EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/XXXX/2016 -ENXXXX  
[…](2017) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and III 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 calcium sorbate (E 203)  
(Text with EEA relevance)   EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending  Annexes II and III 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 calcium sorbate (E 203)  
(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 additives1, and in particular Article 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) Annex III to Regulation (EC) No 1333/2008 lays down a Union list of food additives 
approved for use in food additives, food enzymes, food flavourings, nutrients and their 
conditions of use.  
(3) Commission Regulation (EU) No 231/20122 (2) lays down specifications for food 
additives that are listed in Annexes II and III to Regulation (EC) No 1333/2008.  
(4) Calcium sorbate  (E 203) is a substance authorised as a preservative in a variety of 
foods, as well as in food colour preparations and food flavourings, in accordance with 
Annex es II and III to Regulation (EC) No 1333/2008.    
(5) 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’).  
(6) For that purpose, a program for the re -evaluation of food additi ves is laid down in the 
Commission Regulation (EU) No 257/20103. Pursuant to Regulation (EU) No 
257/2010 the re -evaluation of preservatives  had to be completed  by 31 December 
2015.  
(7) On 30 June 2015 the Authority delivered a Scientific Opinion on the re -evaluation of 
sorbic acid (E 200), potassium sorbate (E 202) and calcium sorbate (E 203) as food 
                                                 
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).  EN 3   EN additives4. The opinion stated that  there was a lack of genotoxicity data on calcium 
sorbate . Consequent ly the authority was not able to confirm  the safety of calcium 
sorbate as a food additive and concluded that this substance should be excluded from 
the group Acceptable Daily Intake (ADI) defined for sorbic acid (E 200) and 
potassium sorbate (E 202). The o pinion stated that genotoxicity studies on calcium 
sorbate need to be performed in order to consider including calcium sorbate in that 
group ADI.  
(8) On 10 June 2016 the Commission launched a public call for scientific and 
technological data on the permitted f ood additives sorbic acid (E 200), potassium 
sorbate (E 202) and calcium sorbate (E 203)5, targeting the data needs identified by the 
Authority in the Scientific Opinion  on the re -evaluation of these sub stances . The call 
invited business operators  interested in the continuity of approval of calcium sorbate 
as a food additive to inform the Commission by 25 November 2016 whether they 
would formally commit to providing the requested genotoxicity data and when those 
data would be available for their ev aluation by the Authority.  However, no  business 
operator  committed to providing the requested genotoxicity data for calcium sorbate 
(E 203). Without those data the Authority cannot complete the re -evaluation  of the 
safety of calcium sorbate  as a food additive and consequently it cannot be determined 
whether this substance still fulfils the conditions pursuant to Article 6(1) of Regulation 
(EC) No 1333/2008  for inclusion in the Union list of approved  food additives.  
(9) It is therefore appropriate to remove calcium sorbate (E 203)  from the Union list of 
approved food additives.   
(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 Council6.   
(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) Therefor e, Annexes II and III to Regulation (EC) No 1333/2008 and the Annex to 
Regulation (EU) No 231/2012 should be amended by removing calcium sorbate (E 
203) from the Union list of authorised food additives since due to the absence of 
appropriate genotoxicity d ata its inclusion in the list can no longer be justified.  
(13) It is appropriate to allow for an arrangement for foods containing calcium sorbate  (E 
203) that have been lawfully placed on the market before the entry in force of this 
Regulation.  
(14) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
                                                 
4  EFSA Journal 2015;13(6):4144  
5  http://ec.europa.eu/food/safety/food_improvement_agents/additives/re -evaluation_en  
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  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex es II and III to Regulation (EC) No 1333/2008 are amended in accordance with the 
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.  
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 . 
Article  4 
Foods containing calcium sorbate  (E 203) that have been lawfully placed on the market before 
the entry into for ce 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,  xx xxxx xxxx  
 For the Commission  
 The President  
 Jean -Claude JUNCKER