Commission Regulation (EU) 2019/319 of 6 February 2019 amending Annex IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council and Annex XV to Commission Regulation (EU) No 142/2011 as regards health certification at import into the Union concerning transmissible spongiform encephalopathies (Text with EEA relevance.)
Date: 2019-02-06
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: Union transit, animal product, animal protein, bovine spongiform encephalopathy, by-product, health certificate, import (EU), intermediate goods, livestock, veterinary inspection




L_2019061EN.01000101.xml










28.2.2019   


EN


Official Journal of the European Union


L 61/1








            COMMISSION REGULATION (EU) 2019/319
of 6 February 2019
         
amending Annex IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council and Annex XV to Commission Regulation (EU) No 142/2011 as regards health certification at import into the Union concerning transmissible spongiform encephalopathies
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to 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 (1), and in particular the first paragraph of Article 23 and the introductory phrase and point (m) of Article 23a thereof,


Having regard to Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (2), and in particular the introductory phrase and point (d) and the final paragraph of Article 42(2) thereof,

Whereas:







(1)


Regulation (EC) No 999/2001 lays down rules for the prevention, control and eradication of transmissible spongiform encephalopathies (‘TSEs’) in bovine, ovine and caprine animals. It applies to the production and placing on the market of live animals and products of animal origin and in certain specific cases to exports thereof. That Regulation also provides a legal basis for the classification, as laid down in Commission Decision 2007/453/EC (3), of Member States and third countries or regions thereof according to their disease status for bovine spongiform encephalopathy (BSE) into those with a negligible BSE risk, a controlled BSE risk and an undetermined BSE risk.












(2)


Annex IX to Regulation (EC) No 999/2001 set outs the requirements for the importation into the Union of live animals, embryos, ova and products of animal origin. More particularly, Chapter B of that Annex sets out the requirements for imports of bovine animals, which takes into account the BSE status of the third countries or regions. In addition, Chapter D of that Annex lays down requirements for the provision of an attestation concerning the TSE related risk in the health certificate required for the importation into the Union of certain animal by-products and derived products, including, inter alia, processed animal protein.












(3)


Chapter B of Annex IX to Regulation (EC) No 999/2001, as amended by Commission Regulation (EU) 2016/1396 (4), requires that live bovine animals imported into the Union must not have been exposed to BSE cases or their cohort. Taking into account the fact that the main transmission route of BSE is through feed contaminated with the BSE prion, that requirement should be amended to provide that live bovine animals imported into the Union may not be BSE cases or their cohort. Chapter B of Annex IX to Regulation (EC) No 999/2001 should therefore be amended accordingly.












(4)


Regulation (EC) No 1069/2009 lays down public health and animal health rules for animal by-products and derived products in order to prevent and minimise risks to public and animal health arising from those products. Commission Regulation (EU) No 142/2011 (5) lays down implementing measures for the public and animal health rules for animal by-products and derived products laid down in Regulation (EC) No 1069/2009, including certain requirements for the importation of animal by-products and derived products from third countries.












(5)


Annex I to Regulation (EU) No 142/2011 lists certain definitions to be used for the purposes of that Regulation. Article 31 of Regulation (EU) No 142/2011 provides that consignments of animal by-products and derived products for importation into or transit through the Union are to be accompanied by health certificates and declarations, in accordance with the models set out in Annex XV thereto.












(6)


Point 1 of Article 11.4.13 of the Terrestrial Animal Health Code of the World Organisation for Animal Health (‘OIE Code’) (6) recommends that meat-and-bone meal and greaves derived from ruminants, as defined in the OIE Code, and commodities containing such products, which originate from countries or zones with a negligible BSE risk status in which there has been an indigenous BSE case, may enter international trade only if the products were derived from cattle born after the date of the effective implementation, in the country, of the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants, as defined in the OIE Code. Point 2 of that Article recommends that meat-and-bone meal and greaves derived from ruminants, as defined in the OIE Code, and commodities containing such products, should not enter international trade if they originate from countries or zones with a controlled or undetermined BSE risk status.












(7)


The OIE Code defines meat-and-bone meal as the solid protein products obtained when animal tissues are rendered, including any intermediate protein product other than peptides of a molecular weight less than 10 000 daltons and amino-acids. Thus, meat-and-bone meal as defined in the OIE Code covers both the definition of meat-and-bone meal set out in point 27 of Annex I to Regulation (EU) No 142/2011 and the definition of processed animal protein set out in point 5 of that Annex.












(8)


In accordance with Article 41(2)(c) of Regulation (EC) No 1069/2009, imports into the Union of meat-and-bone meal, as defined in Union legislation, may only take place if implementing rules have been adopted setting out the conditions for such importation. Since no such implementing rules have been adopted, the importation into the Union of meat-and-bone meal, derived from Category 1 or Category 2 material, is currently not allowed. However, imports into the Union of processed animal protein, as defined in Union legislation, may take place, subject to compliance with the TSE related import conditions laid down in Section B of Chapter D of Annex IX to Regulation (EC) No 999/2001, as well as with the conditions on the import of processed animal protein laid down in Regulation (EU) No 142/2011.












(9)


In order to align the TSE conditions for imports into the Union, laid down in Regulation (EC) No 999/2001, with the recommendations included in the BSE Chapter of the OIE Code, it is appropriate to amend Section B of Chapter D of Annex IX to Regulation (EC) No 999/2001 so that the requirement laid down in that Section take account of the recommendations of Article 11.4.13 of the OIE Code. However, since the use of processed animal protein derived from ruminants in the manufacturing of petfood is authorised in the Union, in order not to apply a discriminatory treatment towards imports compared to European Union production, the recommendations of Article 11.4.13 of the OIE Code should not be followed for the importation of petfood containing processed animal protein derived from ruminants, provided that such petfood is processed and labelled in accordance with Union legislation.












(10)


Section B of Chapter D of Annex IX to Regulation (EC) No 999/2001 should therefore be amended accordingly.












(11)


Products of animal origin may be required to be declared animal by-products by Union law, or by the decision of the responsible operator. When an operator decides that products of animal origin are to be declared as animal by-products, that decision is irreversible. Such animal by-products are excluded from use for human consumption. Certain animal by-products have the same Combined Nomenclature (CN) customs codes as animal products intended for human consumption which are laid down in Annex I to Council Regulation (EEC) No 2658/87 (7). For the classification in the CN customs codes the customs authorities in Member States need to be able to clearly differentiate between products which are fit for human consumption and those which are unfit for human consumption. In order to avoid any confusion for the purpose of that classification, the health guarantees referred to in the import certificates of unprocessed animal by-products should clarify that, although the animal by-products originate from animal products which were fit for human consumption at a former stage, they are now classified and treated as animal by-products which are permanently excluded from the food chain. The model health certificates set out in Chapters 3(D), 3(F) and 8 of Annex XV to Regulation (EU) No 142/2011 should therefore be amended accordingly.












(12)


In addition, the TSE attestation in the model certificates for imports of and transit through the Union of certain animal by-products set out in Chapters 1, 1a, 2(A), 2(B), 3(A), 3(B), 3(C), 3(D), 3(E), 3(F), 4(B), 4(C), 4(D), 6(B), 8, 10(A), 10(B), 11, 12 and 18 of Annex XV to Regulation (EU) No 142/2011 should be amended to take account of the requirements of Chapter D of Annex IX to Regulation (EC) No 999/2001, as amended by Commission Regulation (EU) No 630/2013 (8), by Regulation (EU) 2016/1396 and by this Regulation.












(13)


The import conditions for processed animal protein referred to in the model health certificate set out in Chapter 1 of Annex XV to Regulation (EU) No 142/2011 require the absence of blood from ruminants in processed animal proteins imported from third countries. However, the new TSE attestation set out in point II.7. of that model health certificate, as amended by this Regulation, provides for adequate guarantees to mitigate the TSE risk in such products. Therefore, the wording ‘other than ruminants’ should be deleted in all the model health certificates set out in Annex XV to Regulation (EU) No 142/2011 that are to be amended by this Regulation.












(14)


Chapters 1, 1a, 2(A), 2(B), 3(A), 3(B), 3(C), 3(D), 3(E), 3(F), 4(B), 4(C), 4(D), 6(B), 8, 10(A), 10(B), 11, 12 and 18 of Annex XV to Regulation (EU) No 142/2011 should therefore be amended accordingly.












(15)


In addition, consignments of intermediate products intended for the manufacturing of cosmetic and pharmaceutical products are required to be accompanied by a declaration completed in accordance with the model set out in Chapter 20 of Annex XV to Regulation (EU) No 142/2011 when presented at a border inspection post (‘BIP’) for the purpose of veterinary checks. Intermediate products may consist of or may contain animal by-products. The existing model declaration indicates only a limited number of appropriate HS codes which are to be used by the operator to notify the product to the customs authorities in the Member States. It is not possible to set out an exhaustive list of HS codes in advance in the model declaration which would cover all combinations of animal by-products in the intermediate products. Therefore, it is appropriate to replace the existing HS codes in order that the person responsible for the consignment may declare intermediate products to the BIP by an appropriate HS code in accordance with Commission Decision 2007/275/EC (9). Chapter 20 of Annex XV to Regulation (EU) No 142/2011 should be amended accordingly.












(16)


In order to avoid any disruption of trade, this Regulation should provide for a transitional period during which time the commodities concerned by the amendments made to Regulation (EU) No 142/2011 should continue to be accepted for importation into and transit through the Union, provided that those commodities comply with the requirements laid down in Regulation (EU) No 142/2011 before they were amended by this Regulation.












(17)


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 IX to Regulation (EC) No 999/2001 is amended in accordance with Annex I to this Regulation.


Article 2
Annex XV to Regulation (EU) No 142/2011 is amended in accordance with Annex II to this Regulation.


Article 3
For a transitional period until 30 September 2019, consignments of animal by-products and of derived products accompanied by a health certificate duly completed and signed in accordance with the appropriate model health certificate set out in Chapters 1, 1a, 2(A), 2(B), 3(A), 3(B), 3(C), 3(D), 3(E), 3(F), 4(B), 4(C), 4(D), 6(B), 8, 10(A), 10(B), 11, 12 and 18 of Annex XV to Regulation (EU) No 142/2011 in the version applicable before the amendments provided for by Article 2 of this Regulation, and, where applicable, by a declaration, which has been duly completed and signed in accordance with the model declaration set out in Chapter 20 of that Annex in its version applicable before the amendments provided for by Article 2 of this Regulation, shall continue to be accepted for importation into and transit though the Union, provided that such health certificates or declarations were duly completed and signed no later than 31 July 2019.


Article 4
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, 6 February 2019.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 147, 31.5.2001, p. 1.

(2)  
            OJ L 300, 14.11.2009, p. 1.

(3)  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).

(4)  Commission Regulation (EU) 2016/1396 of 18 August 2016 amending certain Annexes to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 225, 19.8.2016, p. 76).

(5)  Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1).

(6)  http://www.oie.int/international-standard-setting/terrestrial-code/access-online/

(7)  Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

(8)  Commission Regulation (EU) No 630/2013 of 28 June 2013 amending the Annexes to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 179, 29.6.2013, p. 60).

(9)  Commission Decision 2007/275/EC of 17 April 2007 concerning lists of animals and products to be subject to controls at border inspection posts under Council Directives 91/496/EEC and 97/78/EC (OJ L 116, 4.5.2007, p. 9).




ANNEX I
Annex IX to Regulation (EC) No 999/2001 is amended as follows:






(1)


in Chapter B:






(i)


in Section A, the introductory phrase of point (b) is replaced by the following:






‘(b)


the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not the following bovine animals:’














(ii)


in Section B, the introductory phrase of point (b) is replaced by the following:






‘(b)


the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not the following bovine animals:’














(iii)


in Section C, the introductory phrase of point (c) is replaced by the following:






‘(c)


the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not the following bovine animals:’


















(2)


in Chapter D, Section B is replaced by the following:


                                    ‘SECTION B


Health certificate requirements







1.


Imports of the animal by-products and derived products of bovine, ovine and caprine origin referred to in Section A shall be subject to the presentation of a health certificate which has been completed with the following attestation:






(a)


the animal by-product or derived product:






(i)


does not contain and is not derived from specified risk material as defined in point 1 of Annex V to this Regulation; and










(ii)


does not contain and is not derived from mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except if the animals, from which the animal by-product or derived product 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 no BSE indigenous cases; and










(iii)


is derived from animals which have not been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC;




or










(b)


the animal by-product or derived product does not contain and is not derived from bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.














2.


In addition to the requirements of point 1 of this Section, imports of the animal by-products and derived products referred to in points (d) and (f) of Section A shall be subject to the presentation of a health certificate which has been completed with the following attestation:






(a)


the animal by-product or derived product originates from a country or region, which is classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC, and in which there has been no BSE indigenous case;
or










(b)


the animal by-product or derived product originates from a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC in which there has been a BSE indigenous case, and the animal by-product or derived product was derived from animals born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants, as defined in the OIE Terrestrial Animal Health Code, has been effectively enforced in that country or region.




By way of derogation from the preceding paragraph, the attestation referred to in points (a) and (b) shall not be required for the importation of processed petfood, which is packaged and labelled in accordance with Union legislation.










3.


In addition to the requirements of points 1 and 2 of this Section, imports of the animal by-products and derived products referred to in Section A, containing milk or milk products of ovine or caprine animal origin and intended for feed, shall be subject to the presentation of a health certificate which has been completed with the following attestation:






(a)


the ovine and caprine animals from which those animal by-products or derived products have been derived have been kept continuously since birth in a country where the following conditions are fulfilled:






(i)


classical scrapie is compulsorily notifiable;










(ii)


an awareness, surveillance and monitoring system is in place;










(iii)


official restrictions apply to holdings of ovine or caprine animals in the case of a suspicion of TSE or a confirmation of classical scrapie;










(iv)


ovine and caprine animals affected with classical scrapie are killed and completely destroyed;










(v)


the feeding to ovine and caprine animals of meat-and-bone meal or greaves of ruminant origin, as defined in the OIE Terrestrial Animal Health Code, has been banned and effectively enforced in the whole country for a period of at least the preceding seven years;














(b)


the milk and milk products of ovine or caprine animals originate from holdings where no official restrictions are imposed due to a suspicion of TSE;










(c)


the milk and milk products of ovine or caprine animals originate from holdings where no case of classical scrapie has been diagnosed during a period of at least the preceding seven years or, following the confirmation of a case of classical scrapie:






(i)


all ovine and caprine animals on the holding have been killed and destroyed or slaughtered, except for breeding rams of the ARR/ARR genotype, breeding ewes carrying at least one ARR allele and no VRQ allele and other ovine animals carrying at least one ARR allele;
or










(ii)


all animals in which classical scrapie was confirmed have been killed and destroyed, and the holding has been subjected for a period of at least two years since the date of confirmation of the last classical scrapie case to intensified TSE monitoring, including testing with negative results for the presence of TSE in accordance with the laboratory methods set out in point 3.2 of Chapter C of Annex X, of all of the following animals which are over the age of 18 months, except ovine animals of the ARR/ARR genotype:






—


animals which have been slaughtered for human consumption; and










—


animals which have died or been killed on the holding but which were not killed in the framework of a disease eradication campaign.’
                                                                  

























ANNEX II
Annex XV to Regulation (EU) No 142/2011 is amended as follows:






(1)


Chapters 1 to 3(F) are replaced by the following:

                                 ‘CHAPTER 1

Health certificate


For processed animal protein, other than those derived from farmed insects, not intended for human consumption, including mixtures and products other than petfood containing such protein, for dispatch to or for transit through (2) the European Union




Text of image

COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17.




Text of image

I.18. Description of commodity
I.19. Commodity code (HS code)
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use Manufacture of petfood
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species (Scientific name)
Nature of commodity
Manufacturing plant
Net weight
Batch number




Text of image

COUNTRY
Processed animal protein, other than those derived from farmed insects, not intended for human consumption including mixtures and products other than petfood containing such protein
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a) and in particular Article 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Section 1 of Chapter II of Annex X, and Chapter I of Annex XIV thereto and certify that:
II.1. the processed animal protein or product described above contains exclusively processed animal protein not intended for human consumption that:
(a) has been prepared and stored in an establishment or plant approved and supervised by the competent authority in accordance with Article 24 of Regulation (EC) No 1069/2009, and
(b) has been prepared exclusively with the following animal by-products:
(2) either [- carcases and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed, and which are fit for human consumption in accordance with Union legislation, but are not intended for human consumption for commercial reasons;]
(2) and/or [- carcases and the following parts originating either from animals that have been slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human consumption in accordance with Union legislation:
(i) carcases or bodies and parts of animals which are rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of disease communicable to humans or animals;
(ii) heads of poultry;
(iii) hides and skins, including trimmings and splitting thereof, horns and feet, including the phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones;
(iv) pig bristles;
(v) feathers;]
(2) and/or [- blood of animals which did not show any signs of disease communicable through blood to humans or animals, obtained from animals that have been slaughtered in a slaughterhouse after having been considered fit for slaughter for human consumption following an ante-mortem inspection in accordance with Union legislation;]
(2) and/or [- animal by-products arising from the production of products intended for human consumption, including degreased bone, greaves and centrifuge or separator sludge from milk processing;]
(2) and/or [- products of animal origin, or foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise;]
(2) and/or [- blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live animals that did not show signs of any disease communicable through that product to humans or animals;]
(2) and/or [- aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of diseases communicable to humans or animals;]
(2) and/or [- animal by-products from aquatic animals originating from establishments or plants manufacturing products for human consumption;]
Part II: Certification




Text of image

COUNTRY
Processed animal protein, other than those derived from farmed insects, not intended for human consumption including mixtures and products other than petfood containing such protein
II. Health information
II.a. Certificate reference No
II.b.
(2) and/or [- the following material originating from animals which did not show any signs of disease communicable through that material to humans or animals:
(i) shells from shellfish with soft tissue or flesh;
(ii) the following originating from terrestrial animals:
— hatchery by-products,
— eggs,
— egg by-products, including egg shells;
(iii) day-old chicks killed for commercial reasons;]
(2) and/or [- aquatic and terrestrial invertebrates other than species pathogenic to humans or animals and other than insects;]
(2) and/or [- animals and parts thereof of the zoological orders of Rodentia and Lagomorpha, except Category 1 material as referred to in Article 8(a)(iii), (iv) and (v) and Category 2 material as referred to in Article 9(a) to (g) of Regulation (EC) No 1069/2009;]
and
(c) has been subjected to the following processing standard:
(2) either [heating to a core temperature of more than 133°C for at least 20 minutes without interruption at a pressure (absolute) of at least 3 bars produced by saturated steam, with a particle size prior to processing of not more than 50 millimetres;]
(2) or [in the case of non-mammalian protein other than fishmeal, the processing method 1-2-3-4-5-7 (indicate the processing method) as set out in Chapter III of Annex IV to Regulation (EU) No 142/2011;]
(2) or [in the case of fishmeal the processing method 1-2-3-4-5-6-7 (indicate the processing method) as set out in Chapter III of Annex IV to Regulation (EU) No 142/2011;]
(2) or [in the case of porcine blood, the processing method 1-2-3-4-5-7 (indicate the processing method) as set out in Chapter III of Annex IV to Regulation (EU) No 142/2011, where in case of method 7 a heat treatment of at least 80 °C has been applied throughout its substance;]
II.2. the competent authority examined a random sample immediately prior to dispatch and found it to comply with the following standards (3):
Salmonella: Absence in 25 g: n = 5, c = 0, m = 0, M = 0
Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1g;
II.3. the product has undergone all precautions to avoid recontamination with pathogenic agents after treatment;
II.4. the end product:
(2) either [was packed in new or sterilised bags,]




Text of image

COUNTRY
Processed animal protein, other than those derived from farmed insects, not intended for human consumption including mixtures and products other than petfood containing such protein
II. Health information
II.a. Certificate reference No
II.b.
(2) or [was transported in bulk in containers or other means of transport that were thoroughly cleaned and disinfected before use,]
which bear labels indicating ‘NOT FOR HUMAN CONSUMPTION’;
II.5. the end product was stored in enclosed storage;
(2) [II.6. the processed animal protein or product described above contains or is derived from animal-by products of ruminant origin and:
(2) either [originates from a country or region, which is classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC, and in which there has been no indigenous BSE case, and]]
(2) or [originates from a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC in which there has been an indigenous BSE case, and the animal by-product or derived product were derived from animals born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants, as defined in the OIE Terrestrial Animal Health Code, has been effectively enforced in that country or region, and]
(2) either [is derived from other ruminants than bovine, ovine or caprine animals.]
(2) or [is derived from bovine, ovine or caprine animals and does not contain and is not derived from:
(2) either [bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]
(2) or [ (a) specified risk material as defined in point 1 of Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council (4);
(b) mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except from those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Commission Decision2007/453/EC (5), in which there has been no indigenous BSE case,
(c) animal by-product or derived product obtained from bovine, ovine or caprine animals which have been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]]
II.7. the processed animal protein or product described above:
(2) either [does not contain milk or milk products of ovine or caprine animal origin or is not intended for feed for farmed animals, other than fur animals.]
(2) or [contains milk or milk products of ovine or caprine animal origin and is intended for feed for farmed animals, other than fur animals, and the milk or milk products:
(a) are derived from ovine and caprine animals which have been kept continuously since birth in a country where the following conditions are fulfilled:
(i) classical scrapie is compulsorily notifiable;




Text of image

COUNTRY
Processed animal protein, other than those derived from farmed insects, not intended for human consumption including mixtures and products other than petfood containing such protein
II. Health information
II.a. Certificate reference No
II.b.
(ii) an awareness, surveillance and monitoring system is in place for classical scrapie;
(iii) official restrictions apply to holdings of ovine or caprine animals in the case of a suspicion of TSE or the confirmation of classical scrapie;
(iv) ovine and caprine animals affected with classical scrapie are killed and destroyed;
(v) the feeding to ovine and caprine animals of meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE), of ruminant origin has been banned and effectively enforced in the whole country for a period of at least the preceding seven years;
(b) originate from holdings where no official restrictions are imposed due to a suspicion of TSE;
(c) originate from holdings where no case of classical scrapie has been diagnosed during a period of at least the preceding seven years or, following the confirmation of a case of classical scrapie:
(2) either [all ovine and caprine animals on the holding have been killed and destroyed or slaughtered, except for breeding rams of the ARR/ARR genotype, breeding ewes carrying at least one ARR allele and no VRQ allele and other ovine animals carrying at least one ARR allele;]
(2) or [all animals in which classical scrapie was confirmed have been killed and destroyed, and the holding has been subjected for a period of at least two years since the date of confirmation of the last classical scrapie case to intensified TSE monitoring, including testing with negative results for the presence of TSE in accordance with the laboratory methods set out in point 3.2 of Chapter C of Annex X to Regulation (EC) No 999/2001, of all of the following animals which are over the age of 18 months, except ovine animals of the ARR/ARR genotype:
— animals which have been slaughtered for human consumption; and
— animals which have died or been killed on the holding but which were not killed in the framework of a disease eradication campaign.]]
II.8. the processed animal protein or product described above contains or is derived from animal-by products of non-ruminant origin and is, according to the statement of the Consignor referred to in Box I.1,
(2) either [not intended for the production of feed for farmed animals, other than fur animals.]
(2) (6) or [intended for the production of feed for non-ruminant farmed animals, other than fur animals, and the Consignor has undertaken to ensure that the Border Inspection Post of entry will be provided with the results of the analyses carried out in accordance with the methods set out in Annex VI to Commission Regulation (EC) No 152/2009 (7).]
Notes
Part I:
— Box reference I.6: Person responsible for the consignment in the European Union: this box is required to be filled in only if it is a certificate for a commodity to be transited through the European Union; it may be filled in if the certificate is for a commodity that is to be imported into the European Union.
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit commodity. Products in transit may only be stored in free zones, free warehouses and custom warehouses.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship); information is to be provided in the event of unloading and reloading.




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COUNTRY
Processed animal protein, other than those derived from farmed insects, not intended for human consumption including mixtures and products other than petfood containing such protein
II. Health information
II.a. Certificate reference No
II.b.
— Box reference I.19: use the appropriate HS code: 05.05; 05.06; 05.07; 05.11; 23.01 or 23.09.
— Box reference I.25: technical use: any use other than feeding of farmed animals, other than fur animals, and the production or manufacturing of pet food.
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
— Box reference I.28: Species: select from the following: Aves, Ruminantia, Suidae, Mammalia other than Ruminantia or Suidae, Pesca, Mollusca, Crustacea, invertebrates other than Mollusca and Crustacea. In the case of farmed fish, specify the scientific name of the fish.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.
(2) Delete as appropriate.
(3) Where:
n = number of samples to be tested;
m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all samples does not exceed m;
M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more samples is M or more; and
c = number of samples the bacterial count of which may be between m and M, the sample still being considered acceptable if the bacterial count of the other samples is m or less.
(4) OJ L 147, 31.5.2001, p. 1.
(5) OJ L 172, 30.6.2007, p. 84.
(6) The Person responsible for the load referred to in Box I.6 must ensure that, if the processed animal protein or product described in this health certificate is intended to be used for the production of feed for non-ruminant farmed animals, other than fur animals, the consignment must be analysed, in accordance with the methods set out in Annex VI to Regulation (EC) No 152/2009, in order to verify the absence of unauthorised constituents of animal origin. The information on the result of such analysis must be attached to this health certificate when presenting the consignment at an EU border inspection post.
(7) OJ L 54, 26.2.2009, p. 1.
— The signature and the stamp must be in a different colour to that of the printing.
— Note for the person responsible for the consignment in the European Union: This certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

CHAPTER 1a

Health certificate


For processed animal protein derived from farmed insects not intended for human consumption, including mixtures and products other than petfood containing such protein, for dispatch to or for transit through (2) the European Union




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COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17.
I.18. Description of commodity
I.19. Commodity code (HS code)
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Animal feedingstuff Technical use Manufacture of petfood
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species (Scientific name)
Nature of commodity
Manufacturing plant
Net weight
Batch number




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COUNTRY
Processed animal protein derived from farmed insects not intended for human consumption including mixtures and products other than petfood containing such protein
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a) and in particular Article 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Section 1 of Chapter II of Annex X, and Chapter I of Annex XIV thereto and certify that:
II.1. the processed animal protein derived from farmed insects or product described above contains exclusively processed animal protein not intended for human consumption that:
(a) has been prepared and stored in an establishment or plant approved and supervised by the competent authority in accordance with Article 24 of Regulation (EC) No 1069/2009, and
(b) has been prepared exclusively from farmed insects of the following species:
(2) either [- Black Soldier Fly (Hermetia illucens);]
(2) and/or [- Common Housefly (Musca domestica);]
(2) and/or [- Yellow Mealworm (Tenebrio molitor);]
(2) and/or [- Lesser Mealworm (Alphitobius diaperinus);]
(2) and/or [- House cricket (Acheta domesticus);]
(2) and/or [- Banded cricket (Gryllodes sigillatus);]
(2) and/or [- Field Cricket (Gryllus assimilis).]
and
(c) has been processed by method [1]-[2]-[3]-[4]-[5]-[7] (2) as set out in Chapter III of Annex IV to Regulation (EU) No 142/2011;
and
(d) the substrate for the feeding of farmed insects may only contain products of non-animal origin or the following products of animal origin of Category 3 material:
— fishmeal;
— blood products from non-ruminants;
— di and tricalcium phosphate of animal origin;
— hydrolysed proteins from non-ruminants;
— hydrolysed proteins from hides and skins of ruminants;
— gelatine and collagen from non-ruminants;
— eggs and egg products;
— milk, milk based-products, milk-derived products, and colostrum;
— honey;
— rendered fats;
Part II: Certification




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COUNTRY
Processed animal protein derived from farmed insects not intended for human consumption including mixtures and products other than petfood containing such protein
II. Health information
II.a. Certificate reference No
II.b.
and
(e) the substrate for the feeding of insects and the insects or their larvae have not been in contact with any other materials of animal origin than those referred to in point (d) and the substrate did not contain manure, catering waste or other waste.
II.2. the competent authority examined a random sample immediately prior to dispatch and found it to comply with the following standards (3):
Salmonella: Absence in 25 g: n = 5, c = 0, m = 0, M = 0
Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1g;
II.3. the product has undergone all precautions to avoid recontamination with pathogenic agents after treatment;
II.4. the end product:
(2) either [was packed in new or sterilised bags,]
(2) or [was transported in bulk in containers or other means of transport that were thoroughly cleaned and disinfected before use,]
which bear labels indicating ‘NOT FOR HUMAN CONSUMPTION/ PROCESSED INSECT PROTEIN – SHALL NOT BE USED IN FEED FOR FARMED ANIMALS EXCEPT AQUACULTURE AND FUR ANIMALS’;
II.5. the end product was stored in enclosed storage;
(2) [II.6. the processed animal protein or product described above contains or is derived from animal-by products of ruminant origin and:
(2) either [originates from a country or region, which is classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC, and in which there has been no indigenous BSE case, and]]
(2) or [originates from a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC in which there has been an indigenous BSE case, and the animal by-product or derived product were derived from animals born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants, as defined in the OIE Terrestrial Animal Health Code, has been effectively enforced in that country or region, and]]
(2) either [is derived from other ruminants than bovine, ovine or caprine animals.]]
(2) or [is derived from bovine, ovine or caprine animals and does not contain and is not derived from:
(2) either [bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]
(2) or [(a) specified risk material as defined in point 1 of Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council (4);
(b) mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except from those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Commission Decision 2007/453/EC (5), in which there has been no indigenous BSE case,




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COUNTRY
Processed animal protein derived from farmed insects not intended for human consumption including mixtures and products other than petfood containing such protein
II. Health information
II.a. Certificate reference No
II.b.
(c) animal by-product or derived product obtained from bovine, ovine or caprine animals which have been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]]
II.7. the processed animal protein or product described above:
(2) either [does not contain milk or milk products of ovine or caprine animal origin or is not intended for feed for farmed animals, other than fur animals.]
(2) or [contains milk or milk products of ovine or caprine animal origin and is intended for feed for farmed animals, other than fur animals, and the milk or milk products:
(a) are derived from ovine and caprine animals which have been kept continuously since birth in a country where the following conditions are fulfilled:
(i) classical scrapie is compulsorily notifiable;
(ii) an awareness, surveillance and monitoring system is in place for classical scrapie;
(iii) official restrictions apply to holdings of ovine or caprine animals in the case of a suspicion of TSE or the confirmation of classical scrapie;
(iv) ovine and caprine animals affected with classical scrapie are killed and destroyed;
(v) the feeding to ovine and caprine animals of meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE), of ruminant origin has been banned and effectively enforced in the whole country for a period of at least the preceding seven years;
(b) originate from holdings where no official restrictions are imposed due to a suspicion of TSE;
(c) originate from holdings where no case of classical scrapie has been diagnosed during a period of at least the preceding seven years or, following the confirmation of a case of classical scrapie:
(2) either [all ovine and caprine animals on the holding have been killed and destroyed or slaughtered, except for breeding rams of the ARR/ARR genotype, breeding ewes carrying at least one ARR allele and no VRQ allele and other ovine animals carrying at least one ARR allele;]
(2) or [all animals in which classical scrapie was confirmed have been killed and destroyed, and the holding has been subjected for a period of at least two years since the date of confirmation of the last classical scrapie case to intensified TSE monitoring, including testing with negative results for the presence of TSE in accordance with the laboratory methods set out in point 3.2 of Chapter C of Annex X to Regulation (EC) No 999/2001, of all of the following animals which are over the age of 18 months, except ovine animals of the ARR/ARR genotype:
— animals which have been slaughtered for human consumption; and
— animals which have died or been killed on the holding but which were not killed in the framework of a disease eradication campaign.]]
II.8. [the processed animal protein or product described above contains or is derived from animal-by products of non-ruminant origin and is, according to the statement of the Consignor referred to in Box I.1,




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COUNTRY
Processed animal protein derived from farmed insects not intended for human consumption including mixtures and products other than petfood containing such protein
II. Health information
II.a. Certificate reference No
II.b.
(2) either [not intended for the production of feed for farmed animals, other than fur animals.]
(2) (6) or [intended for the production of feed for non-ruminant farmed animals, other than fur animals, and the Consignor has undertaken to ensure that the border inspection post of entry into the European Union will be provided with the results of the analyses carried out in accordance with the methods set out in Annex VI to Commission Regulation (EC) No 152/2009 (7).]
Notes
Part I:
— Box reference I.6: Person responsible for the consignment in the European Union: this box is required to be filled in only if it is a certificate for a commodity to be transited through the European Union; it may be filled in if the certificate is for an a commodity to be imported into the European Union.
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for a transit commodity. Products in transit may only be stored in free zones, free warehouses and custom warehouses.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship); information is to be provided in the event of unloading and reloading.
— Box reference I.19: use the appropriate HS code: 05.11, 23.01 or 23.09.
— Box reference I.25: technical use: any use other than feeding of farmed animals, other than fur animals, and the production or manufacturing of pet food..
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
— Box reference I.28: Species: insects, specify its scientific name.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.
(2) Delete as appropriate.
(3) Where:
n = number of samples to be tested;
m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all samples does not exceed m;
M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more samples is M or more; and
c = number of samples the bacterial count of which may be between m and M, the sample still being considered acceptable if the bacterial count of the other samples is m or less.
(4) OJ L 147, 31.5.2001, p. 1.
(5) OJ L 172 30.6.2007, p. 84.




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COUNTRY
Processed animal protein derived from farmed insects not intended for human consumption including mixtures and products other than petfood containing such protein
II. Health information
II.a. Certificate reference No
II.b.
(6) The Person responsible for the load referred to in Box I.6 must ensure that, if the processed animal protein or product described in this health certificate is intended to be used for the production of feed for non-ruminant farmed animals, other than fur animals, the consignment must be analysed, in accordance with the methods set out in Annex VI to Regulation (EC) No 152/2009, in order to verify the absence of unauthorised constituents of animal origin. The information on the result of such analysis must be attached to this health certificate when presenting the consignment at an EU Border Inspection Post.
(7) OJ L 54, 26.2.2009, p. 1.
— The signature and the stamp must be in a different colour to that of the printing.
— Note for the person responsible for the consignment in the European Union: This certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

CHAPTER 2(A)

Health certificate


For milk, milk-based products and milk-derived products not intended for human consumption for dispatch to or transit through (2) the European Union




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COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17. Number(s) of CITES
I.18. Description of commodity
I.19. Commodity code (HS code)
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Animal feedingstuff Further process Production of petfood
Technical use
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species(Scientific name)
Manufacturing plant
Net weight
Batch number




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COUNTRY
Milk, milk-based products and milk-derived products not for human consumption
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a), and in particular Article 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Section 4 of Chapter II of Annex X, and Chapter I of Annex XIV thereto, and certify that the milk (2), the milk-based products (2) and milk-derived products (2) referred to in box I.28 comply with the following conditions:
II.1. they were produced and derived in (insert name of exporting country) (3), (insert name of region) (3), which is listed in Part I of Annex II to Commission Regulation (EU) No 605/2010 (4), and which has been free from foot-and-mouth disease (FMD) and rinderpest for a period of 12 months immediately prior to export and has not practised vaccination against rinderpest during that period;
II.2. they were produced from raw milk derived from animals which at the time of milking did not show clinical signs of any disease transmissible through milk to humans or animals, and which had been kept for a period of at least30 days prior to production on holdings that were not subject to official restrictions due to foot-and-mouth disease or rinderpest;
II.3. they are milk or milk products that:
(2) either [have undergone one of the treatments or combinations thereof described in point II.4;]
(2) or [comprise whey to be fed to animals of species susceptible to foot-and-mouth disease, and that whey was collected from milk subjected to one of the treatments described in point II.4 and:
(2) either [the whey was collected at least 16 hours after clotting and has a pH below 6;]
(2) (5) or [the whey has been produced at least 21 days before the shipping and during that period no cases of FMD have been detected in the exporting country;]
(2) (5) or [the whey has been produced on …/…/…, this date, in consideration of the foreseen voyage duration, being at least 21 days before the consignment is presented to a border inspection post of the European Union;]]
II.4. they have been subject to one of the following treatments:
(2) either [high temperature short time pasteurisation at 72°C for at least 15 seconds, or an equivalent pasteurisation achieving a negative reaction to a phosphatase test in bovine milk, in combination with:
(2) either [a subsequent second high temperature short time pasteurisation at 72°C for at least 15 seconds or an equivalent pasteurisation which itself achieves a negative reaction to a phosphatase test in bovine milk;]
(2) or [a subsequent drying process that in the case of milk intended for feeding is combined with additional heating to 72°C or higher;]
(2) or [a subsequent process by which the pH is reduced and kept for at least one hour at a level below 6;]
(2) (5) or [the condition that the milk/milk product has been produced at least 21 days prior to the date of shipping and during that period no cases of FMD have been detected in the exporting country;]
(2) (5) or [the milk/milk product has been produced on …/…/…… (insert the date), this date, in consideration of the foreseen voyage duration, being at least 21 days prior to the date that the consignment is presented to a border inspection post of the European Union;]
(2) or [sterilisation at a level of at least F03;]]
Part II: Certification




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COUNTRY
Milk, milk-based products and milk-derived products not for human consumption
II. Health information
II.a. Certificate reference No
II.b.
(2) or [ultra high temperature treatment at 132°C for at least one second in combination with:
(2) either [a subsequent drying process that in the case of milk intended for feeding is combined with additional heating to 72°C or higher;]
(2) or [a subsequent process by which the pH is reduced and kept for at least one hour at a level below 6;]
(2) (5) or [the condition that the milk/milk product has been produced at least 21 days prior to the date of shipping and during that period no cases of FMD has been detected in the exporting country;]
(2) (5) or [the milk/milk product has been produced on …/…/…… (insert the date), this date, in consideration of the foreseen voyage duration, being at least 21 days prior to the date that the consignment is presented to a border inspection post of the European Union;]]
II.5. every precaution was taken to avoid contamination of the milk/milk-based product/milk-derived product after processing;
II.6. the milk/milk-based product/milk-derived product was packed:
(2) either [in new containers;]
(2) or [in vehicles or bulk containers disinfected prior to loading using a product approved by the competent authority;]
and the containers are marked so as to indicate the nature of the milk/milk-based product/milk-derived product and bear labels indicating that the product is Category 3 material and not intended for human consumption;
II.7. the milk, milk-based products and milk-derived products described above:
(2) either [does not contain milk or milk products of ovine or caprine animal origin or is not intended for feed for farmed animals, other than fur animals.]
(2) or [contains milk or milk products of ovine or caprine animal origin and is intended for feed for farmed animals, other than fur animals, and the milk or milk products:
(a) are derived from ovine and caprine animals which have been kept continuously since birth in a country where the following conditions are fulfilled:
(i) classical scrapie is compulsorily notifiable;
(ii) an awareness, surveillance and monitoring system is in place for classical scrapie;
(iii) official restrictions apply to holdings of ovine or caprine animals in the case of a suspicion of TSE or the confirmation of classical scrapie;
(iv) ovine and caprine animals affected with classical scrapie are killed and destroyed;
(v) the feeding to ovine and caprine animals of meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE), of ruminant origin has been banned and effectively enforced in the whole country for a period of at least the preceding seven years;
(b) originate from holdings where no official restrictions are imposed due to a suspicion of TSE;




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COUNTRY
Milk, milk-based products and milk-derived products not for human consumption
II. Health information
II.a. Certificate reference No
II.b.
(c) originate from holdings where no case of classical scrapie has been diagnosed during a period of at least the preceding seven years or, following the confirmation of a case of classical scrapie:
(2) either [all ovine and caprine animals on the holding have been killed and destroyed or slaughtered, except for breeding rams of the ARR/ARR genotype, breeding ewes carrying at least one ARR allele and no VRQ allele and other ovine animals carrying at least one ARR allele;]
(2) or [all animals in which classical scrapie was confirmed have been killed and destroyed, and the holding has been subjected for a period of at least two years since the date of confirmation of the last classical scrapie case to intensified TSE monitoring, including testing with negative results for the presence of TSE in accordance with the laboratory methods set out in point 3.2 of Chapter C of Annex X to Regulation (EC) No 999/2001 (6), of all of the following animals which are over the age of 18 months, except ovine animals of the ARR/ARR genotype:
— animals which have been slaughtered for human consumption; and
— animals which have died or been killed on the holding but which were not killed in the framework of a disease eradication campaign.]]
Notes
Part I:
— Box reference I.6: Person responsible for the load in the European Union: this box is required to be filled in only if it is a certificate for a commodity to be transited through the European union; it may be filled in if the certificate is for a commodity to be imported into the European Union.
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit commodity.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship) is to be provided. In the case of unloading and reloading, the consignor must inform the border inspection post of the European Union.
— Box reference I.19: use the appropriate Harmonised System (HS) code of the World Customs Organisation: 04.01; 04.02; 04.03; 04.04; 23.09.10, 23.09.90, 35.01, 35.02 or 35.04.
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be included.
— Box reference I.25: technical use: any use other than feeding of farmed animals, other than fur animals, and the production or manufacturing of pet food.
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
— Box reference I.28: ’Manufacturing plant’: provide the registration number of treatment or processing establishment.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.




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COUNTRY
Milk, milk-based products and milk-derived products not for human consumption
II. Health information
II.a. Certificate reference No
II.b.
(2) Delete as appropriate.
(3) For completion if the authorisation to import into or transit through the European Union is restricted to certain regions of the third country concerned.
(4) OJ L 175, 10.7.2010, p. 1.
(5) this condition applies only to third countries listed in column ’A’ of Annex I to Regulation (EU) No 605/2010.
(6) OJ L 147, 31.5.2001, p. 1.
— The signature and the stamp must be in a different colour to that of the printing.
— Note for the person responsible for the consignment in the European Union: This certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

CHAPTER 2(B)

Health certificate


For colostrum and colostrum products from bovine animals not intended for human consumption for dispatch to or transit through (2) the European Union




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COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17. Number(s) of CITES
I.18. Description of commodity
I.19. Commodity code (HS code)
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Animal feedingstuff Further process Production of petfood
Technical use
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species(Scientific name)
Manufacturing plant
Net weight
Batch number




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COUNTRY
Colostrum and colostrum products from bovine animals not for human consumption
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a), and in particular Article 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Section 4 of Chapter II of Annex X and Chapter I of Annex XIV thereto, and certify that the colostrum (2) or the colostrum products (2) referred to in box I.28 comply with the following conditions:
II.1. they were produced and derived in (insert name of exporting country) (3), (insert name of region) (3), which is listed in Annex I to Commission Regulation (EU) No 605/2010 (4), and which has been free from foot-and-mouth disease (FMD) and rinderpest for a period of 12 months immediately prior to export and has not practised vaccination against rinderpest during that period;
II.2. they were produced from colostrum derived from animals which at the time of milking did not show clinical signs of any disease transmissible through colostrum to humans or animals, and which had been kept for a period of at least 30 days prior to the date of production on holdings that were not subject to official restrictions due to foot-and-mouth disease or rinderpest;
II.3. they are colostrum or colostrum products of bovine animals that have been subject to high temperature short time pasteurisation at 72°C for at least 15 seconds, or an equivalent pasteurisation achieving a negative reaction to a phosphatase test in bovine colostrum, in combination with:
(2) (5) either [the condition that the colostrum or colostrum products have been produced during a period at least 21 days before the date of shipping and during this period no cases of FMD have been detected in the exporting country,]
(2) (5) or [the condition that the colostrum or colostrum products have been produced on …/…/…… (insert the date), this date, in consideration of the foreseen voyage duration, being at least 21 days before the consignment is presented to a border inspection post of the European Union,]
and have been obtained from animals subject to regular veterinary inspections to ensure that they come from holdings on which all bovine herds are:
(2) (5) either [recognised as officially tuberculosis and brucellosis free (6),]
(2) (5) or [not restricted under the national legislation of the third country of origin for the eradication of tuberculosis and brucellosis,]
and (2) (5) either [recognised as official enzootic-bovine-leukosis-free (6),]
(2) (5) or [included in an official system for the control of enzootic bovine leukosis and there has been no evidence as result of clinical and laboratory testing of this disease in the herd during the period of the preceding two years,]]
II.4. every precaution has been taken to avoid contamination of the colostrum/colostrum product after processing;
II.5. the colostrum or colostrum product was packed:
(2) either [in new containers,]
(2) or [in vehicles or bulk containers disinfected prior to loading using a product approved by the competent authority,]
and the containers are marked so as to indicate the nature of the colostrum/colostrum product and bear labels indicating that the product is Category 3 material and not intended for human consumption;
II.6. the colostrum or colostrum product does not contain milk or milk products of ovine or caprine animal origin.
Notes
Part I:
— Box reference I.6: Person responsible for the load in the European Union: this box is required to be filled in only if it is a certificate for a commodity to be transited through the European Union; it may be filled in if the certificate is for a commodity to be imported into the European Union.
Part II: Certification




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COUNTRY
Colostrum and colostrum products from bovine animals not for human consumption
II. Health information
II.a. Certificate reference No
II.b.
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit commodity.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship) is to be provided. In the case of unloading and reloading in the European Union, the consignor must inform the border inspection post of the European Union.
— Box reference I.19: use the appropriate Harmonised System (HS) code of the World Customs Organisation: 04.04.90; 23.09.10, 23.09.90, 35.01, 35.02 or 35.04.
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be included.
— Box reference I.25: technical use: any use other than feeding of farmed animals, other than fur animals, and the production or manufacturing of pet food..
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
— Box reference I.28: ‘Manufacturing plant’: provide the registration number of the treatment or processing establishment.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.
(2) Delete as appropriate.
(3) For completion if the authorisation for introduction into the European Union is restricted to certain regions of the third country concerned.
(4) OJ L 175, 10.7.2010, p. 1.
(5) This condition applies only to third countries authorised in column ‘A’ of Annex I to Commission Regulation (EU)No 605/2010 (OJ L 175, 10.7.2010, p. 1).
(6) Officially tuberculosis-free and brucellosis-free herd as laid down in Annex A to Council Directive 64/432/EEC (OJ 121, 29.7.1964, p. 1977/64) and officially enzootic-bovine-leukosis-free herd as laid down in Chapter I of Annex D to that Directive.
— The signature and the seal must be in a different colour from that of the printing.
— Note for the importer: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post of the European Union.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

CHAPTER 3(A)

Health certificate


For canned petfood intended for dispatch to or for transit through (2) the European Union




Text of image

COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17.
I.18. Description of commodity
I.19. Commodity code (HS code)
23.09
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Petfood Technical use
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species(Scientific name)
Manufacturing plant
Net weight
Batch number




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COUNTRY
Canned Petfood
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a), and in particular Articles 8 and 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Chapter II of Annex XIII and Chapter II of Annex XIV, thereto and certify that the petfood described above:
II.1. has been prepared and stored in an establishment or plant approved and supervised by the competent authority in accordance with Article 24 of Regulation (EC) No 1069/2009;
II.2. has been prepared exclusively with the following animal by-products:
(2) either [- carcases and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed, and which are fit for human consumption in accordance with Union legislation, but are not intended for human consumption for commercial reasons;]
(2) and/or [- carcases and the following parts originating either from animals that have been slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human consumption in accordance with Union legislation:
(i) carcases or bodies and parts of animals which are rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of disease communicable to humans or animals;
(ii) heads of poultry;
(iii) hides and skins, including trimmings and splitting thereof, horns and feet, including the phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones;
(iv) pig bristles;
(v) feathers;]
(2) and/or [- animal by-products from poultry and lagomorphs slaughtered on the farm as referred to in Article 1(3)(d) of Regulation (EC) No 853/2004 of the European Parliament and of the Council (2a), which did not show any signs of disease communicable to humans or animals]
(2) and/or [- blood of animals which did not show any signs of disease communicable through blood to humans or animals, obtained from animals that have been slaughtered in a slaughterhouse after having been considered fit for slaughter for human consumption following an ante-mortem inspection in accordance with Union legislation;]
(2) and/or [- animal by-products arising from the production of products intended for human consumption, including degreased bone, greaves and centrifuge or separator sludge from milk processing;]
(2) and/or [- products of animal origin, or foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise;]
(2) and/or [- petfood and feedingstuffs of animal origin, or feedingstuffs containing animal by-products or derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise;]
(2) and/or [- blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live animals that did not show signs of any disease communicable through that product to humans or animals;]
(2) and/or [- aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of diseases communicable to humans or animals;]
(2) and/or [- animal by-products from aquatic animals originating from plants or establishments manufacturing products for human consumption;]
Part II: Certification




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COUNTRY
Canned Petfood
II. Health information
II.a. Certificate reference No
II.b.
(2) and/or [- the following material originating from animals which did not show any signs of disease communicable through that material to humans or animals:
(i) shells from shellfish with soft tissue or flesh;
(ii) the following originating from terrestrial animals:
— hatchery by-products,
— eggs,
— egg by-products, including egg shells;
(iii) day-old chicks killed for commercial reasons;]
(2) and/or [- animal by-products from aquatic or terrestrial invertebrates other than species pathogenic to humans or animals;]
(2) and/or [- animals and parts thereof of the zoological orders of Rodentia and Lagomorpha, except Category 1 material as referred to in Article 8(a)(iii), (iv) and (v) of Regulation (EC) No 1069/2009 and Category 2 material as referred to in Article 9(a) to (g) of that Regulation;]
(2) and/or [- material from animals which have been treated with certain substances which are prohibited by Council Directive 96/22/EC (2b), the import of the material being permitted in accordance with Article 35(a)(ii) of Regulation (EC) No 1069/2009;]
II.3. has been subjected to heat treatment to a minimum Fc value of 3 in hermetically sealed containers;
II.4. was analysed by a random sampling of at least five samples from each processed batch by laboratory diagnostic method to ensure adequate heat treatment of the whole consignment as foreseen under point II.3;
II.5. has undergone all precautions to avoid contamination with pathogenic agents after treatment.
(2) [II.6. the petfood described above
(2) either [is derived from other ruminants than bovine, ovine or caprine animals.]
(2) or [is derived from bovine, ovine or caprine animals and does not contain and is not derived from:
(2) either [bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]
(2) or [(a) specified risk material as defined in point 1 of Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council (3);
(b) mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except from those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Commission Decision 2007/453/EC (4), in which there has been no indigenous BSE case,
(c) animal by-product or derived product obtained from bovine, ovine or caprine animals which have been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]]




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COUNTRY
Canned Petfood
II. Health information
II.a. Certificate reference No
II.b.
Notes
Part I:
— Box reference I.6: Person responsible for the consignment in the European Union: this box is required to be filled in only if it is a certificate for a commodity to be transited through the European Union; it may be filled in if the certificate is for a commodity to be imported into the European Union.
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit commodity. Products in transit may only be stored in free zones, free warehouses and custom warehouses.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship); information is to be provided in the event of unloading and reloading in the European Union.
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be given.
— Box reference I.25: technical use: any use other than feeding of farmed animals, other than fur animals, and the production or manufacturing of pet food..
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
— Box reference I.28: Species: select from the following: Aves, Ruminantia, Suidae, Mammalia other than Ruminantia or Suidae, Pesca, Mollusca, Crustacea, invertebrates other than Mollusca and Crustacea.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.
(2) Delete as appropriate.
(2a) OJ L 139, 30.4.2004, p. 55.
(2b) OJ L 125, 23.5.1996, p. 3.
(3) OJ L 147, 31.5.2001, p. 1.
(4) OJ L 172, 30.6.2007, p. 84.
— The signature and the stamp must be in a different colour to that of the printing.
— Note for the person responsible for the consignment in the European Union: This certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

(CHAPTER 3(B)

Health certificate


For processed petfood other than canned petfood, intended for dispatch to or for transit through (2) the European Union




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COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17.
I.18. Description of commodity
I.19. Commodity code (HS code)
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Petfood Technical use
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species(Scientific name)
Manufacturing plant
Net weight
Batch number




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COUNTRY
Processed petfood other than canned petfood
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a), and in particular Articles 8 and 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Chapter II of Annex XIII and Chapter II of Annex XIV thereto, and certify that the petfood described above:
II.1. has been prepared and stored in a plant approved and supervised by the competent authority in accordance with Article 24 of Regulation (EC) No 1069/2009;
II.2. has been prepared exclusively with the following animal by-products:
(2) either [- carcases and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed, and which are fit for human consumption in accordance with Union legislation, but are not intended for human consumption for commercial reasons;]
(2) and/or [- carcases and the following parts originating either from animals that have been slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human consumption in accordance with Union legislation:
(i) carcases or bodies and parts of animals which are rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of disease communicable to humans or animals;
(ii) heads of poultry;
(iii) hides and skins, including trimmings and splitting thereof, horns and feet, including the phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones;
(iv) pig bristles;
(v) feathers;]
(2) and/or [- animal by-products from poultry and lagomorphs slaughtered on the farm as referred to in Article 1(3)(d) of Regulation (EC) No 853/2004 of the European Parliament and of the Council (2a), which did not show any signs of disease communicable to humans or animals]
(2) and/or [- blood of animals which did not show any signs of disease communicable through blood to humans or animals, obtained from animals that have been slaughtered in a slaughterhouse after having been considered fit for slaughter for human consumption following an ante-mortem inspection in accordance with Union legislation;]
(2) and/or [- animal by-products arising from the production of products intended for human consumption, including degreased bone, greaves and centrifuge or separator sludge from milk processing;]
(2) and/or [- products of animal origin, or foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise;]
(2) and/or [- petfood and feedingstuffs of animal origin, or feedingstuffs containing animal by-products or derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise;]
(2) and/or [- blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live animals that did not show signs of any disease communicable through that product to humans or animals;]
(2) and/or [- aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of diseases communicable to humans or animals;]
Part II: Certification




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COUNTRY
Processed petfood other than canned petfood
II. Health information
II.a. Certificate reference No
II.b.
(2) and/or [- animal by-products from aquatic animals originating from plants or establishments manufacturing products for human consumption;]
(2) and/or [- the following material originating from animals which did not show any signs of disease communicable through that material to humans or animals:
(i) shells from shellfish with soft tissue or flesh;
(ii) the following originating from terrestrial animals:
— hatchery by-products,
— eggs,
— egg by-products, including egg shells,
(iii) day-old chicks killed for commercial reasons;]
(2) and/or [- animal by-products from aquatic or terrestrial invertebrates other than species pathogenic to humans or animals;]
(2) and/or [- animals and parts thereof of the zoological orders of Rodentia and Lagomorpha, except Category 1 material as referred to in Article 8(a)(iii), (iv) and (v) of Regulation (EC) No 1069/2009 and Category 2 material as referred to in Article 9(a) to (g) of that Regulation;]
(2) and/or [- material from animals which have been treated with certain substances which are prohibited by Council Directive 96/22/EC (2b), the import of the material being permitted in accordance with Article 35(a)(ii) of Regulation (EC) No 1069/2009;]
II.3.
(2) either [was subjected to a heat treatment of at least 90 °C throughout its substance;]
(2) or [was produced as regards ingredients of animal origin using exclusively products which had been:
(a) in the case of animal by-products or derived products from meat or meat products subjected to a heat treatment of at least 90 °C throughout its substance;
(b) in the case of milk and milk based products,
(i) if they are from third countries or parts of third countries listed in column B of Annex I to Commission Regulation (EU) No 605/2010 (3) submitted to a pasteurisation treatment sufficient to produce a negative phosphatase test;
(ii) with a pH reduced to less than 6 from third countries or parts of third countries listed in column C of Annex I to Regulation (EU) No 605/2010, first submitted to a pasteurisation treatment sufficient to produce a negative phosphatase test;
(iii) if they are from third countries or parts of third countries listed in column C of Annex I to Regulation (EU) No 605/2010, submitted to a sterilisation process or a double heat treatment where each treatment was sufficient to produce a negative phosphatase test on its own;
(iv) if they are from third countries or parts of third countries listed in column C of Annex I to Regulation (EU) No 605/2010, where there has been an outbreak of foot-and-mouth disease in the preceding 12 months or where vaccination against foot-and-mouth disease has been carried out in the preceding12 months, submitted to
either
— a sterilisation process whereby an Fc value equal or greater than 3 is achieved
or
— an initial heat treatment with a heating effect at least equal to that achieved by a pasteurisation process of at least 72 °C for at least 15 seconds and sufficient to produce a negative reaction to a phosphatase test, followed by




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COUNTRY
Processed petfood other than canned petfood
II. Health information
II.a. Certificate reference No
II.b.
either
— a second heat treatment with a heating effect at least equal to that achieved by the initial heat treatment, and which would be sufficient to produce a negative reaction to a phosphatase test, followed, in the case of dried milk, or dried milk-based products by a drying process
or
— an acidification process such that the pH has been maintained at less than 6 for at least one hour;
(c) in the case of gelatine, produced using a process that ensures that unprocessed Category 3 material is subjected to a treatment with acid or alkali, followed by one or more rinses with subsequent adjustment of the pH and subsequent, if necessary repeated, extraction by heat, followed by purification by means of filtration and sterilisation;
(d) in the case of hydrolysed protein produced using a production process involving appropriate measures to minimise contamination of raw Category 3 material, and, in the case of hydrolysed protein entirely or partly derived from ruminant hides and skins produced in a processing plant dedicated only to hydrolysed protein production, using only material with a molecular weight below 10000 Dalton and a process involving the preparation of raw Category 3 material by brining, liming and intensive washing followed by:
(i) exposure of the material to a pH of more than 11 for more than three hours at a temperature of more than 80 °C and subsequently by heat treatment at more than 140 °C for 30 minutes at more than 3,6 bar; or
(ii) exposure of the material to a pH of 1 to 2, followed by a pH of more than 11, followed by heat treatment at 140 °C for 30 minutes at 3 bar;
(e) in the case of egg products submitted to any of the processing methods 1 to 5 or 7, as referred to in Chapter III of Annex IV to Regulation (EU) No 142/2011; or treated in accordance with Chapter II of Section X of Annex III to Regulation (EC) No 853/2004 ;
(f) in the case of collagen submitted to a process ensuring that unprocessed Category 3 material is subjected to a treatment involving washing, pH adjustment using acid or alkali followed by one or more rinses, filtration and extrusion, the use of preservatives other than those permitted by Union legislation being prohibited;
(g) in the case of blood products, produced using any of the processing methods 1 to 5 or 7, as referred to in Chapter III of Annex IV to Regulation (EU) No 142/2011;
(h) in the case of mammalian processed animal protein submitted to any of the processingmethods 1 to 5 or 7 and, in the case of porcine blood, submitted to any of the processing methods 1 to 5 or 7 provided that in the case of method 7 a heat treatment throughout its substance at a minimum temperature of 80 °C has been applied;
(i) in the case of non-mammalian processed protein with the exclusion of fishmeal submitted to any of the processing methods 1 to 5 or 7 as referred to in Chapter III of Annex IV to Regulation (EU) No 142/2011;
(j) in the case of fishmeal submitted to any of the processing methods 1 to 7 as referred to in Chapter III of Annex IV to Regulation (EU) No 142/2011 or to a method and parameters which ensure that the product complies with the microbiological standards for derived products set out in Chapter I of Annex X to Regulation (EU) No 142/2011;
(k) in the case of rendered fat, including fish oils, submitted to any of the processing methods 1 to5 or 7 (and method 6 in the case of fish oil) as referred to in Chapter III of Annex IV to Regulation (EU) No 142/2011 or produced in accordance with Chapter II of Section XII of Annex III to Regulation (EC) No 853/2004; rendered fats from ruminant animals must be purified in such a way that the maximum level of the remaining total insoluble impurities does not excess 0,15 % in weight;




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COUNTRY
Processed petfood other than canned petfood
II. Health information
II.a. Certificate reference No
II.b.
(l) in the case of dicalcium phosphate produced by a process that
(i) ensures that all Category 3 bone-material is finely crushed and degreased with hot water and treated with dilute hydrochloric acid (at a minimum concentration of 4 % and a pH of less than 1,5) over a period of at least two days;
(ii) following the procedure referred to in (i), applies a treatment of the obtained phosphoric liquor with lime, resulting in a precipitate of dicalcium phosphate at pH 4 to 7; and
(iii) finally, air dries the precipitate of dicalcium phosphate with inlet temperature of 65 °C to 325 °C and end temperature between 30 °C and 65 °C ;
(m) in the case of tricalcium phosphate produced by a process that ensures
(i) that all Category 3 bone-material is finely crushed and degreased in counter-flow with hot water (bone chips less than 14 mm);
(ii) continuous cooking with steam at 145 °C during 30 minutes at 4 bar;
(iii) separation of the protein broth from the hydroxyapatite (tricalcium phosphate) by centrifugation; and
(iv) granulation of the tricalcium phosphate after drying in a fluid bed with air at 200 °C ;
(n) in the case of flavouring innards, produced according to a treatment method and parameters, which ensure that the product complies with the microbiological standards referred to inpoint II.4.]
(2) or [was subject to a treatment such as drying or fermentation, which has been authorised by the competent authority;]
(2) or [in the case of aquatic and terrestrial invertebrates other than species pathogenic to humans or animals, has been subject to a treatment which has been authorised by the competent authority and which ensures that the petfood poses no unacceptable risks to public and animal health;]
II.4. was analysed by a random sampling of at least five samples from each processed batch taken during or after storage at the processing plant and complies with the following standards (4):
Salmonella: absence in 25g: n = 5, c = 0, m = 0, M = 0,
Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 gramme;
II.5. has undergone all precautions to avoid contamination with pathogenic agents after treatment;
II.6. was packed in new packaging, which, if the petfood is not dispatched in ready-to-sell packages on which it is clearly indicated that the content is destined for feeding to pets only, bear labels indicating "NOT FOR HUMAN CONSUMPTION";
(2) [II.7. the petfood described above
(2) either [is derived from other ruminants than bovine, ovine or caprine animals.]
(2) or [is derived from bovine, ovine or caprine animals and does not contain and is not derived from:
(2) either [bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]
(2) or [(a) specified risk material as defined in point 1 of Annex V to Regulation (EC)No 999/2001 of the European Parliament and of the Council (5);




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COUNTRY
Processed petfood other than canned petfood
II. Health information
II.a. Certificate reference No
II.b.
(b) mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except from those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Commission Decision 2007/453/EC (6), in which there has been no indigenous BSE case,
(c) animal by-product or derived product obtained from bovine, ovine or caprine animals which have been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]]
Notes
Part I:
— Box reference I.6: Person responsible for the consignment in the European Union: this box is required to be filled in only if it is a certificate for a commodity to be transited through the European Union; it may be filled in if the certificate is for a commodity to be imported into the European Union.
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for a transit commodity. Products intransit may only be stored in free zones, free warehouses and custom warehouses.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship) is to be provided. In case of unloading and reloading, the consignor must inform the border inspection post of entry into the European Union.
— Box reference I.19: use the appropriate Harmonized System (HS) code under the following headings: 04.01; 04.02; 04.03; 04.04; 04.08, 05.04, 05.05, 05.06; 05.11, 15.01, 15.02, 15.03, 15.04, 23.01, 23.09; 28.35.25; 28.35.26; 35.01; 35.02; 35.03 or 35.04.
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be given.
— Box reference I.25: technical use: any use other than feeding of farmed animals, other than fur animals, and the production or manufacturing of pet food.
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
— Box reference I.28: Species: select from the following: Aves, Ruminantia, Suidae, Mammalia other than Ruminantia or Suidae, Pesca, Mollusca, Crustacea, Invertebrates other than Mollusca and crustacea.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.
(2) Delete as appropriate.
(2a) OJ L 139, 30.4.2004, p. 55.
(2b) OJ L 125, 23.5.1996, p. 3.
(3) OJ L 175, 10.7.2010, p. 1.




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COUNTRY
Processed petfood other than canned petfood
II. Health information
II.a. Certificate reference No
II.b.
(4) Where:
n = number of samples to be tested;
m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all samples does not exceed m;
M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more samples is M or more; and
c = number of samples the bacterial count of which may be between m and M, the sample still being considered acceptable if the bacterial count of the other samples is m or less.
(5) OJ L 147, 31.5.2001, p. 1.
(6) OJ L 172, 30.6.2007, p. 84.
— The signature and the stamp must be in a different colour to that of the printing.
— Note for the person responsible for the consignment in the European Union: This certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post of entry into the European Union.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

CHAPTER 3(C)

Health certificate


For dogchews intended for dispatch to or for transit through (2) the European Union




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COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17.
I.18. Description of commodity
I.19. Commodity code (HS code)
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Petfood Technical use
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species(Scientific name)
Manufacturing plant
Net weight
Batch number




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COUNTRY
Dogchews
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a), and in particular Article 10 of that Regulation, and Commission Regulation (EU) No 142/2011 (1b), and in particular Chapter II of Annex XIII and Chapter II of Annex XIV thereto, and certify that the dogchews described above:
II.1. have been prepared exclusively with the following animal by-products:
(2) either [- carcases and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed, and which are fit for human consumption in accordance with Union legislation, but are not intended for human consumption for commercial reasons;]
(2) and/or [- carcases and the following parts originating either from animals that have been slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human consumption in accordance with Union legislation:
(i) carcases or bodies and parts of animals which are rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of disease communicable to humans or animals;
(ii) heads of poultry;
(iii) hides and skins, including trimmings and splitting thereof, horns and feet, including the phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones;
(iv) pig bristles;
(v) feathers;]
(2) and/or [- blood of animals which did not show any signs of disease communicable through blood to humans or animals, obtained from animals that have been slaughtered in a slaughterhouse after having been considered fit for slaughter for human consumption following an ante-mortem inspection in accordance with Union legislation;]
(2) and/or [- animal by-products arising from the production of products intended for human consumption, including degreased bone, greaves and centrifuge or separator sludge from milk processing;]
(2) and/or [- aquatic animals, and parts of such animals, expect sea mammals, which did not show any signs of disease communicable to humans or animals;]
(2) and/or [- animal by-products from aquatic animals originating from plants or establishments manufacturing products for human consumption;]
(2) and/or [- material from animals which have been treated with certain substances which are prohibited by Council Directive 96/22/EC (2a), the import of the material being permitted in accordance with Article 35(a)(ii) of Regulation (EC) No 1069/2009;]
II.2. have been subjected
(2) either [in the case of dogchews made from hides and skins of ungulates or from fish, to a treatment sufficient to destroy pathogenic organisms (including salmonella); and the dogchews are dry;]
(2) and/or [in the case of dogchews made from animal by-products other than hides and skins of ungulates or from fish, to a heat treatment of at least 90°C throughout their substance;]
II.3. were examined by random sampling of at least five samples from each processed batch taken during or after storage at the processing plant and complies with the following standards (3):
Salmonella: absence in 25g: n = 5, c = 0, m = 0, M = 0,
Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 gramme;
Part II: Certification




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COUNTRY
Dogchews
II. Health information
II.a. Certificate reference No
II.b.
II.4. have undergone all precautions to avoid contamination with pathogenic agents after treatment;
II.5. were packed in new packaging;
(2) [II.6. the dogchews described above
(2) either [is derived from other ruminants than bovine, ovine or caprine animals.]]
(2) or [is derived from bovine, ovine or caprine animals and does not contain and is not derived from:
(2) either [bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]
(2) or [(a) specified risk material as defined in point 1 of Annex V to Regulation (EC)No 999/2001 of the European Parliament and of the Council (4);
(b) mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except from those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Commission Decision 2007/453/EC (5), in which there has been no indigenous BSE case,
(c) animal by-product or derived product obtained from bovine, ovine or caprine animals which have been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]]
Notes
Part I:
— Box reference I.6: Person responsible for the consignment in the European Union: this box is to be filled in only if it is a certificate for transit commodity; it may be filled in if the certificate is for a commodity to be imported into the European Union.
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for a transit commodity. Products in transit may only be stored in free zones, free warehouses and custom warehouses.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship); the information is to be provided in the event of unloading and reloading in the European Union.
— Box reference I.19: 05.11, 23.09, 41.01 or 42.05.
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be given.
— Box reference I.25: technical use: any use other than feeding of farmed animals, other than fur animals, and the production or manufacturing of pet food.
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
— Box reference I.28: Species: select from the following: Aves, Ruminantia, Suidae, Mammalia Other Than Ruminantia or Suidae, Pesca, Mollusca, Crustacea, Invertebrates Other Than Mollusca And Crustacea.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.




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COUNTRY
Dogchews
II. Health information
II.a. Certificate reference No
II.b.
(2) Delete as appropriate.
(2a) OJ L 125, 23.5.1996, p. 3.
(3) Where:
— n = number of samples to be tested;
— m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all samples does not exceed m;
— M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more samples is M or more; and
— c = number of samples the bacterial count of which may be between m and M, the sample still being considered acceptable if the bacterial count of the other samples is m or less.
(4) OJ L 147, 31.5.2001, p. 1.
(5) OJ L 172, 30.6.2007, p. 84.
— The signature and the stamp must be in a different colour to that of the printing.
— Note for the person responsible for the consignment in the European Union: This certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post of entry into the European Union.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

CHAPTER 3(D)

Health certificate


For raw petfood for direct sale or animal by-products to be fed to fur animals, intended for dispatch to or for transit through (2) the European Union




Text of image

COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17.
I.18. Description of commodity
I.19. Commodity code (HS code)
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Petfood Technical use
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species(Scientific name)
Nature of commodity
Manufacturing plant
Net weight
Batch number




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COUNTRY
Raw petfood for direct sale or animal by- products to be fed to fur animals
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a) and in particular Article 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Chapter II of Annex XIII and Chapter II of Annex XIV thereto, and certify that the raw petfood or animal by-products described above:
II.1. consist of animal by-products that satisfy the health requirements below;
II.2. consist of animal by-products:
(a) derived from meat which satisfies the relevant animal and public health requirements laid down in:
— Commission Regulation (EU) No 206/2010 (3) and provided that the animals from which the meat is derived come from the third countries, territories or parts thereof (ISO code in the case of a country, or codes in the case of territories or parts thereof);
— and/or Commission Regulation (EC) No 798/2008 (4), and provided that the animals from which the meat is derived come from the third countries, territories or parts thereof (ISO code in the case of a country, or codes in the case of territories or parts thereof) as listed in that Regulation which has been free from Newcastle disease and avian influenza for the last 12 months;
— and/or Commission Regulation (EC) No 119/2009 (5), and provided that the animals from which the meat is derived come from the third countries, territories or parts thereof (ISO code in the case of a country, or codes in the case of territories or parts thereof) as listed in that Regulation which has been free from foot and mouth disease, rinderpest, classical swine fever, African swine fever, swine vesicular disease, Newcastle disease and avian influenza for the preceding 12 months and where no vaccination has taken place during that time (only where relevant for the susceptible species);
(b) derived from animals that, at the slaughterhouse, have passed the ante-mortem health inspection during the period of 24 hours before the time of slaughter and have shown no evidence of the diseases referred in the Regulations referred to in point (a) for which the animals are susceptible; and
(c) derived from animals that have been handled in the slaughterhouse before and at the time of slaughter or killing in accordance with the relevant provisions of Union legislation and have met requirements at least equivalent to those laid down in Chapters II and III of Council Regulation (EC) No 1099/2009 (6); or
(d) in the case of feed for fur animals, are derived from aquatic animals which satisfy the relevant animal and public health requirements laid down in Commission Decision 2006/766/EC (7), and come from countries or territories thereof (ISO code of the country) as listed in Annex II to that Decision;
II.3.1. consist only of the following animal by-products:
(a) carcases and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed which were deemed fit for human consumption in accordance with Union legislation until irreversibly declared as animal by-products for commercial reasons;
(b) parts of slaughtered animals, which are rejected as unfit for human consumption but are not affected by any signs of diseases communicable to humans or animals and derived from carcases that are fit for human consumption in accordance with Union legislation;
II.3.2. in the case of feed for fur animals in addition to II.3.1. consist also of the following animal by-products:
(2) either [- animal by-products from poultry and lagomorphs slaughtered on the farm as referred to in Article 1(3)(d) of Regulation (EC) No 853/2004 of the European Parliament and of the Council (2a), which did not show any signs of disease communicable to humans or animals;]
(2) and/or [- blood of animals which did not show any signs of disease communicable through blood to humans or animals, obtained from animals that have been slaughtered in a slaughterhouse after having been considered fit for slaughter for human consumption following an ante-mortem inspection in accordance with Union legislation;]
(2) and/or [- animal by-products arising from the production of products intended for human consumption, including degreased bone, greaves and centrifuge or separator sludge from milk processing;]
Part II: Certification




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COUNTRY
Raw petfood for direct sale or animal by- products to be fed to fur animals
II. Health information
II.a. Certificate reference No
II.b.
(2) and/or [- products of animal origin, or foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arises;]
(2) and/or [- petfood and feedingstuffs of animal origin, or feedingstuffs containing animal by-products or derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise;]
(2) and/or [- blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live animals that did not show signs of any disease communicable through that product to humans or animals;]
(2) and/or [- aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of diseases communicable to humans or animals;]
(2) and/or [- animal by-products from aquatic animals originating from plants or establishments manufacturing products for human consumption;]
(2) and/or [- the following material originating from animals which did not show any signs of disease communicable through that material to humans or animals:
(i) shells from shellfish with soft tissue or flesh;
(ii) the following originating from terrestrial animals:
— hatchery by-products,
— eggs,
— egg by-products, including egg shells,
(iii) day-old chicks killed for commercial reasons;]
(2) and/or [- animal by-products from aquatic or terrestrial invertebrates other than species pathogenic to humans or animals;]
(2) and/or [- animals and parts thereof of the zoological orders of Rodentia and Lagomorpha, except Category 1 material as referred to in Article 8(a)(iii), (iv) and (v) of Regulation (EC) No 1069/2009 and Category 2 material as referred to in Article 9(a) to (g) of that Regulation;]
II.4. have been obtained and prepared without contact with other material which does not comply with the conditions laid down in the Regulation (EC) No 1069/2009, and it has been handled so as to avoid contamination with pathogenic agents;
II.5. have been packed in final packaging which bear labels indicating ‘RAW PET FOOD — NOT FOR HUMAN CONSUMPTION’ or ‘ANIMAL BY-PRODUCTS FOR FEED FOR FUR ANIMALS — NOT FOR HUMAN CONSUMPTION’ and then placed in leak-proof and officially sealed boxes/containers or in new packaging preventing any leakage and officially sealed boxes/containers which bear labels indicating ‘RAW PET FOOD — NOT FOR HUMAN CONSUMPTION’ or ‘ANIMAL BY-PRODUCTS FOR FEED FOR FUR ANIMALS — NOT FOR HUMAN CONSUMPTION’, and the name and the address of the establishment of destination;
II.6. in the case of raw petfood:
(a) has been prepared and stored in a plant approved and supervised by the competent authority in accordance with Article 24 of Regulation (EC) No 1069/2009 and
(b) was examined by random sampling of at least five samples from each batch taken during storage (before dispatch) and complies with the following standards (8):




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COUNTRY
Raw petfood for direct sale or animal by- products to be fed to fur animals
II. Health information
II.a. Certificate reference No
II.b.
Salmonella: absence in 25 g: n=5, c=0, m=0, M=0
Enterobacteriaceae: n=5, c=2, m=10, M=5000 in 1 gram;
(2) [II.7. [the petfood or animal by-products to be fed to fur animals described above contains or is derived from animal-by products of ruminant origin and:
(2) either [originates from a country or region, which is classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC, and in which there has been no indigenous BSE case, and]]
(2) or [originates from a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC in which there has been an indigenous BSE case, and the animal by-product or derived product were derived from animals born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants, as defined in the OIE Terrestrial Animal Health Code, has been effectively enforced in that country or region, and]]
(2) either [is derived from other ruminants than bovine, ovine or caprine animals.]]
(2) or [is derived from bovine, ovine or caprine animals and does not contain and is not derived from:
(2) either [bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]
(2) or [(a) specified risk material as defined in point 1 of Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council (9);
(b) mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except from animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Commission Decision 2007/453/EC (10), in which there has been no indigenous BSE case,
(c) animal by-product or derived product obtained from bovine, ovine or caprine animals which have been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]]
Notes
Part I:
— Box reference I.6: Person responsible for the consignment in the European Union: this box is required to be filled in only if it is a certificate for a commodity to be transited through the European Union; it may be filled in if the certificate is for a commodity to be imported into the European Union.
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit commodity. Products in transit may only be stored in free zones, free warehouses and custom warehouses.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship) is to be provided. In case of unloading and reloading, the consignor must inform the border inspection post of entry into the European Union.
— Box I.19: use the appropriate Harmonized System (HS) code under the following heading: 04.08; 05.06; 05.08; 05.11, 23.01 or 23.09.
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be given.
— Box reference I.25: technical use: any use other than feeding of farmed animals, other than fur animals, and the production or manufacturing of pet food.
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.




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COUNTRY
Raw petfood for direct sale or animal by- products to be fed to fur animals
II. Health information
II.a. Certificate reference No
II.b.
— Box reference I.28:
Nature of commodity: select raw petfood or animal by-product.
In the case of raw material for the manufacture of raw pet food indicate the scientific name of the species.
In case of raw material for manufacture of feed for fur animals select from the following: Aves, Ruminantia, Suidae, Mammalia other than Ruminantia or Suidae, Pesca, Mollusca, Crustacea, Invertebrates other than Mollusca And Crustacea.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.
(2) Delete as appropriate.
(2a) OJ L 139, 30.4.2004, p. 55.
(3) OJ L 73, 20.3.2010, p. 1.
(4) OJ L 226, 23.8.2008, p. 1.
(5) OJ L 39, 10.2.2009, p. 12.
(6) OJ L 303, 18.11.2009, p. 1.
(7) OJ L 320, 18.11.2006, p. 53.
(8) Where:
n = number of samples to be tested;
m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all samples does not exceed m;
M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more samples is M or more; and
c = number of samples the bacterial count of which may be between m and M, the sample still being considered acceptable if the bacterial count of the other samples is m or less.
(9) OJ L 147, 31.5.2001, p. 1.
(10) OJ L 172, 30.6.2007, p. 84.
— The signature and the stamp must be in a different colour to that of the printing.
— Note for the person responsible for the consignment in the European Union: This certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post of the European Union.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

CHAPTER 3(E)

Health certificate


For flavouring innards for use in the manufacture of petfood, intended for dispatch to or for transit through (2) the European Union




Text of image

COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17.
I.18. Description of commodity
I.19. Commodity code (HS code)
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Petfood Technical use
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species(Scientific name)
Nature of commodity
Manufacturing plant
Net weight
Batch number




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COUNTRY
Flavouring innards for use in the manufactureof petfood
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a), and in particular Article 8 and 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Chapter III of Annex XIII and Chapter II of Annex XIV thereto, and certify that the flavouring innards products described above:
II.1. consist of animal by-products that satisfy the animal health requirements below;
II.2. have been prepared and include the following animal by-products which are exclusively:
(2) either [- carcases and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed, and which are fit for human consumption in accordance with Union legislation, but are not intended for human consumption for commercial reasons;]
(2) and/or [- carcases and the following parts originating either from animals that have been slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human consumption in accordance with Union legislation:
(i) carcases or bodies and parts of animals which are rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of disease communicable to humans or animals;
(ii) heads of poultry;
(iii) hides and skins, including trimmings and splitting thereof, horns and feet, including the phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones;
(iv) pig bristles;
(v) feathers;]
(2) and/or [- blood of animals which did not show any signs of disease communicable through blood to humans or animals, obtained from animals that have been slaughtered in a slaughterhouse after having been considered fit for slaughter for human consumption following an ante-mortem inspection in accordance with Union legislation;]
(2) and/or [- animal by-products arising from the production of products intended for human consumption, including degreased bone, greaves and centrifuge or separator sludge from milk processing; ]
(2) and/or [- products of animal origin, or foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise;]
(2) and/or [- petfood and feedingstuffs of animal origin, or feedingstuffs containing animal by-products or derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise;]
(2) and/or [- blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live animals that did not show signs of any disease communicable through that product to humans or animals;]
(2) and/or [- aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of diseases communicable to humans or animals;]
(2) and/or [- animal by-products from aquatic animals originating from plants or establishments manufacturing products for human consumption;]
(2) and/or [- the following material originating from animals which did not show any signs of disease communicable through that material to humans or animals:
(i) shells from shellfish with soft tissue or flesh;
Part II: Certification




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COUNTRY
Flavouring innards for use in the manufactureof petfood
II. Health information
II.a. Certificate reference No
II.b.
(ii) the following originating from terrestrial animals:
– hatchery by-products,
– eggs,
– egg by-products, including egg shells;
(iii) day-old chicks killed for commercial reasons;]
(2) and/or [- animal by-products from aquatic or terrestrial invertebrates other than species pathogenic to humans or animals;]
(2) and/or [- animals and parts thereof of the zoological orders of Rodentia and Lagomorpha, except Category 1 material as referred to in Article 8(a)(iii), (iv) and (v) of Regulation (EC) No 1069/2009 and Category 2 material as referred to in Article 9(a) to (g) of that Regulation;]
(2) and/or [- material from animals which have been treated with certain substances which are prohibited by Council Directive 96/22/EC (2a), the import of the material being permitted in accordance with Article 35(a)(ii) of Regulation (EC) No 1069/2009;]
II.3. have been subjected to processing in accordance with Chapter III of Annex XIII to Regulation (EU) No 142/2011, in order to kill pathogenic agents;
II.4. was analysed by a random sampling of at least five samples from each processed batch taken during or after storage at the processing plant and complies with the following standards (3) :
Salmonella: absence in 25g: n = 5, c = 0, m = 0, M = 0,
Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 gramme;
II.5. the end product was:
(2) either [packed in new or sterilised bags,]
(2) or [transported in bulk in containers or other means of transport that were thoroughly cleaned and disinfected with a disinfectant approved by the competent authority before use,]
and which bear labels indicating ‘NOT FOR HUMAN CONSUMPTION’;
II.6. the end product was stored in enclosed storage;
II.7. the product has undergone all precautions to avoid contamination with pathogenic agents after treatment;
(2) [II.8. the flavouring innards products described above
(2) either [is derived from other ruminants than bovine, ovine or caprine animals.]]
(2) or [is derived from bovine, ovine or caprine animals and does not contain and is not derived from:
(2) either [bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]
(2) or [(a) specified risk material as defined in point 1 of Annex V to Regulation (EC)No 999/2001 of the European Parliament and of the Council (4);
(b) mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except from those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Commission Decision 2007/453/EC (5), in which there has been no indigenous BSE case,
(c) animal by-product or derived product obtained from bovine, ovine or caprine animals which have been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]]




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COUNTRY
Flavouring innards for use in the manufactureof petfood
II. Health information
II.a. Certificate reference No
II.b.
Notes
Part I:
— Box reference I.6: Person responsible for the consignment in the European Union: this box is required to be filled in only if it is a certificate for a commodity to be transited through the European Union; it may be filled in if the certificate is for a commodity to be imported into the European Union.
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit commodity. Products in transit may only be stored in free zones, free warehouses and custom warehouses.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship); information is to be provided in the event of unloading and reloading in the European Union.
— Box reference I.19: use the appropriate HS code: 05.04; 05.06, 05.11 or 23.09 .
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) should be given.
— Box reference I.25: technical use: any use other than feeding of farmed animals, other than fur animals, and the production or manufacturing of pet food.
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
— Box reference I.28:
— species: select from the following: Aves, Ruminantia, Suidae, Mammalia other than Ruminantia or Suidae, Pesca, Mollusca, Crustacea, Invertebrates other than Mollusca and crustacea
— define the innard product.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.
(2) Delete as appropriate.
(2a) OJ L 125, 23.5.1996, p. 3.
(3) Where:
n = number of samples to be tested;
m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all samples does not exceed m;
M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more samples is M or more; and
c = number of samples the bacterial count of which may be between m and M, the sample still being considered acceptable if the bacterial count of the other samples is m or less.
(4) OJ L 147, 31.5.2001, p. 1.
(5) OJ L 172, 30.6.2007, p. 84.
— The signature and the stamp must be in a different colour to that of the printing.
— Note for the person responsible for the consignment in the European Union: This certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

CHAPTER 3(F)

Health certificate


For animal by-products (3) for the manufacture of petfood, intended for dispatch to or for transit through (2) the European Union




Text of image

COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17.
I.18. Description of commodity
I.19. Commodity code (HS code)
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Manufacture of petfood Further process Technical use
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species(Scientific name)
Nature of commodity
Manufacturing plant
Number of packages
Net weight
Batch number




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COUNTRY
Animal by-products for the manufactureof petfood
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a) and Commission Regulation (EU) No 142/2011 (1b), and in particular Chapter II of Annex XIV thereto, and certify that the animal by-products described above:
II.1.1. consist of animal by-products that satisfy the animal health requirements below;
II.1.2. have been obtained in the territory of: (1c) from animals:
(2) either [(a) that have remained in this territory since birth or for a period of at least three months preceding the date of slaughter or production;]
(2) or [(b) killed in the wild in this territory (1d);]
(2) or [(c) derived from rodents, lagomorphs, aquatic animals or terrestrial or aquatic invertebrates;]
II.1.3. have been obtained from or produced by animals:
(2) either [(a) coming from holdings:
(i) where, for the following diseases for which the animals are susceptible, there has been no case/outbreak of rinderpest, swine vesicular disease, Newcastle disease or highly pathogenic avian influenza during the period of the preceding 30 days, nor of classical or African swine fever during the period of the preceding 40 days; nor in the holdings situated in their vicinity within a 10 km radius, during the period of the preceding 30 days; and
(ii) where there has been no case/outbreak of foot-and-mouth disease during the period of the preceding 60 days, nor in the holdings situated in their vicinity within a 25 km radius, during the period of the preceding 30 days; and
(b) which:
(i) were not killed to eradicate any epizootic disease;
(ii) have remained in their holdings of origin for a period of at least 40 days before the date of departure and which have been transported directly to the slaughterhouse without any contact with other animals which did not comply with the same health conditions;
(iii) at the slaughterhouse, have passed the ante-mortem health inspection during the period of 24 hours preceding the time of slaughter and have shown no evidence of the diseases referred to above for which the animals are susceptible; and
(iv) have been handled in the slaughterhouse before and at the time of slaughter or killing in accordance with the relevant provisions of Union legislation and have met requirements at least equivalent to those laid down in Chapters II and III of Council Regulation (EC)No 1099/2009 (4)]
(2) or [(a) captured and killed in the wild in an area:
(i) in which within a 25 km radius there has been no case/outbreak of any of the following diseases for which the animals are susceptible: foot-and-mouth disease, rinderpest, Newcastle disease or highly pathogenic avian influenza during the period of the preceding 30 days, nor of classical or African swine fever during the period of the preceding 40 days; and
(ii) situated at a distance of at least 20 km from any country or part of the territory of a country not authorised for export to the European Union of poultry material during the preceding 30 days or of porcine material during the preceding 40 days; and
(b) which after killing were transported within a period of 12 hours following the killing for chilling either to a collection centre and immediately afterwards to a game handling establishment, or directly to a game handling establishment;]
Part II: Certification




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COUNTRY
Animal by-products for the manufactureof petfood
II. Health information
II.a. Certificate reference No
II.b.
II.1.4. have been obtained in an establishment around which, within a radius of 10 km, there has been no case/outbreak of the diseases referred to in point II.1.3 for which the animals are susceptible during the period of the preceding 30 days or, in the event of a case of disease, the preparation of raw material for exportation to the European Union has been authorised only after the removal of all meat, and the total cleaning and disinfection of the establishment under the control of an official veterinarian;
II.1.5. have been obtained and prepared without contact with any other material that does not comply with the conditions required above, and it has been handled so as to avoid contamination with pathogenic agents;
II.1.6. have been packed in new packaging preventing any leakage and in officially sealed containers bearing the label indicating ‘RAW MATERIAL ONLY FOR THE MANUFACTURE OF PET FOOD’ and the name and address of the establishment of destination in the European Union;
II.1.7. consist only of the following animal by-products:
(2) either [- carcases and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed which were deemed fit for human consumption in accordance with Union legislation until irreversibly declared as animal by-products for commercial reasons;]
(2) and/or [- carcases and the following parts originating either from animals that have been slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human consumption in accordance with Union legislation:
(i) carcases or bodies and parts of animals which are rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of disease communicable to humans or animals;
(ii) heads of poultry;
(iii) hides and skins, including trimmings and splitting thereof, horns and feet, including the phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones;
(iv) pig bristles;
(v) feathers;]
(2) and/or [- animal by-products arising from the production of products intended for human consumption, including degreased bone, greaves and centrifuge or separator sludge from milk processing;]
(2) and/or [- products of animal origin, or foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise;]
(2) and/or [- aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of diseases communicable to humans or animals;]
(2) and/or [- animal by-products from aquatic animals originating from plants or establishments manufacturing products for human consumption;]
(2) and/or [- the following material originating from animals which did not show any signs of disease communicable through that material to humans or animals:
(i) shells from shellfish with soft tissue or flesh;
(ii) the following originating from terrestrial animals:
— hatchery by-products,
— eggs,
— egg by-products, including egg shells;




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COUNTRY
Animal by-products for the manufactureof petfood
II. Health information
II.a. Certificate reference No
II.b.
(iii) day-old chicks killed for commercial reasons;]
(2) and/or [- animal by-products from aquatic or terrestrial invertebrates, other than species pathogenic to humans or animals;]
(2) and/or [- animals and parts thereof of the zoological orders of Rodentia and Lagomorpha, except Category 1 material as referred to in Article 8(a)(iii), (iv) and (v) of Regulation (EC) No 1069/2009 and Category 2 material as referred to in Article 9(a) to (g) of that Regulation;]
(2) and/or [- material from animals which have been treated with certain substances which are prohibited by Council Directive 96/22/EC (4a), the import of the material being permitted in accordance with Article 35(a)(ii) of Regulation (EC) No 1069/2009;]
II.1.8. have been deep-frozen at the plant of origin or have been preserved in accordance with European Union legislation in such a way that they will not spoil between dispatch and delivery to the plant of destination in the European Union or during the transit through the European Union;
II.1.9. in the case of raw material derived from animals which have been treated with certain substances prohibited by Directive 96/22/EC for the manufacture of petfood, the import being permitted in accordance with Article 35(a)(ii) of Regulation (EC) No 1069/2009:
(a) it has been marked in the third country before entry into the territory of the European Union by a cross of liquefied charcoal or activated carbon on each outer side of each frozen block, or, when the raw material is transported in pallets which are not divided into separate consignments during transport to the petfood plant of destination in the European Union or during the transit through the European Union, on each outer side of each pallet, in a way that the marking covers at least 70 % of the diagonal length of the frozen block and be of at least 10 cm width;
(b) in the case of material which is not frozen, the raw material has been marked in the third country before entry into the territory of the European Union by spraying it with liquefied charcoal or by applying charcoal powder in such a way that the charcoal is clearly visible on the material; and
(c) where the animal by-products are made up of raw material which has been treated as referred to above and other non-treated raw material, all the raw materials have been marked as referred to in point (a) and (b) above.
(2) (5) [II.2. Specific requirements
(2) (6) [II.2.1. The by-products in this consignment come from animals that have been kept in the territory referred to in point (II.1.2), where vaccination programmes against foot-and-mouth disease are being regularly carried out and officially controlled in domestic bovine animals.]
(2) (7) [II.2.2. The by-products in this consignment consist only of animal by-products derived from trimmed offal of domestic ruminants, which have maturated at an ambient temperature of more than + 2 °C for a period of at least three hours, or in the case of masseter muscles of bovine animals and deboned meat of domestic animals, for a period of at least 24 hours.]]
(2) [II.3. the animal by-products for the manufacture of petfood contains or is derived from animal-by products of ruminant origin and:
(2) either [originate from a country or region, which is classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC, and in which there has been no indigenous BSE case, and]]
(2) or [originate from a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC in which there has been an indigenous BSE case, and the animal by-product or derived product were derived from animals born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants, as defined in the OIE Terrestrial Animal Health Code, has been effectively enforced in that country or region, and]]
(2) either [is derived from other ruminants than bovine, ovine or caprine animals.]




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COUNTRY
Animal by-products for the manufactureof petfood
II. Health information
II.a. Certificate reference No
II.b.
(2) or [is derived from bovine, ovine or caprine animals and does not contain and is not derived from:
(2) either [bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]]
(2) or [(a) specified risk material as defined in point 1 of Annex V to Regulation (EC)No 999/2001 of the European Parliament and of the Council (8);
(b) mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except from those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Commission Decision 2007/453/EC(9), in which there has been no indigenous BSE case,
(c) animal by-product or derived product obtained from bovine, ovine or caprine animals which have been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]]]
Notes
Part I:
— Box reference I.6: Person responsible for the consignment in the European Union: this box is to be filled in only if it is a certificate for transit commodity; it may be filled in if the certificate is for a commodity to be imported into the European Union.
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for a transit commodity. Products in transit may only be stored in free zones, free warehouses and custom warehouses.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship); information is to be provided in the case of unloading and reloading in the European Union.
— Box reference I.19: use the appropriate HS code: 05.04; 05.06; 05.07; 05.11.91 or 05.11.99; 23.01; 41.01.
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) should be included.
— Box reference I.25: technical use: any use other than feeding of farmed animals, other than fur animals, and the production or manufacturing of pet food.
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
— Box reference I.28:
— species: select from the following: Aves, Ruminantia, Suidae, Mammalia other than Ruminantia or Suidae, Pesca, Mollusca, Crustacea, invertebrates other than Mollusca and Crustacea;
— Manufacturing plant: provide the veterinary control number of the approved establishment.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.




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COUNTRY
Animal by-products for the manufactureof petfood
II. Health information
II.a. Certificate reference No
II.b.
(1c) The name and ISO code number of the exporting country as laid down in:
— Part 1 of Annex II to Regulation (EU) No 206/2010;
— Part 1 of Annex I to Regulation (EC) No 798/2008, and
— Part 1 of Annex I to Regulation (EC) No 119/2009.
In addition the ISO code of regionalisation in the abovementioned Annexes (where applicable for the susceptible species concerned) must be included.
(1d) Only for countries from which game meat intended for human consumption of the same animal species is authorised for importation into the European Union.
(2) Delete as appropriate.
(3) Excluding raw blood, raw milk, hides and skins, hooves and horn, pig bristles and feathers (see relevant specific certificates in that Annex for the import of these products).
(4) OJ L 303, 18.11.2009, p. 1.
(4a) OJ L 125, 23.5.1996, p. 3.
(5) Supplementary guarantees to be provided when the material of domestic ruminants originated in the territory of a South American or South African country or part thereof from where only maturated and deboned fresh meat of domestic ruminants for human consumption is permitted for exportation to the European Union. The whole masseter muscles of bovine animals, incised in accordance with Part B.1 of Chapter I of Section IV of Annex I to Regulation (EC) No 854/2004 of the European Parliament and of the Council (OJ L 139, 30.4.2004, p. 206), are also permitted.
(6) Only for certain South American countries.
(7) Only for certain South American and South African countries.
(8) OJ L 147, 31.5.2001, p. 1.
(9) OJ L 172, 30.6.2007, p. 84.
— The signature and the stamp must be in a different colour to that of the printing.
— Note for the person responsible for the consignment in the European Union: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post of the European Union.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

                              ’
                           









(2)


Chapters 4(B) to 4(D) are replaced by the following:

                                 ‘CHAPTER 4(B)

Health certificate


For blood products not intended for human consumption that could be used as feed material, intended for dispatch to or for transit through (2) the European Union




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COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17.
I.18. Description of commodity
I.19. Commodity code (HS code)
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Animal feedingstuff Manufacture of petfood Technical use
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species(Scientific name)
Nature of commodity
Manufacturing plant
Batch number




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COUNTRY
Blood products not intended for human consumption that could be used as feed material
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a) and Commission Regulation (EU) No 142/2011 (1b) and certify that the blood products described above:
II.1. consist of blood products that satisfy the health requirements below;
II.2. consist exclusively of blood products not intended for human consumption;
II.3. have been prepared and stored in a plant, approved and supervised by the competent authority in accordance with Article 24 of Regulation (EC) No 1069/2009;
II.4. have been prepared exclusively with the following animal by-products:
(2) either [blood of slaughtered animals, which is fit for human consumption in accordance with Union legislation, but which is not intended for human consumption for commercial reasons;]
(2) and/or [blood of slaughtered animals, which has been rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of diseases communicable to humans or animals, which has been derived from carcases that have been slaughtered in a slaughterhouse and which were considered fit for human consumption following an ante-mortem inspection in accordance with Union legislation;]
II.5. in order to inactivate pathogenic agents, have been submitted
(2) either [to processing in accordance with processing method (3) as set out in Chapter III of Annex IV to Regulation (EU) No 142/2011;]
(2) or [to a method and parameters which ensure that the product complies with the microbiological standards set out in Chapter I of Annex X to Regulation (EU) No 142/2011;]
(2) or [in the case of blood products, including spray dried blood and blood plasma, of porcine origin intended for the feeding of porcine animals, to a heat treatment at a temperature of at least 80°C throughout the substance and the dry blood and blood plasma does not contain more than 8% w/w moisture with a water activity (Aw) of less than 0,60.]
II.6. the end product was:
(2) either [packed in new or sterilised bags;]
(2) or [transported in bulk in containers or other means of transport that were thoroughly cleaned and disinfected with a disinfectant approved by the competent authority before use,]
and which bear labels indicating ‘NOT FOR HUMAN CONSUMPTION’;
II.7. the end product was stored in enclosed storage;
II.8. the product has undergone all precautions to avoid contamination with pathogenic agents after treatment;
(2) and [in the case of blood products, including spray dried blood and blood plasma of porcine origin intended for the feeding of porcine animals, has been stored in dry warehouse conditions under room temperature for a period of at least 6 weeks.]
II.9. have been examined prior to dispatch under the responsibility of the competent authority by taking a random sample during or on removal from storage which was found to comply with the following standards (4):
Salmonella: absence in 25g: n = 5, c = 0, m = 0, M = 0,
Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 gram;
Part II: Certification




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COUNTRY
Blood products not intended for human consumption that could be used as feed material
II. Health information
II.a. Certificate reference No
II.b.
(2) [II.10. the blood products described above
(2) either [is derived from other ruminants than bovine, ovine or caprine animals.]]
(2) or [is derived from bovine, ovine or caprine animals and does not contain and is not derived from:
(2) either [bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]
(2) or [(a) specified risk material as defined in point 1 of Annex V to Regulation (EC)No 999/2001 of the European Parliament and of the Council (5);
(b) mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except from those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Commission Decision 2007/453/EC (6), in which there has been no indigenous BSE case,
(c) animal by-product or derived product obtained from bovine, ovine or caprine animals which have been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]]
II.11. the blood products described above:
(2) either [do not contain milk or milk products of ovine or caprine animal origin or is not intended for feed for farmed animals, other than fur animals.]
(2) or [contain milk or milk products of ovine or caprine animal origin and is intended for feed for farmed animals, other than fur animals, which:
(a) are derived from ovine and caprine animals which have been kept continuously since birth in a country where the following conditions are fulfilled:
(i) classical scrapie is compulsorily notifiable;
(ii) an awareness, surveillance and monitoring system is in place for classical scrapie;
(iii) official restrictions apply to holdings of ovine or caprine animals in the case of a suspicion of TSE or the confirmation of classical scrapie;
(iv) ovine and caprine animals affected with classical scrapie are killed and destroyed;
(v) the feeding to ovine and caprine animals of meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE), of ruminant origin has been banned and effectively enforced in the whole country for a period of at least the precedingseven years;
(b) originate from holdings where no official restrictions are imposed due to a suspicion of TSE;
(c) originate from holdings where no case of classical scrapie has been diagnosed during the period of at least the preceding seven years or, following the confirmation of a case of classical scrapie:




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COUNTRY
Blood products not intended for human consumption that could be used as feed material
II. Health information
II.a. Certificate reference No
II.b.
(2) either [all ovine and caprine animals on the holding have been killed and destroyed or slaughtered, except for breeding rams of the ARR/ARR genotype, breeding ewes carrying at least one ARR allele and no VRQ allele and other ovine animals carrying at least one ARR allele;]
(2) or [all animals in which classical scrapie was confirmed have been killed and destroyed, and the holding has been subjected for a period of at leasttwo years since the date of confirmation of the last classical scrapie case to intensified TSE monitoring, including testing with negative results for the presence of TSE in accordance with the laboratory methods set out in point 3.2 of Chapter C of Annex X to Regulation (EC) No 999/2001, of all of the following animals which are over the age of 18 months, except ovine animals of the ARR/ARR genotype:
— animals which have been slaughtered for human consumption; and
— animals which have died or been killed on the holding but which were not killed in the framework of a disease eradication campaign.]]
II.12. the blood products described above contain or are derived from animal-by products of non-ruminant origin, and are, according to the statement of the Consignor referred to in Box I.1,
(2) either [not intended for the production of feed for farmed animals, other than fur animals.]
(2) (7) or [intended for the production of feed for non-ruminant farmed animals, other than fur animals, and the Consignor has undertaken to ensure that the border inspection post of entry will be provided with the results of the analyses carried out in accordance with the methods set out in Annex VI to Commission Regulation (EC) No 152/2009 (8).]
Notes
Part I:
— Box reference I.6: Person responsible for the consignment in the European Union: this box is required to be filled in only if it is a certificate for a commodity that is to be transited through the European Union; it may be filled in if the certificate is for a commodity that is to be imported into the European Union.
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for a transit commodity. Products in transit may only be stored in free zones, free warehouses and custom warehouses.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship); information is to be provided in the case of unloading and reloading in the European Union.
— Box reference I.19: use the appropriate HS code: 05.11.91, 05.11.99, 35.02 or 35.04.
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) should be included.
— Box reference I.25: technical use: any use other than feeding of farmed animals, other than fur animals, and the production or manufacturing of pet food.
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
— Box reference I.28: Species: select from the following: Aves, Ruminantia, Suidae, Mammalia other than Ruminantia or Suidae , Pesca, Reptilia.




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COUNTRY
Blood products not intended for human consumption that could be used as feed material
II. Health information
II.a. Certificate reference No
II.b.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.
(2) Delete as appropriate.
(3) Insert method 1 to 5 or method 7 as applicable.
(4) Where:
n = number of samples to be tested;
m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all samples does not exceed m;
M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more samples is M or more; and
c = number of samples the bacterial count of which may be between m and M, the sample still being considered acceptable if the bacterial count of the other samples is m or less.
(5) OJ L 147, 31.5.2001, p. 1.
(6) OJ L 172, 30.6.2007, p. 84.
(7) The person responsible for the load referred to in Box I.6 must ensure that, if the blood products described in this health certificate are intended to be used for the production of feed for non-ruminant farmed animals, other than fur animals, the consignment must be analysed, in accordance with the methods set out in Annex VI to Regulation (EC) No 152/2009, in order to verify the absence of unauthorised constituents of animal origin. The information on the result of such analysis must be attached to this health certificate when presenting the consignment at a border inspection post of the European Union.
(8) OJ L 54, 26.2.2009, p. 1.
— The signature and the stamp must be in a different colour to that of the printing.
— Note for the person responsible for the consignment in the European Union: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post of the point of entry into the European Union.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

CHAPTER 4(C)

Health certificate


For untreated blood products, excluding those of equidae, for the manufacture of derived products for purposes outside the feed chain for farmed animals, intended for dispatch to or for transit through (2) the European Union




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COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17.
I.18. Description of commodity
I.19. Commodity code (HS code)
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Technical use
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species (Scientific name)
Manufacturing plant
Batch number




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COUNTRY
Untreated blood products, excluding those of equidae, for the manufacture of derived products for purposes outside the feed chain for farmed animals
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a), and in particular Article 8(c) and Article 8(d) and Article 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Chapter II of Annex XIV thereto, and certify that:
II.1. the blood products described above consist of blood products that satisfy the health requirements below;
II.2. they consist exclusively of blood products not intended for human or animal consumption;
II.3. they have been prepared and stored in a plant supervised by the competent authority or in the establishment of collection, exclusively with the following animal by-products:
(2) either [- blood of slaughtered animals, which is fit for human consumption in accordance with Union legislation, but is not intended for human consumption for commercial reasons;]
(2) and/or [- blood of slaughtered animals, which is rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of diseases communicable to humans or animals, derived from carcases that have been slaughtered in a slaughterhouse and were considered fit for human consumption following an ante-mortem inspection in accordance with Union legislation;]
(2) and/or [- blood of slaughtered animals, which did not show any signs of diseases communicable to humans or animals, obtained from animals that have been slaughtered in a slaughterhouse after having been considered fit for human consumption following an ante-mortem inspection in accordance with Union legislation;]
(2) and/or [- blood and blood products derived from the production of products intended for human consumption;]
(2) and/or [- blood and blood products originating from live animals that did not show signs of any disease communicable through that product to humans or animals;]
(2) and/or [- animal by-products derived from animals which have been submitted to illegal treatment as defined in Article 1(2)(d) of Council Directive 96/22/EC (2a) or Article 2(b) of Council Directive 96/23/EC (2b);]
(2) and/or [- animal by-products containing residues of other substances and environmental contaminants listed in Group B(3) of Annex I to Directive 96/23/EC, if such residues exceed the permitted level laid down in Union legislation or, in the absence thereof, in national legislation;]
II.4. the blood, that such products were manufactured from, was collected in slaughterhouses approved in accordance with Union legislation, in slaughterhouses approved and supervised by the competent authority of the country of collection or from live animals in facilities approved and supervised by the competent authority of the country of collection;
(2) [II.5. in the case of blood products obtained from animals belonging to the taxa Artiodactyla, Perissodactyla and Proboscidea, including crossbreds between species of those taxa, the blood was collected in a country or region where no case of rinderpest, peste des petits ruminants and Rift Valley fever has been recorded for a period of at least the preceding 12 months and in which vaccination has not been carried out against those diseases for a period of at least the preceding 12 months, and;
(2) either [in third countries, territories or parts thereof (insert ISO country code in the case of a country, or codes (3) in the case of territories or parts thereof) where no case of foot-and-mouth disease has been recorded for a period of at least the preceding 12 months and in which vaccination has not been carried out against this disease for a period of at least the preceding 12 months, and]
(2) or [in third countries, territories or parts thereof (insert ISO country code in the case of a country or codes (3) for territories or parts thereof) where no case of foot-and-mouth disease has been recorded for a period of at least the preceding 12 months and in which vaccination programmes against foot-and-mouth disease are being officially carried out and controlled in domestic ruminant animals for a period of at least the preceding 12 months (4), and]]
Part II: Certification




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COUNTRY
Untreated blood products, excluding those of equidae, for the manufacture of derived products for purposes outside the feed chain for farmed animals
II. Health information
II.a. Certificate reference No
II.b.
(2) [II.5.1. in the case of animals other than Suidae and Tayassuidae, in third countries or regions in which :
(2) either [no case of vesicular stomatitis and bluetongue (2) (including the presence of seropositive animals) has been recorded for a period of at least the preceding 12 months and in which vaccination has not been carried out against those diseases for a period of at least the preceding 12 months;]
(2) or [vesicular stomatitis and bluetongue (2) seropositive animals are present (4);]]
(2) [II.5.2. in the case of Suidae and Tayassuidae, in third countries or regions in which no case of swine vesicular disease, classical swine fever and African swine fever has been recorded for a period of at least the preceding 12 months and vaccination has not been carried out against those diseases for a period of at least the preceding 12 months in the susceptible species and:
(2) either [no case of vesicular stomatitis (including the presence of seropositive animals) has been recorded for a period of at least the preceding 12 months and in which vaccination has not been carried out against this disease for a period of at least the preceding 12 months;]]
(2) or [vesicular stomatitis seropositive animals are present (4);]]]
(2) [II.6. in the case of blood products derived from poultry or other avian species the animals and the products come from the territory of the country or region with code . (5)
which has been free from Newcastle disease and highly pathogenic avian influenza as defined in the Terrestrial Animal Health Code of the OIE,
which for a period of at least the preceding 12 months has not carried out vaccination against avian influenza,
where the animals from which the products are derived, have not been vaccinated against Newcastle disease with vaccines prepared from a Newcastle disease master strain showing a higher pathogenicity than lentogenic virus strains;]
II.7. the products were:
(2) either [packed in new or sterilised bags or bottles,]
(2) or [transported in bulk in containers or other means of transport that were thoroughly cleaned and disinfected with a disinfectant approved by the competent authority before use,]
the outer packaging or containers bear labels indicating ‘NOT FOR HUMAN OR ANIMAL CONSUMPTION’;
II.8. the products were stored in enclosed storage;
II.9. all precautions were taken to avoid contamination of the products with pathogenic agents during transport;
(2) [II.10. the untreated blood products described above
(2) either [is derived from other ruminants than bovine, ovine or caprine animals.]]
(2) or [is derived from bovine, ovine or caprine animals and does not contain and is not derived from:
(2) either [bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]
(2) or [(a) specified risk material as defined in point 1 of Annex V to Regulation (EC)No 999/2001 of the European Parliament and of the Council (6);
(b) mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except from those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Commission Decision 2007/453/EC (7), in which there has been no indigenous BSE case,




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COUNTRY
Untreated blood products, excluding those of equidae, for the manufacture of derived products for purposes outside the feed chain for farmed animals
II. Health information
II.a. Certificate reference No
II.b.
(c) animal by-product or derived product obtained from bovine, ovine or caprine animals which have been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]]
Notes
Part I:
— Box reference I.6: Person responsible for the consignment in the European Union: this box is required to be filled in only if it is a certificate for a commodity that is to be transited through the European Union; it may be filled in if the certificate is for a commodity that is to be imported into the European Union.
— Box reference I.11 and I.12: Approval number: the registration number of the establishment or plant, which has been issued by the competent authority.
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for a transit commodity. Products in transit may only be stored in free zones, free warehouses and custom warehouses.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship) is to be provided. In the case of unloading and reloading in the European Union, the consignor must inform the border inspection post of the point of entry into the European Union.
— Box I.19: use the appropriate Harmonized System (HS) code under the following headings: 05.11; 30.02 or 35.02.
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be included.
— Box reference I.25: technical use: any use other than feeding of farmed animals, other than fur animals, and the production or manufacturing of pet food.
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
— Box reference I.28 Species: select from the following: Aves, Ruminantia, Suidae, Mammalia other than Ruminantia or Suidae, Pesca, Reptilian.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.
(2) Delete as appropriate.
(2a) OJ L 125, 23.5.1996, p. 3.
(2b) OJ L 125, 23.5.1996, p. 10.
(3) Code of the territory as it appears in Part 1 of Annex II to Regulation (EU) No 206/2010 (OJ L 73, 20.3.2010, p. 1).
(4) In this case following the veterinary checks provided for in Directive 97/78/EC (OJ L 24, 30.1.1998, p. 9), and in accordance with the conditions laid down in Article 8(4) of that Directive, the products must be transported directly to the establishment at the place of destination.




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COUNTRY
Untreated blood products, excluding those of equidae, for the manufacture of derived products for purposes outside the feed chain for farmed animals
II. Health information
II.a. Certificate reference No
II.b.
(5) Code of the territory as it appears in Part 1 of Annex I to Commission Regulation (EC) No 798/2008 (OJ L 226, 23.8.2008, p. 1).
(6) OJ L 147, 31.5.2001, p. 1.
(7) OJ L 172, 30.6.2007, p. 84.
— The signature and the stamp must be in a different colour to that of the printing.
— Note for the person responsible for the consignment in the European Union: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post of the point of entry into the European Union.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

CHAPTER 4(D)

Health certificate


For treated blood products, excluding those of equidae, for the manufacture of derived products for purposes outside the feed chain for farmed animals, intended for dispatch to or for transit through (2) the European Union




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COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17.
I.18. Description of commodity
I.19. Commodity code (HS code)
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Technical use
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species (Scientific name)
Manufacturing plant
Batch number




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COUNTRY
Treated blood products, excluding those of equidae, for the manufacture of derived products for purposes outside the feed chain for farmed animals
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a), and in particular Article 8(c) and Article 8(d) and Article 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Chapter II of Annex XIV thereto, and certify that:
II.1. the blood products described above consist of blood products that satisfy the requirements below;
II.2. they consist exclusively of blood products not intended for human or animal consumption;
II.3. they have been prepared and stored in a plant supervised by the competent authority, exclusively with the following animal by-products:
(2) either [- blood of slaughtered animals, which is fit for human consumption in accordance with Union legislation, but is not intended for human consumption for commercial reasons;]
(2) and/or [- blood of slaughtered animals, which is rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of diseases communicable to humans or animals, derived from carcases that have been slaughtered in a slaughterhouse and were considered fit for human consumption following an ante-mortem inspection in accordance with Union legislation;]
(2) and/or [- blood of slaughtered animals, which did not show any signs of diseases communicable to humans or animals, obtained from animals that have been slaughtered in a slaughterhouse after having been considered fit for human consumption following an ante-mortem inspection in accordance with Union legislation;]
(2) and/or [- blood and blood products originating from live animals that did not show clinical signs of any disease communicable through these products to humans or animals;]
(2) and/or [- blood and blood products derived from the production of products intended for human consumption;]
(2) and/or [- animal by-products which have been derived from animals which have been submitted to illegal treatment as defined in Article 1(2)(d) of Council Directive 96/22/EC (2a) or Article 2(b) of Council Directive 96/23/EC (2b);]
(2) and/or [- animal by-products containing residues of other substances and environmental contaminants listed in Group B(3) of Annex I to Directive 96/23/EC, if such residues exceed the permitted levels laid down by Union legislation or, in the absence thereof, in national legislation;]
II.4. the blood that these products were manufactured from was been collected in slaughterhouses approved in accordance with Union legislation, in slaughterhouses approved and supervised by the competent authority of the country of collection or from live animals in facilities approved and supervised by the competent authority of the country of collection.
(2) [II.5. In the case of blood products derived from Artiodactyla, Perissodactyla and Proboscidea including their crossbreeds, other than Suidae and Tayassuidae, the products have undergone one of the following treatments, guaranteeing the absence of pathogens of foot-and-mouth disease, vesicular stomatitis, rinderpest, peste des petits ruminants, Rift Valley fever and bluetongue:
(2) either [heat treatment at a temperature of 65 °C for at least three hours, followed by an effectiveness check;]
(2) and/or [irradiation at 25 kGy by gamma rays, followed by an effectiveness check;]
(2) and/or [change in pH to pH 5 for two hours, followed by an effectiveness check;]
(2) and/or [heat treatment of at least 80 °C throughout their substance, followed by an effectiveness check.]]
Part II: Certification




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COUNTRY
Treated blood products, excluding those of equidae, for the manufacture of derived products for purposes outside the feed chain for farmed animals
II. Health information
II.a. Certificate reference No
II.b.
(2) [II.6. In the case of blood products derived from Suidae, Tayassuidae, poultry and other avian species, the products have undergone one of the following treatments guaranteeing the absence of pathogens of the following diseases: foot-and-mouth disease, vesicular stomatitis, swine vesicular disease, classical swine fever, African swine fever, Newcastle disease and highly pathogenic avian influenza, as appropriate to the species:
(2) either [heat treatment at a temperature of 65 °C for at least three hours, followed by an effectiveness check;]
(2) and/or [irradiation at 25 kGy by gamma rays, followed by an effectiveness check;]
(2) and/or [heat treatment of at least 80 °C for Suidae/Tayassuidae (2) and at least 70°C for poultry and other avian species (2) throughout the substance of the product, followed by an effectiveness check]].
(2) [II.7. In the case of blood products derived from species other than those listed in point II.5 or II.6, the products have undergone of the following treatment (please specify): ]
II.8. The products were:
(2) either [packed in new or sterilised bags or bottles,]
(2) or [transported in bulk in containers or other means of transport that were thoroughly cleaned and disinfected with a disinfectant approved by the competent authority before use;] and
the outer packaging or containers bear labels indicating ‘NOT FOR HUMAN OR ANIMAL CONSUMPTION’;
II.9. the products were stored in enclosed storage;
II.10. all precautions were taken to avoid the contamination of the products with pathogenic agents after treatment;
(2) [II.11. The treated blood products described above
(2) either [is derived from other ruminants than bovine, ovine or caprine animals.]]
(2) or [is derived from bovine, ovine or caprine animals and does not contain and is not derived from:
(2) either [bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]
(2) or [(a) specified risk material as defined in point 1 of Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council (3);
(b) mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except from those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Commission Decision 2007/453/EC (4), in which there has been no indigenous BSE case,
(c) animal by-product or derived product obtained from bovine, ovine or caprine animals which have been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]]




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COUNTRY
Treated blood products, excluding those of equidae, for the manufacture of derived products for purposes outside the feed chain for farmed animals
II. Health information
II.a. Certificate reference No
II.b.
Notes
Part I:
— Box reference I.6: Person responsible for the consignment in the European Union: this box is required to be filled in only if it is a certificate for a commodity to be transited through the European Union; it may be filled in if the certificate is for a commodity to be imported into the European Union.
— Box reference I.11 and I.12: Approval number: the registration number of the establishment or plant, which has been issued by the competent authority.
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for a transit commodity. Products in transit may only be stored in free zones, free warehouses and custom warehouses.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship) is to be provided. In the case of unloading and reloading in the European Union, the consignor must inform the BIP of entry into the European Union.
— Box I.19: use the appropriate Harmonized System (HS) code under the following headings: 05.11, 30.02, 35.02 or 35.04.
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be included.
— Box reference I.25: technical use: any use other than feeding of farmed animals, other than fur animals, and the production or manufacturing of pet food.
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
— Box reference I.28 in case of Species: select from the following: Aves, Ruminantia, Suidae, Mammalia other than Ruminantia or Suidae, Pesca, Reptilian.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.
(2) Delete as appropriate.
(2a) OJ L 125, 23.5.1996, p. 3.
(2b) OJ L 125, 23.5.1996, p. 10.
(3) OJ L 147, 31.5.2001, p. 1.
(4) OJ L 172, 30.6.2007, p. 84.
— The signature and the stamp must be in a different colour to that of the printing.
— Note for the person responsible for the consignment in the European Union: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post of the European Union.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

                              ’
                           









(3)


Chapter 6(B) is replaced by the following:

                                 ‘CHAPTER 6(B)

Health certificate


For game trophies or other preparations of birds and ungulates consisting of entire parts which have not been treated, intended for dispatch to or for transit through (2) the European Union




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COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17. Number(s) of CITES
I.18. Description of commodity
I.19. Commodity code (HS code)
I.20. Quantity
I.21.
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Technical use
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Species (Scientific name) Number of packages




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COUNTRY
Game trophies or other preparations of birds and ungulates consisting of entire parts which have not been treated
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a), and Commission Regulation (EU) No 142/2011 (1b), and in particular Chapter II of Annex XIV thereto, and certify that the game trophies described above:
(2) either [II.1. with respect to game trophies or other preparations of cloven-hoofed animals, excluding swine:
(a) (region) has been free from foot-and-mouth disease and rinderpest for a period of the preceding 12 months, and during that period, no vaccination against any of those diseases has taken place; and
(b) the game trophies or other preparations described above:
(i) were obtained from animals which were killed in the territory of that region, which is authorised for the exportation to the European Union of fresh meat of the corresponding susceptible domestic species and where, during the period of the preceding 60 days, there have been no animal health restrictions due to outbreaks of diseases to which the game animals are susceptible; and
(ii) originated from animals that were killed at a distance of at least 20 km from the borders of another third country or part of a third country not authorised to export untreated game trophies of cloven-hoofed animals other than swine to the European Union;]
(2) or [II.1. with respect to game trophies or other preparations of wild swine:
(a) (region) during the period of the preceding 12 months, was free from classical swine fever, African swine fever, swine vesicular disease, foot-and-mouth disease and porcine enteroviral encephalmiyelitis (Teschen disease) and no vaccinations have been carried out against any of those diseases during that 12 month period; and
(b) the game trophies or other preparations described above:
(i) were obtained from animals which were killed in that territory, which is authorised for the exportation to the European Union of fresh meat of the corresponding susceptible domestic species and where, during the period of the preceding 60 days, there have been no animal health restrictions due to outbreaks of diseases to which the swine are susceptible; and
(ii) originated from animals that were killed at a distance of at least 20 km from the borders of another third country or part of a third country not authorised to export untreated game trophies of wild swine to the European Union;]
(2) or [II.1. with respect to game trophies or other preparations of solipeds, the game trophies or other preparations described above were obtained from wild solipeds that were killed in the territory of the exporting country referred to above;]
(2) or [II.1. with respect to game trophies or other preparations of game birds:
(a) (region) is free from highly pathogenic avian influenza and Newcastle disease; and
(b) the game trophies or other preparations described above were obtained from wild game birds that were killed in that region and where during the period of the preceding 30 days there have been no animal health restrictions due to outbreaks of disease to which the wild birds are susceptible;]
II.2. The game trophies or other preparations described above have been packaged without being in contact with other products of animal origin likely to contaminate them, in individual, transparent and closed packages so as to avoid any subsequent contamination.
Part II: Certification




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COUNTRY
Game trophies or other preparations of birds and ungulates consisting of entire parts which have not been treated
II. Health information
II.a. Certificate reference No
II.b.
(2) [II.3. The game trophies or other preparations described above
(2) either [are derived from other ruminants than bovine, ovine or caprine animals.]]
(2) or [are derived from bovine, ovine or caprine animals and does not contain and is not derived from:
(2) either [bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]
(2) or [(a) specified risk material as defined in point 1 of Annex V to Regulation (EC)No 999/2001 of the European Parliament and of the Council (3);
(b) mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except from those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Commission Decision 2007/453/EC (4), in which there has been no indigenous BSE case,
(c) animal by-product or derived product obtained from bovine, ovine or caprine animals which have been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]]
Notes
Part I:
— Box reference I.6: Person responsible for the consignment in the European Union: this box is required to be filled in only if it is a certificate for a commodity to be transited through the European Union; it may be filled in if the certificate is for a commodity to be imported into the European Union.
— Box reference I.11 and I.12: Approval number: the registration number of the establishment or plant, which has been issued by the competent authority.
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit commodity. Products in transit may only be stored in free zones, free warehouses and custom warehouses.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship); information is to be provided in case of unloading and reloading in the European Union.
— Box reference I.19: use the appropriate HS code: 05.05; 05.06, 05.07, 05.11; 96.01 or 97.05.
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be included.
— Box reference I.25: technical use: any use other than for animal consumption.
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
— Box reference I.28: Species: select from the following: Aves, Equidae, Tapiridae, Rhinoceritidae, Antilocaparidae, Bovidae, Camelidae, Cervidae, Giraffidae, Hippopotamindae, Moschidae Suidae, Tayassuidae, Tragulidae and Elephantidae.




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COUNTRY
Game trophies or other preparations of birds and ungulates consisting of entire parts which have not been treated
II. Health information
II.a. Certificate reference No
II.b.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.
(2) Delete as appropriate.
(3) OJ L 147, 31.5.2001, p. 1.
(4) OJ L 172, 30.6.2007, p. 84.
— The signature and the stamp must be in a different colour to that of the printing.
— Note for the person responsible for the consignment in the European Union: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post of the point of entry into the European Union.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

                              ’
                           









(4)


Chapter 8 is replaced by the following:

                                 ‘CHAPTER 8

Health certificate


For animal by-products to be used for purposes outside the feed chain or for trade samples (2), intended for dispatch to or for transit through (2) the European Union




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COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17.
I.18. Description of commodity
I.19. Commodity code (HS code)
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Technical use
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species(Scientific name)
Nature of commodity
Manufacturing plant
Number of packages
Net weight
Batch number




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COUNTRY
Animal by-products to be used for purposes outside the feed chain or for trade samples (2)
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a), and Commission Regulation (EU) No 142/2011 (1b), and in particular Chapter II of Annex XIV thereto, and certify that the animal by-products described above
(2) either [are trade samples which consist of animal by-products intended for particular studies or analyses as referred to in the definition of trade samples in point 39 of Annex I to Regulation (EU) No 142/2011, that bear the label ‘TRADE SAMPLE NOT FOR HUMAN CONSUMPTION’.]
(2) or [satisfy the animal health requirements set out in point II.1.];
II.1. The animal by products described above
II.1.1. have been
(2) either [(a) obtained from materials imported from a third country, territory or partthereof: (3) authorised to export fresh meat to the European Union;]
(2) and/or [(b) obtained in the exporting third country, territory or part thereof: (3) from animals that
either:
(i) have remained in that third country, territory or part thereof eligible to export fresh meat to the European Union since birth or for a period of at least the preceding three months before the date of slaughter; and/or
(ii) were killed in the wild in that third country, territory or part thereof (4);]
(2) and/or [(c) derived from eggs, milk, rodents, lagomorphs, or aquatic animals or terrestrial or aquatic invertebrates;]
(2) [II.1.2. in the case of materials other than materials derived from eggs, milk, rodents, lagomorphs, wool grease, aquatic animals, terrestrial or aquatic invertebrates and unprocessed furs, have been obtained from animals:
(2) either [(a) coming from holdings:
(i) where, for the following diseases for which the animals are susceptible, there has not been any case/outbreak of rinderpest, swine vesicular disease, Newcastle disease or highly pathogenic avian influenza during the period of the preceding30 days, nor of classical or African swine fever during the period of the preceding 40 days; nor in the holdings situated in their vicinity within a 10 km radius, during the period of the preceding 30 days; and
(ii) where there has not been any case/outbreak of foot-and-mouth disease during the period of the preceding 60 days, nor in the holdings situated in their vicinity within a 25 km radius, during the period of the preceding 30 days; and
(b) which:
(i) were not killed to eradicate any epizootic disease;
(ii) remained on their holdings of origin for a period of at least 40 days before the date of departure and which were transported directly to the slaughterhouse without contact with other animals which did not comply with the same health conditions;
(iii) at the slaughterhouse, passed the ante-mortem health inspection during the period of 24 hours before the time of slaughter and showed no evidence of the diseases referred to above for which the animals are susceptible; and
(iv) were handled in the slaughterhouse before and at the time of slaughter or killing in accordance with the relevant provisions of Union legislation and complied with requirements at least equivalent to those laid down in Chapters II and III of Council Regulation (EC) No 1099/2009 (5)]
Part II: Certification




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COUNTRY
Animal by-products to be used for purposes outside the feed chain or for trade samples (2)
II. Health information
II.a. Certificate reference No
II.b.
(2) or [(a) captured and killed in the wild in an area:
(i) where within a 25 km radius there has been no case/outbreak of any of the following diseases for which the animals are susceptible: foot-and-mouth disease, rinderpest, Newcastle disease or highly pathogenic avian influenza during the period of the preceding 30 days nor of classical or African swine fever during the period of the preceding 40 days; and
(ii) that is situated at a distance that exceeds 20 km from the borders separating another territory of a third country or part thereof, which is not authorised at these dates for the exportation of such material to the European Union; and
(b) which after killing were transported within a period of 12 hours for chilling either to a collection centre and immediately afterwards to a game establishment, or directly to a game establishment;]]
(2) [II.1.3. in the case of materials other than materials derived from fish or invertebrates caught in the wild, have been obtained in an establishment around which, within a radius of 10 km, there has been no case/outbreak of diseases referred to in point II.1.2 for which the animals are susceptible during a period of the preceding 30 days or, in the event of a case/outbreak of one of those diseases, the preparation of raw material for exportation to the European Union was authorised only after the removal of all meat, and the total cleaning and disinfection of the establishment under the control of an official veterinarian;]
II.1.4. have been obtained and prepared without contact with other material which does not comply with the conditions required above, and it has been handled so as to avoid contamination with pathogenic agents;
II.1.5. have been packed in new packaging which prevents any leakage or in packaging which has been cleaned and disinfected before use and, in the case of consignments shipped other than via parcel post, in containers sealed under the responsibility of the competent authority, bearing the label indicating ‘ANIMAL BY-PRODUCTS ONLY FOR THE MANUFACTURE OF DERIVED PRODUCTS FOR USES OUTSIDE THE FEED CHAIN’ and the name and address of the establishment of destination in the European Union;
II.1.6. consist only of the following animal by-products:
(2) either [- carcases and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed which were deemed fit for human consumption in accordance with Union legislation until irreversibly declared as animal by-products for commercial reasons;]
(2) and/or [- carcases and the following parts originating either from animals that were slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human consumption in accordance with Union legislation:
(i) carcases or bodies and parts of animals which were rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of disease communicable to humans or animals;
(ii) heads of poultry;
(iii) hides and skins, including trimmings and splitting thereof, horns and feet, including the phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones;
(iv) pig bristles;
(v) feathers;]
(2) and/or [- animal by-products from poultry and lagomorphs slaughtered on the farm as referred to in Article 1(3)(d) of Regulation (EC) No 853/2004 of the European Parliament and of the Council (2a), which did not show any signs of disease communicable to humans or animals;]
(2) and/or [- blood of animals which did not show any signs of disease communicable through blood to humans or animals, obtained from animals that have been slaughtered in a slaughterhouse after having been considered fit for slaughter for human consumption following an ante-mortem inspection in accordance with Union legislation;]




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COUNTRY
Animal by-products to be used for purposes outside the feed chain or for trade samples (2)
II. Health information
II.a. Certificate reference No
II.b.
(2) and/or [- animal by-products arising from the production of products intended for human consumption, including degreased bone, greaves and centrifuge or separator sludge from milk processing;]
(2) and/or [- products of animal origin, or foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arises;]
(2) and/or [- petfood and feedingstuffs of animal origin, or feedingstuffs containing animal by-products or derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arises;]
(2) and/or [- blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live animals that did not show signs of any disease communicable through that product to humans or animals;]
(2) and/or [- aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of diseases communicable to humans or animals;]
(2) and/or [- animal by-products from aquatic animals originating from establishments or plants manufacturing products for human consumption;]
(2) and/or [- the following material originating from animals which did not show any signs of disease communicable through that material to humans or animals:
(i) shells from shellfish with soft tissue or flesh;
(ii) the following originating from terrestrial animals:
— hatchery by-products;
— eggs;
— egg by-products, including egg shells;
(iii) day-old chicks killed for commercial reasons;]
(2) and/or [- animal by-products from aquatic or terrestrial invertebrates, other than species pathogenic to humans or animals;]
(2) and/or [- animals and parts thereof of the zoological orders of Rodentia and Lagomorpha, except Category 1 material as referred to in Article 8(a)(iii), (iv) and (v) of Regulation (EC)No 1069/2009 and Category 2 material as referred to in Article 9(a) to (g) of that Regulation;]
(2) and/or [- furs originating from dead animals that did not show clinical signs of any disease communicable through that product to humans or animals;]
II.1.7. have been deep-frozen at the plant of origin or have been preserved in accordance with European Union legislation in such a way that they will not spoil between the time of dispatch and the time of delivery to the plant of destination.
(2) (6) [II.1.8.
(2) (7)
either [II.1.8.1. The animal by-products in this consignment come from animals that have been obtained in the country, territory or part thereof referred to in point II.1.1, where vaccination programmes against foot-and-mouth disease are regularly carried out and officially controlled in domestic bovine animals.]]




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COUNTRY
Animal by-products to be used for purposes outside the feed chain or for trade samples (2)
II. Health information
II.a. Certificate reference No
II.b.
(2) (8)
and/or [II.1.8.2. The animal by-products in this consignment consist of animal by-products derived from offal or deboned meat.]]
(2) [II.1.9. the animal by-products described above
(2) either [are derived from other ruminants than bovine, ovine or caprine animals.]]
(2) or [are derived from bovine, ovine or caprine animals and does not contain and is not derived from:
(2) either [bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]
(2) or [(a) specified risk material as defined in point 1 of Annex V to Regulation (EC)No 999/2001 of the European Parliament and of the Council (9);
(b) mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except from those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Commission Decision 2007/453/EC (10), in which there has been no indigenous BSE case,
(c) animal by-product or derived product obtained from bovine, ovine or caprine animals which have been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]]
II.1.10 the animal by-products described above:
(2) either [do not contain milk or milk products of ovine or caprine animal origin or is not intended for feed for farmed animals, other than fur animals.]
(2) or [contain milk or milk products of ovine or caprine animal origin and is intended for feed for farmed animals, other than fur animals, and the milk or milk products:
(a) are derived from ovine and caprine animals which have been kept continuously since birth in a country where the following conditions are fulfilled:
(i) classical scrapie is compulsorily notifiable;
(ii) an awareness, surveillance and monitoring system is in place for classical scrapie;
(iii) official restrictions apply to holdings of ovine or caprine animals in the case of a suspicion of TSE or the confirmation of classical scrapie;
(iv) ovine and caprine animals affected with classical scrapie are killed and destroyed;
(v) the feeding to ovine and caprine animals of meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE), of ruminant origin has been banned and effectively enforced in the whole country for a period of at least the preceding seven years;
(b) originate from holdings where no official restrictions are imposed due to a suspicion of TSE;
(c) originate from holdings where no case of classical scrapie has been diagnosed during the period of the preceding seven years or, following the confirmation of a case of classical scrapie:




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COUNTRY
Animal by-products to be used for purposes outside the feed chain or for trade samples (2)
II. Health information
II.a. Certificate reference No
II.b.
(2) either [all ovine and caprine animals on the holding have been killed and destroyed or slaughtered, except for breeding rams of the ARR/ARR genotype, breeding ewes carrying at least one ARR allele and no VRQ allele and other ovine animals carrying at least one ARR allele;]
(2) or [all animals in which classical scrapie was confirmed have been killed and destroyed, and the holding has been subjected for a period of at least two years since the date of confirmation of the last classical scrapie case to intensified TSE monitoring, including testing with negative results for the presence of TSE in accordance with the laboratory methods set out in point 3.2 of Chapter C of Annex X to Regulation (EC) No 999/2001, of all of the following animals which are over the age of 18 months, except ovine animals of the ARR/ARR genotype:
— animals which have been slaughtered for human consumption; and
— animals which have died or been killed on the holding but which were not killed in the framework of a disease eradication campaign.]].
Notes
Part I:
— Box reference I.6: Person responsible for the consignment in the European Union: this box is required to be filled in only if it is a certificate for a commodity to be transited through the European Union; it may be filled in if the certificate is for a commodity to be imported into the European Union.
— Box reference I.11: In the case of consignments for trade samples or analyses: indicate the name and address of the establishment only.
— Box reference I.11 and I.12: Approval number: the registration number of the establishment or plant, which has been issued by the competent authority.
— Box reference I.12: Place of destination: this box is to be filled in:
— products for the manufacture of derived products for uses outside the feed chain: only if it is a certificate for a transit commodity. Products in transit may only be stored in free zones, free warehouses and custom warehouses.
— products for trade samples or analyses: the plant in the European Union indicated in the authorisation of the competent authority where appropriate.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship) is to be provided. In the case of unloading and reloading in the European Union, the consignor must inform the border inspection point of the point of entry into the European Union.
— Box reference I.19: use the appropriate Harmonized System (HS) code under the following headings: 04.01; 04.02; 04.03; 04.04; 04.08; 05.05; 05.06, 05.07; 05.11.91; 05.11.99, 23.01 or 30.01.
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be included.
— Box reference I.25: technical use: any use other than feeding of farmed animals, other than fur animals, and the production or manufacturing of pet food.
— Box reference I.25: for the purposes of the certificate, ‘technical use’ includes use as a trade sample.
— Box reference I.26 and I.27: except for trade samples, which are not sent in transit, fill in according to whether it is a transit or an import certificate.
— Box reference I.28:
— products for the manufacture of derived products for uses outside the feed chain: Manufacturing plant: provide the veterinary control number of the approved establishment.
— products for the particular technological studies or analyses: the plant in the European Union indicated in the authorisation of the competent authority where appropriate.
— Species: select from the following: Aves, Ruminantia, Suidae, Mammalia other than Ruminantia or Suidae, Pesca, Mollusca, Crustacea, invertebrates other than Mollusca and Crustacea.




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COUNTRY
Animal by-products to be used for purposes outside the feed chain or for trade samples (2)
II. Health information
II.a. Certificate reference No
II.b.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.
(2) Delete as appropriate.
(2a) OJ L 139, 30.4.2004, p. 55.
(3) The name and ISO code number of the exporting country as laid down in:
— Part 1 of Annex II to Commission Regulation (EU) No 206/2010 (OJ L 73, 20.3.2010, p. 1);
— Annex I to Commission Regulation (EC) No 798/2008 (OJ L 226, 23.8.2008, p. 1), and
— Annex I to Commission Regulation (EC) No 119/2009 (OJ L 39, 10.2.2009, p. 12).
In addition the ISO code of territories and parts thereof referred to in the Annexes to Regulations (EU) No 206/2010, (EC) No 798/2008 and (EC) No 119/2009 referred to in this note (where applicable for the susceptible species concerned) must be included where applicable.
(4) Only for countries from where the game meat intended for human consumption of the same animal species is authorised for importation into the European Union.
(5) OJ L 303, 18.11.2009, p. 1.
(6) Supplementary guarantees to be provided where the material of domestic ruminants originated in the territory of a South American or South African country or part thereof from where only maturated and deboned fresh meat of domestic ruminants for human consumption is authorised for exportation to the European Union. The whole masseter muscles of bovine animals, incised in accordance with the requirements of Part B.1 of Chapter I of Section IV of Annex Ito Regulation (EC) No 854/2004 of the European Parliament and of the Council (OJ L 139 30.4.2004, p. 206), are also permitted.
(7) Only for certain South American countries.
(8) Only for certain South American and South African countries.
(9) OJ L 147, 31.5.2001, p. 1.
(10) OJ L 172, 30.6.2007, p. 84.
— The signature and the stamp must be in a different colour to that of the printing.
— Note for the person responsible for the consignment in the European Union: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post of the point of entry into the European Union.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

                              ’
                           









(5)


Chapter 10(A), 10(B), 11 and 12 are replaced by the following:

                                 ‘CHAPTER 10(A)

Health certificate


For rendered fats not intended for human consumption to be used as feed material, intended for dispatch to or for transit through (2) the European Union




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COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17.
I.18. Description of commodity
I.19. Commodity code (HS code)
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Animal feedingstuff Manufacture of petfood Technical use
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species(Scientific name)
Nature of commodity
Manufacturing plant
Number of packages
Net weight
Batch number




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COUNTRY
Rendered fats not intended for human consumption to be used as feed material
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a), and in particular Article 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Chapter II of Annex XIV thereto, and certify that the rendered fats described above:
II.1. consist of rendered fats that satisfy the health requirements below;
II.2. consist of rendered fats not intended for human consumption;
II.3. have been prepared and stored in a plant approved and supervised by the competent authority in accordance with Article 24 of Regulation (EC) No 1069/2009 or in accordance with Article 4(2) of Regulation (EC) No 853/2004 of the European Parliament and of the Council (3), in order to kill pathogenic agents;
II.4. have been prepared exclusively with the following animal by-products:
(2) either [- carcases and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed, and which are fit for human consumption in accordance with Union legislation, but are not intended for human consumption for commercial reasons;]
(2) and/or [- carcases and the following parts originating either from animals that have been slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human consumption in accordance with Union legislation:
(i) carcases or bodies and parts of animals which are rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of disease communicable to humans or animals;
(ii) heads of poultry;
(iii) hides and skins, including trimmings and splitting thereof, horns and feet, including the phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones;
(iv) pig bristles;
(v) feathers;]
(2) and/or [- blood of animals which did not show any signs of disease communicable through blood to humans or animals, obtained from animals that have been slaughtered in a slaughterhouse after having been considered fit for slaughter for human consumption following an ante-mortem inspection in accordance with Union legislation;]
(2) and/or [- animal by-products arising from the production of products intended for human consumption, including degreased bone, greaves and centrifuge or separator sludge from milk processing;]
(2) and/or [- products of animal origin, or foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise;]
(2) and/or [- petfood and feedingstuffs of animal origin, or feedingstuffs containing animal by-products or derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arises;]
(2) and/or [- blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live animals that did not show signs of any disease communicable through that product to humans or animals;]
Part II: Certification




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COUNTRY
Rendered fats not intended for human consumption to be used as feed material
II. Health information
II.a. Certificate reference No
II.b.
(2) and/or [- aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of diseases communicable to humans or animals;]
(2) and/or [- animal by-products from aquatic animals originating from plants or establishments manufacturing products for human consumption;]
(2) and/or [- the following material originating from animals which did not show any signs of disease communicable through that material to humans or animals:
(i) shells from shellfish with soft tissue or flesh;
(ii) the following originating from terrestrial animals:
— hatchery by-products,
— eggs,
— egg by-products, including egg shells;
(iii) day-old chicks killed for commercial reasons;]
II.5. (2) either [- in the case of material of porcine origin, come from a country or part of the territory of a country free from foot-and-mouth disease for the period of the preceding 24 months and free from classical swine fever and African swine fever for the period of the preceding12 months;]
(2) and/or [- in the case of material of poultry origin, come from a country or part of a territory of a country free from Newcastle disease and avian influenza for a period of the preceding6 months;]
(2) and/or [- in the case of material of ruminant origin, come from a country or part of a territory of a country free from foot-and-mouth disease for the period of the preceding 24 months and free from rinderpest for the period of the preceding 12 months;]
(2) and/or [- where there has been an outbreak of one of the diseases referred to in point II.5. during the relevant period referred to in point II.5, and where the rendered fats derived from a susceptible species, have been subjected to a heat treatment for at least 70 °C for30 minutes or at least 90 °C for at least 15 minutes, and
details of the critical control points are recorded and maintained so that the owner, operator or their representative and, as necessary, the competent authority can monitor the operation of the plant; the information must include the particle size, critical temperature and, as appropriate, the absolute time, pressure profile, raw material feed rate and fat recycling rate.]
II.6. if derived from ruminant animals, were purified in such way that the maximum levels of remaining total insoluble impurities does not exceed 0,15 % in weight;
II.7. the rendered fats:
(a) have been subjected to processing in accordance with the requirements of Section 3 of Chapter II of Annex X to Regulation (EU) No 142/2011, or a treatment in accordance with Section XII of Annex III to Regulation (EC) No 853/2004, in order to kill pathogenic agents; and
(2) either [(b) are packaged in new containers or in containers that have been cleaned and disinfected if necessary for the prevention of contamination, and all precautions have been taken to prevent their contamination;]
(2) or [(b) where bulk transport is intended, the pipe, pumps and bulk tanks and any other bulk container or bulk road tanker used in the transportation of the product from the manufacturing plant either directly on to the ship or into shore tanks or directly to plants have been checked under the responsibility of the competent authority and found to be clean before use;]
and which bear labels indicating ‘NOT FOR HUMAN CONSUMPTION’;




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COUNTRY
Rendered fats not intended for human consumption to be used as feed material
II. Health information
II.a. Certificate reference No
II.b.
(2) [II.8. the rendered fats described above
(2) either [is derived from other ruminants than bovine, ovine or caprine animals.]]
(2) or [is derived from bovine, ovine or caprine animals and does not contain and is not derived from:
(2) either [bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]
(2) or [(a) specified risk material as defined in point 1 of Annex V to Regulation (EC)No 999/2001 of the European Parliament and of the Council (4);
(b) mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except from those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Commission Decision 2007/453/EC (5), in which there has been no indigenous BSE case,
(c) animal by-product or derived product obtained from bovine, ovine or caprine animals which have been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]]
II.9. the rendered fats described above:
(2) either [does not contain milk or milk products of ovine or caprine animal origin or is not intended for feed for farmed animals, other than fur animals.]
(2) or [contains milk or milk products of ovine or caprine animal origin and is intended for feed for farmed animals, other than fur animals, and the milk or milk products:
(a) are derived from ovine and caprine animals which have been kept continuously since birth in a country where the following conditions are fulfilled:
(i) classical scrapie is compulsorily notifiable;
(ii) an awareness, surveillance and monitoring system is in place for classical scrapie;
(iii) official restrictions apply to holdings of ovine or caprine animals in the case of a suspicion of TSE or the confirmation of classical scrapie;
(iv) ovine and caprine animals affected with classical scrapie are killed and destroyed;
(v) the feeding to ovine and caprine animals of meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE), of ruminant origin has been banned and effectively enforced in the whole country for a period of at least the preceding seven years;
(b) originate from holdings where no official restrictions are imposed due to a suspicion of TSE;
(c) originate from holdings where no case of classical scrapie has been diagnosed during the preceding seven years or, following the confirmation of a case of classical scrapie:




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COUNTRY
Rendered fats not intended for human consumption to be used as feed material
II. Health information
II.a. Certificate reference No
II.b.
(2) either [all ovine and caprine animals on the holding have been killed and destroyed or slaughtered, except for breeding rams of the ARR/ARR genotype, breeding ewes carrying at least one ARR allele and no VRQ allele and other ovine animals carrying at least one ARR allele;]
(2) or [all animals in which classical scrapie was confirmed have been killed and destroyed, and the holding has been subjected for period of at least two years since the date of confirmation of the last classical scrapie case to intensified TSE monitoring, including testing with negative results for the presence of TSE in accordance with the laboratory methods set out in point 3.2 of Chapter C of Annex X to Regulation (EC) No 999/2001, of all of the following animals which are over the age of 18 months, except ovine animals of the ARR/ARR genotype:
— animals which have been slaughtered for human consumption; and
— animals which have died or been killed on the holding but which were not killed in the framework of a disease eradication campaign.]]
Notes
Part I:
— Box reference I.6: Person responsible for the consignment in the European Union: this box is required to be filled in only if it is a certificate for a commodity to be transited through the European Union; it may be filled in if the certificate is for a commodity to be imported into the European Union.
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for a transit commodity. Products in transit may only be stored in free zones, free warehouses and custom warehouses.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship); information is to be provided in the case of unloading and reloading in the European Union.
— Box reference I.19: use the appropriate HS code: 04.05; 15.01; 15.02; 15.03; 15.04; 15.05; 15.06; 15.16.10 or 15.18.
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be included.
— Box reference I.25: technical use: any use other than feeding of farmed animals, other than fur animals or pet animals, and the production or manufacturing of pet food.
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
— Box reference I.28:
— Species: select from the following: Ruminantia, other than Ruminantia
— Manufacturing plant: provide the registration number of the treatment/processing establishment.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.
(2) Delete as appropriate.
(3) OJ L 139, 30.4.2004, p. 55.




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COUNTRY
Rendered fats not intended for human consumption to be used as feed material
II. Health information
II.a. Certificate reference No
II.b.
(4) OJ L 147, 31.5.2001, p. 1.
(5) OJ L 172, 30.6.2007, p. 84.
— The signature and the stamp must be in a different colour to that of the printing.
— Note for the person responsible for the consignment in the European Union: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post of the European Union.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

CHAPTER 10(B)

Health certificate


For rendered fats not intended for human consumption to be used for certain purposes outside the feed chain, intended for dispatch to or for transit through (2) the European Union




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COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17.
I.18. Description of commodity
I.19. Commodity code (HS code)
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Technical use
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species(Scientific name)
Manufacturing plant
Number of packages
Net weight
Batch number




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COUNTRY
Rendered fats not intended for human consumption for certain purposes outside the feed chain
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a), and in particular Articles 8, 9 and 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Chapter II of Annex XIV thereto, and certify that the rendered fats described above:
II.1. consist of rendered fats not intended for human consumption that satisfy the health requirements below;
II.2. have been prepared exclusively with the following animal by-products:
(2) [II.2.1. in the case of materials destined for the production of renewable fuels referred to in point L of Section 2 of Chapter IV of Annex IV to Regulation (EU) No 142/2011, biodiesel or oleochemical products, animal by-products referred to in Articles 8, 9 and 10 of Regulation (EC) No 1069/2009;]
(2) [II.2.2. in the case of materials destined for the production of renewable fuels referred to in point J of Section 2 of Chapter IV of Annex IV to Regulation (EU) No 142/2011, the materials have been prepared exclusively from animal by-products referred to in Articles 9 and 10 of Regulation (EC) No 1069/2009;]
(2) [II.2.3. in the case of materials destined for purposes other than cosmetics, pharmaceuticals or medical devices, the materials have been prepared exclusively from:
(2) either [- animal by-products containing residues of authorised substances or contaminants exceeding the permitted levels referred to in Article 15(3) of Council Directive 96/23/EC (2a);]
(2) and/or [- products of animal origin which have been declared unfit for human consumption due to the presence of foreign bodies in those products;]
(2) and/or [- animals and parts of animals, other than those referred to in Articles 8 and 10 of Regulation (EC) No 1069/2009, that died other than being slaughtered or killed for human consumption, including animals killed for disease control purposes;]
(2) and/or [- carcasses and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed, and which are fit for human consumption in accordance with Union legislation, but are not intended for human consumption for commercial reasons;]
(2) and/or [- carcasses and the following parts originating either from animals that have been slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human consumption in accordance with Union legislation:
(i) carcasses or bodies and parts of animals which are rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of disease communicable to humans or animals;
(ii) heads of poultry;
(iii) hides and skins, including trimmings and splitting thereof, horns and feet, including the phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones;
(iv) pig bristles;
(v) feathers;]
(2) and/or [- blood of animals which did not show any signs of disease communicable through blood to humans or animals obtained from animals that have been slaughtered in a slaughterhouse after having been considered fit for slaughter for human consumption following an ante-mortem inspection in accordance with Union legislation;]
(2) and/or [- animal by-products arising from the production of products intended for human consumption, including degreased bone, greaves and centrifuge or separator sludge from milk processing;]
Part II: Certification




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COUNTRY
Rendered fats not intended for human consumption for certain purposes outside the feed chain
II. Health information
II.a. Certificate reference No
II.b.
(2) and/or [- products of animal origin, or foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arises;]
(2) and/or [- petfood and feeding stuffs of animal origin, or feeding stuffs containing animal by-products or derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arises;]
(2) and/or [- blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live animals that did not show signs of any disease communicable through that product to humans or animals;]
(2) and/or [- aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of diseases communicable to humans or animals;]
(2) and/or [- animal by-products from aquatic animals originating from plants or establishments manufacturing products for human consumption;]
(2) and/or [- the following material originating from animals which did not show any signs of disease communicable through that material to humans or animals:
(i) shells from shellfish with soft tissue or flesh;
(ii) the following originating from terrestrial animals:
— hatchery by-products,
— eggs,
— egg by-products, including egg shells,
(iii) day-old chicks killed for commercial reasons;]
(2) and/or [- aquatic and terrestrial invertebrates other than species pathogenic to humans or animals;]
(2) and/or [- animals and parts thereof of the zoological orders of Rodentia and Lagomorpha, except Category 1 material as referred to in Article 8(a)(iii), (iv) and (v) of Regulation (EC) No 1069/2009and Category 2 material as referred to in Article 9(a) to (g) of that Regulation;]
(2) and/or [- hides and skins, hooves, feathers, wool, horns, hair and fur originating from dead animals that did not show any signs of disease communicable through that product to humans or animals;]
(2) and/or [- adipose tissue from animals which did not show any signs of disease communicable through that material to humans or animals, which were slaughtered in a slaughterhouse and which were considered fit for slaughter for human consumption following an ante-mortem inspection in accordance with Union legislation;]]
(2) [II.2.4. in the case of materials destined for purposes other than the production of organic fertilisers or soil improvers, cosmetics, pharmaceutical or medical devices :
(2) either [- specified risk material as defined in Article 3(1)(g) of Regulation (EC) No 999/2001 of the European Parliament and of the Council (2b);]
(2) and/or [- entire bodies or parts of dead animals containing specified risk material as defined in Article 3(1)(g) of Regulation (EC) No 999/2001 at the time of disposal;]
(2) and/or [- animal by-products which have been derived from animals which have been submitted to illegal treatment as defined in Article 1(2)(d) of Council Directive 96/22/EC (2c) or Article 2(b) of Council Directive 96/23/EC;]




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COUNTRY
Rendered fats not intended for human consumption for certain purposes outside the feed chain
II. Health information
II.a. Certificate reference No
II.b.
(2) and/or [- animal by-products containing residues of other substances and environmental contaminants listed in Group B(3) of Annex I to Directive 96/23/EC, if such residues exceed the permitted levels laid down by Union legislation or, in the absence thereof, by legislation of the Member State of importation;]]
II.3. the rendered fats:
(a) have been subjected to processing in accordance with method (indicate the processing method) as set out in Chapter III of Annex IV to Regulation (EU) No 142/2011, in order to kill pathogenic agents,
(b) have been marked before shipment to the European Union with glyceroltriheptanoate (GTH), so that a homogenous minimum concentration of at least 250 mg GTH per kilogramme fat is achieved,
(c) in the case of rendered fats of ruminant origin, insoluble impurities in excess of 0,15% in weight have been removed,
(d) have been transported under conditions which prevent their contamination, and
(e) bear labels on the packaging or container indicating “NOT FOR HUMAN OR ANIMAL CONSUMPTION”;
(2) [II.4. in the case of materials destined for organic fertilisers, cosmetics, pharmaceuticals, medical devices or soil improvers the rendered fats described above
(2) either [are derived from other ruminants than bovine, ovine or caprine animals.]
(2) or [are derived from bovine, ovine or caprine animals and does not contain and is not derived from:
(2) either [bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]
(2) or [(a) specified risk material as defined in point 1 of Annex V to Regulation (EC)No 999/2001 of the European Parliament and of the Council (3);
(b) mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except from those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Commission Decision 2007/453/EC (4), in which there has been no indigenous BSE case,
(c) animal by-product or derived product obtained from bovine, ovine or caprine animals which have been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]]
Notes
Part I:
— Box reference I.6: Person responsible for the consignment in the European Union: this box is required to be filled in only if it is a certificate for a commodity to be transited through the European Union; it may be filled in if the certificate is for a commodity to be imported into the European Union.
— Box reference I.11 and I.12: Approval number: the registration number of the establishment or plant, which has been issued by the competent authority.




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COUNTRY
Rendered fats not intended for human consumption for certain purposes outside the feed chain
II. Health information
II.a. Certificate reference No
II.b.
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for a transit commodity. Products in transit may only be stored in free zones, free warehouses and custom warehouses.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship) is to be provided. In the case of unloading and reloading in the European Union, the consignor must inform the border inspection post of the point of entry into the European Union.
— Box I.19: use the appropriate Harmonized System (HS) code under the following headings: 04.05; 15.01, 15.02; 15.03; 15.04; 15.05; 15.06; 15.16 or 15.18.
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be included.
— Box reference I.25: technical use: any use other than feeding of farmed animals, other than fur animals or pet animals, and the production or manufacturing of pet food.
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
— Box reference I.28:
Species: select from the following: Ruminantia, other than Ruminantia
Manufacturing plant: provide the registration number of the treatment/processing establishment.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.
(2) Delete as appropriate.
(2a) OJ L 125, 23.5.1996, p. 10.
(2b) OJ L 147, 31.5.2001, p. 1.
(2c) OJ L 125, 23.5.1996, p. 3.
(3) OJ L 147, 31.5.2001, p. 1.
(4) OJ L 172, 30.6.2007, p. 84.
— The signature and the stamp must be in a different colour to that of the printing.
— Note for the person responsible for the consignment in the European Union: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post of the point of entry into the European Union.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

CHAPTER 11

Health certificate


For gelatine and collagen not intended for human consumption to be used as feed material or for purposes outside the feed chain, intended for dispatch to or for transit through (2) the European Union




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COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17.
I.18. Description of commodity
I.19. Commodity code (HS code)
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Animal feedingstuff Manufacture of petfood Technical use
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species(Scientific name)
Manufacturing plant
Number of packages
Net weight
Batch number




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COUNTRY
Gelatine and collagen not intended for human consumption to be used as feed material or for purposes outside the feed chain
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a), and in particular Article 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Chapter I of Annex XIV thereto, and certify that the gelatine/collagen (2) described above:
II.1. consists of gelatine/collagen (2) that satisfy the health requirements below;
II.2. consist exclusively of gelatine/collagen (2) not intended for human consumption;
II.3. has been prepared and stored in a plant approved and supervised by the competent authority in accordance with Article 24 of Regulation (EC) No 1069/2009, in order to kill pathogenic agents;
II.4. has been prepared exclusively with the following animal by-products:
(2) either [- carcases and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed, and which are fit for human consumption in accordance with Union legislation, but are not intended for human consumption for commercial reasons;]
(2) and/or [- carcases and the following parts originating either from animals that have been slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human consumption in accordance with Union legislation:
(i) carcases or bodies and parts of animals which are rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of disease communicable to humans or animals;
(ii) heads of poultry;
(iii) hides and skins, including trimmings and splitting thereof, horns and feet, including the phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones;
(iv) pig bristles;
(v) feathers;]
(2) and/or [- animal by-products arising from the production of products intended for human consumption, including degreased bone, greaves and centrifuge or separator sludge from milk processing;]
(2) and/or [- products of animal origin, or foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arises;]
(2) and/or [- petfood and feedingstuffs of animal origin, or feedingstuffs containing animal by-products or derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arises;]
(2) and/or [- aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of diseases communicable to humans or animals;]
(2) and/or [- animal by-products from aquatic animals originating from plants or establishments manufacturing products for human consumption;]
II.5. the gelatine/collagen (2):
(a) was wrapped, packaged, stored and transported under satisfactory hygiene conditions, and in particular wrapping and packaging took place in a dedicated room, and only preservatives permitted under Union legislation were used.
Part II: Certification




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COUNTRY
Gelatine and collagen not intended for human consumption to be used as feed material or for purposes outside the feed chain
II. Health information
II.a. Certificate reference No
II.b.
Wrappings and packages containing gelatine/collagen (2) bear the words ‘GELATINE/COLLAGEN(2) SUITABLE FOR ANIMAL CONSUMPTION’; and
(2) either [(b) in the case of gelatine, was produced by a process that ensured that unprocessed Category 3 material was subjected to a treatment with acid or alkali, followed by one or more rinses, involving pH adjustment, extraction by heating one or several times in succession, followed by purification by means of filtration and sterilisation, in order to kill pathogenic agents;]
(2) or [(b) in the case of collagen, was produced by a process that ensured that unprocessed Category 3 material was subjected to a treatment involving washing, pH adjustment using acid or alkali followed by one or more rinses, filtration and extrusion, in order to kill pathogenic agents;]
(2) [II.6. in the case of gelatine/collagen (2) from materials other than hides and skins
(2) either [is derived from other ruminants than bovine, ovine or caprine animals.]]
(2) or [is derived from bovine, ovine or caprine animals and does not contain and is not derived from:
(2) either [bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]
(2) or [(a) specified risk material as defined in point 1 of Annex V to Regulation (EC)No 999/2001 of the European Parliament and of the Council (3);
(b) mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except from those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Commission Decision 2007/453/EC (4), in which there has been no indigenous BSE case,
(c) animal by-product or derived product obtained from bovine, ovine or caprine animals which have been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]]
II.7. in the case of gelatine/collagen (2) from materials other than hides and skins described above:
(2) either [does not contain milk or milk products of ovine or caprine animal origin or is not intended for feed for farmed animals, other than fur animals.]
(2) or [contains milk or milk products of ovine or caprine animal origin and is intended for feed for farmed animals, other than fur animals, and the milk or milk products:
(a) are derived from ovine and caprine animals which were kept continuously since birth in a country where the following conditions are fulfilled:
(i) classical scrapie is compulsorily notifiable;
(ii) an awareness, surveillance and monitoring system is in place for classical scrapie;
(iii) official restrictions apply to holdings of ovine or caprine animals in the case of a suspicion of TSE or the confirmation of classical scrapie;




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COUNTRY
Gelatine and collagen not intended for human consumption to be used as feed material or for purposes outside the feed chain
II. Health information
II.a. Certificate reference No
II.b.
(iv) ovine and caprine animals affected with classical scrapie are killed and destroyed;
(v) the feeding to ovine and caprine animals of meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE), of ruminant origin has been banned and effectively enforced in the whole country for a period of at least the preceding seven years;
(b) originate from holdings where no official restrictions are imposed due to a suspicion of TSE;
(c) originate from holdings where no case of classical scrapie has been diagnosed during the period of the preceding seven years or, following the confirmation of a case of classical scrapie:
(2) either [all ovine and caprine animals on the holding have been killed and destroyed or slaughtered, except for breeding rams of the ARR/ARR genotype, breeding ewes carrying at least one ARR allele and no VRQ allele and other ovine animals carrying at least one ARR allele;]
(2) or [all animals in which classical scrapie was confirmed have been killed and destroyed, and the holding has been subjected for a period of at least two years since the date of confirmation of the last classical scrapie case to intensified TSE monitoring, including testing with negative results for the presence of TSE in accordance with the laboratory methods set out in point 3.2 of Chapter C of Annex X to Regulation (EC) No 999/2001, of all of the following animals which are over the age of 18 months, except ovine animals of the ARR/ARR genotype:
— animals which have been slaughtered for human consumption; and
— animals which have died or been killed on the holding but which were not killed in the framework of a disease eradication campaign.]]
Notes
Part I:
— Box reference I.6: Person responsible for the consignment in the European Union: this box is to be filled in only if it is a certificate for a commodity to be transited through the European Union; it may be filled in if the certificate is for a commodity to be imported into the European Union.
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit commodity. Products in transit may only be stored in free zones, free warehouses and custom warehouses.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship) is to be provided. In the case of unloading and reloading in the European Union, the consignor must inform the border inspection post of the point of entry into the European Union.
— Box I.19: use the appropriate Harmonized System (HS) code under the following headings: 35.03 or 35.04.
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be included.
— Box reference I.25: technical use: any use other than feeding of farmed animals, other than fur animals, and the production or manufacturing of pet food.
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
— Box reference I.28: Species: select from the following: Aves, Ruminantia, Suidae, Mammalia other than Ruminantia or Suidae, Pesca.




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COUNTRY
Gelatine and collagen not intended for human consumption to be used as feed material or for purposes outside the feed chain
II. Health information
II.a. Certificate reference No
II.b.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.
(2) Delete as appropriate.
(3) OJ L 147, 31.5.2001, p. 1.
(4) OJ L 172, 30.6.2007, p. 84.
— The signature and the stamp must be in a different colour to that of the printing.
— Note for the person responsible for the consignment in the European Union: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

CHAPTER 12

Health certificate


For hydrolysed protein, dicalcium phosphate and tricalcium phosphate not intended for human consumption to be used as feed material or for uses outside the feed chain, intended for dispatch to or for transit through (2) the European Union




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COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17.
I.18. Description of commodity
I.19. Commodity code (HS code)
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Animal feedingstuff Manufacture of petfood Technical use
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species(Scientific name)
Nature of commodity
Manufacturing plant
Number of packages
Net weight
Batch number




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COUNTRY
Hydrolysed protein, dicalcium phosphate and tricalcium phosphate not intended for human consumption to be used as feed material or for uses outside the feed chain
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a), and in particular Article 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Chapter I of Annex XIV thereto, and certify that the hydrolysed protein/dicalcium phosphate/tricalcium phosphate (2) described above:
II.1. consists of hydrolysed protein/dicalcium phosphate/tricalcium phosphate (2) that satisfy the health requirements below;
II.2. consists exclusively of hydrolysed protein/dicalcium phosphate/tricalcium phosphate (2) not intended for human consumption;
II.3. has been prepared and stored in a plant approved and supervised by the competent authority in accordance with Article 24 of Regulation (EC) No 1069/2009, in order to kill pathogenic agents;
II.4. has been prepared exclusively with the following animal by-products:
(2) either [in the case of dicalcium phosphate derived from defatted bones, carcases and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed, and which are fit for human consumption in accordance with Union legislation, but are not intended for human consumption for commercial reasons;]
(2) or [in the case of other materials:
(2) either [- carcases and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed, and which are fit for human consumption in accordance with Union legislation, but are not intended for human consumption for commercial reasons;]]
(2) and/or [- carcases and the following parts originating either from animals that have been slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human consumption in accordance with Union legislation:
(i) carcases or bodies and parts of animals which are rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of disease communicable to humans or animals;
(ii) heads of poultry;
(iii) hides and skins, including trimmings and splitting thereof, horns and feet, including the phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones;
(iv) pig bristles;
(v) feathers;]]
(2) and/or [- blood of animals which did not show any signs of disease communicable through blood to humans or animals obtained from animals that have been slaughtered in a slaughterhouse after having been considered fit for slaughter for human consumption following an ante-mortem inspection in accordance with Union legislation;]]
(2) and/or [- animal by-products arising from the production of products intended for human consumption, including degreased bone, greaves and centrifuge or separator sludge from milk processing;]]
(2) and/or [- products of animal origin, or foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise;]]
Part II: Certification




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COUNTRY
Hydrolysed protein, dicalcium phosphate and tricalcium phosphate not intended for human consumption to be used as feed material or for uses outside the feed chain
II. Health information
II.a. Certificate reference No
II.b.
(2) and/or [- petfood and feedingstuffs of animal origin, or feedingstuffs containing animal by-products or derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arises;]]
(2) and/or [- blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live animals that did not show signs of any disease communicable through that product to humans or animals;]]
(2) and/or [- aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of diseases communicable to humans or animals;]]
(2) and/or [- animal by-products from aquatic animals originating from plants or establishments manufacturing products for human consumption;]]
(2) and/or [- the following material originating from animals which did not show any signs of disease communicable through that material to humans or animals:
(i) shells from shellfish with soft tissue or flesh;
(ii) the following originating from terrestrial animals:
— hatchery by-products,
— eggs,
— egg by-products, including egg shells;
(iii) day-old chicks killed for commercial reasons;]]
II.5. the hydrolysed protein/dicalcium phosphate/tricalcium phosphate (2):
(a) was wrapped and packaged in packaging which bear labels indicating ‘NOT FOR HUMAN CONSUMPTION’ and was stored and transported under satisfactory hygiene conditions, and in particular the wrapping and packaging took place in a dedicated room, and only preservatives permitted under Union legislation were used; and
(2) either [(b) in the case of hydrolysed protein, was produced by a process involving appropriate measures to minimise contamination of raw Category 3 material.
In the case of hydrolysed proteins entirely or partly derived from ruminants hides and skins, was produced in a processing plant dedicated only to hydrolysed proteins production, using a process involving the preparation of the raw Category 3 material by brining, liming and intensive washing followed by:
(i) the exposure of the material to a pH of more than 11 for more than 3 hours at a temperature of more than 80 °C and subsequently by heat treatment at a temperature of more than 140 °C for 30 minutes at more than 3,6 bar ; or
(ii) the exposure of the material to a pH of 1 to 2, followed by a pH of more than 11, followed by a heat treatment at a temperature of more than 140 °C for 30 minutes at 3 bar.]
(2) or [(b) in the case of dicalcium phosphate, was produced by a process that:
(i) ensures that all Category 3 bone-material is finely crushed and degreased with hot water and treated with dilute hydrochloric acid (at a minimum concentration of 4 % and a pH of less than 1,5) over a period of at least two days,
(ii) followed by a treatment of the obtained phosphoric liquor with lime, resulting in a precipitate of dicalcium phosphate at pH 4 to 7, and




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COUNTRY
Hydrolysed protein, dicalcium phosphate and tricalcium phosphate not intended for human consumption to be used as feed material or for uses outside the feed chain
II. Health information
II.a. Certificate reference No
II.b.
(iii) finally air-dries this precipitate, with an inlet temperature of 65 °C to 325 °C and an end temperature of between 30 °C and 65 °C.]
(2) or [(b) in the case of tricalcium phosphate, was produced by a process ensuring:
(i) that all Category 3 bone-material is finely crushed and degreased in counter-flow with hot water (bone chips less than 14 mm),
(ii) the continuous cooking with steam at 145 °C during 30 minutes at 4 bars,
(iii) the separation of the protein broth from the hydroxyapatite (tricalcium phosphate) by centrifugation, and
(iv) the granulation of the tricalcium phosphate after drying in a fluidised bed with air at 200 °C.]
(2) [II.6. the hydrolysed protein/dicalcium phosphate/tricalcium phosphate (2) described above
(2) either [is derived from other ruminants than bovine, ovine or caprine animals.]]
(2) or [is derived from bovine, ovine or caprine animals and does not contain and is not derived from:
(2) either [bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]
(2) or [(a) specified risk material as defined in point 1 of Annex V to Regulation (EC)No 999/2001 of the European Parliament and of the Council (3);
(b) mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except from those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Commission Decision 2007/453/EC (4), in which there has been no indigenous BSE case,
(c) animal by-product or derived product obtained from bovine, ovine or caprine animals which have been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]]
II.7. the hydrolysed protein/dicalcium phosphate/tricalcium phosphate (2) described above:
(2) either [does not contain milk or milk products of ovine or caprine animal origin or is not intended for feed for farmed animals, other than fur animals.]
(2) or [contains milk or milk products of ovine or caprine animal origin and is intended for feed for farmed animals, other than fur animals, and the milk or milk products:
(a) are derived from ovine and caprine animals which have been kept continuously since birth in a country where the following conditions are fulfilled:
(i) classical scrapie is compulsorily notifiable;
(ii) an awareness, surveillance and monitoring system is in place for classical scrapie;
(iii) official restrictions apply to holdings of ovine or caprine animals in the case of a suspicion of TSE or the confirmation of classical scrapie;




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COUNTRY
Hydrolysed protein, dicalcium phosphate and tricalcium phosphate not intended for human consumption to be used as feed material or for uses outside the feed chain
II. Health information
II.a. Certificate reference No
II.b.
(iv) ovine and caprine animals affected with classical scrapie are killed and destroyed;
(v) the feeding to ovine and caprine animals of meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE), of ruminant origin has been banned and effectively enforced in the whole country for a period of at least the preceding seven years;
(b) originate from holdings where no official restrictions are imposed due to a suspicion of TSE;
(c) originate from holdings where no case of classical scrapie has been diagnosed during the period of the preceding seven years or, following the confirmation of a case of classical scrapie:
(2) either [all ovine and caprine animals on the holding have been killed and destroyed or slaughtered, except for breeding rams of the ARR/ARR genotype, breeding ewes carrying at least one ARR allele and no VRQ allele and other ovine animals carrying at least one ARR allele;]
(2) or [all animals in which classical scrapie was confirmed have been killed and destroyed, and the holding has been subjected for a period of at least two years since the date of confirmation of the last classical scrapie case to intensified TSE monitoring, including testing with negative results for the presence of TSE in accordance with the laboratory methods set out in point 3.2 of Chapter C of Annex X to Regulation (EC) No 999/2001, of all of the following animals which are over the age of 18 months, except ovine animals of the ARR/ARR genotype:
— animals which have been slaughtered for human consumption; and
— animals which have died or been killed on the holding but which were not killed in the framework of a disease eradication campaign.]]
Notes
Part I:
— Box reference I.6: Person responsible for the consignment in the European Union: this box is required to be filled in only if it is a certificate for a commodity to be transited through the European Union; it may be filled in if the certificate is for a commodity to be imported into the European Union.
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for a transit commodity. Products in transit can only be stored in free zones, free warehouses and custom warehouses.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship); information is to be provided in case of unloading and reloading.
— Box reference I.19: use the appropriate HS code: 05.08, 28.35.25; 28.35.26, 29.22; 35.02; 35.03 or 35.04.
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be included.
— Box reference I.25: technical use: any use other than feeding of farmed animals, other than fur animals, and the production or manufacturing of pet food.
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
— Box reference I.28:
— Species: select from the following: Aves, Ruminantia, Suidae, Mammalia other than Ruminantia or Suidae, Pesca, Mollusca, Crustacea, invertebrates other than Mollusca and Crustacea.




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COUNTRY
Hydrolysed protein, dicalcium phosphate and tricalcium phosphate not intended for human consumption to be used as feed material or for uses outside the feed chain
II. Health information
II.a. Certificate reference No
II.b.
— Nature of commodity: specify if hydrolysed protein, dicalcium phosphate or tricalcium phosphate.
— Manufacturing plant: provide the registration number of treatment/processing establishment.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.
(2) Delete as appropriate.
(3) OJ L 147, 31.5.2001, p. 1.
(4) OJ L 94, 1.4.2006, p. 28.
— The signature and the stamp must be in a different colour to that of the printing.
— Note for the person responsible for the consignment in the European Union: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post of the point of entry into the European Union.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

                              ’
                           









(6)


Chapter 18 is replaced by the following:

                                 ‘CHAPTER 18

Health certificate


For horns and horn products, excluding horn meal, and hooves and hoof products, excluding hoof meal, intended for the production of organic fertilisers or soil improvers intended for dispatch to or for transit through (2) the European Union




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COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17. Number(s) of CITES
I.18. Description of commodity
I.19. Commodity code (HS code)
05.07
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Further process Technical use
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species(Scientific name)
Manufacturing plant
Net weight
Batch number




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COUNTRY
Horns and horn products, excluding horn meal, and hooves and hoof products, excluding hoof meal, intended for the production of organic fertilisers or soil improvers
II. Health information
II.a. Certificate reference No
II.b.
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a), and Commission Regulation (EU) No 142/2011 (1b), and in particular Chapter II of Annex XIV thereto, and certify that the horns and horn products, excluding horn meal, and hooves and hoof products, excluding hoof meal (2) described above
II.1. originate from animals
(2) either [that were slaughtered in a slaughterhouse, after undergoing ante-mortem inspection, and were fit, as a result of such inspection, for slaughter for human consumption;]
(2) or [that did not show clinical signs of any disease communicable through that product to humans or animals;]
II.2. horns, horn products, hooves and hoof products must have undergone a heat treatment for one hour at a core temperature of at least 80 °C;
II.3. horns must have been removed without opening the cranial cavity;
II.4. at any stage of processing, storage or transport every precaution must have been taken to avoid cross-contamination.
II.5. the horns and horn products, excluding horn meal, and hooves and hoof products, excluding hoof meal, were packed:
(2) either [in new packaging or containers;]
(2) or [in vehicles or bulk containers disinfected prior to loading using a product approved by the competent authority;]
and the packaging or containers are marked so as to indicate the type of the animal by-product (3) and bear labels indicating ‘NOT FOR HUMAN AND ANIMAL CONSUMPTION’ and the name and address of the establishment of destination .
(2)[II.6. The horns and horn products, excluding horn meal, and hooves and hoof products, excluding hoof meal described above
(2) either [is derived from other ruminants than bovine, ovine or caprine animals.]]
(2) or [is derived from bovine, ovine or caprine animals and does not contain and is not derived from:
(2) either [bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]
(2) or [(a) specified risk material as defined in point 1 of Annex V to Regulation (EC)No 999/2001 of the European Parliament and of the Council (4);
(b) mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except from those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Commission Decision 2007/453/EC (5), in which there has been no indigenous BSE case,
(c) animal by-product or derived product obtained from bovine, ovine or caprine animals which have been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for those animals that were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.]]]
Part II: Certification




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COUNTRY
Horns and horn products, excluding horn meal, and hooves and hoof products, excluding hoof meal, intended for the production of organic fertilisers or soil improvers
II. Health information
II.a. Certificate reference No
II.b.
Notes
Part I:
— Box reference I.6: Person responsible for the consignment in the European Union: this box is required to be filled in only if it is a certificate for a commodity to be transited through the European Union; it may be filled in if the certificate is for a commodity to be imported into the European Union.
— Box reference I.11 and I.12: Approval number: the registration number of the establishment or plant, which has been issued by the competent authority.
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for a transit commodity. Products in transit must only be stored in free zones, free warehouses and custom warehouses.
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship); information is to be provided in the event of unloading and reloading in the European Union.
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be given.
— Box reference I.25: technical use: any use other than for animal consumption.
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
— Box reference I.28: Nature of commodity.
Part II:
(1a) OJ L 300, 14.11.2009, p. 1.
(1b) OJ L 54, 26.2.2011, p. 1.
(2) Delete as appropriate.
(3) Type of product: horns, horn products, hooves, hoof products.
(4) OJ L 147, 31.5.2001, p. 1.
(5) OJ L 172, 30.6.2007, p. 84.
— The signature and the stamp must be in a different colour to that of the printing.
— Note for the person responsible for the consignment in the European Union: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post of the point of entry into the European Union.
Official veterinarian/Official inspector
Name (in capital letters): Qualification and title:
Date: Signature:
Stamp:

                              ’
                           









(7)


Chapter 20 is replaced by the following:

                                 ‘CHAPTER 20

Model declaration


Declaration for the import from third countries and for the transit through (2) the European Union of intermediate products to be used for the manufacture of medicinal products, veterinary medicinal products, medical devices for medical and veterinary purposes, active implantable medical devices, in vitro diagnostics medical devices for medical and veterinary purposes, laboratory reagents and cosmetic products




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COUNTRY:
Veterinary certificate to EU
Part I : Details of dispatched consignment
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the load in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8. Region of origin
Code
I.9. Country of destination
ISO code
I.10. Region of destination
Code
I.11. Place of origin
Name Approval number
Address
Name Approval number
Address
Name Approval number
Address
I.12. Place of destination
Custom warehouse
Name Approval number
Address
Postcode
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane Ship Railway wagon
Road vehicle Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17.
I.18. Description of commodity
I.19. Commodity code (HS code)
I.20. Quantity
I.21. Temperature of product
Ambient Chilled Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging




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I.25. Commodities certified for:
Technical use
I.26. For transit through EU to third country
Third country ISO code
I.27. For import or admission into EU
I.28. Identification of the commodities
Approval number of establishments
Species(Scientific name)
Manufacturing plant
Net weight
Batch number




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COUNTRY
Intermediate products to be used for the manufacture of medicinal products, veterinary medicinal products, medical devices for medical and veterinary purposes, active implantable medical devices, in vitro diagnostics medical devices for medical and veterinary purposes, laboratory reagents, and cosmetic products
II. Health information
II.a. Certificate reference No
II.b.
DECLARATION
I, the undersigned, declare that the intermediate product referred to above is intended to be imported by me into or to be transited through the European Union and satisfies the definition of an intermediate product provided for in point 35 of Annex I to Commission Regulation (EU) No 142/2011 (1a), and in particular that:
(1) it is intended for the manufacture of:
(2) either [- medicinal products,]
(2) and/or [- veterinary medicinal products,]
(2) and/or [- medical devices for medical and veterinary purposes,]
(2) and/or [- active implantable medical devices,]
(2) and/or [- in vitro diagnostic medical devices for medical and veterinary purposes,]
(2) and/or [- laboratory reagents,]
(2) and/or [- cosmetic products;]
(2) its design, transformation and manufacturing stages have been sufficiently completed in order to qualify the material directly or as a component of a product intended for that purpose, except for the fact that it requires further manufacturing or transformation such as mixing, coating, assembling or packaging to make it suitable for placing on the market or putting into service as a medicinal product, veterinary medicinal product, medical device for medical and veterinary purposes, an active implantable medical devices, an in vitro diagnostic medical device for medical and veterinary purposes or a cosmetic product in accordance with the European Union legislation (1b) applicable to those products or as a laboratory reagent;
(3) it has been derived from:
(2) either [- material which may have originated from animals submitted to an illegal treatment as defined in Article 1(2)(d) of Council Directive 96/22/EC (2a) or in Article 2(b) of Council Directive 96/23/EC (2b);]
(2) and/or [- carcases and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed, and which are fit for human consumption in accordance with Union legislation, but are not intended for human consumption for commercial reasons;]
(2) and/or [- carcases and the following parts originating either from animals that have been slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human consumption in accordance with Union legislation:
(i) carcases or bodies and parts of animals which are rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of disease communicable to humans or animals;
(ii) heads of poultry;
(iii) hides and skins, including trimmings and splitting thereof, horns and feet, including the phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones, of animals other than ruminants;
(iv) pig bristles;
(v) feathers;]
Part II: Certification




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COUNTRY
Intermediate products to be used for the manufacture of medicinal products, veterinary medicinal products, medical devices for medical and veterinary purposes, active implantable medical devices, in vitro diagnostics medical devices for medical and veterinary purposes, laboratory reagents, and cosmetic products
II. Health information
II.a. Certificate reference No
II.b.
(2) and/or [- blood of animals which did not show any signs of disease communicable through blood to humans or animals obtained from animals other than ruminants that have been slaughtered in a slaughterhouse after having been considered fit for slaughter for human consumption following an ante-mortem inspection in accordance with Union legislation;]
(2) and/or [- animal by-products arising from the production of products intended for human consumption, including degreased bone, greaves and centrifuge or separator sludge from milk processing;]
(2) and/or [- products of animal origin, or foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise;]
(2) and/or [- petfood and feedingstuffs of animal origin, or feedingstuffs containing animal by-products or derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arises;]
(2) and/or [- blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live animals that did not show signs of any disease communicable through that product to humans or animals;]
(2) and/or [- aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of diseases communicable to humans or animals;]
(2) and/or [- animal by-products from aquatic animals originating from plants or establishments manufacturing products for human consumption;]
(2) and/or [- the following material originating from animals which did not show any signs of disease communicable through that material to humans or animals:
(i) shells from shellfish with soft tissue or flesh;
(ii) the following originating from terrestrial animals:
— hatchery by-products,
— eggs,
— egg by-products, including egg shells;
(iii) day-old chicks killed for commercial reasons;]
(2) and/or [- animal by-products from aquatic or terrestrial invertebrates other than species pathogenic to humans or animals;]
(2) and/or [- animals and parts thereof of the zoological orders of Rodentia and Lagomorpha, except Category 1 material as referred to in Article 8(a)(iii), (iv) and (v) and Category 2 material as referred to in Article 9(a) to (g) of Regulation (EC) No 1069/2009;]
(2) and/or [- products derived from or generated by:
— aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of disease communicable to humans or animals,
— aquatic or terrestrial invertebrates other than species pathogenic to humans or animals,
— animals and parts thereof of the zoological orders of Rodentia and Lagomorpha, except Category 1 material as referred to in Article 8(a)(iii), (iv) and (v) and Category 2 material as referred to in Article 9(a) to (g) of Regulation (EC) No 1069/2009;]




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COUNTRY
Intermediate products to be used for the manufacture of medicinal products, veterinary medicinal products, medical devices for medical and veterinary purposes, active implantable medical devices, in vitro diagnostics medical devices for medical and veterinary purposes, laboratory reagents, and cosmetic products
II. Health information
II.a. Certificate reference No
II.b.
(2) and/or [- animals and parts of animals, other than those referred to in Article 8 or Article 10 of Regulation (EC) No 1069/2009,
(i) that died other than by being slaughtered or killed for human consumption, including animals killed for disease control purposes;
(ii) foetuses;
(iii) oocytes, embryos and semen which are not destined for breeding purposes; and
(iv) dead-in-shell poultry;]
(2) and/or [- animal by-products other than Category 1 material or Category 3 material;]
(4) its outer packaging is labelled ‘FOR MEDICINAL PRODUCTS / VETERINARY MEDICINAL PRODUCTS / MEDICAL DEVICES FOR MEDICAL AND VETERINARY PURPOSES / ACTIVE IMPLANTABLE MEDICAL DEVICES / IN VITRO DIAGNOSTIC MEDICAL DEVICES FOR MEDICAL AND VETERINARY PURPOSES / LABORATORY REAGENTS / COSMETIC PRODUCTS ONLY’ and it is not intended to be diverted at any stage within the European Union for any other use;
(5) the consignment will be transported directly to the place of destination in the European Union as indicated underpoint I.12 of this declaration, that is:
(2) either [an establishment or plant for the production of medicinal products, veterinary medicinal products, medical devices for medical and veterinary purposes, active implantable medical devices, in vitro diagnostic medical devices for medical and veterinary purposes, laboratory reagents or cosmetic products, which has been registered in accordance with Article 23 of Regulation (EC) No 1069/2009],
(2) or [an establishment or plant which has been approved in accordance with Article 24(1)(i) of Regulation (EC) No 1069/2009, from where they may only be dispatched to an establishment or plant referred to in the preceding indent of this point.]
Notes
— Box reference I.19: use appropriate Harmonised System (HS) code in accordance with Commission Decision 2007/275/EC of 17 April 2007 concerning lists of animals and products to be subject to controls at border inspection posts in accordance with Council Directives 91/496/EEC and 97/78/EC (OJ L 116, 4.5.2007, p.9)
— Box reference I.25: technical use: any use other than for animal consumption.
(1a) OJ L 54, 26.2.2011, p. 1.
(1b) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1), Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1) and Directive 98/79/EC of the European Parliament and the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1), Regulation (EC) No 1223/2009 of the European Parliament and of the Council of30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59), as appropriate.
(2) Delete as appropriate.
(2a) OJ L 125, 23.5.1996, p. 3.
(2b) OJ L 125, 23.5.1996, p. 10.
The importer
Name (in capital letters): Address:
Date: Signature:

                              ’.