II 
(Non-legislative acts) 
REGUL ATIONS 
COMMISSION REGUL ATION (EU) 2018/1472 
of 28 September 2018 
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, 
Car minic acid, Car mines (E 120) 
(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) and Article 14 thereof, 
Whereas: 
(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 231/2012 (2) lays down specifi cations for food additives that are listed in 
Annex es II and III to Regulation (EC) No 1333/2008. 
(3)  Coch ineal, Carminic acid, Carmines (E 120) is a substance author ised 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 Januar y 2009 are subject to a new risk assessment by the European Food Safety Author ity 
(‘the Author ity’). 
(5)  For that purpose, a program for the re-evaluation of food additives is laid down in Commission Regulation (EU) 
No 257/2010 (3), according to whic h the re-evaluation of colours had to be compl eted by 31 December 2015. 
(6)  On 18 Novem ber 2015 the Auth ority delivered a Scientific Opinion on the re-evaluation of cochineal, carminic 
acid, carmines (E 120) as a food additive (4). The Author ity concluded that the present dataset did not give 
reasons to revise the Acceptable Daily Intak e (ADI) value for E 120 and that the refined exposure estimates were 
below the ADI for all population groups. Howe ver, the Author ity recommended to revise the current title 
‘Cochi neal, Carminic acid, Carmines’, so that it would more accurate ly reflect the mater ial used as a food additive 
and to updat e the specifi cations as regards the percentage of mater ial not account ed for, the maximum limits for 
toxic elements and the presence of prote inaceous compo unds. 3.10.2018 L 247/1 Official Jour nal of the European Union EN     
(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 Parliament and of the Council on food additives (OJ L 80, 26.3.2010, 
p. 19). 
(4)EFSA Journal 2015; 13(11):4288. (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 procedure referred to in Regulation (EC) No 1331/2008 of the European 
Parliament and of the Council (1). 
(8)  Article 3(1) of Regulation (EC) No 1331/2008 provi des that the Union list of food additives may be updat ed 
either on the initiative of the Commission or followi ng an application. 
(9)  It is theref ore appropr iate to amend Annex II to Regulation (EC) No 1333/2008 and the Annex to Regulation 
(EU) No 231/2012. 
(10)  A reasonable period should be allowed to elapse before the amendments become applicable in order to permit 
food business operat ors to meet the new requirements laid down in this Regulation. 
(11)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
In Annex II to Regulation (EC) No 1333/2008 whenever a reference is made to ‘E 120 Coc hineal, 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 followi ng that of its publication in the Official Journal of the 
European Union. 
It shall apply from 23 October 2019. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 28 September 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  3.10.2018 L 247/2 Official Jour nal of the European Union EN     
(1)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 flavourings (OJ L 354, 31.12.2008, p. 1). ANNEX 
In the Annex to Regulation (EU) No 231/2012 the entr y for ‘E 120 Coch ineal, Carminic acid, Carmines’ is replaced by 
the follo wing: 
‘E 120 CARMINIC ACID, CARMINE 
Synon yms CI Natural Red 4 
Def inition Carminic acid is obtained from aqueous, aqueous alcoholic or alcoholic ex­
tracts from Cochineal, which consists of the dried bodies of the female insect 
Dactylopius coccus Costa. 
Carmines are aluminium lakes of carminic acid in which aluminium and carmi­
nic acid are thought to be present in the molar ratio 1:2. 
The colour ing principle is carminic acid. Minor amounts of its aminat ed form 
4-aminocar minic acid may also be present. 
In commercial products the colour ing principle carminic acid may be present 
in association with ammonium, calcium, potassium or sodium cations, sing ly 
or in combination, and these cations may also be present in excess. Commer ­
cial products may also contain protein aceous mate rial derived from the source 
insect. 
Colour Index No 75470 
Einecs Carminic acid: 215-023-3; carmines: 215-724-4 
Chemical name 7-β-D-g lucop yranosyl-3,5,6,8-tetr ahydro xy-1-methyl-9,10-dio xoanthracene-2- 
carbo xylic acid (carminic acid); carmine is the hydrat ed aluminium chelate of 
this acid 
Chemical formula C22H20O13 (carminic acid) 
Molecular weight 492,39 (carminic acid) 
Assa y Content not less than 90 % carminic acid; not less than 50 % carminic acid in 
the chelat es. 
Descr iption Red to dark red, friable, solid or powder 
Identif ication  
Spectrometr y Carminic acid: 
Maximum in aqueous ammonia solution at ca. 518 nm 
Maximum in dilut e hydroch loric solution at ca. 494 nm 
E 1 %/1 cm 139 at peak around 494 nm in dilute hydroc hlor ic acid 
4-aminocar minic acid: 
Maximum in aqueous ammonia solution at 535 nm 
Maximum in dilut e hydroch loric solution at 530 nm 
E 1 %/1 cm 260 at peak around 535 nm in aqueous ammonia solution, 
pH 9,5 
In commercial products carminic acid may be differ entiated from its amine by 
HPLC 
Purity  
Solvent residues Ethanol: 
Methanol: Not more than 150 mg/kg 
Not more than 50 mg/kg 
Total ash Carminic acid: 
Carmine: Not more than 5 % 
Not more than 12 % 
Prote in (N × 6,25) Carminic acid: 
Carmine: Not more than 2,2 % 
Not more than 25 % 
4-aminocar minic acid Not more than 3 % relative to carminic acid 3.10.2018 L 247/3 Official Jour nal of the European Union EN     Matte r insoluble in dilut e ammonia Carmine: Not more than 1 % 
Arsenic Not more than 1 mg/kg 
Lead Not more than 1,5 mg/kg 
Mercur y Not more than 0,5 mg/kg 
Cadmium Not more than 0,1 mg/kg 
Microbiological criter ia  
Salmonella spp. Absent in 10 g  
Aluminium lakes of this colour may be used.’  3.10.2018 L 247/4 Official Jour nal of the European Union EN