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Date: 2021-09-13 Category: Not Applicable State: Union Government Country: Europe

Commission Implementing Regulation (EU) 2021/1469 of 10 September 2021 amending Implementing Regulation (EU) 2020/2235 as regards the addition of a new model certificate for products of animal origin that originate in the Union, are moved to a third country or territory and moved back to the Union after unloading, storage and reloading in that third country or territory, amending Implementing Regulation (EU) 2021/404 as regards the list of third countries authorised for entry into the Union of products of animal origin originated in and returning to the Union from a third country or territory, and amending Implementing Regulation (EU) 2021/405 as regards the list of third countries or regions thereof authorised for entry into the Union of products of animal origin and certain goods originated in and returning to the Union from a third country or region thereof (Text with EEA relevance)

Issued by European Commission · Directorate-General for Health and Food Safety

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Executive Summary & Key Takeaways

Executive Summary: This regulation amends Implementing Regulations EU 2020/2235, EU 2021/404, and EU 2021/405. It introduces a new model certificate for products of animal origin that originate in the EU, are moved to a third country, and then returned to the EU after storage. It also updates lists of third countries authorized for entry of these products into the Union. This regulation enters into force on the day following its publication in the Official Journal of the European Union. Key Points / Main Content: Amendments to Implementing Regulation EU 2020/2235: * A new Article 30a is inserted, introducing the model animal health/official certificate "STORAGETCPAO" for products of animal origin and certain goods that originated in the Union, moved to a third country for unloading, storage, and reloading before returning to the Union. * Annex III is amended to include Chapter 53, which provides the model animal health/official certificate STORAGETCPAO. Amendments to Implementing Regulation EU 2021/404: * Annex XXII is amended to update the list of third countries authorized for the entry into the Union of consignments of products of animal origin that originated in the Union, were stored in a third country, and are moved back to the Union. * The entries for the United Kingdom, Guernsey, the Isle of Man and Jersey are replaced. Amendments to Implementing Regulation EU 2021/405: * A new Article 26a is inserted, listing third countries authorized for the entry into the Union of products of animal origin and certain goods that originated from the Union, moved to a third country or region, and moved back to the Union after unloading, storage, and reloading. * Consignments must come from third countries or regions authorized according to Annex XXII to Implementing Regulation EU 2021/404 and listed in Decision 2011/163/EU. Impact Analysis: Member States: * Impact: Must recognize and implement the new STORAGETCPAO certificate model for products of animal origin re-entering the Union after storage in third countries. * Action Required: Update their import control procedures and certification processes to accommodate the new certificate and updated lists of approved third countries. Importers/Businesses: * Impact: Can now import products of animal origin that originated in the Union, were stored in approved third countries, and are returning to the Union, provided they meet the new certification requirements. * Action Required: Use the STORAGETCPAO certificate and ensure compliance with all requirements related to the origin, storage, and transportation of the products. Third Countries: * Impact: Those listed in Annex XXII to Implementing Regulation EU 2021/404 are authorized for the storage and subsequent re-export to the EU of products of animal origin originating in the Union. * Action Required: Ensure establishments involved in the storage and reloading of products of animal origin meet EU standards and are registered/approved by their competent authorities.

Key Entities Referenced

European Union: A political and economic union of member states located primarily in Europe. Commission Implementing Regulation EU 2020/2235: A regulation laying down rules for the application of Regulations EU 2016/429 and EU 2017/625 of the European Parliament and of the Council as regards model animal health certificates. Commission Implementing Regulation EU 2021/404: A regulation laying down the lists of third countries, territories or zones thereof from which the entry into the Union of animals, germinal products and products of animal origin is permitted in accordance with Regulation EU 2016/429 of the European Parliament and the Council. Commission Implementing Regulation EU 2021/405: A regulation laying down the lists of third countries or regions thereof authorised for the entry into the Union of certain animals and goods intended for human consumption in accordance with Regulation EU 2017/625 of the European Parliament and of the Council. Regulation EU 2016/429: Regulation of the European Parliament and of the Council on transmissible animal diseases (Animal Health Law). Regulation EU 2017/625: Regulation of the European Parliament and of the Council on official controls and other official activities performed to ensure the application of food and feed law. Commission Delegated Regulation EU 2020/692: Regulation supplementing Regulation EU 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin Commission Delegated Regulation EU 2019/625: Regulation supplementing Regulation EU 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of certain animals and goods intended for human consumption.
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13.9.2021 EN Official Journal of the European Union L 321/21 COMMISSION IMPLEMENTING REGULATION (EU) 2021/1469 of 10 September 2021 amending Implementing Regulation (EU) 2020/2235 as regards the addition of a new model certificate for products of animal origin that originate in the Union, are moved to a third country or territory and moved back to the Union after unloading, storage and reloading in that third country or territory, amending Implementing Regulation (EU) 2021/404 as regards the list of third countries authorised for entry into the Union of products of animal origin originated in and returning to the Union from a third country or territory, and amending Implementing Regulation (EU) 2021/405 as regards the list of third countries or regions thereof authorised for entry into the Union of products of animal origin and certain goods originated in and returning to the Union from a third country or region thereof (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to 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’)(1), and in particular Articles 230(1), 238(3) and 239(3) thereof, Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017on 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 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 (Official Controls Regulation)(2), and in particular Article 90, first paragraph, points (a) and (e), and Articles 126(3) and 127(2) thereof, Whereas: (1) Regulation (EU) 2016/429 lays down rules on animal diseases that are transmissible to animals or to humans, including requirements for official animal health certification for various movements of animals, germinal products and products of animal origin including requirements for entry into the Union. Those requirements related to the entry into the Union of live animals, germinal products and products of animal origin are further specified in Commission Delegated Regulation (EU) 2020/692(3). (2) Regulation (EU) 2017/625 lays down rules for the performance of official controls and other official activities performed by the competent authorities of the Member States to ensure compliance with the rules referred to in its Article 1(2), among others, rules on food safety at all stages of production, processing and distribution and animal health and welfare requirements and animal by-products. (1) OJ L 84, 31.3.2016, p. 1. (2) OJ L 95, 7.4.2017, p. 1. (3) Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin (OJ L 174, 3.6.2020, p. 379).L 321/22 EN Official Journal of the European Union 13.9.2021 (3) Commission Implementing Regulation (EU) 2020/2235(4)lays down model animal health/official certificates and official certificates for the entry into the Union of animals, products of animal origin, composite products, germinal products, animal by-products, sprouts for human consumption and seeds intended for the production of sprouts for human consumption. (4) However, Implementing Regulation (EU) 2020/2235 does not include any model certificate to cover the entry into the Union of those products and goods which originate in the Union and which are moved to a third country or territory, and are then moved back to the Union from that third country or territory after unloading, storage and reloading. It is necessary therefore to amend that Implementing Regulation to provide for such type of model certificate and avoid undue trade disruptions in such cases. (5) Article 229 of Regulation (EU) 2016/429 requires that consignments of animals, germinal products and products of animal origin entering the Union must come from a third country or territory, or zone or compartment thereof, listed in accordance with Article 230(1) of that Regulation. (6) Delegated Regulation (EU) 2020/692 supplements Regulation (EU) 2016/429 as regards the animal health requirements for the entry into the Union of consignments of animals, germinal products and products of animal origin from third countries or territories or zones thereof, or compartments thereof in the case of aquaculture animals. Article 3, first paragraph, point (a) of Delegated Regulation (EU) 2020/692 provides that consignments of animals, germinal products and products of animal origin falling within its scope may only be permitted to enter into the Union if they come from a third country or territory, or zone or compartment thereof, listed for the particular species of animals, germinal products and products of animal origin in accordance with the animal health requirements laid down in that Delegated Regulation. (7) Commission Implementing Regulation (EU) 2021/404(5)establishes the lists of third countries, territories or zones thereof, or in the case of aquaculture animals compartments thereof, from which the entry into the Union of those species and categories of animals and those categories of germinal products and products of animal origin that fall within the scope of Delegated Regulation (EU) 2020/692 is permitted. (8) Annex XXII to Implementing Regulation (EU) 2021/404 provides for the list of third countries authorised for the entry into the Union of consignments of animals, germinal products or products of animal origin originated in and returning to the Union after being transported through a third country or territory. That Annex should be amended to list the third countries or territories authorised for the entry into the Union of consignments of products of animal origin originated in the Union that, after storage in those third countries or territories, are moved back to the Union and to assign the specific conditions that need to be fulfilled in such cases. (9) Regulation (EU) 2017/625 also provides that consignments of certain animals and goods are only to enter the Union from a third country or region thereof which appears on a list drawn up by the Commission for that purpose. (10) Commission Delegated Regulation (EU) 2019/625(6) supplements Regulation (EU) 2017/625 as regards the conditions for the entry into the Union of consignments of certain animals and goods intended for human consumption from third countries or regions thereof in order to ensure that they comply with the relevant requirements established in the rules referred to in Article 1(2)(a) of Regulation (EU) 2017/625 or with requirements recognised to be at least equivalent. (4) Commission Implementing Regulation (EU) 2020/2235 of 16 December 2020 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates, model official certificates and model animal health/official certificates, for the entry into the Union and movements within the Union of consignments of certain categories of animals and goods, official certification regarding such certificates and repealing Regulation (EC) No 599/2004, Implementing Regulations (EU) No 636/2014 and (EU) 2019/628, Directive 98/68/EC and Decisions 2000/572/EC, 2003/779/EC and 2007/240/EC (OJ L 442, 30.12.2020, p. 1). (5) Commission Implementing Regulation (EU) 2021/404 of 24 March 2021 laying down the lists of third countries, territories or zones thereof from which the entry into the Union of animals, germinal products and products of animal origin is permitted in accordance with Regulation (EU) 2016/429 of the European Parliament and the Council (OJ L 114, 31.3.2021, p. 1). (6) Commission Delegated Regulation (EU) 2019/625 of 4 March 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of certain animals and goods intended for human consumption (OJ L 131, 17.5.2019, p. 18).13.9.2021 EN Official Journal of the European Union L 321/23 (11) Commission Implementing Regulation (EU) 2021/405(7) lays down the lists of third countries or regions thereof from which the entry into the Union of products of animal origin and certain goods is permitted, supplementing the lists laid down in Implementing Regulation (EU) 2021/404. To allow the entry into the Union of products of animal origin that do not fall within the scope of Delegated Regulation (EU) 2020/692, Implementing Regulation (EU) 2021/405 should be amended to list the third countries or regions authorised for the entry into the Union of consignments of these products of animal origin and certain goods which originated from the Union that, after storage in those third countries or regions, are moved back to the Union and comply with the conditions laid down in Delegated Regulation (EU) 2019/625. (12) Implementing Regulations (EU) 2020/2235, (EU) 2021/404 and (EU) 2021/405 should therefore be amended accordingly. (13) In the interest of legal certainty, this Regulation should enter into force as a matter of urgency. (14) The measures provided for in this Regulation are in accordance with the opinion the Standing Committee on Plants, Animals, Food and Feed, HAS ADOPTED THIS REGULATION: Article 1 Implementing Regulation (EU) 2020/2235 is amended as follows: (1) the following Article 30a is inserted between Articles 30 and 31: ‘Article 30a Model animal health/official certificate for the entry into the Union of products of animal origin and certain goods that originated in the Union, are moved to a third country or territory and moved back to the Union after unloading, storage and reloading in that third country or territory The animal health/official certificate referred to in Article 1(3), point (b)(i), to be used for the entry into the Union of products of animal origin and certain goods that originated in the Union, are moved to a third country or territory and moved back to the Union after unloading, storage and reloading in that third country or territory, shall correspond to the model STORAGE-TC-PAO drawn up in accordance with the model set out in Chapter 53 of Annex III.’; (2) Annex III is amended in accordance with Annex I to this Regulation. Article 2 Annex XXII to Implementing Regulation (EU) 2021/404 is amended in accordance with Annex II to this Regulation. Article 3 The following Article 26a is inserted between Articles 26 and 27 of Implementing Regulation (EU) 2021/405: ‘Article 26a List of third counties authorised for the entry into the Union of products of animal origin and certain goods that originated from the Union, are moved to a third country or region thereof and moved back to the Union after unloading, storage and reloading in that third country or region thereof (7) Commission Implementing Regulation (EU) 2021/405 of 24 March 2021 laying down the lists of third countries or regions thereof authorised for the entry into the Union of certain animals and goods intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council (OJ L 114, 31.3.2021, p. 118).L 321/24 EN Official Journal of the European Union 13.9.2021 Consignments of products of animal origin and certain goods that originated from the Union, are moved to a third country or region thereof and moved back to the Union after unloading, storage and reloading in that third country or region thereof, shall only be authorised for the entry into the Union if they come from the third countries or regions thereof authorised for the entry into the Union in accordance with Annex XXII to Implementing Regulation (EU) 2021/404 and listed in Decision 2011/163/EU.’. Article 4 This Regulation shall enter into force on the 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, 10 September 2021. For the Commission The President Ursula VON DER LEYEN13.9.2021 EN Official Journal of the European Union L 321/25 ANNEX I Annex III to Implementing Regulation (EU) 2020/2235 is amended as follows: (1) in the list of certificates, a new category is added after the entry for ‘TRANSIT-COMP’, titled ‘transit through the Union to a third country or territory, either by immediate transit or after storage in the Union of composite products’: ‘products of animal origin and certain goods that originate in the Union, are moved to a third country or territory and moved back to the Union after unloading, storage and reloading in that third country or territory STORAGE-TC PAO Chapter 53: Model animal health/official certificate for the entry in to the Union of products of animal origin and certain goods that originate in the Union, are moved to a third country or territory and moved back to the Union after unloading, storage and reloading in that third country or territory’;L 321/26 EN Official Journal of the European Union 13.9.2021 (2) the following Chapter 53 is added after Chapter 52: ‘CHAPTER 53 MODEL ANIMAL HEALTH/OFFICIAL CERTIFICATE FOR THE ENTRY IN TO THE UNION OF PRODUCTS OF ANIMAL ORIGIN AND CERTAIN GOODS THAT ORIGINATE IN THE UNION, ARE MOVED TO A THIRD COUNTRY OR TERRITORY AND MOVED BACK TO THE UNION AFTER UNLOADING, STORAGE AND RELOADING IN THAT THIRD COUNTRY OR TERRITORY (MODEL STORAGE-TC-PAO)13.9.2021 EN Official Journal of the European Union L 321/27COUNTRY Certificate model STORAGE-TC-PAO noitacifitreC :II traP L 321/28 EN Official Journal of the European Union 13.9.2021 II. Health information II.a Certificate reference II.b IMSOC reference II.1. Health attestation I, the undersigned official veterinarian, hereby certify, that the consignment of products of animal origin or goods described in Part I: II.1.1. originate from and has been produced in the Union and was eligible for placing on the market in the Union, and II.1.2. was packed in the Union and, for products of animal origin, marked in the Union in accordance with Section I of Annex II to Regulation (EC) No 853/2004, and II.1.3. is destined to the Union, and II.1.4. has not been tampered and did not undergo any other handling than unloading, storage, re-loading, and transporting in (1)........... and for products of animal origin has been stored and transported in accordance with the relevant requirements of Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council. II.2. Storage attestation I, the undersigned official veterinarian, hereby certify, that the consignment of products of animal origin or goods described in Part I: II.2.1. has been stored in an approved/registered establishment(s), and II.2.2. has been reloaded in the approved/registered establishment under supervision of the competent authority. Notes In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purpose of this certificate, references to the Union in this certificate include the United Kingdom in respect of Northern Ireland. This certificate is intended for the entry into the Union of consignments of products covered by the certificates laid down in Articles 8 to 29 of Implementing Regulation (EU) 2020/2235 that originate from a Member State of the Union, are moved to a third country or territory listed in Annex XXII to Commission Implementing Regulation (EU) 2021/404 with the specific condition ‘Consignments that originate in the Union and are moved to a third country or territory, and moved back to the Union after storage’ and are moved back to the Union from that third country or territory after being unloaded, stored and reloaded. This animal health/official certificate shall be completed according to the notes for the completion of certificates provided for in Chapter 4 of Annex I to Implementing Regulation (EU) 2020/2235. Part I: Box reference 1.7: Indicate the name and ISO country code of the country where the goods were produced, manufactured or packed (labelled with the identification mark). Part II: (1) Code of the zone in accordance with column 2 of the table set out in Part 1 of Annex XXII to Implementing Regulation (EU) 2021/404; only for zones listed with the specific condition ‘Consignments that originate in the Union and are moved to a third country or territory, and moved back to the Union after storage’ in column 6 of that table. Official veterinarian Name (in capital letters) Date Qualification and title Stamp Signature’.13.9.2021 EN Official Journal of the European Union L 321/29 ANNEX II Annex XXII to Implementing Regulation (EU) 2021/404 is amended as follows: (1) in Part 1, the entries for the United Kingdom, Guernsey, the Isle of Man and Jersey are replaced by the following: Animals and From a Member germinal State to other products falling Model certificates Member States within the scope for movements through the of Commission within the Union United Kingdom Delegated or its Crown Regulation (EU) Dependencies 2020/692 ‘GB United GB-0 Products of Consignments Kingdom animal origin that originate in and certain the Union and goods covered are moved to a by the third country or STORAGE-TC- certificates laid territory, and PAO down in Articles moved back to 8 to 29 of the Union after Implementing unloading, Regulation (EU) storage and 2020/2235 reloading Animals and From a Member germinal State to other products falling Model certificates Member States within the scope for movements through the of Delegated within the Union United Kingdom Regulation (EU) or its Crown 2020/692 Dependencies GG GG-0 Products of Consignments Guernsey animal origin that originate in and certain the Union and goods covered are moved to a by the third country or STORAGE-TC- certificates laid territory, and PAO down in Articles moved back to 8 to 29 of the Union after Implementing unloading, Regulation (EU) storage and 2020/2235 reloadingL 321/30 EN Official Journal of the European Union 13.9.2021 Animals and From a Member germinal State to other products falling Model certificates Member States within the scope for movements through the of Delegated within the Union United Kingdom Regulation (EU) or its Crown 2020/692 Dependencies Products of Consignments IM Isle of IM-0 animal origin that originate in and certain the Union and Man goods covered are moved to a by the third country or STORAGE-TC- certificates laid territory, and PAO down in Articles moved back to 8 to 29 of the Union after Implementing unloading, Regulation (EU) storage and 2020/2235 reloading Animals and From a Member germinal State to other products falling Model certificates Member States within the scope for movements through the of Delegated within the Union United Kingdom Regulation (EU) or its Crown 2020/692 Dependencies Products of Consignments JE JE-0 animal origin that originate in Jersey and certain the Union and goods covered are moved to a by the third country or STORAGE-TC- certificates laid territory, and PAO down in Articles moved back to 8 to 29 of the Union after Implementing unloading, Regulation (EU) storage and 2020/2235 reloading’13.9.2021 EN Official Journal of the European Union L 321/31 (2) in Part 3, the following entry is inserted after the entry for the specific condition ‘From a Member State to other Member States through the United Kingdom or its Crown Dependencies’, and before the entry ‘Aqua – Russia to Russia’: ‘Consignments that originate in the Consignments of the commodities referred to in Part 1, column 4, originating in Union and are moved to a third the Union that are moved to the zone referred to in Part 1, column 2, and are country or territory, and moved back then moved back to the Union after unloading, storage and reloading in that to the Union after unloading, storage third country or territory shall be permitted to enter the Union provided that and reloading they are accompanied by the model certificate “STORAGE-TC-PAO” laid down in Implementing Regulation (EU) 2020/2235 in addition to the documents accompanying the consignment for its export to the third country or territory.’

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