G/TBT/N/EU/776  
1 February 2021  
(21-0840) 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 [   ], 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 Regulatio n amending Delegated Regulation (EU) No 2016/128 as 
regards the requirements on pesticides in food for special medical purposes developed to 
satisfy the nutritional requirements of infants and young children (5 page(s), in English; 
2 page(s), in English)  
6. Description of content:  This draft Commission Delegated Regulation aims at aligning 
the definition of "pesticide residues" laid down in Commission Delegated Regulation (EU) 
2016/128 with the more precise definition provided for in Regulation (EC) No 396 /2005 
on maximum residue levels of pesticides to ensure legal certainty and clarity.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Commission Delegated Regulation (EU) 2016/128 lays down inter alia  
specific requirem ents on the use of pesticides in products intended for the production of 
food for special medical purposes developed to satisfy the nutritional requirements of 
infants and young children and on pesticide residues in such food. 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) 2 016/128 taking into account relevant technical and scientific progress. 
The proposed amendments to Delegated Regulation (EU) No 2016/128 relate to the fact 
that Article 3(2)(c) of Regulation (EC) No 396/2005 provides for a more precise definition 
of pestic ide residues, specifying in addition that they may result from active substances 
currently or formerly used in plant protection products and that they may arise as a result 
of use in plant protection, veterinary medicine and as biocides. For reasons of leg al 
certainty and clarity, it is necessary to bring the definition laid down in Delegated G/TBT/N/EU/776  
 
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  Regulation (EU) No 2016/128 in line with the more precise definition provided for 
in  Regulation (EC) No 396/2005. Furthermore, in view of future Implementing 
Regulati ons amending the Annexes to Regulation (EC) No 396/2005 and taking into 
account that the residue definitions for active substances should apply as defined in 
Regulation (EC) No 396/2005, it is   appropriate to include only the parent compounds of 
the active  substances in the lists   set out in Annexes II and III to Delegated Regulation 
(EU) No 2016/128; Protection of human health or safety  
8. Relevant documents:   
• Commission Delegated Regulation (EU) 2016/128 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 food for special medical purpo ses https://eur -lex.europa.eu/legal -
content/EN/ALL/?uri=CELEX%3A32016R0128  
• Regulation (EC) No 396/2005 of the European Parliament and of the Council of 
23 February 2005 on maximum residue levels of pesticides in or on food and feed 
of plant and animal origin and amending Council Directive 91/414/EEC 
https://eur -lex.europa.eu/legal -conte nt/en/ALL/?uri=CELEX%3A32005R0396  
9. Proposed date of adoption:  2nd quarter 2021  
Proposed date of entry into force:  The proposed measure shall enter into force on the 
20th day following its publication in the Official Journal of the EU (about a month after 
adoption approx.).  
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/2021/TBT/EEC/21_0776_00_e.pdf  
https://members.wto.org/crnattachments/ 2021/TBT/EEC/21_0776_01_e.pdf