# L_2016087EN.01000101.xml

| 2.4.2016 | EN | Official Journal of the European Union | L 87/1 |
| --- | --- | --- | --- |

2.4.2016

EN

Official Journal of the European Union

L 87/1

---

COMMISSION REGULATION (EU) 2016/479

of 1 April 2016

amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of steviol glycosides (E 960) as a sweetener in certain energy-reduced or with no added sugars beverages

(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(3) thereof,

Whereas:

| (1) | Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food and their conditions of use. |
| --- | --- |

(1)

Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food and their conditions of use.

| (2) | That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council (2) either on the initiative of the Commission or following an application. |
| --- | --- |

(2)

That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council (2) either on the initiative of the Commission or following an application.

| (3) | On 25 March 2013 an application was submitted for authorisation of the use of steviol glycosides (E 960) as a sweetener in certain energy-reduced or with no added sugars beverages falling under the food subcategory 14.1.5.2 ‘Other’ of Annex II to Regulation (EC) No 1333/2008. The application was subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. |
| --- | --- |

(3)

On 25 March 2013 an application was submitted for authorisation of the use of steviol glycosides (E 960) as a sweetener in certain energy-reduced or with no added sugars beverages falling under the food subcategory 14.1.5.2 ‘Other’ of Annex II to Regulation (EC) No 1333/2008. The application was subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.

| (4) | Steviol glycosides are non-caloric sweet-tasting constituents and may be used to replace caloric sugars in certain beverages, thus reducing the caloric content of those products. Consequently, steviol glycosides provide sweetness to those beverages without delivering additional calories to the final product, offering consumers energy-reduced or with no added sugars products, in accordance with Article 7 of Regulation (EC) No 1333/2008. |
| --- | --- |

(4)

Steviol glycosides are non-caloric sweet-tasting constituents and may be used to replace caloric sugars in certain beverages, thus reducing the caloric content of those products. Consequently, steviol glycosides provide sweetness to those beverages without delivering additional calories to the final product, offering consumers energy-reduced or with no added sugars products, in accordance with Article 7 of Regulation (EC) No 1333/2008.

| (5) | Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the European Food Safety Authority (‘the Authority’) in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008. |
| --- | --- |

(5)

Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the European Food Safety Authority (‘the Authority’) in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008.

| (6) | In 2010, the Authority adopted a scientific opinion (3) on the safety of steviol glycosides for the proposed uses as a food additive (E 960) and established an Acceptable Daily Intake (ADI) of 4 mg/kg body weight/day, expressed as steviol equivalents. In view of the proposed extension of uses as a food additive, the Authority revised the exposure assessment of steviol glycosides and expressed its opinions on 2 May 2014 (4) and on 30 June 2015 (5). As regards those extensions of uses, the Authority concluded that the exposure estimates are below the ADI for all age groups, except for toddlers at the upper range of the high level (95th percentile) estimates, in one country. Exposure calculations carried out by Rijksinstituut voor Volksgezondheid en Milieu showed that the proposed extension of use did not affect the 95th percentile of exposure in young children aged 2 to 6 years in the Netherlands and that non-alcoholic beverages and flavoured fermented milk products remained the main contributors to exposure to steviol glycosides in that age group. |
| --- | --- |

(6)

In 2010, the Authority adopted a scientific opinion (3) on the safety of steviol glycosides for the proposed uses as a food additive (E 960) and established an Acceptable Daily Intake (ADI) of 4 mg/kg body weight/day, expressed as steviol equivalents. In view of the proposed extension of uses as a food additive, the Authority revised the exposure assessment of steviol glycosides and expressed its opinions on 2 May 2014 (4) and on 30 June 2015 (5). As regards those extensions of uses, the Authority concluded that the exposure estimates are below the ADI for all age groups, except for toddlers at the upper range of the high level (95th percentile) estimates, in one country. Exposure calculations carried out by Rijksinstituut voor Volksgezondheid en Milieu showed that the proposed extension of use did not affect the 95th percentile of exposure in young children aged 2 to 6 years in the Netherlands and that non-alcoholic beverages and flavoured fermented milk products remained the main contributors to exposure to steviol glycosides in that age group.

| (7) | Considering that food subcategory 14.1.5.2 covers products not intended to be consumed by toddlers (12 to 35 months old) the proposed uses and use levels of steviol glycosides (E 960) as a sweetener are not of a safety concern. |
| --- | --- |

(7)

Considering that food subcategory 14.1.5.2 covers products not intended to be consumed by toddlers (12 to 35 months old) the proposed uses and use levels of steviol glycosides (E 960) as a sweetener are not of a safety concern.

| (8) | Therefore, it is appropriate to authorise the use of steviol glycosides (E 960) as a sweetener added to the energy-reduced or with no added sugars beverages in food subcategory 14.1.5.2 ‘Other’: coffee, tea and herbal infusion beverages (at maximum level of 30 mg/l), flavoured instant coffee and instant cappuccino products (at maximum level of 30 mg/l) and malt-based and chocolate/cappuccino flavoured drinks (at maximum level of 20 mg/l). |
| --- | --- |

(8)

Therefore, it is appropriate to authorise the use of steviol glycosides (E 960) as a sweetener added to the energy-reduced or with no added sugars beverages in food subcategory 14.1.5.2 ‘Other’: coffee, tea and herbal infusion beverages (at maximum level of 30 mg/l), flavoured instant coffee and instant cappuccino products (at maximum level of 30 mg/l) and malt-based and chocolate/cappuccino flavoured drinks (at maximum level of 20 mg/l).

| (9) | Therefore, Annex II to Regulation (EC) No 1333/2008 should be amended accordingly. |
| --- | --- |

(9)

Therefore, Annex II to Regulation (EC) No 1333/2008 should be amended accordingly.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

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

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 all Member States.

Done at Brussels, 1 April 2016.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 354, 31.12.2008, p. 16.

1

(2)  Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1).

2

(3)  
  EFSA Journal 2010;8(4):1537.

3

EFSA Journal

(4)  
  EFSA Journal 2014;12(5):3639.

4

EFSA Journal

(5)  
  EFSA Journal 2015;13(6):4146.

5

EFSA Journal

---

ANNEX

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

| (1) | in food subcategory 14.1.5.2 ‘Other’ the following entries for E 960 are inserted after the entry for E 491-495 Sorbitan esters: | ‘E 960 | Steviol glycosides | 30 | (60) (93) | only coffee, tea and herbal infusion beverages, energy-reduced or with no added sugars |
| --- | --- | --- | --- | --- | --- | --- |
| | E 960 | Steviol glycosides | 30 | (60) (93) | only flavoured instant coffee and instant cappuccino products, energy-reduced or with no added sugars |
| | E 960 | Steviol glycosides | 20 | (60) (93) | only malt-based and chocolate/cappuccino flavoured drinks, energy-reduced or with no added sugars’ |

(1)

in food subcategory 14.1.5.2 ‘Other’ the following entries for E 960 are inserted after the entry for E 491-495 Sorbitan esters:

‘E 960

Steviol glycosides

30

(60) (93)

only coffee, tea and herbal infusion beverages, energy-reduced or with no added sugars

E 960

Steviol glycosides

30

(60) (93)

only flavoured instant coffee and instant cappuccino products, energy-reduced or with no added sugars

E 960

Steviol glycosides

20

(60) (93)

only malt-based and chocolate/cappuccino flavoured drinks, energy-reduced or with no added sugars’

| (2) | in food subcategory 14.1.5.2 ‘Other’, the following footnotes are added:






  ‘(60): | Expressed as steviol equivalents. |
| --- | --- | --- |

(2)

in food subcategory 14.1.5.2 ‘Other’, the following footnotes are added:

‘(60):

| (93): | Maximum level applies to the ready-to-drink products (e.g. canned) and their mixes and concentrates after preparation and ready for consumption.’ |
| --- | --- |

(93):

---