COMMISSION REGUL ATION (EU) 2016/691 
of 4 May 2016 
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the 
Council as regards the use of food additiv es in edible caseinates 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d 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 Article 10(3) thereof, 
Whereas: 
(1)  Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives appro ved for use in foods 
and their conditions of use. 
(2)  That list may be amended in accordance with the common procedure refer red to in Article 3(1) of Regulation 
(EC) No 1331/2008 of the European Parliament and of the Council (2), either on the initiative of the Commission 
or following an application. 
(3)  Directive (EU) 2015/2203 of the European Parliament and of the Council (3) provides a list of food additives that 
may be used in edible caseinat es. That Directive is a recast of Council Directive 83/417/EEC (4) relating to certain 
lacto protein s (caseins and caseinates) intended for human consum ption. 
(4)  Directive (EU) 2015/2203 provides clarity as regar ds the classif ication of certain substances in edible caseinat es 
whic h are considered food additives. The provisions on food additives in Directive (EU) 2015/2203 should be 
reflected in Annex II to Regulation (EC) No 1333/2008. 
(5)  Edible caseinates belong to dair y products. However , that group is not specif ied in Annex II to Regulation (EC) 
No 1333/2008. Theref ore, a food categor y ‘Edible caseinat es’ should be established and the additives author ised 
in edible caseinat es should be included 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 
those additives constitut es an updat e of the Union list which is not liable to have an effect on human health. 
Theref ore, it is not necessar y to seek the opinion of the European Food Safety Author ity. 
(7)  Annex II to Regulation (EC) No 1333/2008 should be amended according ly. 
(8)  The measures provided for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 5.5.2016 L 120/4 Official Jour nal of the European Union EN     
(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 author is­
ation 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 appro ximation of the laws of the 
Member States relating to caseins and caseinates intended for human consump tion 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 appro ximation of the laws of the Member States relating to certain lactoproteins 
(caseins and caseinates ) inten ded for human consump tion (OJ L 237, 26.8.1983, p. 25). HAS ADOPTED THIS REGUL ATION: 
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 all Member State s. 
Done at Brussels, 4 May 2016. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  5.5.2016 L 120/5 Official Jour nal of the European Union EN     ANNEX 
Annex II to Regulation (EC) No 1333/2008 is amended as follows:  
(1) in Part D, the following entr y is inser ted after the entr y for food catego ry ‘01.8 Dair y analogues, including beverage whit eners’ : 
‘01.9 Edible caseinat es’   
(2) in Part E, the following entr y is inser ted after the last entr y for food categor y ‘01.8 Dair y analogues, including beverag e whit eners’ : 
‘01.9 Edible caseinat es  
E 170 Calcium carbonate quantum satis    
E 331 Sodium citrates quantum satis    
E 332 Potassium citrate s quantum satis    
E 333 Calcium citrates quantum satis    
E 380 Triammonium citrate quantum satis    
E 500 Sodium carbonates quantum satis    
E 501 Potassium carbonate s quantum satis    
E 503 Ammonium carbonates quantum satis    
E 504 Magnesium carbonates quantum satis    
E 524 Sodium hydroxide quantum satis    
E 525 Potassium hydroxide quantum satis    
E 526 Calcium hydroxide quantum satis    
E 527 Ammonium hydroxide quantum satis    
E 528 Magnesium hydroxide quantum satis ’     5.5.2016 L 120/6 Official Jour nal of the European Union EN