EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2016/476 
(POOL/A1/2016/476/476 EN.docx)  
[…](2024) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annex II to Regulation (EU) No 1169/2011 of the European Parliament and of 
the Council on the provision of food information to consumers, as regards behenic acid 
from mustard seeds to be used in the manufacturing of certain emulsifiers  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the C ommission.    
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Regulation (EU) No 1169/2011 of the European Parliament and of the Council  of 
25 October  2011 on the provision of food information to consumers1 establishes the general 
principles, requirements and responsibilities governing food information, and in particular 
food labelling.  
Annex II to Regulation (EU) No 1169/2011  establishes a list of substances or products 
causing allergies or intolerances. Point 10 of that Annex lists mustard and product s thereof.  
To ensure better information to consumers and to take account of the most recent scientific 
knowledge, Article 21(2) of the Regul ation requires the Commission to systemically re -
examine, and where necessary, update Annex II .  
As a part of this re -examination, in 2016, the Commission aske d the European Food Safety 
Authority (the Authority) to issue an opinion on the likelihood of adverse reactions triggered 
in susceptible individuals by the consumption of behenic acid produced from mustard seed 
used in the manufacturing of emulsifiers under specific conditions. The following substances 
were evaluated: E 470a: Sod ium, potassium and calcium salts of fatty acids, E 471: Mono - 
and diglycerides of fatty acids and E 477: Propane -1,2-diol esters of fatty acids. 
On 25 October 2016, the Authority  adopted a scientific opinion concluding that the oral 
consumption of the abov e-mentioned emulsifiers is unlikely to trigger an allergenic reaction 
in mustard -allergic individuals under the proposed condition of use.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Expert Group on Regulation (EU) No 1169/2011 on the provision of food information to 
consumers was consulted during the preparation of  this draft Delegated Regulation  on the 
basis of a Working Document prepared by the Commission services in the meeting  that took 
place on 24 November 2017.  
Following the adoption of t he Authority’s A NS Panel Scientific Opinions (re -evaluation) on 
E4712, on E470a and E470b3, and of the Authority’s  FAF Panel Scientific Opinion on E4774, 
in 2017 and 2018, the Expert Group was consulted for a second time in a meeting  devoted to 
the preparation of this draft Delegated Regulation on 9 October 2019 . In that meeting, one 
delegation expressed doubts on the daily combined dietary exposure to the emulsifiers in 
question estimated by the Authority , in its 2016 scientific opin ion on behenic acid from 
mustard seeds5. In this regard, it was pointed out that different levels for the same emulsifiers 
were indicated in the latest opinions adopted by the Authority’s ANS Panel in 2017 and 2018 
published  in the context of their re -evaluation.  
The Commission sent a new mandate requesting the Authorit y to update its 2016 scientific 
opinion , taking into consideration the newly emerged elements. In its 2023 scientific opinion6, 
                                                 
1 OJ L 304, 22.11.2011, p. 18.  
2 EFSA Journal 2017;15(11):5045.  
3 EFSA Journal 2018;16(3):5180 .  
4 EFSA  Journal 2018;16(12):5497.   
5 EFSA Journal 2016; 14(11):4631.  
6 EFSA Journal 2023;21(9):8240 .  
EN 2  EN the Authority concluded that based on the information and data  available  it is extremely 
unlikely (≤ 1% probability) that oral consumption of emulsifiers to be manufactured using 
behenic acid from mustard seeds (i.e. , E470a, E471 and E477) will trigger an allergic reaction 
in mustard -allergic individuals under the proposed conditions of use.  
Therefore, this draft Delegated Regulation aims at amending point 10 of Annex II to 
Regulation (EU) No 1169/2011 as regards  musta rd, in accordance with the conclusions of the 
Authority’s opinion on the matter.  
Against this background, the Expert Group was consulted again in a meeting that took place 
on 8 December 2023, where the new scientific opinion on behenic acid and the revised  draft 
Delegated Regulation were presented  and discussed . 
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The legal bas is for this draft Delegated Regulation is Arti cle 21(2) of Regulation (EU) 
No 1169/201 1, based on which Annex  II to that Regulation may be amended by delegated 
acts.  
EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annex II to Regulation (EU) No 1169/2011 of the European Parliament and of 
the Council on the provision of food information to consumers, as regards behenic acid 
from mustard seeds to be used in the manufacturing of certain emulsifiers  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functi oning of the European Union , 
Having regard to Regulation (EU) No 1169/2011 of the European Parliament and of the 
Council on the provision of food information to consumers1, and in particular Article  21(2)  
thereof,  
Whereas:  
(1) Annex II to Regulation (EU) No 11 69/2011 establishes a list of substances or products 
causing allergies or intolerances  in susceptible individuals and therefore , the 
information on their presence in food is always to be provided to the consumer  in 
accordance with that Regulation .  
(2) In order to protect consumer against new food allergens and avoid unnecessary 
obligations on the provision of food information, t he update of A nnex II may consist 
in adding substance s to the list or removing substances from that list where it has been 
scienti fically established that  they are not likely t o cause adverse reactions  in 
susceptible individuals .  
(3) To this end, potentially interested parties may communicate the Commission evidence 
establishing that products derived from substances listed in Annex II a re not likely, 
under certain circumstances, to trigger adverse reactions in individuals.  
(4) As part of the re-examination under Arti cle 21(2) and in accordance with Article 
29(1) , point  (a), of Regulation (EC) No 178/2002, the Commission requested the 
Europe an Food Safety Authority  (‘the Authority ’) to give its opinion on the likelihood 
of adverse reactions triggered in susceptible individuals by the intake of behenic acid 
produced from mustard seed and used , under specific conditions, in the manufacturing 
of emulsifiers E 470a sodium, potassium and calcium salts of fatty acids , E 471 mono- 
and diglycerides of fatty acids and E 477 propane -1,2-diol esters of fatty acids . 
(5) On 25 October 2016, on the basis of the data presented, the Authority adopted a 
scientific  opinion2 concluding  that oral consumption of food containing emulsifiers 
manufactured using behenic acid from mustard seeds (E 470a, E 471 and E 477) are 
                                                 
1 OJ L 304, 22.11.2011, p. 18 , ELI:  http://data.europa.eu/eli/reg/2011/1169/oj .  
2 Scientific Opinion related to a notification from DuPont Nutrition Biosciences Aps on behenic acid 
from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of 
Regulation (EU) No 1169/2011 – for permanent exemption from labelling. EFSA Journal 
2016;14(11):4631, 14 pp. doi:10.2903/j.efsa.2016. 4631 .  
EN 4  EN unlikely to trigger an allergic reaction in susceptible individuals (mustard -allergic 
individuals) un der the proposed conditions of use  (i.e., behenic acid with a minimum 
of 85% of purity and obtained after two distillation steps ). 
(6) Following concerns  raised by one Member State relating to the daily exposure to the 
substances in question and to the protein  dose triggering allergic reactions in mustard -
allergic individuals , the Commission requested the Authority to review its 2016 
scientific opinion and, if necessary, to update  it.  
(7) On 25  September 2023, the Authority  published its second scientific opinion3 which 
concluded that , based on the information and data available, it is extremely unlikely  
(≤ 1% probability)  that the oral consumption of emulsifiers manufactured using 
behenic acid from mustard seeds (E470a, E471 and E477) will trigger an allergic 
reaction in mustard‐allergic individuals under the proposed conditions of use . 
(8) On the basis of th ose conclusions,  it is appropriate to exclude the emulsifiers 
manufactured using behenic acid from mustard seeds (E 470a, E 471 and E 477) from 
Annex II to Regulat ion (EU) No 1169/2011.  
(9) Annex II of Regulation (EU) No 1169/2011 sh ould therefore  be amended accordingly . 
(10) In order to enable food business operators to a smooth transition to the new rules, 
appropriate transitional measures should be provided in accordance  with Article 47 of 
Regulation (EU) No 1169/2011 , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Point 10 of Annex II of Regulation (EU) No 1169/2011 is replaced by the following:  
‘10. Mustard and products thereof, except:  
behenic acid with a minimum of 85% of purity and obtained after two distillation steps used 
in the manufacturing of the emulsifiers E 470a, E 471 and E  477;’ . 
Article 2 
Foods legally placed on the market or labelled before  1 April 202 4 which do not comply with 
this Regulation may be marketed u ntil the stocks of th ose foods are exhausted.  
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 . 
It shall apply from  1 April 202 4. 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
                                                 
3 Re-evaluation of behenic acid from  mustard seeds to be used in the manufacturing of certain emulsifiers 
pursuant to Article 21(2) of  Regulation (EU) No 1169/2011 –for permanent exemption from labelling.  
EFSA Journal, 21(9), 1 –27. https://doi.org/10. 2903/j.efsa.2023.8240 .  
EN 5  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN