EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX 
SANCO/11491/2011 
(POOL/E3/2011/1149 1/11491-EN.doc) 
[…](2011) XXX draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX 
amendin g Annex II to Re gulation (EC) No 1333/2008 of th e European Parliament and of 
the Council with regard to steviol glycosides 
(Text with EEA relevance) 
 EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX 
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, 
Having regard to the Treaty on the Functioning of the European Union,  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, 
Whereas: (1) Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for 
use in foods and their conditions of use. 
(2) The European Food Safety Authority (herei nafter referred to as the Authority) 
evaluated the safety of steviol glycosid es, extracted from the leaves of the Stevia 
rebaudiana  Bertoni plant, as sweetener and expressed its opini on on 10 March 2010
2. 
The Authority established an Acceptable Daily Intake (ADI) for steviol glycosides, expressed as steviol equivale nts, of 4 mg/kg body weight/day. Conservative estimates 
of steviol glycosides exposure, both in adults  and in children, suggest that it is likely 
that the ADI would be exceeded at the maximum proposed use levels.  
(3) Taking into account the conclusion of the Authority, the applicants submitted, in 
September 2010, revised uses and the Authorit y was requested to consider those uses. 
A statement on a new exposure assessment was published in January 20113. Despite 
the revised uses, the conclusi on was very similar, namely that both in adults and 
children the ADI can be exceeded for high leve l consumers. The main contributors to 
the total anticipated exposure to steviol gl ycosides are non-alcohol ic flavoured drinks 
(soft drinks).  
(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 
                                                 
1 OJ L 354, 31.12.2008, p. 16. 
2 Scientific Opinion of the Panel on Food Additives an d Nutrient Sources added to food on the safety of 
steviol glycosides for the proposed uses as a food additive. The EFSA Journal (2010); 8(4):1537. 
3 Statement of EFSA: 'Revised exposure assessment fo r steviol glycosides for th e proposed uses as a food 
additive'. The EFSA Journal (2011); 9(01):1972. EN 3   EN appropriate maximum use levels.  Taking into account the potential significant 
contribution of soft drinks to the intake of  steviol glycosides, a reduction in the use 
level for flavoured drinks, compared to the previously proposed us e levels considered 
by the Authority, should be established. 
(5) The Commission will request from producer s and users of steviol glycosides 
information about the actual use of the food additive af ter its authorisation. The 
Commission will make such information available to the Member States. When necessary, the Commission will ask the Auth ority to perform a new refined exposure 
assessment, taking into account the real uses  of steviol glycosides in the different 
subcategories of foodstuffs and the cons umption of normal versus energy reduced 
foodstuffs.  
(6) The Authority expressed in its opinion the ADI for steviol glycosides as steviol 
equivalents. The dietary exposure to the st eviol glycosides was also expressed as 
steviol equivalents. It is therefore appropriate that the maximum permitted use levels should also be expressed as steviol equivale nts. Maximum levels of steviol glycosides 
are expressed as the sum of all named steviol glycosides mentioned in the specifications and can be converted to stev iol equivalents using the conversion factors 
mentioned in the specifications. 
(7) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Anim al Health and neither the European 
Parliament nor the Council has opposed them, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Amendment to Regulation (EC) No 1333/2008 
Annex II to Regulation (EC) No  1333/2008 is amended in accordance with the Annex to this 
Regulation. 
Article 2 
Transitional provision 
By way of derogation to Article 2(1) of  [Commission Regulation (EU) No …/..] amending 
Annex II to Regulation (EC) No  1333/2008 of the European Parliament and of the Council by 
establishing a Union list of food additives, the entries in Part B and Part E of Annex II to 
Regulation (EC) No 1333/2008 con cerning steviol glycosides (E 960) shall apply from the 
date of entry into force of this Regulation. 
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . EN 4   EN This Regulation shall be binding in  its entirety and directly applicable in the Member States. 
Done at Brussels, 
 For the Commission 
 José Manuel BARROSO  The President  
EN 5   EN 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 
 
(2) In Part E the following entries for E 960 are inserted  in numerical order in th e 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 (58) only energy-reduced products or with no added sugar 
  (58): expressed as steviol equivalents 
03. Edible ices  
 E 960 Steviol glycosides 200 (58) only energy-reduced or with no added sugar 
  (58): expressed as steviol equivalents 
04.2.2 Fruit and vegetables in vinegar, oil, or brine  
 E 960 Steviol glycosides 100 (58) only sweet-sour preserves of fruit and vegetables 
  (58): expressed as steviol equivalents 
04.2.4.1 Fruit and vegetable p reparations excluding compote  
 E 960 Steviol glycosides 200 (58) only energy-reduced 
  (58): expressed as steviol equivalents  
EN 6   EN 04.2.5.1 Extra jam and extra jelly as defined by Directive 2001/113/EEC  
 E 960 Steviol glycosides 200 (58) only energy-reduced jams jellies and marmalades 
  (58): expressed as steviol equivalents 
04.2.5.2 Jam, jellies and marmalade s and sweetened chestnut  puree as defined by Directive 2001/113/EEC 
 E 960 Steviol glycosides 200 (58) only energy-reduced jams, jellies and marmalades  
  (58): expressed as steviol equivalents 
04.2.5.3 Other similar fruit or vegetable spreads  
 E 960 Steviol glycosides 200 (58) only dried-fruit-based sandwich spreads, energy-reduced or with no 
added sugar 
  (58): expressed as steviol equivalents 
05.1 Cocoa and Chocolate products as covered by Directive 2000/36/EC  
 E 960 Steviol glycosides 270 (58) only energy-reduced or with no added sugars 
  (58): expressed as steviol equivalents 
05.2 Other confectionery including  breath refreshening microsweets  
 E 960 Steviol glycosides 270 (58) only cocoa or dried fruit based, energy reduced or with no added 
sugar 
 E 960 Steviol glycosides 330 (58) only cocoa, milk, dried fruit or fat based sandwich spreads, energy-
reduced or with no added sugar 
 E 960 Steviol glycosides 350 (58) only confectionary with no added sugar 
 E 960 Steviol glycosides 2000 (58) only breath-freshening micro-sweets, with no added sugar 
 E 960 Steviol glycosides 670 (58) only strongly flavoured freshening throat pastilles with no added 
sugar 
  (58): expressed as steviol equivalents 
05.3 Chewing gum  
 E 960 Steviol glycosides 3300 (58) only with no added sugar 
  (58): expressed as steviol equivalents  
EN 7   EN 05.4 Decorations, coatings and fillings, except fruit based fillings covered  by category 4.2.4  
 E 960 Steviol glycosides 330 (58) only confectionary with no added sugar 
 E 960 Steviol glycosides 270 (58) only cocoa or dried fruit based, energy reduced or with no added 
sugar 
  (58): expressed as steviol equivalents 
06.3 Breakfast cereals  
 E 960 Steviol glycosides 330 (58) only breakfast cereals with a fibre co ntent of more than 15 %, and 
containing at least 20 % bran, energy reduced or with no added sugar 
  (58): expressed as steviol equivalents 
07.2 Fine bakery wares  
 E 960 Steviol glycosides 330 (58) only essoblaten - wafer paper 
  (58): expressed as steviol equivalents 
09.2. Processed fish and fishery pro ducts including mollusks and crustaceans  
 E 960 Steviol glycosides 200 (58) only sweet-sour preserves and semi preserves of fish and marinades of 
fish, crustaceans and molluscs 
  (58): expressed as steviol equivalents 
11.4.1 Table Top Sweeteners in liquid form  
 E 960 Steviol glycosides QS (58)  
  (58): expressed as steviol equivalents 
11.4.2 Table Top Sweeteners in powder form  
 E 960 Steviol glycosides QS (58)  
  (58): expressed as steviol equivalents 
11.4.3 Table Top Sweeteners in tablets  
 E 960 Steviol glycosides QS (58)  
  (58): expressed as steviol equivalents  
EN 8   EN 12.5 Soups and broths  
 E 960 Steviol glycosides 40 (58) only energy-reduced soups 
  (58): expressed as steviol equivalents 
12.6 Sauces  
 E 960 Steviol glycosides 120 (58) except soy-bean sauce (fermented and non-fermented) 
 E 960 Steviol glycosides 175 (58) only soy-bean sauce (fermented and non-fermented) 
  (58): expressed as steviol equivalents 
13.2 Dietary foods for special medical purpo ses defined in Directive 1999/21/EC (excludi ng products from food category 13.1.5) 
 E 960 Steviol glycosides 330 (58)  
  (58): expressed as steviol equivalents 
13.3 Dietary foods for weight co ntrol diets intended to replace total daily food in take or an individual meal (the whole or par t of the total daily diet) 
 E 960 Steviol glycosides 270 (58)  
  (58): expressed as steviol equivalents 
14.1.3 Fruit nectars as defined by Council Directive 2001/112/EC and vege table nectars and similar products 
 E 960 Steviol glycosides 100 (58) only energy-reduced or with no added sugar 
  (58): expressed as steviol equivalents 
14.1.4 Flavoured drinks  
 E 960 Steviol glycosides 80 (58) only energy reduced or with no added sugar;  
  (58): expressed as steviol equivalents 
14.2.1 Beer and malt beverages  
 E 960 Steviol glycosides 70 (58) 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 ‘Obergärig es Einfachbier'; Beers with a 
minimum acidity of 30 milli-equivalents expressed as NaOH; Brown beers of the ‘oud bruin’ type 
  (58): expressed as steviol equivalents  
EN 9   EN 14.2.8 Other alcholic drinks including spir its with less than 15 % of alcohol and mixt ures of alcoholic drinks with non-alcohol ic drinks 
 E 960 Steviol glycosides 150 (58)  
  (58): expressed as steviol equivalents 
15.1 Potato-, cereal-, flou r- or starch-based snacks  
 E 960 Steviol glycosides 20 (58)  
  (58): expressed as stevioles equivalents 
15.2 Processed nuts  
 E 960 Steviol glycosides 20 (58)  
  (58): expressed as steviol equivalents 
16. Desserts excluding products co vered in category 1, 3 and 4  
 E 960 Steviol glycosides 100 (58) only energy-reduced or with no added sugar 
  (58): expressed as steviol equivalents 
17.1 Food supplements supplied in a solid form including capsules and ta blets and similar forms 
 E 960 Steviol glycosides 670 (58)  
  (58): expressed as steviol equivalents 
17.2 Food supplements supplied in a liquid form  
 E 960 Steviol glycosides 200 (58)  
  (58): expressed as steviol equivalents 
17.3 Food supplements supplied in a syrup-type or chewable form  
 E 960 Steviol glycosides 1800 (58)  
  (58): expressed as steviol equivalents