G/TBT/N/EU/1046  
15 February 2024  
(24-1332) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
European Commission  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
European Comm ission,  
EU-TBT Enquiry Point,  
Fax: +(32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tbt/en/  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addit ion, where applicable):  Food 
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Delegated Regulation (EU) No …/… amending Annex II to Regulation (EU) No 
1169/2011 of the European Parliament and of the Council on the provi sion of food 
information to consumers, as regards behenic acid from mustard seeds to be used in the 
manufacturing of certain emulsifiers; (6 page(s), in English)  
6. Description of content:  This draft Commission Regulation aims at excluding behenic 
acid de rived from mustard seed used for the production of certain emulsifiers from the 
obligation to be labelled as an allergen.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Annex II to Regulation (EU) No 1169/2011 includes EU list of food allergens. 
In order to ensure better information to consumers and to take account of the most recent 
scientific knowledge, Article 21(2) of the Regulation requires the Commission to 
systemically re -examine, and where nece ssary, update Annex II. Such updating may 
consist in adding a substance to the list or removing them.  
In this context, following the data submitted by the applicant (Dupont) to the 
Commission, the European Food Safety Authority (EFSA) was requested to issu e an 
opinion considering 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 hav e 
been evaluated: 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.  G/TBT/N/EU/1046  
 
- 2 - 
 
  On 25 October 2016, EFSA adopted a scientific opinion concluding that the oral 
consumption of the above -mentioned emulsifiers is unlikely to trigger an allergenic 
reaction in mustard -allergic individuals under the proposed condition of use. In the light 
of new emerging evidence and a comment from a Member State, EFSA was requested to 
review its initial opinion and, if necessary, update it. On 25 September 2023, EFSA 
published its second opinion, in which it concluded that based on the information and data 
available, it is extremely unlikely (≤ 1% probability) that oral consumption of emu lsifiers 
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.  
The objective of this delegated act is to exempt behenic acid derived from mustard seed 
used for the production of the above -mentioned emulsifiers from the obligation to be 
labelled as an allergen, and therefore amend point 10 of Annex II of the Regulation which 
refers to mustard.  
8. Relevant documents:   
Regula tion (EU) No 1169/2011 of the European Parliament and of the Council of 25 
October 2011 on the provision of food information to consumers.  
https://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:02011R1169 -
20180101  
9. Proposed date of adoption:  1st Quarter 2 024 
Proposed date of entry into force:  The proposed measure shall enter into force on the 
twentieth day following that of its publication in the Official Journal of the European Union.  
10. Final date for comments:  30 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
European Commission,  
EU-TBT Enquiry Point,  
Fax: + (32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
The text is available on the EU -TBT Website : http://ec.europa.eu/growth/to ols-
databases/tbt/en/  
https://members.wto.org/crnattachments/2024/TBT/EEC/24_01496_00_e.pdf