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
Date: 2011-11-11
Institutions: European Commission
Subjects: food inspection, food safety, food substitute, market approval, non-alcoholic beverage, processed foodstuff, sweetener




L_2011295EN.01020501.xml










12.11.2011   


EN


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,

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 (hereinafter referred to as ‘the Authority’) evaluated the safety of steviol glycosides, extracted from the leaves of the Stevia rebaudiana Bertoni plant, as sweetener and expressed its opinion on 10 March 2010 (2). The Authority established an Acceptable Daily Intake (ADI) for steviol glycosides, expressed as steviol equivalents, of 4 mg/kg bodyweight/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 Authority was requested to consider those uses. A statement on a new exposure assessment was 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-alcoholic 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 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 use levels considered by the Authority, should be established.












(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 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 the different subcategories of foodstuffs and the consumption 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 steviol glycosides was also expressed as steviol equivalents. It is therefore appropriate that the maximum permitted use levels should also be expressed as steviol equivalents. Maximum levels of steviol glycosides are expressed as the sum of all named steviol glycosides mentioned in the specifications and can be converted to steviol equivalents using the conversion factors mentioned in the specifications.












(7)


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 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 1129/2011 of 11 November 2011 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 (4), the entries in Parts B and E of Annex II to Regulation (EC) No 1333/2008 concerning 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 20th day following 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)  
            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 proposed uses as a food additive. The EFSA Journal (2010); 8(4):1537.

(3)  Statement of EFSA: ‘Revised exposure assessment for steviol glycosides for the proposed uses as a food additive’. The EFSA Journal (2011); 9(01):1972.

(4)  See page 1 of this Official Journal.




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 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




(60): expressed as steviol equivalents







03.




Edible ices





E 960


Steviol glycosides


200 


(60)


only energy-reduced or with no added sugar




(60): expressed as steviol equivalents







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




(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





E 960


Steviol glycosides


200 


(60)


only energy-reduced jams, jellies and marmalades




(60): expressed as steviol equivalents







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




(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





E 960


Steviol glycosides


270 


(60)


only cocoa or dried fruit based, energy reduced or with no added sugar




E 960


Steviol glycosides


330 


(60)


only cocoa, milk, dried fruit or fat based sandwich spreads, energy-reduced or with no added sugar




E 960


Steviol glycosides


350 


(60)


only confectionary with no added sugar




E 960


Steviol glycosides


2 000 


(60)


only breath-freshening micro-sweets, with no added sugar




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




E 960


Steviol glycosides


270 


(60)


only cocoa or dried fruit based, energy reduced or with no added sugar




(60): expressed as steviol equivalents







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




(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





E 960


Steviol glycosides


200 


(60)


only sweet-sour preserves and semi preserves of fish and marinades of fish, crustaceans and molluscs




(60): expressed as steviol equivalents







11.4.1




Table Top Sweeteners in liquid form





E 960


Steviol glycosides


QS


(60)


 




(60): expressed as steviol equivalents







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





E 960


Steviol glycosides


40 


(60)


only energy-reduced soups




(60): expressed as steviol equivalents







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)




(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)





E 960


Steviol glycosides


270 


(60)


 




(60): expressed as steviol equivalents







14.1.3




Fruit nectars as defined by Council Directive 2001/112/EC and vegetable nectars and similar products





E 960


Steviol glycosides


100 


(60)


only energy-reduced or with no added sugar




(60): expressed as steviol equivalents







14.1.4




Flavoured drinks





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 ‘Obergäriges 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





E 960


Steviol glycosides


150 


(60)


 




(60): expressed as steviol equivalents







15.1




Potato-, cereal-, flour- or starch-based snacks





E 960


Steviol glycosides


20 


(60)


 




(60): expressed as stevioles equivalents







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







17.1




Food supplements supplied in a solid form including capsules and tablets and similar forms





E 960


Steviol glycosides


670 


(60)


 




(60): expressed as steviol equivalents







17.2




Food supplements supplied in a liquid form





E 960


Steviol glycosides


200 


(60)


 




(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