COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/1709 
of 23 September 2021
amending Implementing Regulation (EU) 2019/627 as regards unifor m practical arrangements for the 
perfor mance of official controls on products of animal origin 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng 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 perf ormed to ensure the application of food and feed law, rules on animal health and 
welf are, plant health and plant protection products, amending 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 1099/2009 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/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Offici al 
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 performe d by the 
compet ent author ities 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 distr ibution. In particular , it provides for official controls in 
relation to products of animal origin intended for human consum ption.
(2) Commission Implemen ting Regulation (EU) 2019/627 (2)lays down rules on the practical arrang ements for the 
performa nce 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 Implementing Regulation (EU) 2019/627 on 14 December 2019 , exper iences on the 
practical implementation of this Regulation highlight ed the need for more clarity of certain legal provi sions, in 
particular with regard to certain practical arrangements for post-mor tem inspection and recognised methods for 
detection of mar ine biot oxins in bivalve molluscs.
(4) As regards practical arrangements for post-mor tem inspection, Imp lementing Regulation (EU) 2019/627 should not 
specify who is to carry out the additional practical arrangements for post-mor tem inspection in case of a possible 
risk to human health, animal health or animal welf are. Whether the official veterinar ian or the official auxiliar y 
should carry out post-mor tem inspection is already laid down in Article 18.2(c) of Regulation (EU) 2017/625, 
supplemente d by Articles 7 and 8 of Commission Delegat ed Regulation (EU) 2019/624 (3)and is theref ore not 
required in Implementing Regulation (EU) 2019/627. In addition, a duplication of the requirement for an incision 
of the bronchial and mediastinal lymph nodes in Article 19(1)(b) and (2)(b) should be avoided.
(1)OJ L 95, 7.4.2017, p. 1.
(2)Commission Implementing Regulation (EU) 2019/627 of 15 March 2019 laying down unif orm practical arrangements for the 
perf ormance of official controls on products of animal origin intended for human consump tion in accordance with Regulation (EU) 
2017/625 of the European Parliament and of the Council and amending Commission Regulation (EC) No 2074/2005 as regar ds 
official controls (OJ L 131, 17.5.2019, p. 51).
(3)Commission Delegat ed Regulation (EU) 2019/624 of 8 Febr uary 2019 concer ning specific rules for the perfor mances 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, 17.5.2019, p. 1).EN Offi cial Jour nal of the European Union L 339/84 24.9.2021  (5) In addition, requirements for post-mor tem 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 
imp lementation of the Regulation.
(6) Article 22 of Council Regulation (EC) No 1099/2009 (4)has been deleted from 14 December 2019 on by Regulation 
(EU) 2017/625. Measures in cases of noncompl iance with the requirements for animal welfare, refer red to in that 
Article were replaced by provisions in Article 138 of Regulation (EU) 2017/625. The reference to Article 22 of 
Regulation (EC) No 1099/2009 in Article 44(1) of Implementing Regulation (EU) 2019/627 should theref ore be 
delet ed according ly.
(7) Article 48 of Implementing Regulation (EU) 2019/627 lays down conditions for health marking. These conditions 
are as already established in Commission Implementing Regulation (EU) 2015/1375 (5)in case of Trichinella testin g, 
and in Regulation (EC) No 999/2001 of the European Parliament and of the Council (6)for the testing of 
transmissible spongif orm encephalopath y (TSE). For reasons of clarity, it is appropr iate to replace the wordings 
concer ned in Article 48 of Implementing Regulation (EU) 2019/627 by references to the relevant Regulations.
(8) Article 4 of Directive 2010/63/EU of the European Parliament and of the Council (7)requires Member States to 
ensure that, wherever possible, a method not entailing the use of live animals is to be used. Taking into account that 
for the detection of Paralytic Shellfish Poisoning (PSP) toxins the Standard EN 14526 is available as an alternati ve 
method, compl ying with the conditions of Article 4 of Directive 2010/63/EU, the use of the mouse bioassa y should 
theref ore be discontinued.
(9) Live bivalve molluscs placed on the mark et are not to contain mar ine biot oxins that excee d the limits established in 
Annex III, Section VII, Chapt er V (2) of Regulation (EC) No 853/2004 of the European Parliament and of the 
Council (8). Regarding Pectenot oxins (PTX), the European Food Safety Author ity (EFSA ) has concluded that there are 
no repor ts on adverse effects in humans associated with Pectenot oxins (PTX) group toxins (9). As PTX have been 
remo ved from the health standards for live bivalve molluscs in Commission Delegat ed Regulation (EU) 
2021/1374 (10), it is theref ore appropr iate to remo ve them as well from the provisions of Implementing Regulation 
(EU) 2019/627.
(10) Fisher y products derived from aquaculture are to be tested in accordance with Council Directive 96/23/EC (11)and 
Commission Decision 97/747/EC (12)as regards contaminants and pesticides. Wild caught fisher y products should 
also be tested to establish compliance as regar ds contaminants in accordance with Commission Regulation (EC) 
No 1881/2006 (13). The current legislation should be modifi ed according ly.
(11) Implementing Regulation (EU) 2019/627 should be amended according ly.
(12) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
(4)Council Regulation (EC) No 1099/2009 of 24 Sept ember 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 spongif orm 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 purposes (OJ L 276, 20.10.2010, p. 33).
(8)Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 Apr il 2004 laying down specific hygiene rules for 
food of animal origin (OJ L 139, 30.4.2004, p. 55)
(9)https://doi.org/10.2903/j.efsa.2009.1109
(10)Commission Delegat ed Regulation (EU) 2021/1374 of 12 Apr il 2021 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 297, 20.8.2021, p. 1).
(11)Council Directive 96/23/EC of 29 Apr il 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)
(12)Commission Decision 97/747/EC of 27 Octo ber 1997 fixing the levels and frequencies of sampling provided for by Council Directive 
96/23/EC for the monit oring of certain substances and residues thereof in certain animal products (OJ L 303, 6.11.1997, p. 12)
(13)Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (OJ 
L 364, 20.12.2006, p. 5)EN Offi cial Jour nal of the European Union 24.9.2021 L 339/85  HAS ADOPTED THIS REGUL ATION:
Article 1
Implementing Regulation (EU) 2019/627 is amended as follo ws:
(1) in Articles 18(3), 19(2), 20(2), 21(2), 22(2) and 23(2), the introduct ory sentence is replaced by the following:
‘Post-mor tem inspection procedures shall be carried out in accordance with Article 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 welfa re indicate d in accordance 
with Article 24:’;
(2) in Article 19(2), point (b), the words ‘an incision of the bronc hial and mediastinal lymph nodes (Lnn. bifurc ationes, 
epar teriales and mediastinales);’ are delet ed.
(3) in Article 24, the introduct ory senten ce is replaced by the follo wing:
‘The additional post-mor tem inspection procedures refer red to in Articles 18(3), 19(2), 20(2), 21(2), 22(2) and 23(2) 
shall be carried out using incision and palpation of the carcase and offal, where, in the opinion of the official 
veterinar ian, a possible risk to human health, animal health or animal welfare is indicate d by one of the following:’;
(4) In Article 27(1), point(c) is replaced by the followi ng:
‘(c) in the case of other game ungulate s, not covered by points (a) and (b) the post-mor tem procedures for bovine 
animals laid down in Article 19;’;
(5) in Article 44, paragraph 1 is replaced by the followi ng:
‘1. In cases of non-com pliance with the rules concer ning 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 Regulation (EC) No 1099/2009, the official veterinar ian 
shall verify that the food business operat or immediately take s the necessar y corrective measures and prevents 
recur rence.’;
(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 lagomor phs, having 
undergone ante-mor tem and post-mor tem inspection, and large wild game having undergone post mor tem 
inspection, in accordance with Article 18(2)(a), (b) and (c) of Regulation (EU) 2017/625, where there are no 
grounds for declar ing the meat unfit for human consum ption. However , the 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 Chapt er A of Annex III to 
Regulation (EC) No 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 followi ng 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.EN Offi cial Jour nal of the European Union L 339/86 24.9.2021  Done at Brussels, 23 Septembe r 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 24.9.2021 L 339/87  ANNEX 
Annex V and Annex VI to Implementing Regulation (EU) 2019/627 are amended as follows:
(1) in Annex V Chapt er I is replaced by the followi ng:
‘CHAPTER I
PARAL YTIC SHELLFISH POISON DETECTION METHOD
A. The paralytic shellf ish poisoning (PSP) toxins cont ent of the whole body or any part edible separately of bivalve 
molluscs shall be deter mined using the method descr ibed in the Standard EN 14526 (*) or any other 
internati onally recognised validate d method not entailing the use of a live animal.
B. The abov ementioned methods shall deter mine at least the followi ng compo unds:
(a) Toxins Carbamat e STX, NeoSTX, gonyaut oxin 1 and 4 (GTX1 and GTX4 isomers deter mined together) and 
gonyaut oxin 2 and 3 (GTX2 and GTX3 isomers determined together);
(b) Toxins N-sulf o-carbamo yl (B1), gonyaut oxin-6 (B2), N-sulf ocarbamo yl-gonyaut oxin 1 and 2 (C1 and C2 
isomers determined together), N-sulf ocarbamo yl-gonyaut oxin 3 and 4 (C3 and C4 isomers deter mined 
together);
(c) Toxins decarbamo yl dcSTX, dcNeoSTX, decarbamo ylgonyaut oxin-2 and -3 (isomers determined together).
B.1. If new analogues of the above toxins, for whic h a toxicity equivalent factor (TEF) has been established, appear , they 
shall be included in the analysis;
B.2. Total toxicity will be expressed in μg STX 2HCL equivalents/Kg and shall be calculated using TEFs as 
recommended in the most recent EFSA opinion or FAO OMS repor t, upon proposal of the European Reference 
Laboratory for mar ine bioto xins and its National Reference Laborat ories netw ork and acceptance by the 
European Commission. The TEFs used will be published in the European Reference Laborator y for mar ine 
bioto xins website (**);
C. If the results are challenged, the reference method shall be the method descr ibed in the Standard EN 14526 as 
refer red in Part A.
_____________
(*) Determination of saxit oxin-group toxins in shellf ish – HPLC method using pre-column derivatization with 
pero xide or periodate oxidation.
(**) http://www .aecosan.msssi.gob.es/en/CRLMB/web/home.html ”;
(2) in Annex V, Chapt er III, point (b) of Part A is delet ed;
(3) in Annex VI, Part D of Chapt er I, a new paragraph is added at the end:
‘For wild caught fisher y products monitor ing arrange ments shall be established to control compliance with the EU 
legislation on contaminants, in accordance with Regulation (EC) No 1881/2006 setting maximum levels for certain 
contaminants in food’ .EN Offi cial Jour nal of the European Union L 339/88 24.9.2021