EN   EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX  
SANTE/11719/2017 
(POOL/E2/2017/11719/11719-EN.doc)  
D055959/03 […](2018) XXX  draft 
 
COMMISSION REGULATION (EU) …/… 
of XXX  
amending the Annex t o Regulation (EU) No 231/2012 laying down s pecifications for food 
additives listed in Annexes II  and III to Regulation (EC) No 13 33/2008 of the European 
Parliament and of the Council as regards specifications for cer tain sorbitan esters (E 491 
Sorbitan monostearate, E 492 Sorb itan tristearate and E 495 Sor bitan monopalmitate) 
(Text with EEA relevance) 
  
EN 1  EN COMMISSION REGULATION (EU) …/… 
of XXX  
amending the Annex to Regulation (EU) No 231/2012 laying down s pecifications for food 
additives listed in Annexes II and III to Regulation (EC) No 13 33/2008 of the European 
Parliament and of the Council as  regards specifications for cer tain sorbitan esters (E 491 
Sorbitan monostearate, E 492 Sor bitan tristearate and E 495 Sor bitan monopalmitate) 
(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 P arliament and of the 
Council of 16 December 2008 on food additives1, and in particular Art icle 14 thereof, 
Having regard to Regulation (EC) No 1331/2008 of the European P arliament and of the 
Council of 16 December 2008 establishing a common authorisation  procedure for food 
additives, food enzymes and food flavourings2, and in particular Article 7(5) thereof, 
Whereas: (1) Commission Regulation (EU) No 231/2012
3 lays down specifications for food 
additives listed in Annexes II a nd III to Regul ation (EC) No 13 33/2008. 
(2) Those specifications may be updated in accordance with the comm on procedure 
referred to in Article 3(1) o f Regulation (EC) No 1331/2008, ei ther on the initiative of 
the Commission or following an application. 
(3) On 14 October 2014 an application was submitted for the amendme nt of specifications 
concerning the food additives sorbitan monostearate (E491), sor bitan tristearate 
(E492) and sorbitan monopalmitate (E495). The application was m ade available to the 
Member States pursuant to Art icle 4 of Regulation (EC) No 1331/ 2008.  
(4) The current Union specifications lay down a range of congealing  temperatures (an 
identification parameter) for sorbitan monostearate (E491), sor bitan tristearate (E492) 
and sorbitan monopalmitate (E495).  
(5) The applicant requests that the reference to the congealing ran ge as an identification 
method of sorbitan monostearate (E491), sorbitan tristearate (E 492) and sorbitan 
monopalmitate (E495) in the Union specifications be removed as it is not an optimal 
method for identification due t o a lack of a clear and common m ethodology. 
(6) In its opinion of 5 May 20174 the European Food Safety A uthority (‘the Authority’) 
concluded that the amendment to the specifications as regards t he removal of the 
                                                 
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 13 33/2008 of the European Parliament and 
of the Council (OJ L 83, 22.3.2012, p. 1).  
EN 2  EN parameter ‘congealing range’ for identification of sorbitan mon ostearate (E491), 
sorbitan tristearate (E492) and sorbitan monopalmitate (E495) a s proposed by the 
applicant would not give ris e to a safety concern.  
(7) The Authority also concluded that the removal of the congealing  range from the Union 
specifications would result in less characterisation of the var ious sorbitan esters of 
saturated fatty acids, and that this identification parameter c ould be replaced by 
another one. The Authority noted that out of all analytical met hods available, gas 
chromatography analysis appears to deliver the most accurate an d reliable results and 
is fit for purposes of food controls. 
(8) Consequently, it is appropriate  to amend the Union specificatio ns regarding the 
removal of the ‘congealing range’ as an identification paramete r for the food additives 
sorbitan monostearate (E491), so rbitan tristearate (E492) and s orbitan monopalmitate 
(E495) and to replace it by 'Iden tification test - by acid valu e, iodine value, gas 
chromatography'. 
(9) The Annex to Regulation (EU) No 231/2012 should therefore be am ended 
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 
The Annex to Regulation (EU) No 231/2012 is amended in accordan ce with the Annex to this 
Regulation. 
Article 2 
This Regulation shall enter into force on the twentieth day fol lowing that of its publication in 
the Official Journal of  the European Union . 
This Regulation shall be binding i n its entirety and directly a pplicable in all Members States. 
Done at Brussels, 
 For the Commission 
 The President  Jean-Claude JUNCKER 
                                                                                                                                                         
4 EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sour ces added to food), 2017. 
Scientific Opinion on the re-evaluation of sorbitan monostearat e (E 491), sorbitan tristearate (E 492), 
sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and s orbitan monopalmitate (E 495) when 
used as food additives. EFSA Journal 2017;15(5):4788, 56 pp. ht tps://doi.org/10.2903/j.efsa.2017.4788