EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10263/2018 CIS Rev. 1 
(POOL/E2/2018/10263/10263R1 -EN 
CIS.doc)  
[…](2018) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
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 
Cochineal, Carminic acid, Carmines (E 120)  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
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 
Cochineal, Carminic acid, Carmines (E 120)  
(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 Article 
14 thereof,  
Where as: 
(1) Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives 
approved for use in food and their conditions of use.  
(2) Commission  Regulation (EU) No 231/20122 lays down specifications for food 
additives that are listed in Annexes II an d III to Regulation (EC) No 1333/2008.  
(3) Cochineal, Carminic acid, Carmines (E 120)  is a substance authorised as a colour  in a 
variety of foods 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 additiv es is laid down in 
Commission Regulation (EU) N o 257/20103, according to which the re -evaluation of 
colours  had to be completed by 31 December 2015.  
(6) On 18 November  2015 the Authority delivered a Scientific Opinion on the re -
evaluation of cochineal, carminic acid, carmines (E 120) as a food additive4. The 
Authority concluded  that the present dataset d id not give reason s to revise the 
Acceptable Daily Intake (ADI) value for E 120 and that the r efined exposure estimates  
were below the ADI for all popula tion groups . However, the Authority recommend ed 
to revis e the current title ‘ Cochineal, Carminic acid, Carmines’ , so that it  would more 
accurately reflect the material used  as a food additive and to update the specifications 
                                                 
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 Parl iament and of the Council on food additives (OJ L 80, 26.3.2010, p. 19).   
4 EFSA Journal 2015 ; 13(11):4288 . EN 2  EN as regards  the percentage of ma terial not accounted for, the maximum limits for toxic 
elements and the presence of proteinaceous compounds.  
(7) 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 proced ure referred to 
in Regulation (EC) No 1331/2008 of the European P arliament and of the Council5. 
(8) 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 followi ng an 
application.  
(9) It is therefore appropriate to amend Annex II to Regulation (EC) No 1333/2008 and 
the Anne x to Regulation (EU) No 231/2012.  
(10) A reasonable period should be allowed to elapse before the amendment s become 
applicable in order to permit food business operators to meet the new requirements 
laid down in this Regulation.  
(11) 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  
In Annex II to Regulation (EC) No 1333/2008 whenever a reference is made to ‘E 120 
Cochineal, Carminic acid, Carmines’ it shall be  replaced by ‘E 120 Carminic acid, Carmine’ . 
Article 2  
The Annex to Regulation ( EU) No 231/2012 is amended in accordance with the Annex  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 . 
It shall apply from [Office o f Publi cation please insert the date: 12  months after entry into 
force.] XX XXXX XXXX.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER  
                                                 
5 Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 
establishing a common authorisation procedure for f ood additives, food enzymes and food flavourings 
(OJ L 354, 31.12.2008, p. 1).