EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12445/2015 
(POOL/E2/2015/12445/12445 -EN.doc) 
D043699/03  
[…](2016) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of 
the Council as regards the use of food additives in edible caseinates  
(Text with EEA relevance)    
EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of 
the Council as regards the use of food additives in edible caseinates  
(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 13 33/2008 of the European Parliament and of the 
Council of 16 December 2008 on food additives1, and in particular Article 10(3) 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) That list may be amended in accordance with the common procedure referred to in 
Article 3(1) of Regulation (EC) No 1331/2008  of the European Parliament and of the 
Council2, either on the initiative of the Commission or following an  application.  
(3) Directive (EU) 2015/2203  of the European Parliament and of the Council3 provides a 
list of food additives that may be used in edible caseinates. That Directive is a recast of 
Council Directive 83/4174 relating to certain lactoproteins (casein s and caseinates) 
intended for human consumption.  
(4) Directive (EU) 2015/2203 provides clarity as regards the classification  of certain 
substances in edible caseinates which are considered food additives. The  provisions on  
food additives in Directive (EU) 201 5/2203 should be reflected in Annex II to 
Regulation (EC) No 1333/2008.   
(5) Edible caseinates belong to dairy products. However, t hat group is not specified  in 
Annex II to Regulation (EC) No 1333/2008. Therefore, a food category 'Edible 
caseinates ' should be established and the additives authorised in edible caseinates 
should be in cluded  with the respective conditions of use.  
(6) The transfer will ensure  legal clarity  and does not introduce new uses of food 
additives. The extended use of th ose additives  constitutes an update of the Union list 
                                                 
1 OJ L 354, 31.12.2008, p. 16.  
2 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 ). 
3 Directive (EU) 2015/2203 of the European Parliament and of the Council of 25 November 2015 on the 
approximation of the laws of the Member States relating to caseins and caseinates intended for human 
consumption and repealing Council Directive 83/417/EEC  (OJ L 314, 1.12.2015, p. 1 ). 
4 Council  Directive 83/417/EEC  of 25 July  1983 on the approximation of the laws of the Member States 
relating to certain lactoproteins (caseins and caseinates) intended for human consumption (OJ L 237, 
26.8.1983, p. 25) .  
EN 3   EN which is not liable to have an effect on human health. Therefore, it is not necessary to 
seek the opinion of the European Food Safety Authority.  
(7) Annex II to Regulation (EC) No 1333/2008 should be amended accordingly . 
(8) 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  
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the  Annex to this 
Regulation.  
Article  2 
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 al l Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude J UNCKER