# Commission Regulation (EU) No 957/2014Show full title

Commission Regulation (EU) No 957/2014 of 10 September 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 removal of montan acid            esters (E 912) (Text with EEA relevance)         

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U.K.

# Commission Regulation (EU) No 957/2014                     

# of 10 September 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 removal of montan acid esters (E 912)                     

# (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,                        

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(2) lays down specifications for food additives that are listed in Annexes II and III to Regulation (EC) No 1333/2008.

(3)Montan acid esters (E 912) are waxes authorised as glazing agents for surface treatment of citrus fruit, melons, papayas,                              mangos, avocados and pineapples in accordance with Annex II to Regulation (EC) No 1333/2008.

(4)Article 32(1) of Regulation (EC) No 1333/2008 provides that all food additives that were already permitted in the Union before                              20 January 2009 are subject to a new risk assessment by the European Food Safety Authority (‘the Authority’).

(5)For that purpose, a program for the re-evaluation of food additives is laid down in the Commission Regulation (EU) No 257/2010(3). Pursuant to Regulation (EU) No 257/2010 the re-evaluation of food additives other than colours and sweeteners has to be                              done until 31 December 2018. However, certain food additives, including montan acid esters (E 912), havehigher priority and                              should be evaluated earlier.

(6)Pursuant to Article 6(1) of Regulation (EU) No 257/2010, the interested business operator(s) and any other interested party                              shall submit the data related to the re-evaluation of a food additive within the period set by the Authority in its call for                              data.

(7)On 15 February 2012 the Authority launched a public call for scientific data on montan acid esters (E 912)(4) inviting interested parties and stakeholders to submit the requested data or to provide information by 1 June 2012.

(8)On 7 June 2013 the Authority delivered a Scientific Opinion on the re-evaluation of montan acid esters (E 912) as food additives(5). The opinion stated that no data on toxicokinetics and reproductive and developmental toxicity of montan acid esters were                              available. The available data on short-term and subchronic toxicity, genotoxicity and chronic toxicity and carcinogenicity                              of montan acid esters were limited. No data on the usage were submitted. Based on those limitations the Authority concluded                              that montan acid esters as food additive could not be evaluated.

(9)Article 6(5) of Regulation (EU) No 257/2010 provides that where the information necessary for the completion of the re-evaluation                              of a particular food additive is not provided by the interested business operator(s) and any other interested party to the                              Authority within the set deadlines, the food additive may be removed from the Union list of approved food additives in accordance                              with the procedure laid down in Article 10(3) of Regulation (EC) No 1333/2008. Accordingly, the specifications of this food                              additive should also be removed from Regulation (EU) No 231/2012.

(10)Pursuant to Article 10(3) of Regulation (EC) No 1333/2008, the Union list of approved food additives shall be amended in accordance                              with the procedure referred to in Regulation (EC) No 1331/2008 of the European Parliament and of the Council(6).

(11)Article 3(1) of Regulation (EC) No 1331/2008 provides that the Union list of food additives may be updated either on the initiative                              of the Commission or following an application.

(12)Therefore, Annex II to Regulation (EC) No 1333/2008 and the Annex to Regulation (EU) No 231/2012 should be amended by removing                              montan acid esters (E 912) from the Union list of authorised food additives since due to the absence of recent scientific                              evidence its inclusion in the list can no longer be justified.

(13)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*.                  

Foods containing montan acid esters (E 912) that have been lawfully placed on the market before the entry into for of this                     Regulation, may continue to be marketed until stocks are exhausted.                  

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 10 September 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 Section 3 ‘Additives other than colours and sweeteners’, the entry for the food additive E 912 is deleted.

In Part E, in food category 4.1.1 ‘Entire fresh fruit and vegetables’, the entry for the food additive E 912 is deleted.

## ANNEX IIU.K.

In the Annex to Regulation (EU) No 231/2012, the entry for food additive E 912 is deleted.

1

OJ L 354, 31.12.2008, p. 16.                           

2

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).                           

3

Commission Regulation (EU) No 257/2010 of 25 March 2010 setting up the program for the re-evaluation of approved food additives                              in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives (OJ L 80, 26.3.2010, p. 19).                           

4

http://www.efsa.europa.eu/en/dataclosed/call/120215a.htm

5

EFSA Journal 2013; 11(6):3236.

6

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).