Proposal for a Council Directive amending Directive 2000/29/EC as regards the delegation of the tasks of laboratory testing
Date: 2009-08-11
Institutions: European Commission
Subjects: EU Member State, delegation of power, health certificate, medical diagnosis, plant health control, plant health legislation, research body, scientific apparatus

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 11.8.2009 
COM(2009) 424 final 

2009/0117 (CNS) 

Proposal for a 

COUNCIL DIRECTIVE 

amending Directive 2000/29/EC as regards the delegation of the tasks of laboratory 
testing  

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

The  delegation  of  laboratory  tasks  to  subsidiary  bodies  in  the  context  of  official 
controls  to  be  performed  by  the  competent  authorities  of  the  Member  States  in  the 
plant  health  area  (Article  2(1)(g)(ii)  of  Directive  2000/29/EC1)  has  become  a 
recurrent  subject  of  discussion  these  last  years  between  the  Member  States  and  the 
Commission.  

On several occasions, Member States mentioned the difficulties to re-organise their 
national plant protection services in light of the current provisions of EU plant health 
legislation which require the bodies to which the laboratory tasks may be delegated 
to be charged exclusively with specific public functions.  

The provisions for delegation were introduced in the Directive in 1991. Since then, 
the  structure  and  tasks  of  the  plant  health  authorities  of  the  Member  States  have 
evolved. In several Member States the organisations to which the official laboratory 
analyses  could  be  delegated  (universities  and  research  organisations,  private 
laboratories)  would  frequently  not  meet  the  requirements  of  Article  2(1)(g)(ii)  of 
Directive 2000/29/EC and possible risks of conflict of interests could also show up. 
However, involvement of such organisations is needed for very specialised analyses 
for  the  detection  and  confirmation  of  harmful  organisms  that  are  not  present  in  the 
EU  and  for  which  expertise  is  limited.  Also,  laboratory  tests  carried  out  in  the 
framework  of  Directive  2000/29/EC  are  highly  technical  tasks  requiring  widely 
different technical facilities and highly specialised and scarce laboratory staff. 

In order to adapt the requirements on the delegation of laboratory testing to existing 
needs, it appears appropriate to modify at short term Article 2(1)(g)(ii) of Directive 
2000/29/EC.  In  a  Council  working  Party  which  was  held  on  December  2007,  a 
majority of the Chief Plant Health officers (COPHS) supported this approach. 

2. 

CONSULTATION OF STAKEHOLDERS AND IMPACT ASSESSMENT 

A light scoping paper illustrating the issue has been produced in April 2008. Because 
of  the  limited  impact  of  the  proposed  changes,  no  full  impact  assessment  of  the 
proposed changes was deemed necessary. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL  

The  proposed  amendments  to  Article  2(1)(g)(ii)  of  Directive  2000/29/EC  would 
include:  

1 

Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the 
Community  of  organisms  harmful  to  plants  or  plant  products  and  against  their  spread  within  the 
Community, OJ L 169, 10.7.2000, p. 1. 

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A  provision  to  allow  legal  persons  carrying  out  delegated  tasks  to  diversify 
their  activities  with  other  laboratory  testing  activities  than  those  referred  to 
under that Directive; 

A  provision  allowing  delegation  of  laboratory  testing  to  legal  persons  which 
are  not  charged  exclusively  with  public  functions  in  the  framework  of  that 
Directive; 

In both cases, provisions ensuring that the delegated tasks provided for under 
the  Directive  remain  under  the  authority  and  supervision  of  the  responsible 
official  bodies  in  a  Member  State  and  that  those  responsible  official  bodies 
verify  that  the  legal  persons  in  question  are  impartial  and  free  of  conflict  of 
interest as regards the execution of the delegated tasks. 

4. 

BUDGETARY IMPLICATIONS 

This  proposal  for  a  Council  Directive  has  no  financial  implications  for  the 
Community budget. 

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2009/0117 (CNS) 

Proposal for a 

COUNCIL DIRECTIVE 

of 

amending Directive 2000/29/EC as regards the delegation of the tasks of laboratory 
testing  

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 37 thereof, 

Having regard to the proposal from the Commission, 

Having regard to the opinion of the European Parliament,2 

Whereas: 

(1) 

(2) 

(3) 

Under  Council  Directive  2000/29/EC  of  8  May  2000  on  protective  measures  against 
the introduction into the Community of organisms harmful to plants or plant products 
and against their spread within the Community3 the responsible official bodies in the 
Member  States  may  only  delegate  the  tasks  provided  for  in  that  Directive,  including 
laboratory testing, to a legal person which under its officially approved constitution is 
charged exclusively with specific public functions. 

The  laboratory  tests  which  have  to  be  carried  out  in  the  framework  of  Directive 
2000/29/EC  are  of  a  highly  technical  nature  and  concern  different  scientific  fields. 
Such  tests  require  a  wide  range  of  different  and  expensive  technical  facilities  and 
highly  specialised  laboratory  staff  capable  of  adapting  to  the  rapid  development  of 
diagnostic methodology. The number of tests to be carried out has been growing over 
recent  years.  As  a  result,  it  has  grown  increasingly  difficult  to  find  legal  persons 
fulfilling all the necessary requirements.  

For these reasons it is appropriate to provide that the numerous and diverse laboratory 
tests required under Directive 2000/29/EC may, in addition to legal persons which are 
exclusively  charged  with  specific  public  functions,  be  delegated  to  legal  persons  not 
fulfilling  this  requirement,  such  as  universities,  research  institutes  or  private 
laboratories, provided that they satisfy certain conditions. 

2 
3 

OJ C […], […], p. […]. 
OJ L 169, 10.7.2000, p. 1. 

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(4) 

At the same time it is appropriate to allow legal persons carrying out delegated tasks in 
accordance  with  Directive  2000/29/EC  to  use  their  laboratories  for  testing  activities 
which do not form part of their specific public functions. 

(5) 

Article 2(1)(g) of Directive 2000/29/EC should therefore be amended accordingly. 

HAS ADOPTED THIS DIRECTIVE:  

Article 1 

The second subparagraph of Article 2(1)(g) of Directive 2000/29/EC shall be replaced by the 
following:  

'The  responsible  official  bodies  in  a  Member  State  may,  in  accordance  with  national 
legislation,  delegate  the  tasks  provided  for  in  this  Directive  to  be  accomplished  under  their 
authority  and  supervision  to  a  legal  person,  whether  governed  by  public  or  by  private  law, 
provided  that  such  person,  and  its  members,  has  no  personal  interest  in  the  outcome  of  the 
measure it takes. The responsible official bodies in the Member States shall ensure that such a 
legal  person  is,  under  its  officially  approved  constitution,  charged  exclusively  with  specific 
public  functions,  with  the  exception  of  laboratory  testing  which  such  a  legal  person  may 
perform even where it is not part of its specific public functions. 

However,  notwithstanding  the  second  sentence  of  the  second  subparagraph,  the  responsible 
official  bodies  in  a  Member  State  may  delegate  the  laboratory  testing  provided  for  in  this 
Directive  to  a  legal  person  which  does  not  comply  with  that  provision,  provided  that  the 
responsible official body concerned shall ensure throughout the time of the delegation that the 
legal person to which it delegates laboratory testing remains impartial and that no conflict of 
interest exists between the exercise of the tasks delegated to it and its other activities.'  

Article 2 

Member  States  shall  adopt  and  publish,  by  30  June  2010  at  the  latest,  the  laws,  regulations 
and  administrative  provisions  necessary  to  comply  with  this  Directive.  They  shall  forthwith 
communicate to the Commission the text of those provisions and a correlation table between 
those provisions and this Directive. 

They shall apply those provisions from 1 July 2010. 

When Member States adopt those provisions, they shall contain a reference to this Directive 
or be accompanied by such a reference on the occasion of their official publication. Member 
States shall determine how such a reference is to be made. 

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

Article 3 

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Article 4 

This Directive is addressed to the Member States. 

Done at Brussels, 

For the Council 
The President 

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