EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10764/2021 
(POOL/E2/2021/10764/10764 -EN.docx)  
[…](2022) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing Regulation (EU) 2017/625 of the European Parliament and of the 
Council by laying down rules for the performance of official controls as regards 
contaminants in food  
(Text with EEA relevance)    
EN 1  EN COMMISSION DELEGATED REGULATION (EU) C(2022) 744  
of XXX  
supplementing Regulation (EU) 2017/625 of the European Parliament and of the 
Council by laying down rules for the performance of official controls as regards 
contaminants in food  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EU) 2017/625 of  the European Parliament and of the Council of 
15 March 2017 on official controls and other official activities performed to ensure the 
application of food and feed law, rules on animal health and welfare, plant health and plant 
protection products, amendi ng Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 
1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and 
(EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 
1/2005 and (EC) No 109 9/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 
2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 
882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 
89/662/EEC, 90/425/EE C, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council 
Decision 92/438/EEC (Official Controls Regulation ) (1), and in particular Article 19(2) , point 
(a), thereof,  
Whereas:  
(1) Regulation (EU) 2017/625 lays down rules for the performance of official controls and 
other official activities by the competent authorities of the Member States for verifying 
compliance with Union legislation on food and food safety. Article 109 of that 
Regulation provides for an obligation for Member States to ensure that official 
controls are performed by the competent authorities on the basis of a multi -annual 
national control plan (‘MANCP’). Regulation (EU) 2017/625 furthermore specifies the 
general co ntent of the MANCP, requires Member States to provide in their MANCP 
official controls on contaminants in food and, in this regard, empowers the 
Commission to lay down specific requirements for the performance of official 
controls, including, where appropr iate, the range of samples and the stage of 
production, processing and distribution where the samples are to be taken .  
(2) Regulation (EU) 2017/625 repealed Council Directive 96/23/EC  (2), which provided 
measures to monitor certain substances, including conta minants, in live animals and 
products of animal origin and specifically set requirements for Member States’ 
monitoring plans for the detection of residues or substances within its scope. However, 
Regulation (EU) 2017/625 does not incorporate all the measur es provided for in that 
                                                 
(1) OJ L 95, 7.4.2017, p. 1.  
(2) Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues 
thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and 
Decisions 89/187/EEC and 91/664/EEC (OJ L 125, 23.5.1996, p. 10).    
EN 2  EN Directive or in the acts adopted by the Commission on its basis. This Regulation 
together with Commission Implementing  Regulation (EU) C(2022) 740  [publications  
office please add here the number of this  Regulation once it is associa ted, along the 
whole Regulation ] (3) aims therefore at ensuring continuity of the rules of Directive 
96/23/EC concerning the content of the MANCP and its preparation, as well as the 
range of samples and the stage of production, processing and distribution where the 
samples are to be taken as regards contaminants in food, within the framework of 
Regulation (EU) 2017/625 .  
(3) However,  in line with Article 19 of Regulation  (EU) 2017/625, which refers in a 
comprehensive manner  to contaminants in food, it is appropriate that this Regulation 
applies  also to official controls necessary to detect the presence of all contaminants 
falling within the scope of Council Regulation (EEC) No 315/93  (4). Therefore,  this 
Regulation should ap ply to the official controls necessary to detect the presence in 
food of contaminants for which maximum levels or other regulatory levels requiring or 
triggering action by the competent authorities are established by Union legislation .  
(4) The presence of mer cury in food can be considered to occur due to environmental 
contamination since pesticides containing mercury have now been prohibited in the 
Union for more than thirty years . Official controls as regards maximum levels of 
mercury compounds as set out in Regulation (EC) No 396/2005 of the European 
Parliament and of the Council  (5). Commission Directive 2006/125/EC  (6), 
Commission Delegated Regulation (EU) 2016/127  (7) and Commission Delegated 
Regulation (EU) 2016/128  (8) should  therefore  also be covered by this Regulation 
instead of the specific rules on controls for residues of pesticides . 
(5) In order to ensure that official controls are efficiently targeted in all Member States, it 
is appropriate to set out rules on the combinations of con taminants or contaminant 
groups and commodit y groups to be sample d by Member States and the sampling 
strategy , including  criteria to use for defining the content of their plans  and the 
performance of the related official controls . 
(6) It is therefore appropria te to supplement Article 19(1) of Regulation (EU) 2017/625 by 
laying down rules for the performance of the official controls as regards contaminants  
in food . 
                                                 
(3) Commission Implementing Regulation (EU ) C(2022) 740 of XXX on uniform practical arrangements 
for the performance of official controls as regards contaminants in food, on specific additional content 
of multi -annual national control plans and specific additional arrangements for their preparation  (…,…, 
p….).  
(4) Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community pr ocedures for 
contaminants in food (OJ L 37, 13.2.1993, p. 1).  
(5) 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 am ending 
Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).  
(6) Commission Directive 2006/125/EC of 5 December 2006 on processed cereal -based foods and baby 
foods for infants and young children  (OJ L 339, 6.12.2006, p. 16 ). 
(7) 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 compositional 
and information requirements for infant formula and follow -on formula and as regards  requirements on 
information relating to infant and young child feeding  (OJ L 25 , 2.2.2016, p. 1) . 
(8) Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation 
(EU) No 609/2013 of the European Parliament and of the Counci l as regards the specific compositional 
and information requirements for food for special medical purposes  (OJ L 25 , 2.2.2016, p. 30) .  
EN 3  EN (7) Article 150(1) of the Regulation (EU) 2017/625 lays down a transitional period 
obliging Member States to perform official controls in accordance with Directive 
96/23/EC until 14 December 2022. Article 19(1) of Regulation (EU) 2017/625 
provides that official controls to verify compliance with the rules on food and food 
safety as well as feed a nd feed safety shall include official controls on relevant 
substances including substances to be used in food contact materials, contaminants, 
non-authorised, prohibited and undesirable substances whose use or presence on crops 
or animals or to produce or process food or feed may result in residues of those 
substances in food or feed.  However, since the last monitoring plans adopted by 
Member States under Directive 96/23/EC will apply to the year 2022, and thus beyond 
14 December 2022 , it is appropriate tha t this Regulation applies from 1 January 2023 .  
HAS ADOPTED THIS REGULATION:  
Article 1  
For the purposes of this Regulation, the definition of ‘contaminant ’ in Article 1( 1), second 
subparagraph of Council Regulation (EEC) No 315/93 applies.   
Article 2 
Membe r States shall control  the presence of contaminants  in food in accordance with Annex I . 
Member States shall adopt a sampling strategy  in accordance with the criteria set out in 
Annex II . 
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 . 
It shall apply from 1 January 2023.  
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