COMMI SSION REGUL ATION (EU) 2020/771 
of 11 June 2020 
amending Annexes II and III 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 the use of Annatto, 
Bixin, Norbixin (E 160b) 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng 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 foods and 
their conditions of use. 
(2) 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, food flavourings, nutr ients and their conditions of use. 
(3) Commission Regulation (EU) No 231/2012 (2) lays down specific ations for food additives that are listed in Annex es 
II and III to Regulation (EC) No 1333/2008. 
(4) The Union lists of food additives and the specifi cations may be updat ed 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 (3), 
either on the initiative of the Commission or follo wing an application. 
(5) Annatto, Bixin, Norbixin (E 160b) is a substance author ised as a colour in a variety of foods in accordance with 
Annex II to Regulation (EC) No 1333/2008. 
(6) Annatto, Bixin, Norbixin (E 160b) is extract ed from the seeds of the annatt o tree (Bixa orellana L.) and confer s a 
yellow to red colour to food. The main pigments in annatt o extracts are bixin and norbixin. In spite of their 
similar ity in structure, bixin and norbixin have significantly differ ent physico-chemical proper ties and, theref ore, 
differ ent applications depending on the charact eristics of the food matr ix. 
(7) 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 Authority (‘the 
Authority’). Commission Regulation (EU) No 257/2010 (4) provides that the re-evaluation of food colours had to be 
compl eted by 31 December 2015. 
(8) On 4 Apr il 2008, an application was submitted for the author isation of the use of five new annatto extracts 
catego rised as bixin- or norbixin-based, with a view to replacing the currently author ised annatto extracts (E 160b). 
The application included new proposed uses and use levels for bixin and norbixin separat ely, while current uses and 
use levels are listed for a sing le food additive (Annatt o, Bixin, Norbixin (E 160b)). The proposed uses and use levels 
for bixin and norbixin concer n the food categor ies in whic h Annatto, Bixin, Norbixin (E 160b) is currently 
author ised, as well as a few additional food categor ies in which Annatto, Bixin, Norbixin (E 160b) is currently not 
author ised, but other food colours are already author ised. 
(1)OJ L 354, 31.12.2008, p. 16. 
(2)Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specificat ions 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)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). 
(4)Commission Regulation (EU) No 257/2010 of 25 March 2010 setting up a 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). EN Offi cial Jour nal of the European Union 12.6.2020                                                                                                                                         L 184/25   (9) Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the Author ity 
in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008 and the 
specifi cations set out in the Annex to Regulation (EU) No 231/2012, excep t where the update in question is not 
liable to have an effect on human health. 
(10) On 19 May 2008, the Commission requeste d the Author ity to evaluate the safety of the five new annatto extracts, at 
the proposed uses and use levels. Upon analysis of the application, the Authority identif ied major data gaps and 
indicated that new toxicological studies would be needed. Consequently , the Commission decided on 14 Januar y 
2011 that the safety evaluation of the five new extracts would be carried out as a part of the re-evaluation of 
Annatto, Bixin, Norbixin (E 160b), as provided for by Regulation (EU) No 257/2010. 
(11) On 24 August 2016, the Authority issued a scientifi c opinion on the safety of annatto extracts (E 160b) as a food 
additive (5). As regards the annatt o extracts currently author ised the Author ity concluded that the safet y of their use 
within the specifi cations defined in Regulation (EU) No 231/2012 (solvent-extracte d bixin and norbixin, alkali- 
extract ed annatto and oil-extract ed annatto) could not be assessed due to lack of data, both in terms of identif ication 
and toxicological studies. As regar ds the new annatto extracts and, in particular , aqueous-processed bixin (Annatto 
E), the Author ity could not conclude on its safety due to equiv ocal genot oxicity results. For the four remaining new 
extracts (‘solvent-extracted bixin’, ‘solvent-extract ed norbixin’, ‘alkali-processed norbixin, acid-precipitated’ and 
‘alkali-processed norbixin, not acid-precipitated’), the Auth ority indicated that they should compl y with the 
specifi cations recommended in the scientific opinion. Finally , the Auth ority derived an acceptable daily intake (ADI) 
of 6 mg bixin/kg body weight (bw) per day and an ADI of 0,3 mg norbixin/kg bw per day. Exposure estimat es linke d 
to the proposed uses and use levels for bixin were below the ADI for all population groups and for the two refined 
exposure scenar ios (brand-lo yal and non-brand-lo yal exposure scenar ios). Howe ver, for norbixin, those estimat es 
exceed ed the ADI at the high level (95th percentile) for infants, toddle rs and children in the refined brand-lo yal 
exposure scenar io. 
(12) Following the publication of this scientifi c opinion, the Commission requeste d from the applicant some 
clarifications about the request ed uses and maximum use levels of bixin and norbixin. Based on this, on 
16 Febr uary 2017, the applicant submitted to the Commission modifi cations to the original application, such as a 
remo val of some of the request ed new uses and a modification of some of the request ed use levels. On 2 March 
2017, the Commission request ed the Author ity for technical assistance as rega rds the estimation of the exposure to 
bixin and norbixin on the basis of the revised uses and use levels proposed by the applicant. 
(13) As requeste d, on 10 August 2017, the Author ity published a statement on the exposure assessment of bixin and 
norbixin (6) as regards those revised uses and use levels. It concluded that the dietar y exposure for bixin did not 
exceed the ADI in any exposure scenar io. However , it concluded that the dietar y exposure for norbixin exce eded the 
ADI at the high level (95th percentile) for toddle rs and children in the two refined exposure scenar ios (brand-lo yal 
and non-brand-lo yal exposure scenar ios). 
(14) On 30 August 2017, the applicant submitted data from a new genoto xicity study for Annatto E. 
(15) Taking into account the outcome of the exposure assessment published by the Author ity on 10 August 2017, the 
applicant revised again the proposed uses and uses levels for bixin and norbixin, and submitted to the Commission 
on 20 July 2018 three alternati ve scenar ios of uses and use levels. 
(16) On 1 August 2018, the Commission request ed the Auth ority to carry out an evaluation on the new genoto xicity 
data for Annatto E generat ed by the applicant and to indicate whether it is possible to conclude on the safety of this 
annatto extract. The Auth ority was also request ed to carry out a new exposure assessment for bixin and norbixin, on 
the basis of the revised uses and use levels of bixin and norbixin submitted by the applicant in the form of three 
alternati ve scenar ios. 
(17) On 13 March 2019, the Author ity published a scientifi c opinion on the safet y of Annatto E and the exposure to 
bixin and norbixin (7). As regar ds the safety of Annatto E, the Authority concluded that it does not raise concer n for 
genoto xicity and it stated that the ADIs established in 2016 for bixin and norbixin can be applied also to Annatto E. 
As regar ds the exposure at the revised uses and use levels submitted by the applicant on 20 July 2018, for bixin, the 
(5)EFSA Journal 2016;14(8):4544. 
(6)EFSA Journal 2017;15(8):4966. 
(7)EFSA Journal 2019;17(3):5626. EN Offi cial Jour nal of the European Union L 184/26                                                                                                                                         12.6.2020   Authority stated that none of the exposure estimates exceeded the ADI of 6 mg/kg bw per day. For norbixin, the 
Authority found that the ADI was reached at the high level (95th percentile) for todd lers in the two refined 
exposure assessment scenar ios but only in one countr y. Howe ver, consider ing the uncer tainties and the very likely 
overestimation of the exposure, the Author ity concluded that the level of exposure does not raise a health concer n 
for any of the three scenar ios of uses and use levels for bixin and norbixin. 
(18) It results from the above considerations that it is appropr iate to amend the Annex es to Regulation (EC) No 
1333/2008. First, since Annatto bixin (E 160b(i)) and Annatto norbixin (E 160b(ii)) have different toxicological 
proper ties and, theref ore, differ ent ADIs, the food additive ‘Annatto, Bixin, Norbixin (E 160b)’ should be delet ed 
from the Union list of author ised food additives in Part B of Annex II to that Regulation and two separate food 
additives, namely Annatto bixin (E 160b(i)) and Annatto norbixin (E 160b(ii)) should be listed. As a consequence, 
the author ised uses and conditions of use for the food additive ‘Annatto, Bixin, Norbixin (E 160b)’ should be deleted 
from the list of author ised conditions of use in food in Part E of Annex II to Regulation (EC) No 1333/2008, and any 
referen ces to it contained in the Annex es to the Regulation should be replaced by references to the two new food 
additives. As regards these two new additives, their author ised uses and use levels should be laid down. On the basis 
of the Auth ority’s assessments refer red to abov e, the uses as requested by the applicant on its last revision of the 
application should be author ised but only at the levels used in the third, and most conser vative, use and use levels 
scenar io thereof. 
(19) Regulation (EU) No 231/2012 should also be amended. On the one side, the three annatt o extracts referred to 
therein (‘solvent-extracte d bixin and norbixin’, ‘alkali-extracted annatto and oil-extract ed annatt o’) should no long er 
be author ised, since their safety could not be assessed, and, theref ore, their specifi cations should be delet ed. On the 
other side, the two new Annatto bixin extracts (‘solvent-extract ed bixin’ and ‘aqueous-processed bixin’) and the 
three new Annatto norbixin extracts (‘solvent-extracted norbixin’, ‘alkali-processed norbixin, acid-precipitated’ and 
‘alkali-processed norbixin, not acid-precipitat ed’) do not pose a safety concer n and specifi cations for them as 
regards each of the two new additives should be added to the Annex to that Regulation. Those specifications should 
be those recommended by the Auth ority in the scientifi c opinion on the safety of annatt o extracts (E 160b) as a food 
additive, issued on 24 August 2016. 
(20) Annex es II and III to Regulation (EC) No 1333/2008 as well as the Annex to Regulation (EU) No 231/2012 should 
theref ore be amended according ly. 
(21) Even if the annatto extracts author ised until the date of application of this Regulation should no long er be 
author ised, since their safety could not be assessed, it is very unlike ly that they would have different toxicological 
proper ties and theref ore pose a health concer n whic h would require that, with immediate effect as of the date of 
application of this Regulation, they are not at all placed on the market or remain on it. Theref ore, in order to allow 
for a smooth transition between those three extracts and the new ones, it is appropr iate to allow that during a 
transitional period both the old and the new extracts can legally be placed, and remain, on the mark et. 
(22) For the same reasons, it is also appropr iate that foods containing the annatt o extracts author ised until the date of 
application of this Regulation that have been lawfully placed on the mark et before or during that transitional period 
may continue to be market ed until the existing stoc ks are exhausted. 
(23) The measures provid ed 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 
Annex es II and III to Regulation (EC) No 1333/2008 are 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. EN Offi cial Jour nal of the European Union 12.6.2020                                                                                                                                         L 184/27   Article 3 
1. Until 2 Januar y 2021, the food additive Annatto, Bixin, Norbixin (E 160b) may continue to be placed on the mark et 
as such in accordance with the rules applicable before 2 July 2020. 
2. Until 2 Januar y 2021, foods containing Annatto, Bixin, Norbixin (E 160b) which are produced and labelled in 
accordance with the rules applicable before 2 July 2020, may continue to be placed on the market. After that date, they 
may remain on the mark et until the exhaustion of stoc ks. 
Article 4 
This Regulation shall enter into force on the twentieth day followi ng 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 States. 
Done at Brussels, 11 June 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union L 184/28                                                                                                                                         12.6.2020   ANNEX I 
(1) Annex II to Regulation (EC) No 1333/2008 is amended as follows: 
(a) in point 2 of Part A, point 5 is replaced by the follo wing: 
‘5. The colours E 123, E 127, E 160b(i), E 160b(ii), E 161g, E 173 and E 180 and mixtures thereof may not be sold directly to the consumer .’ 
(b) in Part B, point 1: ‘Colours ’, the entr y for E 160b (Annatt o, Bixin, Norbixin) is replaced by the followi ng two entr ies: 
‘E 160b(i) Annatto bixin 
E 160b(ii) Annatto norbixin’   
(c) Part E is amended as follo ws: 
1) Categor y 01.4 (Flav oured fermente d milk products including heat-treate d products) is amended as follows: 
(i) the entr y for E 160b (Annatt o, Bixin, Norbixin) is replaced by the follo wing:  
‘E 160b(i) Annatto bixin 15 (94)   
E 160b(ii) Annatto norbixin 4 (94)’    
(ii) the followi ng footnote (94) is added after footnote (74): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ 
2) Categor y 01.7.2 (Ripened cheese) is amended as follo ws: 
(i) the entr ies for E 160b (Annatt o, Bixin, Norbixin) are replaced by the followi ng:  
‘E 160b(i) Annatto bixin 15 (94) only ripened orange, yello w and broke n-white cheese and red 
and green pest o cheese  
E 160b(ii) Annatto norbixin 15 (94) only ripened orange, yello w and broke n-white cheese and red 
and green pest o cheese  
E 160b(ii) Annatto norbixin 50  only red Leicester cheese  
E 160b(ii) Annatto norbixin 35  only Mimolette cheese’   
(ii) the followi ng footnote (94) is added after footnote (83): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ EN Offi cial Jour nal of the European Union 12.6.2020                                                                                                                                         L 184/29   3) Categor y 01.7.3 (Edible cheese rind) is amended as follows: 
(i) the entr y for E 160b (Annatt o, Bixin, Norbixin) is replaced by the follo wing:  
‘E 160b(i) Annatto bixin 20 (94)   
E 160b(ii) Annatto norbixin 20 (94)’    
(ii) the followi ng footnote (94) is added after footnote (67): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ 
4) Categor y 01.7.5 (Processed cheese) is amended as follows: 
(i) the entr y for E 160b (Annatt o, Bixin, Norbixin) is replaced by the follo wing:  
‘E 160b(i) Annatto bixin 15 (94)   
E 160b(ii) Annatto norbixin 8 (94)’    
(ii) the followi ng footnote (94) is added after footnote (66): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ 
5) in Categor y 01.7.6 (Cheese products (excluding products falling in cate gory 16)), the entr y for E 160b (Annatto, Bixin, Norbixin) is replaced by the followi ng:  
‘E 160b(ii) Annatto norbixin 8  only ripened orange, yellow and broke n-white products’   
6) in categor y 02.1 (Fats and oils essentially free from water (excluding anhydrous milkf at)), the entr y for E 160b (Annatt o, Bixin, Norbixin) is replaced by the following:  
‘E 160b(i) Annatto bixin 10  only fats’   
7) in cate gory 02.2.2 (Other fat and oil emulsions including spreads as defined by Council Regulation (EC) No 1234/2007 and liquid emulsions), the entr y for E 160b (Annatt o, 
Bixin, Norbixin) is replaced by the following:  
‘E 160b(i) Annatto bixin 10  excl uding reduced fat butt er’   
8) in categor y 03 (Edible ices), the entr y for E 160b (Annatt o, Bixin, Norbixin) is replaced by the follo wing:  
‘E 160b(ii) Annatto norbixin 20’     EN Offi cial Jour nal of the European Union L 184/30                                                                                                                                         12.6.2020   9) Categor y 04.2.5.2 (Jam, jellies and mar malades and sweet ened chestnut purée as defined by Directive 2001/113/EC) is amended as follo ws: 
(i) the followi ng new entr ies for E 160b(i) (Annatt o bixin) and E 160b(ii) (Annatt o norbixin) are inser ted after the entr y for E 160a (Caroten es):  
‘E 160b(i) Annatto bixin 20 (94) excep t chestnut purée  
E 160b(ii) Annatto norbixin 20 (94) excep t chestnut purée’   
(ii) the followi ng footnote (94) is added after footnote (66): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ 
10) Categor y 04.2.5.3 (Other similar fruit or vege table spreads) is amended as follows: 
(i) the followi ng new entr ies for E 160b(i) (Annatt o bixin) and E 160b(ii) (Annatt o norbixin) are inser ted after the entr y for E 142 (Green S):  
‘E 160b(i) Annatto bixin 20 (94) excep t crèm e de pruneaux  
E 160b(ii) Annatto norbixin 20 (94) excep t crèm e de pruneaux’   
(ii) the followi ng footnote (94) is added after footnote (60): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ 
11) Categor y 04.2.6 (Processed potato products) is amended as follows : 
(i) the followi ng new entr ies for E 160b(i) (Annatt o bixin) and E 160b(ii) (Annatt o norbixin) are inser ted after the entr y for E 160a (Caroten es):  
‘E 160b(i) Annatto bixin 10 (94) only dried potato granules and flakes  
E 160b(ii) Annatto norbixin 10 (94) only dried potato granules and flakes’   
(ii) the followi ng footnote (94) is added after footnote (46): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ 
12) Categor y 05.2 (Other confecti oner y including breath freshening microsweets) is amended as follows : 
(i) the followi ng new entr ies for E 160b(i) (Annatt o bixin) and E 160b(ii) (Annatt o norbixin) are inser ted after the entr ies for E 124 (Ponceau 4R, Coch ineal Red A):  
‘E 160b(i) Annatto bixin 30 (94)   
E 160b(ii) Annatto norbixin 25 (94)’    EN Offi cial Jour nal of the European Union 12.6.2020                                                                                                                                         L 184/31   (ii) the followi ng footnote (94) is added after footnote (72): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ 
13) Categor y 05.4 (Decorations, coatings and fillings, excep t fruit-based fillings covered by categor y 4.2.4) is amended as follows: 
(i) the entr y for E 160b (Annatt o, Bixin, Norbixin) is replaced by the follo wing:  
‘E 160b(i) Annatto bixin 80 (94) only decorations and coatings  
E 160b(ii) Annatto norbixin 20 (94) only decorations and coatings’   
(ii) the followi ng footnote (94) is added after footnote (73): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ 
14) in categor y 06.3 (Breakf ast cereals), the entr y for E 160b (Annatt o, Bixin, Norbixin) is replaced by the follo wing:  
‘E 160b(ii) Annatto norbixin 20  only extr uded puffed and or fruit-f lavoured breakf ast cereals’   
15) Categor y 06.5 (Noodles) is amended as follo ws: 
(i) the followi ng new entr ies for E 160b(i) (Annatt o bixin) and E 160b(ii) (Annatt o norbixin) are inser ted after the entr y for group II (Colours at quantum satis):  
‘E 160b(i) Annatto bixin 20 (94)   
E 160b(ii) Annatto norbixin 20 (94)’    
(ii) the followi ng footnote (94) is added after footnote (81): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ 
16) Categor y 06.6 (Batters) is amended as follows : 
(i) the entr y for E 160b (Annatt o, Bixin, Norbixin) is replaced by the follo wing:  
‘E 160b(i) Annatto bixin 50 (94) only batt ers for coating  
E 160b(ii) Annatto norbixin 50 (94) only batt ers for coating’   EN Offi cial Jour nal of the European Union L 184/32                                                                                                                                         12.6.2020   (ii) the followi ng footnote (94) is added after footnote (81): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ 
17) in categor y 07.2 (Fine baker y wares), the entr y for E 160b (Annatto, Bixin, Norbixin) is replaced by the followi ng:  
‘E 160b(ii) Annatto norbixin 10’     
18) Categor y 08.2 (Meat preparations as defined by Regulation (EC) No 853/2004) is amended as follows: 
(i) the followi ng new entr ies for E 160b(i) (Annatt o bixin) and E 160b(ii) (Annatt o norbixin) are inser ted after the entr y for E 150a-d (Caramels):  
‘E 160b(i) Annatto bixin 20 (94) only breakfast sausag es with a minimum cereal conte nt of 6 % 
and burger meat with a minimum vegetable and/or cereal con­
tent of 4 % mixed within the meat ; In these products, the 
meat is minced in such a way so that the muscle and fat tissue 
are compl etely dispersed, so that fibre mak es an emulsion with 
the fat, giving those products their typical appearance  
E 160b(ii) Annatto norbixin 20 (94) only breakfast sausag es with a minimum cereal conte nt of 6 % 
and burger meat with a minimum vegetable and/or cereal con­
tent of 4 % mixed within the meat ; In these products, the 
meat is minced in such a way so that the muscle and fat tissue 
are compl etely dispersed, so that fibre mak es an emulsion with 
the fat, giving those products their typical appearance’   
(ii) the followi ng footnote (94) is added after footnote (66): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ 
19) Categor y 08.3.1 (Non-heat–treated meat products) is amended as follows: 
(i) the followi ng new entr ies for E 160b(i) (Annatt o bixin) and E 160b(ii) (Annatt o norbixin) are inser ted after the entr y for E 160a (Caroten es):  
‘E 160b(i) Annatto bixin 20 (94) only chor izo sausag e, salchichon, pastur mas and sobrasada  
E 160b(ii) Annatto norbixin 20 (94) only chor izo sausag e, salchichon, pastur mas and sobrasada’   
(ii) the followi ng footnote (94) is added after footnote (66): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ EN Offi cial Jour nal of the European Union 12.6.2020                                                                                                                                         L 184/33   20) Categor y 08.3.2 (Heat-treated meat products) is amended as follows: 
(i) the followi ng new entr ies for E 160b(i) (Annatt o bixin) and E 160b(ii) (Annatt o norbixin) are inser ted after the entr y for E 160a (Caroten es):  
‘E 160b(i) Annatto bixin 20 (94) only sausages , pâté s, terrines and luncheon meat  
E 160b(ii) Annatto norbixin 20 (94) only sausages , pâté s, terrines and luncheon meat’   
(ii) the followi ng footnote (94) is added after footnote (66): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ 
21) Categor y 08.3.3 (Casings and coatings and decorations for meat) is amended as follows: 
(i) the entr y for E 160b (Annatt o, Bixin, Norbixin) is replaced by the follo wing:  
‘E 160b(i) Annatto bixin 50 (94)   
E 160b(ii) Annatto norbixin 50 (94)’    
(ii) the followi ng footnote (94) is added after footnote (89): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ 
22) Categor y 09.2 (Processed fish and fisher y products including molluscs and crustaceans) is amended as follows: 
(i) the entr y for E 160b (Annatt o, Bixin, Norbixin) concer ning ‘only smok ed fish’ is replaced by the follo wing new entr ies for Annatto bixin and Annato norbixin, respectively 
for ‘only smoked fish’ and for ‘only surimi and similar products and salmon substitutes’:  
‘E 160b(i) Annatto bixin 10 (94) only smoke d fish  
E 160b(i) Annatto bixin 30 (94) only surimi and similar products and salmon substitutes  
E 160b(ii) Annatto norbixin 10 (94) only smoke d fish  
E 160b(ii) Annatto norbixin 30 (94) only surimi and similar products and salmon substitutes’   
(ii) the followi ng footnote (94) is added after footnote (85): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ EN Offi cial Jour nal of the European Union L 184/34                                                                                                                                         12.6.2020   23) Categor y 12.5 (Soups and broths) is amended as follows : 
(i) the followi ng new entr ies for E 160b(i) (Annatt o bixin) and E 160b(ii) (Annatt o norbixin) are inser ted after the entr y for Group III (Colours with combined maximum 
limit):  
‘E 160b(i) Annatto bixin 15 (94)   
E 160b(ii) Annatto norbixin 10 (94)’    
(ii) the followi ng footnote (94) is added after footnote (60): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ 
24) Categor y 12.6 (Sauces) is amended as follows: 
(i) the followi ng new entr ies for E 160b(i) (Annatt o bixin) and E 160b(ii) (Annatt o norbixin) are inser ted after the entr y for E 110 (Sunset Yellow FCF/Orange Yellow S):  
‘E 160b(i) Annatto bixin 30 (94) including pick les, relishes, chutney and piccalilli; excl uding 
tomat o-based sauces  
E 160b(ii) Annatto norbixin 30 (94) including pick les, relishes, chutney and piccalilli; excl uding 
tomat o-based sauces’   
(ii) the followi ng footnote (94) is added after footnote (65): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ 
25) in categor y 14.1.4 (Flavour ed drinks), the followi ng new entr y for E 160b(i) (Annatto bixin) is inser ted after the entr y for E 124 (Ponceau 4R, Cochineal Red A):  
‘E 160b(i) Annatto bixin 20’     
26) in categor y 14.2.6 (Spir it drinks as defined in Regulation (EC) No 110/2008), the entr y for E 160b (Annatt o, Bixin, Norbixin) is replaced by the following:  
‘E 160b(i) Annatto bixin 10  only liqueurs’   
27) in categor y 14.2.8 (Other alcoholic drinks including mixtures of alcoholic drinks with non-alcoholic drinks and spirits with less than 15 % of alcohol), the entr y for E 160b 
(Annatt o, Bixin, Norbixin) is replaced by the followi ng:  
‘E 160b(ii) Annatto norbixin 10  only alcoholic drinks with less than 15 % of alcohol’   EN Offi cial Jour nal of the European Union 12.6.2020                                                                                                                                         L 184/35   28) Categor y 15.1 (Potato-, cereal-, flour - or starc h-based snac ks) is amended as follows: 
(i) the two entr ies for E 160b (Annatt o, Bixin, Norbixin) are replaced by the followi ng:  
‘E 160b(i) Annatto bixin 20 (94)   
E 160b(ii) Annatto norbixin 20 (94)’    
(ii) the followi ng footnote (94) is added after footnote (71): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ 
29) Categor y 15.2 (Processed nuts) is amended as follows: 
(i) the entr y for E 160b (Annatt o, Bixin, Norbixin) is replaced by the follo wing:  
‘E 160b(i) Annatto bixin 10 (94)   
E 160b(ii) Annatto norbixin 10 (94)’    
(ii) the followi ng footnote (94) is added after footnote (60): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ 
30) Categor y 16 (Desser ts excluding products covered in catego ry 1, 3 and 4) is amended as follows : 
(i) the entr y for E 160b (Annatt o, Bixin, Norbixin) is replaced by the follo wing:  
‘E 160b(i) Annatto bixin 15 (94)   
E 160b(ii) Annatto norbixin 7,5 (94)’    
(ii) the followi ng footnote (94) is added after footnote (74): 
‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatt o norbixin) are added in combination, the higher individual maximum level applies to the sum, but the 
individual maximum levels shall not be exceed ed.’ 
(2) In Part 2 of Annex III to Regulation (EC) No 1333/2008, the entr y for E 900 (Dimethyl polysilo xane) is replaced by the follo wing: 
‘E 900 Dimeth yl polysilo xane 200 mg/kg in the preparation, 
0,2 mg/l in final food Colour preparations of E 160a carote nes, E 
160b(i) annatt o bixin, E 160b(ii) annatto nor­
bixin, E 160c papr ika extract, capsanthin, 
capsor ubin, E 160d lycopene and E 160e beta- 
apo-8′-carot enal’   EN Offi cial Jour nal of the European Union L 184/36                                                                                                                                         12.6.2020   ANNEX II 
In the Annex to Regulation (EU) No 231/2012, the respective entr ies for E 160b Annatto, Bixin, Norbixin: (i) Solvent-extracte d bixin and norbixin, (ii) alkali extract ed annatto and (iii) oil 
extract ed annatto are replaced by the follo wing: 
‘E 160 b (i) ANNA TTO BIXIN 
(I) SOL VENT -EXTRA CTED BIXIN                                                                 
Synonyms Annatto B, Orlean, Terre orellana, L. Orang e, CI Natural Orang e 4 
Def inition Solvent-extracted bixin is obtained by the extraction of the outer coating of the seeds of 
the annatt o tree (Bixa orellana L.) with one or more of the followi ng food grade solvents: 
aceton e, methanol, hexane, ethanol, isoprop yl alcohol, ethyl acetat e, alkaline alcohol or 
supercr itical carbon dioxide. The resulting preparation may be acidif ied, followe d by the 
remo val of the solvent, drying and milling. 
Solvent-extracted bixin contains several coloured compo nents; the major colour ing 
principle is cis-bixin, a minor colour ing principle is trans-bixin; ther mal degradation 
products of bixin may also be present as a result of processing. 
Colour Index No 75120 
Einecs 230-248-7 
Chemical name cis-Bixin: Methyl (9-cis)-h ydrogen-6,6'-diapo-Ψ,Ψ-carot enedioate 
Chemical formula cis-Bixin: C25H30O4 
Molecular weight 394,5 
Assa y Not less than 85 % colour ing matt er (expressed as bixin) 
E1 %1cm 3090 at ca. 487 nm in tetrah ydrofuran and aceton e 
Descr iption Dark red-brown to red-pur ple powder 
Identif ication  
Solubility Insoluble in water , slightly soluble in ethanol 
Spectrometr y The sample in acetone shows absorbance maxima at about 425, 457 and 487 nm 
Purity  
Norbixin Not more than 5 % of total colour ing matt ers EN Offi cial Jour nal of the European Union 12.6.2020                                                                                                                                         L 184/37   Residual Solvents Aceton e: Not more than 30 mg/kg 
Methanol: Not more than 50 mg/kg 
Hexane: Not more than 25 mg/kg 
Ethanol: 
Isoprop yl alcohol: 
Ethyl acetate : not more than 50 mg/kg, sing ly or in com­
bination 
Arsenic Not more than 2 mg/kg 
Lead Not more than 1 mg/kg 
Mercur y Not more than 1 mg/kg 
Cadmium Not more than 0,5 mg/kg   
(II) AQUEOUS-PR OCESSED BIXIN                                                                  
Synonyms Annatto E, Orlean, Terre orellana, L. Orang e, CI Natural Orange 4 
Def inition Aqueous-proce ssed bixin is prepared by the extraction of the outer coating of the seeds of 
the annatto tree (Bixa orellana L.) by abrading the seeds in the presence of cold, mildly- 
alkaline water . The resultant preparation is acidified to precipitate bixin whic h is then 
filtered, dried and milled. 
Aqueous-proce ssed bixin contains several coloured compo nents; the major colour ing 
principle is cis-bixin, a minor colour ing principle is trans-bixin; ther mal degradation 
products of bixin may also be present as a result of processing. 
Colour Index No 75120 
Einecs 230-248-7 
Chemical name cis-Bixin: Methyl (9-cis)-h ydrogen-6,6'-diapo-Ψ,Ψ-carot enedioate 
Chemical formula cis-Bixin: C25H30O4 
Molecular weight 394,5 
Assa y Not less than 25 % colour ing matt er (expressed as bixin) 
E1 %1cm 3090 at ca. 487 nm in tetrah ydrofuran and aceton e 
Descr iption Dark red-brown to red-pur ple powder 
Identif ication  
Solubility Insoluble in water , slightly soluble in ethanol EN Offi cial Jour nal of the European Union L 184/38                                                                                                                                         12.6.2020   Spectrometr y The sample in acetone shows absorbance maxima at about 425, 457 and 487 nm 
Purity  
Norbixin Not more than 7 % of total colour ing matt ers 
Arsenic Not more than 2 mg/kg 
Lead Not more than 1 mg/kg 
Mercur y Not more than 1 mg/kg 
Cadmium Not more than 0,5 mg/kg   
E 160 b (ii) ANNA TTO NORBIXIN 
(I) SOL VENT -EXTRA CTED NORBIXIN                                                                  
Synonyms Annatto C, Orlean, Terre orellana, L. Orange, CI Natural Orange 4 
Def inition Solvent-extracted norbixin is obtained from the outer coating of the seeds of the annatto 
tree (Bixa orellana L.) by washing with one or more of the follo wing food grade solvents: 
aceton e, methanol, hexane, ethanol, isoprop yl alcohol, ethyl acetat e, alkaline alcohol or 
supercr itical carbon dioxide followed by solvent remo val, crystallization and drying. 
Aqueous alkali is added to the resultant powder , which is then heat ed to hydrolyse the 
colour ing matter and cooled. The aqueous solution is filtered, and acidified to precipitate 
the norbixin. The precipitate is filtered, washed, dried and milled, to give a granular 
powder . 
Solvent-extracted norbixin contains several coloured compo nents; the major colour ing 
principle is cis-norbixin, a minor colour ing principle is trans-norbixin; ther mal 
degradation products of norbixin may also be present as a result of processing. 
Colour Index No 75120 
Einecs 208-810-8 
Chemical name cis-Norbixin: 6,6'-Diapo-Ψ,Ψ-caroten edioic acid 
cis-Norbixin dipotassium salt: Dipotassium 6,6'-diapo-Ψ,Ψ-carot enedioate 
cis-Norbixin disodium salt: Disodium 6,6'-diapo-Ψ,Ψ-carot enedioate 
Chemical formula cis-Norbixin: C24H28O4 
cis-Norbixin dipotassium salt: C24H26K2O4 
cis-Norbixin disodium salt: C24H26Na 2O4 EN Offi cial Jour nal of the European Union 12.6.2020                                                                                                                                         L 184/39   Molecular weight 380,5 (acid), 456,7 (dipotassium salt), 424,5 (disodium salt) 
Assa y Not less than 85 % colour ing matt er (expressed as norbixin) 
E1 %1cm 2870 at ca. 482 nm in 0,5 % potassium hydro xide solution 
Descr iption Dark red-brown to red-pur ple powder 
Identif ication  
Solubility Soluble in alkaline water , slightly soluble in ethanol 
Spectrometr y The sample in 0,5 % potassium hydro xide solution shows absorbance maxima at about 
453 nm and 482 nm 
Purity  
Residual Solvents Aceton e: Not more than 30 mg/kg 
Methanol: Not more than 50 mg/kg 
Hexane: Not more than 25 mg/kg 
Ethanol: 
Isoprop yl alcohol: 
Ethyl acetate : not more than 50 mg/kg, sing ly or in com­
bination 
Arsenic Not more than 2 mg/kg 
Lead Not more than 1 mg/kg 
Mercur y Not more than 1 mg/kg 
Cadmium Not more than 0,5 mg/kg   
(II) ALKALI-PR OCESSED NORBIXIN, ACID-PRECIPIT ATED                                                                  
Synonyms Annatto F, Orlean, Terre orellana, L. Orange, CI Natural Orange 4 
Def inition Alkali-processed norbixin (acid-precipitat ed) is prepared by the extraction of the outer 
coating of the seeds of the annatt o tree (Bixa orellana L.) with aqueous alkali. The bixin is 
hydrolysed to norbixin in hot alkaline solution and is acidif ied to precipitate the norbixin. 
The precipitate is filtered, dried and milled to give a granular powder . 
Alkali-processed norbixin contains several coloured compo nents; the major colour ing 
principle is cis-norbixin, a minor colour ing principle is trans-norbixin; ther mal 
degradation products of norbixin may also be present as a result of processing. EN Offi cial Jour nal of the European Union L 184/40                                                                                                                                         12.6.2020   Colour Index No 75120 
Einecs 208-810-8 
Chemical name cis-Norbixin: 6,6'-Diapo-Ψ,Ψ-caroten edioic acid 
cis-Norbixin dipotassium salt: Dipotassium 6,6'-diapo-Ψ,Ψ-carot enedioate 
cis-Norbixin disodium salt: Disodium 6,6'-diapo-Ψ,Ψ-carot enedioate 
Chemical formula cis-Norbixin: C24H28O4 
cis-Norbixin dipotassium salt: C24H26K2O4 
cis-Norbixin disodium salt: C24H26Na 2O4 
Molecular weight 380,5 (acid), 456,7 (dipotassium salt), 424,5 (disodium salt) 
Assa y Not less than 35 % colour ing matt er (expressed as norbixin) 
E1 %1cm 2870 at ca. 482 nm in 0,5 % potassium hydro xide solution 
Descr iption Dark red-brown to red-pur ple powder 
Identif ication  
Solubility Soluble in alkaline water , slightly soluble in ethanol 
Spectrometr y The sample in 0,5 % potassium hydro xide solution shows absorbance maxima at about  
453 nm and 482 nm 
Purity  
Arsenic Not more than 2 mg/kg 
Lead Not more than 1 mg/kg 
Mercur y Not more than 1 mg/kg 
Cadmium Not more than 0,5 mg/kg   
(III) ALKALI-PR OCESSED NORBIXIN, NOT ACID-PRECIPIT ATED                                                                  
Synonyms Annatto G, Orlean, Terre orellana, L. Orange, CI Natural Orang e 4 
Def inition Alkali-processed norbixin (not acid-precipitated) is prepared by the extraction of the outer 
coating of the seeds of the annatt o tree (Bixa orellana L.) with aqueous alkali. The bixin is 
hydrolysed to norbixin in hot alkaline solution. The precipitate is filtered, dried and milled 
to give a granular powder . Extracts contain mainly the potassium or sodium salt of norbixin 
as the major colour ing matter . EN Offi cial Jour nal of the European Union 12.6.2020                                                                                                                                         L 184/41   Alkali-processed norbixin (not acid-precipitat ed) contains several coloured compo nents; 
the major colour ing principle is cis-norbixin, a minor colour ing principle is trans-norbixin; 
ther mal degradation products of norbixin may also be present as a result of processing. 
Colour Index No 75120 
Einecs 208-810-8 
Chemical name cis-Norbixin: 6,6'-Diapo-Ψ,Ψ-caroten edioic acid 
cis-Norbixin dipotassium salt: Dipotassium 6,6'-diapo-Ψ,Ψ-carot enedioate 
cis-Norbixin disodium salt: Disodium 6,6'-diapo-Ψ,Ψ-carot enedioate 
Chemical formula cis-Norbixin: C24H28O4 
cis-Norbixin dipotassium salt: C24H26K2O4 
cis-Norbixin disodium salt: C24H26Na 2O4 
Molecular weight 380,5 (acid), 456,7 (dipotassium salt), 424,5 (disodium salt) 
Assa y Not less than 15 % colour ing matt er (expressed as norbixin) 
E1 %1cm 2870 at ca. 482 nm in 0,5 % potassium hydro xide solution 
Descr iption Dark red-brown to red-pur ple powder 
Identif ication  
Solubility Soluble in alkaline water , slightly soluble in ethanol 
Spectrometr y The sample in 0,5 % potassium hydro xide solution shows absorbance maxima at about  
453 nm and 482 nm 
Purity  
Arsenic Not more than 2 mg/kg 
Lead Not more than 1 mg/kg 
Mercur y Not more than 1 mg/kg 
Cadmium Not more than 0,5 mg/kg’   EN Offi cial Jour nal of the European Union L 184/42                                                                                                                                         12.6.2020   