EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX   
SANCO/7125/2011 
[…](2012) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
amending Regulation (EU) No 28/2012 laying  down requirements fo r the certification 
for imports into and transit through the Union of certain composite products 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
amending Regulation (EU) No 28/2012 laying down requirem ents for the certification 
for imports into and transit through the Union of certain composite products 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Council Directive 2002/99/ EC of 16 December 2002 laying down the 
animal health rules governi ng the production, processing, di stribution and introduction of 
products of animal origin for human consumption
1 , and in particular Ar ticle 8(5) and Article 
9 (2) and 4(b) thereof, 
Whereas:  (1) Regulation (EU) No 28/2012 lays down down requirements for the certification for 
imports into and transit through the Union of certain composite products 
(2) Egg products represent an animal health risk and animal hea lth guarantees are 
requested upon import into and transit thr ough the EU of such products. The same 
guarantees should apply to egg products wh en used in the processing of composite 
products. 
(3) Meat products and milk products  of  EU origin that are used in the processing of 
composite products in third countries and whic h are intended to be re-exported to  the 
EU after such processing do not represen t any animal health risk for the EU. 
(4) It is therefore appropriate to allow the use of such products for the processing of 
composite products.  
(5) The certificates for import and transit of composite products laid down in Regulation 
(EU) No 28/2012 should be amended accordingly. 
(6) To avoid any disruption of trade, the use of  certificates issued in accordance with 
Decision 2007/275/EC prior to the date of ap plication of this Re gulation should be 
authorised for a transitional period.  
                                                
 
1 OJ L 18, 23.1.2003, p. 11.  
EN 3   EN (7) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Regulation (EU) No 28/2012 is amended as follows:  
Annex I and II are replaced by th e Annexes to this Regulation. 
Article 2 
Ttransitional period  
Without prejudice to the transitional peri od defined in Regulation (EU) No 28/2012, 
consignments of certain compos ite products for which the releva nt health certificates have 
been issued in accordance with Regulation (EU) No 28/2012 before the entry into force of this 
Regulation may continue to be introduced into the Union until 1st January 2013. 
Article 3 
Entry into force and application 
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,  
 For the Commission 
 José Manuel BARROSO  The President  
EN 4   EN  ANNEX I  
Model Health Certificate for import into the European Union of composite products 
intended for human consumption 
COUNTRY:  Veterinary certificate to EU  
I.2. Certificate reference No I.2.a. 
I.3. Central competent authority I.1. Consignor 
 Name 
 Address 
 
 Tel. I.4. Local competent authority 
I.5. Consignee 
 Name 
 Address  
 Postcode 
 Tel. I.6. 
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 
 Name Approval number  Address 
 Name Approval number 
 Address I.12.  Part I : Details of di spatched consignment 
I.13. Place of loading I. 14. Date of departure 
I.16. Entry BIP in EU 
   I.15. Means of transport 
 
 Aeroplane  Ship  Railway wagon  
 Road vehicle  Other  
 Identification  Documentation references I.17.  
 I.19. Commodity code (HS code) 
  I.18. Description of commodity 
 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 
  Manufacturing plant Number of packages Natu re of commodity Net weight Batch number 
       
  
EN 5   EN  COUNTRY Composite products intended for human consumption  
 II. Health information II.a. Certificate reference No II.b. 
 Part II: Certification 
 
 
 
  I, the undersigned official veterinarian/official inspector hereby certify that  
 II.1  I am aware of the relevant provisions of  Regulations (EC) 178/2002,  (EC) No 852/2004 and 
(EC) No 853/2004, in particular Article 6.1(b) on  the origin of the products of animal origin 
used in the production of the composite produc ts described above and certify that the 
composite products described above were produced  in accordance with those requirements, in 
particular that they come from (an) establis hment(s) implementing a programme based on the 
HACCP principles in ac cordance with Regulation (EC) No 852/2004; 
I II.2 the composite products de scribed above contain : 
(1)either  [II.2.A Meat products, treated stomachs, bladders and intestines(2) in any quantity which meet the 
animal health requirements in Commission Decision 2007/777/EC and contain the following 
meat constituents which meet the criteria indicated below: 
Species (A) Treatment (B) Origin (C) Approved Establishment(s) (D) 
   
(A) Insert the code for the relevant species of  meat product, treated stomachs, bladders and 
intestines where BOV = domestic bovine anim als (Bos taurus, Bison bison, Bubalus 
bubalis and their crossbreds); OVI = domestic  sheep (Ovis aries) and goats (Capra 
hircus); EQI = domestic equine animals (E quus caballus, Equus  asinus and their 
crossbreds), POR = domestic porcine animal s (Sus scrofa); RM  = domestic rabbits, 
PFG = domestic poultry and farmed feathere d game, RUF farmed non-domestic animals 
other than suidae and solipeds; RUW = wild non-domestic animals other than suidae and 
solipeds; SUW = wild non-domestic suid ae: EQW = wild non-domestic solipeds, 
WL = wild lagomorphs, WGB = wild game birds.  
(B) Insert A, B, C, D, E or F for the required treatment as specified and defined in Parts 2, 3 
and 4 of Annex II to Decision 2007/777/EC.  
(C) Insert the ISO code of the country of or igin of the meat product, treated stomachs, 
bladders and intestines as listed in Annex II, Part 2 to Decision 2007/777/EC and, in the 
case of regionalization by Union legislation for the relevant meat constituents, the region 
as indicated in Part 1 of Annex II to Deci sion 2007/777/EC. The country of origin of the 
meat products must be the same as the country  of export in box 1.7 or a Member State of 
the EU. 
(D) Insert EU approval number of  the establishments of origin of the meat products, treated 
stomachs, bladders and intestines c ontained in the composite product.  
(E) If containing material from bovine, ovine or  caprine animals, th e fresh meat and/or 
intestines used in the preparat ion of the meat products and/or  treated intestines shall be 
subject to the following conditions depending on the BSE risk category of the country of 
origin: 
(1) (E.1) for imports from a country or a region with a negligible BSE risk as listed in 
Annex to Commission Decision  2007/453/EC as amended: 
(1) the country or region is classified  in accordance with Article 5(2) of 
Regulation (EC) No 999/2001 as a country  or region posing a negligible BSE 
risk; 
(2) the animals from which the products of bovine, ovine and caprine animal 
origin were derived were born, conti nuously reared and slaughtered in the 
country with negligible BSE risk a nd passed ante-mortem and post-mortem 
inspections; 
(1) (3) if in the country or region there have been BSE indigenous cases:  
(1) (a) the animals were born after the date from which the ban on the feeding 
of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced, or 
(1) (b) the products of bovine, ovine and cap rine animal origin do not contain 
and are not derived from specified risk  material as defined in Annex V 
to Regulation (EC) No 999/2001, or  mechanically separated meat 
obtained from bones of bovine, ovine or caprine animals.  
EN 6   EN  COUNTRY Composite products intended for human consumption  
 II. Health information II.a. Certificate reference No II.b. 
(1) (E.2) for imports from a country or a region with a controlled BSE risk as listed in 
Annex to Commission Decision  2007/453/EC as amended: 
(1) the country or region is classified  in accordance with Article 5(2) of 
Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk; 
(2) the animals from which the products of bovine, ovine and caprine animal 
origin were derived passed ante-m ortem and post-mortem inspections; 
(3) animals from which the products of bovi ne, ovine and caprine animal origin 
destined for export were derived have  not been slaughtered after stunning by 
means of gas injected into the cranial cavity or killed by the same method or 
slaughtered by laceration after stunning of central nervous tissue by means of 
an elongated rod-shaped instrument introduced into the cranial cavity; 
(1)(3) (4) the products of bovine, ovine and caprine animal origin do not contain and 
are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mech anically separate d meat obtained 
from bones of bovine, ovine  or caprine animals. 
(1)(4) (5) in the case of intestines originally  sourced from a country or a region with a 
negligible BSE risk, imports of treated  intestines shall be subject to the 
following conditions: 
(a) the country or region is classified in accordance with Article 5(2) of 
Regulation (EC) No 999/2001 as a country or region posing a controlled 
BSE risk; 
(b) the animals from which the products of bovine, ovine and caprine 
animal origin were derived were born, continuously reared and 
slaughtered in the country or region with a negligible BSE risk and 
passed ante-mortem and pos t-mortem inspections; 
(1) (c) if the intestines are sourced from a country or region where there have 
been BSE indigenous cases: 
(1) (i) the animals were born after the date from which the ban on the 
feeding of ruminants with meat-a nd-bone meal and greaves derived 
from ruminants had been enforced; or 
(1) (ii) the products of bovine, ovine and caprine animal origin do not 
contain and are not derived from speci fied risk material as defined 
in Annex V to Regulation (EC) No 999/2001.  
(1) (E.3) for imports from a country or a region w ith an undetermined BSE risk as listed in 
Annex to Commission Decision 2007/453/EC: 
(1) the animals from which the products of bovine, ovine and caprine animal 
origin were derived have not been fed meat-and-bone meal or greaves derived from ruminant s and passed ante-mortem and post-mortem 
inspections; 
(2) the animals from which the products of bovine, ovine and caprine animal 
origin were derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered 
by laceration after stunning of central nervous tissue by means of an 
elongated rod-shaped instrument in troduced into the cranial cavity; 
(1)(5) (3) the products of bovine, ovine and caprine animal origin are not derived from: 
(i) specified risk material as defi ned in Annex V to Regulation (EC) 
No 999/2001;  
(ii) nervous and lymphatic tissues exposed during the deboning process; 
(iii) mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals.  
(1)(4) (4) in the case of intestines originally  sourced from a country or a region with a 
negligible BSE risk, imports of treated  intestines shall be subject to the 
following conditions: 
(a) the country or region is classified in accordance with Article 5(2) of  
EN 7   EN  COUNTRY Composite products intended for human consumption  
 II. Health information II.a. Certificate reference No II.b. 
Regulation (EC) No 999/2001 as a country or region posing an 
undetermined BSE risk; 
(b) the animals from which the products of bovine, ovine and caprine 
animal origin were derived were born, continuously reared and 
slaughtered in the country or region with a negligible BSE risk and 
passed ante-mortem and pos t-mortem inspections; 
(1) (c) if the intestines are sourced from a country or region where there have 
been BSE indigenous cases: 
(1) (i) the animals were born after the date from which the ban on the 
feeding of ruminants with meat-a nd-bone meal and greaves derived 
from ruminants had been enforced; or 
(1) (ii) the products of bovine, ovine and caprine animal origin do not 
contain and are not derived from speci fied risk material as defined 
in Annex V to Regulation (EC) No 999/2001.] 
(1)and/or  [II.2.B Processed dairy products(6) in an amount of half or more of the substance of the composite 
product or not shelf stable dairy products in any quantity that  
(a) have been produced in the EU  or in the establishment ………………………………….. 
(approval number of the establishm ents of origin of the dair y products contained in the 
composite product authorised at  the time of production for export of dairy products to 
the EU. The country of origin of the dairy pr oducts must be the same as the country of 
export in box 1.7 or a Member State of the EU)  
 The country of origin indicated in box I.7 mu st be listed in Annex I to Regulation (EU) 
No 605/2010 and the treatment applied is confor m to the treatment provided for in that 
list for the relevant country. 
(b) have been produced from milk obtained from  animals : 
(i) under the control of the o fficial veterinary service, 
(ii) belonging to holdings which were no t under restrictions due to foot-and-mouth 
disease or rinderpest, and,  
(iii) subject to regular veterinary inspections to  ensure that they satisfy the animal health 
conditions laid down in Chapter I of Secti on IX of Annex III to Regulation (EC) No 
853/2004 and in Directive 2002/99/EC, 
(c) are dairy products made from raw milk obtained from  
(1) either [cows, ewes, goats or buffaloes and prior to import into the territory of the 
European Union have undergone or been produced from raw milk which has 
undergone 
(1) either [a pasteurisation treatment involvi ng a single heat treatment with a 
heating effect at least equivalent to that achieved by a pasteurisation 
process of at least 72°C for at 15 seconds and where applicable, 
sufficient to ensure a negative r eaction to an alkaline phosphatase 
test applied immediately after the heat treatment] 
(1) or [a sterilisation process, to achieve an F 0 value equal to or greater 
than three;] 
(1) or [an ultra high temperature (UHT) tr eatment at not less than 135°C in 
combination with a suitable holding time;] 
(1) or [a high temperature short time past eurisation treatment (HTST) at 
72°C for 15 seconds, or a treatment w ith an equivalent pasteurisation 
effect, applied to milk with a pH  lower than 7.0 achieving, where 
applicable, a negative reaction to  a alkaline phosphatase test 
(1) or [a high temperature short time past eurisation treatment (HTST) at 
72°C for 15 seconds, or a treatment w ith an equivalent pasteurisation 
effect, applied twice to milk with a pH equal to or greater than 7.0 
achieving, where applicable, a negative reaction to a alkaline 
phosphatase test, immedi ately followed by  
(1) either [lowering the pH below 6 for one hour;]  
EN 8   EN  COUNTRY Composite products intended for human consumption  
 II. Health information II.a. Certificate reference No II.b. 
(1) or [additional heating equal to or greater than 72°C , combined 
with desiccation;]] 
(1) or [animals other than cows, ewes, goats or  buffaloes and prior to import into the 
territory of the European Union have undergone or been produced from raw milk which has undergone  
(1) either [a sterilisation process, to achieve an F 0 value equal to or greater 
than three;] 
(1) or [an ultra high temperature (UHT) tr eatment at not less than 135°C in 
combination with a suitable holding time;]] 
(d) were produced on …………………………. or between ……………………………… 
and ……………………………...(7).] 
(1)and/or  [II.2.C Processed fishery products that originate from the approved establishment 
N°(8)………situated in the country(9) ……………] 
(1)and/or  [II.2.D Processe d egg products that originate from the approved country(9)…….. ] 
were produced from eggs coming from an establishment which at the date of issue of the certificate is 
free from highly pathogenic avian influenza as defined in Regulation (EC) No 798/2008 and  
 either  
 (1)II.2.D.1 [within a 10km radius of which, incl uding, where appropriate, the territory of a 
neighbouring country, there has been no outbreak of highly pathogenic avian 
influenza or Newcastle disease for at least the previous 30 days.] 
 or 
  (1)II.2.D.2 [the egg produ cts were processed: 
 (1)either [liquid egg white was treated: 
  (1)either  [with 55.6 °C for 870 seconds.]  
  (1)or [with 56.7 °C for 232 seconds.]  
 (1)or [10% salted yolk was treated with 62.2°C for 138 seconds.] 
 (1)or [dried egg white was treated: 
  (1)either [with 67 °C for 20 hours.]  
  (1)or [with 54.4 °C for 513 hours.] 
 (1)or [whole eggs were at least treated: 
  (1) either [with 60°C for 188 seconds.] 
  (1)or [completely cooked.]  
 [whole egg blends were at least treated]: 
  (1)either [with 60 °C for 188 seconds.]  
  (1)or [with 61.1°C for 94 seconds.] 
 
Notes 
Part I : 
● Box reference I.7: Insert the ISO code of the count ry of origin of the com posite product c ontaining meat 
product, treated stomachs, bladders and intestines as listed in Anne x II, Part 2 to Decision 2007/777/EC 
and/or for processed dairy products in Annex I to  Commission Regulation (EU) No 605/2010 and/or for 
processed fishery products in Annex I and II to Commission Decision 2006/766/E C and/or for processed 
egg products in Annex I part 1 to Commission Regulation (EC) No 798/2008. 
● Box reference I.11: Name, address and registration/approval number if av ailable of the establishments of 
production of the composite product(s). Name of the c ountry of origin which must be the same as the 
country of origin in box 1.7. 
● 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 info rm the border inspection post of introduction into the  
EN 9   EN  COUNTRY Composite products intended for human consumption  
 II. Health information II.a. Certificate reference No II.b. 
European Union. 
● Box reference I.19: Use the appropriate Harmoni sed System (HS) code of the World Customs 
Organisation: codes of the following headings: 16.01; 16.02; 16.03; 16.04; 16 .05; 19.01; 19.02; 19.05; 
20.04; 20.05; 21.03; 21.04; 21.05; 21.06. 
● Box reference I.20: Indicate total gross weight and total net weight. 
● Box reference I.23: for containers or boxes, the cont ainer number and the seal number (if applicable) must 
be included. 
● Box reference I.28: manufacturing plant: insert the name and approval number if available of the 
establishments of production of th e composite product(s). Nature of commodity: in case of composite 
products containing meat pr oducts, treated stomachs, bladders a nd intestines indicate 'meat product', 
'treated stomachs', 'bladders' or 'intestines'. In case of composite product containi ng dairy products indicate 
'dairy product'. In case of composite product cont aining processed fishery products specify whether 
aquaculture or wild origin. In ca se of composite product containing e gg products specify the egg content 
percentage.  
Part II: 
(1) Keep as appropriate. 
(2) Meat products as laid down in point 7.1 of Annex I to Regulation (EC) No 853/2004 and treated stomachs, 
bladders and intestines as laid down in point 7. 9 of Annex I to Regulation (EC) No 853/2004 that have 
undergone one of the treatments laid down in Annex II part 4 to Decision 2007/777/EC.  
(3) By way of derogation from point 4, carcasses, half car casses or half carcasses cut into no more than three 
wholesale cuts, and quarters containing no specified risk material other than the vertebral column, 
including dorsal root ganglia, may be imported.  
 When removal of the vertebral column is not requir ed, carcasses or wholesale cuts of carcasses of bovine 
animals containing vertebral column shall be identifie d by a blue stripe on the label referred to in 
Regulation (EC) No 1760/2000. 
 The number of bovine carcasses or wholesale cuts of carcasses, from which removal of the vertebral 
column is required as well as the number where remova l of the vertebral column is not required shall be 
added to the document referred to in Article 2 (1 ) of Regulation (EC) No 136/2004 in case of imports. 
(4) Only applicable to imports of treated intestines. 
(5) By way of derogation from point 3, carcasses, half car casses or half carcasses cut into no more than three 
wholesale cuts, and quarters containing no specified risk material other than the vertebral column, 
including dorsal root ganglia, may be imported . 
 When removal of the vertebral column is not requir ed, carcasses or wholesale cuts of carcasses of bovine 
animals containing vertebral column shall be identified by a clearly visible blue stripe on the label referred 
to in Regulation (EC) No 1760/2000. 
 Specific information on the number of bovine carca sses or wholesale cuts of carcasses, from which 
removal of the vertebral column is required and from which removal of the vertebral column is not 
required shall be added to the docume nt referred to in Article 2 (1) of  Regulation (EC) No 136/2004 in case 
of imports. 
(6) Raw milk and dairy products means, raw milk and da iry products for human consumption as defined in in 
point 7.2 of Annex I to Regulation (EC) No 853/2004. 
(7) Date or dates of production. Imports of raw milk a nd dairy products shall not be allowed when obtained 
either prior to the date of authorisation for exportati on 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 and dairy products from this third country or part thereof. 
(8) Number of the fishery product establis hment authorised to export to the EU. 
(9) Country of origin authorised to export to the EU. 
(10) In case of composite products  containing only egg or fishery products the signature of an official Inspector 
can be accepted. 
● The colour of the signature shall be different to that of the printing. Th e same rule applie s to stamps other 
than those embossed or watermark.   
EN 10   EN  COUNTRY Composite products intended for human consumption  
 II. Health information II.a. Certificate reference No II.b. 
 Official veterinari an/Official inspector(10) 
 Name (in capital letters): Qualification and title: 
 Date: Signature:  Stamp: 
  
EN 11   EN ANNEX II  
Model Health Certificate for transit through or storage in the European Union of 
composite products intended for human consumption 
COUNTRY:  Veterinary certificate to EU  
I.2. Certificate reference No I.2.a. 
I.3. Central competent authority I.1. Consignor 
 Name 
 Address 
 
 Tel. 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.  
I.11. Place of origin 
 
 Name Approval number 
 Address 
 Name Approval number  Address 
 Name Approval number 
 Address I.12. Place of destination 
 
 Custom warehouse  Ship supplier  
 Name Approval number 
 Address 
  Postcode Part I : Details of di spatched consignment 
I.13. Place of loading I. 14. Date of departure 
I.16. Entry BIP in EU 
   I.15. Means of transport 
 
 Aeroplane  Ship  Railway wagon  
 Road vehicle  Other  
 Identification  Documentation references I.17.  
 I.19. Commodity code (HS code) 
  I.18. Description of commodity 
 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 third country  
 
 Third country ISO code  I.27.  
 I.28. Identification of the commodities 
  Manufacturing plant Number of packages Natu re of commodity Net weight Batch number 
       
  
EN 12   EN  COUNTRY Composite products in tended for human consumption 
 Transit/Storage 
 II. Health information II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
  I, the undersigned official veteri narian/official inspector hereby certify that the composite products 
described above contain : 
(1)either  [II.1.A Meat products, treated stom achs, bladders and intestines(2) in any quantity and such meat 
products, treated stomachs, bladders and in testines have been produced according to 
Commission Decision 2007/777/EC and contain the following meat constitu ents and meet the 
criteria indicated below: 
 Species (A) Treatment (B) Origin (C) 
    (A) Insert the code for the relevant species of m eat product, treated stomachs,  bladders and intestines 
where BOV = domestic bovine animals (Bos ta urus, Bison bison, Bubalus bubalis and their 
crossbreds); OVI = domestic sheep (Ovis aries) a nd goats (Capra hircus); EQI = domestic equine 
animals (Equus caballus, Equus as inus and their crossbreds), POR = domestic porcine animals 
(Sus scrofa); RM = domestic ra bbits, PFG = domestic poultry a nd farmed feathered game, RUF 
farmed non-domestic animals other than suidae and solipeds; RUW = wild non-domestic animals 
other than suidae and solipeds; SUW = wild  non-domestic suidae: EQW = wild non-domestic 
solipeds, WL = wild lagomorphs , WGB = wild game birds. 
 (B) Insert A, B, C, D, E or F for the required treat ment as specified and define d in Parts 2, 3 and 4 of 
Annex II to Decision 2007/777/EC. 
 (C) Insert the ISO code of the country of origin of the meat product, treated  stomachs, bladders and 
intestines as listed in Annex II, Part 2 to Decision 2007/777/EC and, in the case of 
regionalization by Union legislation for the relevant  meat constituents, the region as indicated in 
Part 1 of Annex II to Decision 2007/777/EC. The coun try of origin of the meat products must be 
the same as the country of export in box 1.7 or a Member State of the EU. 
(1)and/or  [II.1.B Processed dairy products(3) in an amount of half or more of the s ubstance of the composite 
product or not shelf stable dairy products in any quantity that  
 (a) originate in the EU or in the country i ndicated in box I.7 which is listed in Annex I to 
Regulation (EU) No 605/2010 and the treatmen t applied is conform to the treatment 
provided for in that list for the relevant c ountry. The country of origin of the dairy 
products must be the same as the country of export in box 1.7 or a Member State of the 
EU; 
 (b) have been produced from milk obtained from animals: 
 (i) under the control of the o fficial veterinary service, 
 (ii) belonging to holdings which were no t under restrictions due to foot-and-mouth 
disease or rinderpest, and,  
 (iii) subject to regular veterinary inspections to ensure that they satisfy the animal health 
conditions laid down in Chapter I of Secti on IX of Annex III to Regulation (EC) No 
853/2004 and in Directive 2002/99/EC, 
 (c) are dairy products made from raw milk obtained from  
 (1) either  [cows, ewes, goats or buffaloes and pr ior to import into the territory of the 
European Union have undergone or been produced from raw milk which has 
undergone 
  (1) either  [a pasteurisation treatment involv ing a single heat treatment with 
a heating effect at least equivalent to that achieved by a 
pasteurisation process of at l east 72°C for at 15 seconds and 
where applicable, sufficient to ensure a negative reaction to an 
alkaline phosphatase test applie d immediately after the heat 
treatment] 
  (1) or [a sterilisation process, to achieve an F0 value equal to or greater 
than three;] 
  (1) or [an ultra high temperature (UHT) treatment at not less than 
135°C in combination with a suitable holding time;] 
  (1) or [a high temperature short time pa steurisation treatment (HTST) at  
EN 13   EN  COUNTRY Composite products in tended for human consumption 
 Transit/Storage 
 II. Health information II.a. Certificate reference number II.b. 
72°C for 15 seconds, or a trea tment with an equivalent 
pasteurisation effect, applied to milk with a pH lower than 7.0 
achieving, where applicable, a negative reaction to a alkaline 
phosphatase test]; 
  (1) or [a high temperature short time pa steurisation treatment (HTST) at 
72°C for 15 seconds, or a trea tment with an equivalent 
pasteurisation effect, applied twice to milk with a pH equal to or 
greater than 7.0 achieving, where applicable, a negative reaction 
to a alkaline phosphatase test , immediately followed by  
  (1) either  [lowering the pH below 6 for one hour;] 
 (1) or [additional heating equal to or greater than 72 °C, 
combined with desiccation;]] 
 (1) or [animals other than cows, ewes, goats or buffaloes and prior to import into 
the territory of the European Union have undergone or been produced from 
raw milk which has undergone 
  (1) either  [a sterilisation process, to achieve an F0 value equal to or greater 
than three;] 
  (1) or [an ultra high temperature (UHT) treatment at not less than 
135°C in combination with a suitable holding time;]] 
 (d) were produced on …………………………. or between ……………………………… 
and ……………………………...  (4).] 
and/or           II.1.C Processed egg products that originate from the approved country(5) 
 Were produced from eggs coming from an estab lishment which at the date of issue of the 
certificate is free from highly pathogenic avian influenza as de fined in Regulation (EC) No 
798/2008 and  
 either  
 (1)II.1.C.1 [within a 10km radius of which, incl uding, where appropriate, the territory of a 
neighbouring country, there has been no outbreak of highly pathogenic avian influenza or Newcastle disease for at least the previous 30 days.] 
 or 
  (1)II.1.C.2 [the egg produ cts were processed: 
 (1)either [liquid egg white was treated: 
  (1)either  [with 55.6 °C for 870 seconds.]  
  (1)or [with 56.7 °C for 232 seconds.]  
 (1)or [10% salted yolk was treated with 62.2°C for 138 seconds.] 
 (1)or [dried egg white was treated: 
  (1)either [with 67 °C for 20 hours.]  
  (1)or [with 54.4 °C for 513 hours.] 
 (1)or [whole eggs were at least treated: 
  (1) either [with 60°C for 188 seconds.] 
  (1)or [completely cooked.]  
 [whole egg blends were at least treated]: 
  (1)either [with 60 °C for 188 seconds.]  
  (1)or [with 61.1°C for 94 seconds.] 
 
Notes 
Part I : 
● Box reference I.7: Insert the ISO code of the count ry of origin of the meat product, treated stomachs, 
bladders and intestines as listed in Annex II, Part 2 to Decision 2007/ 777/EC and/or for processed dairy 
product in Annex I to Commission Regulation (EU) No 605/2010.  
EN 14   EN  COUNTRY Composite products in tended for human consumption 
 Transit/Storage 
 II. Health information II.a. Certificate reference number II.b. 
● Box reference I.11: Name, address of  the establishments of  production of the composite product(s). Name 
of the country of origin which must be the same as the country of origin in box 1.7; 
 Approval number is not applicable.  
● Box reference I.15: Registration number (railway wagons or container a nd 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 Harmoni sed System (HS) code of the World Customs 
Organisation: codes of the following headings: 16.01; 16.02; 16.03; 16.04; 16 .05; 19.01; 19.02; 19.05; 
20.04; 20.05; 21.03; 21.04; 21.05; 21.06. 
● Box reference I.20: Indicate total gross weight and total net weight. 
● Box reference I.23: for containers or boxes, the cont ainer number and the seal number (if applicable) must 
be included. 
● Box reference I.28: manufacturing plant: insert th e name and approval number if available of the 
establishments of production of th e composite product(s). Nature of commodity: in case of composite 
products containing meat pr oducts, treated stomachs, bladders a nd intestines indicate 'meat product', 
'treated stomachs', 'bladders' or 'intestines'. In case of composite product containi ng dairy products indicate 
'dairy product'.  
Part II: 
(1) Keep as appropriate. 
(2) Meat products as laid down in point 7.1 of Annex I to Regulation (EC) No 853/2004 and treated stomachs, 
bladders and intestines as laid down in point 7. 9 of Annex I to Regulation (EC) No 853/2004 that have 
undergone one of the treatments laid down in Annex II part 4 to Decision 2007/777/EC.  
(3) Raw milk and dairy products means, raw milk and da iry products for human consum ption as defined in in 
point 7.2 of Annex I to Regulation (EC) No 853/2004. 
(4) Date or dates of production. Imports of raw milk a nd dairy products shall not be allowed when obtained 
either prior to the date of authorisation for exportati on 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 and dairy products from this third country or part thereof. 
● The colour of the signature shall be different to that of the printing. The same ru le applies to stamps other 
than those embossed or watermark. 
 Official veterinarian / Official inspector  
 Name (in capital letters): Qualification and title:  Date: Signature: 
 Stamp: