COMMISSION REGUL ATION (EU) 2015/639 
of 23 Apr il 2015 
amending Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the 
Council as regards the use of silicon dioxide (E 551) in polyvin yl alcohol-poly ethy lene glycol-g raf t- 
co-polymer (E 1209) 
(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 III to Regulation (EC) No 1333/2008 lays down a Union list of food additives appro ved for use in food 
additives, food enzymes, flavourings, nutr ients and their conditions of use. 
(2)  That list may be updated 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)  Commission Regulation (EU) No 685/2014 (3) author ises the use of polyviny l alcohol-polyeth ylene glycol-g raft- 
co-polymer (PVA-PEG graft co-polymer) (E 1209) in food supplements in solid form. 
(4)  In order to impro ve the flow proper ties of the polymer powder , silicon dioxide (E 551) is used in PVA-PEG graft 
co-polymer . The expect ed carry-over of silicon dioxide in the final food via the use of PVA-PEG graft co-polymer 
is 300-500 mg/kg. At this level silicon dioxide has no technological function in the food supplement. 
(5)  The European Food Safety Authority evaluated the safet y of PVA-PEG graft co-polymer when used as a food 
additive and concluded that its use in food supplements as film coating is of no safety concer n for the proposed 
uses (4). The safet y assessment also included the specifi ed use of silicon dioxide in PVA-PEG graft co-polymer . 
(6)  It is theref ore appropr iate to author ise the use of silicon dioxide in PVA-PEG graft co-polymer . 
(7)  Part 2 of Annex III to Regulation (EC) No 1333/2008 should theref ore 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, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Part 2 of Annex III to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation. 24.4.2015 L 106/16 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 i­
sation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1). 
(3)Commission Regulation (EU) No 685/2014 of 20 June 2014 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 regar ds polyvinyl alcohol-polyeth ylene 
glycol-graf t-co-polymer in solid food supplements (OJ L 182, 21.6.2014, p. 23). 
(4)EFSA Jour nal 2013; 11(8):3303. 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, 23 Apr il 2015. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER   
ANNEX 
In Part 2 of Annex III to Regulation (EC) No 1333/2008 the following entr y is inser ted after the third entr y for food 
additive E 551: 
‘E 551 Silicon dioxide 5 000 mg/kg in the preparation E 1209 polyviny l alcohol-polyeth ylene 
glycol-g raft-co-polymer ’   24.4.2015 L 106/17 Official Jour nal of the European Union EN