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27.7.2013 Official
Journal
of
the
European
Union L
202/11
COMMISSION REGULATION (EU) No 724/2013
of 26 July 2013
amending Regulation (EU) No 231/2012 as regards specifications on several polyols
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
those specifications and is available for commercial use.
That form of isomalt is cost-saving and time-efficient for
the industry and is consequently of interest, for example,
Having regard to the Treaty on the Functioning of the European
to confectionery manufacturers. Therefore, the
Union,
description of Isomalt (E 953) in the specifications
should be amended.
Having regard to Regulation (EC) No 1333/2008 of the
European Parliament and of the Council of 16 December
2008 on food additives (
(6) The
specifications
laid
down
by
Regulation
(EU)
No

1 ), and in particular Article 14 thereof,
231/2012 provide that one of the purity criteria for
polyols is the level of demineralisation or residual
Having regard to Regulation (EC) No 1331/2008 of the
minerals, characterised by chlorides, sulphates and/or
European Parliament and of the Council of 16 December
sulphated ashes. The same polyols are used as excipients
2008 establishing a common authorisation procedure for
for pharmaceutical products, and the European Phar
food additives, food enzymes and food flavourings (
macopoeia have adopted conductivity as the method to

2 ), and in
particular Article 7(5) thereof,
evaluate the level of demineralisation of polyols. By
doing so, a triple measure (of chlorides, sulphates
and/or sulphated ashes) was replaced by a single one,
Whereas:
simpler to carry out, cost-effective and more friendly to
the environment. Therefore, specifications should be
amended for the food additives Sorbitol (E 420 (i)),
(1) Commission
Regulation
(EU)
No
231/2012
( 3 ) lays down
Sorbitol syrup (E 420 (ii)), Mannitol (E 421 (i)),
specifications for food additives listed in Annexes II and
Mannitol manufactured by fermentation (E 421 (ii)),
III to Regulation (EC) No 1333/2008.
Isomalt (E 953), Maltitol (E 965 (i)), Maltitol syrup (E
965 (ii)), Xylitol (E 967) and Erythritol (E 968) by
deleting the criteria on chlorides, sulphates and
(2) Those
specifications
may
be
updated
in
accordance
with
sulphated ashes and replacing them with a single
the common procedure referred to in Article 3(1) of
criterion, conductivity.
Regulation (EC) No 1331/2008, either on the initiative
of the Commission or following an application.
(7) Pursuant
to
Article
3(2)
of
Regulation
(EC)
No
1331/2008, the Commission is to seek the opinion of
(3) On
29
November
2011
an
application
was
submitted
for
the European Food Safety Authority in order to update
the amendment of specifications concerning several
the Union list of food additives, except where the update
polyols which was subsequently made available to the
in question is not liable to have an effect on human
Member States.
health. Since the updates concerned are not liable to
have an effect on human health, it is not necessary to
seek the opinion of the European Food Safety Authority.
(4) Regulation
(EU)
No
231/2012
lays
down
specifications
for Mannitol (E 421(i)) and Mannitol manufactured by
fermentation (E 421(ii)). In order to achieve more clarity
and coherence, the currently authorised food additive
(8) Regulation
(EU)
No
231/2012
should
therefore
be
‘Mannitol (E 421(i))’ should be renamed as ‘Mannitol by
amended accordingly.
hydrogenation and consequently its definition should be
altered. Therefore, the specifications for that food addive
should be amended.
(9) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health and
(5) Isomalt
(E
953)
is
manufactured
in
a
two-stage
process
in
neither the European Parliament nor the Council has
which sugar is first transformed into isomaltulose and
opposed them,
then hydrogenated. The crystalline form is obtained by
a drying process afterwards. A request was made to
include a different form of isomalt, aqueous solutions
HAS ADOPTED THIS REGULATION:
of isomalt, in the specifications laid down by Regulation
(EU) No 231/2012. The proposed form complies with
Article 1
( 1 ) OJ L 354, 31.12.2008, p. 16.
( 2 ) OJ L 354, 31.12.2008, p. 1.
The Annex to Regulation (EU) No 231/2012 is amended in
( 3 ) OJ L 83, 22.3.2012, p. 1.
accordance with the Annex to this Regulation.

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L 202/12
EN
Official Journal of the European Union
27.7.2013
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official
Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in the Member States.
Done at Brussels, 26 July 2013.
For the Commission
The President
José Manuel BARROSO

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EN
27.7.2013 Official
Journal
of
the
European
Union L
202/13
ANNEX
The Annex to Regulation (EU) No 231/2012 is amended as follows:
(1) In the entry for food additive E 420 (i) Sorbitol, the specifications as regards purity are replaced by the following:
‘Purity
Water content Not
more
than
1,5
%
(Karl
Fischer
Method)
Conductivity Not
more
than
20
μS/cm (on 20 % dry solids solution) at
temperature 20 °C
Reducing sugars Not
more
than
0,3
%
(expressed
as
glucose
on
dry
weight
basis)
Total sugars Not
more
than
1
%
(expressed
as
glucose
on
dry
weight
basis)
Nickel Not
more
than
2
mg/kg
(expressed
on
dry
weight
basis)
Arsenic Not
more
than
3
mg/kg
(expressed
on
dry
weight
basis)
Lead Not
more
than
1
mg/kg
(expressed
on
dry
weight
basis)’
(2) In the entry for food additive E 420 (ii) Sorbitol syrup, the specifications as regards purity are replaced by the
following:
‘Purity
Water content Not
more
than
31
%
(Karl
Fischer
Method)
Conductivity Not
more
than
10
μS/cm (on the product as such) at
temperature 20 °C
Reducing sugars Not
more
than
0,3
%
(expressed
as
glucose
on
dry
weight
basis)
Nickel Not
more
than
2
mg/kg
(expressed
on
dry
weight
basis)
Arsenic Not
more
than
3
mg/kg
(expressed
on
dry
weight
basis)
Lead Not
more
than
1
mg/kg
(expressed
on
dry
weight
basis)’
(3) The entry for food additive E 421(i) Mannitol is amended as follows:
(a) the heading is replaced by the following:
‘E 421 (i) MANNITOL BY HYDROGENATION’
(b) the definition is replaced by the following:
‘Definition Manufactured
by
catalytic
hydrogenation
of
carbohydrate
solutions containing glucose and/or fructose.
The product contains min. 96 % mannitol. The part of
the product which is not mannitol is mainly composed
of sorbitol (2 % max), maltitol (2 % max) and isomalt
(1,1 GPM (1-O-alpha-D-Glucopyranosyl-D-mannitol
dehydrate): 2
% max and 1,6 GPS (6-O-alpha-D-
Glucopyranosyl-D-Sorbitol): 2
% max). Unspecified
impurities shall not represent more than 0,1 % of each.’

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L 202/14
EN
Official Journal of the European Union
27.7.2013
(c) the specifications as regards purity are replaced by the following:
‘Purity
Water content Not
more
than
0,5
%
(Karl
Fischer
Method)
Conductivity Not
more
than
20
μS/cm (on 20 % dry solids solution) at
temperature 20 °C
Reducing sugars Not
more
than
0,3
%
(expressed
as
glucose)
Total sugars Not
more
than
1
%
(expressed
as
glucose)
Nickel Not
more
than
2
mg/kg
Lead Not
more
than
1
mg/kg’
(4) In the entry for food additive E 421(ii) Mannitol manufactured by fermentation the specifications as regards purity are
replaced by the following:
‘Purity
Arabitol Not
more
than
0,3
%
Water content Not
more
than
0,5
%
(Karl
Fischer
Method)
Conductivity Not
more
than
20
μS/cm (on 20 % dry solids solution) at
temperature 20 °C
Reducing sugars Not
more
than
0,3
%
(expressed
as
glucose)
Total sugars Not
more
than
1
%
(expressed
as
glucose)
Lead Not
more
than
1
mg/kg’
(5) The entry for food additive E 953 Isomalt is amended as follows:
(a) the specification as regards description is replaced by the following:
‘Description Odourless,
white,
slightly
hygroscopic,
crystalline
mass
or
aqueous solution with a minimum concentration of
60 %’
(b) the specifications as regards purity are replaced by the following:
‘Purity
Water content Not
more
than
7
%
for
solid
product
(Karl
Fischer
Method)
Conductivity Not
more
than
20
μS/cm (on 20 % dry solids solution) at
temperature 20 °C
D-Mannitol Not
more
than
3
%
D-Sorbitol Not
more
than
6
%
Reducing sugars Not
more
than
0,3
%
(expressed
as
glucose
on
dry
weight
basis)
Nickel Not
more
than
2
mg/kg
(expressed
on
dry
weight
basis)
Arsenic Not
more
than
3
mg/kg
(expressed
on
dry
weight
basis)
Lead Not
more
than
1
mg/kg
(expressed
on
dry
weight
basis)’

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EN
27.7.2013 Official
Journal
of
the
European
Union L
202/15
(6) In the entry for food additive E 965 (i) Maltitol, the specifications as regards purity are replaced by the following:
‘Purity
Appearance of the aqueous solution
The solution is clear and colourless
Water content Not
more
than
1
%
(Karl
Fischer
Method)
Conductivity Not
more
than
20
μS/cm (on 20 % dry solids solution) at
temperature 20 °C
Reducing sugars Not
more
than
0,1
%
(expressed
as
glucose
on
an
anhydrous basis)
Nickel Not
more
than
2
mg/kg
(expressed
on
anhydrous
basis)
Arsenic Not
more
than
3
mg/kg
(expressed
on
anhydrous
basis)
Lead Not
more
than
1
mg/kg
(expressed
on
anhydrous
basis)’
(7) In the entry for food additive E 965 (ii) Maltitol syrup, the specifications as regards purity are replaced by the
following:
‘Purity
Appearance of the aqueous solution
The solution is clear and colourless
Water content Not
more
than
31
%
(Karl
Fischer
Method)
Conductivity Not
more
than
10
μS/cm (on the product as such) at
temperature 20 °C
Reducing sugars Not
more
than
0,3
%
(expressed
as
glucose
on
an
anhydrous basis)
Nickel Not
more
than
2
mg/kg
Lead Not
more
than
1
mg/kg’
(8) In the entry for food additive E 967 Xylitol, the specifications as regards purity are replaced by the following:
‘Purity
Water content Not
more
than
1
%
(Karl
Fischer
Method)
Conductivity Not
more
than
20
μS/cm (on 20 % dry solids solution) at
temperature 20 °C
Reducing sugars Not
more
than
0,2
%
(expressed
as
glucose
on
dry
weight
basis)
Other polyhydric alcohols Not
more
than
1
%
(expressed
on
dry
weight
basis)
Nickel Not
more
than
2
mg/kg
(expressed
on
dry
weight
basis)
Arsenic Not
more
than
3
mg/kg
(expressed
on
dry
weight
basis)
Lead Not
more
than
1
mg/kg
(expressed
on
dry
weight
basis)’

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L 202/16
EN
Official Journal of the European Union
27.7.2013
(9) In the entry for food additive E 968 Erythritol, the specifications as regards purity are replaced by the following:
‘Purity
Loss on drying Not
more
than
0,2
%
(70
°C,
6
hours,
in
a
vacuum
desiccator)
Conductivity Not
more
than
20
μS/cm (on 20 % dry solids solution) at
temperature 20 °C
Reducing substances Not
more
than
0,3
%
expressed
as
D-glucose
Ribitol and glycerol Not
more
than
0,1
%
Lead Not
more
than
0,5
mg/kg’

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Document Outline

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