COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to Article 294(6) of the Treaty on the Functioning of the European Union concerning the position of the Council on the adoption of a Regulation of the European Parliament and of the Council concerning the placing on the market and use of biocidal products
Date: 2011-08-11
Institutions: European Commission
Subjects: chemical product, cost-effectiveness analysis, economic analysis, market approval, plant health control

EUROPEAN COMMISSION 

Brussels, 11.8.2011 
COM(2011) 498 final 

2009/0076 (COD) 

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT pursuant to Article 294(6) of the Treaty on the Functioning of the 
European Union concerning the 

position of the Council on the adoption of a Regulation of the European Parliament and 
of the Council concerning the placing on the market and use of biocidal products 

 
 
 
 
  
 
2009/0076 (COD) 

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT pursuant to Article 294(6) of the Treaty on the Functioning of the 
European Union concerning the 

position of the Council on the adoption of a Regulation of the European Parliament and 
of the Council concerning the placing on the market and use of biocidal products 

1. 

BACKGROUND 

Please note that this Communication refers to the title of the Regulation and the numbers of 
articles as they were presented in the text of the political agreement (17474/10). 

Date of transmission of the proposal to the European Parliament and 
to the Council 
(document COM(2009) 267 final – 2009/0076 COD): 

12 June 2009 

Date  of  the  opinion  of  the  European  Economic  and  Social 
Committee: 

17 February 2010 

Date of the opinion of the European Parliament, first reading: 

22 September 2010 

Date of adoption of the position of the Council: 

21 June 2011 

2. 

OBJECTIVE OF THE PROPOSAL FROM THE COMMISSION 

The  objective  of  the  proposal  is  to  improve  the  functioning  of  the  internal  market  through 
further  harmonisation  of  the  rules  on  the  authorisation  and  mutual  recognition  of  biocidal 
products, whilst ensuring a high level of protection of both human and animal health and the 
environment. 

3. 

COMMENTS ON THE POSITION OF THE COUNCIL 

3.1. 

General comments 

The  European  Parliament  gave  its  opinion  at  first  reading  on  22  September  2010.  The 
Commission accepted in full, in part or in principle 193 of the 309 amendments adopted by 
the European Parliament in its first reading. Around half of these 193 amendments are already 
reflected,  at  least  in  part,  in  the  common  position.  The  position  of  the  Commission  on  the 
amendments  adopted  by  the  European  Parliament  in  its  first  reading  is  set  out  in  document 
SP(2010)7193. 

The  Commission  accepted  amendments,  either  fully  or  in  principle  or  in  part,  which  would 
clarify  the  context  of  the  proposal  or  further  improve  it.  These  include,  in  particular, 
modifications to the definition of biocidal products, the scope of derogations under exclusion 
criteria, the extension of the scope of the Union authorisation, the criteria for low-risk biocidal 
products and the provisions on treated articles. 

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The Commission rejected amendments which would alter the nature of the proposal, such as 
amendments  which  lower  the  level  of  environmental  and  human  health  protection  or 
undermine  the  internal  market  in  biocidal  products.  It  also  rejected  amendments  that  are 
practically or technically not feasible or pose an unnecessary burden for the industry and the 
competent authorities. 

The Commission considers that the common position does not alter the key objectives of the 
proposal and can thus support it. Nevertheless, the Commission considers that certain aspects 
of  the  text  should  be  improved  and  would  be  happy  to  work  with  the  other  institutions  in 
order to make such improvements. In particular, with regard to the procedures foreseen for the 
establishment  of  Maximum  Residue  Levels,  the  wording  of  the  common  position  is  not 
compatible with Regulation (EC) No 470/2009 and this inconsistency should be addressed as 
a priority. 

3.2. 

Detailed comments 

3.2.1.  Parliamentary  amendments  accepted  in  full,  in  part  or  in  principle  by  the 

Commission and incorporated in full, in part or in principle in the common position 

Amendments 1, 4-7, 9-10, 13, 21-23, 25, 27, 30-35, 37-39, 43-44, 49, 53, 55, 56, 58, 62-63, 
70, 75, 79, 80, 82-83, 85-91, 93-96, 112, 115, 116, 123-125, 137, 139, 142-144, 160-161, 165, 
167-172,  178-181,  183-187,  189-190,  194,  199,  206-215,  218-220,  225-232,  234-235,  239, 
241-242,  247-249,  255-257,  266-267, 269, 272, 275-277, 279, 292-296, 299-303,  308, 310-
312, 316, 319-320, 323-329, 331-332, 341, 346-347, 354, 359/rev and 360-361 were accepted 
in  full,  in  part  or  in  principle  by  the  Commission  and  incorporated  in  full,  in  part  or  in 
principle in the Council's position.  

3.2.2.  Parliamentary amendments rejected by the Commission but incorporated in full, in 

part or in principle in the common position 

Amendments 2, 3, 17, 20, 52, 54, 69, 71, 126, 156 and 349 were rejected by the Commission 
but incorporated in the Council's position in full, in part or in principle. These amendments 
mainly concern reduced time limits for the inclusion and renewal of inclusion of candidates 
for substitution as well as other active substances and shorter deadlines for certain tasks to be 
carried out by the European Chemicals Agency (further 'the Agency'). While the Commission 
rejected them on grounds that they would increase the administrative and regulatory burden 
by  adding  to  the  workload  of  the  Agency,  Member  States  and  economic  operators  without 
clear  benefits  in  terms  of  improved  levels  of  protection,  the  Council  considered  them 
acceptable. 

3.2.3.  Parliamentary  amendments  accepted  in  full,  in  part  or  in  principle  by  the 

Commission but not incorporated in the common position 

Amendments 11, 16, 24, 36, 48, 58-59, 62, 65-66, 72-74, 77-78, 99, 101, 106, 118, 120-121, 
157, 162, 166, 175, 178, 191, 193, 196, 200, 203-204, 221-223, 236, 332, 358 and 361 were 
accepted  in  full,  in  part  or  in  principle  by  the  Commission  but  not  incorporated  in  the 
Council's  position.  The  most  common  reasons  for  the  rejection  of  the  amendments  by  the 
Council  are  inconsistency  with  other  changes  introduced  by  the  Council,  placing  of  undue 
administrative  burden  on  industry,  competent  authorities  or  the  Agency  and  no  clear  added 
value of the amendments. 

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3.2.4.  Parliamentary  amendments  rejected  by  the  Commission  and  the  Council  and  not 

incorporated in the common position 

Amendments 12, 14-15, 19, 26, 28, 40-42, 45-47, 50-51, 57, 64, 81, 84, 92, 97-98, 100, 102-
105, 107-111, 117, 119, 122, 127-136, 138, 140-141, 145-147, 150, 158-159, 163-164, 173-
174, 176, 182, 188, 192, 195, 197-198, 201, 205, 216-217, 224, 233, 237-238, 240, 246, 250-
253, 258-259, 262-265, 270-271, 274, 280-288, 291, 297, 306-307, 309, 318, 321-322, 330, 
342-343, 350 and 353 were rejected by both the Commission and the Council.  

3.2.5.  Changes made by the Council to the Proposal  

The Council proposed the following main changes to the Commission proposal: 

Inclusion  of  active  substances:  the  Council  has  changed  the  procedure  for  the  approval  of 
inclusions of active substances. The list of approved active substances would not be included 
as an Annex to the Regulation but would be established as a free standing measure through 
implementing measures and regularly updated. The Commission considers that the approval 
of  active  substances  should  be  undertaken  by  using  an  Annex  to  the  Regulation. 
Consequently, any additions or amendments to the annex listing approved active substances 
would constitute changes to non-essential elements of the Regulation and would be adopted 
through delegated acts based on Article 290 TFEU. However, in order to allow the legislative 
procedure  to  continue,  it  will  not  oppose  the  changes  introduced  by  the  Council.  The 
Commission has made a declaration on this matter at the time of the political agreement (see 
Annex 1). 

Simplified authorisation procedure: the Council replaced the concept of 'low-risk biocidal 
products' with products subject to a simplified authorisation procedure. The criteria proposed 
for these products would be more focused on the properties of the substances contained in the 
product rather than on a case by case risk assessment of the product itself as was the case in 
the  Commission's  proposal.  These  products  would  no  longer  be  subject  to  a  Union  level 
authorisation  procedure  as  foreseen  in  the  Commission's  proposal  but  would  instead  be 
submitted  for  authorisation  in  one  Member  State.  Once  an  authorisation  is  granted  in  one 
Member State, the product could then, subject to the submission of a notification, be marketed 
in each of the  other Member States.  The  Commission considers that the Council's approach 
will encourage the development and marketing of biocidal products that present a lower risk 
to man and the environment and can therefore accept the Council's position on this issue. 

The  scope  of  the  Union  authorisation:  According  to  the  Council's  position,  the  Union 
authorisation would, as of 2013, be open for biocidal products falling within product types 6, 
7, 9, 10, 12, 13 and 22 and, as of 2020, for biocidal products falling within product types 14, 
15, 17, 21 and 23, provided that the products concerned have similar conditions of use across 
the Union. At the latest by 2017, the Commission would carry out a review and accompany it, 
if  appropriate,  with  legislative  proposals;  e.g.  to  postpone  the  opening  of  the  Union 
authorisation for some or all product types listed. While the Commission initially proposed a 
Union  authorisation  system  with  much  more  limited  scope,  it  can,  in  principle,  accept  the 
Council's  position  provided  the  extension  is  implemented  gradually  and  that  adequate 
resources  are  provided  to  the  Agency  and  the  Commission.  The  Commission  has  made  a 
declaration underlining the resource implications and calling on the Member States to take the 
consequent  steps  to  ensure  the  provision  of  adequate  resources  under  the  new  financial 
perspectives (see Annex 2). 

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Treated  articles:  In  line  with  the  approach  taken  by  the  European  Parliament,  the  Council 
introduced the 'primary biocidal function' as the criterion for differentiating between biocidal 
products  and  treated  articles.  Furthermore,  it  shifted  the  focus  of  control  from  biocidal 
products to active substances. The Council decided to impose stricter requirements for treated 
articles  where  the  active  substances  are  intended  to  be  released  ('external  effect')  than  for 
treated articles where the active substances are not intended to be released ('internal effect'). 
Further rules may be adopted by the Commission, including the possibility of a notification 
scheme. The Commission can support these changes concerning treated articles as they are in 
line with the objectives of the Regulation. 

Nature  and  composition  of  the  Biocidal  Products  Committee:  the  Commission  initially 
proposed  the  Committee  to  be  composed  of  independent  scientific  experts  who  would  be 
nominated  by  the  Member  States  but  appointed  by  the  Management  Board  of  the  Agency. 
The Council opted for an approach according to which the members of the Committee would 
be  directly  appointed  by  the  Member  States  and  there  would  be  close  links  between  the 
Committee  and  Member  States'  competent  authorities.  Given  that  the  responsibility  for  the 
detailed  implementation  of  the  Regulation  will  fall  on  the  competent  authorities  in  the 
Member  States  it  is  coherent  that  these  same  authorities  should  be  closely  involved  in  the 
work  of  the  Biocidal  Products  Committee.  The  Commission  can,  therefore,  accept  the 
Council's position. 

Fees: the Commission initially proposed a system whereby the fee for a Union authorisation 
would be paid to the Agency which would then reimburse the Member State for the work as 
an evaluating competent authority. The Council's position is based on a system where for the 
procedures  carried  out  at  the  Union  level,  one  fee  is  paid  to  the  Agency  for  its  work  and 
another  is  paid  to  the  competent  authority  which  carries  out  the  role  of  the  evaluating 
competent  authority.  This  is  acceptable  to  the  Commission.  Further,  the  Commission's 
proposal  foresaw  that  the  amount  of  fees  payable  to  the  Agency  as  well  as  the  harmonised 
structure (including issues such as reimbursements, reductions/waiving) of fees applicable to 
both  the  Agency  and  the  Member  States  would  be  adopted  by  means  of  delegated  acts. 
However, the Council's position foresees that the level of fees payable to the Agency and the 
rules defining conditions of payment and possible reductions should be adopted by means of 
implementing acts. With regard to the establishment of a harmonised structure of fees for the 
Agency and the Member States, Council has provided that the Commission may address these 
questions through guidance documents. Whilst the Commission regrets the approach taken by 
the  Council,  it  can  accept  it  in  order  to  allow  for  the  legislative  procedure  to  continue.  The 
Commission made a declaration set out in Annex 1 with respect to the Council's position on 
the use of delegated acts for setting the fees payable to the Agency. 

To  take  account  of  the  resource  implications  resulting  from  the  changes  introduced  by  the 
Council and the Parliament in the first reading, including the need to adjust the fee system as 
a  way  to  reduce  the  impact  on  the  Union  budget,  the  Commission  has  prepared  a  revised 
financial statement which is attached as Annex 3 to this Communication. 

4. 

CONCLUSION 

The  changes  introduced  by  the  Council  are  acceptable  to  the  Commission  as  they  are 
consistent  with  the  objectives  of  the  Commission's  proposal  and  further  build  upon  it. 
Therefore the Commission can accept the Council's position. 

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The  Commission  already  outlined  its  concerns  over  the  increased  resource  implications 
resulting for the Agency and the Commission in the declaration set out in Annex 2. In light of 
the additional tasks allocated to the Agency and the time needed to prepare all aspects of its 
future  work  as  well  as  the  fact  that  the  legislative  process  is  taking  longer  than  initially 
anticipated, the Commission considers it necessary to postpone the date of applicability of the 
proposed Regulation to 1 September 2013 with the exception of provisions which allow the 
Commission  and  the  Agency  to  take  preparatory  steps  (e.g.  delegated/implementing 
acts,guidance documents). 

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Annex 1 

Declaration on comitology 

In a spirit of compromise, the Commission will not stand against a qualified majority vote in 
favour  of  the  Presidency  text.  However,  the  Commission  would  underline  that  it  does  not 
share the views of the Council that the measures for the approval of active substances (Article 
8a) and for rules on fees payable to the European Chemicals Agency (Article 70(1)) are of an 
implementing nature and thus fall under Article 291 TFEU. As regards both these matters, the 
Commission  is  of  the  view  Article  290  is  the  appropriate  procedure  given  that  they  entail 
measures  of  general  application  which  would  modify  or  supplement  the  non-essential 
elements of the Regulation. 

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Annex 2 

Declaration on resource implications 

The extension of the scope of the Union authorisation together with additional tasks allocated 
to  the  European  Chemicals  Agency,  the  shorter  deadlines  and  the  increased  frequency  of 
renewals for active substances will necessarily result in a significant increase in the workload 
of the Agency and the Commission. At the same time, the workload for national authorities 
will accordingly be reduced as a result of a wider scope of Union authorisation. In light of the 
increased  workload,  the  Agency  and  the  Commission  will  need  additional  financial  and 
human  resources  to  ensure  effective  implementation  of  the  Regulation.  In  view  of  this,  the 
Commission  calls  on  the  Council  to  address  these  requirements  under  the  new  financial 
perspectives. The Commission is prepared to work with the Council on a suitable solution.  

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Annex 3 

LEGISLATIVE FINANCIAL STATEMENT FOR PROPOSALS 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1.  Title of the proposal/initiative  

1.2.  Policy area(s) concerned in the ABM/ABB structure 

1.3.  Nature of the proposal/initiative  

1.4.  Objective(s)  

1.5.  Grounds for the proposal/initiative  

1.6.  Duration and financial impact  

1.7.  Management method(s) envisaged  

2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

2.2.  Management and control system  

2.3.  Measures to prevent fraud and irregularities  

3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

3.1.  Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget  line(s) 
affected  

3.2.  Estimated impact on expenditure  

3.2.1. Summary of estimated impact on expenditure  

3.2.2. Estimated impact on operational appropriations  

3.2.3. Estimated impact on appropriations of an administrative nature 

3.2.4. Compatibility with the current multiannual financial framework 

3.2.5. Third-party participation in financing  

3.3.  Estimated impact on revenue

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LEGISLATIVE FINANCIAL STATEMENT FOR PROPOSALS 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative  

Proposal  for  a  regulation  of  the  European  Parliament  and  of  the  Council  concerning  the 
placing on the market and use of biocidal products. 

1.2. 

Policy area(s) concerned in the ABM/ABB structure1  

Policy area: 07 Environment  

Activity Code 07 03: Implementation of Union environmental policy and legislation 

1.3. 

Nature of the proposal/initiative  

X The proposal/initiative relates to a new action  

(cid:133) The proposal/initiative relates to a new action following a pilot project/preparatory action2  

(cid:133) The proposal/initiative relates to the extension of an existing action  

(cid:133) The proposal/initiative relates to an action redirected towards a new action  

1.4. 

Objectives 

1.4.1.  The Commission's multiannual strategic objective(s) targeted by the proposal/initiative 

Development of New Policy Initiatives (ABB code 07 05) – 2008 AMP 

To  prepare  and  propose  environment  policies,  measures  and  initiatives,  based  on 
comprehensive  and  precise  data  on  the  state  of  the  environment  and  pressures  on  it, 
consulting  widely  with  interested  parties,  implementing  the  6th  EC  Environment  Action 
Programme.  To  prepare  policy  responses  that  may  be  necessary  in  the  light  of  new 
evidence of threats to the environment, or to human health from the environment. 

1.4.2. 

Specific objective(s) and ABM/ABB activity(ies) concerned 

Specific objective No.1c 

To  develop  new  policy  initiatives  to  contribute  to  the  objectives  of  the  6th  EAP  priority 
area of environment and health. Contribute to a high level of quality of life and social well 
being for citizens by providing an environment where the level of pollution does not give 
rise  to  harmful  effects  on  human  health  and  the  environment  and  by  encouraging  a 
sustainable urban development. 

ABM/ABB activity(ies) concerned ABB code 07 05 

1 
2 

ABM: Activity-Based Management – ABB: Activity-Based Budgeting. 
As referred to in Article 49(6)(a) or (b) of the Financial Regulation. 

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1.4.3.  Expected result(s) and impact 

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 

The objectives of the proposal are to ensure a high level of protection of public health and 
the environment as well as the harmonisation of the internal market for biocidal products, 
while enhancing competitiveness and innovation.   

To achieve these objectives it is necessary that the hazards and risks from active substances 
and  biocidal  products  are  fully  known  before  they  are  placed  on  the  market. 

To  ensure  the  efficient  implementation  of  the  proposal  it  is  appropriate  to  rely  on  the 
existing  European  Chemicals  Agency,  which  will  receive  and  deliver  opinions  on  data 
submitted  by  industry,  for  example,  for  the  evaluation  of  active  substances  or  certain 
biocidal products, and will be the focal point for providing scientific advice and assistance 
to  the  Commission,  to  Member  State  competent  authorities,  to  enterprises,  especially 
SMEs, and for making relevant information available to the public. 

The  harmonisation  of  the  internal  market  for  biocidal  products  and  the  enhancement  of 
competitiveness and innovation will be strengthened by having a coherent approach to the 
treatment  of  applications  submitted  by  industry,  by  simplifying  procedures  for  the 
authorisation  of  products,  and  by  encouraging  the  development  of  ‘new’  substances  and 
products  having  a  better  public  health  or  environmental  profile,  so  as  to  enable  the 
European Union to compete better with its international competitors, and bring about the 
greater availability of substances or products with lower risks. 

1.4.4. 

Indicators of results and impact 

Specify the indicators for monitoring implementation of the proposal/initiative. 

The objectives and indicators identified to date are as follows: 

Objectives 

Indicators for the policy 

Assessment  of  new  active  substances  in 
view of their approval 

Number of opinions delivered. 

Renewal of approval of active substances 

Number of opinions delivered. 

Time from reception of a valid application to 
transmission of opinion to the Commission. 

Establishment  of 
between active substances 

technical  equivalence 

Time from reception of a valid application to 
transmission of opinion to the Commission. 

Number of opinions delivered. 

Time from reception of a valid application to 
transmission of opinion to the Commission. 

Authorisations of products  

Number of opinions delivered. 

Time from reception of a valid application to 
transmission of opinion to the Commission. 

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Opinion  in  case  of  disagreement  during 
mutual recognition procedures 

Number of opinions delivered. 

Time  from  reception  of  a  Commission 
request  to  transmission  of  opinion  to  the 
Commission. 

Tasks 
related 
confidentiality 

to  data 

sharing  and 

Number of searches in the database. 

Number  of  request  for  information  for  non-
confidential data. 

Development  of  general  and  specific 
guidance documents 

Number of guidance documents developed. 

Maintenance  of  Union  register  on  biocidal 
products 

Number of searches in the database 

Completion  of  the  review  programme  of 
existing substances 

Number of opinions delivered. 

Time  from  reception  of  a  draft  Competent 
authority report to finalisation of Competent 
authority report. 

1.5. 

Grounds for the proposal/initiative  

1.5.1.  Requirement(s) to be met in the short or long term  

Before  any  active  substance  can  be  authorised  for  use  in  a  biocidal  product,  it  must  be 
assessed whether its use poses any unacceptable risk for the environment or public health. 
This assessment is done by Member State competent authorities followed by a peer review 
organised at the Union level, before a decision is taken by the Commission. 

In addition, to improve  the  authorisation process of biocidal products, it is proposed that 
certain products will be authorised directly at the Union level at the choice of the applicant. 
Other categories of biocidal products will continue being authorised at Member State level. 

Also,  for  biocidal  products  to  be  authorised  by  the  Member  States,  through  the  mutual 
recognition  procedure,  divergence  of  opinions  between  Member  States  will  need  to  be 
addressed  through  an  ad  hoc  conflict  resolution  procedure.  Most  of  these  divergences  of 
opinions are expected to be of a scientific or a technical nature.  

Processes aimed at facilitating data sharing between prospective applicants, at establishing 
technical equivalence of substances manufactured from different sources, at disseminating 
information,  at  identifying  active  substance  manufacturers  entitled  to  place  their  active 
substance on the Union market will also have to be improved and or developed. 

Last, genuine scientific and technical support, including the development and maintenance 
of IT tools, for the implementation of the Regulation will need to be provided. 

All these tasks are described in further details in Appendix II. 

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1.5.2.  Added value of EU involvement 

Until  today  the  Commission  Joint  Research  Centre  provides  a  significant  input  to  the 
review  programme  of  existing  active  substances3.  However,  with  the  downsizing  of  its 
activities in the field of chemical substances due to the transfer of many of these activities 
to ECHA, the Commission JRC already announced that it would also stop its activities in 
the  field  of  biocidal  products  at  the  end  of  2013  and  would  then  concentrate  on  other 
priorities. 

As  the  Commission  services  will  then  no  longer  have  the  expertise  and  resources  to 
address issues of scientific or technical nature linked to the evaluation of active substances 
and  the  authorisation  of  biocidal  products,  it  was  considered  most  appropriate  to  seek 
advice and support from an external body. 

Relying  on  an  external  body  to  carry  out  the  risk  assessment  is  also  in  line  with  the 
approach  adopted  in  other  sectors  such  as  medicinal  products,  plant  protection  products, 
food,  where  there  is  a  clear  separation  between  risk  assessment  (carried  out  by  scientific 
bodies) and risk management (carried out by the Commission). 

Having excluded the possibility of establishing a specific body to be in charge of the risk 
assessment  of  active  substances  and  biocidal  products,  three  existing  bodies  were 
considered  as  possible  candidates  to  provide  this  scientific  and  technical  support  in  the 
field of biocides: 

-  The  European  Agency  for  the  Evaluation  of  Medicinal  Products  (EMEA),  because  the 
proposal  to  authorise  certain  biocidal  products  at  the  Union  level  is  modelled  upon  the 
lines and principles of what already exist since 1995 for medicinal products for veterinary 
and human use; 

-  The  European  Food  Safety  Authority  (EFSA),  because  Directive  98/8/EC  is  often 
referred  to  as  the  sister  Directive  of  Directive  91/414/EEC  regulating  the  placing  on  the 
market  of  plant  protection  products  and  where  EFSA  is  the  official  scientific  body  in 
charge of preparing opinions for the Commission; and 

- The European Chemicals Agency (ECHA). 

Limited synergies can however be expected from the first two options. On the other hand, 
the  choice  of  ECHA  is  expected  to  create  significant  synergies,  on  the  basis  of  the 
following considerations: 

3 

The current Directive 98/8/EC provides for the systematic evaluation of active substances, which were already 
on the market on 14 May 2000, when that Directive came into force. This evaluation is carried out by Member 
States,  which  have  all  been  allocated  a  number  of  substances  for  which  they  have  to  produce  assessment 
reports. These assessment reports are then peer reviewed by the other Member States and discussed at different 
meetings  organised  by  the  Commission  JRC  for  the  scientific  and  technical  issues  and  then  by  DG 
Environment  for  the  final  discussions  before  the  final  steps  of  the  decision-making  process  are  taken 
(Comitology procedure). The scientific and technical discussions and the associated preparatory work (reading 
the reports and analysing the different issues) require significant resources, which are currently provided by the 
Commission JRC and financed under the LIFE + programme under budget line 07 03 07. 

EN 

13 

   EN 

 
                                                 
- First and foremost, the evaluation of active substances used in biocidal products follows 
many of the methodologies and principles that also apply to chemical substances regulated 
under  the  REACH  Regulation.  Data  requirements  are  similar  and  the  risk  assessment  of 
these substances, notably when they have certain hazardous properties, is even of the direct 
competence of ECHA. 

-  In  addition,  the  proposal  includes  rules  concerning  data  sharing  for  biocidal  products, 
which have now been aligned on those of REACH and makes the sharing of data involving 
testing on vertebrate animals mandatory. Only REACH and ECHA have already set up the 
mechanisms and the databases to make such sharing possible. 

- Another important element of choice is that many of the ECHA scientific staff is already 
familiar with biocidal products, through previous work at the Commission JRC, in Member 
States Competent Authorities as well as in industry. 

-  Last  but  not  least,  producers,  downstream  users  of  biocidal  products  and  even  the 
Commission already have a number of obligations under REACH. Notably, the data held 
by  the  Commission  JRC  relating  to  active  substances  under  evaluation  in  the  review 
programme shall be made available to ECHA, in accordance with the provision of Article 
16 of the REACH Regulation. 

For  these  reasons,  it  is  felt  that  the  ECHA,  amongst  the  other  options  at  hand  -  a  new 
agency, the Commission JRC, the EMEA or EFSA - is the most effective one in terms of 
possible synergies . 

In  addition,  with  the  phasing  out  of  the  Commission  JRC  support  concerning  the  review 
programme  of  existing  active  substances  announced  for  the  end  of  2013,  ECHA  is 
expected to take over that role from 2014 onwards. 

The  legislative  proposal  therefore  relies  on  the  assumption  that  a  number  of  tasks  of  a 
scientific  and  technical  nature  related  to  the  assessment  of  active  substances  used  in 
biocidal products and of certain biocidal products will be given to ECHA. 

To this end, financial resources are needed to ensure that ECHA has the appropriate level 
of staff and is able to convene as many meetings as necessary to deliver its opinions to the 
Commission. 

EN 

14 

   EN 

 
1.5.3.  Lessons learned from similar experiences in the past 

The  proposal  is  based  on  the  conclusions  of  a  study  carried  out  in  2007  to  analyse  the 
deficiencies  of 
this  study  (available  at 
http://ec.europa.eu/environment/biocides/study.htm) were incorporated in the Commission 
report  on  the  impacts  of  the  implementation  of  Directive  98/8/EC  (available  at 
http://ec.europa.eu/environment/biocides/impl_report.htm). 

the  current  Directive.  The  results  of 

The  Impact  Assessment  carried  out  by  the  Commission  addresses  five  policy  issues  that 
require action: the extension of the scope of the Regulation to include articles and materials 
treated  with  biocidal  products;  the  improvement  of  procedures  for  product  authorisation 
with  the  possibility  to  authorise  certain  products  at  the  Union  level;  the  introduction  of 
mandatory data-sharing at product authorisation and active substance approval stage along 
the  principles  of  the  REACH  Regulation;  a  clarification  on  data  requirements  with  a 
combination of data waiving with the use of existing information and a new approach for 
low-risk  biocidal  products;  a  partial  harmonisation  of  fee  structure  to  encourage  the 
development  of  more  new  active  substances  and  the  retention  of  more  existing  active 
substances. 

1.5.4.  Coherence and possible synergy with other relevant instruments 

See 1.5.2. 

1.6. 

Duration and financial impact  

(cid:133) Proposal/initiative of limited duration  

–  (cid:133)  Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY  

–  (cid:133)  Financial impact from YYYY to YYYY  

X Proposal/initiative of unlimited duration4 

1.7.  Management mode(s) envisaged5  

X Centralised direct management by the Commission  

X Centralised indirect management with the delegation of implementation tasks to: 

–  (cid:133)  executive agencies  

4 

5 

The duration of the action is not limited in time as the proposal establishes the rules applicable to the placing 
on the market of biocidal products. The financial impact is, however, expected to be limited to supporting the 
European  Chemicals  Agency  (ECHA)  in  taking  up  the  additional  tasks  related  to  the  assessment  of  active 
substances used in biocidal products and of certain biocidal products. ECHA will indeed receive from industry 
specific  fees  for  certain  of  these  activities  as  well  as  an  annual  fee  for  products  authorised  by  the  Union. 
It is expected that ECHA will be taking steps to prepare for these tasks from the year 2011. As 2013 is the last 
year of the current financial programming, estimates of the commitment and payment appropriations have been 
limited to that of 2012 and 2013 in this financial statement. 
A  detailed  analysis  of  the  ECHA  budget  for  these  additional  tasks  is  provided  in  appendixes  to  this  revised 
financial statement for the years 2012 and 2013 as well as for the next 8 following years (i.e. until 2021), in 
order to match the timetable attached to the REACH revised legislative Financial Statement (SEC(2006)924). 
Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: 
http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html 

EN 

15 

   EN 

 
                                                 
 
–  X  bodies set up by the Communities6  

–  (cid:133)  national public-sector bodies/bodies with public-service mission  

–  (cid:133)  persons entrusted with the implementation of specific actions pursuant to Title V of 
the  Treaty  on  European  Union  and  identified  in  the  relevant  basic  act  within  the 
meaning of Article 49 of the Financial Regulation  

(cid:133) Shared management with the Member States  

(cid:133) Decentralised management with third countries  

(cid:133) Joint management with international organisations (to be specified) 

If more than one management mode is indicated, please provide details in the "Comments" section. 

Comments  

The overall responsibility for the implementation and enforcement of the proposed legislation will 
rest with the Commission services. However, the scientific and technical support will be provided 
by the European Chemicals Agency. ECHA will in particular have to provide opinions on the level 
of risk presented by active substances used in biocidal products as well as on the authorisations of 
certain biocidal products. ECHA will provide opinions on the basis of which the Commission will 
take decisions. 

2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

Specify frequency and conditions. 

In  order  to  evaluate  the  progress  of  implementation  and  effects  of  the  new  policy,  the 
indicators  as  set  out  in  1.4.4  will  be  gathered and  monitored  at  regular  intervals.  For  the 
most part, this will be done as part of the normal activity of ECHA on an annual basis. 

In addition to this, Member States shall submit to the Commission every three years a report on 
enforcement and control measures and results of these measures. The Commission shall also 
draw  up  a  report  on  the  implementation  of  the  Regulation  and  in  particular  on  the 
functioning  of  the  Union  authorisation  procedure  and  on  the  implementation  of  the 
provisions concerning treated articles. 

2.2.  Management and control system  

2.2.1.  Risk(s) identified  

As  the  Council  text  would  significantly  increase  the  workload  for  ECHA  and  the 
Commission, increased resources would need to be provided to cover the additional tasks 
to be carried out. 

6 

As referred to in Article 185 of the Financial Regulation. 

EN 

16 

   EN 

 
                                                 
Increased resources are provided through this revised financial statement. However, it will 
need  to  be  monitored  over  time  whether  these  resources  correspond  correctly  with  these 
additional tasks. 

2.2.2.  Control method(s) envisaged  

As indicated in Section 2.1, ECHA will report annually on the progress of implementation 
and on the effects of the new policy. Member States will also report every three years on 
enforcement  and  control  measures.  This  information  will  be  used  by  the  Commission  in 
order to prepare the report on the implementation of the Regulation. 

Also,  in  view  of  the  number  of  assumptions  and  the  degree  of  uncertainties  with  the 
different calculations underlying this financial statement, ECHA staff levels will have to be 
reviewed on an annual basis taking into account the real volume of activities. 

2.3.  Measures to prevent fraud and irregularities  

Specify existing or envisaged prevention and protection measures. 

The  European  Chemicals  Agency  has  specific  budgetary  control  mechanisms  and 
procedures which are based on Regulation (EC, Euratom) No 2343/2002. 

The Management Board of ECHA, which comprises representatives of the Member States, 
the  Commission  and  the  European  Parliament  (Article  79(1)  of  the  REACH  Regulation), 
produces an estimate of the revenue and expenditure of ECHA (Article 96(5)) and adopts 
the final  budget (Article  96(9)).  Each year, the  provisional and final accounts are sent to 
the  European  Court  of  Auditors  (paragraphs  4  and  7  of  Article  97).  The  European 
Parliament  gives  a  discharge  to  the  Executive  Director  of  ECHA  regarding  the 
implementation of the budget (Article 97(10)). 

In  order  to  combat  fraud,  corruption  and  other  unlawful  activities,  the  provisions  of 
Regulation (EC) No 1073/1999 concerning investigations conducted by the European Anti-
Fraud  Office  (OLAF)  apply  without  restrictions  to  ECHA,  in  accordance  with  Article 
98(1) of Regulation (EC) No 1907/2006. 

In accordance with Article 98(2), ECHA is also bound by the Inter-institutional Agreement 
of  May 25, 1999  concerning  internal  investigations  by  the  European  Anti-Fraud  Office 
(OLAF). 

EN 

17 

   EN 

 
3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

3.1. 

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget  line(s) 
affected  

•  Existing expenditure budget lines  

Heading of 
multiannual 
financial 
framework 

Budget line 

Type of  
expenditure

Contribution  

Number  
[Description………………………...……….] 

Diff./non-
diff 
(7) 

from 
EFTA8 
countries 

from 
candidate 
countries9 

from third 
countries 

within the meaning 
of Article 18(1)(aa) 
of the Financial 
Regulation  

07 03 60 01 

2 

2 

European  Chemicals  Agency  -  Activities  in 
the field of biocides legislation - Contribution 
to Titles 1 and 2 from Heading 2 

07 03 60 02  

European Chemicals Agency -Activities in the 
field of biocides legislation - Contribution to 
Title 3 from Heading 2 

Diff. 

YES 

NO 

NO 

NO 

Diff. 

YES 

NO 

NO 

NO 

These  budget  lines  will  cover  ECHA’s  staff  and  administrative  expenditure  (titles  1  and  2)  and 
ECHA's  operating  expenditure  (title  3)  for  the  activities  to  be  carried  out  in  the  field  of  biocidal 
products  in  accordance  with  this  Regulation,  as  part  of  the  annual  subsidy  to  the  European 
Chemicals Agency (ECHA) from the Union budget (in addition to any appropriations granted under 
budget items 02 03 03 01 and 02 03 03 02 to finance the activities of the REACH Regulation (EC) 
No 1907/2006 and CLP Regulation (EC) No 1272/2008). 

•  No new budget lines are requested  

7 
8 
9 

Diff. = Differentiated appropriations 
EFTA: European Free Trade Association.  
Candidate countries and, where applicable, potential candidate countries from the Western Balkans. 

EN 

18 

   EN 

 
                                                 
3.2. 

Estimated impact on expenditure  

3.2.1. 

Summary of estimated impact on expenditure  

Heading of multiannual financial 
framework:  

2 

Conservation  and  management  of  natural  resources  (including  market 
expenditure and direct payments) 

EUR million (to 3 decimal places) 

DG: ENV 

201210 

2013 

Estimates of the operational 
appropriations are limited to 
the current financial 
programming running until 
2013. 

TOTAL 

(cid:121) Operational appropriations  

Number of budget line: 07 03 60 01 

Number of budget line: 07 03 60 02 

of 

Appropriations 
administrative 
from the envelope for specific programmes11  
Number of budget line 

an 

TOTAL appropriations 
for DG ENV 

Commitments 

Payments 

Commitments 

Payments 

(1) 

(2) 

(1a) 

(2a) 

nature 

financed 

1,507 
1,507 
1,249 
1,249 

4,050 
4,050 
2,302 
2,302 

Commitments 

(3) 

=1+1a 
+3 

2,756 

6,352 

Payments 

=2+2a 

2,756 

6,352 

5,557 
5,557 
3,551 
3,551 

9,108 

9,108 

10 

11 

EN 

Expenditure for 2012 are based on the subsidy to ECHA from the date of adoption onwards. Some preparatory measures are also financed in 2011 and 2012 under the LIFE 
Programme (budget line 07 03 07) for an estimated amount of 1,500 M€. 
Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former "BA" lines), indirect research, direct 
research. 

19 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
(cid:121) TOTAL operational appropriations  

Commitments 

Payments 

(cid:121)  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes  

+3 

(4) 

(5) 

(6) 

2,756 

6,352 

2,756 

6,352 

TOTAL appropriations  
under HEADING 2 
of the multiannual financial framework 

Commitments 

=4+ 6 

2,756 

6,352 

Payments 

=5+ 6 

2,756 

6,352 

  9,108 

  9,108 

  9,108 

  9,108 

EN 

20 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Heading of multiannual financial 
framework:  

5 

Administrative expenditure 

EUR million (to 3 decimal places) 

Estimates of the administrative appropriations are 
limited to the current financial programming 
running until 2013. 

TOTAL 

2012 

2013 

DG: ENV 

(cid:121) Human resources  

(cid:121) Other administrative expenditure  

0,204 

0,204 

TOTAL DG ENV 

Appropriations  

0,204 

0,204 

TOTAL appropriations 
under HEADING 5 
of the multiannual financial framework  

(Total 
= Total payments) 

commitments 

0,204 

0,204 

0,408 

0,408 

0,408 

2012 

2013 

Estimates of the total appropriations are limited to 
the current financial programming running until 
2013. 

TOTAL 

EUR million (to 3 decimal places) 

TOTAL appropriations  
under HEADINGS 1 to 5 
of the multiannual financial framework  

Commitments 

2,960 

6,556 

Payments 

2,960 

6,556 

9,516 

9,516 

EN 

21 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.2.  Estimated impact on operational appropriations  

–  (cid:133)  The proposal/initiative does not require the use of operational appropriations  

–  X  The proposal/initiative requires the use of operational appropriations, as explained below: 

Commitment appropriations in EUR million (to 3 decimal places) 

Indicate 
objectives and 
outputs  

2012 

2013 

Estimates of the operational appropriations are limited to the current financial 
programming running until 2013. 

TOTAL 

OUTPUTS 

(cid:216) 

Type 
of 
output
12 

Avera
ge 
cost  
of the 
output 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

Total 
number 
of 
outputs 

Total  
cost 

SPECIFIC OBJECTIVE No 1: 

ECHA scientific and technical 
support 

Please refer to Appendix 1 for a detailed breakdown of ECHA’s costs and to Appendix 2 for the main underlying 
assumptions. 

TOTAL COST 

2,756 

6,352 

9,108 

12 

Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.). 

EN 

22 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.3.  Estimated impact on appropriations of an administrative nature 

3.2.3.1.  Summary  

–  (cid:133)  The  proposal/initiative  does  not 

require 

the  use  of  administrative 

appropriations  

–  X  The  proposal/initiative  requires  the  use  of  administrative  appropriations,  as 

explained below: 

EUR million (to 3 decimal places) 

2012 

2013 

Estimates of the administrative appropriations are limited to the 
current financial programming running until 2013. 

TOTAL 

HEADING 5 
of the multiannual 
financial framework 

Human resources  

07  01  02  11  01  – 
Missions 

0,02413 

0,024 

07  01  02  11  03  – 
Committees  

0,18014 

0,180 

Other administrative 
expenditure  

Subtotal HEADING 5 
of the multiannual 
financial framework  

0,204 

0,204 

  0,408 

Additional resources will be required to cover participation in meetings held in ECHA and for 
the organisation of an increased number of meetings of the Standing Committee on Biocidal 
Products. 

TOTAL 

0,204 

0,204 

  0,408 

13 
14 

20 2-day missions to Agency per year at 1,200 EUR per mission 
Standing Committee on Biocidal Products: 6 one-day meetings per year at 30,000 EUR/meeting 

EN 

23 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.3.2.  Estimated requirements of human resources  

–  (cid:133)  The proposal/initiative does not require the use of human resources  

–  X  The  proposal/initiative  requires  the  use  of  human  resources,  as  explained 

below: 

Estimate to be expressed in full amounts (or at most to one decimal place) 

2012 

2013 

Estimates of human resources are limited to 
the current financial programming running 
until 2013 

(cid:121) Establishment plan posts (officials and temporary agents) 

07 01 01 01 (Headquarters and Commission’s 
Representation Offices) 

0 

3 

XX 01 01 02 (Delegations) 

XX 01 05 01 (Indirect research) 

10 01 05 01 (Direct research) 

(cid:121) External personnel (in Full Time Equivalent unit: FTE)15 

XX 01 02 01 (CA, INT, SNE from the "global 
envelope") 

XX 01 02 02 (CA, INT, JED, LA and SNE in 
the delegations) 

XX 01 04 yy 16 

- at Headquarters17 

- in delegations  

XX 01 05 02 (CA, INT, SNE - Indirect 
research) 

10 01 05 02 (CA, INT, SNE - Direct research) 

Other budget lines (specify) 

TOTAL 

0 

3 

No additional staff will be necessary in 2012. Three additional posts will be required in 2013. 
These posts will be provided through internal re-deployment. See Appendix IV for a detailed 
breakdown. 

Description of tasks to be carried out: 

Officials and temporary agents 

Additional staff is required to process the opinions received from ECHA and to turn 
these opinions into Commission decisions through delegated and implementing acts. 

External personnel 

15 

16 
17 

CA= Contract Agent; INT= agency staff ("Intérimaire"); JED= "Jeune Expert en Délégation" (Young 
Experts in Delegations); LA= Local Agent; SNE= Seconded National Expert;  
Under the ceiling for external personnel from operational appropriations (former "BA" lines). 
Essentially  for  Structural  Funds,  European  Agricultural  Fund  for  Rural  Development  (EAFRD)  and 
European Fisheries Fund (EFF). 

EN 

24 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.4.  Compatibility with the current multiannual financial framework  

–  (cid:133)  Proposal/initiative is compatible the current multiannual financial framework. 

–  X  Proposal/initiative  will  entail  reprogramming  of  the  relevant  heading  in  the 

multiannual financial framework. 

Explain what reprogramming is required, specifying the budget lines concerned and the corresponding 
amounts. 

2,960 M€ in 2012 (1,507 M€ for budget line 07 03 60 01 and 1,249 M€ for budget line 07 03 60 02) 

6,556 M€ in 2013 (4,050 M€ for budget line 07 03 60 01 and 2,302 M€ for budget line 07 03 60 02) 

–  (cid:133)  Proposal/initiative requires application of the flexibility instrument or revision 

of the multiannual financial framework18. 

3.2.5.  Third-party contributions  

–  The proposal/initiative does not provide for co-financing by third parties.  

18 

See points 19 and 24 of the Interinstitutional Agreement. 

EN 

25 

   EN 

 
                                                 
3.3. 

Estimated impact on revenue  

–  X  Proposal/initiative has no financial impact on revenue. 

–  (cid:133)  Proposal/initiative has the following financial impact: 

– 

– 

(cid:133) 

(cid:133) 

on own resources  

on miscellaneous revenue  

There is no impact on the revenue side of the Union budget. ECHA's budget foresees 
its own revenues consisting of the fees paid by industry, which ECHA is authorised 
to collect by virtue of the tasks entrusted to it under this Regulation and a balancing 
subsidy from the Union budget. 

The proposal foresees that ECHA would charge fees (see Appendix II), in particular 
for the approval and renewal of approval of active substances, for the evaluation of 
application  for  the  authorisation,  modification  of  authorisation  and  renewal  of 
authorisation of certain biocidal products at the Union level, as well as an annual fee 
to be paid by holders of Union authorisations and a submission fee to be paid by all 
applicants for a first national authorisation of a product.  

Although the activities relating to approval of active substances and authorisation of 
biocidal  products  are  expected  to  be  self-financed  after  a  few  years,  a  balancing 
subsidy from the Union budget could still be necessary, if the fee structure does not 
cover the expenses.  

The present financial fiche has been established with the hypothesis that some tasks 
would not be covered by the fees: 

– 

– 

– 

– 

– 

– 

Preparation of opinions on questions referred to ECHA by virtue of Article 30 
of  the  proposal,  in  case  of  disagreement  between  Member  States  during  a 
mutual recognition procedure 

Tasks related to data sharing and confidentiality 

Development of general and specific guidance documents 

Completion of Review Programme for existing substances 

Reductions for SMEs (as proposed in point (a) of Article 70(2)) 

Other tasks of Union interest not covered by fees 

Also, the proposal requires a clear separation of ECHA's budget between activities to 
be carried out in accordance with the provisions of the REACH Regulation and the 
new and additional tasks derived from this proposal. As a consequence, expenditures 
and  revenues  under  these  additional  tasks  have  to  be  clearly  identified  by  the 
accounting system of the Agency. 

EN 

26 

   EN 

 
Appendix I 

Draft Budget for the European Chemicals Agency (in Euros) 

Tasks related to biocidal products 

Expenditure 

Title1 
Salaries & allowances 
Other personnel costs* 

Total Title 1 

Title 2* 
20 Rental of building and associated costs 
21 Information & communication technology 
22 Movable property and associated costs 
23 Current administrative expenditure 
25 Meetings expenditure 

2012 

2013 

2014 

2015 

2016 

2017 

2018 

2019 

2020 

2021 

1.014.600 
157.300 

4.109.400 
637.000 

6.388.100 
990.200 

6.568.500 
1.018.100 

6.708.000 
1.039.700 

7.565.300 
1.172.600 

8.168.600 
1.266.100 

9.786.900 
1.517.000 

12.530.100 
1.942.200 

13.774.200 
2.135.000 

1.171.900 

4.746.400 

7.378.300 

7.586.600 

7.747.700 

8.737.900 

9.434.700 

11.303.900 

14.472.300 

15.909.200 

173.600 
115.100 
24.000 
21.900 
400 

703.100 
466.100 
97.300 
88.800 
1.700 

1.093.000 
724.500 
151.300 
138.100 
2.700 

1.123.900 
745.000 
155.500 
142.000 
2.800 

1.147.800 
760.800 
158.800 
145.000 
2.800 

1.294.500 
858.100 
179.100 
163.500 
3.200 

1.397.700 
926.500 
193.400 
176.600 
3.500 

1.674.600 
1.110.000 
231.700 
211.500 
4.100 

2.144.000 
1.421.200 
296.700 
270.800 
5.300 

2.356.800 
1.562.300 
326.100 
297.700 
5.800 

Total Title 2 

335.000 

1.357.000 

2.109.600 

2.169.200 

2.215.200 

2.498.400 

2.697.700 

3.231.900 

4.138.000 

4.548.700 

Title 3* 
3003-3006 Substances, products and technical equivalence 
3007 Assistance and guidance through helpdesk 
3008 Scientific IT tools** 
3009 Scientific and technical advice to EU institutions and bodies 
3011 Biocidal product committee 
3011 Fees paid to rapporteurs 
3012 Board of appeal 
3013 Communication including translations 
3022 Management Board and management of the Agency 
3030 Missions 
3031 External training 
38 International activities 

Total Title 3 

Total 

Revenues 

Union subvention 
Fee income of agency 
Over income to next year 

Total 
*Relative to staff costs (based on ECHA 2011budget) 
**Between 2014 and 2021, annual maintenance costs fixed at 20% of the initial development costs 

7.400 
50.000 
1.000.000 
8.300 
0 
0 
0 
100.000 
44.300 
25.000 
3.700 
10.900 

15.900 
59.500 
1.700.000 
17.900 
1.131.200 
56.000 
22.400 
300.000 
95.500 
25.800 
8.000 
46.900 

24.200 
90.800 
400.000 
27.300 
1.171.200 
111.000 
34.200 
200.000 
145.600 
39.300 
12.300 
71.500 

24.700 
92.400 
400.000 
27.800 
1.086.900 
271.000 
34.900 
200.000 
148.300 
40.000 
12.500 
72.800 

25.300 
94.600 
400.000 
28.400 
1.197.800 
275.000 
35.700 
200.000 
151.800 
41.000 
12.800 
74.500 

28.200 
105.400 
400.000 
31.700 
1.235.800 
444.800 
39.800 
200.000 
169.200 
45.700 
14.200 
83.000 

30.600 
114.500 
400.000 
34.400 
1.287.000 
452.600 
43.200 
200.000 
183.700 
49.600 
15.500 
90.200 

35.300 
132.200 
400.000 
39.700 
1.345.000 
474.000 
49.900 
200.000 
212.100 
57.200 
17.900 
104.100 

45.100 
169.000 
400.000 
50.800 
1.302.800 
874.000 
63.800 
200.000 
271.200 
73.200 
22.800 
133.100 

49.800 
186.500 
400.000 
56.000 
1.480.600 
880.000 
70.300 
200.000 
299.200 
80.800 
25.200 
146.900 

1.249.600 

3.479.100 

2.327.400 

2.411.300 

2.536.900 

2.797.800 

2.901.300 

3.067.400 

3.605.800 

3.875.300 

2.756.500 

9.582.500 

11.815.300 

12.167.100 

12.499.800 

14.034.100 

15.033.700 

17.603.200 

22.216.100 

24.333.200 

2.756.500 
0 
0 

6.351.800 
3.230.700 
0 

4.936.800 
6.878.500 
0 

3.151.800 
9.015.300 
0 

3.053.000 
9.446.800 
0 

1.842.200 
12.191.900 
0 

1.974.600 
13.059.100 
0 

2.954.300 
14.648.900 
0 

-322.800 
22.538.900 
0 

-1.386.400 
25.719.600 
0 

2.756.500 

9.582.500 

11.815.300 

12.167.100 

12.499.800 

14.034.100 

15.033.700 

17.603.200 

22.216.100 

24.333.200 

EN 

27 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix 

II 

Applied methodology and main underlying assumptions for the financial model of the 
European Chemicals Agency for activities relating to biocides 

At the time of the political agreement, the Commission made a statement pointing out that the 
Council  text  would  significantly  increase  the  workload  for  ECHA  and  the  Commission  and 
that increased resources would need to be provided to cover the additional tasks to be carried 
out. 

Concerning  the  role  of  ECHA,  the  Council's  political  agreement  has  introduced  some 
important changes as compared to the Commission's initial proposal: 

•  the  scope  of  the  EU  centralised  procedure  for  product  authorisation  has  been  widened 
significantly  which  will  mean  that  the  Agency  –  but  also  the  Commission  -  will  have  to 
process considerably more applications than initially foreseen; 

•  ECHA will have a greater involvement in data sharing in order to avoid duplicate testing 
on  vertebrates  and  will  also  be  called  upon  to  take  decisions  regarding  the  "technical 
equivalence" of similar active substances; 

•  ECHA is now explicitly identified as providing the secretariat for the co-ordinating group 

overseeing mutual recognition; 

•  ECHA will be responsible for maintenance of the Register for Biocidal Product which will 

also include information important in view of data sharing; 

•  Finally, ECHA will only receive the fees necessary for its work including the functioning 
of  the  Biocidal  Product  Committee.  Member  States  will  charge  their  own  fees  directly 
including  when  they  are  acting  as  an  evaluating  Member  State  for  an  application  at  EU 
Level. 

This revised financial fiche takes account of the additional workload both for ECHA and for 
the Commission.  

This revised financial fiche also takes into account the revised timing for the adoption of the 
Regulation. As the regulation is now expected to be adopted around mid-2012, the 2012 staff 
levels and resources have been adjusted accordingly. 

19  staff  will  be  needed  in  2012  rising  rapidly  to  59  in  2013  to  eventually  reach  110  by 
2021(further details are provided in Appendix III). 

The majority of ECHA's additional resource costs will be covered by the additional revenues 
derived from fees. However, there will need to be an EU subsidy for the early years to bridge 
the  gap  until  the  fee  revenues  achieve  a  sufficient  level.  ECHA  will  also  face  significant 
investment  costs  in  the  IT  system  necessary  to  manage  the  information  flow  linking 
applicants, Agency, Member States, the Commission and the general public.  

While  recognizing  that  the  Union  is  in  a  period  of  severe  financial  constraints,  it  is 
nevertheless unrealistic to load further tasks on ECHA and the Commission without allocating 
the resources necessary to carry out these additional tasks. 

EN 

28 

   EN 

 
 
Title 1 costs (staff costs) 

Due to the fact that the Commission JRC in Ispra currently has a major role in operating the 
review  programme  of  active  substances  used  in  biocidal  products  established  by  Directive 
98/8/EC,  significant  experience  exists  with  regard  to  how  long  certain  tasks  take  and  what 
kind  of  resources  are  needed  in  order  to  carry  them  out  (differentiation  between  different 
categories of staff). 

Based  on  this  experience  and  on  the  model  developed  for  the  operation  of  REACH,  a  staff 
model has been developed for the operation of the activities related to biocides. The output of 
this staff model is how many staff (by grade) are required in a given year to fulfil the tasks of 
ECHA (operational tasks of the biocides legislation).  

To these staff numbers additional resource requirements have been added for the management 
and training of these resources, taking into account economies of scale that can be achieved in 
particular in support tasks and staff from existing arrangements set up for the implementation 
of  the  REACH  Regulation  (e.g.  for  international  relations,  for  external  communication, 
helpdesk services, the Legal Department, Audit and Internal Control, Human Resources (HR), 
Finance,  Information  Technology  (IT)  Building  Management).  Based  on  the  current  ECHA 
staff  ratio,  these  additional  resources  amount  to  30%  of  those  required  for  the  operational 
tasks related to the biocidal legislation. 

For  the  scientific  staff,  the  ratio  in  %  of  AD  and  AST  grades  is  in  compliance  with  the 
REACH  staff  model.  As  is  the  case  for  staff  carrying  out  REACH  related  tasks,  a  higher 
number of AD than AST staff is justified because of the complexity of the scientific tasks. 

For  2012,  it  is  proposed  that  ECHA  should  be  able  to  recruit  staff  to  prepare  the  ground 
before the date when ECHA tasks relating to biocidal products come into operation.  

From 2013, ECHA would then be responsible for the different tasks set out in the proposal. 

From  2014,  the  responsibility  of  coordinating  the  review  programme  of  existing  substances 
would be transferred from the Commission JRC to ECHA. ECHA would therefore need extra 
resources  to  carry  out  this  additional  task.  Based  on  the  current  assumptions,  ECHA  would 
require  5  additional  scientific  officers  to  carry  that  task  (who  could  already  be  recruited  in 
second semester of 2013 to prepare the activities and ensure a smooth hand-over). It has also 
been taken into account that, based on the current pace of less than 30 dossiers being finalised 
every  year  by  Member  States,  the  Review  Programme  would  last  until  2024,  assuming  that 
the  pace  of  evaluation  would  speed  up  to  50  dossiers  being  finalised  every  year  as  certain 
dossiers could be grouped for substances supported in several product-types.  

Appendix III sets out the proposed establishment plan related to this proposal. The budget set 
out  in  Appendix  I  takes  into  account  permanent  /  temporary  staff  (i.e.  that  appears  in 
establishment  plan)  and  contract  agents  (count  for  staff  costs  but  do  not  appear  in 
establishment plan). 

All the resources computed have been multiplied by the average annual cost by grade and that 
has led to the total staff costs. In addition, the weighting factor for Helsinki (121.3% – cost of 
living adjustment applicable to all staff) and an annual indexation of 2% have been applied. 

EN 

29 

   EN 

 
The other personnel costs in Title 1 have been assumed to represent 15.5% of salary costs of 
permanent / temporary staff - based on the current ratio between Articles 110, 111, 119 and 
the other Articles of Title 1 of the 2011 Agency budget. 

Applied average costs for permanent/temporary staff by grade per annum (source ECHA) 

Grade 

AD 13 
AD 12 
AD 5-11 
AST 7-11 
AST 1-6 

Salary 
243.156 
195.900 
120.288 
104.778 
66.872 

Applied average costs for contract agents by function group per annum (source ECHA) 

Grade 

Salary 

FG IV 
FG III 
FG II 

55.632 
54.648 
34.992 

For the purpose of the computation of the staff required it has been assumed that per year the 
following resources would be needed: 

– 

– 

– 

– 

– 

a desk officer per 8 applications for product authorisation; 

a desk officer per 8 applications for new active substance evaluation; 

a desk officer per 20 applications for the establishment of technical equivalence; 

a desk officer per 30 applications to amend an existing product authorisation; 

a  desk  officer  per  20  opinions  requested  in  case  of  disagreement  during  Mutual 
Recognition. 

Title 2 costs (building, equipment and miscellaneous operating expenditure) 

All  building,  equipment,  furniture,  IT  and  other  administrative  expenditure  are  directly 
proportional to the number of required staff and have been assumed to represent - based on 
the current ratio between Title 1 and Title 2 of the 2011 Agency budget - 28.6% of the total of 
Title 1. 

Title 3 costs (Operating expenditure) 

The  major  cost  driver  for  the  general  operating  expenditure  is  the  expenditure  for  the 
Committee  for  Biocidal  Products.  The  current  average  cost  of  a  three  day  meeting  of  the 
ECHA Member State Committee is 70.000 EUR. 

For  the  Committee  for  Biocidal  Products  and  its  experts  groups,  the  costs  include  the 
to  currently  applicable 
reimbursement  of 
Commission rates. 

travel,  hotel,  daily  allowances  according 

EN 

30 

   EN 

 
 
 
 
 
 
The number of meeting-days/year of the Biocidal Products Committee has been set to 17 in 
2013. Thereafter the number of meetings will increase to reflect the proportional increase in 
the number of opinions to be delivered. 

The costs of sub-groups meetings has also been taken into account, assuming that there would 
be 4 sub-groups that would each meet 7 times a year on average during 2 days with 15 experts 
present in 2013 and 2014. Thereafter the number of meetings will also increase to reflect the 
proportional increase in the number of opinions to be delivered. 

There  is  no  coverage  for  the  meetings  of  the  Coordination  Group,  as  these  meetings  are 
planned  to  be  organised  in  ECHA  back-to-back  to  the  meetings  of  the  Biocidal  Products 
Committee. 

Awareness  rising  to  alert  companies  to  their  responsibilities  will  need  to  take  place  in  the 
early years of the coming into force of the Regulation – a specific campaign will need to be 
planned and executed. While the staff needs for this activity is covered by the horizontal and 
support  staff  the  work  will  also  require  a  budget  to  cover  the  cost  of  at  least  one  event 
(100.000  EUR);  the  production  and  translation  (into  22  languages)  of  Guidance,  an  IT 
manual,  simple  publications  explaining  the  legislation  and  its  implications  (400.000  EUR); 
webinars  for  companies  (10.000  EUR);  advertising  and  PR  support  (80.000  EUR);  and  a 
benchmarking survey at the start of the campaign for evaluation purposes (10.000 EUR). The 
costs of these activities are covered by the Communication budget for 2012, 2013 and 2014.  

Mission  costs  reflect  the  many  activities  (support  to  Commission  services,  IT  development, 
monitoring of the current review programme, awareness raising) which will require intensive 
contacts  with  the  Commission  services,  Member  States  competent  authorities,  industry  and 
other stakeholders. 

The IT costs reflect the future needs. 1 million EUR and 1.7 million EUR will be necessary in 
respectively 2012 and 2013 due to the complexity of the transactions, number of active users, 
and new elements. This would also bring future amounts to a level of 400,000 EUR per year 
since  maintenance  should  be  calculated  as  20%  of  the  initial  investment.  This  level  of 
maintenance  is  justified  especially  as  it  is  not  realistic  to  assume  a  stable  system  after  the 
initial investment without considerable evolving elements. 

It has also been assumed for the purpose of the computation of ECHA expenses that 12.5% of 
the  fee  paid  to  ECHA  would  be  paid  back  to  the  Rapporteur  in  charge  of  coordinating  the 
peer-review of the scientific evaluation carried out by the evaluating Competent Authority. 

EN 

31 

   EN 

 
Computation of expected fee income: 

It  is  assumed  that  ECHA  will  have  a  very  simple  fee  structure  for  tasks  related  to  biocidal 
products.  

For the purpose of the computation of the expected fee income it has been assumed that: 

– 

– 

– 

– 

– 

– 

– 

Fees for approval of an active substance amount to EUR 80,000 

Fees for renewal of an approval amount to EUR 20,000 when a thorough evaluation 
is required but can be reduced to 5,000 when this is not the case. 

Fees for amendments to product authorisation range from EUR 5.000 to EUR 20.000 
depending on the nature of the amendment and the extent to which data need to be 
re-assessed. 

Fees for the establishment of technical equivalence amount to EUR 20,000 

Fees  for  product  authorisation  amount  to  EUR  80,000  but  can  be  increased  to 
120.000, when there will be a need to perform a comparative risk assessment. 

Annual fees amount to EUR 20,000 

Submission fees for a first national authorisation of a product amount to EUR 4,000 

The specific needs of SMEs will be taken into account, as appropriate. 

The amounts of fees above were calculated to ensure that the Agency would function on the 
basis of full-costs recovery and become self-financed by 2021. 

It should be born in mind that a fee will also be charged by the evaluating Member State. For 
a product authorisation issued at Union level, applicants will thus have to pay EUR 80.000 to 
ECHA and another fee to the evaluating Member State. If one compares these fees with what 
would need to be paid in the case of mutual recognition (an evaluating fee to the Reference 
Member State and processing fees to the Concerned Member State), it is assumed that the fees 
charged for the centralised procedure will be of the same order of magnitude as those charged 
for a Mutual Recognition procedure involving 18, and possibly less, Member States, as one 
should  also  take  into  account  all  the  support  costs  associated  with  the  submission  of 
applications  in  different  Member  States  that  will  be  saved  for  companies  opting  for  the 
centralised procedure.  

The submission fee, to be paid by all applicants for a first national authorisation of a product, 
is  intended  to  cover  the  costs  of  ECHA  support  to  national  authorisation  and  mutual 
recognition  of  these  authorisations.  ECHA  will  indeed  provide  the  secretariat  to  the 
coordination group overseeing mutual recognition and an IT platform, which should be used 
by  applicants  for  the  submission  of  their  applications  and  the  dissemination  of  their 
application to Member States. 

One of the other underlying  assumptions for the computation of the expected fee income is 
the number of products for which applications for a Union authorisation will be submitted. 

EN 

32 

   EN 

 
The computation is rather complex and includes several parameters or assumptions: 

•  the number of products on the market today (20.000); 

•  the  proportion  of  products  to  be  eventually  supported  and  authorised  in  accordance  with 

the proposed Regulation (2/3);  

•  the  application  of  the  new  concept  of  biocidal  product  family,  which  will  facilitate  the 
authorisation  of  very  similar  products  through  one  application  and  decision  (it  was 
assumed that biocidal product families would contain 6 products on average for PT 1 to 5); 

•  the  timing  of  decisions  to  be  taken  regarding  the  approval  of  active  substances  in  the 

context of the Review programme for existing active substances; 

•  the obligation that products containing existing active substances should be authorised in 
accordance  with  the  proposed  Regulation  within  two  years  of  the  approval  of  active 
substances; 

•  the  product-types  included  in  the  scope  and  the  timelines  for  these  product-types  to  be 

eligible for the centralised procedure as proposed by the Council; 

•  30% of companies will opt for the centralised procedure when they will be in the position 

to do so. 

All this taken into account, it is expected that the number of applications will raise from 10 in 
2014 to 140 in 2021, as indicated in the table below: 

2013 

2014 

2015 

2016 

2017 

2018 

2019 

2020 

2021 

Applications/year 

0 

10 

40 

50 

70 

70 

70 

140 

140 

Similarly, the number of expected applications for the establishment of technical equivalence 
has been set to 50 per year in the early years of the coming into force of the Regulation, and to 
20 afterwards, as one would expect a peak of requests during these years, as companies will 
be  expected  to  seek  the  establishment  of  the  technical  equivalence  of  their  active  substance 
with  the  one  supported  under  the  Review  programme  for  existing  active  substances  before 
starting to negotiate data sharing agreements. 

2013 

2014 

2015 

2016 

2017 

2018 

2019 

2020 

2021 

Applications/year 

50 

50 

50 

20 

20 

20 

20 

20 

20 

Last but not least, in view of the number of assumptions and the degree of uncertainties with 
the different calculations, the staff levels will have to be reviewed on an annual basis taking 
into account the real volume of activities. 

As an indication, a revenue increase from fees of 200.000 EUR would allow a 1 FTE increase 
to the staff level and a EUR 40.000-addition to Title 3. Conversely, if fees do not materialize 
as expected, then staff and Title 3 costs should be also adjusted accordingly. 

EN 

33 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix III 

Staff requirements in full time equivalent (FTE) 

Completion of review programme 

Approval of new active substances 

Renewal of active substance approvals 

Technical equivalence 

Authorisation of biocidal products 

Amendments of Union authorisations 

Mutual Recognition disagreements 

Data sharing and confidentiality 

Communication and guidance 

Committees and board of appeal 

IT development and maintenance 

Support staff 

Overall Management 

Total staff 

2012 

2013 

2014 

2015 

2016 

2017 

2018 

2019 

2020 

2021 

5,0 

0,6 

0,2 

0,3 

2,5 

0,9 

1,0 

2,0 

0,7 

3,0 

0,8 

8,0 

2,0 

4,1 

0,8 

4,0 

2,0 

10,0 

2,0 

5,3 

2,0 

47 

12 

47 

12 

2,0 

5,0 

1,0 

4,0 

2,0 

3,0 

1,0 

1,0 

16 

3 

11 

8 

5,0 

1,3 

0,6 

0,2 

0,3 

2,5 

0,9 

1,3 

0,4 

2,0 

0,7 

3,0 

0,8 

5,0 

2,8 

4,2 

0,8 

4,0 

2,0 

9,0 

3,0 

5,2 

3,0 

43 

16 

50 

9 

5,0 

1,3 

0,6 

0,2 

2,5 

0,9 

5,0 

1,8 

0,2 

0,1 

2,0 

0,7 

2,0 

0,5 

5,0 

2,8 

4,1 

0,7 

3,0 

1,0 

10,0 

2,0 

5,3 

3,0 

45 

14 

50 

9 

5,0 

1,3 

0,6 

0,2 

1,0 

0,4 

5,0 

1,8 

0,8 

0,3 

2,0 

0,7 

2,0 

0,5 

5,0 

2,8 

4,2 

0,8 

3,0 

1,0 

9,0 

3,0 

5,2 

3,0 

44 

15 

50 

9 

5,0 

1,3 

0,6 

0,2 

0,2 

1,0 

0,4 

8,8 

3,1 

1,5 

0,5 

2,0 

0,7 

2,0 

0,5 

5,0 

2,8 

4,2 

0,8 

3,0 

1,0 

5,0 

1,3 

0,6 

0,2 

0,4 

1,0 

0,4 

8,8 

3,1 

2,7 

0,9 

2,0 

0,7 

2,0 

0,5 

5,0 

2,8 

4,3 

0,8 

3,0 

1,0 

5,0 

1,3 

0,6 

0,2 

4,0 

1,4 

1,0 

0,4 

8,8 

3,1 

3,8 

1,3 

2,0 

0,7 

2,0 

0,5 

5,0 

2,8 

4,3 

0,9 

3,0 

1,0 

5,0 

1,3 

0,6 

0,2 

6,0 

2,1 

1,0 

0,4 

5,0 

1,3 

0,6 

0,2 

6,0 

2,1 

1,0 

0,4 

17,5 

17,5 

6,1 

5,0 

1,8 

2,0 

0,7 

2,0 

0,5 

5,0 

2,8 

4,3 

0,9 

3,0 

1,0 

6,1 

6,0 

2,1 

2,0 

0,7 

2,0 

0,5 

5,0 

2,8 

4,5 

0,9 

3,0 

1,0 

11,0 

11,0 

14,0 

18,0 

17,0 

4,0 

5,5 

3,0 

50 

19 

60 

9 

4,0 

5,6 

3,0 

52 

20 

60 

12 

6,0 

10,2 

5,0 

63 

28 

80 

9 

7,0 

11,0 

5,0 

81 

29 

100 

10 

7,0 

11,1 

5,0 

81 

29 

100 

10 

AD 

AST 

AD 

AST 

AD 

AST 

AD 

AST 

AD 

AST 

AD 

AST 

AD 

AST 

AD 

AST 

AD 

AST 

AD 

AST 

AD 

AST 

AD 

AST 

AD 

AST 

AD 

AST 

TA 

CA 

Overall 

19 

59 

59 

59 

59 

69 

72 

87 

110 

110 

Draft Establishment Plan 

2012 

2013 

2014 

2015 

2016 

2017 

2018 

2019 

2020 

2021 

11 

47 

50 

50 

50 

60 

60 

80 

100 

100 

EN 

34 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
  
 
  
  
  
  
 
  
 
 
 
 
 
 
 
  
  
 
  
 
  
  
  
 
  
 
 
  
 
  
  
 
  
 
 
  
 
  
  
 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix IV 

Commission resources 

The number of opinions to be delivered by the Agency is expected to rise from 85 in 2013 to 
more than 400 in 2021 (see table below). 

2012 

2013 

2014 

2015 

2016 

2017 

2018 

2019 

2020 

2021 

Approval of new active substances 

of 

Approval 
substances 
Renewal  of  active 
approvals  

existing 

active 

substance 

Authorisation of biocidal products 

Amendments 
authorisations 

of 

Union 

Opinion  in  case  of  disagreement 
during Mutual Recognition 

5 

50 

0 

0 

0 

5 

50 

0 

0 

0 

30 

30 

5 

50 

3 

10 

0 

30 

5 

50 

3 

40 

5 

30 

5 

50 

0 

40 

25 

30 

5 

50 

0 

70 

45 

30 

5 

50 

2 

70 

80 

30 

5 

50 

4 

70 

5 

50 

40 

140 

115 

150 

30 

30 

Total 

85 

85 

98 

133 

150 

200 

237 

274 

415 

These  opinions  will  have  to  be  turned  into  Commission  decisions  through  delegated  and 
implementing acts. 

This  will  represent  a  significant  increase  to  the  current  workload,  for  which  additional 
resources will need to be provided. 

On the basis of the current practice and of the experience of other Commission services, it is 
estimated that one AST will be required for every 40 opinions. AD posts will also be needed 
to manage and coordinate the team of AST. 

The number of additional posts would thus rise from 2 in 2013 to 12 in 2021. 

2012 

2013 

2014 

2015 

2016 

2017 

2018 

2019 

2020 

2021 

AD 

AST 

Total 

1 

1 

2 

1 

1 

2 

1 

1 

2 

1 

3 

4 

1 

3 

4 

1 

5 

6 

1 

6 

7 

1 

7 

8 

2 

10 

12 

The additional posts of 2013 will be provided through internal re-deployment. The evolution 
of the needs will be assessed in the annual exercice of allocation of ressources. 

EN 

35 

   EN