Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Directive 92/66/EEC introducing Community measures for the control of Newcastle disease
Date: 2017-12-06
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, EU reference laboratory, action programme, avian influenza, poultry, protection of animal life, veterinary inspection, veterinary medicine

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   EUROPEAN COMMISSION  Brussels, 6.12.2017  COM(2017) 742 final 2017/0329 (COD)  Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Directive 92/66/EEC introducing Community measures for the control of Newcastle disease (Text with EEA relevance)  
 
 
1. 

LEGAL CONTEXT OF THIS DIRECTIVE 

EXPLANATORY MEMORANDUM 

Council Directive 92/66/EEC lays down measures to be applied in the event of an outbreak of 
Newcastle disease in poultry and in certain birds. Among other things, the Directive confers 
on the Council, acting by qualified majority on a proposal from the Commission, the power to 
amend  the  Directive's  Annexes.  Inter  alia,  the  Council  has  therefore  the  power  to  amend, 
Annexes V, VI and VII which cover the designation of an EU Reference Laboratory (EURL) 
for Newcastle disease, the template to be used by Member States to report to the Commission 
on  the  situation  of  the  disease,  and  the  control  measures  applied,  as  well  as  the  criteria  for 
Member  States  to  draw  up  contingency  plans  to  be  implemented  in  the  event  of  a  disease 
outbreak. 

Those empowerments conferred on the Council are at odds with the new system of legislation 
and  executive  rule-making  introduced  by  the  Treaty  on  the  Functioning  of  the  European 
Union (TFEU), more specifically with Article 291. Furthermore, in relation to the designation 
of EURLs, the current provisions for amending Annex V of Council Directive 92/66/EEC are 
inconsistent  with  the  new  designation  regime  for  EURLs  introduced  by  Regulation  (EU) 
2017/625 on Official Controls ('OCR'). This Regulation requires the Commission to designate 
EURLs by means of implementing acts.  

The objective  of this  Proposal is to amend Council  Directive  92/66/EEC to  be aligned with 
the TFEU and new official control provisions in order to ensure legal coherence and certainty 
to enable the necessary simplification of procedures.  

The current European Reference Laboratory (EURL) for Newcastle disease is located in the 
United Kingdom. Hence, it needs to be replaced by an EURL located in one of the other 27 
Member  States  in  view  of  the  United  Kingdom  exiting  the  EU.  The  current  procedure  for 
designating an EURL for Newcastle disease is via a Council Directive. Therefore, an aligned 
and simplified decision procedure is urgently needed to enable the new EURL to be properly 
functioning by the date when the United Kingdom will exit the EU. This technical revision of 
the Directive will enable the use of the required implementing procedure to designate a new 
EURL for Newcastle disease within the tight deadlines related to BREXIT. 

Whilst the main objective is to align the Directive in question with the TFEU and EU rules on 
the designation of EURLs, the measures proposed will also provide greater legal consistency 
and more streamlined implementing procedures. 

2. 

CONSULTATIONS PRIOR TO THE ADOPTION OF THIS DIRECTIVE 

The  revision  of  Directive  92/66/EEC  concerns  purely  necessary  technical  changes.  Those 
changes are needed to ensure consistency with the TFEU and Regulation (EU) 2017/625 on 
official controls. Stakeholders were widely consulted on both the Treaty and the Regulation. 

In addition, considering the purely technical/procedural nature of the intended changes, a full 
public  consultation  strategy  is  not  considered  necessary  in  this  specific  case.  The  4-week 
feedback mechanism on the Roadmap will apply. 

3. 

LEGAL BASIS OF THIS DIRECTIVE 

The legal basis is Article 43(2) TFEU. 

4. 

BUDGETARY IMPLICATION 

The proposal does not imply incurring any expenditure which is not already foreseen in the 
financial statement of the common financial  framework. No additional human resources  are 
envisaged either. 

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2017/0329 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Council Directive 92/66/EEC introducing Community measures for the 
control of Newcastle disease 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 43(2) thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 
Having regard to the opinion of the European Economic and Social Committee1, 

Acting in accordance with the ordinary legislative procedure, 

Whereas:  

(1) 

(2) 

(3) 

(4) 

(5) 

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Council  Directive  92/66/EEC2  lays  down  the  Union  control  measures  to  be  taken  in 
the  event  of  an  outbreak  of  Newcastle  disease  in  poultry,  racing  pigeons  and  other 
birds kept in captivity.  

Article  15  of  Directive  92/66/EEC  provides  that  the  European  Union  reference 
laboratory for Newcastle disease is referred to in Annex V to that Directive. Annex V 
to that Directive duly refers to that laboratory and lists its functions and duties.  

Article  19  of  Directive  92/66/EEC  lays  down  control  measures  to  be  taken  by  the 
Member States in the event that carrier pigeons or birds kept in captivity are suspected 
of being infected with Newcastle disease. It provides that to the extent required for the 
proper  application  of  those  control  measures,  the  Member  States  are  to  furnish  the 
Commission  with  information  on  the  disease  situation  and  the  control  measures 
applied in accordance with the model form set out in Annex VI to that Directive. 

Article  21  of  Directive  92/66/EEC  provides  that  Member  States  are  to  draw  up 
contingency plans, specifying the national measures to be implemented in the event of 
an outbreak of Newcastle disease. It provides that the criteria to be applied for drawing 
up those plans are set out in Annex VII to that Directive. 

Article  24  of  Directive  92/66/EEC  provides  that  the  Annexes  thereto  are  to  be 
amended,  as  and  when  required,  by  the  Council  acting  by  a  qualified  majority  on  a 
proposal  from  the  Commission,  in  particular  to  take  into  account  developments  in 
research and in diagnostic procedures.  

OJ C […], […], p. […]. 
Council  Directive  92/66/EEC  of  14  July  1992  introducing  Community  measures  for  the  control  of 
Newcastle disease (OJ L 260, 5.9.1992, p. 1). 

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(6) 

(7) 

Annexes V, VI and VII to Directive 92/66/EEC set out respectively (i) the indication 
of  the  European  Union  reference  laboratory  for  Newcastle  disease  as  well  as  its 
functions  and  duties,  (ii)  the  model  form  to  be  used  by  Member  States  in  order  to 
report on the disease situation and the control measures applied; and (iii) the criteria to 
be applied by Member States for drawing up contingency plans specifying the national 
measures to be implemented in the event of an outbreak of Newcastle disease.  

In order to simplify and streamline the procedures regarding the control of Newcastle 
disease, in particular taking into account the new rules in relation to the designation of 
European Union reference laboratories provided for by Article 93 of Regulation (EU) 
2017/625 of the European Parliament and of the Council3, and also the new system of 
implementing acts provided for in Article 291 of the Treaty on the Functioning of the 
European Union, and to ensure uniform conditions for the implementation of Directive 
92/66/EEC,  Annexes  V,  VI  and  VII  to  Directive  92/66/EEC  should  be  deleted  and 
implementing powers in the fields covered by those Annexes should be conferred on 
the  Commission.  Those  powers  should  be  exercised  in  accordance  with  Regulation 
(EU) No 182/2011 of the European Parliament and of the Council4.  

(8) 

For  reasons  of  clarity,  the  functions  and  duties  of  the  European  Union  reference 
laboratory  for  Newcastle  disease  should  be  laid  down  in  Article  15  of  Directive 
92/66/EEC, and the criteria for the contingency plans should be laid down in Article 
21 of that Directive.  

(9) 

For  reasons  of  consistency  and  efficiency,  Member  States  should  ensure  timely 
transposition of the provisions of this Directive.  

(10)  Directive 92/66/EEC should therefore be amended accordingly, 

HAVE ADOPTED THIS DIRECTIVE:  

Article 1 
Amendments to Directive 92/66/EEC 

Directive 92/66/EEC is amended as follows:  

(1) 

Article 15 is replaced by the following:  

‘Article 15 

1. 

The Commission shall, by means of implementing acts, designate a European 
Union  reference  laboratory  for  Newcastle  disease.  Those  implementing  acts 
shall  be  adopted  in  accordance  with  the  examination  procedure  referred  to  in 
Article 25. 

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Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official 
controls and other official activities performed to ensure the application of food and feed law, rules on 
animal  health  and  welfare,  plant  health  and  plant  protection  products,  amending  Regulations  (EC) 
No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) 
No  652/2014,  (EU)  2016/429  and  (EU)  2016/2031  of  the  European  Parliament  and  of  the  Council, 
Council  Regulations  (EC)  No  1/2005  and  (EC)  No  1099/2009  and  Council  Directives  98/58/EC, 
1999/74/EC,  2007/43/EC,  2008/119/EC  and  2008/120/EC,  and  repealing  Regulations  (EC) 
No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 
89/608/EEC, 89/662/EEC,  90/425/EEC, 91/496/EEC, 96/23/EC,  96/93/EC and 97/78/EC and  Council 
Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1). 
Regulation  (EU)  No  182/2011  of  the  European  Parliament  and  of  the  Council  of  16  February  2011 
laying down the rules and general principles concerning mechanisms for control by the Member States 
of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). 

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2. 

The  functions  and  duties  of  the  European  Union  reference  laboratory  for 
Newcastle disease shall be the following:  

(a) 

to  coordinate,  in  consultation  with  the  Commission,  the  methods 
employed  in  the  Member  States  for  diagnosing  Newcastle  disease, 
specifically by: 

(i) 

(ii) 

typing, storing and supplying strains of the Newcastle disease virus 
for serological tests and the preparation of antisera; 

supplying standard sera and other reference reagents to the national 
reference laboratories in order to standardise the tests and reagents 
used in the Member States; 

(iii)  building  up  and  retaining  a  collection  of  Newcastle  disease  virus 

strains and isolates; 

(iv)  organising periodical comparative tests of diagnostic procedures at 

Union level; 

(v) 

collecting  and  collating  data  and  information  on  the  methods  of 
diagnosis used and the results of tests carried out in the Union; 

(vi)  characterising isolates of Newcastle disease viruses by the most up-
to-date methods available to promote a greater understanding of the 
epidemiology of Newcastle disease; 

(vii)  keeping abreast of developments in Newcastle disease surveillance, 

epidemiology and prevention throughout the world; 

(viii)  retaining  expertise  on  Newcastle  disease  virus  and  other  pertinent 

viruses to enable a rapid differential diagnosis; 

(ix)  acquiring a  thorough knowledge  of  the preparation and use  of the 
products  of  veterinary  immunology  used  to  eradicate  and  control 
Newcastle disease; 

(b) 

to actively assist in the diagnosis of outbreaks of Newcastle disease in 
Member States by receiving virus isolates for confirmatory diagnosis, 
characterisation and epidemiology studies; 

(c) 

to  facilitate  the  training  or  retraining  of  experts  in  laboratory  diagnosis 
with a view to the harmonisation of techniques throughout the Union.’; 

(2) 

Article 19 is amended as follows: 

(a) 

paragraph 5 is replaced by the following: 

‘5.  To the extent that it is required for the proper application of the measures 
laid  down  in  this  Article,  the  Member  States  shall  submit  to  the 
Commission, within the framework of the Standing Committee on Plants, 
Animals,  Food  and  Feed,  information  on  the  disease  situation  and  the 
control measures applied.’; 

(b) 

the following paragraph 6 is added: 

6. 

The  Commission  may,  by  means  of  implementing  acts,  lay  down  rules 
regarding  the  information  to  be  submitted  by  the  Member  States  to  the 
Commission  as  provided  for  in  paragraph  5.  Those  implementing  acts 

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shall  be  adopted in  accordance  with the examination  procedure referred 
to in Article 25.’  

(3) 

Article 21 is replaced by the following:  

‘Article 21 

1. 

Each Member State shall draw up a contingency plan, specifying the national 
measures to be implemented in the event of an outbreak of Newcastle disease. 
The  contingency  plan  shall  be  updated,  as  appropriate,  to  take  account  of 
developments in the situation. 

The contingency plan must allow access to facilities, equipment, personnel and 
all other appropriate materials necessary for the rapid and efficient eradication 
of  the  outbreak  of  Newcastle  disease.  It  must  give  a  precise  indication of  the 
vaccine  requirements  which  each  Member  State  deems  necessary  for 
emergency vaccination. 

The  contingency  plans  and  any  updates  thereto  shall  be  submitted  to  the 
Commission. 

The Commission shall examine the contingency plans and any updates thereto 
in order to determine whether they permit the desired objective to be attained 
and shall suggest to the Member State concerned any amendments required in 
particular  to  ensure  that  they  are  compatible  with  those  of  the  other  Member 
States. 

The Commission shall approve the contingency plans and any updates thereto, 
if necessary amended,  in  accordance  with  the examination procedure referred 
to in Article 25. 

The Commission may, by means of implementing acts, lay down criteria to be 
applied  by  Member  States  for  drawing  up  the  contingency  plans.  Those 
implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 25.’ 

2. 

3. 

4. 

(4) 

Article 25 is replaced by the following: 

‘Article 25 

1. 

The  Commission  shall  be  assisted  by  the  Standing  Committee  on  Plants, 
Animals,  Food  and  Feed  established  by  Article  58(1)  of  Regulation  (EC) 
No 178/2002 of the European Parliament and of the Council(*). That committee 
shall be a committee within the meaning of Regulation (EU) No 182/2011 of 
the European Parliament and of the Council(**). 

2.  Where  reference  is  made  to  this  Article,  Article  5  of  Regulation  (EU) 

No 182/2011 shall apply. 

_________________________ 

(*) 

Regulation  (EC)  No  178/2002  of  the  European  Parliament  and  of  the  Council  of  28  January 
2002  laying  down  the  general  principles  and  requirements  of  food  law,  establishing  the 
European  Food  Safety  Authority  and  laying  down  procedures  in  matters  of  food  safety 
(OJ L 31, 1.2.2002, p. 1). 

(**)  Regulation  (EU)  No  182/2011  of  the  European  Parliament  and  of  the  Council  of 
16 February 2011  laying  down  the  rules  and  general  principles  concerning  mechanisms  for 
control by the Member States of the Commission’s exercise of implementing powers (OJ L 55, 
28.2.2011, p. 13).’; 

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(5) 

Annexes V, VI and VII are deleted. 

Article 2 
Transposition  

By 30 June 2018, Member States shall adopt and publish the measures necessary to  comply 
with this Directive. They shall immediately inform the Commission thereof. 

They shall apply those measures from 1 January 2019. 

When Member States adopt those measures, they shall contain a reference to this Directive or 
be accompanied by such a reference on the occasion of their official publication. The methods 
of making such reference shall be laid down by Member States. 

Article 3 
Transitional provision 

The designation of the Community reference laboratory for Newcastle disease referred to in 
Annex  V  to  Directive  92/66/EEC,  before  the  amendments  made  by  this  Directive,  shall 
remain effective until a European Union reference laboratory for Newcastle disease has been 
duly  designated  in  accordance  with  Article  15  of  Directive  92/66/EEC,  as  amended  by  this 
Directive.  

Article 4 
Entry into force 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 5 
Addressees 

This Directive is addressed to the Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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