COMMISSION IMPLEMENTING DECISION (EU) 2019/2098 
of 28 November 2019 
on temporar y animal health requirements for consignments of products of animal origin for human 
consumption originating in and retur ning to the Union follo wing a refusal of entr y by a third 
countr y 
(notified under document C(2019)8092) 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng regar d to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the 
production, processing, distr ibution and introduction of products of animal origin for human consum ption (1), and in 
particular the third indent of point 5 of Article 8 thereof, 
Whereas: 
(1) Directive 2002/99/EC lays down the general animal health rules govern ing the introduction into the Union of 
products of animal origin intended for human consump tion from third countr ies. More particularly , it provi des for 
the adoption by the Commission of rules concer ning certain types of introduction of those products. The animal 
health rules laid down in that Directive do not affect, and are applied in parallel with, the rules on veteri nary chec ks 
laid down in Council Directive 97/78/EC (2). 
(2) Directive 97/78/EC lays down rules governing the organisation of veteri nary chec ks on consignments of products of 
animal origin entering the Union from third countr ies, including products falling within the scope of Directive 
2002/99/EC. Article 15 of Directive 97/78/EC provid es that Member States are to author ise the re-imp ortation of 
such products where they have been refused by a third countr y, subject to certain conditions. Those conditions 
include certificat ion requirements, and they are intende d to protect public and animal health. 
(3) Regulation (EU) 2017/625 of the European Parliament and of the Council (3) repealed Directive 97/78/EC with effect 
from 14 December 2019. That Regulation established a new legal framewor k for official controls and other official 
activities to verify the correct application of Union agri-food chain legislation. It lays down rules concer ning, inter 
alia, official controls on consignments of products of animal origin entering the Union, including food. In addition, 
Regulation (EU) 2016/429 of the European Parliament and of the Council (4) repealed Directive 2002/99/EC with 
effect from 21 Apr il 2021. Regulation (EU) 2016/429 lays down rules for the prevention of animal diseases, 
including rules for the entr y into the Union of products of animal origin. The rules laid down in those two 
Regulations are applied in parallel, but while the rules laid down in Regulation (EU) 2017/625 are horizontal in 
nature, those laid down in Regulation (EU) 2016/429 are more sector -specifi c as they concer n animal health. 
(4) Supplementar y rules have now been established by Commission Delegat ed Regulation (EU) 2019/2074 (5) under 
Regulation (EU) 2017/625 for the performance of official controls on consignments of animals and goods 
originating from and retur ning to the Union follo wing a refusal of entr y by a third countr y. Those supplementing 
(1)OJ L 18, 23.1.2003, p. 11. 
(2)Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinar y chec ks on 
products entering the Community from third countr ies (OJ L 24, 30.1.1998, p. 9). 
(3)Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official 
activities perfor med to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant 
prot ection 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 (Offic ial Controls Regulation) (OJ L 95, 7.4.2017, p. 1). 
(4)Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and 
amending and repealing certain acts in the area of animal health (Animal Health Law) (OJ L 84, 31.3.2016, p. 1). 
(5)Commission Delegat ed Regulation (EU) 2019/2074 of 23 Sept ember 2019 supplementing Regulation (EU) 2017/625 of the European 
Parliament and of the Council as regards rules on specific official controls on consignments of certain animals and goods originating 
from, and retur ning to the Union following a refusal of entr y by a third countr y (OJ L 316, 6.12.2019, p. 6). EN Offi cial Jour nal of the European Union 9.12.2019                                                                                                                                        L 317/111   rules aim to verify compl iance of the retur ning consignments with, inter alia, animal health requirements and refer 
to those requirements as set out in Union animal health rules. That Delegat ed Regulation applies from 
14 December 2019, in line with the date of application of Regulation (EU) 2017/625. 
(5) Commission acts for the implementation of Directive 2002/99/EC currently do not lay down specifi c animal health 
requirements for the re-entr y into the Union of products of animal origin, whic h have been expor ted from the Union 
and have been refused entr y by a third countr y. Theref ore animal health requirements specific for the re-entr y into 
the Union of consignments of products of animal origin destined for human consum ption, whic h have been 
expor ted from the Union and have been refused entr y by third countr ies should be laid down to provide lega l 
certainty as regards the animal health requirements applicable to those consignments, and to mitig ate poten tial 
animal health risks after 14 December 2019, followi ng the repeal of Directive 97/78/EC. 
(6) In particular , the unloading, storage and re-loading of these products in third countr ies should not lead to risks for 
the spread and introduction into the Union of pathogen s of certain listed animal diseases referred to in Annex I to 
Directive 2002/99/EC. 
(7) In addition to the original documents issued by the compet ent author ity of the Member State of expor t, it should 
also be permissible to verify the origin of consignments of products of animal origin for human consum ption on 
the basis of the electronic equivalent of the original official certificate submitt ed in the information manag ement 
system for official controls refer red to in Article 131 of Regulation (EU) 2017/625 (IMSOC) and established by 
Commission Implementing Regulation (EU) 2019/1715 (6). 
(8) A consignment of products of animal origin for human consump tion which has been retur ned to the Union 
follo wing refusal of entr y by a third countr y should be allowed to be transpor ted to a place of destination in the 
Union, where the compe tent author ity of the place of destination in the Union has agreed to receive that 
consignment. 
(9) It is necessar y to ensure that consignments of products of animal origin for human consump tion which have been 
retur ned to the Union follo wing a refusal of entr y by a third countr y arrive at their place of destination in the 
Union. Theref ore, the procedural requirements laid down in Commission Delegat ed Regulation (EU) 2019/1666 (7) 
should apply to the monitori ng of the transpor t and arrival of such consignments, from the border control post of 
arrival into the Union to the establishment at the place of destination. 
(10) The animal health requirements laid down in this Implementing Decision should apply until 21 Apr il 2021, as 
Regulation (EU) 2016/429 and the Commission Delegat ed Regulation on animal health rules for the entr y into the 
Union, move ment and handling after the entr y of certain animals, germinal products and products of animal origin 
from third countr ies or territori es, apply from that date. 
(11) The measures provided for in this Decision are in accordance with the opinion of the Standing Committ ee on Plants, 
Animals, Food and Feed, 
HAS ADOPTED THIS DECISION: 
Article 1 
1. The compet ent author ity at the border control post shall author ise the entr y into the Union of consignments of 
products of animal origin defined in Article 2(4) of Council Directive 2002/99/EC originating in and retur ning to 
the Union followi ng a refusal of entr y by a third countr y where the follo wing requirements are fulfilled: 
(a) the consignment is accompan ied by the original official certificate or document issued by the compet ent 
author ity of the Member State of expor t, or its electronic equivalent submitte d in the information management 
system for official controls refer red to in Article 131 of Regulation (EU) 2017/625 (IMSOC) and established by 
Implementing Regulation (EU) 2019/1715 or an authenticated copy thereof; 
(6)Commission Implementing Regulation (EU) 2019/1715 of 30 September 2019 laying down rules for the functioning of the 
information management system for official controls and its system components (‘the IMSOC Regulation’) (OJ L 261, 14.10.2019, 
p. 37). 
(7)Commission Delegat ed Regulation (EU) 2019/1666 of 24 June 2019 supplementing Regulation (EU) 2017/625 of European 
Parliament and the Council as regar ds conditions for monitoring the transpor t and arrival of consignments of certain goods from the 
border control post of arrival to the establishment at the place of destination in the Union (OJ L 255, 4.10.2019, p. 1). EN Offi cial Jour nal of the European Union L 317/112                                                                                                                                       9.12.2019   (b) the consignment is accompanied by a declaration from the compet ent author ity of the place of destination in the 
Union conf irming that it agrees to receive the consignment and indicating the place of destination for its retur n 
to the Union; 
(c) the consignment is accompanied by one of the followi ng documents indicating the reason for the refusal of 
entr y by the third countr y, where applicable the place and date of unloading, storage and re-loading in the third 
countr y, and the followi ng information: 
(i) in the case of containers or packag es with an intact original seal, a declaration by the operat or responsible 
for the consignment conf irming that the transpor t has take n place under conditions appropr iate for the 
type of products of animal origin and the cont ents of the consignment were not altered during the 
transpor t; or 
(ii) an official declaration of the compet ent author ity or other public author ity of the third countr y confir ming 
that the requirements of point (d) have been compl ied with; 
(d) where the products of animal origin were unloaded in a third countr y, the compe tent author ity or other public 
author ity of the third countr y has attes ted that : 
(i) the products of animal origin did not undergo any handling other than the unloading, storag e and re- 
loading in the third countr y; 
(ii) effective measures were put in place to avoid the contamination of the products of animal origin with 
disease agents which cause transmissible animal diseases listed in Annex I to Directive 2002/99/EC during 
the unloading, storag e and re-loading in the third countr y; 
(iii) the place of any unloading, stora ge and re-loading in the third countr y was not subject to animal health 
move ment restr ictions due to transmissible animal diseases listed in Annex I to Directive 2002/99/EC 
during the unloading, storage and re-loading in the third countr y. 
2. By way of derogation from paragraph 1(a), in cases where the documentation refer red to in that provi sion was not 
issued by the compet ent author ity of the Member State of expor t, the origin of the consignment shall be 
authenticated in another way based on documented evidence present ed by the operat or responsible for the 
consignment. 
3. The compet ent author ity at the border control post shall monit or the transpor t to and arrival at the place of the 
destination of the consignment of the products of animal origin in accordance with Articles 2 and 3 of Commission 
Delegat ed Regulation (EU) 2019/1666. 
Article 2 
This Decision shall apply from 14 December 2019 to 21 Apr il 2021. 
Article 3 
This Decision is addressed to the Member States. 
Done at Brussels, 28 November 2019.  
For the Commission 
Vytenis ANDRIUKAITIS 
Member of the Commission     EN Offi cial Jour nal of the European Union 9.12.2019                                                                                                                                        L 317/113