EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12696/2020 
(POOL/E1/2020/12696/12696 -EN.docx)  
[…](2021) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Delegated Regulation (EU) No 2016/127 as regards the requirements on 
pesticides in infant formula and follow -on formula  
(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 , among other  acts, 
Commission Delegated Regulation (EU)  No 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 formula and follow -on formula and as regards requirements on information 
relating to infant and young child feeding2. 
This delegated Regulation aims to amend Delegated Regulation (EU)  No 2016/127 
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) 2016/127 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 2016/127 , subject to the 
general requirements  set out in Articles 6 and 9 of the same Regulation, to the 
                                                 
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 repealing 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. 1  
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 91/414/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 additional requirements of Article 10, and taking into account relevant technical and 
scien tific progress . 
The proposed amendments  to Delegated Regulation (EU) No 2016/127 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 Delegated Regulation (EU) No 2016/127  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 IV and V  to Delegated Regulation (EU) No 2016/127.  
 EN 4  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Delegated Regulation (EU) No 2016/127 as regards the requirements on 
pesticides in infant formula and follow -on formula  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EU) No 609/2013  of the European Parliament and of the 
Council of 12 June 201 3 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, 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 953/20096, and in particular 
Article  11(2) thereof,   
Whereas:  
(1) Commi ssion Delegated Regulation (EU) 2016/1277 lays down , among other issues,  
specific requirements on pesticides and the residues thereof in infant formula and  in 
follow -on formula .  
(2) Delegated Regula tion (EU) 2016/127 defines residue  of pesticides by using the 
terminology of Regulation (EC) No 1107/2009  of the European Parliament and of the 
Council 8. 
(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 
pesticide residue contained in Delegated Regulation (EU) 2016/127 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 IV and V to 
                                                 
6 OJ L 181, 29.6.2013, p. 35.  
7 Commi ssion 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 formulae and follow -on formulae and as regards requirements 
on information relating to infant and young child feeding  (OJ L 25, 2.2.2016, p. 1 ). 
8 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concerni ng the placing of plant protection products on the market and repealing Council Directives 
79/117/EEC 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 Delegated Regulation (EU) No 2016/127 in view of future amendments to Regulation 
(EC) No 396/2005 . 
(6) Delegated Regulation (EU) 2016/127 should th erefore be amended accordingly.  
HAS ADOPTED THIS REGULATION : 
Article 1  
Article 4, paragraph 1 of Delegated Regulation (EU) No 2016/127 is replaced by the 
following:  
‘1. For the purposes of this Article, ‘residue’  means  pesticide residue as referred to in  point 
(c) Article 3(2) of Regulation (EC) No 396/ 2005.’  
Article 2 
Annexes IV and V to Delegated Regulation (EU) No 2016/127 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 Commissi on 
 The President  
 Ursula VON DER LEYEN