(2)

Annex II is amended as follows: (a) Part 1 is replaced by the following: ‘PART 1 Models of health certificates “Milk-RM” : Health certificate for raw milk from third countries or parts thereof authorised in column A of Annex I intended for further processing in the European Union before being used for human consumption. “Milk-RMP” : Health certificate for dairy products derived from raw milk for human consumption, from third countries or parts thereof authorised in column A of Annex I intended for importation into the European Union. “Milk-HTB” : Health certificate for dairy products derived from milk of cows, ewes, goats and buffaloes for human consumption from third countries or parts thereof authorised in column B of Annex I intended for importation into the European Union. “Milk-HTC” : Health certificate for dairy products for human consumption from third countries or parts thereof authorised in column C of Annex I intended for importation into the European Union. “Colostrum-C/CPB” : Health certificate for colostrum of cows, ewes, goats and buffaloes and colostrum-based products derived from colostrum of the same species from third countries or parts thereof listed in column A of Annex I for human consumption intended for importation into the European Union. “Milk/ Colostrum-T/S” : Animal health certificate for raw milk, colostrum, dairy products or colostrum-based products for human consumption, intended for transit through or storage in the European Union. Explanatory notes (a) The health certificates shall be issued by the competent authorities of the third country of origin, in accordance with the appropriate model set out in Part 2 of this Annex, according to the layout of the model that corresponds to the raw milk, colostrum, dairy products or colostrum-based products concerned. They shall contain, in the numbered order that appears in the model, the attestations that are required for any third country and, as the case may be, those supplementary guarantees that are required for the exporting third country concerned. (b) The original of the health certificate shall consist of a single sheet printed on either pages or, where more text is required, such that all the sheets form a whole and cannot be separated. (c) A separate, single health certificate must be presented for each consignment of the commodity concerned, exported to the same destination from a third country listed in the table in Annex I and transported in the same railway wagon, road vehicle, aircraft or ship. (d) The original of the health certificate and the labels referred to in the model certificate shall be drawn up in at least one official language of the Member State where border inspection takes place and of the Member State of destination. However, those Member States may allow it to be drawn up in another official language of the European Union instead of their own, accompanied, if necessary, by an official translation. (e) Where additional sheets are attached to the health certificate for the purpose of identifying the commodities making up the consignment, such additional sheets shall also be considered to form part of the original certificate, provided the signature and stamp of the certifying official veterinarian appear on each page. (f) Where the health certificate comprises more than one page, each page shall be numbered “–x (page number) of y (total number of pages) –” on the bottom of the page and shall bear the certificate reference number allocated by the competent authority on the top of the page. (g) The original of the health certificate must be completed and signed by a representative of the competent authority responsible for verifying and certifying that the raw milk, colostrum, dairy products or colostrum-based products meet the health conditions laid down in Section IX of Chapter I of Annex III to Regulation (EC) No 853/2004 and in Directive 2002/99/EC. (h) The competent authorities of the exporting third country shall ensure that principles of certification equivalent to those laid down in Council Directive 96/93/EC ( 3 ) are complied with. (i) The colour of the signature of the official veterinarian shall be different from that of the printing on the health certificate. That requirement shall also apply to stamps other than embossed stamps or watermarks. (j) The original of the health certificate must accompany the consignment until it reaches the border inspection post of introduction into the European Union. (k) Where the model certificate states that certain statements shall be kept as appropriate, statements which are not relevant, may be crossed out and initialled and stamped by the certifying officer, or completely deleted from the certificate. (3) OJ L 13, 16.1.1997, p. 28.’" (b) in Part 2, the following model certificate is added: Text of image ‘Model Colostrum/Colostrum-based products- C/CBP Health Certificate for colostrum of cows, ewes, goats and buffaloes and colostrum- based products derived from colostrum of the same species from third countries or parts thereof listed in column A of Annex I for human consumption intended for importation into the European Union COUNTRY Veterinary certificate to EU 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. I.7. Country of origin ISO code I.8. I.9. Country of destination ISO code I.10. I.11. Place of origin Name Approval number Address I.12. I.13. Place of loading I.14. Date of departure I.15. Means of transport Aeroplane Ship Railway wagon Road vehicle Other Identification Documentary 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 I.25. Commodities certified for: Human consumption I.26. I.27. For import or admission into EU I.28. Identification of the commodities Species (Scientific name) Manufacturing plant Number of packages Net weight Batch number Part I: Details of dispatched consignment Text of image Part II: Certification COUNTRY Model Colostrum/Colostrum –Based Products C/CBP Colostrum and colostrum based products from third countries or parts thereof listed in column A of Annex I for human consumption intended for importation II. Health information II.a. Certificate reference number II.b. II.1 Animal Health Attestation I, the undersigned official veterinarian, declare that I am aware of the relevant provisions of Directive 2002/99/EC and of Regulation (EC) No 853/2004 and hereby certify that the colostrum /colostrum-based products (1) described in Part I: have been obtained or manufactured from colostrum obtained from animals: (i) under the control of the official veterinary service; (ii) which were in a third country or part thereof that has been free of foot-and-mouth disease and of rinderpest for a period of at least 12 months prior to the date of this certificate, and where vaccination against foot-and-mouth disease has not been carried out during that period; (iii) belonging to holdings which were not under restrictions due to foot-and-mouth disease or rinderpest, and (iv) subject to regular veterinary inspections to ensure that they satisfy the animal health conditions laid down in Chapter I of Section IX of Annex III to Regulation (EC) No 853/2004 and in Directive 2002/99/EC. II.2 Public Health Attestation I, the undersigned official inspector, declare that I am aware of the relevant provisions of Regulations (EC) No 178/2002, (EC) No 852/2004, (EC) No 853/2004 and (EC) No 854/2004 and hereby certify that the colostrum/colostrum-based products made with colostrum (1) described in Part I were produced in accordance with those provisions, and in particular that: (a) they were manufactured from colostrum: (i) which comes from holdings registered in accordance with Regulation (EC) No 852/2004 and checked in accordance with Annex IV to Regulation (EC) No 854/2004; (ii) which was produced, collected, cooled, stored and transported in accordance with the hygiene conditions laid down in Chapter I of Section IX of Annex III to Regulation (EC) No 853/2004; (iii) which complies with the guarantees on the residues status of colostrum provided by the monitoring plans for the detection of residues or substances submitted in accordance with Directive 96/23/EC, and in particular, Article 29 thereof; (iv) which, pursuant to testing for residues of antibacterial drugs carried out by the food business operator in accordance with the requirements of point 4 in Part III of Chapter I of Section IX of Annex III to Regulation (EC) No 853/2004, complies with the maximum residue limits for residues of antibacterial veterinary medicinal products laid down in the Annex to Regulation (EU) No 37/2010; (v) which has been produced under conditions guaranteeing compliance with the maximum residue levels for pesticides laid down in Regulation (EC) No 396/2005, and maximum levels for contaminants laid down in Regulation (EC) No 1881/2006; (b) they come from an establishment implementing a programme based on the HACCP principles in accordance with Regulation (EC) No 852/2004; (c) they have been processed, stored, wrapped, packaged and labeled in accordance with Chapters III and IV of Section IX of Annex III to Regulation (EC) No 853/2004; (d) they meet the relevant requirements laid down in Chapter II, Section IX of Annex III to Regulation (EC) N0 853/2004 and the relevant microbiological criteria laid down in Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs, and (e) the guarantees covering live animals and products thereof provided by the residue plans submitted in accordance with Directive 96/23/EC, and in particular Article 29 thereof are fulfilled. Text of image COUNTRY Model Colostrum/Colostrum –Based Products C/CBP Colostrum and colostrum based products from third countries or parts thereof listed in column A of Annex I for human consumption intended for importation II. Health information II.a. Certificate reference number II.b. Notes This certificate is intended for colostrum or colostrum–based products from third countries or parts thereof authorised in column A of Annex I to Regulation (EU) No 605/2010. Part I: Box reference I.7: Provide name and ISO code of the country or part thereof as appearing in Annex I to Commission Regulation (EU) No 605/2010 of 2 July 2010 laying down animal and public health and veterinary certification conditions for the introduction into the European Union of raw milk and dairy products intended for human consumption (OJ L 175, 10.7.2010, p. 1). Box reference I.11: Name, address and approval number of the establishment of dispatch. Box reference I.15: Registration number (railway wagons or container and road vehicle), flight number (aircraft) or name (ship). In case of unloading and reloading, the consignor must inform the border inspection post of introduction into the European Union. Box reference I.19: Use the appropriate Harmonised System (HS) code under the following headings: 04.01; 04.02; 04.03; 04.04; 04.05; 04.06; 04.10; 15.17; 17.02; 19.01; 21.05; 21.06; 22.02; 28.35; 30.01; 35.01; 35.02 or 35.04. Box reference I.20: Indicate total gross weight and total net weight. Box reference I.23: For containers or boxes, the container number and the seal number (if applicable) should be included. Box reference I.28: Manufacturing plant: introduce the approval number of the production holding(s), collection centre or standardization centre approved for exportation to the European Union. Part II: (1) Keep as appropriate. The colour of the signature shall be different to that of the printing. The same rule applies to stamps other than those embossed or watermark. Official veterinarian Name (in capital letters): Qualification and title: Date: Signature:’ Stamp: (c) Part 3, is replaced by the following: ‘PART 3 Text of image Model Milk/Colostrum-T/S Animal Health Certificate for raw milk, dairy products, colostrum and colostrum-based products for human consumption intended for transit through or storage in the European Union COUNTRY Veterinary certificate to EU 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 Postal code Tel. No I.7. Country of origin ISO code I.8. Region of origin Code I.9. Country of destination ISO code I.10. I.11. Place of origin Name Approval number Address I.12. Place of destination Customs warehouse Ship supplier Name Approval number Address Postal code I.13. Place of loading I.14. Date of departure I.15. Means of transport Aeroplane Ship Railway wagon Road vehicle Other Identification Documentary 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 I.25. Commodities certified for: Human consumption I.26. For transit through EU to 3rd Country 3rd country ISO code I.27. I.28. Identification of the commodities Species (Scientific name) Manufacturing plant Number of packages Net weight Batch number Part I: Details of dispatched consignment Text of image Part II: Certification COUNTRY Model Milk/Colostrum-T/S Raw milk, dairy products, colostrum and colostrum-based products for human consumption for transit or storage II. Health information II.a. Certificate reference number II.b. II.1 Animal Health Attestation I, the undersigned official veterinarian, hereby certify that the [raw milk] / [dairy products] / [colostrum] / [colostrum-based products] (1) (2) for [transit] / [storage] (2) in the European Union described in Part I: (a) come from a country or part thereof authorised for imports to the European Union of raw milk, dairy products, colostrum or colostrum-based products as laid down in Annex I to Regulation (EU) No 605/2010; (b) comply with the relevant animal health conditions for the products concerned as laid down in the animal health attestation in Part II.1 of the model health certificates [Milk-RM] / [Milk-RMP] / [Milk-HTB] / [Milk-HTC]/[Colostrum-C/CBP](2) in Part 2 of Annex II to Regulation (EU) No 605/2010; (c) was/were produced on … (3) or between … (3) and … (3). Notes Part I: Box reference I.7: Provide name and ISO code of the country or part thereof as appearing in Annex I to Commission Regulation (EU) No 605/2010 of 2 July 2010 laying down animal and public health and veterinary certification conditions for the introduction into the European Union of raw milk and dairy products intended for human consumption (OJ L 175, 10.7.2010, p. 1). Box reference I.11: Name, address and approval number of the establishment of dispatch. Name of the country of origin which must be the same as the country of export. Box reference I.15: Registration number (railway wagons or container and road vehicles), flight number (aircraft) or name (ship). In the case of transport in containers, the total number of containers and their registration number and where there is a serial number of the seal it must be indicated in box I.23. In case of unloading and reloading, the consignor must inform the border inspection post of introduction into the European Union. Box reference I.19: Use the appropriate Harmonised System (HS) code under the following headings: 04.01; 04.02; 04.03; 04.04; 04.05; 04.06; 15.17; 17.02; 19.01; 21.05; 21.06.; 22.02; 28.35; 30.01; 35.01; 35.02; 35.04 or 04.10. Box reference I.20: Indicate total gross weight and total net weight. Box reference I.23: For containers or boxes, the container number and the seal number (if applicable) should be included. Box reference I.28: Manufacturing plant: introduce the approval number of the production holding(s), collection centre or standardization centre approved for exportation to the European Union. Part II: (1) Raw milk, dairy products, colostrum and colostrum –based products means raw milk, dairy products, colostrum and colostrum-based products for human consumption in transit or storage in accordance with Article 12(4) or Article 13 of Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (OJ L 24, 30.1.1998, p. 9). (2) Keep as appropriate. (3) Date or dates of production. Imports of raw milk, dairy products, colostrum and colostrum-based products shall not be allowed when obtained either prior to the date of authorisation for exportation to the European Union of the third country or part thereof mentioned under I.7 and I.8, or during a period where restrictive measures have been adopted by the European Union against imports of raw milk, dairy products, colostrum and colostrum-based products from this third country or part thereof. The colour of the signature shall be different to that of the printing. The same rule applies to stamps other than those embossed or watermark. Text of image COUNTRY Model Milk/Colostrum-T/S Raw milk, dairy products, colostrum and colostrum-based products for human consumption for transit or storage II. Health information II.a. Certificate reference number II.b. Official veterinarian Name (in capital letters): Qualification and title: Date: Signature:’ Stamp: