G/TBT/N/EU/1024  
27 October 2023  
(23-7251) 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 amending Delegated Regulation (EU) 2016/127 as 
regards the protein -related requirements for infant and follow -on formula  manufactured 
from protein hydrolysates; (5 page(s), in English), (8 page(s), in English)  
6. Description of content:  This delegated Regulation aims to amend Delegated Regulation 
(EU) 2016/127 by amending the compositional requirements set out by that Regu lation 
for the protein content, protein source, protein processing and protein quality for infant 
and follow -on formula manufactured from protein hydrolysates based on the relevant 
EFSA scientific opinion.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Regulation (EU) 2016/127 provides that infant and follow -on formula 
manufactured from protein hydrolysates are to comply with the requirements for protein 
content, protein source, protein processing as well as wi th the requirements for protein 
quality as set out in point 2.3 of Annex I and Annex II of that Regulation. These 
requirements correspond to the composition of the three protein hydrolysates used in 
infant and follow -on formulae that had been positively ev aluated by the Authority so far. 
The requirements of the Regulation apply to infant formula and follow -on formula 
manufactured from protein hydrolysates as of 22 February 2022.  
Regulation (EU) 2016/127 also provides that these requirements may be amended i n the 
future in order to allow the placing on the market of formulae manufactured from protein G/TBT/N/EU/1024  
 
- 2 - 
 
  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 FrieslandCampina  Nederland 
B.V. 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 a protein hydrolysate the 
composition of which does not comply with the requirements laid down in R egulation (EU) 
2016/127.  
In its opinion published on 18 July 2023, EFSA concluded that the protein hydrolysate in 
question is a nutritionally safe and suitable protein source for use in infant and follow -on 
formula. Taking into account the conclusions of t hat opinion, it is appropriate to allow the 
placing on the market of infant and follow -on formulae manufactured from that protein 
hydrolysate and amend Regulation (EU) 2016/127 accordingly; Protection of human 
health or safety  
8. Relevant documents:   
Comm ission 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 formula and follow -on 
formu la and as regards requirements on information relating to infant and young child 
feeding ( EUR-Lex - 32016R0127 - EN - EUR-Lex (europa.eu) ) 
Nutritional safety and suitability of a specific protein hydrolysate derived from a whey 
protein concentrate and used in an infant formula and follow -on formula manufactured 
from hydrolysed protein by FrieslandCampina Nederland B.V.  
9. Proposed date of adoption:  2nd quarter 2024  
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:  60 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/2023/TBT/EEC/23_13181_00_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_13181_01_e.pdf