EN    EN EN 
SANCO/10492/2010 Rev3 EN    EN  EUROPEAN COMMISSION  
Brussels, 
C(2010)  
Draft 
COMMISSION REGULATION 
of 
laying down requirements for the certificatio n for imports into and transit through the 
Union of certain composite products a nd amending Decision 2007/275/EC and 
Regulation (EC) No 1162/2009  EN 2   EN Draft 
COMMISSION REGULATION 
of 
laying down requirements for the certificatio n for imports into and transit through the 
Union of certain composite products a nd amending Decision 2007/275/EC and 
Regulation (EC) No 1162/2009 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Council Directive 97/78/ EC of 18 December 1997 laying down the 
principles governing the orga nisation of veterinary chec ks on products entering the 
Community from third countries
1, and in particular Article 3(5) thereof; 
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 consumption2 , and in particular Article 8(5) thereof, 
Having regard to Regulation (EC) No 853/2004 of the European Parliament and of the 
Council of 29 April 2004 laying down specific hygiene rules for food of animal origin3, and in 
particular the first paragr aph of Article 9 thereof, 
Having regard to Regulation (E C) No 854/2004 of the European Parliament and the Council 
laying down specific rules for the organisation of official controls on products of animal 
origin intended for human consumption 4, and in particular the first paragraph of Article 16 
thereof,  
Having regard to Regulation (EC) No 882/20045 of the European Parliament and of the 
Council of 29 April 2004 on official controls performed to ensure the verification of 
compliance with feed and food law, animal health  and animal welfare rules and in particular 
Article 48(1) and the first subpara graph of Article 63(1) thereof; 
Whereas:  
                                                 
1 OJ L 24, 30.1.1998, p. 9. 
2 OJ L 18, 23.1.2003, p. 11. 
3 OJ L 139, 30.4.2004, p. 55. 
4 OJ L 139, 30.4.2004, p. 206. 
5 OJ L 165, 30.4.2004, p. 1. EN 3   EN (1) Directive 97/78/EC provides that veterinary checks on products from third countries 
introduced into the Union are to be carried  out by Member States in accordance with 
that Directive and with Regulation (EC) No 882/2004. 
(2) Regulation (EC) No 882/2004 lays down genera l rules for the performance of official 
controls to verify compliance with ru les aiming, in particular, at preventing, 
eliminating or reducing to acceptable levels  risks to humans and animals, either 
directly or through the environment. 
(3) Directive 2002/99/EC lays down the general animal health rules governing all stages 
of the production, processing and distribution within the Union and the introduction 
from third countries of produc ts of animal origin and products obtained intended for 
human consumption. 
(4) Regulation (EC) No 853/2004 lays down spec ific rules on the hygiene of food of 
animal origin for food business operators. Arti cle 6(4) of that Re gulation provides that 
food business operators importing food contai ning both products of  plant origin and 
processed products of animal origin (com posite products) are to ensure that the 
processed products of animal origin cont ained in such food satisfy certain public 
health requirements laid down therein. In addition, Regulati on (EC) No 853/2004 
provides that food business operators must be able to demonstrate that they have done 
so, for example through appropriate  documentation or certification.  
(5) Regulation (EC) No 853/2004 applies from 1 January 2006. However, the application 
of a number of measures laid  down therein with immediate effect from that date would 
have presented practical difficulties in certain cases. 
(6) Commission Regulatio n (EC) No 2076/20056 therefore provided that, by way of 
derogation from Article 6(4) of Regulati on (EC) No 853/2004, food business operators 
importing food containing composite products were to be exempt from the obligation 
provided for in that Article. 
(7) Commission Regulation (E C) No 1162/2009 of 30 November 2009 laying down 
transitional measures for the implementati on of Regulations (EC) No 853/2004, (EC) 
No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council7 
repealed and replaced Regulation (EC)  No 2076/2005. Regulation (EC) No 1162/2009 
contains the same derogation from Article 6(4) of Regulation (EC) No 853/2004 as did 
Regulation (EC) No 2076/2005.  
(8) In addition, Regulation (EC) No 1162/2009 provides that imports of composite 
products are to comply with the harmonised Union rules, where applicable, and with 
the national rules implemented by the Member States in other cases.  
(9) Regulation (EC) No 1162/2009 a pplies until 31 December 2013. 
(10) Commission Decision 2007/275/EC of 17 Apr il 2007 concerning lists of animals and 
products to be subject to controls at bor der inspection posts under Council Directives 
                                                 
6  OJ L 338, 22.12.2005, p. 83. 
7 OJ L 314, 1.12.2009, p. 10. EN 4   EN 91/496/EEC and 97/78/EC8 provides that certain composite  products are to be subject 
to veterinary checks, when imported into the Union. Pursuant to that Decision, the 
composite products subjected to veterinary checks are all those containing processed 
meat products, those containing half or more  of their substance of any one processed 
product of animal origin other than pro cessed meat products and those containing no 
processed meat products and less than half  of their substance of processed milk 
product where the final products do not m eet certain requirements laid down in 
Decision 2007/275/EC. 
(11) In addition, Decision 2007/275/EC lays do wn certain certifi cation requirements 
regarding the composite products subject to  veterinary checks. It provides that 
composite products containing processed m eat products are to be accompanied at 
introduction into the Union by the relevant certificate for meat products laid down in 
Union legislation. Composite products contai ning processed milk products, which are 
to be subjected to veterinary checks, are to be accompanied at introduction into the Union by the relevant certificate laid down in Union legislation. In addition, composite 
products containing only processed fishery or  egg products which are to be subjected 
to veterinary checks are to be accompani ed at introduction into the Union by the 
relevant certificate laid down in Union le gislation or a commercial document where 
there is no certificate so required. 
(12) The composite products subjected to ve terinary checks pursuant to Decision 
2007/275/EC are, by their very nature, the one s that may present also a higher public 
health risk. The levels of potential public health risk vary depending on the product of 
animal origin which is included in the com posite product, the percen tage in which that 
product of animal origin is present in the composite produc t and the treatments applied 
to it as well as the shelf stability of the composite product. 
(13) It is therefore appropriate that the public  health requirements la id down in Regulation 
(EC) No 853/2004 apply to those composite products even before the expiry of the 
derogation provided for in Regulation (EC) No 1162/2009. 
(14) In particular, the certification of compliance with public health requirements  as laid 
down in Regulation (EC) No 853/2004 should be  provided for in this Regulation for 
the importation of the composite products containing processed meat products, of 
those composite products containing half or more of their substance of milk products 
or of processed fishery or egg products a nd of those composite products containing no 
processed meat products and less than half  of their substance of processed milk 
products where the final products in not shel f-stable at ambient temperature or where 
they have not clearly undergone in thei r manufacture a complete cooking or heat 
treatment process throughout th eir substance, so that any raw product is not denatured. 
(15) As a consequence, the derogation laid down in Regulation (EC) No 1162/2009 should 
no longer apply for those composite products. 
(16) The animal health requirements concerning  those composite produc ts are already laid 
down in Union legislation. Pursuant to t hose requirements, those composite products 
should in particular only be impor ted from approved third countries. 
                                                
 
8 OJ L 116, 4.5.2007, p. 9. EN 5   EN (17) A specific model health certifi cate attesting that such composite products imported 
into the Union comply with those public and animal health requirements should be 
laid down in this Regulation. As a conseque nce, the certification requirements laid 
down in Decision 2007/275/EC should no longe r apply for those composite products.  
(18) For the other composite products containing half or more of their substance of 
products of animal origin other than milk  products or fishery or egg products, the 
certification requirements laid down in Decision 2007/275/EC s hould continue to 
apply. However, for reasons of simplificatio n and clarity of Uni on legislation, it is 
appropriate to include those ce rtification requirements in this Regulation, so that the 
main rules on the certification of composite  products be laid down in only one act. 
(19) Decision 2007/275/EC and Regulation (E C) No 1162/2009 should therefore be 
amended accordingly. 
(20) Due to animal health reasons, a certificat e and specific conditions for transit via the 
Union should be provided for. However these conditions should be applicable only to 
composite products containing processed meat  products or processed dairy products.  
(21) Specific conditions for transit via the Union of consignments to and from Russia 
should be provided for, owing to the geogra phical situation of Kaliningrad, which only 
concerns Latvia, Lithuania and Poland. 
(22) 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.  
  (23) 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 
Subject matter 
This Regulation lays down rules on the certifica tion of consignments of certain composite 
products introduced into the Union from third countries. 
 
Article 2 
Definitions 
 
For the purposes of th is Regulation, the defi nitions in Article 2 of  Decision 2007/275/EC shall 
apply. 
 EN 6   EN Article 3 
Imports of certain composite products 
 
1. Consignments of the following composite  products introduced in to the Union shall 
come from a third country or part thereo f authorised for the introduction into the 
Union of consignments of the products of an imal origin contained in those composite 
products and the products of animal origin used for the production of such composite 
products originate from establishments in compliance with Article 6.1(b) of 
Regulation (EC) N°853/2004: 
(a) composite products containing processed meat products, as referred to in 
Article 4(a) of Decision 2007/275/EC;  
(b) composite products containing proc essed milk products and covered by 
Article 4(b) and (c) of Decision 2007/275/EC; 
(c) composite products containing half or more of their substance of processed 
fishery or egg products and covere d by Article 4(b) of Decision 
2007/275/EC. 
2. Consignments of composite products referre d to in paragraph 1 shall be accompanied 
by a health certificate in acco rdance with the model health certificate set out in 
Annex I and comply with the conditions  established in such certificates. 
3. Consignments of composite products containi ng half or more of  their substance of 
products of animal origin other than those referred to in paragraph 1 shall come from 
a third country or part thereof authoris ed for the introduction into the Union of 
consignments of the products of animal or igin contained in those composite products 
and shall be accompanied at introduction in to the Union by the relevant certificate 
laid down in Union legislation for thos e products of animal origin or by a 
commercial document where there is no certificate so required. 
 
Article 4 
Transit and storage of cert ain composite products 
 
1. The introduction into the Un ion of consignments of com posite products referred to in 
Article 3(1) (a) and (b) not intended for im portation into the Uni on but destined for a 
third country either by immediate transit or  after storage in the Union, in accordance 
with Articles 11, 12 or 13 of Council Directive 97/78/EC, sha ll only be authorised if 
the consignments comply with the following conditions: 
(a) they come from a third country or part thereof authorised for the 
introduction into the Union of consi gnments of the products of animal 
origin contained in those compos ite products and comply with the 
appropriate treatment conditions for su ch products, as provided for in EN 7   EN Commission Decision 2007/777/EC9 and Commission Re gulation (EU) No 
605/201010 for the product of anim al origin concerned; 
(b) they are accompanied by a health ce rtificate drawn up in accordance with 
the model health certificate set out in Annex II; 
(c) they comply with the specific animal health requirements for the 
importation into the Union of the products  of animal origin  contained in the 
composite products concerned, as set out in the animal health attestation in 
the model health certificate referred to in point (b); 
(d) they are certified as acceptable fo r transit, including for storage as 
appropriate, on the common veterinary entry document referred to in Article 2(1) of Commissi on Regulation (EC) No 136/2004
11, signed by the 
official veterinarian of the border in spection post of introduction into the 
Union. 
 
Article 5  
Derogation for transit of consignments  coming from and destined to Russia 
 
1.  By way of derogation from Article 4, the transit by road or by ra il through the Union, 
between designated border inspection posts in  Latvia, Lithuania and Poland, listed in 
Commission Decision 2009/821/EC12, of consignments of composite products 
referred to Article 3 coming from and destin ed to Russia directly or via another third 
country shall be authorised provided that  the following conditions are complied with: 
(a)  the consignment is sealed with a serially numbered seal at the border 
inspection post of introduction into th e Union by the veterinary services of 
the competent authority; 
(b)  the documents accompanying the consignment and referred to in Article 7 
of Directive 97/78/EC are stampe d "ONLY FOR TRANSIT TO RUSSIA 
VIA THE EU" on each page by the offici al veterinarian of the competent 
authority responsible for the border in spection post of introduction into the 
Union; 
(c)  the procedural requirements provi ded for in Article 11 of Directive 
97/78/EC are complied with; 
(d)  the consignment is certified as acceptable for transit on the common 
veterinary entry document by the o fficial veterinarian of the border 
inspection post of introduction into the Union. 
                                                 
9  OJ L 312, 30.11.2007, p. 49. 
10  OJ L 175, 10.7.2010, p. 1. 
11  OJ L 21, 28.1.2004, p. 11. 
12  OJ L 296, 12.11.2009, p. 1.  EN 8   EN 2.  Unloading or storage, as defined in Ar ticle 12(4) or in Article 13 of Directive 
97/78/EC, of such consignments on Uni on territory shall not be allowed. 
3.  Regular audits shall be made by the compet ent authority to ensure that the number of 
consignments and the quantities of products  leaving the Union te rritory matches the 
number and quantities entering the Union. 
 
Article 6 
Amendment to Decision 2007/275/EC  
 
Article 5 of Decision 2007/275/EC is deleted. 
 
Article 7 
Amendment to Regulation (EC) No 1162/2009 
 
In Regulation (EC) No 1162/2009, the first subpar agraph of Article 3(2) is replaced by the 
following: 
"2. By way of derogation from Article 6(4) of Regulation (EC) No 853/2004, food 
business operators importing food containi ng both products of plant origin and 
processed products of animal origin, other th an those referred to in Article 3(1) of 
Regulation (EU) No XXX/2010, shall be exempt from the obligation provided for in that Article." 
Article 8 
Transitional provision 
 
For a transitional period until 31 may 2012, consignm ents of composite products in respect of 
which the relevant certificates have been i ssued in accordance with Article 5 of Decision 
2007/275/EC before 1 January 2012 may contin ue to be introduced into the Union. 
 
Article 9 
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 .  
It shall apply from 1 January 2012.  
This Regulation shall be binding in  its entirety and directly applicable in all Member States. EN 9   EN Done at Brussels, 
 For the Commission 
 José Manuel BARROSO  The President EN 10   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.1. Consignor I.2. Certificate reference number
Name
I.3. Central competent authority
Address
I.4. Local competent authority
Tel.
I.5. Consignee 
Name
Address
Postal code
Tel.
I.7.Country of origin ISO code I.8. Region of origin Code I.9. Country of destination ISO code
I.11. Place of origin
Name Approval number
Address
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Seal/Container number I.24.Type of packaging
I.25. Commodities certified for:
Human consumption
I.27. For import or admission into EU
I.28. Identification of the commodities
Manufacturing plant Number of packages Nature of commodity Net weight Batch numberI.26.Part I: Details of dispatched consignment I.6.
I.12.
I.17.1.10.I.2.a.
 
 
  EN 11   EN  COUNTRY composite products intended for human consumption  
 II. Health information II.a. Certificate reference 
number II.b. 
 P.art 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) N°852/2004 and 
(EC) N°853/2004, in particular Article 6.1(b) on the origin of the products of animal origin 
used in the production of the composite prod ucts described above and certify that the 
composite products described above were produced  in accordance with  those requirements, 
in particular that they come from (an) esta blishment(s) implementing a programme based on 
the HACCP principles in accordan ce with Regulation (EC) N°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 an imals (Bos taurus, Bison bison, Bubalus 
bubalis and their crossbreds); OVI = domes tic sheep (Ovis aries) and goats (Capra 
hircus); EQI = domestic equine animals (E quus caballus, Equus  asinus and their 
crossbreds), POR = domestic porcine animals (Sus scrofa); RM = domestic rabbits, PFG 
= domestic poultry and farmed feathered ga me, RUF farmed non-dom estic 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 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 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 Community legislation for the relevant meat constituents, the 
region as indicated in Part 1 of Annex II to Decision 2007/777/EC The country of origin 
of the meat products must be the same  as the country of export in box 1.7 
(D) insert EU approval number of the establishm ents 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, the 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 regi on with a negligible BSE risk as listed 
in Annex to Commission Deci sion 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, continuously reared and slaughtered in the country 
with negligible BSE risk and passed an te-mortem and post-mo rtem 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 12   EN  COUNTRY composite products intended for human consumption  
 II. Health information II.a. Certificate reference 
number II.b. 
(1) (E.2). for imports from a country or a re gion with a controlled BSE risk as listed 
in Annex to Commission Deci sion 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-morte m 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 mechanically se parated 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 treate d 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-and-bone meal and greaves derived from ruminants ha d been enforced; or 
 (1) (ii) 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.  
(1) (E.3). for imports from a country or a re gion with 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 
ruminants and passed ante-morte m 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 th e same method or sla ughtered by laceration 
after stunning of central nervous tissue by means of an elongated rod-shaped 
instrument introduced 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 treate d 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 an EN 13   EN  COUNTRY composite products intended for human consumption  
 II. Health information II.a. Certificate reference 
number II.b. 
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 th e date from which the ban on the 
feeding of ruminants with meat-and-bone meal and greaves derived from ruminants ha d been enforced; or 
 (1 ) (ii) 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. 
 
 (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 establishment ………………………………….. (approval 
number of the establishments of  origin of the milk products  contained in the composite 
product authorised at the time of production for export of milk products to the EU. The 
country of origin of the dairy products must be the same as the country of export in box 
1.7)  
 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 official veterinary service, 
(ii) belonging to holdings which were not 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 Section 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 involving 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 reaction 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) treatment at not less 
than 135°C in combination with a suitable holding time;] 
(1)or [a high temperature short tim e pasteurisation treatment 
(HTST) at 72°C for 15 seconds, or a treatment with an equivalent pasteurisation effe ct, 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 tim e pasteurisation treatment 
(HTST) at 72°C for 15 seconds, or a treatment with an 
equivalent pasteurisation effe ct, applied twice to milk EN 14   EN  COUNTRY composite products intended for human consumption  
 II. Health information II.a. Certificate reference 
number II.b. 
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;] 
(1)or [additional heating equal to or greater than 72 
 °C or more, 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) treatment 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 Processed e gg products  that originate from the approved Country(9)……..  
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 Annex II, Part 2 to Decision 2007/777/EC 
and/or in Annex I to Commission Regulation (EU) No 605/2010 and/or in Annex I and II to Commission 
Decision 2006/766 and/or in Annex I pa rt 1 to Commission Regulation 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 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]: 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 20: Indi cate 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 the 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 cas e of composite product contai ns milk products indicate 
'milk product'. In case of composite product contai ns processes fishery products specify whether 
aquaculture or wild origin. In cas e of composite product contains egg 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  carcasses or half carcasses cut into no more than 
three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, EN 15   EN  COUNTRY composite products intended for human consumption  
 II. Health information II.a. Certificate reference 
number II.b. 
including dorsal root ganglia, may be imported.  
When removal of the vertebral column is not required, carcasses or wholesale cuts of carcasses of 
bovine animals containing vertebral column shall be iden tified 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 re moval of the vertebral 
column is required as well as he 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  carcasses 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 required, carcasses or wholesale cuts of carcasses of 
bovine animals containing vertebral column shall be id entified by a clearly visible blue stripe on the 
label referred to in Regulation (EC) No 1760/2000. 
Specific information on the number of bovine carcasses or wholesale cuts of carcasses, from which 
removal of the vertebral column is required and fro m which removal 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. 
(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.  
 Official veterinarian/o fficial Inspector(10)  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp: 
 EN 16   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.1. Consignor I.2. Certificate reference number
Name
I.3. Central competent authority
Address
I.4. Local competent authority
Tel.
I.5. Consignee I.6. Person responsible for the load in EU 
Name Name
Address Address
Postal code Postal code
Tel. Tel.
I.7.Country of origin ISO code I.8. Region of origin Code I.9. Country of destination ISO code
I.11. Place of origin I.12. Place of destination
Name Approval number Customs warehouse Ship supplier
Address
Name Approval number
Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Seal/Container number 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.28. Identification of the commodities
Manufacturing plant Number of packages Nature of commodity Net weight Batch numberI.27.Part I: Details of dispatched consignment I.2.a.
I.10.
I.17.
  EN 17   EN  COUNTRY composite products intended for human consumption  
 II. Health information II.a. Certificate reference 
number II.b. 
 P.art II: Certification 
 
 
 
 I, the undersigned official veterinarian/official inspector hereby certify that the compos ite products described above 
contain : 
(1)either  [II.1.A meat products, treated stomachs, 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 and contain the fo llowing meat constituents and meet the 
criteria indicated below: 
Species (A) Treatment (B) Origin (C) 
  
 
(A) Insert the code for the relevant species of  meat product, treated stomachs, bladders and 
intestines where BOV = domestic bovine an imals (Bos taurus, Bison bison, Bubalus 
bubalis and their crossbreds); OVI = domes tic sheep (Ovis aries) and goats (Capra 
hircus); EQI = domestic equine animals (E quus caballus, Equus  asinus and their 
crossbreds), POR = domestic porcine animals (Sus scrofa); RM = domestic rabbits, PFG 
= domestic poultry and farmed feathered ga me, RUF farmed non-dom estic 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 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 Community legislation for the relevant meat constituents, the 
region as indicated in Part 1 of Annex II to Decision 2007/777/EC The country of origin 
of the meat products must be the same  as the country of export in box 1.7 
(1)and/ or  [II.1.B processed dairy products(3) 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) Originate in the country indicated in box I.7 which is listed in Annex I to Regulation 
(EU) No 605/2010 and the treatment applied is conform to the treatment provided for 
in that list for the relevant country. The coun try of origin of the dairy products must be 
the same as the country of export in box 1.7) 
(b) have been produced from milk obtained from  animals: 
(i) under the control of the official veterinary service, 
(ii) belonging to holdings which were not 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 Section 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 prio r 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 leas t 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 F 0 value equal to or greater 
than three;] 
(1)or [an ultra high temperature (UHT) treatment at not less than 135°C EN 18   EN  COUNTRY composite products intended for human consumption  
 II. Health information II.a. Certificate reference 
number II.b. 
in combination with a suitable holding time;] 
(1)or [a high temperature short time pasteurisation treatment (HTST) at 
72°C for 15 seconds, or a treatment 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 pasteurisation treatment (HTST) at 
72°C for 15 seconds, or a treatment 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 or 
more, 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) treatment at not less than 135°C 
in combination with a suitable holding time;]] 
(d) were produced on …………………………. or between ……………………………… 
and ……………………………...(4). 
 
Notes 
Part I : 
● Box reference I.7: Provide the country and ISO code of the territory as appearing in Insert the ISO code of 
the country of origin of the meat product , treated stom achs, bladders and intestin es as listed in Annex II, 
Part 2 to Decision 2007/777/EC and/or in Annex I to Commission Regulation EU N° 605/2010 and/or  
● 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 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 Harmoni sed System (HS) code of the World Customs 
Organisation: codes: 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 20: Indi cate 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 a nd approval number if available of the establishments of 
production of the composite product(s). . Nature of commodity: in case of com posite products containing 
meat products, treated stomachs, bl adders and intestines indicate 'meat product' , 'treated stomachs', 
'bladders' or 'intestines'. In case of composite produc t contains milk products i ndicate 'milk product'. In 
case of composite product contains processes fishery products specify whether aquaculture or wild origin. 
In case of composite product contains egg 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, EN 19   EN  COUNTRY composite products intended for human consumption  
 II. Health information II.a. Certificate reference 
number II.b. 
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 consumption 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. 
(5)      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.  
 Official veterinarian/ Official inspector (5) 
 Name (in capital letters): Qualification and title:  Date: Signature: 
 Stamp: