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Food Safety

Introduction

In the field of aquaculture and aquaculture products, the basic Union legal provision is Council Directive 2006/88/EC on animal health requirements for aquaculture animals, and on the prevention and control of certain diseases as amended by Commision Directive 2008/53/EC, Commission Implementing Directive 2012/31/EU and Commission Implementing Directive 2014/22/EU.

Council Directive 2006/88/EC lays down:

  • minimum control measures in the event of a suspicion or outbreak of certain diseases in aquatic animals
  • minimum preventive measures aimed at increasing the awareness of the competent authorities, aquaculture production businesses operators and others related to this industry, concerning diseases of aquaculture animals
  • the animal health requirements to be applied for the placing on the market and the imports of aquaculture animals and products thereof.

The provisions of Directive 2006/88/EC are applicable to fish, molluscs and crustaceans at all their life stages reared in a farm or mollusc farming area, including any aquatic animal from the wild intended for a farm or mollusc farming area.

From 1 August 2008, Directive 2006/88/EC repealed the following Directives:

  • Directive 91/67/EEC concerning the animal health conditions governing the placing on the market of aquaculture animals and products
  • Directive 93/53/EEC introducing minimum Community measures for the control of certain fish diseases
  • Directive 95/70/EC introducing Community measures for the control of certain diseases affecting bivalve molluscs

Minimum control measures in the event of a suspicion or outbreak of certain diseases

An outbreak of a disease affecting aquatic animals can quickly take on epizootic proportions, causing mortality and disturbances on a scale liable to reduce severely the profitability of aquaculture. Therefore it is important that control measures are taken when the presence of such a disease is suspected so that immediate and effective actions can be implemented as soon as its presence is confirmed. Such measures are aimed at preventing the spread of the disease, in particular by carefully controlling movements of aquaculture animals and products thereof liable to spread the infection.

The diseases of Union importance and the susceptible species included in Directive 2006/88/EC are listed in Part II of Annex IV. Those diseases are classified in two categories:

  • Exotic diseases or diseases of special importance which have never been detected in the Union. EU policy with regard to those diseases is the swift eradication as a first option. When one of those diseases is suspected, the official services must initiate official investigations to confirm or rule out its presence. No movements of aquatic animals, whether dead or alive, are allowed without the authorisation of the official service. When the presence of the disease is confirmed, aquaculture animals should be harvested as soon as possible to avoid the spread of the disease.
  • Non exotic diseases or important diseases that have been detected in the Union. EU policy with regard to those diseases is either to contain them or to eradicate them in the long term. Where aquatic animals are suspected of being infected with a non-exotic disease an official investigation must be initiated to confirm or rule out the presence of the disease. Disease-free areas will lose their status as free from the disease until it is proven that the disease is eradicated.
  • Article 43 of Directive 2006/88/EC may be used as legal basis to control diseases not listed in Part II of Annex IV that constitute a significant risk for the animal health of aquaculture or wild aquatic animals in a Member State.

The EU Reference Laboratories for aquatic diseases are the following:

Preventive measures

Directive 2006/88/EC is focused on disease prevention. It introduces a system of authorisation of aquaculture production businesses and certain processing establishments. To be authorised, they have to comply with certain minimum requirements as regards traceability, implementation of good hygiene practices and risk-based health surveillance. This new system would provide a complete overview of the aquaculture industry which would assist in the prevention, control and eradication of aquatic animal diseases.

Once the aquaculture production businesses and authorised processing establishments are authorised, Member States shall establish a publicly available register (refer to sub-heading below). This provision is implemented by Commission Decision 2008/392/EC implementing Council Directive 2006/88/EC as regards an Internet-based information page to make information on aquaculture production businesses and authorised processing establishments available by electronic means.

Another important preventative measure is the obligation for all farms and mollusc farming areas to implement a risk-based surveillance scheme. This scheme aims to detect:

Commission Decision 2008/896/EC on guidelines for the purpose of the risk-based animal health surveillance schemes provided for in Council Directive 2006/88/EC ensures a consistent approach amongst Member States in this regard.

Register of aquaculture production businesses and authorised processing establishments

All aquaculture production businesses and authorised processing establishments are to be authorised, and Member States shall establish a publicly available register containing information on each farm, including information on the species kept and the health status of the farms as regards the diseases listed in Annex IV to Council Directive 2006/88/EC.

The link to Member States and EFTA states' web pages with register of aquaculture production businesses and authorised processing establishments in their territory can be found below:

Member States:

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Austria
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Croatia
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Cyprus
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Czech Republic
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Denmark
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Estonia
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Finland
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Greece
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Hungary
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Ireland
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Lithuania
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The Netherlands
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Poland
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Slovenia
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Spain

EFTA states:

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Iceland
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Switzerland

Other countries

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United Kingdom (Northern Ireland)

Another important preventive measure is the obligation for all farms and mollusc farming areas to implement a risk-based surveillance scheme. This scheme aims to detect:

Placing on the market and imports

Directive 2006/88/EC governs any placing on the market within each Member State, between different Member States and imports into the European Union. In general terms, this means that aquaculture animals and products from both within the EU and from non-EU countries must broadly fulfill similar animal health requirements before they can be moved.

The main principle of these regulations is that aquaculture animals which are intended for a Member State, zone or compartment declared free of or under a surveillance or an eradication programme as regards a listed disease, must originate from a non-EU country, Member State, zone or compartment declared disease free of that disease if the animals are susceptible or may act as vector for that disease.

Consequently, whether a movement is in compliance with the animal health placing on the market/import rules will be mainly determined by the following 3 factors:

  • The health status at the place of destination as regards the diseases listed in Part II of Annex IV to the Directive. The relevant issue would be whether the place of destination has been declared free of or is under a surveillance or an eradication programme.
  • The species in question. The relevant issue would be whether the animal of the consignment are susceptible or regarded as vector species to the diseases listed in Part II of Annex IV to the Directive.
    • Susceptible species are listed in Part II of Annex IV to the Directive
    • Vector species and the conditions under which these species shall be regarded as vectors can be found in Annex I to Regulation (EC) No 1251/2008.
  • The health status at the place of origin.

As a general rule, when the consignment contains susceptible/vector species and the place of destination has been declared free of or is under surveillance or eradication programme, freedom at the place of origin is required.

Detailed rules can be found in the following implementing measures:

  • Commission Regulation (EC) No 1251/2008 implementing Council Directive 2006/88/EC as regards conditions and certification requirements for the placing on the market and the import into the EU of aquaculture animals and products thereof and laying down a list of vector species.
  • Commission Regulation (EC) No 1252/2008 derogating from Regulation (EC) No 1251/2008 and suspending imports into the EU from Malaysia of consignments of certain aquaculture animals;
  • Commission Regulation (EC) No 1250/2008 amending Regulation (EC) No 2074/2005 as regards certification requirements for import of fishery products, live bivalve mollusc, echinoderms, tunicates and marine gastropods intended for human consumption.
  • Commission Decision 2008/946/EC implementing Council Directive 2006/88/EC as regards requirements for quarantine of aquaculture animals
  • 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.

A Guidance document (last updated 9 March 2010) has been drafted to provide an introduction into the animal health requirements for placing on the market, import and transit of aquaculture animals according to Council Directive 2006/88/EC and Commission Regulation (EC) No 1251/2008.

Disease control measures

Commission Implementing Decision (EU) 2015/1554 of 11 September 2015 laying down rules for the application of Directive 2006/88/EC as regards requirements for surveillance and diagnostic methods

This decision sets out:

  1. The minimum requirements for surveillance, buffer zones and sampling and diagnostic method to be used by the Member States in connection with determination of disease status of the Member State, zones or compartments thereof for the non-exotic diseases listed in Part II to Annex IV of Directive 2006/88/EC;
  2. The diagnostic methos to be used for the laboratory examination in the case of the suspicion or confirmation of the presence of listed diseases; and
  3. The minimum control measures to be applied in the event of confirmation of a listed disease in a member State, zone or compartment not declared free of that listed disease.

This decision entered into force 1 April 2016 and repealed the following decisions:

  • Commission Decision 2003/466/EC of 13 June establishing criteria for zoning and official surveillance following suspicion or confirmation of the presence of infectious salmon anaemia (ISA).
  • Commission Decision 2001/183/EC of 22 February 2001 laying down the sampling plans and diagnostic methods for the detection and confirmation of certain fish diseases and repealing Decision 92/532/EEC. (applies to VHS and IHN)
  • Commission Decision 2002/878/EC of 6 November 2002 establishing the sampling plans and diagnostic methods for the detection and confirmation of the presence of the mollusc diseases

Health status of Member States and other EEA countries, zones or compartments

It is necessary for competent authorities to know the health status of Member State and other EEA Countries, zone or compartment from where the aquatic animals are sourced and of the area of destination.

This information can be found in the following sources:

1.Commission Decision 2009/177/EC implementing Council Directive 2006/88/EC as regards surveillance and eradication programmes and disease-free status of Member States, zones and compartments. Annex I to this Decision lists:

  • Disease-free areas comprising more than 75% of the territory of a Member State (Annex I Part C to Commission Decision 2009/177/EC);
  • Areas with an approved surveillance programme comprising more than 75% of the territory of a Member State( Annex I Part A to Commission Decision 2009/177/EC);
  • Areas with an approved eradication programme (Annex I Part B to Commission Decision 2009/177/EC).

2. In the following Member States and other EEA Countries official web sites may be found for:

  • Disease-free areas comprising less than 75% of the territory of a Member State or another EEA Country;
  • Areas with approved surveillance or eradication programmes comprising less than 75% of the territory of a Member State

EU Member States

Other EEA countries

3.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 recognises particular health status of some Member States as regards certain diseases not listed in Directive 2006/88/EC. The diseases currently listed in that decision are the following:

  • Spring viraemia in carp (SVC)
  • Bacterial kidney disease (BKD)
  • Infectious pancreas necrosis (IPN)
  • Infections with Gyrodactylus salaris (GS)_
  • Salmonid alphavirus (SAV)
  • Ostreid herpesvirus 1 µvar (OsHV-1µVar)

Declarations

Before obtaining the disease free status or the status of under an eradication programme for compartments or zones comprising less than 75% of their territory, Member States shall publish electronically a provisional declaration and alert the Commission and the other Member States. Declarations shall take effect 60 days after the date of publication. Within the 60-day period, the Commission or Member States may seek clarification or additional information in relation to the supporting evidence provided by the Member State making the provisional declaration and follow other elements of the procedure provided for in Article 83 of Commission Delegated Regulation (EU) 2020/689.

Declarations shall contain data pursuant to:

  • Chapter 3 of Part II of Regulation (EU) 2020/689 and Article 10 of Regulation (EU) 2020/2002, concerning eradication programmes;
  • Chapter 4 of Part II of Regulation (EU) 2020/689 and Article 11 of Regulation (EU) 2020/2002, concerning declarations of disease-free status.

The data to be included in such declarations is as follows:

View declarations

For further information contact SANTE AQUA DECLARATIONS

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