# Commission Regulation (EU) No 497/2014Show full title

Commission Regulation (EU) No 497/2014 of 14 May 2014 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament            and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards the use of Advantame as a sweetener            (Text with EEA relevance)         

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U.K.

# Commission Regulation (EU) No 497/2014                     

# of 14 May 2014

# amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission                        Regulation (EU) No 231/2012 as regards the use of Advantame as a sweetener                     

# (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 Articles 10(3) and 14 thereof,                        

Having regard to 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(2), and in particular Article 7(5) thereof,                        

Whereas:

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

(2)Commission Regulation (EU) No 231/2012(3) lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008.

(3)Those lists may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008,                              either on the initiative of the Commission or following an application.

(4)An application for authorisation of the use of Advantame as a sweetener in several food categories was submitted in May 2010.                              The application was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.

(5)There is a technological need for the use of Advantame as a high-intensity sweetener in various food and tabletop products                              in order to replace caloric sugars (sucrose, glucose, fructose, etc.) thus allowing for a reduction of the caloric content                              of those foodstuffs. The addition of Advantame as a sweetener to the categories of foods in which high-intensity sweeteners                              are authorised according to Annex II to Regulation (EC) No 1333/2008 will provide manufacturers with greater flexibility in                              formulating energy-reduced foods with a similar taste profile as the full-caloric equivalent. The flavour and sweetness qualities                              of Advantame, coupled with good stability characteristics, mean that Advantame provides an alternative to already approved                              high-intensity sweeteners, offering consumers and the food industry the option to choose from a wider selection of sweeteners,                              thus reducing the intake of each individual sweetener.

(6)The European Food Safety Authority (‘the Authority’) evaluated the safety of Advantame when used as a food additive and expressed                              its opinion on 31 July 2013(4). The Authority established an Acceptable Daily Intake (ADI) for Advantame of 5 mg/kg bw/day. Conservative estimates of advantame                              exposure for high level adults and children consumers were below the ADI for the proposed use levels. After considering all                              the data on stability, degradation products, toxicology and exposure, the Authority concluded that Advantame would not be                              of safety concern at the proposed uses and use levels as a sweetener.

(7)Therefore, it is appropriate to authorise the use of Advantame as a sweetener in the food categories specified in Annex I                              to this Regulation and to assign E 969 as an E-number to that food additive.

(8)The specifications for Advantame should be included in Regulation (EU) No 231/2012 when it is included in the Union list of                              food additives laid down in Annex II to Regulation (EC) No 1333/2008 for the first time.

(9)Regulations (EC) No 1333/2008 and (EU) No 231/2012 should therefore be amended accordingly.

(10)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain                              and Animal Health,

HAS ADOPTED THIS REGULATION:

# Article 1U.K.

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

# Article 2U.K.

The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this Regulation.

# Article 3U.K.

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, 14 May 2014.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

## ANNEX IU.K.

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

In Part B, in Table 2 ‘Sweeteners’, the following new entry is inserted after the entry for food additive E 968 Erythritol:

In Part E, the following entries for E 969 are inserted in numerical order in the food categories referred to:

### PART E: AUTHORISED FOOD ADDITIVES AND CONDITIONS OF USE IN FOOD CATEGORIESU.K.

## ANNEX IIU.K.

In the Annex to Regulation (EU) No 231/2012, the following new entry is inserted after the entry for food additive E 968:

### **‘E 969 ADVANTAME**

1

OJ L 354, 31.12.2008, p. 16.                           

2

OJ L 354, 31.12.2008, p. 1.                           

3

Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II                              and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).                           

4

EFSA Journal 2013; 11(7):3301.