HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
12.11.2011 Official
Journal
of
the
European
Union L
295/205
COMMISSION REGULATION (EU) No 1131/2011
of 11 November 2011
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the
Council with regard to steviol glycosides
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) While
considering
the
need
for
new
products
which
are
energy-reduced to be placed on the market, the use of
steviol glycosides as sweetener should be authorised at
appropriate maximum use levels. Taking into account the
Having regard to the Treaty on the Functioning of the European
potential significant contribution of soft drinks to the
Union,
intake of steviol glycosides, a reduction in the use level
for flavoured drinks, compared to the previously
proposed use levels considered by the Authority,
should be established.
Having regard to Regulation (EC) No 1333/2008 of the
European Parliament and of the Council of 16 December
2008 on food additives ( 1 ), and in particular Article 10 and
Article 30(5) thereof,
(5) The
Commission
will
request
from
producers
and
users
of steviol glycosides information about the actual use of
the food additive after its authorisation. The Commission
Whereas:
will make such information available to the Member
States. When necessary, the Commission will ask the
Authority to perform a new refined exposure assessment,
taking into account the real uses of steviol glycosides in
(1) Regulation
(EC)
No
1333/2008
lays
down
a
Union
list
of
the different subcategories of foodstuffs and the
food additives approved for use in foods and their
consumption of normal versus energy-reduced foodstuffs.
conditions of use.
(2) The
European
Food
Safety
Authority
(hereinafter
referred (6) The Authority expressed in its opinion the ADI for
to as ‘the Authority’) evaluated the safety of steviol
steviol glycosides as steviol equivalents. The dietary
glycosides, extracted from the leaves of the Stevia
exposure to the steviol glycosides was also expressed as
rebaudiana Bertoni plant, as sweetener and expressed its
steviol equivalents. It is therefore appropriate that the
opinion on 10 March 2010 (
maximum permitted use levels should also be expressed

2 ). The Authority established
an Acceptable Daily Intake (ADI) for steviol glycosides,
as steviol equivalents. Maximum levels of steviol
expressed as steviol equivalents, of 4 mg/kg body
glycosides are expressed as the sum of all named
weight/day. Conservative estimates of steviol glycosides
steviol glycosides mentioned in the specifications and
exposure, both in adults and in children, suggest that it
can be converted to steviol equivalents using the
is likely that the ADI would be exceeded at the
conversion factors mentioned in the specifications.
maximum proposed use levels.
(7) The
measures
provided
for
in
this
Regulation
are
in
(3) Taking
into
account
the
conclusion
of
the
Authority,
the
accordance with the opinion of the Standing
applicants submitted, in September 2010, revised uses
Committee on the Food Chain and Animal Health and
and the Authority was requested to consider those
neither the European Parliament nor the Council has
uses. A statement on a new exposure assessment was
opposed them,
published in January 2011 (


3 ). Despite the revised uses,
the conclusion was very similar, namely that both in
adults and children the ADI can be exceeded for high-
level consumers. The main contributors to the total
anticipated exposure to steviol glycosides are non-
HAS ADOPTED THIS REGULATION:
alcoholic flavoured drinks (soft drinks).
( 1 ) OJ L 354, 31.12.2008, p. 16.
( 2 ) Scientific Opinion of the Panel on Food Additives and Nutrient
Sources added to food on the safety of steviol glycosides for the
Article 1
proposed uses as a food additive. The EFSA Journal (2010);
8(4):1537.
Amendment to Regulation (EC) No 1333/2008
( 3 ) Statement of EFSA: ‘Revised exposure assessment for steviol
glycosides for the proposed uses as a food additive’. The EFSA
Annex II to Regulation (EC) No 1333/2008 is amended in
Journal (2011); 9(01):1972.
accordance with the Annex to this Regulation.

---

L 295/206
EN
Official Journal of the European Union
12.11.2011
Article 2
lation (EC) No 1333/2008 concerning steviol glycosides (E 960)
shall apply from the date of entry into force of this Regulation.
Transitional provision
By way of derogation to Article 2(1) of Commission Regulation
(EU) No 1129/2011 of 11 November 2011 amending Annex II
Article 3
to Regulation (EC) No 1333/2008 of the European Parliament
and of the Council by establishing a Union list of food
This Regulation shall enter into force on the 20th day following
additives ( 1 ), the entries in Parts B and E of Annex II to Regu
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, 11 November 2011.
For the Commission
The President
José Manuel BARROSO
( 1 ) See page 1 of this Official Journal.

---

12.11.2011 Off
ANNEX
Annex II to Regulation (EC) No 1333/2008 is amended as follows:
(1) in Part B2 the following entry for E 960 is inserted after the entry for E 959:
‘E 960 Steviol
glycosides’
EN

(2) in Part E the following entries for E 960 are inserted in numerical order in the food categories referred to:
PART E: AUTHORISED FOOD ADDITIVES AND CONDITIONS OF USE IN FOOD CATEGORIES
Category
number
E-number Name
Maximum level (mg/l or
mg/kg as appropriate)
Footnotes restrictions/exception
01.4 Flavoured
fermented
milk
products
including
heat
treated
products
E 960 Steviol
glycosides 100 (60) only
energy-reduced
products
or
with
no
added
sugar
icial
(60): expressed as steviol equivalents
Jour
03. Edible
ices
nal
of
E 960 Steviol
glycosides 200 (60) only
energy-reduced
or
with
no
added
sugar
the
(60): expressed as steviol equivalents
European
04.2.2 Fruit
and
vegetables
in
vinegar,
oil,
or
brine
E 960 Steviol
glycosides 100 (60) only
sweet-sour
preserves
of
fruit
and
vegetables
Union
(60): expressed as steviol equivalents
04.2.4.1 Fruit
and
vegetable
preparations
excluding
compote
E 960 Steviol
glycosides 200 (60) only
energy-reduced
(60): expressed as steviol equivalents
04.2.5.1
Extra jam and extra jelly as defined by Directive 2001/113/EC
E 960 Steviol
glycosides 200 (60) only
energy-reduced
jams
jellies
and
marmalades
(60): expressed as steviol equivalents
04.2.5.2
Jam, jellies and marmalades and sweetened chestnut puree as defined by Directive 2001/113/EC
L
295/207
E 960 Steviol
glycosides 200 (60) only
energy-reduced
jams,
jellies
and
marmalades
(60): expressed as steviol equivalents

---

L 295/208
Category
number
E-number Name
Maximum level (mg/l or
mg/kg as appropriate)
Footnotes restrictions/exception
04.2.5.3 Other
similar
fruit
or
vegetable
spreads
E 960 Steviol
glycosides 200 (60) only
dried-fruit-based
sandwich
spreads,
energy-reduced
or
with no added sugar
EN

(60): expressed as steviol equivalents
05.1 Cocoa
and
Chocolate
products
as
covered
by
Directive
2000/36/EC
E 960 Steviol
glycosides 270 (60) only
energy-reduced
or
with
no
added
sugars
(60): expressed as steviol equivalents
05.2 Other
confectionery
including
breath
refreshening
microsweets
Off
icial
E 960 Steviol
glycosides 270 (60)
only cocoa or dried fruit based, energy reduced or with no
added sugar
Jour
nal
E 960 Steviol
glycosides 330 (60) only
cocoa,
milk,
dried
fruit
or
fat
based
sandwich
spreads,
energy-reduced or with no added sugar
of
the
E 960 Steviol
glycosides 350 (60) only
confectionary
with
no
added
sugar
European
E 960 Steviol
glycosides 2
000 (60) only
breath-freshening
micro-sweets,
with
no
added
sugar
Union
E 960 Steviol
glycosides 670 (60) only
strongly
flavoured
freshening
throat
pastilles
with
no
added sugar
(60): expressed as steviol equivalents
05.3 Chewing
gum
E 960 Steviol
glycosides 3
300 (60) only
with
no
added
sugar
(60): expressed as steviol equivalents
05.4
Decorations, coatings and fillings, except fruit based fillings covered by category 4.2.4
E 960 Steviol
glycosides 330 (60) only
confectionary
with
no
added
sugar
12.11.2011
E 960 Steviol
glycosides 270 (60)
only cocoa or dried fruit based, energy reduced or with no
added sugar
(60): expressed as steviol equivalents

---

12.11.2011 Off
Category
number
E-number Name
Maximum level (mg/l or
mg/kg as appropriate)
Footnotes restrictions/exception
06.3 Breakfast
cereals
E 960 Steviol
glycosides 330 (60) only
breakfast
cereals
with
a
fibre
content
of
more
than
15
%,
and containing at least 20 % bran, energy reduced or with no
added sugar
EN

(60): expressed as steviol equivalents
07.2 Fine
bakery
wares
E 960 Steviol
glycosides 330 (60) only
essoblaten
-
wafer
paper
(60): expressed as steviol equivalents
09.2.
Processed fish and fishery products including molluscs and crustaceans
icial
E 960 Steviol
glycosides 200 (60) only
sweet-sour
preserves
and
semi
preserves
of
fish
and
Jour
marinades of fish, crustaceans and molluscs
nal
(60): expressed as steviol equivalents
of
the
11.4.1 Table
Top
Sweeteners
in
liquid
form
European
E 960 Steviol
glycosides QS (60)
(60): expressed as steviol equivalents
Union
11.4.2 Table
Top
Sweeteners
in
powder
form
E 960 Steviol
glycosides QS (60)
(60): expressed as steviol equivalents
11.4.3 Table
Top
Sweeteners
in
tablets
E 960 Steviol
glycosides QS (60)
(60): expressed as steviol equivalents
12.5 Soups
and
broths
L
E 960 Steviol
glycosides 40 (60) only
energy-reduced
soups
295/209
(60): expressed as steviol equivalents

---

L 295/210
Category
number
E-number Name
Maximum level (mg/l or
mg/kg as appropriate)
Footnotes restrictions/exception
12.6 Sauces
E 960 Steviol
glycosides 120 (60) except
soy-bean
sauce
(fermented
and
non-fermented)
E 960 Steviol
glycosides 175 (60) only
soy-bean
sauce
(fermented
and
non-fermented)
EN

(60): expressed as steviol equivalents
13.2
Dietary foods for special medical purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5)
E 960 Steviol
glycosides 330 (60)
(60): expressed as steviol equivalents
13.3
Dietary foods for weight control diets intended to replace total daily food intake or an individual meal (the whole or part of the total daily diet)
Off
E 960 Steviol
glycosides 270 (60)
icial
(60): expressed as steviol equivalents
Jour
nal
14.1.3
Fruit nectars as defined by Council Directive 2001/112/EC and vegetable nectars and similar products
of
the
E 960 Steviol
glycosides 100 (60) only
energy-reduced
or
with
no
added
sugar
European
(60): expressed as steviol equivalents
14.1.4 Flavoured
drinks
Union
E 960 Steviol
glycosides 80 (60) only
energy
reduced
or
with
no
added
sugar
(60): expressed as steviol equivalents
14.2.1 Beer
and
malt
beverages
E 960 Steviol
glycosides 70 (60) only
alcohol-free
beer
or
with
an
alcohol
content
not
exceeding 1,2 % vol.; ‘Bière de table/Tafelbier/Table beer’
(original wort content less than 6 %) except for ‘Obergriges
Einfachbier’; beers with a minimum acidity of 30 milli-
equivalents expressed as NaOH; Brown beers of the ‘oud
bruin’ type
(60): expressed as steviol equivalents
14.2.8
Other alcoholic drinks including spirits with less than 15 % of alcohol and mixtures of alcoholic drinks with non-alcoholic drinks
12.11.2011
E 960 Steviol
glycosides 150 (60)
(60): expressed as steviol equivalents

---

12.11.2011 Off
Category
number
E-number Name
Maximum level (mg/l or
mg/kg as appropriate)
Footnotes restrictions/exception
15.1 Potato-,
cereal-,
flour-
or
starch-based
snacks
E 960 Steviol
glycosides 20 (60)
(60): expressed as stevioles equivalents
EN

15.2 Processed
nuts
E 960 Steviol
glycosides 20 (60)
(60): expressed as steviol equivalents
16. Desserts
excluding
products
covered
in
category
1,
3
and
4
E 960 Steviol
glycosides 100 (60) only
energy-reduced
or
with
no
added
sugar
(60): expressed as steviol equivalents
icial
17.1
Food supplements supplied in a solid form including capsules and tablets and similar forms
Jour
nal
E 960 Steviol
glycosides 670 (60)
of
(60): expressed as steviol equivalents
the
European
17.2 Food
supplements
supplied
in
a
liquid
form
E 960 Steviol
glycosides 200 (60)
Union
(60): expressed as steviol equivalents
17.3 Food
supplements
supplied
in
a
syrup-type
or
chewable
form
E 960 Steviol
glycosides 1
800 (60)
(60): expressed as steviol equivalents
L
295/211

---