G/TBT/N/EU/923  
13 September 2022  
(22-6764) 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 addition, where applicable):  Food 
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Delegated Regulation amending Commission Delega ted Regulation (EU) 
2016/127 as regards the protein requirements for infant and follow -on formula 
manufactured from protein hydrolysates.; (5 page(s), in English), (7 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 Regulation 
for the protein content, protein source, protein processing and protein quality for infant 
and follow -on formula manufactured from hydrolysates based o n 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 with 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 two pr otein hydrolysates used in infant 
and follow -on formulae that had been positively evaluated by the Authority so far. The 
requirements of the Regulation are applicable to infant formula and follow -on formula 
manufactured from protein hydrolysates as of 22 F ebruary 2022.  
Regulation (EU) 2016/127 also provides that these requirements may be amended in the 
future in order to allow the placing on the market of formulae manufactured from protein G/TBT/N/EU/923  
 
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  hydrolysates with a composition different from the ones already posi tively assessed, 
following a case -by-case evaluation of their safety and suitability by EFSA.  
In this context, the Commission has received a request from meyer.science GmbH on 
behalf of HIPP -Werk Georg Hipp OHG and Arla Foods Ingredients 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 Regulation (EU) 2016/127.  
In its op inion published on 9 March 2022, EFSA 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 
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 formula and follow -on 
formula 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 whey 
protein concentrate and used in an infant and follow ‐on formula manufactured from 
hydrolysed protein by HIPP ‐Werk Georg Hipp OHG (dossier submitted by meyer.science 
GmbH) | EFSA (europa.eu)  
9. Proposed date of adoption:  4th quarter 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:  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/tools -
databases/tbt/en/  
https://members.wto.org/crnatta chments/2022/TBT/EEC/22_6117_00_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/EEC/22_6117_01_e.pdf