EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10426/2020 feedback 
(POOL/G4/2020/10426/10426 -EN 
feedback.docx)  
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Commission Implementing Regulation (EU) 2019/627 as regards uniform 
practical arrangements for the performance of official controls on products of animal 
origin  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Commission Implementing Regulation (EU) 2019/627 as regards uniform 
practical arrangements for the performance of official controls on products of animal 
origin  
(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 Eur opean 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, amending Regul ations (EC) No 999/2001, (EC) No 396/2005, (EC) No 
1069/2009, (EC) 1107/2009, (EU) 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 1099/2009 and Cou ncil 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/EEC, 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 18(8) thereof,  
Whereas:  
(1) Regulation (EU) 2017/625 lays down rules for the official controls and other official 
activities performed b y the competent authorities of the Member States to verify 
compliance with Union legislation inter alia in the area of food safety at all stages of 
production, processing and distribution. In particular, it provides for official controls 
in relation to pro ducts of animal origin intended for human consumption.  
(2) Commission Implementing Regulation (EU) 2019/6272 lays down rules on the 
practical arrangements for the performance of official controls on products of animal 
origin in accordance with Article 18(8) of  Regulation (EU) 2017/625.  
(3) Since the date of application of Regulation (EU) 2019/627 on 14 December 2019, 
experiences on the practical implementation of this Regulation highlighted the need 
for more clarity of certain legal provisions, in particular with regard to certain practical 
arrangements for post -mortem inspection and recognised methods for detection of 
marine biotoxins in bivalve molluscs . 
                                                 
1  OJ L 95, 7.4.2017, p. 1.  
2  Commission Implementing Regulation (EU) 2019/627 of 15 March 2019 laying down uniform practical 
arrangements for the performance of official controls on products of animal origin intended for human 
consumption in accordance with Regulation (EU) 2017/625 of  the European Parliament and of the 
Council and amending Commission Regulation (EC) No 2074/2005 as regards official controls (OJ L 
131, 17.5.2019, p. 51)   
EN 2  EN (4) As regards practical arrangements for post -mortem inspection, Implementing 
Regulation (EU) 2019/627 should not specify who is to carry out  the additional 
practical arrangements for post -mortem inspection in case of a possible risk to human 
health, animal health or animal welfare. Whether the official veterinarian or the 
official auxiliary should carry out post -mortem inspection is already laid down in 
Article 18.2(c) of Regulation (EU) 2017/625 , supplemented by Articles 7 and 8 of 
Commission Delegated Regulation (EU) 2019/6243 and is therefore not required in 
Implementing Regulation (EU) 2019/627 . In addition, a duplication of the requirement  
for an incision of the bronchial and mediastinal lymph in Article 19 (1)(b) and (2)(b) of 
Implementing Regulation (EU) 2019/627 should be avoided.  
(5) In addition, requirements for post -mortem inspection for farmed game contain 
duplications in particular with regard to requirements applicable to  the family of 
Suidae . The requirements  should be further clarified to facilitate implementation of the 
Regulation . 
(6) Article 22 of Council Regulation (EC) No 1099/20094 has been deleted from 14  
December 2019 by Regulation (EU) 2017/625. Measures in cases of noncompliance 
with the requirements for animal welfare, referred to in that Article were  replaced by 
provisions in Article 138  of Regulation (EU) 2017/625. The reference to Article 22 of 
Counc il Regulation (EC)  No 1099/2009 in Article 44(1) of Regulation (EU) 2019/627 
should therefore be deleted accordingly . 
(7) Article 48 of Regulation (EU) 2019/627 lays down conditions for  health marking. 
These  conditions are as already established  in Commission Implementing Regulation 
(EU) 2015/13755 in case of Trichinella  testing, and in Regulation (EC) No 999/20016 
for the testing of transmissible spongiform encephalopathy  (TSE) . For reasons  of 
clarity , it is appropriate to replace the wordings concerned in Article 48 of Regulation 
(EU) 2019/627 by references to the relevant Regulations.  
(8) Article 4 of Directive 2010/63/EU7 requires Member States to ensure that, wherever 
possible, a method not entailing  the u se of live animals is to be used. Taking  into 
account that for the detection of Paralytic Shellfish Poison ing (PSP) toxins , the 
Standard EN 14526 is available as an alternative method , which compl ies with the 
conditions of Article 4 of Directive 2010/63/EU , the use of the mouse bioassay should 
therefore be discontinued ; 
(9) Live b ivalve molluscs placed on the market are not to contain marine biotoxins that 
exceed the limits established in Annex III, Section VII, Chapter V (2) of Regulation 
(EU) N o 853/20048. Regarding Pectenotoxins (PTX), the Europe an Food Safety 
                                                 
3 Commission Delegated Regulation (EU) 2019/624 of 8 February 2019 concerning specific rules for the  
performances of official controls on the production of meat and relaying areas of live bivalve molluscs 
in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council (OJ L 
131, 17.05.2019, p. 1)  
4 Council Regulation (EC) No 109 9/2009 of 24 September 2009 on the protection of animals at the time of 
killing ( OJ L 303, 18.11.2009, p. 1 ) 
5 Commission Implementing Regulation (EU) 2015/1375 of 10 August 2015 laying down specific rules on 
official controls for Trichinella  in meat (OJ L 212, 11.8.2015, p. 7)  
6 Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down 
rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies ( OJ 
L 147, 31 .5.2001, p. 1)  
7 Directive 2010/63/EU  of the European Parliament and of the Council of 22 September 2010 on the protection 
of animals used for scientific p urposes ( OJ L 276, 20.10.2010, p. 33 ) 
8 Regulation (EC) N° 853/2004 of the European Parliament and of  the Council of 29 April 2004 laying 
down specific hygiene rules for food of animal origin OJ L 139 30.4.2004, p. 55   
EN 3  EN Authority ( EFSA ) has concluded that there are no reports on adverse effects in humans 
associated with PTX group toxins9. As PTX have been removed from the health 
standards in live bivalve  molluscs in Delegated Regulation [SANTE 10432/202010, it 
is therefore appropriate to remove them as well from  the provisions of  Commission 
Implementing Regulation (EU) 2019 /627. 
(10) Fishery products derived from aquaculture are  to be tested in accordance with 
Directive 96/23/EC11 and Decision 97/747/EC12 as regards  contaminants and 
pesticides. Wild caught fishery products should also be tested to establish compliance 
as regards contaminants  in accordance with Regulation (EC) No 1881/200613. The 
current legislation should be modified accordingly.  
(11) Implementing Regulati on (EU) 2019/627 should be amended accordingly.  
(12) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Implementing Regulation (EU) 2019/627 is amended as follows:  
1) In Articles 18 (3), 19(2), 20(2), 21(2), 22(2) and 23 (2), the introductory sentenc e is replaced 
by the following:  
’Post-mortem inspection procedures shall be carried out in accordance with Art icle 18 
(2)(c) of Regulation (EU) 2017/625 and Article 7 and 8 of Regulation (EU) 2019/624, 
using incision and palpation of the carcase and offal, when there are indications of a 
possible risk to human health, animal health or animal welfare indicated in accordance 
with Article 24 :’ 
2) In Article 19 (2), point (b), the words ‘ an incision of the bronchial and mediastinal lymph 
nodes ( Lnn. bifurcationes, eparteriales and mediastinales );’ are deleted.  
3) In Article 24, the introductory sentence is replaced by the following:  
’The additional  post-mortem inspection procedures referred to in Articles 18(3), 19(2), 
20(2), 21(2), 22(2) and 23(2) shall be carried out using incisions and palpations of the 
carcase and offal, where, in the opinion of the official veterinarian, a possible risk to 
human health, animal health or animal welfare  is indicated by one of the following :’  
                                                                                                                                                         
 
9 https://doi.org/10.2903/j.efsa.2009.1109  
10 Commission Delegated Regulation XXXX/YYY of ../../…. amending Annex III to Regulation (EC) No  
853/2004 of the European Parliament and of the Council on specific hygiene requirements for food of 
animal origin  (OJ L …, ../../…., p. ..)[SANTE/10432/2020]  
11 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 –32 
 
12 Commission Decision 97/747/EC of 27 October 1997 fixing the levels and frequencies of sampling provided 
for by Council Directive 96/23/EC for the monitoring of certain substances and residues thereof in 
certain animal products  OJ L 303, 6.11.1997, p. 12 –15 
  
13 Commission Regulation (EC) No 1881/2006 of 19 December 2006 settin g maximum levels for certain 
contaminants in foodstuffs OJ L 364, 20.12.2006, p. 5 –24 
    
EN 4  EN 4) In Article 27(1), point  (c) is replaced by the following:  
‘(c) in the case of ot her game ungulates, not covered by points (a) and (b) the post -mortem 
procedures for bovine animals laid down in Article 19 ;’ 
5) In Article 44, paragraph 1 is replaced by the following:   
’1. In cases of non compliance with the rules concerning the protection of animals  at the 
time of slaughter or killing laid down in Articles 3 to 9 and Articles 14 to 17 and  19 of 
Council Regulation (EC) No 1099/2009, the official veterinarian shall verify that  the food 
business operator immediately takes the necessary corrective measures and  prevents 
recurrence .’  
6)  In Article 48(2), point (a) is replaced by the following:  
‘(a) the health mark is applied only to domestic ungulates and farmed game mammals 
other than lagomorphs, having undergone ante -mortem a nd post mortem inspection, and 
large wild game having undergone post mortem inspection, in accordance with Article 
18(2)(a), (b) and (c) of Regulation (EU) 2017/625, where there are no grounds for 
declaring the meat unfit for human consumption. However, th e mark may be applied 
before the results of any examination for Trichinella  and/or TSE testing are available, in 
accordance with the provisions laid down respectively in Article 4(3) of Implementing 
Regulation (EU) 2015/1375 and in Chapter A of Annex III t o Regulation 999/2001, 
points 6.2 and 6.3 of point I and points 7.2 and 7.3 of point II .’  
7)  Annex V is amended in accordance with the text set out in the Annex  to this Regulation   
 
8)  Annex VI is amended in accordance with the text set out in the Annex  to this Regulation.  
Article 2  
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 Memb er States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER  LEYEN