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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)

EU Regulation No 1131/2011 · Adopted 11 November 2011 · Extends to United Kingdom

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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 additivesf1, 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 2010f2. 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 2011f3. 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:

Annotations to the whole text

Footnotes

f1

OJ L 354, 31.12.2008, p. 16.

f2

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.

f3

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

Contents

  1. 1Amendment to Regulation (EC) No 1333/2008
  2. 2Transitional provision
  3. 3Article 3
  4. Signature
  5. Annex Annex

1Amendment to Regulation (EC) No 1333/2008

Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.

2Transitional 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 additivesf1, 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.

3

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Signature

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

Annex II to Regulation (EC) No 1333/2008 is amended as follows:

  1. (1)

    in Part B2 the following entry for E 960 is inserted after the entry for E 959:

    ‘

    E 960Steviol glycosides

    ’

  2. (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 numberE-numberNameMaximum level (mg/l or mg/kg as appropriate)Footnotesrestrictions/exception
    01.4 Flavoured fermented milk products including heat treated products
    E 960Steviol glycosides100(60)only energy-reduced products or with no added sugar
    (60): expressed as steviol equivalents
    03. Edible ices
    E 960Steviol glycosides200(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 960Steviol glycosides100(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 960Steviol glycosides200(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 960Steviol glycosides200(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 960Steviol glycosides200(60)only energy-reduced jams, jellies and marmalades
    (60): expressed as steviol equivalents
    04.2.5.3 Other similar fruit or vegetable spreads
    E 960Steviol glycosides200(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 960Steviol glycosides270(60)only energy-reduced or with no added sugars
    (60): expressed as steviol equivalents
    05.2 Other confectionery including breath refreshening microsweets
    E 960Steviol glycosides270(60)only cocoa or dried fruit based, energy reduced or with no added sugar
    E 960Steviol glycosides330(60)only cocoa, milk, dried fruit or fat based sandwich spreads, energy-reduced or with no added sugar
    E 960Steviol glycosides350(60)only confectionary with no added sugar
    E 960Steviol glycosides2 000(60)only breath-freshening micro-sweets, with no added sugar
    E 960Steviol glycosides670(60)only strongly flavoured freshening throat pastilles with no added sugar
    (60): expressed as steviol equivalents
    05.3 Chewing gum
    E 960Steviol glycosides3 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 960Steviol glycosides330(60)only confectionary with no added sugar
    E 960Steviol glycosides270(60)only cocoa or dried fruit based, energy reduced or with no added sugar
    (60): expressed as steviol equivalents
    06.3 Breakfast cereals
    E 960Steviol glycosides330(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 960Steviol glycosides330(60)only essoblaten - wafer paper
    (60): expressed as steviol equivalents
    09.2. Processed fish and fishery products including molluscs and crustaceans
    E 960Steviol glycosides200(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 960Steviol glycosidesQS(60)
    (60): expressed as steviol equivalents
    11.4.2 Table Top Sweeteners in powder form
    E 960Steviol glycosidesQS(60)
    (60): expressed as steviol equivalents
    11.4.3 Table Top Sweeteners in tablets
    E 960Steviol glycosidesQS(60)
    (60): expressed as steviol equivalents
    12.5 Soups and broths
    E 960Steviol glycosides40(60)only energy-reduced soups
    (60): expressed as steviol equivalents
    12.6 Sauces
    E 960Steviol glycosides120(60)except soy-bean sauce (fermented and non-fermented)
    E 960Steviol glycosides175(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 960Steviol glycosides330(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 960Steviol glycosides270(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 960Steviol glycosides100(60)only energy-reduced or with no added sugar
    (60): expressed as steviol equivalents
    14.1.4 Flavoured drinks
    E 960Steviol glycosides80(60)only energy reduced or with no added sugar
    (60): expressed as steviol equivalents
    14.2.1 Beer and malt beverages
    E 960Steviol glycosides70(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 960Steviol glycosides150(60)
    (60): expressed as steviol equivalents
    15.1 Potato-, cereal-, flour- or starch-based snacks
    E 960Steviol glycosides20(60)
    (60): expressed as stevioles equivalents
    15.2 Processed nuts
    E 960Steviol glycosides20(60)
    (60): expressed as steviol equivalents
    16. Desserts excluding products covered in category 1, 3 and 4
    E 960Steviol glycosides100(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 960Steviol glycosides670(60)
    (60): expressed as steviol equivalents
    17.2 Food supplements supplied in a liquid form
    E 960Steviol glycosides200(60)
    (60): expressed as steviol equivalents
    17.3 Food supplements supplied in a syrup-type or chewable form
    E 960Steviol glycosides1 800(60)
    (60): expressed as steviol equivalents