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4.6.2013 Official
Journal
of
the
European
Union L
150/17
COMMISSION REGULATION (EU) No 510/2013
of 3 June 2013
amending Annexes I, II and III to Regulation (EC) No 1333/2008 of the European Parliament and of
the Council as regards the use of iron oxides and hydroxides (E 172), hydroxypropyl methyl
cellulose (E 464) and polysorbates (E 432-436) for marking of certain fruits
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(6) Those
lists
may
be
amended
in
accordance
with
the
procedure referred to in Regulation (EC) No
1331/2008 of the European Parliament and of the
Council of 16 December 2008 establishing a common
Having regard to the Treaty on the Functioning of the European
authorisation procedure for food additives, food enzymes
Union,
and food flavourings ( 2 ).
Having regard to Regulation (EC) No 1333/2008 of the
(7) Pursuant
to
Article
3(1)
of
Regulation
(EC)
No
European Parliament and of the Council of 16 December
1331/2008, the Union list of food additives may be
2008 on food additives (
updated either on the initiative of the Commission or

1 ), and in particular Article 9(2),
Article 10(3) and Article 30(5) thereof,
following an application.
Whereas:
(8)
An application for authorisation of the use of iron oxides
and hydroxides (E 172) as a contrast enhancer, hydroxy
propyl methyl cellulose (E 464) as a glazing agent for
indelible marking of certain fruits and polysorbates (E
432-436) as emulsifiers in the contrast enhancer prep
(1) Annex
I
to
Regulation
(EC)
No
1333/2008
lays
down
functional classes of food additives in foods and of food
aration was submitted on 8 April 2011 and has been
additives in food additives and food enzymes.
made available to the Member States.

(9) New
marking
technology
using
a
carbon
dioxide
laser
for
(2) Where
necessary
as
a
result
of
scientific
progress
or
tech
etching information on the surface of fresh fruit was
nological developments additional functional classes may
developed. Some foodstuffs develop a distinguishable
be added to Annex I to Regulation (EC) No 1333/2008.
mark on its surface due to the direct depigmentation
action of a laser beam, but some of them do not.
Therefore, there is a technological need for the use of
iron oxides and hydroxides (E 172) as a contrast
(3) Research
and
development
have
shown
that
iron
oxides
enhancer, hydroxypropyl methyl cellulose (E 464) as a
and hydroxides (E 172) when applied to the surface of
glazing agent and polysorbates (E 432-436) as emul
fruit or vegetables following depigmentation of certain
sifiers in the contrast enhancer preparation in order to
parts (e.g. by laser treatment), enhance the contrast of
improve the contrast and to allow indelible marking of
these parts to the remaining surface by interacting with
certain fruits. Iron oxides and hydroxides (E 172) provide
certain released components of the epidermis. That effect
sufficient contrast of marked areas to the remaining
can be used for marking fruit or vegetables. Therefore, it
surface of the fruit, hydroxypropyl methyl cellulose (E
is appropriate to add a new functional class ‘contrast
464) forms a thin protective film on the marked areas
enhancers’ to Annex I to Regulation (EC) No 1333/2008.
and polysorbates (E 432-436) ensure a homogenous
dispersion of the food additive preparation on the
marked areas of foodstuffs.
(4) Annex
II
to
Regulation
(EC)
No
1333/2008
lays
down
a
Union list of food additives approved for use in foods
and their conditions of use.
(10) The
use
of
food
additives
should
have
advantages
and
benefits for the consumer. The new marking technology
can be used to repeat all or some of the mandatory
information particulars required by the Union legislation
(5) Annex
III
to
Regulation
(EC)
No
1333/2008
lays
down
a
or by the legislation of the Member States. In addition,
Union list of food additives approved for use in food
the consumers may benefit from the use of the new
additives, food enzymes, flavourings, nutrients and their
marking technology when the brand name and
conditions of use.
production method are provided on a voluntary basis.
( 1 ) OJ L 354, 31.12.2008, p. 16.
( 2 ) OJ L 354, 31.12.2008, p. 1.

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L 150/18
EN
Official Journal of the European Union
4.6.2013
(11) Furthermore, the new indelible marking technology
Union lists of food additives set out in Annexes II and III
provides an alternative to removable adhesive paper
to Regulation (EC) No 1333/2008, except where the
stickers which are currently in use and limits the risks
update in question is not liable to have an effect on
of losing, mixing up or inverting food items and
human health. Since the authorisation of use of iron
therefore facilitates transportation and storage of the
oxides and hydroxides (E 172) and hydroxypropyl
fruits concerned. For that purpose, the indication of the
methyl cellulose (E 464) for marking of citrus fruit,
PLU-code (an identification number used by food
melons and pomegranates and polysorbates (E 432-
business operators to facilitate check-out and inventory
436) for use in the contrast enhancer preparation
control of products), the QR-code (matrix barcode
constitutes updates of these lists which are not liable to
enabling the encoded information to be scanned at
have an effect on human health, it is not necessary to
high speed) and of a barcode can also be useful.
seek the opinion of the European Food Safety Authority.
Therefore, it is appropriate to allow such information
on certain fruits.
(15) Pursuant
to
the
transitional
provisions
of
Commission
(12) Iron oxides and hydroxides (E 172), hydroxypropyl
Regulation (EU) No 1129/2011 of 11 November 2011
methyl cellulose (E 464) and polysorbates (E 432-436)
amending Annex II to Regulation (EC) No 1333/2008 of
are to be used in small quantities and only on the
the European Parliament and of the Council by estab
external part of fruit and are not expected to migrate
lishing a Union list of food additives ( 6 ), Annex II estab
significantly into the internal part. For that reason, the
lishing the Union list of food additives approved for use
treatment of fruit of which the peels are not commonly
in foods and conditions of use applies from 1 June 2013.
consumed is not liable to have an effect on human
In order to allow the use of iron oxides and hydroxides
health. It is therefore appropriate only to allow the use
(E 172) and hydroxypropyl methyl cellulose (E 464) for
of iron oxides and hydroxides (E 172) and hydroxy
marking on certain fruits before that date, it is necessary
propyl methyl cellulose (E 464) for marking of citrus
to specify an earlier date of application with regard to
fruit, melons and pomegranates and polysorbates (E
these food additives.
432-436) for use in the contrast enhancer preparation.
(13) Iron
oxides
and
hydroxides
(E
172)
were
last
evaluated
by the Scientific Committee for Food in 1975 (
(16) Therefore,
Annexes
I,
II
and
III
to
Regulation
(EC)
No

1 ). It was
1333/2008 should be amended accordingly.
shown that only 1 % of the iron oxides and hydrated

iron oxides were likely to become solubilised in the
human gastrointestinal tract and therefore the
Committee established an acceptable daily intake
without specifying an upper limit. Hydroxypropyl
methyl cellulose (E 464) was last evaluated by the
(17) The
measures
provided
for
in
this
Regulation
are
in
Scientific Committee for Food in 1992 (
accordance with the opinion of the Standing

2 ). A group
acceptable daily intake ‘not specified’ was allocated for
Committee on the Food Chain and Animal Health and
5 of the modified celluloses. In 1983 the Committee
neither the European Parliament nor the Council has
allocated to the group of polysorbates (E 432-436) an
opposed them,
acceptable daily intake at a level of 10 mg/kg bw/day ( 3 ).
The Report from the Commission on Dietary Food
Additive Intake in the European Union ( 4 ) concluded
that polysorbates (E 432-436) may require a more
realistic intake assessment based on actual use levels of
HAS ADOPTED THIS REGULATION:
the food additives. The European Food Safety Authority
is expected to carry out that intake assessment during the
re-evaluation of polysorbates (E 432-436) by the end of
2016 as foreseen by Commission Regulation (EU) No
257/2010 ( 5 ). By then, only insignificant contributors
Article 1
to the total intake of those substances should be
examined for a potential extension of use.
Annexes I, II and III to Regulation (EC) No 1333/2008 are
amended in accordance with the Annex to this Regulation.
(14) Pursuant to Article 3(2) of Regulation (EC) No
1331/2008, the Commission is to seek the opinion of
the European Food Safety Authority in order to update
Article 2
This Regulation shall enter into force on the twentieth day
( 1 ) http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_01.pdf
following that of its publication in the Official Journal of the
( 2 ) http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_32.pdf
European Union.
( 3 ) http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_15.pdf
( 4 ) COM(2001) 542 final.
( 5 ) OJ L 80, 26.3.2010, p. 19.
( 6 ) OJ L 295, 12.11.2011, p. 1.

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EN
4.6.2013 Official
Journal
of
the
European
Union L
150/19
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 3 June 2013.
For the Commission
The President
José Manuel BARROSO

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L 150/20
ANNEX
Regulation (EC) No 1333/2008 is amended as follows:
(1) in Annex I the following entry 27 is added:
‘27. “contrast enhancers” are substances which, when applied to the external surface of fruit or vegetables following depigmentation of predefined parts (e.g. by laser treatment), help to distinguish these parts
from the remaining surface by imparting colour following interaction with certain components of the epidermis.’;
EN

(2) Annex II is amended as follows:
(a) in Part B, Section 3 ‘Additives other than colours and sweeteners’, after the entry for E 170, the following entry is inserted:
‘E 172 Iron
oxides
and
hydroxides’
(b) in Part E, the food category 04.1.1 ‘Entire fresh fruit and vegetables’ is amended as follows:
(i) the following entry E 172 is inserted before the entry for E 200-203:
Off
‘E 172 Iron
oxides
and
hydroxides
6 only
as
a
contrast
enhancer
for
marking
citrus
fruit,
Period of application:
icial
melons and pomegranates in order to:
From 24 June 2013.’
Jour
— repeat all or some of the mandatory information
nal
particulars required by the Union legislation and/or
national law,
of
the
and/or
European
— provide on a voluntary basis brand name,
production method, PLU-code, QR-code and/or
barcode
Union
(ii) the following entry E 464 is inserted after the entry for E 445:
‘E 464 Hydroxypropyl
methyl
cellulose 10 only
for
citrus
fruit,
melons
and
pomegranates
in
order
Period of application:
to:
From 24 June 2013.’
— repeat all or some of the mandatory information
particulars required by the Union legislation and/or
national law,
and/or
— provide on a voluntary basis brand name,
production method, PLU-code, QR-code and/or
barcode
(3) in Part 2 of Annex III, the entry for ‘E 432 – E 436’ is replaced by the following:
4.6.2013
‘E 432 – E 436 Polysorbates quantum
satis Preparations
of
colours,
contrast
enhancers,
fat
soluble
antioxidants
and
glazing
agents
for
fruit’

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Document Outline

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