EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12694/2020 
(POOL/E1/2020/12694/12694 -EN.docx)  
[…](2021) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
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  
(Text with EEA relevance)   EN 2  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Article 11(2) of 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 control1 empowers the 
European Commission to adopt delegated acts in order to update  the delegated acts 
adopted pursua nt to Article 11(1) of that Regulation, namely , amongst other  acts, 
Commission Delegated Regulation (EU)  No 2016/128  of 25 September 2015 
supplementing Regulation (EU) No 609/2013 of the European Parliament and of the 
Council as regards the specific compos itional and information requirements for food 
for special medical purposes2. 
This delegated Regulation aims to amend Delegated Regulation (EU)  No 2016/128  
by align ing the definition of a pesticide residue  laid down  in that Regulation with the 
more detailed definition provided for in 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 .3  
2. CONSULTATIONS  PRIOR  TO THE ADOPTION  OF THE  ACT  
Member States' experts were consulted within the Expert Group on food intended for 
infants and young children, food for special medical purposes and total diet 
replacement for weight control4, which met on the subject on  25 September 20195. 
Member States` experts were also consulted within the Expert Working Group on 
Pesticides Residues Monitoring, which met on the subject on 14 October 2019.  
Member States strongly supported the proposed alignment of the definition of a 
pesticide residue laid down in Delegated Regulation (EU) 2016/128 with the 
definition provided for in Article 3(2)(c) of Regulation (EC) No 396/2005.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The legal basis of this delegated Regulation is Article 11(2) of Regulation (EU) 
No 609/2013 . Pursuant to that provision , the Commission is empowered to adopt 
delegated acts in order to update  the Delegated acts adopted pursuant to Article 11( 1) 
of that Regulation, such as Delegated Regulation (EU) No 2016/128, subject to the 
general requirements  set out in Articles 6 and 9 of the same Regulation, to the 
additional requirements of Article 10, and taking into account relevant technical and 
scien tific progress . 
                                                 
1 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 and repeal ing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 
1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of 
the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009  (OJ L 181, 
29.6.2013 , p. 35 ). 
2 OJ L 25, 2.2.2016,  p. 30 . 
3 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 9 1/414/EEC  (OJ L 70, 16.3.2005, p. 1 ). 
4 Reference E02893 in the Register of Commission Expert Groups and other similar entities.  
5 https://ec.europa.eu/food/sites/food/files/safety/docs/labelling -nutrition_expert -
group_20190925_sum.pdf  EN 3  EN 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 pesticide residues , specifying in addition that they may resul t 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 legal certainty and clarity , it is necessary  to bring  the definition  laid 
down in Deleg ated 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 Regulations amend ing 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 list s set out in Annex es II 
and III to Deleg ated Regulation (EU) No 2016/128 . EN 4  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
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  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulatio n (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 and repealing Council 
Directive 92/52/EEC, Com mission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 
2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and 
Commission Regulations (EC) No 41/2009 and (EC) No 953/20096, and in particular 
Article  11(2) thereof,   
Whereas:  
(1) Com mission Delegated Regulation (EU) 2016/1287 lays down , among other issues , 
specific requirements on pesticides  and the residue s thereof, in food for special 
medical purposes developed to satisfy the nutritional requirements of infants and 
young children . 
(2) Delegated Regula tion (EU) 2016/128  defines  residue  of pesticides  by using the 
terminology of Regulation (EC) No 1107/2009  of the European Parliament and of the 
Council8. 
(3) However, Article 3(2)(c) of Regulation (EC) No 396/2005  of the European Parliament 
and of the Council9 provides for a more precise definition of pesticide residues .  
(4) For reasons of legal certainty and clarity , it is necessary  to align the definition of a 
pesticide residue contained in Delegated Regulation (EU) 2016/ 128 with the definition 
contained in Article 3(2)(c) of Regulation (EC) No 396/2005 .  
(5) 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 list s set out in Annex es II and III to 
                                                 
6 OJ L 181, 29.6.2013, p. 35.  
7 Commi ssion De legated Regulation (EU) 2016/128  of 25 September 2015 supplementing Regulation 
(EU) No 609/2013 of the European P arliament and of the Council as regards the specific compositional 
and information requirements for food for s pecial medical purposes  (OJ L 25, 2.2.2016, p. 30 ). 
8 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concerning the placing of plant protection products on the market and repealing Council Directives 
79/117/EE C and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).  
9 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  (OJ L 70, 16.3.2005, p  1). EN 5  EN Deleg ated Regulation (EU) No 2016/128 , in view of future amendments to Regulation 
(EC) No 396/2005 . 
(6) Delegated Regulation (EU) 2016/128  should th erefore be amended accordingly.  
HAS ADOPTED THIS REGULATION : 
Article 1  
Article 3, paragraph 1, of Deleg ated Regulation (EU) No 2016/128  is replaced by the 
following:  
‘1. For the purposes of this Article, ‘residue’ means pesticide residue as referred to in  
point (c) of  Article 3(2) of Regulation (EC) No 396/2005. ’  
 
Article 2  
Annex es II and III to Delegated Regulation (EU) No 2016/128 are amended in accordance 
with the Annex to this Regulation.  
Article 3 
This Regulation  shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN