G/TBT/N/EU/526  
 
17 November 2017  
(17-6297) 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 Commission,  
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 [  ], other:  
4. Products covered (HS or CCCN where applica ble, 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 Delegated Regulation (EU) 
2016/127 with regard to protein requirements for follow -on formula (and its accompanying 
annex) (4 pages + 2 pages of annex, in English)   
6. Description of content: This draft Commission Delegated Regulation aims to amend 
Commission Delegated Regulat ion (EU) 2016/127 which sets, among others, composition 
and labelling requirements for infant formula and follow -on formula.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health and safety.  
Commi ssion Delegated Regulation (EU) 2016/127 on infant formula and follow -on formula 
lays down inter alia compositional and labelling rules for infant formula and follow -on 
formula.  
Article 11(2) of Regulation (EU) No 609/2013 on food intended for infants and young 
children, food for special medical purposes and total diet replacement for weight control 
empowers the Commission to adopt delegated acts in order to update amongst others 
Delegated Regulation (EU) 2016/127 taking into account relevant technical and scientific 
progress.  
The Commission received a request from a company for evaluation of a follow -on formula 
based on cow's milk intact protein with a protein content of at least 1.6 g/100 kcal, which 
is below the minimum of 1.8 g protein/100kcal (0.43 g pr otein/100 kJ) specified in 
Annex  II to Delegated Regulation (EU) 2016/127, so that it could be placed on the market.  G/TBT/N/EU/526  
 
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  The European Food Safety Authority was  consulted and on 5 April 2017 adopted its 
opinion, that the use of follow -on formula, based on cows ' milk intact protein or goats' milk 
intact protein, with a protein content of 1.6 g/100 kcal (0.38 g/100 kJ) and otherwise 
complying with the requirements of relevant EU legislation is safe and suitable for healthy 
infants living in Europe with an intake of complementary foods of a sufficient quality. 
Therefore, it is proposed that the minimum protein content required in Delegated 
Regulation (EU) 2016/127 for follow -on formula based on cows' milk or goats' milk protein 
should be lowered to 1.6 g/100 kcal ( 0,38 g/100 kJ).  
8. Relevant documents:   
 Codex Standard for follow -up formula CODEX STAN 156 -1987 
http://www.codexalimentarius.org/download/standards/293/CXS_156e.pdf  
 
 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 spe cific 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:32016R0127&from=EN  
 
 Regulation (EU) No 609/2013 of the European Parl iament and of the Council of 
12 June 2013 on food intended for infants and young children, food for special 
medical purposes, and total diet replacement for weight control http://eur -
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:181:0035:0056:EN:PDF  
 
 European Food Safety Authority (EFSA), Scientific Opinion on the safety and 
suitability for use by infants of follow -on formulae with a protein content of at least 
1.6g/100kcal, EFSA Jo urnal 2017;  15(5):4781  
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4781/epdf  
9. Proposed date of adoption:  End of January 2018  
Proposed date of entry into force:  20 days from publication in the Official Journal of the 
EU (The provisions shall apply from 22 February 2020)  
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/crnattachments/2017/TBT/EEC/17_5142_00_e.pdf  
https://members.wto.org/crnattachments/2017/TBT/EEC/17_5142_01_e.pdf