13.1.2022   

EN

Official Journal of the European Union

L 8/36


COMMISSION IMPLEMENTING REGULATION (EU) 2022/36

of 11 January 2022

amending Annex III to Implementing Regulation (EU) 2020/2235 as regards model certificates for the entry into the Union of consignments of certain live aquatic animals and products of animal origin

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 on laying specific hygiene rules for food of animal origin (1), and in particular Article 7(2), point (a), thereof,

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’) (2), and in particular Articles 238(3) and 239(3) thereof,

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, 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) (3), and in particular Article 90, first paragraph, points (a) and (b), and Article 126(3) thereof,

Whereas:

(1)

Commission Implementing Regulation (EU) 2020/2235 (4) lays down rules regarding animal health certificates provided for in Regulation (EU) 2016/429, official certificates provided for in Regulation (EU) 2017/625, and animal health/official certificates based on those Regulations, required for the entry into the Union of certain consignments of animals and goods (hereinafter together referred to as ‘the certificates’). In particular, Annex III to Implementing Regulation (EU) 2020/2235 lays down, inter alia, model certificates for the entry into the Union of consignments of certain live aquatic animals and products of animal origin.

(2)

More specifically, Chapters 1 (MODEL BOV), 2 (MODEL OVI), 24 (MODEL MP-PREP), 25 (MODEL MPNT), 26 (MODEL MPST), 27 (MODEL CAS), 41 (MODEL GEL), 42 (MODEL COL), 43 (MODEL RCG), 44 (MODEL TCG) and 50 (MODEL COMP) of Annex III to Implementing Regulation (EU) 2020/2235 set out model animal health/official certificates, and official certificates, for the entry into the Union of consignments of products of bovine, ovine and caprine origin. Regulation (EC) No 999/2001 of the European Parliament and of the Council (5) was recently amended by Commission Regulation (EU) 2021/1176 (6) in order to update, inter alia, the requirements for the entry into the Union of products of bovine, ovine and caprine origin by adding specific conditions in the case of the entry into the Union of ruminant products from a country with a controlled BSE risk where they are derived from animals originating from a country with an undetermined BSE risk. Those new requirements for the entry into the Union of those consignments should be reflected in those model animal health/official certificates and official certificates. It is therefore necessary to amend those models accordingly.

(3)

In addition, the public health and animal health attestations in the model animal health/official certificates for the entry into the Union of consignments of certain categories of meat products intended for human consumption set out in Chapters 25 (MODEL MPNT) and 26 (MODEL MPST) of Annex III to Implementing Regulation (EU) 2020/2235 should be amended in order to accurately reflect the requirements concerning the entry into the Union of products of animal origin from farmed and wild cervid animals laid down in Annex IX, Chapter F, to Regulation (EC) No 999/2001 and the establishment of origin of animals from which fresh meat was obtained laid down in Article 150 of Commission Delegated Regulation (EU) 2020/692 (7) respectively. It is therefore necessary to amend those models accordingly.

(4)

Chapter 27 of Annex III to Implementing Regulation (EU) 2020/2235 sets out model animal health/official certificate for the entry into the union of casings intended for human consumption (MODEL CAS). In accordance with Article 148 of Delegated Regulation (EU) 2020/692, point II.2.2. of that model animal health/official certificate provides the possibility for third countries or territories, or zones thereof, authorised for the entry into the Union of fresh meat and therefore listed in Annex XIII to Commission Implementing Regulation (EU) 2021/404 (8), for the entry into the Union of consignments of casings without certifying the application of the risk-mitigating treatments provided for in point 2 of Annex XXVI to Delegated Regulation (EU) 2020/692. However, the current text of that point is not clear enough as regards the zone of origin of the casings when this possibility is applicable. To clarify that such a possibility applies only to the zones listed in Annex XIII to Implementing Regulation (EU) 2021/404, the code of the zone of origin of the casings should be included, as it appears in Annex XIII to Implementing Regulation (EU) 2021/404. It is therefore necessary to amend that model accordingly.

(5)

Furthermore, Chapters 28 (MODEL FISH-CRUST-HC) and 31 (MODEL MOL-HC) of Annex III to Implementing Regulation (EU) 2020/2235 set out model animal health/official certificates for the entry into the Union of consignments of live fish, live crustaceans, and products of animal origin from those animals intended for human consumption, and consignments of live bivalve molluscs, echinoderms, tunicates, marine gastropods and products of animal origin from those animals intended for human consumption. In order to improve the clarity of the notes in those models, it should be clearly specified that the consignments of products of animal origin from aquatic animals which require the completion of the animal health attestations set out in Part II.2 are those which have not been excluded from the scope of Delegated Regulation (EU) 2020/692, pursuant to Article 1, point (6), of that Regulation. Specifically, the consignments of products of animal origin from aquatic animals, other than live aquatic animals, entering the Union ready for direct human consumption, without undergoing further processing in the Union do not require the completion of the animal health attestations set out in Part II.2. Defining ‘further processing’ will also clarify the situation concerning such consignments. It is therefore necessary to amend those models accordingly.

(6)

Moreover, recent amendments introduced to Article 167, points (a) and (b), and Article 169(3), point (b), of Delegated Regulation (EU) 2020/692 by Commission Delegated Regulation (EU) 2021/1705 (9) should be reflected in the animal health attestations of Chapters 28 (MODEL FISH-CRUST-HC) and 31 (MODEL MOL-HC) of Annex III to Implementing Regulation (EU) 2020/2235. It is therefore necessary to amend those models accordingly.

(7)

In addition, it is necessary to clarify that the validity period of the model animal health/official certificates laid down in points II. 2.8. of Chapters 28 (MODEL FISH-CRUST-HC) and 31 (MODEL MOL-HC) of Annex III to Implementing Regulation (EU) 2020/2235 applies only to the consignments of live aquatic animals covered by these animal health/official certificates. It is therefore necessary to amend those models accordingly.

(8)

Furthermore, Chapters 33, 34 and 35 of Annex III to Implementing Regulation (EU) 2020/2235 set out model animal health/official certificates for the entry into the Union of raw milk intended for human consumption (MODEL MILK-RM); dairy products intended for human consumption derived from raw milk or that are not required to undergo a specific risk-mitigating treatment (MODEL MILK-RMP/NT); and dairy products intended for human consumption that are required to undergo a pasteurisation treatment (MODEL DAIRY-PRODUCTS-PT). However, those models do not reflect the alternatives to the residency period of the animals from which the milk was obtained in the third country, territory or zone thereof of origin of the milk or the dairy products, now laid down in Article 154 of Delegated Regulation (EU) 2020/692, as recently amended by Commission Delegated Regulation (EU) 2021/1705. It is therefore necessary to amend those models accordingly.

(9)

Chapter 45 of Annex III to Implementing Regulation (EU) 2020/2235 sets out the model official certificate for the entry into the Union of consignments of honey and other apiculture products intended for human consumption (MODEL HON). In order to ensure the authenticity of those consignments, the guarantees for such consignments should be improved by aligning them with certain rules laid down in Council Directive 2001/110/EC (10). It is therefore necessary to amend that model accordingly.

(10)

Chapters 50 and 52 of Annex III to Implementing Regulation (EU) 2020/2235 set out model animal health/official certificate for the entry into the Union of not shelf-stable composite products and shelf-stable composite products, containing any quantity of meat products except gelatine, collagen and highly refined products, and intended for human consumption (MODEL COMP), and the model animal health certificate for the transit through the Union to a third country, either by immediate transit, or after storage in the Union of not shelf-stable composite products and shelf-stable composite products containing any quantity of meat products and intended for human consumption (MODEL TRANSIT-COMP). Both of those models include a specific animal health attestation for dairy products contained in composite products. As regards the place of production, the animal health attestation does not reflect the possibility to certify that the dairy products contained in the composite products were produced in a Member State. Dairy products produced in a Member State comply with all the necessary animal health guarantees and that possibility should therefore be included in those models. In addition, the animal health attestation should be amended to clarify the different options provided to certify the species of origin of the milk from which the dairy products were produced. It is therefore necessary to amend those models accordingly.

(11)

In addition, Chapters 50 (MODEL COMP) and 52 (MODEL TRANSIT-COMP) of Annex III to Implementing Regulation (EU) 2020/2235 should be amended to provide the possibility for third countries or territories, or zones thereof to certify different origins of processed products contained in the composite products, if such products comply with the relevant public health and animal health requirements. It is therefore necessary to amend those models accordingly.

(12)

Annex III to Implementing Regulation (EU) 2020/2235 should be therefore amended accordingly.

(13)

In order to avoid any disruption to trade as regards the entry into the Union of consignments of certain live aquatic animals and products of animal origin, the use of certificates issued in accordance with Implementing Regulation (EU) 2020/2235, as applicable prior to the amendments made by this Implementing Regulation, should continue to be authorised during a transitional period subject to certain conditions.

(14)

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

Annex III to Implementing Regulation (EU) 2020/2235 is amended in accordance with the Annex to this Regulation.

Article 2

For a transitional period until 15 September 2022, consignments of certain live aquatic animals and products of animal origin, accompanied by the appropriate animal health/official certificates, official certificates, or animal health certificates issued in accordance with the models set out in Chapters 1, 2, 24 to 28, 31, 33 to 35, 41 to 45, 50 and 52 of Annex III to Implementing Regulation (EU) 2020/2235, as applicable before the amendments made to that Implementing Regulation by this Implementing Regulation, shall continue to be authorised for entry into the Union provided that the certificate was issued no later than 15 June 2022.

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 11 January 2022.

For the Commission

The President

Ursula VON DER LEYEN


(1)   OJ L 139, 30.4.2004, p. 55.

(2)   OJ L 84, 31.3.2016, p. 1.

(3)   OJ L 95, 7.4.2017, p. 1.

(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)  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).

(6)  Commission Regulation (EU) 2021/1176 of 16 July 2021 amending Annexes III, V, VII and IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards genotyping of positive TSE cases in goats, the determination of age in ovine and caprine animals, the measures applicable in a herd or flock with atypical scrapie and the conditions for imports of products of bovine, ovine and caprine origin (OJ L 256, 19.7.2021, p. 56).

(7)  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).

(8)  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).

(9)  Commission Delegated Regulation (EU) 2021/1705 of 14 July 2021 amending Delegated Regulation (EU) 2020/692 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 339, 24.9.2021, p. 40).

(10)  Council Directive 2001/110/EC of 20 December 2001 relating to honey (OJ L 10, 12.1.2002, p. 47).


ANNEX

Annex III to Implementing Regulation (EU) 2020/2235 is amended as follows:

(1)

In Chapter 1, point II.1.10 of the public health attestation is replaced by the following:

‘II.1.10.

with regard to bovine spongiform encephalopathy (BSE):

(1) either

[the country or region of origin is classified in accordance with Commission Decision 2007/453/EC (A) as a country or region posing a negligible BSE risk, and

(1) either

[the animals from which the meat or minced meat is derived were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk;]

(1) or

[the animals from which the meat or minced meat is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk, and:

(1) either

[(i)

the meat or minced meat does not contain and is not derived from specified risk material as defined in of Annex V, point 1(a), to Regulation (EC) No 999/2001;]

(1) or

[(i)

the carcases, half carcases or half carcases cut into no more than three wholesale cuts, and quarters contain no specified risk material as defined in Annex V, point 1(a), to Regulation (EC) No 999/2001 other than the vertebral column, including dorsal root ganglia, and the carcases or wholesale cuts of carcases of animals aged over 30 months and containing vertebral column are identified by a clearly visible red stripe on the label referred to in Article 13 or 15 of Regulation (EC) No 1760/2000 of the European Parliament and of the Council (B) (3);]

(ii)

the animals from which the meat or minced meat is derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;]

(1) or

[the animals from which the meat or minced meat is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk and:

(1) either

[(i)

the meat or minced meat does not contain and is not derived from specified risk material as defined in Annex V, point 1(a), to Regulation (EC) No 999/2001;]

(1) or

[(i)

the carcases, half carcases or half carcases cut into no more than three wholesale cuts, and quarters contain no specified risk material as defined in Annex V, point 1(a), to Regulation (EC) No 999/2001 other than the vertebral column, including dorsal root ganglia, and the carcases or wholesale cuts of carcases of animals aged over 30 months and containing vertebral column are identified by a clearly visible red stripe on the label referred to in Article 13 or 15 of Regulation (EC) No 1760/2000 (3);]

(ii)

the animals from which the meat or minced meat is derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(iii)

the animals from which the meat or minced meat is derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health (C);

(iv)

the meat or minced meat was produced and handled in a manner which ensures that it does not contain and was not contaminated with nervous and lymphatic tissues exposed during the deboning process;]]

(1) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk, and

(a)

the animals from which the meat or minced meat is derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity; and

(1) either

[(b)

the meat or minced meat does not contain and is not derived from specified risk material as defined in Annex V, point 1(a) to Regulation (EC) No 999/2001; and]

(1) or

[(b)

the carcases, half carcases or half carcases cut into no more than three wholesale cuts, and quarters contain no specified risk material as defined in Annex V, point 1(a), to Regulation (EC) No 999/2001 other than the vertebral column, including dorsal root ganglia, and the carcases or wholesale cuts of carcases of animals aged over 30 months and containing vertebral column are identified by a clearly visible red stripe on the label referred to in Article 13 or 15 of Regulation (EC) No 1760/2000 (3); and]

(1) either

[(c)

the animals from which the meat or minced meat is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible or a controlled BSE risk;]

(1) or

[(c)

the animals from which the meat or minced meat is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk and

(i)

the animals from which the meat or minced meat is derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health;

(ii)

the meat or minced meat was produced and handled in a manner which ensures that it does not contain and was not contaminated with nervous and lymphatic tissues exposed during the deboning process;]]

(1) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region with an undetermined BSE risk, and

(a)

the animals from which the meat or minced meat is derived have not been:

(i)

slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(ii)

fed meat-and-bone meal or greaves derived from ruminants, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health;

(1) either

[(b)

the meat or minced meat does not contain and is not derived from specified risk material as defined in Annex V, point 1(a), to Regulation (EC) No 999/2001;]

(1) or

[(b)

the carcases, half carcases or half carcases cut into no more than three wholesale cuts, and quarters contain no specified risk material as defined in Annex V, point 1(a), to Regulation (EC) No 999/2001 other than the vertebral column, including dorsal root ganglia, and the carcases or wholesale cuts of carcases of animals aged over 30 months and containing vertebral column are identified by a clearly visible red stripe on the label referred to in Article 13 or 15 of Regulation (EC) No 1760/2000 (3);]

(c)

the meat or minced meat does not contain and is not derived from nervous and lymphatic tissues exposed during the deboning process.]

(A)  Commission Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84)"

(B)  Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97 (OJ L 204, 11.8.2000, p. 1)."

(C)  https://www.oie.int/en/standard-setting/terrestrial-code/access-online/’;"

(2)

In Chapter 2, point II.1.10 of the public health attestation is replaced by the following:

‘II.1.10.

with regard to bovine spongiform encephalopathy (BSE):

(1) either

[the country or region of origin is classified in accordance with Commission Decision 2007/453/EC (D) as a country or region posing a negligible BSE risk, and

(1) either

[the animals from which the meat or minced meat is derived were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk;]

(1) or

[the animals from which the meat or minced meat is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk, and:

(i)

the meat or minced meat does not contain and is not derived from specified risk material as defined in Annex V, point 1(b), to Regulation (EC) No 999/2001;

(ii)

the animals, from which the meat or minced meat is derived, have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;]

(1) or

[the animals from which the meat or minced meat is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk and:

(i)

the meat or minced meat does not contain and is not derived from specified risk material as defined in Annex V, point 1(b), to Regulation (EC) No 999/2001;

(ii)

the animals from which the meat or minced meat is derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(iii)

the animals from which the meat or minced meat is derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health (E);

(iv)

the meat or minced meat was produced and handled in a manner which ensures that it does not contain and was not contaminated with nervous and lymphatic tissues exposed during the deboning process;]

(1) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk, and

(a)

the animals from which the meat or minced meat is derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity; and

(b)

the meat or minced meat does not contain and is not derived from specified risk material as defined in Annex V, point 1(b), to Regulation (EC) No 999/2001; and

(1) either

[(c)

the animals from which the meat or minced meat is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible or a controlled BSE risk;]

(1) or

[(c)

the animals from which the meat or minced meat is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk and

(i)

the animals from which the meat or minced meat is derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health;

(ii)

the meat or minced meat was produced and handled in a manner which ensures that it does not contain and was not contaminated with nervous and lymphatic tissues exposed during the deboning process;]]

(1) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region with an undetermined BSE risk, and

(a)

the animals from which the meat or minced meat is derived have not been:

(i)

slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(ii)

fed meat-and-bone meal or greaves derived from ruminants, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health;

(b)

the meat or minced meat does not contain and is not derived from:

(i)

specified risk material as defined in Annex V, point 1(b), to Regulation (EC) No 999/2001;

(ii)

nervous and lymphatic tissues exposed during the deboning process;]

(D)  Commission Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84)"

(E)  https://www.oie.int/en/standard-setting/terrestrial-code/access-online/’;"

(3)

Chapter 24 is amended as follows:

(a)

point II.1.11 of the public health attestation is replaced by the following:

(2)

[II.1.11.

if containing material from bovine, ovine or caprine animals, with regard to bovine spongiform encephalopathy (BSE):

(2) either

[the country or region of origin is classified in accordance with Commission Decision 2007/453/EC (F) as a country or region posing a negligible BSE risk, and

(2) either

[the animals from which the meat preparation is derived were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there have been no BSE indigenous cases;]

(2) or

[the animals from which the meat preparation is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there has been at least one BSE indigenous case, and the meat preparation does not contain and is not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;]

(2) or

[the animals from which the meat preparation is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk and:

(i)

the meat preparation does not contain and is not derived from specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

the meat preparation does not contain and is not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

the animals from which the meat preparation is derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;]

(2) or

[the animals from which the meat preparation is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk and:

(i)

the meat preparation does not contain and is not derived from specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

the meat preparation does not contain and is not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

the animals from which the meat preparation is derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;]

(iv)

the animals from which the meat preparation is derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health (G);

(v)

the meat preparation was produced and handled in a manner which ensures that it does not contain and was not contaminated with nervous and lymphatic tissues exposed during the deboning process;]]

(2) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk, and

(a)

the animals from which the meat preparation is derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(b)

the meat preparation does not contain and is not derived from:

(i)

specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

mechanically separated meat obtained from bones of bovine, ovine and caprine animals.

(2) either

[(c)

the animals from which the meat preparation is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible or a controlled BSE risk;]

(2) or

[(c)

the animals from which the meat preparation is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk and

(i)

the animals from which the meat preparation is derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health;

(ii)

the meat preparation was produced and handled in a manner which ensures that it does not contain and was not contaminated with nervous and lymphatic tissues exposed during the deboning process;]]

(2) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region with an undetermined BSE risk, and

(a)

the animals from which the meat preparation is derived have not been:

(i)

slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(ii)

fed meat-and-bone meal or greaves derived from ruminants, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health;

(b)

the meat preparation does not contain and is not derived from:

(i)

specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

nervous and lymphatic tissues exposed during the deboning process.]]

(F)  Commission Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84)."

(G)  https://www.oie.int/en/standard-setting/terrestrial-code/access-online/’ "

(b)

in the Notes, the first and the second introductory paragraphs, are replaced by the following:

‘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, references to European Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland.

This animal health/official certificate is intended for entry into the Union of meat preparations (as defined in Annex I, point 1.15, to Regulation (EC) No 853/2004) prepared from fresh meat of bovine animals, ovine and/or caprine animals, domestic breeds of porcine animals, camelid animals and/or cervid animals and/or animals of the family Bovidae other than bovine, ovine and caprine animals, wild breeds of porcine animals, leporidae, poultry other than ratites, ratites, game birds, and wild land mammals other than ungulates and leporidae including when the Union is not the final destination for such meat preparation.’;

(4)

Chapter 25 is amended as follows:

(a)

point II.1.4.1. of the public health attestation is replaced by the following:

(1) [II.1.4.1.

if obtained from meat of domestic porcine animals, this meat fulfills the requirements of Commission Implementing Regulation (EU) 2015/1375 (H), and in particular:

(1) either

[has been subjected to an examination by a digestion method for Trichinella with negative results;]

(1) or

[has been subjected to a freezing treatment in accordance with Annex II to Implementing Regulation (EU) 2015/1375;]

(1)(9) or

[in the case of meat from domestic porcine animals kept solely for fattening and slaughter, comes from a holding or category of holdings that has been officially recognized by the competent authorities as free from Trichinella in accordance with Annex IV to Implementing Regulation (EU) 2015/1375;]]

(H)  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).’;"

(b)

point II.1.11. of the public health attestation is replaced by the following:

(2) [II.1.11.

if containing material from bovine, ovine or caprine animals, with regard to bovine spongiform encephalopathy (BSE):

(2) either

[the country or region of origin is classified in accordance with Commission Decision 2007/453/EC (I) as a country or region posing a negligible BSE risk, and

(2) either

[the animals from which the meat products are derived were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there have been no BSE indigenous cases;]

(2) or

[the animals from which the meat products are derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there has been at least one BSE indigenous case, and the meat products do not contain and are not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;]

(2) or

[the animals from which the meat products are derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk and:

(i)

the meat products do not contain and are not derived from specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

the meat products do not contain and are not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

the animals from which the meat products are derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;]

(2) or

[the animals from which the meat products are derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk and:

(i)

the meat products do not contain and are not derived from specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

the meat products do not contain and are not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

the animals from which the meat products are derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;]

(iv)

the animals from which the meat products are derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health (J);

(v)

the meat products were produced and handled in a manner which ensures that they do not contain and were not contaminated with nervous and lymphatic tissues exposed during the deboning process;]]

(2) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk, and

(a)

the animals from which the meat products are derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(b)

the meat products do not contain and are not derived from:

(i)

specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

mechanically separated meat obtained from bones of bovine, ovine and caprine animals.

(2) either

[(c)

the animals from which the meat products are derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible or a controlled BSE risk;]

(2) or

[(c)

the animals from which the meat products are derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk and

(i)

the animals from which the meat products are derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health;

(ii)

the meat products were produced and handled in a manner which ensures that they do not contain and were not contaminated with nervous and lymphatic tissues exposed during the deboning process;]]

(2) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region with an undetermined BSE risk, and

(a)

the animals from which the meat products are derived have not been:

(i)

slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(ii)

fed meat-and-bone meal or greaves derived from ruminants, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health;

(b)

the meat products do not contain and are not derived from:

(i)

specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

nervous and lymphatic tissues exposed during the deboning process.]]

(I)  Commission Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84)."

(J)  https://www.oie.int/en/standard-setting/terrestrial-code/access-online/’;"

(c)

the following points II.1.13. and II.1.14. are added to the public health attestation after point II.1.12.:

(1)(10) [II.1.13.

if containing material from farmed cervidae:

the product contains or is derived exclusively from meat, excluding offal and spinal cord, of farmed cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognised by the competent authorities with negative results and is not derived from animals coming from a herd where chronic wasting disease has been confirmed or is officially suspected.]

(1)(11) [II.1.14.

if containing material from wild cervidae:

the product contains or is derived exclusively from meat, excluding offal and spinal cord, of wild cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognised by the competent authorities with negative results and is not derived from animals coming from a region where chronic wasting disease has been confirmed in the last three years or is officially suspected.]’;

(d)

points II.2.5. and II.2.6. of the animal health attestation are replaced by the following:

‘II.2.5.

has been processed from fresh meat obtained from:

(1) either

[animals kept in an establishment that was not subject to national restriction measures for animal health reasons, including the relevant listed diseases referred to in Annex I to Commission Delegated Regulation (EU) 2020/692 (K) and emerging diseases at the time of dispatch of the animals to the slaughterhouse and in and around the establishment, in an area of 10 km radius, including where appropriate the territory of a neighbouring country, such diseases have not been reported during the period of 30 days prior to the date of dispatch of the animals to the Union;]

(1) or

[wild animals which originate from a place in and round which none of the listed diseases relevant for the species of origin of the meat products in accordance with Annex I to Commission Delegated Regulation (EU) 2020/692, has been reported during the period of 30 days prior to the date of dispatch of the meat product to the Union;],

II.2.6.

after processing has been handled until packaging in a way to prevent cross contamination that could introduce an animal health risk;

(8) [II.2.7.

is intended for a Member State which has been granted the status free from infection with Newcastle disease virus without vaccination in accordance with Commission Delegated Regulation (EU) 2020/689 (L), and has been obtained from poultry which have not been vaccinated against infection with Newcastle disease virus with a live vaccine during the period of 30 days prior to the date of slaughter].

(K)  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)  Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (OJ L 174, 3.6.2020, p. 211).’;"

(e)

the following footnotes (9) to (11) are added to the Notes to Part II after the footnote (8):

(9)

The derogation for domestic porcine animals coming from a holding officially recognised as applying controlled housing conditions, can only be applied in countries listed in Annex VII to Implementing Regulation (EU) 2015/1375.

(10)

Applicable when the meat has been obtained from a country mentioned in Annex IX, Chapter F, point 1, to Regulation (EC) No 999/2001.

(11)

Applicable when the meat has been obtained from a country mentioned in Annex IX, Chapter F, point 2, to Regulation (EC) No 999/2001.’;

(5)

Chapter 26 is amended as follows:

(a)

point II.1.11 of the public health attestation is replaced by the following:

(1) [II.1.11.

if containing material from bovine, ovine or caprine animals, with regard to bovine spongiform encephalopathy (BSE):

(1) either

[the country or region of origin is classified in accordance with Commission Decision 2007/453/EC (M) as a country or region posing a negligible BSE risk, and

(1) either

[the animals from which the meat products are derived were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there have been no BSE indigenous cases;]

(1) or

[the animals from which the meat products are derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there has been at least one BSE indigenous case, and the meat products do not contain and are not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;]

(1) or

[the animals from which the meat products are derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk and:

(i)

the meat products do not contain and are not derived from specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

the meat products do not contain and are not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

the animals from which the meat products are derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;]

(1) or

[the animals from which the meat products are derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk and:

(i)

the meat products do not contain and are not derived from specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

the meat products do not contain and are not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

the animals from which the meat products are derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;]

(iv)

the animals from which the meat products are derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health (N);

(v)

the meat products were produced and handled in a manner which ensures that they do not contain and were not contaminated with nervous and lymphatic tissues exposed during the deboning process;]]

(1) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk, and

(a)

the animals from which the meat products are derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(1) either

[(b)

the meat products do not contain and are not derived from:

(i)

specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

mechanically separated meat obtained from bones of bovine, ovine and caprine animals.]

(1) or

[(b)

the meat products contain and are derived from treated intestines sourced from animals which were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there have been no BSE indigenous cases;]

(1) or

[(b)

the meat products contain and are derived from treated intestines sourced from animals which originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there has been at least one BSE indigenous case, and:

(1) either

[(i)

the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants has been enforced;]

(1) or

[(i)

the treated intestines of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001.]]

(1) either

[(c)

the animals from which the meat products are derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible or a controlled BSE risk;]

(1) or

[(c)

the animals from which the meat products are derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk and

(i)

the animals from which the meat products are derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health;

(ii)

the meat products were produced and handled in a manner which ensures that they do not contain and were not contaminated with nervous and lymphatic tissues exposed during the deboning process;]]

(1) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region with an undetermined BSE risk, and

(a)

the animals from which the meat products are derived have not been:

(i)

slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(ii)

fed meat-and-bone meal or greaves derived from ruminants, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health;

(1) either

[(b)

the meat products do not contain and are not derived from:

(i)

specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

nervous and lymphatic tissues exposed during the deboning process.]

(1) or

[(b)

the meat products contain and are derived from treated intestines sourced from animals which were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there have been no BSE indigenous cases;]

(1) or

[(b)

the meat products contain and are derived from treated intestines sourced from animals which originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there has been at least one BSE indigenous case, and:

(1) either

[(i)

the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants has been enforced;]

(1) or

[(i)

the treated intestines of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001.]]]]

(M)  Commission Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84)."

(N)  https://www.oie.int/en/standard-setting/terrestrial-code/access-online/’;"

(b)

the following points II.1.13. and II.1.14. are added to the public health attestation after point II.1.12.:

(1)(11) [II.1.13.

if containing material from farmed cervidae:

the product contains or is derived exclusively from meat, excluding offal and spinal cord, of farmed cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognised by the competent authorities with negative results and is not derived from animals coming from a herd where chronic wasting disease has been confirmed or is officially suspected.]

(1)(12) [II.1.14.

if containing material from wild cervidae:

the product contains or is derived exclusively from meat, excluding offal and spinal cord, of wild cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognised by the competent authorities with negative results and is not derived from animals coming from a region where chronic wasting disease has been confirmed in the last three years or is officially suspected.]’;

(c)

points II.2.2. to II.2.4. of the animal health attestation are replaced by the following:

(1) either

[II.2.2.

has been processed from fresh meat from only one species of animals, with code ____ (4), and the fresh meat used for the processing of the meat product has undergone the specific treatment ____(5), which is specifically assigned in Annex XV, Part 1, to Implementing Regulation (EU) 2021/404 to the species of origin of the fresh meat and to the zone referred to in point II.2.1. and has been obtained from animals originating from:

(1) either

[the zone referred to in point II.2.1.;]]

(1) or

[the zone with code _____ (6), which, at the date of issue of this animal health/official certificate, is listed for entry into the Union of fresh meat of the species from which the meat product has been processed in

(1) either

[Annex XIII, Part 1, to Implementing Regulation (EU) 2021/404, in the case of fresh meat of ungulates;]]] (7)

(1) or

[Annex XIV, Part 1, to Implementing Regulation (EU) 2021/404, in the case of fresh meat of poultry and game birds;]]]

(1) or

[a Member State;]]]

(1) or

[II.2.2.

has been processed from fresh meat of poultry, with code ____(4), which originate from a zone listed for entry into the Union of fresh meat of poultry where there has been a case or an outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus and the fresh meat used for the processing of the meat product has undergone at least the specific treatment “D”(5);]

(1) or

[II.2.2.

has been processed mixing fresh meat from different species of animals, with codes ____ , ____ , ____(4), and such fresh meat:

(1) either

[II.2.2.1.

has been mixed before the final treatment and, after mixing, has undergone the specific treatment ____(5), as it is the most severe of the treatments specifically assigned in Annex XV, Part 1, to Implementing Regulation (EU) 2021/404 to the different species of origin of the fresh meat and to the zone referred to in point II.2.1., and has been obtained from animals originating from:

(1) either

[the zone referred to in point II.2.1.]]

(1) or

[the zone with

(1)

[code _____(6) which, at the date of issue of this animal health/official certificate, is listed in Annex XIII, Part 1, to Implementing Regulation (EU) 2021/404 for entry into the Union of fresh meat of the species from which the meat product has been processed;](7)

(1)

[code _____(6) which, at the date of issue of this animal health/official certificate, is listed in Annex XIV, Part 1, to Implementing Regulation (EU) 2021/404 for entry into the Union of fresh meat of the species from which the meat product has been processed;]]]

(1) or

[a Member State;]]

(1) or

[II.2.2.1.

has been mixed after the final treatment and, before the mixing, has undergone the specific treatment(s) ________, _________, ________(8), as specifically assigned in Annex XV, Part 1, to Implementing Regulation (EU) 2021/404 to the different species of origin of the fresh meat and to the zone referred to in point II.2.1., and has been obtained from animals originating from:

(1) either

[the zone referred to in point II.2.1.;]]

(1) or

[the zone with

(1)

[code ______(6) which, at the date of issue of this animal health/official certificate, is listed in Annex XIII, Part 1, to Implementing Regulation (EU) 2021/404 for entry into the Union of fresh meat of the species from which the meat product has been processed;] (7)

(1)

[code _____(6) which, at the date of issue of this animal health/official certificate, is listed in Annex XIV, Part 1, to Implementing Regulation (EU) 2021/404 for entry into the Union of fresh meat of the species from which the meat product has been processed;]]]

(1) or

[a Member State.]]

(1) or

[II.2.2.

has

(a)

been processed from fresh meat from one species of animals or mixing fresh meat from different species of animals, with codes ____ , ____ , ____(4);

(b)

been processed from fresh meat obtained from animals originating from the zone/s with code/s ______, _____ , _____(3) which, at the date of issue of this animal health/official certificate, is/are listed in Annex XV, Part 1, to Implementing Regulation (EU) 2021/404 for entry into the Union of meat products subject to the application of one of the specific treatments defined in Annex XXVI to Commission Delegated Regulation (EU) 2020/692 (O) to the fresh meat of the relevant species;

(c)

undergone the specific ‘treatment B’ (5);]

II.2.3.

has been processed from fresh meat obtained from:

(1) either

[animals kept in an establishment that was not subject to national restriction measures for animal health reasons, including the relevant listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 and emerging diseases at the time of dispatch of the animals to the slaughterhouse and in and around the establishment, in an area of 10 km radius, including where appropriate the territory of a neighbouring country, such diseases have not been reported during the period of 30 days prior to the date of dispatch of the animals to the Union;]

(1) or

[wild animals which originate from a place in and round which none of the listed diseases relevant for the species of origin of the meat products in accordance with Annex I to Commission Delegated Regulation (EU) 2020/692, has been reported during the period of 30 days prior to the date of dispatch of the meat product to the Union;],

II.2.4.

after processing, has been handled until packaging in a way to prevent cross contamination that could introduce an animal health risk;

(9) [II.2.5.

is intended for a Member State which has been granted the status free from infection with Newcastle disease virus without vaccination in accordance with Commission Delegated Regulation (EU) 2020/689 (P), and has been obtained from poultry that have not been vaccinated against infection with Newcastle disease virus with a live vaccine during the period of 30 days prior to the date of slaughter].

(O)  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)"

(P)  Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (OJ L 174, 3.6.2020, p. 211).’;"

(d)

the following Footnotes (11) and (12) are added to the Notes to Part II, after footnote (10):

(11)

Applicable when the meat has been obtained from a country mentioned in Annex IX, Chapter F, point 1, to Regulation (EC) No 999/2001.

(12)

Applicable when the meat has been obtained from a country mentioned in Annex IX , Chapter F, point 2, to Regulation (EC) No 999/2001.’;

(6)

Chapter 27 is amended as follows:

(a)

point II.1.7. of the public health attestation is replaced by the following:

(1) [II.1.7.

If derived from bovine, ovine or caprine animals, with regard to bovine spongiform encephalopathy (BSE):

(1) either

[the country or region of origin is classified in accordance with Commission Decision 2007/453/EC (Q) as a country or region posing a negligible BSE risk, and(4)

(1)

[the animals from which the casings are derived were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk;]

(1)

[the animals from which the casings are derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk and:

(i)

if derived from bovine animals, the casings do not contain and are not derived from specified risk material as defined in Annex V, point 1(a)(iii), to Regulation (EC) No 999/2001;

(ii)

the animals from which the casings are derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;]

(1)

[the animals from which the casings are derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk and:

(i)

if derived from bovine animals, the casings do not contain and are not derived from specified risk material as defined in Annex V, point 1(a)(iii), to Regulation (EC) No 999/2001;

(ii)

the animals from which the casings are derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(iii)

the animals from which the casings are derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health (R);]]

(1) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk, and (4)

(1)

[the animals from which the casings are derived were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there have been no BSE indigenous cases;]

(1)

[the animals from which the casings are derived were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there has been at least one BSE indigenous case and, if the casings derived from bovine animals:

(i)

the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants has been enforced,

(ii)

or the casings do not contain and are not derived from specified risk material as defined in Annex V, point 1(a)(iii), to Regulation (EC) No 999/2001.]

(1)

[the animals from which the casings are derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk and:

(i)

the animals from which the casings are derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity,

(ii)

if derived from bovine animals, the casings do not contain and are not derived from specified risk material as defined in Annex V, point 1(a)(iii), to Regulation (EC) No 999/2001;]

(1)

[the animals from which the casings are derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk and

(i)

the animals from which the casings are derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity,

(ii)

the animals from which the casings are derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health,

(iii)

if derived from bovine animals, the casings do not contain and are not derived from specified risk material as defined in Annex V, point 1(a)(iii), to Regulation (EC) No 999/2001;]]

(1) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region with an undetermined BSE risk, and(4)

(1)

[the casings and the animals from which the casings are derived comply with the following requirements:

(i)

the animals from which the casings are derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(ii)

the animals from which the casings are derived have not been fed meat-and-bone meal or greaves derived from ruminants, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health;

(iii)

if derived from bovine animals, the casings do not contain and are not derived from specified risk material as defined in Annex V, point 1(a)(iii), to Regulation (EC) No 999/2001;]

(1)

[the animals from which the casings are derived were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there have been no BSE indigenous cases;]

(1)

[the animals from which the casings are derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there has been at least one BSE indigenous case and, if the casings derived from bovine animals:

(i)

the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants has been enforced,

(ii)

or the casings do not contain and are not derived from specified risk material as defined in Annex V, point 1(a)(iii), to Regulation (EC) No 999/2001.]]]

(Q)  Commission Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84)."

(R)  https://www.oie.int/en/standard-setting/terrestrial-code/access-online/’;"

(b)

point II.2.2. of the animal health attestation is replaced by the following:

(1) either

[II.2.2.

have been

(a)

processed from bladders and/or intestines obtained from [bovine](1), [ovine and/or caprine](1), [kept porcine animals](1) , and

(b)

processed in and dispatched from the zone/s with code/s: _______ (3), which at the date of issuance of this animal health/official certificate, is/are authorised for entry into the Union of fresh meat of such species of animals and listed in Annex XIII, Part 1, to Implementing Regulation (EU) 2021/404, without any specific condition indicated in column 5 of the table in Part 1 of that Annex;]

(1) or

[II.2.2.

have been processed from bladders and/or intestines obtained from [bovine](1), [ovine and/or caprine](1), [kept porcine animals](1) and during their processing have been:

(1) either

[salted with sodium chloride (NaCl), either dry or as saturated brine (aw<0,80), for a continuous period of 30 days or longer, at temperature of 20oC or above;]]

(1) or

[salted with phosphate supplemented salt containing 86,5 % NaCl, 10,7 % Na2HPO4 and 2,8 % Na3PO4 (weight/weight/weight), either dry or as saturated brine (aw<0,80), for a continuous period of 30 days or longer, at a temperature of 20oC or above;]]

(1) or

[II.2.2.

have been processed from bladders and/or intestines obtained from animals other than bovine, ovine, caprine and/or porcine animals and during their processing have been:

(1) either

[salted with sodium chloride (NaCl) for 30 days;]]

(1) or

[bleached;]]

(1) or

[dried after scraping;]]’;

(7)

Chapter 28 is amended as follows:

(a)

the animal health attestation is amended as follows:

(i)

point II.2.3.3. is replaced by the following:

‘II.2.3.3.

They are aquatic animals which are dispatched directly from the place of origin to the Union;’;

(ii)

point II.2.6.3. is replaced by the following:

‘II.2.6.3.

from the time of loading at the place of origin until the time of arrival in the Union, the animals in the consignment are not transported in the same water or (4)[container] (4)[well-boat] together with aquatic animals which are of a lower health status or which are not intended for entry into the Union;’;

(iii)

points II.2.7.3. and II.2.8. are replaced by the following:

(4) [II.2.7.3.

In the case of products of animal origin from aquatic animals other than live aquatic animals, the legible and visible label referred to in point II.2.7.1. contains one of the following statements:

(a)

‘fish intended for human consumption after further processing in the European Union’;

(b)

‘crustaceans intended for human consumption after further processing in the European Union’.]

(4) (10) II.2.8.

Validity of animal health/official certificate

This animal health/official certificate shall be valid for the period of 10 days from the date of issue. In the case of transport by waterway/sea of aquatic animals, this period of 10 days may be extended by the duration of the journey by waterway/sea.’;

(b)

Notes are amended as follows:

(i)

in the inroductory part, the following description of ‘Further processing’ is added after description of ‘Aquaculture animals’:

‘ ‘Further processing’ means any type of measures and techniques, carried out before the placing on the market for human consumption, affecting anatomical wholeness, such as bleeding, evisceration, heading, slicing and filleting which produce waste or by-products which could cause a risk of disease spread.’;

(ii)

footnote (2) of the Notes to Part II is replaced by the following:

(2)

Part II.2. of this animal health/official certificate shall not apply and shall be deleted when the consignment consists of: (a) species other than those listed in the Annex to Commission Implementing Regulation (EU) 2018/1882 (S); or (b) wild aquatic animals and products of animal origin from those aquatic animals which are landed from fishing vessels for direct human consumption; or (c) products of animal origin from aquatic animals, other than live aquatic animals, which are ready for direct human consumption without undergoing further processing in the Union.

(S)  Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L 308, 4.12.2018, p. 21).’;"

(iii)

footnote (10) to the Notes to Part II is replaced by the following:

(10)

Shall apply only to the consignments of live aquatic animals.

(11)

to be signed by:

an official veterinarian when Part II.2. Animal health attestation is not deleted

a certifying officer or an official veterinarian when Part II.2. Animal health attestation is deleted.’;

(8)

Chapter 31 is amended as follows:

(a)

the animal health attestation is amended as follows:

(i)

point II.2.3.3. is replaced by the following:

‘II.2.3.3.

They are aquatic animals which are dispatched directly from the place of origin to the Union;’

(ii)

point II.2.6.3. is replaced by the following:

‘II.2.6.3.

from the time of loading at the place of origin until the time of arrival in the Union, the animals in the consignment are not transported in the same water or (4)[container] (4)[well-boat] together with aquatic animals which are of a lower health status or which are not intended for entry into the Union;’

(iii)

point II.2.8. is replaced by the following:

(4) (10)

II.2.8.

Validity of animal health/official certificate

This animal health/official certificate shall be valid for the period of 10 days from the date of issue. In the case of transport by waterway/sea of aquatic animals, this period of 10 days may be extended by the duration of the journey by waterway/sea.’;

(b)

Notes are amended as follows:

(i)

in the inroductory part, the following description of ‘Further processing’ is added after description of ‘Aquaculture animals’:

‘ ‘Further processing’ means any type of measures and techniques, carried out before the placing on the market for human consumption, affecting anatomical wholeness, such as bleeding, evisceration, heading, slicing and filleting which produce waste or by-products which could cause a risk of disease spread.’;

(ii)

footnote (2) of the Notes to Part II is replaced by the following:

(2)

Part II.2. of this animal health/official certificate shall not apply and shall be deleted when the consignment consists of: (a) species other than those listed in the Annex to Commission Implementing Regulation (EU) 2018/1882 (T); or (b) wild aquatic animals and products of animal origin from those aquatic animals which are landed from fishing vessels for direct human consumption; or (c) products of animal origin from aquatic animals other than live aquatic animals which are ready for direct human consumption, without undergoing further processing in the Union.

(T)  Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L 308, 4.12.2018, p. 21).’;"

(iii)

footnote (10) to the Notes to Part II is replaced by the following:

(10)

Shall apply only to the consignments of live aquatic animals.

(11)

to be signed by:

an official veterinarian when Part II.2. Animal health attestation is not deleted

a certifying officer or an official veterinarian when Part II.2. Animal health attestation is deleted.’

(9)

in Chapter 33, point. II.2.2. of the animal health attestation is replaced by the following:

‘II.2.2.

has been obtained from animals of the species [Bos Taurus,](1) [Ovis aries,](1) [Capra hircus,](1) [Bubalus bubalis,](1) [Camelus dromedarius](1) that:

(1) either

[have remained in the zone/s referred to under point II.2.1. since birth, or for the period of at least 3 months prior to the date of milking;]

(1) or

[were introduced in the zone/s referred to under point II.2.1. from:

(1) either

[another third country or territory, or zone thereof which is listed for entry into the Union of raw milk, colostrum or colostrum-based products and the animals remained there for the period of at least 3 months prior to the date of milking;]]

(1) or

[a Member State;]]’;

(10)

in Chapter 34, point. II.2.3. of the animal health attestation is replaced by the following:

‘II.2.3.

have been processed from raw milk obtained from animals of the species [Bos Taurus,](1) [Ovis aries,](1) [Capra hircus,](1) [Bubalus bubalis,](1) [Camelus dromedarius](1) that:

(1) either

[have remained in the zone/s referred to under point II.2.1. since birth, or for the period of at least 3 months prior to the date of milking;]

(1) or

[were introduced in the zone/s referred to under point II.2.1. from:

(1) either

[another third country or territory, or zone thereof which is listed for entry into the Union of raw milk, colostrum or colostrum-based products and the animals remained there for the period of at least 3 months prior to the date of milking;]]

(1) or

[a Member State;]]’;

(11)

in Chapter 35, point II.2.3. of the animal health attestation is replaced by the following:

‘II.2.3.

have been processed from raw milk obtained from animals of the species [Bos Taurus,](1) [Ovis aries,](1) [Capra hircus,](1) [Bubalus bubalis,](1) [Camelus dromedarius](1) that:

(1) either

[have remained in the zone/s referred to under point II.2.1. since birth, or for the period of at least 3 months prior to the date of milking;]

(1) or

[were introduced in the zone/s referred to under point II.2.1. from:

(1) either

[another third country or territory, or zone thereof which is listed for entry into the Union of raw milk, colostrum or colostrum-based products and the animals remained there for the period of at least 3 months prior to the date of milking;]]

(1) or

[a Member State;]]’;

(12)

in Chapter 41, point II.1.6. of the public health attestation is replaced by the following:

(1) [II.1.6.

in the case of gelatine of bovine, ovine and caprine animal origin, and except for gelatine derived from hides and skins,

(1) either

[the country or region of origin is classified in accordance with Commission Decision 2007/453/EC (U) as a country or region posing a negligible bovine spongiform encephalopathy (BSE) risk, and(2)

(1)

[the animals from which the gelatine is derived were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there have been no BSE indigenous cases;]

(1)

[the animals from which the gelatine is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there has been at least one BSE indigenous case, and the gelatine does not contain and is not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;]

(1)

[the animals from which the gelatine is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk and:

(i)

the gelatine does not contain and is not derived from specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001 of the European Parliament and of the Council (V);

(ii)

the gelatine does not contain and is not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

the animals from which the gelatine is derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;]

(1)

[the animals from which the gelatine is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk and:

(i)

the gelatine does not contain and is not derived from specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

the gelatine does not contain and is not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

the animals from which the gelatine is derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;]

(iv)

the animals from which the gelatine is derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health (W);

(v)

the gelatine was produced and handled in a manner which ensures that it does not contain and was not contaminated with nervous and lymphatic tissues exposed during the deboning process;]]

(1) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk, and

(a)

the animals from which the gelatine is derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(b)

the gelatine does not contain and is not derived from:

(i)

specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

mechanically separated meat obtained from bones of bovine, ovine and caprine animals.

(1) either

[(c)

the animals from which the gelatine is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible or a controlled BSE risk;]

(1) or

[(c)

the animals from which the gelatine is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk and

(i)

the animals from which the gelatine is derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health;

(ii)

the gelatine was produced and handled in a manner which ensures that it does not contain and was not contaminated with nervous and lymphatic tissues exposed during the deboning process;]]

(1) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region with an undetermined BSE risk, and

(a)

the animals from which the gelatine is derived have not been:

(i)

slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(ii)

fed meat-and-bone meal or greaves derived from ruminants, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health;

(b)

the gelatine does not contain and is not derived from:

(i)

specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

nervous and lymphatic tissues exposed during the deboning process.]]

(U)  Commission Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84)."

(V)  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)."

(W)  https://www.oie.int/en/standard-setting/terrestrial-code/access-online/’;"

(13)

in Chapter 42, point II.1.6. of the public health attestation is replaced by the following:

(1) [II.1.6.

in the case of collagen of bovine, ovine and caprine animal origin, and except for collagen derived from hides and skins,

(1) either

[the country or region of origin is classified in accordance with Commission Decision 2007/453/EC (X) as a country or region posing a negligible bovine spongiform encephalopathy (BSE) risk, and(2)

(1)

[the animals from which the collagen is derived were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there have been no BSE indigenous cases;]

(1)

[the animals from which the collagen is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there has been at least one BSE indigenous case, and the collagen does not contain and is not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;]

(1)

[the animals from which the collagen is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk and:

(i)

the collagen does not contain and is not derived from specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001 of the European Parliament and of the Council (Y);

(ii)

the collagen does not contain and is not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

the animals from which the collagen is derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;]

(1)

[the animals from which the collagen is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk and:

(i)

the collagen does not contain and is not derived from specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

the collagen does not contain and is not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

the animals from which the collagen is derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;]

(iv)

the animals from which the collagen is derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health (Z);

(v)

the collagen was produced and handled in a manner which ensures that it does not contain and was not contaminated with nervous and lymphatic tissues exposed during the deboning process;]]

(1) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk, and

(a)

the animals from which the collagen is derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(b)

the collagen does not contain and is not derived from:

(i)

specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

mechanically separated meat obtained from bones of bovine, ovine and caprine animals.

(1) either

[(c)

the animals from which the collagen is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible or a controlled BSE risk;]

(1) or

[(c)

the animals from which the collagen is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk and

(i)

the animals from which the collagen is derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health;

(ii)

the collagen was produced and handled in a manner which ensures that it does not contain and was not contaminated with nervous and lymphatic tissues exposed during the deboning process;]]

(1) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region with an undetermined BSE risk, and

(a)

the animals from which the collagen is derived have not been:

(i)

slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(ii)

fed meat-and-bone meal or greaves derived from ruminants, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health;

(b)

the collagen does not contain and is not derived from:

(i)

specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

nervous and lymphatic tissues exposed during the deboning process.]]

(X)  Commission Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84)."

(Y)  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)."

(Z)  https://www.oie.int/en/standard-setting/terrestrial-code/access-online/’;"

(14)

in Chapter 43, point II.1.4. of the public health attestation is replaced by the following:

(1) [II.1.4.

in the case of raw material of bovine, ovine and caprine animal origin, and except for hides and skins,

(1) either

[the country or region of origin is classified in accordance with Commission Decision 2007/453/EC (AA) as a country or region posing a negligible bovine spongiform encephalopathy (BSE) risk, and(7)

(1)

[the animals from which the raw material is derived were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there have been no BSE indigenous cases;]

(1)

[the animals from which the raw material is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there has been at least one BSE indigenous case, and the raw material does not contain and is not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;]

(1)

[the animals from which the raw material is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk and:

(i)

the raw material does not contain and is not derived from specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

the raw material does not contain and is not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

the animals from which the raw material are derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;]

(1)

[the animals from which the raw material is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk and:

(i)

the raw material does not contain and is not derived from specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

the raw material does not contain and is not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

the animals from which the raw material is derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;]

(iv)

the animals from which the raw material is derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health (BB);

(v)

the raw material was produced and handled in a manner which ensures that it does not contain and was not contaminated with nervous and lymphatic tissues exposed during the deboning process;]]

(1) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk, and

(a)

the animals from which the raw material is derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(b)

the raw material does not contain and is not derived from:

(i)

specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

mechanically separated meat obtained from bones of bovine, ovine and caprine animals.

(1) either

[(c)

the animals from which the raw material is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible or a controlled BSE risk;]

(1) or

[(c)

the animals from which the raw material is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk and

(i)

the animals from which the raw material is derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health;

(ii)

the raw material was produced and handled in a manner which ensures that it does not contain and was not contaminated with nervous and lymphatic tissues exposed during the deboning process;]]

(1) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region with an undetermined BSE risk, and

(a)

the animals from which the raw material is derived has not been:

(i)

slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(ii)

fed meat-and-bone meal or greaves derived from ruminants, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health;

(b)

the raw material does not contain and is not derived from:

(i)

specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

nervous and lymphatic tissues exposed during the deboning process.]]

(AA)  Commission Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84)."

(BB)  https://www.oie.int/en/standard-setting/terrestrial-code/access-online/’;"

(15)

in Chapter 44, point II.1.7. of the public health attestation is replaced by the following:

(1) [II.1.7.

in the case of treated raw materials of bovine, ovine and caprine animal origin, and except for hides and skins,

(1) either

[the country or region of origin is classified in accordance with Commission Decision 2007/453/EC (CC) as a country or region posing a negligible bovine spongiform encephalopathy (BSE) risk, and(5)

(1)

[the animals from which the treated raw material is derived were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there have been no BSE indigenous cases;]

(1)

[the animals from which the treated raw material is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there has been at least one BSE indigenous case, and the treated raw material does not contain and is not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;]

(1)

[the animals from which the treated raw material is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk and:

(i)

the treated raw material does not contain and is not derived from specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001 of the European Parliament and of the Council (DD);

(ii)

the treated raw material does not contain and is not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

the animals from which the treated raw material is derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;]

(1)

[the animals from which the treated raw material is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk and:

(i)

the treated raw material does not contain and is not derived from specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

the treated raw material does not contain and is not derived from mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

the animals from which the treated raw material is derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;]

(iv)

the animals from which the treated raw material is derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health (EE);

(v)

the treated raw material was produced and handled in a manner which ensures that they do not contain and were not contaminated with nervous and lymphatic tissues exposed during the deboning process;]]

(1) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk, and

(a)

the animals from which the treated raw material was derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(b)

the treated raw material does not contain and is not derived from:

(i)

specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

mechanically separated meat obtained from bones of bovine, ovine and caprine animals.

(1) either

[(c)

the animals from which the treated raw material is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible or a controlled BSE risk;]

(1) or

[(c)

the animals from which the treated raw material is derived originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk, and

(i)

the animals from which the treated raw material is derived have not been fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health;

(ii)

the treated raw material was produced and handled in a manner which ensures that it does not contain and was not contaminated with nervous and lymphatic tissues exposed during the deboning process;]]

(1) or

[the country or region of origin is classified in accordance with Decision 2007/453/EC as a country or region with an undetermined BSE risk, and

(a)

the animals from which the treated raw material is derived have not been:

(i)

slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(ii)

fed meat-and-bone meal or greaves derived from ruminants, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health;

(b)

the treated raw material does not contain and is not derived from:

(i)

specified risk material as defined in Annex V, point 1, to Regulation (EC) No 999/2001;

(ii)

mechanically separated meat obtained from bones of bovine, ovine and caprine animals;

(iii)

nervous and lymphatic tissues exposed during the deboning process.]]

(CC)  Commission Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84)."

(DD)  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)."

(EE)  https://www.oie.int/en/standard-setting/terrestrial-code/access-online’;"

(16)

Chapter 45 is replaced by the following: