EN    EN EN    EN EN 
SANCO/10091/2007/rev 5 EN 2   EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
C(2007) 
  
Draft 
COMMISSION REGULATION 
of […] 
amending Commission Regulation No 2074/2005 as regards the animal health 
certification requirements for import of fi sh, molluscs and crustaceans intended for 
human consumption 
 
 This document does not necessarily re present the view of the Commission EN 3   EN Draft 
COMMISSION REGULATION 
of […] 
amending Commission Regulation No 2074/2005 as regards the animal health 
certification requirements for import of fi sh, molluscs and crustaceans intended for 
human consumption 
 (Text with EEA relevance) 
  
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
Having regard to Council Directive 2006/88/E C of 24 October 2006 on animal health 
requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals
1, and in particular Artic les 22, 24 and 25 thereof, 
Having regard to Council Directive 2002/ 99/EC of 16 December 2002 laying down the 
animal health rules governing the production, processing, distribution and introduction of 
products of animal origin for human consumption2, 
Having regard to Regulation (EC) No 852/2004 of the European Parliament and of the 
Council of 29 April 2004 on the hygiene of foodstuffs3, and in particular Article 13(2) 
thereof, 
Having regard to Regulation (EC) No 853/2004 of the European Parliament and of the 
Council of 29 April 2004 laying down specifi c hygiene rules for f ood of animal origin4, and 
in particular Articles 9, 10 and 11 thereof, 
Having regard to Regulation (EC) No 854/2004 of the European Parliament and of the 
Council of 29 April 2004 laying down specific rules for the organization of  official controls 
on products of animal origin intended for human consumption5, and in particular Articles 16, 
17 and 18 thereof, 
Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the 
Council of 29 April 2004 on official controls pe rformed to ensure the compliance with feed 
                                                 
1  OJ L 328/14, 24.11 
2 OJ L 18, 23.1.2003, p. 11.  
3 OJ L 139, 30.04.2004, p. 1. 
4 OJ L. 139, 30.04.2004, p. 55, as last amended by…… 
5 OJ L 139, 30.4.2004, p. 206, as last amended by Council Regulation 1791/2006 (OJ L 363, 20.12.2006, 
p. 1). EN 4   EN and food law, animal health and animal welfare rules6, and in particular Article 63 thereof, 
Whereas: (1) Annex VI of Commission Regulation (EC)  No 2074/2005 of 5 December 2005 laying 
down implementing measures for certain  products under Regulation (EC) No 
853/2004 of the European Parliament and of  the Council and for the organisation of 
official controls under Regulation (EC) No  854/2004 of the European Parliament and 
of the Council and Regulation (EC) No 882/ 2004 of the European Parliament and of 
the Council, derogating from Regulati on (EC) No 852/2004 of the European 
Parliament and of the Council and amendi ng Regulations (EC) No 853/2004 and (EC) 
No 854/2004
7 lays down model for joint public a nd animal health certificates for 
imports of fishery products and bivalve molluscs intended for human consumption.  
(2) Commission Regulation 2008/ xx/EC (SANCO/10576/EC) lays down certain animal 
health requirements for placing on the market  and import of aquaculture animals and 
products thereof, including imports for human consumption. 
(3) The Model certificates laid down in Regulation (EC) No 2074/2005 should be 
amended to be in line with the requiremen ts laid down in Dir ective 2006/88/EC and 
Commission Regulation 2008/xx/EC(SANCO/10576/EC). 
(4) Public health provisions for live bivalve molluscs in Section VII to Annex III of 
Regulation (EC) 853/2004 do also  apply to live echinoderm s, tunicates and marine 
gastropods. It is therefore appropriate to extend the sc ope of the certificate by 
including live echinoderms, live tuni cates and live marine gastropods. 
(5) It is appropriate to provide for a transi tional period to permit Member States and 
industry to take the necessary measures to  comply with the new requirements laid 
down in this Regulation. 
(6) 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 
 
Commission Regulation (EC) No 2074/2005 is amended as follows: 
1. Appendix IV to Annex VI is replaced by Annex I to this Regulation. 2. Appendix V Part A to Annex VI is replaced by Annex II to this Regulation. 
                                                
 
6 OJ L 165, p. 30.04.2004, p. 1, as last amended by (EC) No 1791/2006 (OJ No. L 363, 20.12.2006, p. 1). 
7 OJ L 338, 22.12.2005, p. 27, as last amended by (EC) No 1244/2007 (OJ No. L 281, 25.10.2007, p. 12). EN 5   EN Article 2 
Transitional measures 
(1) Consignments of fishery products or live bi valve molluscs for which a certificate has 
been issued in accordance with Comm ission Regulation (EC) No 2074/2005 as 
amended by Commission Regulation (EC) No 1664/2006, may be imported into or 
transited through the Community until 1 December 2008. 
(2) By way of derogation from paragraph 1, c onsignments of fishery products for which 
the animal health attestation laid down in Annex I is not applicab le, as described in 
note (2) of Part II of Annex I, and consignments of live bivalve molluscs for which the 
animal health attestation laid down in Annex II is not applicable, as  described in note 
(2) of Part II of Annex II, may be impor ted into or transite d through the Community 
accompanied by a certificate drawn up in conformity with the model laid down in Commission Regulation (EC)  No 2074/2005 as amended by  Commission Regulation 
(EC) No 1664/2006 until 1 August 2010.  
 
Article 3 
Entry into force 
This Regulation shall enter into  force on the twentieth day follo wing that of its publication in 
the Official Journal of  the European Union .  
It shall apply from 1 August 2008. This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
 
Done at Brussels, 
 For the Commission 
 Markos KYPRIANOU  Member of the Commission EN 6   EN ANNEX I  
Appendix IV to Annex VI  
MODEL HEALTH CERTIFICATE FOR IMPORTS OF FISHERY 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
Postal code I.4. Local Competent Authority
Tel. No.
I.5. Consignee 
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.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. Identification of container/Seal 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
Species Approval number of establishments
(Scientific name) Nature of commodity Treatment type Manufacturing plant Number of packages Net weightI.17.
I.26.Part I : Details of dispatched consignment I.2.a.
I.6.
I.12.I.10.
 EN 7   EN  COUNTRY Fishery products  
 II. Health information II.a. Certificate reference 
number II.b. 
 Part II: Certification 
 
 
 
 II.1. (1) Public health attestation 
I, the undersigned, declare that I am aware of the relevant provisions of Regulations (EC) 
No 178/2002, 852/2004, 853/2004 and 854/2004 and certify that the fishery products described above 
were produced in accordance with those requirements, in particular that they: 
– come from (an) establishment(s) implementi ng a programme based on the HACCP principles 
in accordance with Re gulation (EC) No 852/2004; 
– have been caught and handled on board vesse ls, landed, handled and where appropriate 
prepared, processed, frozen and thawed hygienical ly in compliance with the requirements laid 
down in Section VIII, Chapters I to IV of  Annex III to Regulation (EC) No 853/2004; 
– satisfy the health standards laid down in Sec tion VIII, Chapter V of Annex III to Regulation 
(EC) No 853/2004 and the criteria laid do wn in Regulation (EC) No 2073/2005 on 
microbiological criter ia for foodstuffs; 
– have been packaged, stored and transported in compliance with Section VIII, Chapters VI to 
VIII of Annex III to Regulation (EC) No 853/2004; 
– have been marked in accordance with Secti on I of Annex II to Regulation (EC) No 853/2004 
– the guarantees covering live animals and products thereof, if from aquaculture origin, provided 
by the residue plans submitted in accordance with Directive 96/23/EC, and in particular 
Article 29 thereof, are fulfilled; and 
– have satisfactorily undergone the official contro ls laid down in Annex III to Regulation (EC) 
No 854/2004. 
II. 2. (2)(4)Animal health attestation for fish a nd crustaceans of aquaculture origin  
II.2.1   (3)(4)[ Requirements for susceptible species to Epizootic ulcerative syndrome (EUS),  Epizootic 
  haematopoietic necrosis (EHN), Taura syndrome and Yellowhead disease  
I, the undersigned official inspector, hereby certify th at the aquaculture animals or  products thereof referred 
to in Part I of this certificate: 
II.2.1.1.   (4)(5)originate from an country/territory, zone or compartment declared free from (4)[EUS]  (4)[EHN 
(4)[Taura syndrome] (4)[Yellowhead disease] in accordance with Chapter VII of Council Directive 
2006/88/EC or the relevant OIE  Standard by the competent authority of the country of origin, and 
i) where the relevant diseases are notifiable to the competent authority and reports of 
suspicion of infection of the relevant dis ease must be immediately investigated by 
the official services, 
ii) all introduction of species susceptible to the relevant diseases come from an area 
declared free of the disease,, and 
iii) species susceptible to the relevant diseases are not vaccinated against the relevant 
diseases] 
II.2.2 (3)(4)[Requirements for species susceptible to Viral haemorrhagic septicaemia (VHS), Infectious 
haematopoietic necrosis (IHN), Infectious salmon anaemia (ISA), Spring viraemia of carp (SVC), 
Koi herpes virus (KHV) and White spot disease  
I, the undersigned official inspector, hereby certify th at the aquaculture animals or  products thereof referred 
to in Part I of this certificate: 
II.2.2.1.   (4)(6)originate from an country/territory, zone or compartment declared free from (4)[VHS]   
(4)[IHN] (4)[ISA] (4)[SVC]  (4)[KHV] (4)[White spot disease] in accordance with Chapter VII of Council 
Directive 2006/88/EC or the relevant OIE  Standard by the competent authority of the country of origin, 
i) where the relevant diseases are notifiable to the competent authority and reports of 
suspicion of infection of the relevant dis ease must be immediately investigated by 
the competent authority, 
ii) all introduction of species susceptible to the relevant diseases come from an area 
declared free of the disease,, and 
iii) species susceptible to the relevant diseases are not vaccinated against the relevant 
diseases] EN 8   EN  COUNTRY Fishery products  
 II. Health information II.a. Certificate reference 
number II.b. 
II.2.3. Transport and labelling requirements 
I, the undersigned official inspector, hereby certify that: 
II.3.2.1    the aquaculture animals referred to above are placed under conditions, including with a water 
 quality, that do not alter their health status;  
II.2.3.2.   the transport container or well boat prior to loading is clean and disinfected or 
 previously unused; and 
II.2.3.3.    the consignment is identified by a legible label on the exterior of the container, or when  
 transported by well boat, in the ship's manifest , with the relevant information referred to in 
 boxes I.7 to I.13 of Part I of this ce rtificate, and the following statement:  
 ["(4)[Fish](4)[Crustaceans] intended for human consumption in the Community”]. 
 
Notes 
Part I: 
y Box reference I.8: Region of origin: For frozen or processed bivalve molluscs, indicate the production 
area. 
y Box  reference I.11: Place of origin: name and address of the dispatch establishment.  
y Box reference I.15: Registration  number (railway wagons or containe r and lorries), flight number 
(aircraft) or name (ship). Separate information is to be provided in the event of unloading and 
reloading. 
y Box  reference I.19: use the appropriate HS codes: 03.01, 03.02, 03.03, 03.04, 03.05, 03.06, 03.07, 
05.11.91, 15.04, 15.18.00 , 16.03, 16.04, 16.05. 
y Box reference I.23: Identification of co ntainer/Seal number: Not compulsory.  
y Box reference I.28: Nature of commodity: Specify whether aquaculture or wild origin. 
 Treatment type: Specify whether live, chilled, frozen or processed. 
 Manufacturing plant: includes factory vessel, freezer vessel, cold store,
 processing plant. 
Part II : 
(1) Part II.1 does not  apply to countries with special public hea lth certification requirements laid down in 
equivalence agreements or ot her Community legislation.  
(2) Part II.2 does not  apply to:   
a) non-viable crustaceans,  
b) fish, which are slaughtered and eviscerated before dispatch, 
c) aquaculture animals and products thereof, which are placed on the market for human consumption 
without further processing, provid ing that they are packed in retail-sale packages which comply 
with the provisions for such packages  in Council Regulation (EC) No 853/2004, 
d) crustaceans destined for processi ng establishments authorised in accordance with Article 4 (2) of 
Directive 2006/88/EC, or for dispatch centres, purif ication centres or similar businesses which are 
equipped with an effluent treatme nt system inactivating the pathoge ns in question, or where the 
effluent is subject to other types of treatment reducing the risk of transmitting diseases to the 
natural waters to an acceptable level, and  
e) crustaceans which are intended for further pr ocessing before human consumption without 
temporary storage at the place of processing and packed an labelled for that purpose in accordance 
with Council Regulation (EC) No 853/2004.      
(3) Part II.2.1 and II.2.2 only  applies to species susceptible to one or more of the diseases referred to in 
the title. Susceptible species are listed  in Annex IV to Directive 2006/88/EC. 
(4) Keep as appropriate.  EN 9   EN  COUNTRY Fishery products  
 II. Health information II.a. Certificate reference 
number II.b. 
(5) For consignments of species susceptible to EU S, EHN, Taura syndrome a nd/or Yellowhead disease 
this statement must be kept for the consignment to  be authorised into any part of the Community. 
(6) To be authorised into a Member State, zone or compartment (boxes I.9 and I.10 of Part I of the 
certificate) declared from VHS, IHN,  ISA, SVC, KHV or Whitespot dise ase or with a surveillance or 
eradication programme establ ished in accordance with  Articles 44 (1) or 44 (2) of Council Directive 
2006/88/EC, one of these stat ements must be kept if the consi gnment contain species to susceptible 
the disease(s) for which disease freedom or progra mme(s) apply(ies). Data on  the disease status of 
each farms and mollusc farming areas in the Community is accessible on http://ec.europa.eu/food/animal/liv eanimals/aquaculture/index_en.htm. 
y The colour of the stamp and signature must be differen t to that of the other particulars in the certificate. 
 
 Official inspector 
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp: EN 10   EN ANNEX II  
Appendix V to Annex VI  
Part A 
MODEL HEALTH CERTIFICATE FOR IMPO RTS OF LIVE BIVALVE MOLLUSCS 
ECHINODERMS, TUNICATES AND MA RINE GASTROPODS INTENDED FOR 
HUMAN CONSUMPTION 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number
Name
I.3. Central Competent Authority
Address
Postal code I.4. Local Competent Authority
Tel. No.
I.5. Consignee 
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.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)
03 07
I.20.Quantity
I.22. Number of packages
I.23. Identification of container/Seal 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
Species Approval number of establishments
(Scientific name) Manufacturing plant Number of packages Net weightI.17.
I.26.Part I : Details of dispatched consignment I.2.a.
I.6.
I.10.
I.12.
I.21.
 EN 11   EN  COUNTRY Live bivalve molluscs, echinoderms, tunicates 
and marine gastropods  
 II. Health information II.a. Certificate reference 
number II.b. 
 Part II: Certification 
 
 
 
 II.1. (1)Public health attestation for live bivalve molluscs, echinoderms, tunicates and marine 
gastropods 
I, the undersigned, 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 certify that the (4)[live 
bivalve molluscs] (4)[live echinoderms] (4)[live tunicates] (4)[live marine gastropods] described above 
were produced in accordance with those requirements, in particular that they: 
– come from (an) establishment(s) implementin g a programme based on the HACCP principles 
in accordance with Re gulation (EC) No 852/2004; 
– have been harvested, where necessary relayed and transported in accordance with Section VII, 
Chapters I and II of Annex III to Regulation (EC) No 853/2004; 
– were handled, where necessary purified, and packaged in compliance with Section VII, 
Chapters III and IV of Annex III to Regulation (EC) No 853/2004; 
– satisfy the health standards laid down in Sectio n VII, Chapter V of Annex III to Regulation 
(EC) No 853/2004 and the criteria laid down in Regulation (EC) No 2073/2005 on 
microbiological criter ia for foodstuffs; 
– have been packaged, stored and transported in compliance with Section VII, Chapters VI and 
VIII of Annex III to Regulation (EC) No 853/2004; 
– have been marked and labelled in accordance with Section I of Annex II and Section VII, 
Chapter VII of Annex III to Regulation (EC) No 853/2004; 
– in the case of pectinidae  harvested outside classified produc tion areas, comply with the specific 
requirements laid down in Section VII, Ch apter IX of Annex III to Regulation (EC) 
No 853/2004, and 
– have satisfactorily undergone th e official controls laid down in Annex II to Regulation (EC) 
No 854/2004. 
II. 2. (2)(4)Animal health attestation for live bi valve molluscs of aquaculture origin 
II.2.1 (3)(4)[ Requirements for species susceptible to Bonamia exitiosa, Perkinsus marinus and Microcytos 
mackini  
I, the undersigned official in spector, hereby certify that the live bivalv e molluscs referred to in Part I of this 
certificate: 
II.2.1.1.  (4)(5)originate from an country/territory, zone or compartment declared free from (4)[Bonamia exitiosa] 
(4)[Perkinsus marinus] (4)[Mikrocytos mackini] in accordance with Chapter VII of Council Directive 
2006/88/EC or the relevant OIE  Standard by the competent authority of the country of origin,  
i) where the relevant diseases are notifiable to the competent authority authority and 
reports of suspicion of infection of th e relevant disease must be immediately 
investigated by the official services, and 
ii) all introduction of species susceptible to the relevant diseases come from an area 
declared free of the disease.] 
II.2.2 (3)(4)[ Requirements for species susceptible to Marteilia refringens and Bonamia ostreae  
I, the undersigned official inspector, hereby certify that the live bivalve molluscs referred to above: 
II.2.2.1. (4)(6)originate from an country/territory, zone or compartment declared free from (4)[Marteilia 
 refringens] (4)[Bonamia ostreae] in acco rdance with Chapter VII of Council Directive 
2006/88/EC  or the relevant OIE  Standard by the competent authorit y of the country of origin, and 
i) where the relevant diseases are notifiable to the competent authority authority and 
reports of suspicion of infection of th e relevant disease must be immediately EN 12   EN  COUNTRY Live bivalve molluscs, echinoderms, tunicates 
and marine gastropods  
 II. Health information II.a. Certificate reference 
number II.b. 
investigated by the official services, and 
ii) all introduction of species susceptible to the relevant diseases come from an area 
declared free of the disease.] 
II.2.3. Transport and labelling requirements 
I, the undersigned official inspector, hereby certify that: 
II.2.3.1.    the live bivalve molluscs referred to above are placed under conditions, including with a water 
 quality, that do not alter their health status,     
II.2.3.2   the transport container or well boat prior to loading is clean and disinfected or 
 previously unused; and 
II.2.3.3   the consignment is identified by a legible label on the exterior of the micro container, or when  
 transported by well boat, in the ship's manifest , with the relevant information referred to in 
 boxes I.7 to I.13 of Part I of this ce rtificate, and the following statement:  
"Live bivalve molluscs intended for human consumption in the Community”. 
 
Notes 
Part I: 
y Box reference I.8: Region of origin: indicate the production area. 
y Box  reference I.11: Place of origin: name and address of the dispatch establishment.  
y Box reference I.15: Registration  number (railway wagons or containe r and lorries), flight number 
(aircraft) or name (ship). Separa te information is to be provided in the event of unloading and 
reloading. 
y Box reference I.23: Identification of co ntainer/Seal number: Not compulsory.  
y Box reference I.28: Manufacturing plant: incl udes dispatch centre, purification centre 
  
Part II : 
(1) Part II.1 does not  apply to countries with special public hea lth certification requirements laid down in 
Equivalence Agreements or ot her Community legislation.  
(2) Part II.2 does not apply to:  
a) live bivalve molluscs placed on the market for human consumption without further processing, 
providing that they are packed in retail-sale packages which comply with the provisions for such 
packages in Council Regulation (EC) No 853/2004, 
b) live bivalve molluscs destined fo r processing establishments author ised in accordance with Article 
4 (2) of Directive 2006/88/EC, or for dispatch cen tres, purification centres  or similar businesses 
which are equipped with an effluent treatment sy stem inactivating the pathogens in question, or 
where the effluent is subject to other types of treatment reducing the risk of transmitting diseases 
to the natural waters to an acceptable level, and 
c) live bivalve molluscs which are intended for further processing before human consumption 
without temporary storage at the place of proce ssing and packed an labelled for that purpose in 
accordance with Council Regulation (EC) No 853/2004.      
(3) Part II.2.1 and II.2.2 only  applies to species susceptible to one or more of the diseases referred to in 
the title. Susceptible species are listed  in Annex IV to Directive 2006/88/EC. 
(4) Keep as appropriate.  
(5) For consignments of species susceptible to Bonamia exitiosa, Perkinsus marinus and Microcytos 
mackini this statement must be kept for the cons ignment to be authorised into any part of the 
Community. 
(6) To be authorised into a Member State, zone or compartment (boxes I.9 and I.10 of Part I of the EN 13   EN  COUNTRY Live bivalve molluscs, echinoderms, tunicates 
and marine gastropods  
 II. Health information II.a. Certificate reference 
number II.b. 
certificate) declared from Marteilia refringens or Bonamia ostreae or with a surveillance or eradication 
programme established in accordan ce with Articles 44 (1) or 44 (2) of Council Dir ective 2006/88/EC, 
one of these statements must be kept if the consignment contain species to susceptible the disease(s) 
for which disease freedom or programme(s) apply(ies) . Data on the disease status of each farms and 
mollusc farming areas in the Community is accessible on 
http://ec.europa.eu/food/animal/li veanimals/aquaculture/index_en.htm.  
y The colour of the stamp and signature must be differen t to that of the other particulars in the certificate. 
 
 Official inspector 
 Name (in capital letters): Qualification and title:  Date: Signature: 
 Stamp: