II 
(Non-legislative acts)  
REGULATIONS  
COMMISSION REGULATION (EU) No 346/2010  
of 15 April 2010  
amending Regulation (EC) No 1251/2008 as regards the placing on the market and import 
requirements for consignments of aquaculture animals intended for Member States or parts 
thereof with national measures approved by Decision 2010/221/EU  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European 
Union,  
Having regard to Council Directive 2006/88/EC 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 
Article 25 and Article 61(3) thereof,  
Whereas:  
(1) Commission Decision 2010/221/EU approving national 
measures for limiting the impact of certain diseases in 
aquaculture animals and wild aquatic animals in 
accordance with Article 43 of Council Directive 
2006/88/EC (  2 ) allows certain Member States to impose 
requirements on the introduction into their territories or 
parts thereof of consignments of certain aquaculture 
animals in order to prevent the introduction of or to 
control spring viraemia of carp (SVC), bacterial kidney 
disease (BKD), infectious pancreatic necrosis virus (IPN) 
and infection with  Gyrodactylus salaris  (GS). That Decision 
replaces Commission Decision 2004/453/EC of 29 April 
2004 implementing Council Directive 91/67/EEC as 
regards measures against certain diseases in aquaculture 
animals (  3 ). 
(2) To prevent the introduction of or to control the spread 
of those diseases, consignments of aquaculture animals 
intended for farming, relaying areas, put and take 
fisheries, open ornamental facilities, or restocking 
introduced into a Member State or part thereof listed 
in Annexes I and II to Decision 2010/221/EU of 
species susceptible to the diseases for which the Member State or part thereof is regarded as disease-free 
or for which it has an eradication programme, should 
originate from an area with an equivalent health status.  
(3) To ensure that those requirements are complied with, 
such consignments should be accompanied by an 
animal health certificate providing the necessary attes ­
tations.  
(4) For movements of aquaculture animals within the 
European Union (placing on the market), specific 
animal health certificates are laid down in Decision 
2004/453/EC. In the interest of simplification of Union 
legislation, the necessary animal health conditions as 
regards the diseases covered by the approved national 
measures should now be included in the animal health 
certificates for placing on the market laid down in 
Commission Regulation (EC) No 1251/2008 of 
12 December 2008 implementing Council Directive 
2006/88/EC as regards conditions and certification 
requirements for the placing on the market and the 
import into the Community of aquaculture animals and 
products thereof and laying down a list of vector 
species (  4 ). Annex II to that Regulation should therefore 
be amended accordingly.  
(5) The relevant model animal health certificates for imports 
of aquaculture animals into the Union, laid down in 
Regulation (EC) No 1251/2008 already include attes ­
tations as regards those diseases. However, those attes ­
tations should be amended to take account of the prin ­
ciples for imports of aquaculture animals laid down in 
Directive 2006/88/EC and the Aquatic Animal Health 
Code of the World Organisation for Animal Health 
(OIE). Annex IV to that Regulation should therefore be 
amended accordingly.EN 24.4.2010 Official Journal of the European Union L 104/1  
( 1 ) OJ L 328, 24.11.2006, p. 14.  
( 2 ) OJ L 98, 20.4.2010, p. 7.  
( 3 ) OJ L 202, 7.6.2004, p. 4.  (  4 ) OJ L 337, 16.12.2008, p. 41.(6) The placing on the market and import requirements for 
consignments of aquaculture animals intended for 
Member States and parts thereof with national 
measures approved by Decision 2010/221/EU should 
only apply to species susceptible to the relevant 
diseases. Consequently, a list of species susceptible to 
those diseases should be set out in Annex II to Regu ­
lation (EC) No 1251/2008.  
(7) However, as fish of any species that are present in waters 
where fish of species infected with GS are present, may 
spread that disease, the placing on the market and import 
requirements related to GS should also apply to 
consignments of fish of any species introduced into 
Member States or parts thereof listed in Decision 
2010/221/EU as free of that disease.  
(8) As the model animal health certificates laid down in 
Regulation (EC) No 1251/2008, as amended by this 
Regulation, cover all the national measures approved in 
accordance with Article 43 of Directive 2006/88/EC and 
Decision 2004/453/EC is repealed by Decision 
2010/221/EU, Article 18 of Regulation (EC) No 
1251/2008 should be deleted.  
(9) It is appropriate to provide for transitional measures to 
allow Member States and the industry to take the 
necessary measures to comply with the requirements 
laid down in this Regulation.  
(10) To ensure that animal health certificates are correctly 
issued in those cases where certain statements of the 
model animal health certificates set out in Regulation 
(EC) No 1251/2008 are not relevant and in those cases 
where they consist of more than one sheet of paper, 
further clarification should be provided for in the 
explanatory notes. Annex V to that Regulation should 
therefore be amended accordingly.  
(11) Regulation (EC) No 1251/2008 should therefore be 
amended accordingly.  
(12) The measures provided for in this Regulation are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Regulation (EC) No 1251/2008 is amended as follows:  
1. In Article 1, point (b) is replaced by the following:  
‘(b) animal health conditions for the placing on the market 
of: 
(i) ornamental aquatic animals either originating from 
or intended for closed ornamental facilities; and  
(ii) aquaculture animals intended for farming, relaying 
areas, put and take fisheries, open ornamental facilities and restocking in Member States and parts 
thereof with national measures approved by 
Commision Decision 2010/221/EU (*);  
___________  
(*) OJ L 98, 20.4.2010, p. 7.’  
2. The following Article 8a is inserted:  
‘Article 8a  
Aquaculture animals intended for farming, relaying 
areas, put and take fisheries, open ornamental facilities 
and restocking in Member States and parts thereof with 
national measures approved by Decision 2010/221/EU  
1. Consignments of aquaculture animals intended for 
farming, relaying areas, put and take fisheries, open orna ­
mental facilities, or restocking shall be accompanied by an 
animal health certificate completed in accordance with the 
model set out in Part A of Annex II and the explanatory 
notes set out in Annex V, where the animals:  
(a) are introduced into Member States or parts thereof listed 
in the second and fourth column of the table set out in:  
(i) Annex I to Decision 2010/221/EU as free of one or 
more of the diseases listed in the first column of that 
table; or  
(ii) Annex II to Decision 2010/221/EU as subject to an 
eradication programme for one or more of the 
diseases listed in the first column of that table;  
(b) are of species which are listed in Part C of Annex II as 
species susceptible to the diseases, for which the Member 
State concerned or part thereof is regarded as disease- 
free, or for which an eradication programme applies in 
accordance with Decision 2010/221/EU, as referred to in 
point (a).  
2. Consignments of animals referred to in paragraph 1 
shall comply with the animal health requirements set out 
in the model animal health certificate and explanatory 
notes as referred to in paragraph 1.  
3. Paragraph 1 and 2 shall apply to consignments of fish 
of any species originating from waters where species listed in 
Part C of Annex II as species susceptible to infection with  
Gyrodactylus salaris , are present, where those consignments 
are intended for a Member State or part thereof listed in 
Annex I to Decision 2010/221/EU as free of  Gyrodactylus 
salaris  (GS).’  
3. Article 18 is deleted.  
4. Annexes II, IV and V are amended in accordance with the 
Annex to this Regulation.EN L 104/2 Official Journal of the European Union 24.4.2010Article 2  
Transitional provisions  
1. For a transitional period until 31 July 2010, consignments 
of aquaculture animals accompanied by animal health 
certificates issued in accordance with Parts A or B of Annex 
IV to Regulation (EC) No 1251/2008 before the amendments 
introduced by the present Regulation, may continue to be 
imported into or transited through the Union.  
2. For a transitional period until 31 July 2011, consignments 
of aquaculture animals accompanied by animal health 
certificates issued in accordance with Part A or B of Annex 
IV to Regulation (EC) No 1251/2008 before the amendments 
introduced by the present Regulation, may continue to be imported into or transited through the Union provided that 
the animal health attestations as regards spring viraemia of 
carp (SVC), bacterial kidney disease (BKD), infectious pancreatic 
necrosis virus (IPN) and Infection with  Gyrodactylus salaris  (GS) 
set out in Part II of those certificates are not applicable.  
Article 3  
Entry into force and applicability  
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 15 May 2010.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels, 15 April 2010.  
For the Commission  
The President  
José Manuel BARROSOEN 24.4.2010 Official Journal of the European Union L 104/3ANNEX  
Annexes II, IV and V are amended as follows:  
(1) Annex II is amended as follows:  
(a) Part A is replaced by the following:  
‘PART A  
Model animal health certificate for the placing on the market of aquaculture animals for farming, relaying, put 
and take fisheries, open ornamental facilities and restocking
EN L 104/4 Official Journal of the European Union 24.4.2010EN 24.4.2010 Official Journal of the European Union L 104/5EN L 104/6 Official Journal of the European Union 24.4.2010EN 24.4.2010 Official Journal of the European Union L 104/7EN L 104/8 Official Journal of the European Union 24.4.2010(b) the following Part C is added:  
‘PART C  
List of species susceptible to diseases for which national measures are approved under Decision 
2010/221/EU  
Disease  Susceptible species  
Spring Viraemia of Carp (SVC)  Bighead carp ( Aristichthys nobilis ), goldfish ( Carassius auratus ), crucian 
carp ( Carassius carassius ), grass carp ( Ctenopharyngodon idellus ), common 
carp and koi carp ( Cyprinus carpio ), silver carp ( Hypophthalmichthys 
molitrix ), sheatfish ( Silurus glanis ), and tench ( Tinca tinca ), Orfe ( Leuciscus 
idus) 
Bacterial kidney disease (BKD)  Family:  Salmonidae  
Infectious pancreatic necrosis virus (IPN)  Rainbow trout ( Oncorhynchus mykiss ), brook trout ( Salvelinus fontinalis ), 
brown trout ( Salmo trutta ), Atlantic salmon ( Salmo salar ), and Pacific 
salmon ( Oncorhynchus spp .) and whitefish ( Coregonus lavaretus ) 
Infection with  Gyrodactilys salaris  Atlantic salmon ( Salmo salar ), rainbow trout ( Oncorhynchus mykiss ), 
Arctic char ( Salvelinus alpinus ), North American brook trout ( Salvelinus 
fontinalis ), grayling ( Thymallus thymallus ), North American lake trout 
(Salvelinus namaycush ) and brown trout ( Salmo trutta ).’EN 24.4.2010 Official Journal of the European Union L 104/9(2) Annex IV is amended as follows:  
(a) Part A is replaced by the following:  
‘PART A  
Model animal health certificate for the import into the European Union of aquaculture animals for farming, 
relaying, put and take fisheries and open ornamental facilities
EN L 104/10 Official Journal of the European Union 24.4.2010EN 24.4.2010 Official Journal of the European Union L 104/11EN L 104/12 Official Journal of the European Union 24.4.2010EN 24.4.2010 Official Journal of the European Union L 104/13EN L 104/14 Official Journal of the European Union 24.4.2010(b) Part B is replaced by the following:  
‘PART B  
Model animal health certificate for the import into the European Union of ornamental aquatic animals intended 
for closed ornamental facilities
EN 24.4.2010 Official Journal of the European Union L 104/15EN L 104/16 Official Journal of the European Union 24.4.2010EN 24.4.2010 Official Journal of the European Union L 104/17EN L 104/18 Official Journal of the European Union 24.4.2010(3) Annex V is replaced by the following:  
‘ANNEX V  
Explanatory notes  
(a) Certificates shall be issued by the competent authorities of the country of origin, based on the appropriate model 
set out in Annex II and IV to this Regulation taking into account the place of destination and use of the 
consignment after the arrival at the destination.  
(b) Considering the status of the place of destination as regards non-exotic diseases referred to in Part II of Annex IV 
to Directive 2006/88/EC in the EU Member State or diseases for which the place of destination has measures 
approved by to Decision 2010/221/EU approving national measures in accordance with Article 43 of Council 
Directive 2006/88/EC, the appropriate specific requirements shall be incorporated and completed in the 
certificate.  
(c) The “Place of origin” shall be the localisation of the farm or mollusc farming area where the aquaculture animals 
were reared reaching their commercial size relevant for the consignment covered by this certificate. For wild 
aquatic animals “place of origin” shall be the place of harvest.  
(d) Where the model certificate states that certain statements shall be kept as appropriate, statements which are not 
relevant, may be crossed out and initialled and stamped by the certifying officer, or completely deleted from the 
certificate.  
(e) The original of each certificate shall consist of a single sheet of paper, or, where more text is required it must be 
in such a form that all sheets of paper required are part of an integrated whole and indivisible.  
(f) For import into the Union from third countries, the original of the certificate and the labels referred to in the 
model certificate shall be drawn up in at least one of the official languages of the Member State of the border 
inspection post of introduction of the consignment into the Union and of the Member State of destination. 
However, those Member States may authorise the certificate to be drawn up in the official language of another 
Member State, and accompanied, if necessary, by an official translation.  
(g) Where additional sheets are attached to the certificate for the purpose of identifying the items making up the 
consignment, such additional sheets shall also be considered to form part of the original of the certificate, 
provided the signature and stamp of the certifying official inspector appear on each page.  
(h) When the certificate, including any additional sheets as referred to in (g), comprises more than one page, each 
page shall be numbered “–x (page number)  of y (total number of pages) –” on the bottom and shall bear the certificate 
reference number allocated by the competent authority on the top.  
(i) The original of the certificate must be completed and signed by an official inspector not more than 72 hours 
prior to loading of the consignment, or not more than 24 hours in those cases were the aquaculture animals 
must be inspected within 24 hours of loading. The competent authorities of the country of origin shall ensure 
that principles of certification equivalent to those laid down in Directive 96/93/EC are followed.  
(j) The colour of the signature shall be different from that of the printing. The same requirement shall apply to 
stamps other than embossed stamps or watermarks.  
(k) For import into the Union from third countries, the original of the certificate must accompany the consignment 
until it reaches the EU border inspection post. For consignments placed on the market within the Union, the 
original of the certificate must accompany the consignment until it reaches its final destination.  
(l) A certificate issued for live aquaculture animals shall be valid for 10 days from the date of issue. In the case of 
transport by ship, the time of validity is prolonged by the time of journey at sea. To that end, the original of a 
declaration by the ship's master, drawn up in accordance with the addendum drawn up in conformity with the 
model laid down in Part D of Annex IV, shall be attached to the animal health certificate.  
(m) Please note that the general conditions on the transport of animals laid down in Council Regulation (EC) No 
1/2005 on the protection of animals during transport and related operations and amending Directives 
64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97 may, where applicable, require measures to be 
taken after entry into the Union if the requirements of that Regulation are not fulfilled.’EN 24.4.2010 Official Journal of the European Union L 104/19