HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 129/28
EN
Official Journal of the European Union
14.5.2013
COMMISSION REGULATION (EU) No 438/2013
of 13 May 2013
amending and correcting Annex II to Regulation (EC) No 1333/2008 of the European Parliament
and of the Council as regards the use of certain food additives
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
in Annex II to Regulation (EC) No 1333/2008, certain
errors have been introduced and should be corrected. In
particular, the use of antioxidants in peeled, cut and
shredded fruit and vegetables should be restricted to
Having regard to the Treaty on the Functioning of the European
prepacked refrigerated unprocessed fruit and vegetables
Union,
ready for consumption only. The use of Sorbic acid —
sorbates, Benzoic acid — benzoates; p-hydroxybenzoates
(E 200-219) should continue to be authorised in heat-
Having regard to Regulation (EC) No 1333/2008 of the
treated meat products and the use of Natamycin (E 235)
European Parliament and of the Council of 16 December
should continue to be authorised in heat-treated dried
2008 on food additives ( 1 ), and in particular Article 10(3)
cured sausages. Maximum limits for the use of
thereof,
Curcumine (E 100) in processed fish and fishery
products including molluscs and crustaceans should be
introduced corresponding to the levels specified in
Directive 94/36/EC. The maximum limits for the use of
Whereas:
Silicon dioxide — silicates (E 551-559) should be
changed to quantum satis as specified in Directive
95/2/EC and for the use of Silicon dioxide — silicates
(E 551-553) as specified by Commission Regulation (EU)
(1) Annex
II
to
Regulation
(EC)
No
1333/2008
lays
down
a
Union list of food additives approved for use in foods
No 380/2012 of 3 May 2012 amending Annex II to
and their conditions of use.
Regulation (EC) No 1333/2008 of the European

Parliament and of the Council as regards the conditions
of use and the use levels for aluminium-containing food
additives ( 6 ).
(2) That
list
may
be
updated
in
accordance
with
the
common procedure referred to in Article 3(1) of Regu
lation (EC) No 1331/2008 of the European Parliament
and of the Council of 16 December 2008 establishing a
(5) There
are
clarifications
necessary
as
regards
the
use
of
common authorisation procedure for food additives, food
food additives in certain food categories. In food category
enzymes and food flavourings ( 2 ) either on the initiative
13.1.4 ‘Other food for young children’ conditions of use
of the Commission or following an application.
for the food additives E 332 ‘Potassium citrates’ and E
338 ‘Phosphoric acid’ should be set. In food category
14.2.6 ‘Spirit drinks as defined in Regulation (EC) No
(3) The
Union
list
of
food
additives
was
established
based
on
110/2008’ the use of food colours should not be auth
food additives permitted for use in foods in accordance
orised in Geist as defined in Annex II.17 of Regulation
with European Parliament and Council Directive
(EC) No 110/2008 of the European Parliament and of
94/35/EC of 30 June 1994 on sweeteners for use in
the Council of 15 January 2008 on the definition,
foodstuffs (
description, presentation, labelling and the protection of

3 ), European Parliament and Council
Directive 94/36/EC of 30 June 1994 on colours for
geographical indications of spirit drinks and repealing
use in foodstuffs (
Council Regulation (EEC) No 1576/89 (

4 ) and European Parliament and

7 ). The use of
Council Directive 95/2/EC of 20 February 1995 on
the food colours Quinoline Yellow (E 104), Sunset
food additives other than colours and sweeteners (
Yellow FCF/Orange Yellow S (E 110) and Ponceau 4R,

5 )
and after reviewing their compliance with Articles 6, 7
Cochineal Red A (E 124) in certain spirit drinks should
and 8 of Regulation (EC) No 1333/2008. The Union list
be reintroduced as this use is not of safety concern for
set out in Annex II to Regulation (EC) No 1333/2008
children. It should be clarified that Caramels (E 150a-d)
lists food additives on the basis of the categories of food
can be used in all products belonging to food category
to which those additives may be added.
14.2.7.1 ‘Aromatised wines’.
(4)
Due to the difficulties encountered during the transfer of
food additives to the new categorisation system provided
(6) Therefore,
the
Union
list
of
food
additives
should
be
corrected, clarified and completed in order to include
all the uses permitted and complying with Articles 6, 7
( 1 ) OJ L 354, 31.12.2008, p. 16.
and 8 of Regulation (EC) No 1333/2008.
( 2 ) OJ L 354, 31.12.2008, p. 1.
( 3 ) OJ L 237, 10.9.1994, p. 3.
( 4 ) OJ L 237, 10.9.1994, p. 13.
( 6 ) OJ L 119, 4.5.2012, p. 14.
( 5 ) OJ L 61, 18.3.1995, p. 1.
( 7 ) OJ L 39, 13.2.2008, p. 16.

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EN
14.5.2013 Official
Journal
of
the
European
Union L
129/29
(7) Pursuant
to
Article
3(2)
of
Regulation
(EC)
No (9) The
measures
provided
for
in
this
Regulation
are
in
1331/2008, the Commission has to seek the opinion
accordance with the opinion of the Standing
of the European Food Safety Authority (‘the Authority’)
Committee on the Food Chain and Animal Health, and
in order to update the Union list of food additives set out
neither the European Parliament nor the Council has
in Annex II to Regulation (EC) No 1333/2008, except
opposed them,
where the update in question is not liable to have an
effect on human health. Since the Union list is amended
HAS ADOPTED THIS REGULATION:
in order to include uses already permitted in accordance
Article 1
with Directive 94/35/EC, Directive 94/36/EC, and
Directive 95/2/EC, it constitutes an update of that list
Annex II to Regulation (EC) No 1333/2008 is amended in
which is not liable to have an effect on human health.
accordance with the Annex to this Regulation.
Therefore, it is not necessary to seek the opinion of the
Article 2
Authority.
This Regulation shall enter into force on the twentieth day
(8) Annex
II
to
Regulation
(EC)
No
1333/2008
should following that of its publication in the Official Journal of the
therefore be amended and corrected accordingly.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 May 2013.
For the Commission
The President
José Manuel BARROSO

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L 129/30
ANNEX
Part E of Annex II to Regulation (EC) No 1333/2008 is amended as follows:
(1) In food category 01.7.1 ‘Unripened cheese excluding products falling in category 16’, the entry concerning ‘Group I’ is replaced by the following:
EN

‘Group I Additives except mozzarella’
(2) In food category 04.1.2 ‘Peeled, cut and shredded fruit and vegetables’, the entries concerning food additives E 300 ‘Ascorbic acid’, E 301 ‘Sodium ascorbate’, E 302 ‘Calcium ascorbate’, E 330 ‘Citric acid’, E
331 ‘Sodium citrates’, E 332 ‘Potassium citrates’ and E 333 ‘Calcium citrates’ are replaced by the following:
‘E 300 Ascorbic
acid quantum
satis only
prepacked
refrigerated
unprocessed
fruit
and
vegetables
ready
for
Off
consumption and prepacked unprocessed and peeled potatoes
icial
E 301 Sodium
ascorbate quantum
satis only
prepacked
refrigerated
unprocessed
fruit
and
vegetables
ready
for
Jour
consumption and prepacked unprocessed and peeled potatoes
nal
E 302 Calcium
ascorbate quantum
satis only
prepacked
refrigerated
unprocessed
fruit
and
vegetables
ready
for
of
consumption and prepacked unprocessed and peeled potatoes
the
European
E 330 Citric
acid quantum
satis only
prepacked
refrigerated
unprocessed
fruit
and
vegetables
ready
for
consumption and prepacked unprocessed and peeled potatoes
E 331 Sodium
citrates quantum
satis only
prepacked
refrigerated
unprocessed
fruit
and
vegetables
ready
for
Union
consumption and prepacked unprocessed and peeled potatoes
E 332 Potassium
citrates quantum
satis only
prepacked
refrigerated
unprocessed
fruit
and
vegetables
ready
for
consumption and prepacked unprocessed and peeled potatoes
E 333 Calcium
citrates quantum
satis only
prepacked
refrigerated
unprocessed
fruit
and
vegetables
ready
for
consumption and prepacked unprocessed and peeled potatoes’
(3) Food category 08.2.2 ‘Heat-treated processed meat’ is amended as follows:
(a) the following entry concerning food additive E 200-219 is inserted after the entry concerning food additive E 200-203 ‘Sorbic acid — sorbates’:
‘E 200-219 Sorbic
acid
—
sorbates,
quantum satis (1)
(2) only
surface
treatment
of
dried
meat
products’
14.5.2013
Benzoic acid —
benzoates;
p-hydroxybenzoates

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14.5.2013 Off
(b) the following entry concerning food additive E 235 is inserted after the entry concerning food additive E 210-213 ‘Benzoic acid — benzoates’:
‘E 235 Natamycin
1 (8) only
surface
treatment
of
dried
cured
sausages’
(c) the following footnote (8) is inserted after footnote (7):
EN
‘(8): mg/dm2 surface (not present at a depth of 5 mm)’;

(4) Food category 09.2 ‘Processed fish and fishery products including molluscs and crustaceans’ is amended as follows:
(a) the entry concerning food additive E 100 ‘Curcumin’ for use in fish paste and crustacean paste is replaced by the following:
‘E 100 Curcumin 100 (35) only
fish
paste
and
crustacean
paste’
(b) the entry concerning the food additive E 100 ‘Curcumine’ for use in smoked fish is replaced by the following:
icial
Jour
‘E 100 Curcumin 100 (37) only
smoked
fish’
nal
of
(c) footnotes (35), (36), and (37) are replaced by the following:
the
European
‘(35): Maximum individually or for the combination of E 100, E 102, E 120, E 122, E 142, E 151, E 160e, E 161b
(36): Maximum individually or for the combination of E 100, E 102, E 120, E 122, E 129, E 142, E 151, E 160e, E 161b
Union
(37): Maximum individually or for the combination of E 100, E 102, E 120, E 151, E 160e’;
(5) Food category 13.1.4 ‘Other foods for young children’ is amended as follows:
(a) the entries concerning food additives E 331 ‘Sodium citrates’, E 332 ‘Potassium citrates’ and E 338 ‘Phosphoric acid’ are replaced by the following:
‘E 331 Sodium
citrates 2
000 (43)
E 332 Potassium
citrates quantum
satis (43)
E 338 Phosphoric
acid (1)
(4)
(44)’
(b) the following footnotes (43) and (44) are added:
L
129/31
‘(43): E 331 and E 332 are authorised individually or in combination and in conformity with the limits set in Directives 2006/141/EC, 2006/125/EC and 1999/21/EC
(44): In conformity with the limits set in Directives 2006/141/EC, 2006/125/EC and 1999/21/EC’;

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L 129/32
(6) In food category 13.1.5.2 ‘Dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC’, the text in the first row is replaced by the following:
‘The additives of categories 13.1.2 and 13.1.3 are applicable, except for E 270, E 333, E 341’;
(7) Food category 14.2.6 ‘Spirit drinks as defined in Regulation (EC) No 110/2008’ is amended as follows:
EN

(a) the entries concerning food additives belonging to Group II, Group III and concerning food additives E 123 ‘amaranth’ and E 150a-d ‘Caramels’ are replaced by the following:
‘Group II Colours
at quantum satis quantum
satis except:
spirit
drinks
as
defined
in
Article
5(1)
and
sales
denominations
listed
in Annex II, paragraphs 1-14 of Regulation (EC) No 110/2008 and spirits
(preceded by the name of the fruit) obtained by maceration and distillation,
Geist (with the name of the fruit or the raw material used), London Gin,
Sambuca, Maraschino, Marrasquino or Maraskino and Mistrà
Off
Group III Colours
with
combined
200 except:
spirit
drinks
as
defined
in
Article
5(1)
and
sales
denominations
listed
icial
maximum limit
in Annex II, paragraphs 1-14 of Regulation (EC) No 110/2008 and spirits
(preceded by the name of the fruit) obtained by maceration and distillation,
Jour
Geist (with the name of the fruit or the raw material used), London Gin,
Sambuca, Maraschino, Marrasquino or Maraskino and Mistrà
nal
of
E 123 Amaranth 30 except:
spirit
drinks
as
defined
in
Article
5(1)
and
sales
denominations
listed
the
in Annex II, paragraphs 1-14 of Regulation (EC) No 110/2008 and spirits
(preceded by the name of the fruit) obtained by maceration and distillation,
European
Geist (with the name of the fruit or the raw material used), London Gin,
Sambuca, Maraschino, Marrasquino or Maraskino and Mistrà
Union
E 150a-d Caramels quantum
satis
except: fruit spirits, spirits (preceded by the name of the fruit) obtained by
maceration and distillation Geist (with the name of the fruit or the raw
material used), London Gin, Sambuca, Maraschino, Marrasquino or
Maraskino and Mistrà. Whisky, whiskey can only contain E 150a’
(b) the following entries concerning food additives E 104 and E 110 are inserted after the entry concerning Group III:
‘E 104 Quinoline
Yellow 180 (61) except:
spirit
drinks
as
defined
in
Article
5(1)
and
sales
denominations
listed
in Annex II, paragraphs 1-14 of Regulation (EC) No 110/2008 and spirits
(preceded by the name of the fruit) obtained by maceration and distillation,
Geist (with the name of the fruit or the raw material used), London Gin,
Sambuca, Maraschino, Marrasquino or Maraskino and Mistrà
E 110 Sunset
Yellow
FCF/
100 (61) except:
spirit
drinks
as
defined
in
Article
5(1)
and
sales
denominations
listed
Orange Yellow S
in Annex II, paragraphs 1-14 of Regulation (EC) No 110/2008 and spirits
14.5.2013
(preceded by the name of the fruit) obtained by maceration and distillation,
Geist (with the name of the fruit or the raw material used), London Gin,
Sambuca, Maraschino, Marrasquino or Maraskino and Mistrà’

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14.5.2013 Off
(c) the following entry concerning food additive E 124 is inserted after the entry concerning food additive E 123 ‘Amaranth’:
‘E 124 Ponceau
4R,
Cochineal
170 (61) except:
spirit
drinks
as
defined
in
Article
5(1)
and
sales
denominations
listed
Red A
in Annex II, paragraphs 1-14 of Regulation (EC) No 110/2008 and spirits
(preceded by the name of the fruit) obtained by maceration and distillation,
Geist (with the name of the fruit or the raw material used), London Gin,
Sambuca, Maraschino, Marrasquino or Maraskino and Mistrà’
EN

(d) the following footnote (61) is added:
‘(61): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III’;
(8) In food category 14.2.7.1 ‘Aromatised wines’, the following entry concerning food additive E 150a-d Caramels is deleted:
‘E 150a-d Caramels quantum
satis only americano, bitter vino’
(9) In food category 17.1 ‘Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms’, the entry concerning food additives E 551-559 ‘Silicon dioxide
— silicates’ is replaced by the following:
icial
‘E 551-559 Silicon
dioxide
—
quantum satis Period
of
application:
Jour
silicates
until 31 January 2014
nal
of
E 551-553 Silicon
dioxide
—
quantum satis Period
of
application:
silicates
From 1 February 2014’
the
European
(10) In food category 17.2 ‘Food supplements supplied in a liquid form’, the entry concerning food additives E 551-559 ‘Silicon dioxide — silicates’ is replaced by the following:
Union
‘E 551-559 Silicon
dioxide
—
quantum satis Period
of
application:
silicates
until 31 January 2014
E 551-553 Silicon
dioxide
—
quantum satis Period
of
application:
silicates
From 1 February 2014’
(11) In food category 17.3 ‘Food supplements supplied in a syrup-type or chewable form’, the entry concerning food additives E 551-559 ‘Silicon dioxide — silicates’ is replaced by the following:
‘E 551-559 Silicon
dioxide
—
quantum satis Period
of
application:
silicates
until 31 January 2014
E 551-553 Silicon
dioxide
—
quantum satis Period
of
application:
silicates
From 1 February 2014’
L
129/33

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