EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/10966/2014 […](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annex II to Regulation (EC) No 13 33/2008 of the European Parliament and of 
the Council and the Annex to Commission Regulati on (EU) No 231/2012  as regards the 
removal of montan acid esters (E 912) 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of 
the Council and the Annex to Commission Re gulation (EU) No 231/2012 as regards the 
removal of montan ac id 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 a nd their conditions of use. 
(2) Commission Regulation (EU) No 231/2012 lays down specifications for food 
additives that are listed in Annexes II  and III to Regula tion (EC) No 1333/2008
2. 
(3) Montan acid esters (E 912) are waxes auth orised as glazing agents for surface 
treatment of citrus fruit, melons, papa yas, mangos, avocados and pineapples in 
accordance with Annex II to Regulation (EC) No 1333/2008. 
(4) Article 32(1) of Regulation (EC) No 1333/200 8 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 Safe ty Authority (‘the Authority’). 
(5) For that purpose, a program for the re-evalua tion of food additives is laid down in the 
Commission Regulation (EU)  No 257/20103. Pursuant to Regulation (EU) No 
257/2010 the re-evaluation of food additives ot her than colours and sweeteners has to 
be done until 31 December 2008. However, ce rtain food additives, including montan 
acid esters (E 912), have  higher 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 inte rested party shall submit the data related to the re-
evaluation of a food additive within the peri od set by the Authority in its call for data. 
                                                
 
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 additiv es in accordance with Regulati on (EC) No 1333/2008 of the 
European Parliament and of the Council on food additives (OJ L 80, 26.03.2010, p.19).  
EN 3   EN (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 Sc ientific Opinion on the re-evaluation of 
montan acid esters (E 912) as food additives5. 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 toxici ty, genotoxicity and 
chronic toxicity and carcinogeni city 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 Regulati on (EU) No 257/2010 provides th at where the information 
necessary for the completion of the re-evalua tion of a particular food additive is not 
provided by the interested bus iness operator(s) and any othe r interested party to the 
Authority within the set dead lines, 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.  Accord ingly, the specifications of this food 
additive should also be remove d 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 wi th the procedure referred to 
in Regulation (EC) No 1331/2008
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 init iative of the Commission or following an 
application. 
(12) Therefore, Annex II to Regulation (EC) No 1333/2008 and the Annex to Commission 
Regulation (EU) No 231/2012 should be ame nded 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 l onger be justified. 
(13) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Annex II to Regulation (EC) No 1333/2008 is ame nded in accordance with Annex I to this 
Regulation. 
Article 2 
The Annex to Regulation (EU)  No 231/2012 is amended in accordance with Annex II to this 
Regulation. 
                                                
 
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.).  
EN 4   EN Article 3 
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, 
 For the Commission 
 The President  José Manuel BARROSO  
EN 5   EN ANNEX I  
Annex II to Regulation (EC) No 1333/2008 is amended as follows: 
(1)  In Part B, in Section 3 “Additives  other than colours and sweeteners”, the entry for the food additive E 912 is deleted. 
(2)  In Part E, in food category 4.1.1 “Ent ire fresh fruit and vegetables”, the entr y for the food additive E 912 is deleted. 
 
ANNEX II 
 
In the Annex to Regulation (EU) No 231/2012, the entry for food additive E 912 is deleted.