EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12606/2019 
(POOL/E2/2019/12606/12606 -EN.docx)  
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
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)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
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 EUROPEAN COMMISSION,  
Having regard 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 additives1, 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 additive s 
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 
approved for use in food additives, food enzymes, food flavourings, nutrients and their 
conditions of use.  
(3) Commission Regulation (EU) No 231/20122 lays down specifications for food 
additives that are listed in Annexes II and III to Regulation (EC) No 1333/2008.  
(4) The Union lists of food additives and the specifications may be updated in accordance 
with the common procedure referred to in Article 3(1) of Regulation (EC) No 
1331/2008 of the  European Parliament and of the Council3, either on the initiative of 
the Commission or following an application.  
(5) Annatto, Bixin, Norbixin (E 160b) is a substance authorised 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 extracted from the seeds of the annatto tree ( Bixa 
orellana  L.) and confers a yellow to red colour to food . The main pigments in annatto 
extracts are bixin and norbixin. In spite of their similarity in structure, bixin and 
norbixin have significantly different physico -chemical properties and, therefore, 
different applications depending on the characteristics of the food matrix.  
                                                 
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 Parliam ent 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 authorisation procedure for food additives, food enzymes and food flavourings 
(OJ L 35 4, 31.12.2008, p. 1 ). EN 2  EN (7) Article 32(1) of Regulation (EC) No 1333/2008  provides that all food additives that 
were already permitted in the Union before 20 January 2009 are  subject to a new risk 
assessment by the European Food Safety Authority (ʻthe Authority̕’). Commission 
Regulation (EU) No 257/20104 provides that the re -evaluation of food colours  had to 
be completed by 31 December 2015 . 
(8) On 4 April  2008, an application was submitted for the authorisation of the use of  five 
new annatto extracts categorised as bixin - or norbixin -based, with a view to replacing 
the currently authorised annatto extracts (E 160b).  The application included new 
proposed uses and use levels for  bixin and norbixin  separately, while current uses and 
use levels are listed for a single food additive ( Annatto, Bixin, No rbixin (E 160b)) . 
The proposed uses and use levels for bixin  and norbixin  concern the food categories in 
which Annatto, Bixin, Norbixin (E 160b)  is currently authorised, as well as a few 
additional food categories in which Annatto, Bixin, Norbixin (E 160b)  is currently no t 
authorised, bu t other food colours are already authorised.     
(9) Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek 
the opinion of the Authority in order to update the Union list of food additives set out 
in Annex II to Regulation (EC) No 1333/2008 and the specifications set out in the 
Annex to Regulation (EU) No 231/2012 , except where the update in question is not 
liable to have an effect on human health.  
(10) On 19 May 20 08, the Commission requested the Authorit y to evaluate the safety of the 
five new annatto extracts, at the proposed uses and use levels. Upon analysis of the 
application , the Authority identified major data gaps and indicated that new 
toxicological studies would be needed. Consequently, the Commi ssion decided on 14 
January 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 scientific opinion on the  safety of annatto 
extracts (E 160b) as a food additive5. As regards the annatto extracts  currently 
authorised  the Authority concluded  that the safety of their use  within the specifications 
defined in Regulation (EU) No 23 1/2012 (solvent -extracted bixin and norbixin, alkali -
extracted annatto and oil -extracted annatto)  could not be assessed due to lack of data, 
both in terms of identification and toxicological studies. As regards the new annatto 
extract s and, in particular,  aqueous -processed bixin  (Annatto E) , the Authority could 
not conclude on its  safety due to equivocal genotoxicity results. For the four remaining 
new extracts (‘solvent -extracted bixin ’, ‘solvent -extracted norb ixin’, ‘alkali -processed  
norbixin , acid-precipitated ’ and ‘alkali -processed  norbixin , not acid -precipitated ’), the 
Authority indicated that they should comply with the specifications recommended in 
the scientific opinion . Finally, t he Authority derive d 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 estimates linked to the proposed uses and use levels for bixin were 
below the ADI for all population groups and for the two  refined exposure  scenarios  
(brand -loyal and non brand -loyal exposure scenarios) . However, f or norbixin, those 
                                                 
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 addi tives (OJ L 80, 26.3.2010, p. 19).  
5 EFSA Journal 2016;14(8):45 44. EN 3  EN estimates exceed ed the ADI at the high level 95th percentile for infants, toddlers and 
children in the refined brand -loyal exposure scenario .  
(12) Following the publication of this scientifi c opinion, the Commission requested from 
the applicant some clarifications about the requested  uses and maximum use levels of 
bixin and norbixin. Based on this,  on 16 February 2017,  the applicant submitted to the 
Commission modifications to the original application, such as a removal of some of 
the requested new uses and a modification of some of the requested use levels.  On 2 
March 2017 , the Commission requested the Authority for technical assistance as 
regards the estimatio n of the exposure to bixin and norbixin on the basis of the revised 
uses and use levels proposed by the applicant.  
(13) As requested, o n 10 August 2017, the Authority published  a statement on the exposure 
assessment of bixin and norbixin6 as regards those revis ed uses and use levels . It 
concluded that the dietary exposure for bixin d id not exceed the ADI  in any exposure 
scenario . However , it concluded that the dietary exposure for norbixin exceed ed the 
ADI at the high level  (95th percentile) for toddlers and children  in the two refined 
exposure scenarios  (brand -loyal and non brand -loyal exposure scenarios).  
(14) On 30 August 2017 , the applicant submitted data from a new genotoxicity study for 
Annatto E.  
(15) Taking into account the outcome  of the exposure assessment published by the 
Authority 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 
alternative scenarios of uses and use leve ls.  
(16) On 1 August 2018 , the Commission requested the Authority to carry out an evaluation 
on the new genotoxicity data for Annatto E generated by the applicant and to indicate 
whether it is possible to conclude on the safety of this annatto extract. The Authority 
was also requested to carry out a new exposure assessment for bixin and norbixin , on 
the basis of the revised uses a nd use levels of bixin  and norbixin  submitted by the 
applicant in the form of three alternative scenarios.  
(17) On 1 3 March 2019 , the Authority published a scientific opinion on the safety of 
Annatto E and the exposure to bixin and norbixin7. As regards the saf ety of Annatto E , 
the Authority concluded that  it does not raise concern for genotoxicity  and it stated 
that the ADIs established in 2016 for bixin and norbixin can be applied also to Annatto 
E. As regards the exposure at the revised uses and use levels submitted by the 
applicant on 10 August 2017, f or bixin , the 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 tod dlers in the two 
refined exposure assessment scenarios but only in one country. However, c onsidering 
the uncertainties and the very likely overestimation of the exposure, the Authority 
concluded that the level of exposure does not raise a health concern fo r any of the 
three scenarios of uses and use levels for bixin and norbixin . 
(18) It results from the above considerations that it is appropriate 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 properties and, therefore, dif ferent 
ADIs, the food additive ‘ Annatto, Bixin, Norbixin (E 160b)’  should be deleted from 
                                                 
6 EFSA Journal 2017;15(8):4966 . 
7 EFSA Journal 2019;17(3):5626 . EN 4  EN the Union list of authorised food additives in Part B of Annex II to that Regulation  and 
two sep arate food additives, namely Annatto bixin (E 160 b(i)) and Annatto norbixin 
(E 160b(i i)) should be listed . As a consequence, the authorised uses and condition s of 
use for the food additive ‘ Annatto, Bixin, Norbixin (E 160b)’  should be deleted from 
the list  of authorised conditions of use in food in Part E of Annex II to Regulation 
(EC) No 1333/2008, and any re ferences to it contained in the Annexes to the 
Regulation should be replaced by references to the two new food additives. As regards 
these two new add itives, their authorised uses and use levels should be laid down. On 
the basis of the Authority’s assessments referred to above, the uses as requested by the 
applicant on its last revision of the application should be authorised but only at the 
levels used  in the third , and most conservative,  use and use levels scenario  thereof . 
(19) Regulation (EU) No 231/2012 should also be amended. On the one side, the three 
annatto extracts referred to therein ('solvent -extracted bixin and norbixin ’, ‘alkali -
extracted annatto and oil -extracted annatto ’) should no longer be authorised , since 
their safety could not be assessed , and, therefore, their specifications should be 
deleted .  On the other side, the two new Annatto bixin extracts (‘solvent -extracted 
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 -precipitated ’) do not pose a safety concern and 
specifications 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 Authority  in the scientific opinion on the safety of annatto 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 therefore be amended accordingly . 
(21) Even if the annatto extracts authorised until this Regulation  should no longer be 
authorised, since their safety could not be assessed, it is very unlikely that they would 
have different toxicological properties and therefore pose a health concern which 
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. Therefore, in order 
to allow for a smooth transition between those three extracts and the new ones, it is 
appropriate to allow that during a transit ional period both the old and the new extracts 
can be legally be placed, and remain, on the market.  
(22) For the  same reasons, it is also appropriate that foods containing the annatto extracts 
authorised until this Regulation that have been lawfully placed on t he market before or 
during that transitional period  may continue to be marketed  until the existing stocks 
are exhausted .  
(23) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and  Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex es II and III to Regulation (EC) No 1333/2008  are amended in accordance with Annex 
I to this Regulation . EN 5  EN Article 2 
The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this 
Regulation .  
Article 3 
1. Until xxxx (six months after date of entry into force of this Regulation) , the food 
additive Annatto, Bixin, Norbixin (E 160b ) may continue to be placed on the market  
as such in accordance with the rules applicable before xxxx (da te of entry into force 
of this Regulation) .  
2. Until xxxx (six months after date of entry into force of this Regulation) , foods 
containing Annatto, Bixin, Norbixin (E 160b) which are produced and labelled in 
accordance with the rules applicable before xxx x (date of entry into force  of this 
Regulation ), may continue to be placed on the market. After that date, they may 
remain on the market until the exhaustion of stocks.  
Article 4 
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 States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der LEYEN