Date: 2016-04-02Category: Not ApplicableState: Union GovernmentCountry: Europe
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)
Executive Summary:
Commission Regulation (EU) 2016/479 amends Annex II to Regulation (EC) No 1333/2008, authorizing the use of steviol glycosides (E 960) as a sweetener in certain energy-reduced or no-added-sugar beverages. The regulation was adopted on April 1, 2016, and entered into force on the twentieth day following its publication in the Official Journal of the European Union. This change follows an application for authorization and a safety assessment by the European Food Safety Authority (EFSA).
Key Points / Main Content:
* **Amendment to Annex II of Regulation (EC) No 1333/2008:**
* Updates the Union list of food additives to include specific uses of steviol glycosides (E 960).
* **Authorization of Steviol Glycosides (E 960) in Beverages:**
* Permits the use of E 960 as a sweetener in energy-reduced or no-added-sugar beverages under food subcategory 14.1.5.2 ("Other").
* Specifies maximum levels for E 960 in the following beverages:
* Coffee, tea, and herbal infusion beverages: 30 mg/l.
* Flavoured instant coffee and instant cappuccino products: 30 mg/l.
* Malt-based and chocolate-cappuccino flavoured drinks: 20 mg/l.
* **Conditions of Use:**
* Maximum levels are expressed as steviol equivalents.
* Maximum levels apply to ready-to-drink products (e.g., canned) and their mixes and concentrates after preparation and ready for consumption.
Impact Analysis:
**Manufacturers of Energy-Reduced or No-Added-Sugar Beverages:**
* Impact: Can now use steviol glycosides (E 960) as a sweetener in specific beverage categories, potentially reducing the caloric content of their products.
* Action Required: Ensure compliance with the specified maximum levels for E 960 in their products and adhere to the labeling requirements for food additives.
**European Food Safety Authority (EFSA):**
* Impact: The EFSA's scientific opinions on the safety of steviol glycosides formed the basis for this regulation.
* Action Required: Continue monitoring and assessing the safety of steviol glycosides based on new scientific information.
**Member States:**
* Impact: Must ensure that the regulation is directly applicable within their territories.
* Action Required: Implement and enforce the new provisions regarding the use of steviol glycosides in beverages.
**Consumers:**
* Impact: Will have access to energy-reduced or no-added-sugar beverages sweetened with steviol glycosides.
* Action Required: No direct action required.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An executive branch of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation (EC) No 1333/2008: A regulation of the European Parliament and of the Council on food additives.
Regulation (EC) No 1331/2008: A regulation of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings.
Steviol glycosides (E 960): A non-caloric sweetener used as a food additive.
European Food Safety Authority (EFSA): An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
Brussels: The de facto capital city of the European Union, located in Belgium; where the regulation was adopted.
Acceptable Daily Intake (ADI): The amount of a specific substance (in this case, steviol equivalents) that a person can consume every day for their entire life without any adverse health effects. Here, it's established at 4 mg/kg body weight/day for steviol glycosides.
2.4.2016 EN Official Journal of the European Union L 87/1
II
(Non-legislative acts)
REGULATIONS
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.
(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.
(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.
(1) OJ L 354, 31.12.2008, p. 16.
(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).L 87/2 EN Official Journal of the European Union 2.4.2016
(6) In 2010, the Authority adopted a scientific opinion (1) 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 (2) and on 30 June 2015 (3).
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.
(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.
(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) EFSA Journal 2010;8(4):1537.
(2) EFSA Journal 2014;12(5):3639.
(3) EFSA Journal 2015;13(6):4146.2.4.2016 EN Official Journal of the European Union L 87/3
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 cap
puccino products, energy-reduced or with no
added sugars
E 960 Steviol glycosides 20 (60) (93) only malt-based and chocolate/cappuccino fla
voured 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.
(93): Maximum level applies to the ready-to-drink products (e.g. canned) and their mixes and concentrates after
preparation and ready for consumption.’