COMMISSION REGUL ATION (EU) No 506/2014 
of 15 May 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 regards Ethyl lauro yl 
arginate as a preser vativ e in certain heat-treated meat products 
(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), Article 14 and Article 30(5) thereof, 
Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 
establishing a common author isation procedure for food additives, food enzymes and food flavouri ngs (2), and in par­
ticular Article 7(5) 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)  Commission Regulation (EU) No 231/2012 (3) lays down specifications for food additives listed in Annex es II 
and III to Regulation (EC) No 1333/2008. 
(3)  The Union list and the specifications may be updat ed in accordance with the common procedure referred to 
in Article 3(1) of Regulation (EC) No 1331/2008 either on the initiative of the Commission or following an 
application. 
(4) On 5 May 2006, an application was submitted for author isation of the use of Ethyl lauro yl arginate as a preser va­
tive in several food categor ies. The application was made available to the Member States pursuant to Article 4 of 
Regulation (EC) No 1331/2008. 
(5)  Subsequently , in Apr il of 2007 the European Food Safe ty Author ity (the Author ity) evaluated the safety of the 
use of Ethyl lauro yl arginate as a food preser vative and allocat ed an Accept able Daily Intake (ADI) of 0,5 mg/kg 
body weight (4). Conser vative estimat es of exposure to the substance, both in adults and in children, sugges ted 
that it was likely that the ADI would be excee ded at the maximum proposed use levels for several food 
catego ries. 
(6)  Follo wing these conclusions, the applicant revised its uses and use levels and requested an author isation of the 
use in heat-treate d meat products. In July 2013 the Author ity published a statement on a refined exposure assess ­
ment of Ethyl lauro yl arginate based on its revised proposed uses as a food additive (5), and concluded that the 
exposure for all population groups is belo w the Acceptable Daily Intake (ADI) of 0,5 mg/kg bw/da y. 
(7)  There is a technological need to use Ethyl lauro yl arginate as a preser vative in heat-treate d meat products in order 
to improve the microbiological quality of those food products, including inhibiting the growth of harmful micro- 
organisms such as Lister ia monocytog enes. As the use of Ethyl lauro yl arginate in heat treated meat products will 
help maintaining their quality and safety , it is appropr iate to author ise its use in heat-treate d meat products and 
to assign number E 243 to that food additive. 16.5.2014 L 145/35 Official Jour nal of the European Union EN     
(1)OJ L 354, 31.12.2008, p. 16. 
(2)OJ L 354, 31.12.2008, p. 1. 
(3)Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specificatio ns 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). 
(4)The EFSA Jour nal (2007) 511, p. 1. 
(5)EFSA Jour nal 2013;11(6):3294. (8)  The specifi cations for Ethyl lauro yl arginate (E 243) should be included in Regulation (EU) No 231/2012 when it 
is included in the Union list of food additives laid down in Annex II to Regulation (EC) No 1333/2008 for the 
first time. 
(9)  Regulations (EC) No 1333/2008 and (EU) No 231/2012 should theref ore be amended according ly. 
(10)  The measures provided for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
the Food Chain and Animal Health, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with 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. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 15 May 2014. 
For the Commission 
The Presid ent 
José Manuel BARR OSO  16.5.2014 L 145/36 Official Jour nal of the European Union EN     ANNEX I 
Annex II to Regulation (EC) No 1333/2008 is amended as follows: 
(1)  In Part B, point 3 ‘Additives other than colours and sweet eners ’, the following new entr y is inser ted after the entr y 
for ‘E 242 Dimethyl dicarbonate’: 
‘E 243 Ethyl lauro yl arginat e’  
(2)  In Part E, in food categor y 08.2.2 ‘Heat treated processed meat’, the following new entr y is inser ted:  
‘E 243 Ethyl lauro yl 
arginate 160  Except emulsifi ed 
sausages, smoked 
sausages and liver 
paste’    
ANNEX II 
In the Annex to Regulation (EU) No 231/2012, the following new entr y is inser ted after the specif ications for food addi ­
tive E 242: 
‘E 243 ETHYL LAUROYL ARGINA TE 
Synon yms Laur ic arginat e ethyl ester; lauramide arginine ethyl ester; ethyl- Να-lauro yl-L-ar gina ­
te·HCl; LAE; 
Def inition Ethyl lauro yl arginate is synthesized by esterifying arginine with ethanol, followed by 
reacting the ester with lauro yl chlor ide. The resultant ethyl lauro yl arginate is reco v­
ered as the hydrochlori de salt, which is filtered and dried. 
ELINCS 434-630-6 
Chemical name Ethyl -Να-dodecano yl-L-argina te·HCl 
Chemical formula C20H41N4O3Cl 
Molecular Weight 421,02 
Assa y Not less than 85 % and not more than 95 % 
Descr iption White powder 
Identif ication  
Solubility Freely soluble in water , ethanol, prop ylene glycol and glycerol 
Purity  
Να-Lauro yl-L-arginine Not more than 3 % 
Laur ic acid Not more than 5 % 
Ethyl laurat e Not more than 3 % 
L-Arginine·HCl Not more than 1 % 
Ethyl arginat e·2HCl Not more than 1 % 
Lead Not more than 1 mg/kg 
Arsenic Not more than 3 mg/kg 
Cadmium Not more than 1 mg/kg 
Mercur y Not more than 1 mg/kg’   16.5.2014 L 145/37 Official Jour nal of the European Union EN