HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 173/8
EN
Official Journal of the European Union
3.7.2012
COMMISSION REGULATION (EU) No 583/2012
of 2 July 2012
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the
Council as regards the use of polysorbates (E 432-436) in coconut milk
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
in its opinion of 8 July 1983 ( 3 ). The Report from the
Commission on Dietary Food Additive Intake in the
European Union ( 4 ) concluded that polysorbates (E 432-
Having regard to the Treaty on the Functioning of the European
436) may require a more realistic intake assessment
Union,
based on actual use levels of the food additives. The
European Food Safety Authority (‘the Authority’) is
expected to carry out that intake assessment during the
Having regard to Regulation (EC) No 1333/2008 of the
re-evaluation of polysorbates (E 432-436) by the end of
European Parliament and of the Council of 16 December
2016 as foreseen by Commission Regulation (EU) No
2008 on food additives ( 1 ), and in particular Article 10(3) and
257/2010 ( 5 ). Until then, only insignificant contributors
Article 30(5) thereof,
to the total intake of those substances should be
examined for a potential extension of use. The
expected intake of polysorbates (E 432-436) via its use
Whereas:
in coconut milk as assessed on the basis of total market
distribution data of coconut milk provided by the
applicant remains far below the ADI and thus will not
(1) Annex
II
to
Regulation
(EC)
No
1333/2008
lays
down
a
lead to a significant additional exposure. Coconut milk is
Union list of food additives approved for use in foods
a non-widely consumed product, which is mainly used
and their conditions of use.
for the preparation of Asian food and desserts. The
assessed intake is negligible and much less than 1 % of
ADI, which is not considered to be a significant
contributor. Therefore, that particular extension of use
(2) That
list
may
be
amended
in
accordance
with
the
procedure referred to in Regulation (EC) No
is not considered to be of safety concern.
1331/2008 of the European Parliament and of the
Council of 16 December 2008 establishing a common
authorisation procedure for food additives, food enzymes
(7) Pursuant
to
Article
3(2)
of
Regulation
(EC)
No
and food flavourings ( 2 ).
1331/2008, the Commission is to seek the opinion of
the Authority in order to update the Union list of food
additives set out in Annex II to Regulation (EC) No
(3) Pursuant
to
Article
3(1)
of
Regulation
(EC)
No
1333/2008, except where the update in question is not
1331/2008, the Union list of food additives may be
liable to have an effect on human health. Since the auth
updated either on the initiative of the Commission or
orisation of use of polysorbates (E 432-436) as emul
following an application.
sifiers in coconut milk constitutes an update of that list
which is not liable to have an effect on human health, it
is not necessary to seek the opinion of the Authority.
(4)
An application for authorisation of the use of polyoxy
ethylene sorbitan monooleate (polysorbate 80, E 433) as
an emulsifier in coconut milk was submitted and has
been made available to the Member States.
(8) In
Annex
II
to
Regulation
(EC)
No
1333/2008
poly
sorbates (E 432-436) are authorised as a group, as they
belong to the same chemical group of substances defined
(5) Coconut
milk,
which
is
a
fruit
preparation
made
of
the
as mixtures of the partial esters of sorbitol and its mono-
internal layer below the peel of coconut together with
and dianhydrides with fatty acids. It is therefore appro
water via homogenisation, cannot remain in the form of
priate to allow the use of all polysorbates (E 432-436) in
an emulsion without the use of an emulsifier. Polyoxy
coconut milk and not only the use of the food additive
ethylene sorbitan monooleate (polysorbate 80, E 433)
polyoxyethylene sorbitan monooleate (polysorbate 80,
and polysorbates (E 432-436) in general have been
E 433).
approved as the most effective emulsifiers used for this
purpose in third countries.
(9) Pursuant
to
the
transitional
provisions
of
Commission
Regulation (EU) No 1129/2011 of 11 November 2011
(6) To
the
group
of
polysorbates
(E
432-436)
an
acceptable
amending Annex II to Regulation (EC) No 1333/2008
daily intake (ADI) value was allocated at a level of
10 mg/kg bw/day by the Scientific Committee on Food
( 3 ) Report of the Scientific Committee for Food concerning emulsifiers,
stabilisers, thickeners and gelling agents (15th series, 1985).
( 1 ) OJ L 354, 31.12.2008, p. 16.
( 4 ) COM(2001) 542 final.
( 2 ) OJ L 354, 31.12.2008, p. 1.
( 5 ) OJ L 80, 26.3.2010, p. 19.

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EN
3.7.2012 Official
Journal
of
the
European
Union L
173/9
of the European Parliament and of the Council by estab
Committee on the Food Chain and Animal Health and
lishing a Union list of food additives ( 1 ), Annex II estab
neither the European Parliament nor the Council has
lishing the Union list of food additives approved for use
opposed them,
in foods and conditions of use applies from 1 June 2013.
In order to allow the use of polysorbates (E 432-436) in
coconut milk before that date, it is necessary to specify
HAS ADOPTED THIS REGULATION:
an earlier date of application with regard to that food
additive.
Article 1
Annex II to Regulation (EC) No 1333/2008 is amended in
accordance with the Annex to this Regulation.
(10) Therefore,
Annex
II
to
Regulation
(EC)
No
1333/2008
should be amended accordingly.
Article 2
This Regulation shall enter into force on the twentieth day
(11) The
measures
provided
for
in
this
Regulation
are
in
following that of its publication in the Official Journal of the
accordance with the opinion of the Standing
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 2 July 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 295, 12.11.2011, p. 1.
ANNEX
In Part E of Annex II to Regulation (EC) No 1333/2008 the following entry is inserted in the food category 04.2.4.1 ‘Fruit
and vegetable preparations excluding compote’ after the entry for E 405:
‘E 432-436 Polysorbates 500 (1) only
coconut
milk Period
of
application:
From 23 July 2012’

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