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20.3.2013 Official
Journal
of
the
European
Union
L
77/3
REGULATIONS
COMMISSION REGULATION (EU) No 244/2013
of 19 March 2013
amending Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the
Council as regards the use of Tricalcium phosphate (E 341 (iii)) in nutrient preparations intended
for use in foods for infants and young children
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
The technological need of Tricalcium phosphate (E 341
(iii)) as a food additive relates to its ability to provide
unique properties as a free-flowing agent to mixtures in
Having regard to the Treaty on the Functioning of the European
powder form. The product may take up to 10 % of its
Union,
own weight of moisture (humidity) from the
environment avoiding any lumps in a mix and keeping
preparations free-flowable, which is considered to be a
Having regard to Regulation (EC) No 1333/2008 of the
benefit to the consumer.
European Parliament and of the Council of 16 December
2008 on food additives ( 1 ), and in particular Articles 10(3)
and 30(5) thereof,
(6) The
Scientific
Committee
for
Food
advised
on
the
safety
of Tricalcium phosphate (E 341 (iii)) as a food additive in
nutrient preparations intended for use in infant formulae
Whereas:
and follow-on formulae and expressed its opinion on
7 June 1996 ( 4 ), concluding that its use is acceptable
provided that the total levels of calcium, phosphorus
(1) Annex
III
to
Regulation
(EC)
No
1333/2008
lays
down
a
and the ratio between them are not exceeded.
Union list of food additives approved for use in food
additives, food enzymes, food flavourings, nutrients and
(7) Calcium
salts
of
orthophosphoric
acid,
including
their conditions of use.
tricalcium phosphate, are mineral substances that are
authorised for use in infant formulae and follow-on
formulae in accordance with Annex III to Directive
(2) That
list
may
be
amended
in
accordance
with
the
2006/141/EC. The authorisation of the use of Tricalcium
procedure referred to in Regulation (EC) No
phosphate (E 341 (iii)) as an anti-caking agent in nutrient
1331/2008 of the European Parliament and of the
preparations intended for use in infant formulae and
Council of 16 December 2008 establishing a common
follow-on formulae is therefore not considered of safety
authorisation procedure for food additives, food enzymes
concern, as long as the total amounts of calcium and
and food flavourings ( 2 ).
phosphorus remain within the limits for these two
minerals and within the calcium:phosphorus ratio as set
in that Directive.
(3) Pursuant
to
Article
3(1)
of
Regulation
(EC)
No
1331/2008, the Union list of food additives may be
updated either on the initiative of the Commission or
(8) Pursuant
to
Article
3(2)
of
Regulation
(EC)
No
following an application.
1331/2008, the Commission is to seek the opinion of
the European Food Safety Authority in order to update
the Union list of food additives set out in Annex III to
(4)
An application for the authorisation of use of Tricalcium
Regulation (EC) No 1333/2008, except where the update
phosphate (E 341 (iii)) as an anti-caking agent added to
in question is not liable to have an effect on human
nutrient preparations intended for use in infant formulae
health.
and follow-on formulae as defined by Commission
Directive 2006/141/EC of 22 December 2006 on
infant formulae and follow-on formulae and amending
(9) Since
the
authorisation
of
use
of
Tricalcium
phosphate
Directive 1999/21/EC (
(E 341 (iii)) as an anti-caking agent in nutrient prep

3 ) was submitted on 19 June
2009 and has been made available to the Member States.
arations intended for use in infant formulae and
follow-on formulae should comply with the limit for
calcium, phosphorus and the calcium:phosphorus ratio
(5) The
application
concerns
a
new
entry
in
Section
B
of
set in Directive 2006/141/EC, the update of that list is
Part 5 of Annex III to Regulation (EC) No 1333/2008.
not liable to have an effect on human health. For that
reason, it is not necessary to seek the opinion of the
European Food Safety Authority.
( 1 ) OJ L 354, 31.12.2008, p. 16.
( 2 ) OJ L 354, 31.12.2008, p. 1.
( 3 ) OJ L 401, 30.12.2006, p. 1.
( 4 ) Reports of the Scientific Committee for Food, Fortieth series, 1997.

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L 77/4
EN
Official Journal of the European Union
20.3.2013
(10) It is therefore appropriate to authorise the use of
HAS ADOPTED THIS REGULATION:
Tricalcium phosphate (E 341 (iii)) as an anti-caking
agent in nutrient preparations intended for use in
infant formulae and follow-on formulae.
Article 1
Annex III to Regulation (EC) No 1333/2008 is amended in
(11) Consequently, Annex III to Regulation (EC) No
1333/2008 should be amended accordingly.
accordance with the Annex to this Regulation.

(12) The
measures
provided
for
in
this
Regulation
are
in
Article 2
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health and
This Regulation shall enter into force on the twentieth day
neither the European Parliament nor the Council has
following that of its publication in the Official Journal of the
opposed them,
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 March 2013.
For the Commission
The President
José Manuel BARROSO
ANNEX
In Section B of Part 5 of Annex III to Regulation (EC) No 1333/2008, the entry for food additive E 341 (iii) is replaced by
the following:
‘E 341 (iii) Tricalcium Maximum carry-over 150 mg/kg as P 2 O 5 All
Infant formulae and follow-on
phosphate
and within the limit for calcium, phos nutrients
formulae as defined by
phorus and calcium:phosphorus ratio as
Directive 2006/141/EC
set in Directive 2006/141/EC
Maximum level of 1 000 mg/kg expressed All
Processed cereal based foods
as P 2 O 5 from all uses in final food nutrients
and baby foods for infants
mentioned in point 13.1.3 of Part E of
and young children as
Annex II is respected
defined by Directive
2006/125/EC’

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