Commission Delegated Regulation (EU) 2021/881 of 23 March 2021 amending Delegated Regulation (EU) 2020/689 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (Text with EEA relevance)
Commission Delegated Regulation (EU) 2021/881 of 23 March 2021 amending Delegated Regulation (EU) 2020/689 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Derogations from approval by the Commission for certain disease-free statuses and certain eradication programmes for aquatic animal diseases
Delegated Regulation (EU) 2020/689 is amended as follows:
1.
Article 83 is replaced by the following:
‘Article 83
Derogations from approval by the Commission for certain disease-free statuses and certain eradication programmes for aquatic animal diseases
1. By way of derogation from the requirement to submit eradication programmes to the Commission for approval as provided for in Article 31(1)(b) and Article 31(2) of Regulation (EU) 2016/429 or from the requirements to obtain approval by the Commission for disease-free status laid down in Article 36(4) and 37(4) of that Regulation, for aquatic animal diseases, such approval for zones or compartments which cover less than 75 % of the territory of a Member State, and where the water catchment supplying the zone or compartment is not shared with another Member State or third country, shall be gained in accordance with the following procedure:
(a)
a Member State makes a provisional declaration of freedom or of the establishment of an eradication programme for the zone or compartment, which fulfils the requirements as set out in this Regulation;
(b)
this provisional declaration is published electronically by the Member State, and the Commission and Member States are alerted to the publication;
(c)
60 days after publication, the provisional declaration shall take effect and the zone or compartment referred to in this paragraph shall achieve disease-free status or have the eradication programme approved.
2. Within the 60-day period referred to in point (c) of paragraph 1, 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.
3. Where written comments are made by at least one Member State, or the Commission, within the period referred to in point (c) of paragraph 1 indicating concerns relating to the evidence which supports the declaration, the Commission, the Member State which made the declaration and where relevant, the Member State which has sought clarification or additional information, shall together examine the submitted evidence in order to resolve the concerns.
In such cases, the period referred to in point (c) of paragraph 1 shall be prolonged automatically for 60 days from the date on which the first concerns were raised. There shall be no further prolongation of this period.
4. Where the process referred to in paragraph 3 fails, the provisions laid down in Articles 31(3), 36(4) and 37(4) of Regulation (EU) 2016/429 shall apply.’
2.
In Article 86, the following indent is inserted after the sixth indent:
‘–
Decision 2010/367/EU;’;
3.
Annexes IV and VI to Delegated Regulation (EU) 2020/689 are amended in accordance with the Annex to this Regulation.
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union .
It shall apply from 21 April 2021.
ANNEX
Annexes IV and VI to Delegated Regulation (EU) 2020/689 are amended as follows:
(1)
Annex IV is amended as follows:
(a)
in Part II, in Chapter 1, Section 1 is amended as follows:
(i)
point 1(c) is replaced by the following
‘(c)
since the beginning of the testing or sampling referred to in point (b)(i), all bovine animals introduced into the establishment originate from establishments free from infection with MTBC and:
(i)
originate from a Member State or a zone free from infection with MTBC; or
(ii)
are bovine animals over 6 weeks of age and have tested negative in an immunological test:
during the 30 days prior to their introduction into the establishment; or
during the 30 days after their introduction provided they have been kept isolated during this period; and’;
(ii)
point 2 is replaced by the following:
‘2.
By way of derogation from point 1, the status free from infection with MTBC may be granted to an establishment if all bovine animals originate from establishments free from infection with MTBC and:
(a)
originate from a Member State or a zone free from infection with MTBC; or
(b)
if they are bovine animals over 6 weeks of age, they have tested negative to an immunological test:
(i)
during the 30 days prior to their introduction into the establishment; or
(ii)
during the 30 days after their introduction provided they have been kept in isolation during this period.’;
(b)
in Part VI, Chapter 1 is amended as follows:
(i)
in Section 3, point 2(a) is replaced by the following:
‘(a)
the requirements laid down in point 1(c) and (d) of Section 1 and point 1(b)(c) and (d) and, if relevant, point 2 of Section 2 are fulfilled.’;
(ii)
in Section 4, point 2 is replaced by the following:
‘2.
If the status free from BVD has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in point 1(c) and (d) of Section 1 and point 1(b), (c) and (d) and, if relevant, point 2 of Section 2 are fulfilled.’;
(2)
Annex VI is amended as follows:
(a)
Part II is amended as follows:
(i)
in Chapter 1, in Section 1, the introductory phrase is replaced by the following:
‘Health visits and sampling for the surveillance referred to in Article 3(2)(b)(ii) and (iii) must comply with the following requirements:’;
(ii)
Chapter 2 is amended as follows:
—
in Section 1, the introductory phrase is replaced by the following:
‘Health visits and sampling for the surveillance referred to in Article 3(2)(b)(ii) and (iii) must comply with the following requirements:’;
—
Section 5 is replaced by the following:
‘
Section 5
Diagnostic and sampling methods
1.
The organs or tissue material to be sampled and examined must be:
(a)
Histology: anterior-kidney, liver, heart, pancreas, intestine, spleen and gill;
(b)
Immunohistochemistry: mid-kidney and heart including valves and bulbus arteriosus ;
(c)
Conventional RT-PCR and RT-qPCR analysis: mid-kidney and heart;
(d)
Virus culture: mid-kidney, heart and spleen;
Organ pieces from a maximum of five fish may be pooled.
2.
The diagnostic method to be used to grant or to maintain the status free from infection with HPR-deleted ISAV in accordance with Sections 2, 3 and 4 must be RT-qPCR, followed by conventional RT-PCR and sequencing of the HE-gene of positive samples in accordance with the detailed methods and procedures which must be those approved by the EURL for fish diseases.
In the case of a positive sequencing result for HPR-deleted ISAV, further samples must be tested before the implementation of the initial control measures provided for in Articles 55 to 65.
Those samples must be tested as follows in accordance with the detailed methods and procedures approved by the EURL for fish diseases:
(a)
Screening of the samples by RT-qPCR, followed by conventional RT-PCR and sequencing of the HE-gene of positive samples to verify HPR-deletion; or
(b)
Detection of ISAV antigen in tissue preparations by means of specific antibodies against ISAV; or
(c)
Isolation in cell culture and subsequent identification of HPR-deleted ISAV.
3.
When a suspicion of infection with HPR-deleted ISAV must be confirmed or ruled out in accordance with Article 55, the following visit, sampling and testing procedure must comply with the following requirements:
(a)
The suspected establishment must be subject to at least one health visit and one sampling of 10 moribund fish, when clinical signs or post-mortem lesions consistent with infection with HPR-deleted ISAV are observed, or a minimum of 30 fish when clinical signs or post-mortem lesions are not observed. Samples shall be tested using one or more of the diagnostic methods set out in point 2 in accordance with the detailed diagnostic methods and procedures approved by the EURL for fish diseases;
(b)
In the case of a positive result for infection with HPR-deleted ISAV, further samples shall be tested before the implementation of the initial control measures provided in Article 58. A suspected case of infection with HPR-deleted ISAV shall be confirmed in accordance with the following criteria using one or more of the detailed diagnostic methods and procedures approved by the EURL for fish diseases:
(i)
Detection of ISAV by RT-qPCR, followed by conventional RT-PCR and sequencing of the HE-gene to verify HPR-deletion; or
(ii)
Detection of ISAV in tissue preparations by means of specific antibodies against ISAV; or
(iii)
Isolation and identification of ISAV in cell culture from at least one sample from any fish from the establishment;
(c)
Where the presence of clinical, gross pathological or histopathological findings consistent with infection are observed, the findings must be corroborated using one or more of the diagnostic methods set out in point 3(b), in accordance with the detailed methods and procedures approved by the EURL for fish diseases.
The suspicion of HPR-deleted ISAV may be ruled out, if tests and health visits over a period of 12 months from the date of the suspicion are found to reveal no further evidence of the presence of the virus.’;
(iii)
in Chapter 3, in Section 1, the introductory phrase is replaced by the following:
‘Health visits and sampling for the surveillance referred to in Article 3(2)(b)(ii) and (iii) must comply with the following requirements:’;
(iv)
in Chapter 4, in Section 1, the introductory phrase is replaced by the following:
‘Health visits and sampling for the surveillance referred to in Article 3(2)(b)(ii) and (iii) must comply with the following requirements:’;
(v)
in Chapter 5, in Section 1, the introductory phrase is replaced by the following:
‘Health visits and sampling for the surveillance referred to in Article 3(2)(b)(ii) and (iii) must comply with the following requirements:’;
(vi)
in Chapter 6, in Section 1, the introductory phrase is replaced by the following:
‘Health visits and sampling for the surveillance referred to in Article 3(2)(b)(ii) and (iii) must comply with the following requirements:’;
(b)
Part III is amended as follows:
(i)
in Chapter 3, in Section 3, in point (b), the introductory phrase is replaced by the following:
‘(b)
repopulation occurs using molluscs that originate from establishments which are:’;
(ii)
in Chapter 4, in Section 3, in point (b), the introductory phrase is replaced by the following:
‘(b)
repopulation occurs using molluscs that originate from establishments which are:’;
(iii)
in Chapter 5, in Section 3, in point (b), the introductory phrase is replaced by the following:
‘(b)
repopulation occurs using molluscs that originate from establishments which are:’;
(iv)
in Chapter 6, in Section 3, in point (b), the introductory phrase is replaced by the following:
‘(b)
repopulation occurs using crustaceans that originate from establishments which are:’.
