/EC of 5 July 1995 laying
down specific criteria of purity concerning sweeteners for
use in foodstuffs (1), Commission Directive 95/45/EC of
26 July 1995 laying down specific purity criteria
concerning colours for use in foodstuffs (2) and Commis-
sion Directive 96/77/EC of 2 December 1996 laying
down specific purity criteria on food additives other than
colours and sweeteners (3) should be maintained until the
corresponding additives are entered in the Annexes to
this Regulation. At that time, the specifications related to
such additives should be set out in a Regulation. Those
specifications
should relate directly to the additives
included in the Community lists in the Annexes to this
Regulation. However, considering the complex character
for the sake of
and substance of such specifications,
clarity they should not be integrated as such in the Com-
munity lists but should be set out in one or more sepa-
rate Regulations.

Council of … establishing a common authorisation
procedure for food additives,
food enzymes and food
flavourings (4).

(11) Under 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 (5), the
European Food Safety Authority (hereinafter referred to
as the ‘Authority’) is to be consulted on matters likely to
affect public health.

(12) A food additive which falls within the scope of Regu-
lation (EC) No 1829/2003 of the European Parliament
and of the Council of 22 September 2003 on genetically
modified food and feed (6) should be subject
to the
authorisation procedure under
that Regulation with
regard to the safety assessment of the genetic modifica-
tion, while the final authorisation of the food additive
should be granted under this Regulation.

significantly different

(13) A food additive already approved under this Regulation
which is prepared by production methods or using
from those
starting materials
included in the risk assessment of
the Authority, or
different from those covered by the specifications laid
submitted for evaluation by the
down,
Authority. ‘Significantly different’ could mean inter alia a
change of the production method from extraction from a
plant
a
by
micro-organism or a genetic modification of the original
micro-organism, a change in starting materials, or a
change in particle size.

fermentation

should be

production

using

to

(9)

Some food additives are permitted for specific uses for
certain authorised oenological practices and processes.
The use of such food additives should comply with this
Regulation and with the specific provisions laid down in
the relevant Community legislation.

(10)

In order to ensure harmonisation, the risk assessment
and approval of food additives should be carried out in
accordance with the procedure laid down in Regulation
(EC) No …/2008 of the European Parliament and of the

(1) OJ L 178, 28.7.1995, p. 1. Directive as last amended by Directive

2006/128/EC (OJ L 346, 9.12.2006, p. 6).

(2) OJ L 226, 22.9.1995, p. 1. Directive as last amended by Directive

2006/33/EC (OJ L 82, 21.3.2006, p. 10).

(14)

Food additives should be kept under continuous observa-
tion and should be re-evaluated whenever necessary in
the light of changing conditions of use and new scientific
information.

(15) Member States which maintained on 1 January 1992
prohibitions on the use of certain additives in certain
specific foods which are considered traditional and are
produced on their
territory should be permitted to
continue to apply those prohibitions. Moreover, as regard
products such as ‘Feta’ or ‘Salame cacciatore’, this Regu-
lation should be without prejudice to more restrictive
rules linked to the use of certain denominations under
Council Regulation (EC) No 510/2006 of 20 March 2006

(4) See page 1 of this Official Journal.
(5) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Regulation (EC)

(3) OJ L 339, 30.12.1996, p. 1. Directive as last amended by Directive

2006/129/EC (OJ L 346, 9.12.2006, p. 15).

No 575/2006 (OJ L 100, 8.4.2006, p. 3).

(6) OJ L 268, 18.10.2003. p. 1.

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on the protection of geographical indications and desig-
nations of origin for agricultural products and food-
stuffs (1) and Council Regulation (EEC) No 2082/92 of
14 July 1992 on certificates for specific character for
agricultural products and foodstuffs (2).

(20)

In particular the Commission should be empowered to
amend the Annexes of
this Regulation and to adopt
appropriate transitional measures. Since those measures
are of general scope and are designed to amend non-es-
sential elements of this Regulation,
inter alia by supple-
menting 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.

(16) Unless subject to further restrictions, an additive may be
present in food, other than by direct addition, as a result
of carry-over from an ingredient in which the additive
was permitted, provided that the level of the additive in
the final food is no greater than would be introduced by
the use of
the ingredient under proper technological
conditions and good manufacturing practice.

(17)

(18)

Food additives remain subject to the general
labelling
obligations as 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 adver-
tising of foodstuffs (3) and, as the case may be, in Regu-
lation (EC) No 1829/2003 and in Regulation (EC)
No 1830/2003 of the European Parliament and of the
Council of 22 September 2003 concerning the trace-
ability and labelling of genetically modified organisms
and the traceability of food and feed products produced
from genetically modified organisms (4).
In addition,
specific provisions on the labelling of food additives sold
as such to the manufacturer or to the final consumer
should be contained in this Regulation.

Sweeteners authorised under this Regulation may be used
in table-top sweeteners sold directly to consumers. Manu-
facturers of such products should make information
available to the consumer by appropriate means to allow
them to use the product in a safe manner. Such informa-
tion could be made available in a number of ways
including on product labels, internet websites, consumer
information lines or at the point of sale. In order to
adopt a uniform approach to the implementation of this
requirement, guidance drawn up at Community level may
be necessary.

(19)

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 (5).

(1) OJ L 93, 31.3.2006, p. 12. Regulation as amended by Regulation (EC)

No 1791/2006 (OJ L 363, 20.12.2006, p. 1).

(2) OJ L 208, 24.7.1992, p. 9. Regulation as repealed by Regulation (EC)

No 509/2006 (OJ L 93, 31.3.2006, p. 1).

(3) 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).

(4) OJ L 268, 18.10.2003, p. 24.
(5) OJ L 184, 17.7.1999, p. 23. Decision as amended by Council Decision

2006/512/EC (OJ L 200, 22.7.2006, p. 11).

(21) On grounds of efficiency, the normal time-limits for the
regulatory procedure with scrutiny should be curtailed
for the adoption of certain amendments to Annexes II
and III relating to substances already authorised under
other Community law as well as any appropriate transi-
tional measures related to these substances.

(22)

In order to develop and update Community law on food
additives in a proportionate and effective way, it is neces-
sary 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 of
the European Parliament and of the Council of 29 April
2004 on official controls performed to ensure the verifi-
cation of compliance with feed and food law, animal
health and animal welfare rules (6).

(23) Member States are to carry out official controls in order
to enforce compliance with this Regulation in accordance
with Regulation (EC) No 882/2004.

(24)

Since the objective of
this Regulation, namely to lay
down Community rules on food additives, cannot be
sufficiently achieved by the Member States and can there-
fore, 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 subsidiarity as set out in Article 5
of the Treaty. In accordance with the principle of propor-
tionality, as set out in that Article, this Regulation does
not go beyond what is necessary in order to achieve that
objective.

(25)

Following the adoption of this Regulation the Commis-
sion, assisted by the Standing Committee on the Food
Chain and Animal Health, should review all the existing
authorisations for criteria, other than safety, such as
intake, technological need and the potential to mislead
the consumer. All food additives that are to continue to

(6) OJ L 165, 30.4.2004, p. 1. Corrected version in OJ L 191, 28.5.2004,
amended by Council Regulation (EC)

p. 1. Regulation as
No 1791/2006.

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be authorised in the Community should be transferred to
the Community lists in Annexes II and III to this Regu-
lation. Annex III to this Regulation should be completed
with the other food additives used in food additives and
food enzymes as well as carriers for nutrients and their
conditions of use in accordance with Regulation (EC)
No …/2008 (*). To allow a suitable transition period, the
provisions
than the provisions
concerning carriers for food additives and food additives
in flavourings, should not apply until 1 January 2011.

in Annex III, other

(26) Until the future Community lists of food additives are
it is necessary to provide for a simplified
food additives

established,
procedure allowing the current lists of
contained in the existing Directives to be updated.

(27) Without prejudice to the outcome of the review referred
to in recital 25, within one year following the adoption
of
this Regulation the Commission should set up an
evaluation programme for the Authority to re-evaluate
that were already
the safety of
approved in the Community. That programme should
define the needs and the order of priorities according to
which the approved food additives are to be examined.

the food additives

(28)

This Regulation repeals and replaces the following acts:
Council Directive 62/2645/EEC on the approximation of
the rules of the Member States concerning the colouring
matters authorised for use in foodstuffs intended for
human consumption (1), Council Directive 65/66/EEC of
26 January 1965 laying specific criteria on purity for
preservatives authorised for use in foodstuffs intended for
human consumption (2), Council Directive 78/663/EEC
of 25 July 1978 laying down specific criteria of purity
for emulsifiers, stabilizers, thickeners and gelling agents
for use in foodstuffs (3), Council Directive 78/664/EEC of
25 July 1978 laying down specific criteria of purity for
antioxidants which may be used in foodstuffs intended
for human consumption (4), First Commission Directive
81/712/EEC of 28 July 1981 laying down Community
methods of analysis for verifying that certain additives
used in foodstuffs satisfy criteria of purity (5), Council
Directive 89/107/EEC of 21 December 1988 on the
approximation of
the Member States
concerning food additives authorised for use in foodstuffs
intended for human consumption (6), Directive 94/35/EC
the Council of
of

the European Parliament and of

laws of

the

(*) See page 1 of this Official Journal.
(1) OJ 115, 11.11.1962, p. 2645/62. Directive as last amended by Direc-

tive 95/45/EC (OJ L 226, 22.9.1995, p. 1).

(2) OJ 22, 9.2.1965, p. 373/65. Directive as last amended by Commission

Directive 96/77/EC (OJ L 339, 30.12.1996, p. 1).

(3) OJ L 223, 14.8.1978, p. 7. Directive as amended by Commission Direc-

tive 92/4/EEC (OJ L 55, 29.2.1992, p. 96).

(4) OJ L 223, 14.8.1978, p. 30. Directive as last amended by Commission

Directive 96/77/EC.

(5) OJ L 257, 10.9.1981, p. 1.
(6) OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC)

No 1882/2003 of the European Parliament and of the Council.

30 June 1994 on sweeteners for use in foodstuffs (7),
Directive 94/36/EC of the European Parliament and of
the Council of 30 June 1994 on colours for use in food-
stuffs (8), Directive 95/2/EC of the European Parliament
and of the Council of 20 February 1995 on food addi-
than colours and sweeteners (9), Decision
tives other
No 292/97/EC of the European Parliament and of the
Council of 19 December 1996 on the maintenance of
national laws prohibiting the use of certain additives in
the production of certain specific foodstuffs (10) and
Commission Decision 2002/247/EC of 27 March 2002
suspending the placing on the market and import of
additive
containing
jelly
E 425 konjac (11). However, it is appropriate that certain
provisions of those acts remain in force during a transi-
tional period to allow time for the preparation of the
Community lists in the Annexes to this Regulation,

confectionary

food

the

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter

This Regulation lays down rules on food additives used in foods
to ensure the effective functioning of the internal market and a
high level of protection of human health and protection of
including fair practices in food trade,
consumers'
taking account of, where appropriate, the protection of
the
environment.

interests,

For those purposes, this Regulation provides for:

(a) Community lists of approved food additives as set out in

Annexes II and III;

(b) conditions of use of food additives in foods, including in
food additives and in food enzymes as covered by Regu-
lation (EC) No …/2008 (**), and in food flavourings as
covered by Regulation (EC) No …/2008 of the European
Parliament and of the Council of … on flavourings and

(7) OJ L 237, 10.9.1994, p. 3. Directive as last amended by Directive

2006/52/EC (OJ L 204, 26.7.2006, p. 10).

(8) OJ L 237, 10.9.1994, p. 13. Directive as amended by Regulation (EC)

No 1882/2003.

(9) OJ L 61, 18.3.1995, p. 1. Directive as last amended by Directive

2006/52/EC.

(10) OJ L 48, 19.2.1997, p. 13.
(11) OJ L 84, 28.3.2002, p. 69.
(**) See page 32 of this Official Journal.

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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 2001/13/EC (1);

such food results, or may be reasonably expected to result,
in it or its by-products becoming directly or indirectly a
component of such foods;

(c) rules on the labelling of food additives sold as such.

The following are not considered to be food additives:

Article 2

Scope

1.

This Regulation shall apply to food additives.

This Regulation shall not apply to the following substances

2.
unless they are used as food additives:

(a) processing aids;

(b) substances used for the protection of plants and plant
products in accordance with Community rules relating to
plant health;

(c) substances added to foods as nutrients;

(d) substances used for

the treatment of water for human
consumption falling within the scope of Council Directive
98/83/EC of 3 November 1998 on the quality of water
intended for human consumption (2);

(e)

flavourings falling within the scope of Regulation (EC)
No …/2008 (*).

This Regulation shall not apply to food enzymes falling

3.
within the scope of Regulation (EC) No …/2008 (**).

(i) monosaccharides, disaccharides or oligosaccharides
and foods containing these substances used for their
sweetening properties;

(ii)

foods, whether dried or
in concentrated form,
including flavourings incorporated during the manu-
facturing of
their
aromatic, sapid or nutritive properties together with a
secondary colouring effect;

compound foods, because of

(iii)

substances used in covering or coating materials,
which do not form part of foods and are not intended
to be consumed together with those foods;

(iv) products containing pectin and derived from dried
apple pomace or peel of citrus fruits or quinces, or
from a mixture of them, by the action of dilute acid
followed by partial neutralisation with sodium or
potassium salts (‘liquid pectin’);

(v)

chewing gum bases;

(vi) white or yellow dextrin, roasted or dextrinated starch,
starch modified by acid or alkali treatment, bleached
starch, physically modified starch and starch treated by
amylolitic enzymes;

This Regulation shall apply without prejudice to any

4.
specific Community rules concerning the use of food additives:

(vii) ammonium chloride;

(a)

in specific foods;

(b) for purposes other than those covered by this Regulation.

(viii) blood plasma, edible gelatin, protein hydrolysates and

their salts, milk protein and gluten;

Article 3

Definitions

(ix)

amino acids and their salts other than glutamic acid,
glycine, cysteine and cystine and their salts having no
technological function;

(x)

caseinates and casein;

1.
For the purposes of this Regulation, the definitions laid
down in Regulation (EC) No 178/2002 and (EC) No 1829/2003
shall apply.

(xi)

inulin;

For the purposes of this Regulation the following defini-

2.
tions shall also apply:

(a)

‘food additive’ shall mean any substance not normally
consumed as a food in itself and not normally used as a
characteristic ingredient of food, whether or not it has nutri-
tive value, the intentional addition of which to food for a
technological purpose
in the manufacture, processing,
preparation, treatment, packaging, transport or storage of

(1) See page 46 of this Official Journal.
(2) OJ L 330, 5.12.1998, p. 32. Directive as amended by Regulation (EC)

No 1882/2003 of the European Parliament and of the Council.

(*) See page 46 of this Official Journal.
(**) See page 32 of this Official Journal.

(b)

‘processing aid’ shall mean any substance which:

(i)

is not consumed as a food by itself;

(ii)

is intentionally used in the processing of raw materials,
foods or their ingredients, to fulfil a certain technolo-
gical purpose during treatment or processing; and

(iii) may result in the unintentional but technically unavoid-
able presence in the final product of residues of the
substance or
its derivatives provided they do not
present any health risk and do not have any technolo-
gical effect on the final product;

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(c)

‘functional class’ shall mean one of the categories set out in
Annex I based on the technological function a food additive
exerts in the foodstuff;

Food additives in Annex II shall be listed on the basis of

3.
the categories of food to which they may be added.

(d)

‘unprocessed food’ shall mean a food which has not under-
gone any treatment resulting in a substantial change in the
original state of the food, for which purpose the following
in particular are not regarded as resulting in substantial
change: dividing, parting, severing, boning, mincing, skin-
ning, paring, peeling, grinding, cutting, cleaning, trimming,
deep-freezing, freezing, chilling, milling, husking, packing or
unpacking;

4.
Food additives in Annex III shall be listed on the basis of
the food additives, food enzymes, food flavourings and nutrients
or categories thereof to which they may be added.

Food additives shall comply with the specifications as

5.
referred to in Article 13.

(e)

‘food with no added sugars’ shall mean a food without the
following:

Article 5

(i) any added monosaccharides or disaccharides;

Prohibition of non-compliant

food additives

and/or

non-compliant food

(ii) any added food containing monosaccharides or disac-
charides which is used for its sweetening properties;

(f)

‘energy-reduced food’ shall mean a food with an energy
value reduced by at least 30 % compared with the original
food or a similar product;

(g)

‘table-top sweeteners’ shall mean preparations of permitted
sweeteners, which may contain other food additives and/or
food ingredients and which are intended for sale to the final
consumer as a substitute for sugars;

(h) ‘quantum satis’ shall mean that no maximum numerical level
is specified and substances shall be used in accordance with
good manufacturing practice, at a level not higher than is
necessary to achieve the intended purpose and provided the
consumer is not misled.

CHAPTER II

COMMUNITY LISTS OF APPROVED FOOD ADDITIVES

Article 4

Community lists of food additives

1.
Only food additives included in the Community list in
Annex II may be placed on the market as such and used in
foods under the conditions of use specified therein.

No person shall place on the market a food additive or any food
in which such a food additive is present if the use of the food
additive does not comply with this Regulation.

Article 6

General conditions for inclusion and use of food additives
in Community lists

1.
A food additive may be included in the Community lists
in Annexes II and III only if it meets the following conditions
and, where relevant, other legitimate factors:

(a)

it does not, on the basis of the scientific evidence available,
pose a safety concern to the health of the consumer at the
level of use proposed; and

(b) there is a reasonable technological need that cannot be
achieved by other economically and technologically practic-
able means; and

(c)

its use does not mislead the consumer.

2.
To be included in the Community lists in Annexes II and
III a food additive must have advantages and benefits for the
consumer and therefore serve one or more of the following
purposes:

(a) preserving the nutritional quality of the food;

(b) providing necessary ingredients or constituents for foods
manufactured for groups of consumers with special dietary
needs;

Only food additives included in the Community list in
2.
Annex III may be used in food additives, in food enzymes and
in food flavourings under
the conditions of use specified
therein.

(c) enhancing the keeping quality or stability of a food or
improving its organoleptic properties, provided that
the
nature, substance or quality of the food is not changed in
such a way as to mislead the consumer;

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(d) aiding in the manufacture, processing, preparation, treat-
ment, packing, transport or storage of food, including food
additives, food enzymes and food flavourings, provided that
the food additive is not used to disguise the effects of the
use of faulty raw materials or of any undesirable practices or
techniques,
including unhygienic practices or techniques,
during the course of any such activities.

3.
By way of derogation from paragraph 2(a), a food additive
which reduces the nutritional quality of a food may be included
in the Community list in Annex II provided that:

(a)

the food does not constitute a significant component of a
normal diet; or

(b) the food additive is necessary for the production of foods

for groups of consumers with special dietary needs.

Article 7

Specific conditions for sweeteners

(b) making food more visually appealing and helping to identify

flavours normally associated with particular foods;

(c) giving colour to food otherwise colourless.

Article 9

Functional classes of food additives

1.
Food additives may be assigned in Annexes II and III to
one of the functional classes in Annex I on the basis of the
principal technological function of the food additive.

Allocating a food additive to a functional class shall not
preclude it from being used for several functions.

2. Where necessary, as a result of scientific progress or tech-
nological development,
the measures, designed to amend
non-essential elements of this Regulation, relating to additional
functional classes which may be added to Annex I shall be
adopted in accordance with the regulatory procedure with scru-
tiny referred to in Article 26(3).

A food additive may be included in the Community list in
Annex II for the functional class of sweetener only if, in addi-
tion to serving one or more of
in
the purposes set out
Article 6(2), it serves one or more of the following purposes:

(a) replacing sugars for the production of energy-reduced food,

non-cariogenic food or food with no added sugars; or

(b) replacing sugars where this permits an increase in the

shelf-life of the food; or

Article 10

The content of the Community lists of food additives

1.
A food additive which complies with the conditions set
out in Articles 6, 7 and 8 may, in accordance with the proce-
dure referred to in Regulation (EC) No …/2008 (*), be included
in:

(c) producing food intended for particular nutritional uses as

(a)

the Community list in Annex II to this Regulation; and/or

defined in Article 1(2)(a) of Directive 89/398/EEC.

Article 8

(b) the Community list in Annex III to this Regulation.

The entry for a food additive in the Community lists in

2.
Annexes II and III shall specify:

(a)

the name of the food additive and its E number;

Specific conditions for colours

(b) the foods to which the food additive may be added;

A food additive may be included in the Community list in
Annex II for the functional class of colour only if, in addition to
serving one or more of the purposes set out in Article 6(2), it
serves one of the following purposes:

(a) restoring the original appearance of

food of which the
colour has been affected by processing, storage, packaging
and distribution, whereby visual acceptability may have been
impaired;

(c)

the conditions under which the food additive may be used;

(d) if appropriate, whether there are any restrictions on the sale

of the food additive directly to the final consumer.

3.
The Community lists in Annexes II and III shall be
amended in accordance with the procedure referred to in Regu-
lation (EC) No …/2008 (*).

(*) See page 1 of this Official Journal.

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Article 11

CHAPTER III

Levels of use of food additives

USE OF FOOD ADDITIVES IN FOODS

1. When establishing the conditions of use referred to in
Article 10(2)(c):

(a)

the level of use shall be set at the lowest level necessary to
achieve the desired effect;

(b) the levels shall take into account:

(i) any acceptable daily intake, or equivalent assessment,
established for the food additive and the probable daily
intake of it from all sources;

(ii) where the food additive is to be used in foods eaten by
special groups of consumers, the possible daily intake of
the food additive by consumers in those groups.

2. Where appropriate, no maximum numerical level shall be
fixed for a food additive (quantum satis). In that case, the food
additive shall be used in accordance with the principle of
quantum satis.

The maximum levels of food additives set out in Annex II
3.
shall apply to the food as marketed, unless otherwise stated. By
way of derogation from this principle, for dried and/or concen-
trated foods which need to be reconstituted the maximum levels
shall apply to the food as reconstituted according to the instruc-
tions on the label taking into account the minimum dilution
factor.

4.
The maximum levels for colours set out in Annex II shall
apply to the quantities of colouring principle contained in the
colouring preparation unless otherwise stated.

Article 12

Food additives falling within the scope of Regulation (EC)
No 1829/2003

A food additive falling within the scope of Regulation (EC)
No 1829/2003 may be included in the Community lists in
Annexes II and III in accordance with this Regulation only when
it is covered by an authorisation in accordance with Regulation
(EC) No 1829/2003.

Article 13

Article 14

Use of food additives in unprocessed foods

Food additives shall not be used in unprocessed foods, except
where such use is specifically provided for in Annex II.

Article 15

Use of

food additives in foods for infants and young

children

Food additives shall not be used in foods for infants and young
children as referred to in Directive 89/398/EEC,
including
dietary foods for infants and young children for special medical
purposes, except where specifically provided for in Annex II to
this Regulation.

Article 16

Use of colours for markings

Only food colours listed in Annex II to this Regulation may be
used for the purpose of health marking as provided for in
Council Directive 91/497/EEC of 29 July 1991 amending and
consolidating Directive 64/433/EEC on health problems
affecting intra-Community trade in fresh meat to extend it to
the production and marketing of fresh meat (1) and other mark-
ings required on meat products, for the decorative colouring of
eggshells and for the stamping of eggshells as provided for in
Regulation (EC) No 853/2004 of the European Parliament and
of the Council of 29 April 2004 laying down specific hygiene
rules for food of animal origin (2).

Article 17

Carry-over principle

Specifications of food additives

1.

The presence of a food additive shall be permitted:

in particular, to
The specifications of food additives relating,
origin, purity criteria and any other necessary information, shall
included in the
be adopted when the
Community lists in Annexes II and III for the first time,
in
accordance with the procedure referred to in Regulation (EC)
No …/2008 (*).

food additive

is

(*) See page 1 of this Official Journal.

(a)

in a compound food other than as referred to in Annex II,
where the food additive is permitted in one of the ingredi-
ents of the compound food;

(1) OJ L 268, 24.9.1991, p. 69. Directive as amended by Regulation (EC)

No 806/2003 (OJ L 122, 16.5.2003, p. 1).

(2) OJ L 139, 30.4.2004, p. 55. Corrected version in OJ L 226, 25.6.2004,
p. 22. Regulation as last amended by Commission Regulation (EC)
No 1243/2007 (OJ L 281, 25.10.2007, p. 8).

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(b) in a food to which a food additive, food enzyme or food

flavouring has been added, where the food additive:

(i)

is permitted in the food additive, food enzyme or food
flavouring in accordance with this Regulation; and

(ii) has been carried over to the food via the food additive,

food enzyme or food flavouring; and

(iii) has no technological function in the final food;

(c)

in a food which is to be used solely in the preparation of a
compound food and provided that
the compound food
complies with this Regulation.

2.
Paragraph 1 shall not apply to infant formulae, follow-on
formulae, processed cereal-based foods and baby foods and
dietary foods for special medical purposes intended for infants
and young children as referred to in Directive 89/398/EEC,
except where specifically provided for.

Article 19

Traditional foods

The Member States listed in Annex IV may continue to prohibit
the use of certain categories of food additives in the traditional
foods produced on their territory as listed in that Annex.

CHAPTER IV

LABELLING

Article 20

Labelling of food additives not intended for sale to the final
consumer

3. Where a food additive in a food flavouring, food additive
or food enzyme is added to a food and has a technological func-
tion in that food, it shall be considered a food additive of that
food and not a food additive of the added flavouring, food addi-
tive or food enzyme, and must then comply with the conditions
of use for that food as provided for.

Food additives not intended for sale to the final consumer,
1.
whether sold singly or mixed with each other and/or with ingre-
dients, as defined in Article 6(4) of Directive 2000/13/EC, may
only be marketed with the labelling provided for in Article 21
of this Regulation, which must be easily visible, clearly legible
and indelible. The information shall be in a language easily
understandable to purchasers.

4. Without prejudice to paragraph 1, the presence of a food
additive used as a sweetener shall be permitted in a compound
food with no added sugars,
in an energy-reduced compound
food, in compound dietary foods intended for low-calorie diets,
in non-cariogenic compound foods, and in a compound food
with an increased shelf-life, provided that
the sweetener is
permitted in one of the ingredients of the compound food.

2. Within its own territory, the Member State in which the
product is marketed may, in accordance with the Treaty, stipu-
late that the information provided for in Article 21 shall be
given in one or more of the official
languages of the Com-
munity, to be determined by that Member State. This shall not
preclude such information from being indicated in several
languages.

Article 18

Interpretation decisions

Where necessary, it may be decided in accordance with the regu-
latory procedure referred to in Article 26(2) whether or not:

(a) a particular food belongs to a category of food referred to in

Annex II; or

(b) a food additive listed in Annexes II and III and permitted at
quantum satis is used in accordance with the criteria referred
to in Article 11(2); or

Article 21

General

labelling requirements for food additives not
intended for sale to the final consumer

1. Where food additives not intended for sale to the final
consumer are sold singly or mixed with each other and/or other
food ingredients and/or with other substances added to them,
their packaging or containers shall bear the following informa-
tion:

(a)

the name and/or E-number laid down in this Regulation in
respect of each food additive or a sales description which
includes the name and/or E-number of each food additive;

(b) the statement ‘for food’ or the statement ‘restricted use in
food’ or a more specific reference to its intended food use;

(c) a given substance meets the definition of food additive in

Article 3.

(c)

if necessary, the special conditions of storage and/or use;

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(d) a mark identifying the batch or lot;

(e)

instructions for use, if the omission thereof would preclude
appropriate use of the food additive;

(f)

the name or business name and address of the manufac-
turer, 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;
where the same limit on quantity applies to a group of
components used singly or in combination, the combined
percentage may be given as a single figure; the limit on
quantity shall be expressed either numerically or by the
quantum satis principle;

(h) the net quantity;

(i)

the date of minimum durability or use-by-date;

(j) where relevant,

information on a food additive 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. Where food additives are sold mixed with each other
their packaging or
food ingredients,
and/or with other
containers shall bear a list of all ingredients in descending order
of their percentage by weight of the total.

3. Where substances (including food additives or other food
ingredients) are added to food additives to facilitate their
storage,
their
packaging or containers shall bear a list of all such substances in
descending order of their percentage by weight of the total.

standardisation, dilution or dissolution,

sale,

4.
By way of derogation from paragraphs 1, 2 and 3, the
information required in paragraph 1 points (e) to (g) and in
paragraphs 2 and 3 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.

5.
By way of derogation from paragraphs 1, 2 and 3, where
food additives 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.

identifying the lot to which a foodstuff belongs (1) and Regu-
lation (EC) No 1829/2003, food additives sold singly or mixed
with each other and/or other food ingredients intended for sale
to the final consumer may be marketed only if their packaging
contains the following information:

(a)

the name and E-number laid down in this Regulation in
respect of each food additive or a sales description which
includes the name and E-number of each food additive;

(b) the statement ‘for food’ or the statement ‘restricted use in
food’ or a more specific reference to its intended food use.

By way of derogation from paragraph 1(a),

2.
description of a table-top sweetener shall
‘…-based table-top sweetener’, using the name(s) of
sweetener(s) used in its composition.

the sales
include the term
the

3.
The labelling of a table-top sweetener containing polyols
and/or aspartame and/or aspartame-acesulfame salt shall bear
the following warnings:

(a) polyols: ‘excessive consumption may induce laxative effects’;

(b) aspartame/aspartame-acesulfame salt:

‘contains a source of

phenylalanine’.

4. Manufacturers of table-top sweeteners shall make available
by appropriate means the necessary information to allow their
safe use by consumers. Guidance for the implementation of this
paragraph may be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 26(3).

5.
For the information provided for in paragraphs 1 to 3 of
this Article, Article 13(2) of Directive 2000/13/EC shall apply
accordingly.

Article 23

Other labelling requirements

Article 22

Labelling of food additives intended for sale to the final
consumer

Articles 20, 21 and 22 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.

1. Without prejudice to Directive 2000/13/EC, Council
Directive 89/396/EEC of 14 June 1989 on indications or marks

(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).

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CHAPTER V

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.

PROCEDURAL PROVISIONS AND IMPLEMENTATION

Article 24

Information obligation

A producer or user of a food additive shall

inform the
1.
Commission immediately of any new scientific or technical
information which might affect the assessment of the safety of
the food additive.

2.
For a food additive already approved under this Regulation
which is prepared by production methods or using starting
materials significantly different from those included in the risk
assessment of the European Food Safety Authority (hereinafter
referred to as the ‘Authority’), a producer or user shall, before
marketing the food additive, submit to the Commission the
necessary data to allow an evaluation of the food additive with
regard to the modified production method or characteristics to
be undertaken by the Authority.

3.
A producer or user of a food additive shall, at the request
of the Commission, inform it of the actual use of the food addi-
tive. Such information shall be made available to Member States
by the Commission.

Article 25

Monitoring of food additive intake

1. Member States shall maintain systems to monitor the
consumption and use of food additives on a risk-based approach
and report their findings with appropriate frequency to the
Commission and the Authority.

After

the Authority has been consulted, a common
2.
methodology for the gathering of information by the Member
States on dietary intake of food additives in the Community
shall be adopted in accordance with the regulatory procedure
referred to in Article 26(2).

Article 26

Committee

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)
to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

The time-limits laid down in Article 5a(3)(c) and (4)(b) and (e)
of Decision 1999/468/EC shall be 2 months, 2 months and
4 months respectively.

Article 27

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 28

Establishment of Community lists of food additives

1.
Food additives which are permitted for use in foods under
Directives 94/35/EC, 94/36/EC and 95/2/EC, as amended on the
basis of Article 29 of this Regulation, and their conditions of
use shall be entered in Annex II to this Regulation after a review
their compliance with Articles 6, 7 and 8 thereof. The
of
measures relating to the entry of such additives in Annex II,
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 26(4). The review
shall not include a new risk assessment by the Authority. The
review shall be completed by … (*).

Food additives and uses which are no longer needed shall not
be entered in Annex II.

The Commission shall be assisted by the Standing

1.
Committee on the Food Chain and Animal Health.

(*) Two years after the date of entry into force of this Regulation.

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2.
Food additives authorised for use in food additives in
Directive 95/2/EC and their conditions of use shall be entered in
Part 1 of Annex III to this Regulation after a review of their
compliance with Article 6 thereof. The measures relating to the
entry of such additives in Annex III, which are designed to
amend non-essential elements of
this Regulation, shall be
adopted in accordance with the regulatory procedure with scru-
tiny referred to in Article 26(4). The review shall not include a
new risk assessment by the Authority. The review shall be
completed by … (*).

Food additives and uses which are no longer needed shall not
be entered in Annex III.

Foods placed on the market or labelled before … (***) which do
not comply with Article 21(1)(i) and (4) of
this Regulation
may be marketed until their date of minimum durability or
use-by-date.

Article 30

Re-evaluation of approved food additives

Food additives which were permitted before … (****) shall
to a new risk assessment carried out by the

1.
be subject
Authority.

Food additives authorised for use in food flavourings in
3.
Directive 95/2/EC and their conditions of use shall be entered in
Part 4 of Annex III to this Regulation after a review of their
compliance with Article 6 thereof. The measures relating to the
entry of such additives in Annex III, which are designed to
this Regulation, shall be
amend non-essential elements of
adopted in accordance with the regulatory procedure with scru-
tiny referred to in Article 26(4). The review shall not include a
new risk assessment by the Authority. The review shall be
completed by … (*).

Food additives and uses which are no longer needed shall not
be entered in Annex III.

4.
Specifications of the food additives covered under para-
graphs 1 to 3 of this Article shall be adopted, in accordance
with Regulation (EC) No …/2008 (**), at the moment those
food additives are entered in the Annexes in accordance with
those paragraphs.

5.
The measures relating to any appropriate transitional
measures, which are designed to amend non-essential elements
of
inter alia by supplementing it, shall be
adopted in accordance with the regulatory procedure with scru-
tiny referred to in Article 26(3).

this Regulation,

Article 29

Transitional measures

Until the establishment of the Community lists of food additives
as provided for in Article 28 is completed, the Annexes to
Directives 94/35/EC, 94/36/EC and 95/2/EC shall be amended,
where necessary, by measures, designed to amend non-essential
elements of those Directives, adopted by the Commission in
accordance with the regulatory procedure with scrutiny referred
to in Article 26(4).

After

the Authority,

consultation of

2.
an evaluation
programme for those additives shall be adopted by … (*****), in
referred to in
accordance with the regulatory procedure
Article 26(2). The evaluation programme shall be published in
the Official Journal of the European Union.

Article 31

Repeals

1.

The following acts shall be repealed:

(a) Directive 62/2645/EEC;

(b) Directive 65/66/EEC;

(c) Directive 78/663/EEC;

(d) Directive 78/664/EEC;

(e) Directive 81/712/EEC;

(f) Directive 89/107/EEC;

(g) Directive 94/35/EC;

(h) Directive 94/36/EC;

(i) Directive 95/2/EC;

(j) Decision No 292/97/EC;

(k) Decision 2002/247/EC.

References to the repealed acts shall be construed as refer-

2.
ences to this Regulation.

Article 32

Transitional provisions

By way of derogation from Article 31, the following provisions
shall continue to apply until the transfer under Article 28(1), (2)
and (3) of this Regulation of food additives already permitted
in Directives 94/35/EC, 94/36/EC and 95/2/EC has been
completed:

(a) Article 2(1),

(2) and (4) of Directive 94/35/EC and the

Annex thereto;

(*) Two years after the date of entry into force of this Regulation.
(**) See page 1 of this Official Journal.

(***) 12 months after the date of entry into force of this Regulation.
(****) Date of entry into force of this Regulation.
(*****) One year after the date of entry into force of this Regulation.

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(b) Article 2(1) to (6), (8), (9) and (10) of Directive 94/36/EC

and Annexes I to V thereto;

(c) Articles 2 and 4 of Directive 95/2/EC and Annexes I to VI

thereto.

(c),

the authorisations

Notwithstanding point
for E 1103
Invertase and E 1105 Lysozyme laid down in Directive 95/2/EC
shall be repealed with effect from the date of application of the
Community list on food enzymes in accordance with Article 17
of Regulation (EC) No …/2008 (*).

Article 33

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 … (**).

However, Article 4(2) shall apply to Parts 2, 3 and 5 of
Annex III from 1 January 2011 and Article 22(4) shall apply
from … (***). Article 29 shall apply from … (****).

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, …

For the European Parliament

The President

For the Council

The President

(*) See page 32 of this Official Journal.

(**) One year after the date of entry into force of this Regulation.
(***) Two years after the date of entry into force of this Regulation.
(****) Date of entry into force of this Regulation.

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ANNEX I

FUNCTIONAL CLASSES OF FOOD ADDITIVES IN FOODS AND OF FOOD ADDITIVES IN FOOD ADDITIVES
AND FOOD ENZYMES

1.

‘Sweeteners’ are substances used to impart a sweet taste to foods or in table-top sweeteners.

2.

3.

4.

5.

‘Colours’ are substances which add or restore colour in a food, and include natural constituents of foods and natural
sources which are normally not consumed as foods as such and not normally used as characteristic ingredients of
food. Preparations obtained from foods and other edible natural source materials obtained by physical and/or
chemical extraction resulting in a selective extraction of the pigments relative to the nutritive or aromatic constituents
are colours within the meaning of this Regulation.

‘Preservatives’ are substances which prolong the shelf-life of foods by protecting them against deterioration caused by
micro-organisms and/or which protect against growth of pathogenic micro-organisms.

‘Antioxidants’ are substances which prolong the shelf-life of foods by protecting them against deterioration caused by
oxidation, such as fat rancidity and colour changes.

‘Carriers’ are substances used to dissolve, dilute, disperse or otherwise physically modify a food additive or a
flavouring, food enzyme, nutrient and/or other substance added for nutritional or physiological purposes to a food
without altering its function (and without exerting any technological effect themselves) in order to facilitate its hand-
ling, application or use.

6.

‘Acids’ are substances which increase the acidity of a foodstuff and/or impart a sour taste to it.

7.

‘Acidity regulators’ are substances which alter or control the acidity or alkalinity of a foodstuff.

8.

‘Anti-caking agents’ are substances which reduce the tendency of individual particles of a foodstuff to adhere to one
another.

9.

‘Anti-foaming agents’ are substances which prevent or reduce foaming.

10.

‘Bulking agents’ are substances which contribute to the volume of a foodstuff without contributing significantly to its
available energy value.

11.

‘Emulsifiers’ are substances which make it possible to form or maintain a homogenous mixture of two or more
immiscible phases such as oil and water in a foodstuff.

12.

‘Emulsifying salts’ are substances which convert proteins contained in cheese into a dispersed form and thereby bring
about homogenous distribution of fat and other components.

13.

‘Firming agents’ are substances which make or keep tissues of fruit or vegetables firm or crisp, or interact with gelling
agents to produce or strengthen a gel.

14.

‘Flavour enhancers’ are substances which enhance the existing taste and/or odour of a foodstuff.

15.

‘Foaming agents’ are substances which make it possible to form a homogenous dispersion of a gaseous phase in a
liquid or solid foodstuff.

16.

‘Gelling agents’ are substances which give a foodstuff texture through formation of a gel.

17.

‘Glazing agents’ (including lubricants) are substances which, when applied to the external surface of a foodstuff,
impart a shiny appearance or provide a protective coating.

18.

‘Humectants’ are substances which prevent foods from drying out by counteracting the effect of an atmosphere
having a low degree of humidity, or promote the dissolution of a powder in an aqueous medium.

19.

‘Modified starches’ are substances obtained by one or more chemical treatments of edible starches, which may have
undergone a physical or enzymatic treatment, and may be acid or alkali thinned or bleached.

20.

‘Packaging gases’ are gases other than air, introduced into a container before, during or after the placing of a foodstuff
in that container.

21.

‘Propellants’ are gases other than air which expel a foodstuff from a container.

22.

‘Raising agents’ are substances or combinations of substances which liberate gas and thereby increase the volume of a
dough or a batter.

23.

‘Sequestrants’ are substances which form chemical complexes with metallic ions.

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24.

‘Stabilisers’ are substances which make it possible to maintain the physico-chemical state of a foodstuff; stabilisers
include substances which enable the maintenance of a homogenous dispersion of two or more immiscible substances
in a foodstuff, substances which stabilise, retain or intensify an existing colour of a foodstuff and substances which
including the formation of cross-links between proteins enabling the
increase the binding capacity of the food,
binding of food pieces into re-constituted food.

25.

‘Thickeners’ are substances which increase the viscosity of a foodstuff.

26.

‘Flour treatment agents’ are substances, other than emulsifiers, which are added to flour or dough to improve its
baking quality.

Community list of food additives approved for use in foods and conditions of use.

ANNEX II

Community list of food additives approved for use in food additives, food enzymes and food flavourings, and their condi-
tions of use.

ANNEX III

Community list of carriers in nutrients and their conditions of use.

Part 1 Carriers in food additives

Part 2 Food additives other than carriers in food additives

Part 3 Food additives including carriers in food enzymes

Part 4 Food additives including carriers in food flavourings

Part 5 Carriers in nutrients and other substances added for nutritional and/or for other physiological purposes

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TRADITIONAL FOODS FOR WHICH CERTAIN MEMBER STATES MAY CONTINUE TO PROHIBIT THE USE
OF CERTAIN CATEGORIES OF FOOD ADDITIVES

ANNEX IV

Member State

Foods

Categories of additives which may continue to
be banned

Germany

France

France

France

France

Austria

Finland

Sweden
Finland

Denmark

Denmark

Spain

Italy

Italy

(‘Bier nach deutschem

All except propellant gases

Traditional German beer
Reinheitsgebot gebraut’)

Traditional French bread

Traditional French preserved truffles

Traditional French preserved snails

All

All

All

Traditional
(‘confit’)

French goose

and duck preserves

All

Traditional Austrian ‘Bergkäse’

All except preservatives

Traditional Finnish ‘Mämmi’

All except preservatives

Traditional Swedish and Finnish fruit syrups

Colours

Traditional Danish ‘Kødboller’

Preservatives and colours

Traditional Danish ‘Leverpostej’

Preservatives (other than sorbic acid) and
colours

Traditional Spanish ‘Lomo embuchado’

All except preservatives and antioxidants

Traditional Italian ‘Mortadella’

Traditional Italian ‘Cotechino e zampone’

except

preservatives,

All
pH-adjusting agents,
stabilisers and packaging gas

flavour

antioxidants,
enhancers,

except

preservatives,

All
pH-adjusting agents,
stabilisers and packaging gas

flavour

antioxidants,
enhancers,

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STATEMENT OF THE COUNCIL'S REASONS

I.

INTRODUCTION

On 28 July 2006, the Commission adopted the proposal for a Regulation on food additives (1). The
proposal is based on Article 95 of the Treaty establishing the European Community.

The European Parliament adopted its Opinion at first reading on 10 July 2007 (2).

Following the European Parliament's first reading opinion, the Commission submitted an amended
proposal on 24 October 2007 (3).

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 Economic and
Social Committee adopted on 25 April 2007 (4).

II. OBJECTIVE

The proposed Regulation, as part of four proposals designed to overhaul the Community's rules on food
improvement agents, would update and simplify the existing Community legislation with regard to food
additives.

Through the proposed Regulation, a Community list of food additives and of food additives approved
for use in food additives, food enzymes and food flavourings including their conditions of use, will be
established. The proposed Regulation will also establish rules on the labelling of food additives.

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.

III. ANALYSIS OF THE COMMON POSITION

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:

— ‘Misleading the consumer’ (in line with amendments 3 and 26)

The Council included, in recital 7 and Article 6, elements integrating the notion of misleading the
consumer.

— Protection of the environment (in line with amendments 1 and 7)

The Council considered that, apart from scientific evidence, the authorisation of the food addi-
tives should also take into account other relevant factors, such as the protection of the environ-
ment. The Council also included a reference to the protection of the environment among the
objectives of the proposed Regulation.

(1) COM(2006) 428 final.
(2) Doc. 11640/07 CODEC 776.
(3) COM(2007) 673.
(4) OJ C 168, 20.7.2007, p. 29.

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— Protection of consumers with a food intolerance or allergy (in line with amendment 1)

The Council recognised that the use and maximum levels of food additives should take into
account the exposure of special groups of consumers, e.g. consumers with allergies.

— Regulatory comitology procedure with scrutiny (in line with amendment 48, 51, 64/rev, 67/rev,

68/rev, 79 and 80)

The Council adapted the proposal to the new comitology procedure rules, requiring the regula-
tory procedure with scrutiny to be applied for the adoption of measures supplementing the
proposed Regulation.

The Council decided, on grounds of efficiency, to use the regulatory procedure with scrutiny with
curtailed time limits for the establishment of Community lists of additives and for transitional
measures, until the establishment of Community lists, to amend Annexes to Directives 94/35/EC,
94/36/EC and 95/2/EC.

— Interpretation decisions

The Council regrouped all the provisions on interpretation decisions into a new single Article
and, as they would not supplement the Regulation, left them subject to the regulatory comitology
procedure without scrutiny.

— Provision prohibiting the placing on the market of non compliant food additives (in line with amend-

ments 9 and 22)

For reasons of clarity, legal certainty and proper functioning of the market, the Council inserted
an Article on the prohibition on placing non-compliant food additives on the market. This is
consistent with the proposals on flavourings and on food enzymes.

— Authorisation of additives falling 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)
(in line with amendment 4)

The Council agrees that the two authorisation procedures for any substance can be carried out
simultaneously, although the final authorisation should be granted under the additives Regulation.
The Council subjected that principle to some drafting changes in order to make the provision
more compatible with Regulation (EC) No 1829/2003.

— Transitional measures for products already on the market (in line with amendment 56)

The Council provided for a 1 year transition period from the date of entry into force of the Regu-
lation. Foods lawfully placed on the market or labelled during this year may be marketed until
their date of minimum durability or use-by-date.

— Labelling

The Council streamlined the labelling provisions in order to duplicate the provisions already laid
down by Directive 2000/13/EC, 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 in line with amendments 42 and 44.

(1) OJ L 268, 18. 10.2003, p. 1.

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— Nanotechnology (in line with amendment 35)

Similar to the proposal of the European Parliament, the Council considered that a new evaluation
of a food additive is necessary if a food additive is produced by production methods significantly
different from those included in the previous risk assessment. Different conditions of use can be
imposed in consequence of the new evaluation.

The Commission has accepted the Common Position agreed by the Council.

2. The amendments of the European Parliament

In its Plenary vote, on 10 July 2007, the European Parliament adopted 59 amendments to the
proposal.

In its Common Position, the Council, incorporated, in full or in principle, 33 amendments.

(a) Amendments incorporated in the Common Position

In addition to amendments already mentioned in part 1 above, the Common Position incorpo-
rates other European Parliament's first reading amendments, either in full or in part, that are of a
technical/editorial nature and aimed at improving the clarity of the text of the proposal (amend-
ments 8, 13, 14, 18, 19, 21, 36, 37, 39, 46, 55, 57, 58, 59, 60).

(b) Amendments not introduced (1)

The Council was not able to accept all the amendments, for the following reasons:

— Precautionary principle (amendment 78 — recital 10)

The precautionary principle is one of the general principles underlying the general food
law (2). Consequently, it applies to the proposed Regulation with no need for a specific refer-
ence to it. Moreover, in the risk analysis framework, the precautionary principle can only be
taken into account in the context of risk management, never in the risk assessment phase, as
suggested by the European Parliament.

— Food additives not to be used with other food additives (amendment 34 — Article 10(2))

Articles 1 and 10(2)(c) already stipulate that conditions of use of food additives have to be
specified in the Community list, hence amendment 34 is superfluous.

— Re-evaluation programme
Article 30(2a new))

to

review authorisations

(amendments 5, 54 — recital 14,

For the Council, a system of continuous observation and of re-evaluation whenever necessary
in the light of changing conditions and of new scientific information, will guarantee food
safety. An additional review would represent an unnecessary administrative burden for produ-
cers, users, EFSA, the Commission and the Member States.

(1) Numbering of Articles in this part refers to the text of the Common Position.
(2) 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).

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— Review of existing authorisations (amendment 6, 52, 69rev — recital 21, Article 30(1) and (2))

The Council maintains that the additives already authorised shall be transferred into the list of
authorised additives after review of the criteria other then safety. However, EFSA is tasked to
undergo the re-evaluation of currently authorised food additives with respect to their safety. It
is not appropriate to link these two reviews.

— Definition of food additives and scope of the proposed Regulation

— to include in the scope post-harvest plant protection products (amendment 10 — Article 2(b)):
Plant protection products used for post-harvest
to Directive
91/414/EEC, which already provides that if a plant protection product falls under the defi-
nition of other Community law, the latter will be applicable.

treatment are subject

— to exclude from the scope microbial cultures (amendment 11 — Article 2(da) new): Some
cultures are added to foods towards the end of their manufacture for an intended preser-
vation effect and therefore could be considered to be food additives. For that reason, they
should not be excluded from the scope of the proposed Regulation.

— blood protein not to be considered as an additive (amendment 16 — Article 3(2)(a)(viii)): At
present substances consisting of blood proteins are considered as falling under the scope
of Community law on food additives. The Council considers that the exclusion of blood
protein as an additive in Article 3(2) is not appropriate.

— Decisions submitted to the regulatory comitology procedure (amendment 12, 40, 47 — Articles 2(5),

18(c) introduction, 25(2))

Decisions on whether or not a given substance falls within the scope of the Regulation are of
merely interpretative nature. Therefore, they do not fall within the scope of the regulatory
comitology procedure with scrutiny.

— Definitions and exclusions (additional technological effect) (amendment 15 — Article 3(2)(a)(ii))

considers

The Council
in
Article 3(2)(a)(ii) is too broad and may exclude from the definition substances used as food
additives.

technological effect’

the addition of

‘an additional

that

— Food reduced in sugars (amendment 20, 29 — Articles 3(2)(i), 7(a))

The introduction of this concept into the Regulation would result in an increase in variety of
products in which sweeteners may be used and may lead to the increased consumption of
such additives, which would not benefit the consumers.

— Benefits to the consumer (amendment 24 — Article 6(1)(b))

Amendment 24 provides that one of the conditions for including a food additive into the
Community list should be a reasonable technological need in terms of benefits to the
consumer. However, Article 6(2) already stipulates that an additive needs to have benefits and
advantages for the consumers in order to be included in the Community list. Amendment 24
is therefore not necessary.

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— Explanation of the basis for the final decision (amendment 28 — Article 6(3a new))

The decision whether or not to include food additives in the Community list is taken through
the regulatory procedure with scrutiny on the basis of the proposal from the Commission.
These proposals include recitals explaining their background, thus amendment 28 is super-
fluous.

— Specific conditions for sweeteners (amendment 73 — Article 7(b))

The Council considered that the deletion of the sentence would be too restrictive.

— Additives potentially misleading the consumers (e.g. colors) (amendment 30 — Article 8(1a new))

The provision in Article 6 concerning general conditions for authorisation of food additives
provide that an additive should not mislead the consumer. In addition the Council, in order
to define the term ‘misleading the consumers’ clarified this notion in recital 7.

— Specifications in the Community lists:

— Identification of the additive group (amendment 33 — Article 10(2)(a)): Article 9 provides
that a food additive will be allocated to a functional class. As an additive can fall into
several functional classes, the Council could not support such an amendment requiring
the identification of all the classes to which an additive can belong.

— Specification of

can be added (amendment 33 —
Article 10(2)(b)): The amendment is not necessary as enzymes, flavourings and additives
are considered as food.

to which additives

substances

the

— Labelling of genetically modified organisms (GMO's) (amendment 38 and 63 — Article 12)

As mentioned in recital 16, food additives remain subject to the labelling provisions defined
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 (1) and in Regulation (EC) No 1829/2003 of the European
Parliament and of the Council of 22 September 2003 on genetically modified food and
feed (2) (The labelling of food ingredients, including additives, produced from, containing and
consisting of GMO's, is provided for in Articles 12 and 13 of Regulation (EC) No 1829/2003).
The Council adopted a prudent approach, not accepting amendments that could interfere
with the scope of the horizontal Regulations in force.

— Labelling (amendments 43 and 45 — Articles 21(4), 22(3a new))

First of all, the Council considered that only certain information can be provided by the
accompanying documents supplied with or prior to the delivery. Secondly, as there are
already provisions on the labelling of allergens, which are listed in Annex IIIa of Directive
2000/13/EC, the Council considered that it is not appropriate to go beyond those provisions
in this legislative act.

(1) 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).
(2) 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).

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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.