G/TBT/N/EU/636  
 
19 December 2018  
(18-8023) Page: 1/3 
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 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 am ending Commission Delegated Regulation (EU) 
2016/127 with regard to vitamin D requirements for infant formula and erucic acid 
requirements for infant formula and follow -on formula (5 pages + 2 pages of annex, in 
English)    
6. Description of content: This draft Commission Delegated Regulation aims to amend 
Commission Delegated Regulation (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 o f urgent problems where 
applicable: Protection of human health and safety.  
Commission 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 
formu la. 
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 ot hers, 
Delegated Regulation (EU) 2016/127 taking into account relevant technical and scientific 
progress.  
Concerns have been raised that high consumption of formula containing 3 μg/100 kcal of 
vitamin D, combined with additional vitamin D intakes through su pplementation, could 
lead some infants to consume vitamin D at amounts that could pose safety risks.  G/TBT/N/EU/636  
 
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  The European Food Safety Authority was consulted and on 28 June 2018 adopted its 
opinion, that the use of infant formula containing vitamin D at 3 μg/100 kcal may lead 
some infants aged at about 4 months to consume amounts of vitamin D above the 
tolerable upper intake level from formula alone. It further concluded that the use of a 
maximum vitamin D content of 2.5 μg/100 kcal in infant formula does not resu lt in intakes 
of vitamin D above the tolerable upper intake level from formula alone. Therefore, it is 
proposed that the maximum vitamin D content permitted under Delegated Regulation 
(EU) 2016/127 for infant formula should be lowered to 2.5 μg/100 kcal.  
Maximum levels for erucic acid have been established in several foodstuffs, including 
infant formulae and follow -on formulae by Commission Regulation (EC) No 1881/2006. 
The same maximum levels for erucic acid in infant and follow -on formula are provided in  
Delegated Regulation (EU) 2016/127. For reasons of legal certainty and clarity, especially 
in view of future amendments to Regulation (EC) No 1881/2006 as regards erucic acid, it 
is proposed that the provision on the maximum content of erucic acid in Dele gated 
Regulation (EU) 2016/127 should be deleted.  
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 specific composit ional 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 Parliament 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:PD
F 
• European Food Safety A uthority (EFSA), Scientific Opinion on the update of the 
tolerable upper intake level for vitamin D for infants, EFSA Journal 
2018;16(8):5365 
https://efsa.onlinelibrary.wiley .com/doi/10.2903/j.efsa.2018.5365  
• European Food Safety Authority (EFSA), Scientific Opinion on euric acid in feed 
and food, EFSA Journal 2016;14(11):4593 
https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2016.4593  
9. Proposed date of adoption:  End of February 2019  
Proposed date of entry into force:  20 days from publication in the Official Journal of 
the EU (The provisions shall apply from 22 Februa ry 2020)  
10. Final date for comments: 60 days from notification  G/TBT/N/EU/636  
 
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  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/2018/TBT/EEC/18_6512_00_e.pdf  
https://members.wto.org/crnattachments/2018/TBT/EEC/18_6512_01_e.pdf