G/TBT/N/EU/858  
2 December 2021  
(21-9070) 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/tb t/en/  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Food; 
Food products in general (ICS 67.040)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Delegated Regulation amending Delegated Regulation (EU) 2016/127 as 
regards the protein requirements for infant and follow -on formula manufactured from 
protein hydrolysates (5 page(s), in English; 5 page(s), in English)  
6. Description of content:  This delegated Regulation aims to amend Delegated Regulation 
(EU) 2016/127 by amending the specifications set out by that Regulation for the protein 
content, protein source, protein processing and protein quality for infant and follow -on 
formula manufactured from hydrolysates.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Regulation (EU) 2016/127  establishes that infant formula and follow -on 
formula manufactured from protein hydrolysates should only be allowed on the market if 
their composition corresponds to a particular formula, which was the only protein 
hydrolysate assessed by EFSA at the time  of the adoption of the Regulation. The 
requirements of the Regulation shall apply to infant formula and follow -on formula 
manufactured from protein hydrolysates from 22 February 2022. Regulation (EU) 
2016/127 also provides that these requirements may be a mended in the future in order 
to allow the placing on the market of formulae manufactured from protein hydrolysates 
with a composition different from the ones already positively assessed, following a case -
by-case evaluation of their safety and suitability by EFSA. In this context, the Commission 
has received a request from Danone for the evaluation by EFSA of the safety and 
suitability of two products, an infant formula as well as a follow -on formula manufactured 
from protein hydrolysates. In its opinion EF SA concluded that the protein hydrolysate for 
which the dossier has been submitted is a nutritionally safe and suitable protein source 
for use in infant and follow -on formula. Taking into account the conclusions of that G/TBT/N/EU/858  
 
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  opinion, it is appropriate to allow the placing on the market of infant and follow -on 
formulae manufactured from the protein hydrolysate in question and amend Regulation 
(EU) 2016/127 accordingly; Protection of human health or safety  
8. Relevant documents:   
Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing 
Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards 
the specific compositional and information requirements for infant formulae and follow -
on formulae and as regards requirements on information relating to infant and young 
child feeding  
http://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:320 16R0127&from=EN  
EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), 2020. 
Nutritional safety and suitability of a specific protein hydrolysate derived from whey 
protein concentrate and used in an infant and follow ‐on formula manufactu red from 
hydrolysed protein by Danone Trading ELN B.V.  
Nutritional safety and suitability of a specific protein hydrolysate derived from whey 
protein concentrate and used in  an infant and follow ‐on formula manufactured from 
hydrolysed protein by Danone Trading ELN B.V. - - 2020 - EFSA Journal - Wiley Online 
Library  
9. Proposed date of adoption:  February 2022  
Proposed date of entry into force:  The proposed measure shall enter into force 
following its publication in the Official Journal of the EU.  
10. Final date for comments:  15 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/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2021/TBT/EEC/21_7492_00_e.pdf  
https://members.wto.org/crnattachments/2021/TBT/EEC/21_7492_01_e.pdf