Directive 2003/114/EC of the European Parliament and of the Council of 22 December 2003 amending Directive 95/2/EC on food additives other than colours and sweeteners
Date: 2003-12-22
Institutions: Council of the European Union, European Parliament
Subjects: approximation of laws, consumer protection, food additive, foodstuff, foodstuffs legislation, human nutrition

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DIRECTIVE 2003/114/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Directive 95/2/EC on food additives other than colours and sweeteners

of 22 December 2003

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,

(5)

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),

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

Whereas:

(1)

(2)

(3)

(4)

Food additives may be approved for use in foodstuffs
only if they comply with Annex II to Council Directive
89/107/EEC of 21 December 1988 on the approxima-
tion of the laws of the Member States concerning food
additives authorised for use in foodstuffs intended for
human consumption (3).

Directive 95/2/EC of the European Parliament and of the
Council of 20 February 1995 on food additives other
than colours and sweeteners (4) lays down a list of food
additives that may be used in the Community and the
conditions for their use.

There have been technical developments in the field of
food additives since the adoption of Directive 95/2/EC.
That Directive should be adapted to take account of
those developments.

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 mate-
rials for their production (5) provides for the adoption of
a list of additives necessary for the storage and use of
flavourings, and the adoption of any special conditions
for the use of such additives that may be necessary for
the protection of public health and to ensure fair trade.

(1) OJ C 208, 3.9.2003, p. 30.
(2) Opinion of

the European Parliament of 3 July 2003 (not yet
published in the Official Journal), and Decision of the Council of 1
December 2003.

(3) OJ L 40, 11.2.1989, p. 27. Directive as amended by Directive 94/
34/EC of the European Parliament and of the Council (OJ L 237,
10.9.1994, p. 1).

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

2003/52/EC (OJ L 178, 17.7.2003, p. 23).

It
is desirable to incorporate into Directive 95/2/EC
those measures on additives necessary for the storage
and use of flavourings, in order to contribute to trans-
parency and consistency of Community legislation, and
to facilitate compliance with Community legislation on
food additives by food manufacturers, especially by small
and medium-sized enterprises. In addition, according to
Regulation (EC) No 178/2002 of the European Parlia-
ment 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 (6),
flavourings fall within the definition of ‘food’.

(6) While the use of additives which are necessary to ensure
the safety and quality of flavourings and to facilitate
their storage and use should be authorised, the levels of
additives present
in such flavourings should be the
minimum required to achieve the intended purpose. In
addition,
should be guaranteed correct,
adequate and non-misleading information on the use of
additives.

consumers

(7)

(8)

The presence of an additive in a foodstuff, due to the use
of a flavouring, is generally low and the additive does
not have a technological
function in the foodstuff.
However,
if under certain circumstances the additive
does have a technological function in the compound
foodstuff, it should be considered as an additive of the
the
compound foodstuff and not as an additive of
flavouring, and the relevant rules relating to the additive
in the particular foodstuff should apply,
including the
labelling rules laid down 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 (7).

In accordance with Directive 88/388/EEC, food manu-
facturers should be informed about the concentrations
of all additives in flavourings in order to enable them to
comply with Community legislation. That Directive also
requires quantitative labelling of each component subject
to a quantitative limitation in a foodstuff. A quantitative
limitation is expressed either numerically or by the
‘quantum satis’ principle.

(6) OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC)

No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

(5) OJ L 184, 15.7.1988, p. 61. Directive as amended by Commission

(7) OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive

Directive 91/71/EEC (OJ L 42, 15.2.1991, p. 25).

2003/89/EC (OJ L 308, 25.11.2003, p. 15).

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(9)

(10)

(11)

In accordance with the principle of proportionality, it is
necessary and appropriate for the achievement of the
basic objective of ensuring market unity and a high level
of consumer protection to lay down rules on the use of
additives in flavourings. This Directive does not go
beyond what is necessary in order to achieve the objec-
tives pursued in accordance with the third paragraph of
Article 5 of the Treaty.

In accordance with a request from a Member State and
the opinion of the Scientific Committee on Food, estab-
lished by Commission Decision 97/579/EC of 23 July
1997 setting up Scientific Committees in the field of
consumer health and food safety (1), hydrogenated poly-
1-decene, which was authorised at national level under
Directive 89/107/EEC, should be authorised at Com-
munity level.

(E 230), orthophenyl phenol

Biphenyl
(E 231) and
sodium orthophenyl phenol (E 232) are listed as preser-
vatives in and on citrus fruits in Directive 95/2/EC.
However, they fall under the definition of ‘plant protec-
tion products’
in Council Directive 91/414/EEC of 15
July 1991 concerning the placing of plant protection
products on the market (2). Therefore, they should no
longer come within the scope of Directive 95/2/EC. The
Member States and the Commission should take all
possible steps to ensure that there is no legal vacuum
with regard to these substances. Authorisation to place
on the market
these substances as plant protection
products should be dealt with as swiftly as possible.

(12) On 4 April 2003, the Scientific Committee on Food
stated that the temporary acceptable daily intake for E
214 to E 219 p-hydroxybenzoic acid alkyl esters and
their sodium salts should be withdrawn if no further
data are submitted in respect of intake and toxicity.

(13) Directive 95/2/EC should therefore be amended accord-

ingly.

(14)

Council Directive 67/427/EEC of 27 June 1967 on the
use of certain preservatives for the surface treatment of
citrus fruit and on the control measures to be used for
the qualitative and quantitative analysis of preservatives
in and on citrus fruit (3) lays down the control measures
on preservatives in and on citrus fruits. Since those
preservatives are no longer authorised for use in citrus
fruits by Directive 95/2/EC,
it is necessary to repeal
Directive 67/427/EEC.

(15)

The Scientific Committee on Food has been consulted
on the adoption of provisions that may have an effect
upon public health, pursuant to Article 6 of Directive
89/107/EEC,

(1) OJ L 237, 28.8.1997, p. 18. Decision as amended by Decision

2000/443/EC (OJ L 179, 18.7.2000, p. 13).

(2) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Regulation

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

(3) OJ 148, 11.7.1967, p. 1.

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 95/2/EC is hereby amended as follows:

1. Article 1(3)(v) shall be replaced by the following:

‘(v) “stabilisers” are substances which make it possible to
maintain the physico-chemical state of a foodstuff; stabi-
lisers 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 increase the binding capacity of the
food,
including the formation of cross-links between
proteins enabling the binding of food pieces into re-
constituted food;’

2. Article 3 shall be amended as follows:

(a) paragraph 1 shall be replaced by the following:

‘1.

The presence of a food additive is permissible:

(a) in a compound foodstuff other than one mentioned
in Article 2(3), to the extent to which the food addi-
tive is permitted in one of the ingredients of the
compound foodstuff;

(b) in a foodstuff where a flavouring has been added, to
the extent to which the food additive is permitted in
the flavouring in compliance with this Directive and
has been carried over
to the foodstuff via the
flavouring, provided the food additive has no tech-
nological function in the final foodstuff; or

(c) if the foodstuff is destined to be used solely in the
preparation of a compound foodstuff and to an
extent such that the compound foodstuff conforms
to the provisions of this Directive.’;

(b) the following paragraph shall be added:

the presence of additives

‘3.
The level of additives in flavourings shall be
limited to the minimum necessary to guarantee the
safety and quality of flavourings and to facilitate their
storage. Furthermore,
in
flavourings must not mislead consumers or present a
hazard to their health. If the presence of an additive in a
foodstuff, as a consequence of adding flavourings, has a
shall be
function in the foodstuff,
technological
considered as an additive of the foodstuff and not as an
additive of the flavouring.’;

it

3. the Annexes shall be amended as set out in the Annex to

this Directive.

Article 2

1.
Before 1 July 2004, the Commission and the European
Food Safety Authority shall review the conditions for the use of
additives E 214 to E 219.

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Before 27 January 2006, the Commission shall submit to
2.
the European Parliament and the Council a report on the
progress of the re-evaluation of additives. This re-evaluation
shall in particular focus on E 432 to E 436 (polysorbates) as
well as E 251 and E 252 (nitrates) and E 249 and E 250
(nitrites).

2. When Member States adopt these measures, they shall
contain a reference to this Directive or shall be accompanied
by such a reference on the occasion of their official publication.
The methods of making such reference shall be laid down by
Member States.

Directive 67/427/EEC shall be repealed.

Article 3

Article 4

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive in order to:

— authorise trade in and use of products conforming with this

Directive by 27 July 2005 at the latest,

— prohibit trade in and use of products not conforming with
this Directive by 27 January 2006 at the latest; however,
products placed on the market or labelled before that date
which do not comply with this Directive may be marketed
until stocks are exhausted.

They shall forthwith inform the Commission thereof.

Article 5

This Directive shall enter into force on the day of its publica-
tion in the Official Journal of the European Union.

Article 6

This Directive is addressed to the Member States.

Done at Brussels, 22 December 2003.

For the European Parliament

The President

P. COX

For the Council

The President

A. MATTEOLI

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The Annexes to Directive 95/2/EC shall be amended as follows:

1.

in Annex I:

(a) Note 2 shall be replaced by the following:

ANNEX

‘2. The substances listed under numbers E 407, E 407a and E 440 may be standardised with sugars, on condition that this is stated in addition

to the number and designation.’;

(b) in the list of additives:

— the entire entry for E 170 shall be replaced by ‘E 170 Calcium carbonate’,

— in the entry for E 466, the name ‘Cellulose gum’ shall be added,

— in the entry for E 469, the name ‘Enzymatically hydrolysed cellulose gum’ shall be added;

2.

in Annex II:

(a) the name ‘E 170 Calcium carbonates’ shall be replaced throughout by ‘E 170 Calcium carbonate’;

(b) the following shall be added to the list of additives and the maximum levels concerning ‘Cocoa and chocolate products as defined in Directive

2000/36/EC’:

‘E 472c

Citric
acid esters of
mono- and diglycerides
of fatty acids

quantum satis’

(c) the following shall be inserted in the list of additives and the maximum level for ‘Frozen and deep-frozen unprocessed fruit and vegetables;

prepacked, refrigerated unprocessed fruit and vegetables ready for consumption and prepacked, unprocessed and peeled potatoes’:

‘E 296

Malic acid

quantum satis (only for peeled potatoes)’

(d) the following shall be added to the list of additives and the maximum level for ‘Fruit compote’:

‘E 440
E 509

Pectin
Calcium chloride

quantum satis (only for fruit compote other than apple)’

(e) the following shall be inserted in the list of additives and the maximum level for ‘Mozzarella and whey cheese’:

‘E 460ii

Powdered cellulose

quantum satis (only for grated and sliced cheese)’

(f) the following rows shall be added at the end of the Annex:

‘UHT goat milk

E 331

Sodium citrates

4 g/l

Chestnuts in liquid

E 410
E 412
E 415

Locust bean gum
Guar gum
Xanthane gum

quantum satis’

3.

in Annex III:

A. part A shall be amended as follows:

(a) the designation ‘Partially baked, pre-packed bakery wares intended for retail sale’ shall be replaced by the following: ‘Partially baked, pre-

packed bakery wares intended for retail sale and energy-reduced bread intended for retail sale’;

(b) at the end of this part, the following rows shall be added:

‘Crayfish tails, cooked, and prepacked
marinated cooked molluscs

2 000

Flavourings

1 500’

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B. part C shall be amended as follows:

(a) the following rows shall be deleted:

‘E 230

Biphenyl, diphenyl

Surface
fruit

treatment of

citrus

70 mg/kg

E 231

E 232

Orthophenyl phenol (*)

Sodium orthophenyl phenol (*)

9
>=

>;

Surface treatment of citrus
fruit

12 mg/kg individually or
combination
orthophenyl phenol

expressed

in
as

(*) The deletion of E 231 orthophenyl phenol and E 232 sodium orthophenyl phenol shall enter into force as soon as requirements for the labelling of

foodstuffs treated with these substances become applicable by virtue of Community legislation on maximum residue limits for pesticides.’

(b) the following foodstuff shall be added to E 1105:

‘Wine in accordance with Regulation
(EC) No 1493/1999 (*) and its imple-
menting Regulation (EC) No 1622/
2000 (**)

Pro memoria

(*) Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine (OJ L 179, 14.7.1999, p.1). Regulation as last

amended by Commission Regulation (EC) No 1795/2003 (OJ L 262, 14.10.2003, p. 1).

(**) Commission Regulation (EC) No 1622/2000 of 24 July 2000 laying down certain detailed rules for implementing Regulation (EC) No 1493/1999 on the
common organisation of the market in wine and establishing a Community code of oenological practices and processes (OJ L 194, 31.7.2000, p.1). Regu-
lation as last amended by Regulation (EC) No 1410/2003 (OJ L 201, 8.8.2003, p. 9).’

C. part D shall be amended as follows:

(a) the following foodstuffs and maximum levels shall be added at the end of this part:

‘E 310

E 311

E 312

E 320

Propyl gallate

Octyl gallate

Dodecyl gallate

Essential oils

1 000 mg/kg (gallates and BHA, indivi-
dually or in combination)

Butylated hydroxyanisole (BHA)

Flavourings other than essential oils

100 mg/kg (gallates,
combination) or 200 mg/kg (BHA)’

individually or in

(b) in the list of foodstuffs concerning E 315 and E 316, the designation ‘Semi-preserved and preserved meat products’ shall be replaced by the

following: ‘Cured meat products and preserved meat products’;

4.

in Annex IV:

(a) the following foodstuff and maximum level concerning E 338 to E 452 shall be added:

‘Flavourings

40 g/kg’

(b) the following foodstuff and maximum level concerning E 338 to E 452 shall be deleted:

‘Cider and perry

2 g/l’

(c) the following foodstuff and maximum level shall be added to E 416:

‘Flavourings

50 g/kg’

(d) the following foodstuffs and maximum levels concerning E 432 to E 436 shall be added:

‘Flavourings, except liquid smoke flavour-
ings and flavourings based on spice oleo-
resins (*)

containing

Foodstuffs
smoke
flavourings and flavourings based on spice
oleoresins

liquid

10 g/kg

1 g/kg

(*) Spice oleoresins are defined as extracts of spices from which the extraction solvent has been evaporated leaving a mixture of the volatile oil and resinous mate-

rial from the spice.’

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(e) the following foodstuff and maximum level concerning E 444 shall be added:

(f) the following entry concerning E 551 shall be inserted after the list of foodstuffs and maximum levels for E 535 to E 538:

‘Flavoured cloudy spirit drinks containing
less than 15 % alcohol by volume

300 mg/l’

‘E 551

Silicon dioxide

Flavourings

50 g/kg’

(g) the following foodstuff and maximum level shall be added to E 900:

(h) in the list of foodstuffs and maximum levels for E 901 to E 904, the entry: ‘E 903 Carnauba wax’ shall be deleted and the following entry

concerning E 903 shall be added after the entry ‘E 904 shellac’:

‘Flavourings

10 mg/kg’

‘E 903

Carnauba wax

As glazing agents only:

— confectionery (including chocolate)

500 mg/kg

1 200 mg/kg (only for chewing gum)

— small products of

fine bakery wares

200 mg/kg

coated with chocolate

— snacks

— nuts

— coffee beans

— dietary food supplements

— fresh citrus

fruits, melons,

apples,
pears, peaches and pineapples (surface
treatment only)

200 mg/kg

200 mg/kg

200 mg/kg

200 mg/kg

200 mg/kg’

(i) the following foodstuffs and maximum levels shall be added to E 459:

‘Encapsulated flavourings in

— flavoured teas and flavoured powdered

500 mg/l

instant drinks

— flavoured snacks

1 g/kg in foodstuffs as consumed or as
reconstituted according to the instructions
of the manufacturer’

(j) the following rows shall be added at the end of the Annex:

‘E 907

Hydrogenated poly-1-decene

As glazing agent for

— sugar confectionery

— dried fruits

Flavourings

E 1505

E 1517

E 1518

E 1520

Triethyl citrate

Glyceryl diacetate (diacetin)

Glyceryl triacetate (triacetin)

Propan-1,2-diol (propylene glycol)

E 1519

Benzyl alcohol

Flavourings for

— liqueurs, aromatised wines, aromatised
aromatised
drinks

and

wine-based
wine-products cocktails

2 g/kg

2 g/kg

3 g/kg from all sources in foodstuffs as
consumed or as reconstituted according to
the instructions of the manufacturer; indi-
vidually or in combination. In the case of
beverages, the maximum level of E 1520
shall be 1 g/l.

100 mg/l

— confectionery including chocolate and

fine bakery wares

250 mg/kg from all sources in foodstuffs
as consumed or as reconstituted according
to instruction of the manufacturer’

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5.

in Annex V:
(a) the following row shall be added at the end of the Annex:

‘E 555

Potassium aluminium silicate

In E 171 titanium dioxide and E 172 iron oxides and hydroxides (max 90 % relative to
the pigment)’

(b) for E 468, the name ‘Cross-linked cellulose gum’ shall be added;

6.

in Annex VI:
(a) in the introductory note, the following subparagraph shall be inserted after the first subparagraph:

‘Formulae and weaning foods for infants and young children may contain E 1450 starch sodium octenyl succinate resulting from the addition
of vitamin preparations or polyunsaturated fatty acid preparations. The carry over of E 1450 in the product ready for consumption is not to be
more than 100 mg/kg from vitamin preparations and 1 000 mg/kg from polyunsaturated fatty acid preparations.’;

(b) in part 4

— the title shall be replaced by the following:

‘FOOD ADDITIVES PERMITTED IN DIETARY FOODS FOR INFANTS AND YOUNG CHILDREN FOR SPECIAL MEDICAL PURPOSES AS
DEFINED IN DIRECTIVE 1999/21/EC (*)

(*) Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes, (OJ L 91, 7.4.1999, p. 29).’

— the following shall be added to the table:

‘E 472c

Citric acid esters of mono- and
diglycerides of fatty acids

7,5 g/l sold as powder

9 g/l sold as liquid

From birth onwards’